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	U.S. Attorney General Merrick Garland said that the Justice Department would file an appeal with the U.S. Supreme Court seeking to block the entirety of Kacsmaryk&#39;s order suspending the FDA approval of the abortion pill mifepristone. 


Mifepristone Abortion Pill Access in Limbo: Justice Department May Ask Supreme Court&#39;s Intervention

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	A U.S. federal appeals court has temporarily blocked a decision by a Texas judge to halt the FDA&#39;s approval of a widely used abortion drug.


Women&#39;s Reproductive Rights: US Court Preserves Access To Abortion Pill For Now, But With Tighter Rules

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	New York and California are stockpiling an alternative abortion medication in case a Texas judge&#39;s order suspending the FDA approval of the primary drug, mifepristone, goes into effect later this week.


New York and California Prepare For Potential Mifepristone Ban In Texas With Stockpiling Of Alternative Abortion Medications

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<ul>
<li>U.S. Attorney General Merrick Garland said that the Justice Department would file an appeal with the U.S. Supreme Court seeking to block the entirety of Kacsmaryk&#39;s order suspending the FDA approval of the abortion pill mifepristone.&nbsp;</li>
<li>Garland said the administration &quot;will be seeking emergency relief from the Supreme Court to defend the FDA&#39;s scientific judgment and protect Americans&#39; access to safe and effective reproductive care.&quot;</li>
<li>The New Orleans-based 5th U.S. Circuit Court of Appeals put on hold part of last Friday&#39;s order by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, while he hears a lawsuit by anti-abortion groups seeking to ban it.</li>
<li>The Planned Parenthood Federation of America condemned the 5th Circuit&#39;s decision as a rejection of science and law.</li>
<li>&quot;The federal judiciary has &mdash; for the second time this week &mdash; rejected science and the law, and this time, the court decided they had the authority to re-write mifepristone&#39;s label,&quot; CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/13/abortion-pill-mifepristone-court-keeps-it-on-market-blocks-mail-delivery.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;citing Alexis McGill Johnson, president of Planned Parenthood.&nbsp;</li>
<li>&quot;If allowed to stand, the consequences of this decision will be catastrophic not just for medication abortion access but the entire drug approval system,&quot; he added.</li>
<li>A U.S. federal appeals court has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31784287/womens-reproductive-rights-us-court-preserves-access-to-abortion-pill-for-now-but-with-tighter-ru" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">temporarily blocked</a>&nbsp;a decision by a Texas judge.&nbsp;</li>
<li>The abortion pill mifepristone will remain available in the U.S. for now but with some restrictions, including requiring in-person doctor visits to obtain the drug and limiting its use to the first seven weeks of pregnancy from the current ten, a federal appeals court ruled.</li>
</ul>

Mifepristone Abortion Pill Access in Limbo: Justice Department May Ask Supreme Court's Intervention

<ul>
<li>A U.S. federal appeals court has temporarily blocked a decision by a Texas judge to halt the FDA&#39;s approval of a widely used abortion drug.</li>
<li>The abortion pill mifepristone will remain available in the U.S. for now but with some restrictions, including requiring in-person doctor visits to obtain the drug and limiting its use to the first seven weeks of pregnancy from the current ten, a federal appeals court ruled.</li>
<li>Related Content:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31766180/new-york-and-california-prepare-for-potential-mifepristone-ban-in-texas-with-stockpiling-of-alter" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">New York and California Prepare For Potential Mifepristone Ban In Texas With Stockpiling Of Alternative Abortion Medications</a>.</li>
<li>In his last week ruling, Texas Judge Matthew Kacsmaryk ordered pulling mifepristone from the market in seven days, saying the FDA had violated federal rules that allowed for the accelerated approval of some drugs.&nbsp;</li>
<li>The order was set to take effect on Friday.</li>
<li>The Biden administration, the anti-abortion groups, or both could also seek to appeal immediately to the U.S. Supreme Court,&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/legal/us-appeals-court-preserves-limited-approval-abortion-pill-2023-04-13/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Reuters</a>&nbsp;reported.</li>
<li>Wednesday&#39;s ruling came from a panel of three 5th Circuit judges, two appointed by then-President Donald Trump and one by George W. Bush, both Republicans, Reuters added.</li>
<li>Judge Catharina Haynes, the Bush appointee, partly dissented, saying she would have temporarily blocked Kacsmaryk&#39;s order entirely.</li>
<li>The emergency stay is meant to remain in place until the 5th Circuit can hear the Biden administration&#39;s appeal of Kacsmaryk&#39;s order more fully.&nbsp;</li>
<li>It was first approved for the termination of pregnancy up until seven weeks gestation.</li>
<li>The 2016 changes, among other things, reduced the number of in-person visits that patients must make from three to one and allowed the pills to be prescribed to women at up to 10 weeks gestation instead of up to seven weeks.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

Women's Reproductive Rights: US Court Preserves Access To Abortion Pill For Now, But With Tighter Rules

<ul>
<li>New York and California are stockpiling an alternative abortion medication in case a Texas judge&#39;s order suspending the FDA approval of the primary drug, mifepristone, goes into effect later this week.</li>
<li>The alternative option, misoprostol, is FDA-approved to treat gastric ulcers,&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/abortion-pill-ruling-new-york-california-stockpile-misoprostol.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">noted</a>&nbsp;CNBC. But the use of misoprostol alone to induce abortions is endorsed by the World Health Organization and is used in countries where mifepristone is unavailable.</li>
<li>Also Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31752497/attorney-generals-of-over-20-states-sound-alarm-over-suspension-of-abortion-med-approval-devastat" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Attorney Generals of Over 20 States Sound Alarm Over Suspension Of Abortion Med Approval: &quot;Devastating Risks&quot; Ahead</a>.</li>
<li>It will remain on the market if U.S. District Judge Matthew Kacsmaryk&#39;s order suspending mifepristone takes effect this week Saturday.</li>
<li>More than half of abortions in the U.S. use a combination of mifepristone and misoprostol.</li>
<li>Some U.S. abortion providers are prepared to offer misoprostol as a stand-alone treatment, CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/alternative-abortion-pill-could-be-used-if-the-mifepristone-ban-is-upheld.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;citing Jenny Ma, senior staff attorney at the Center for Reproductive Rights, a legal advocacy group representing abortion providers worldwide. Ma also said that other providers might not be ready to switch to a misoprostol-only regimen.</li>
<li>New York Gov. Kathy Hochul ordered the state health department to purchase 150,000 doses of misoprostol, a five-year pill supply. Hochul&#39;s announcement comes a day after Gov. Gavin Newsom said California has secured 2 million misoprostol pills.</li>
<li>Hochul said she is working with New York&#39;s legislature to require private insurers to cover misoprostol when prescribed off-label for abortions.</li>
<li>The Justice Department and Danco Laboratories, the distributor of mifepristone, have asked the U.S. 5th Circuit Court of Appeals to block Kacsmaryk&#39;s ruling by noon Thursday.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

<ul>
<li>In a new court filing, the Democratic attorneys general for 23 U.S. states have reportedly warned that a federal judge&#39;s decision to suspend the FDA&#39;s approval of mifepristone &quot;presents devastating risks to millions of people,&quot; including those in states where abortion remains legal.</li>
<li>The attorneys general, in their filing, called on the U.S. 5th Circuit Court of Appeals to keep mifepristone on the market.</li>
<li>Last week Friday, a U.S. judge suspended the FDA&#39;s approval of mifepristone, an abortion pill to&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">terminate</a>&nbsp;a pregnancy through ten weeks gestation.</li>
<li>But he put his decision on hold for one week to give the Biden administration time to appeal.</li>
<li>Also Read -&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/04/31739346/drugmakers-stand-up-for-reproductive-rights-pfizer-and-biogen-among-300-condemning-abortion-pill-" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Drugmakers Stand Up for Reproductive Rights: Pfizer and Biogen Among 300 Condemning Abortion Pill Approval Suspension</a>.</li>
<li>Kacsmaryk&#39;s ruling will take effect at 12 a.m. CT on Saturday if the 5th Circuit does not halt it.</li>
<li>Citing the filing, CNBC&nbsp;<a class="editor-rtfLink" href="https://www.cnbc.com/2023/04/11/abortion-texas-mifepristone-ruling-order-threatens-access.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;that attorneys general and the District of Columbia condemned Kacsmaryk&#39;s ruling as &quot;legally erroneous&quot; and warned it would undermine the FDA&#39;s approval process.</li>
<li>The attorneys general argued that Kacsmaryk&#39;s order would &quot;eviscerate the sovereign decisions&quot; made by the states to protect access to abortion when last year, the Supreme Court&#39;s decision overturned Roe v. Wade, which said there was a federal constitutional right to abortion.</li>
<li>Kacsmaryk&#39;s decision does not affect the availability of misoprostol, which the World Health Organization recommends as a standalone abortion drug.</li>
<li>States such as California are stockpiling misoprostol if Kacsmaryk&#39;s decision goes into effect.</li>
<li>Photo via Wikimedia Commons</li>
</ul>

Large Cap

Attorney Generals of Over 20 States Sound Alarm Over Suspension Of Abortion Med Approval: "Devastating Risks" Ahead

<ul>
<li>Today, the FDA announced the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/04/n31699749/fda-commissioner-and-chief-scientist-announce-decision-to-withdraw-approval-of-makena" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">final decision to withdraw</a>&nbsp;approval of Privately held-Covis Pharma&#39;s&nbsp;Makena (hydroxyprogesterone caproate injection), a drug approved under the accelerated approval pathway to reduce the risk of preterm birth.&nbsp;</li>
<li>The decision was issued jointly by the FDA Commissioner and Chief Scientist.&nbsp;</li>
<li>Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed.</li>
<li>The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit.&nbsp;</li>
<li>The agency&#39;s approval required the sponsor to conduct a post-marketing confirmatory study.&nbsp;</li>
<li>The confirmatory study did not verify clinical benefit, and the FDA&#39;s Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug&#39;s approval in 2020.&nbsp;</li>
<li>The sponsor requested a hearing, which was held in&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31252820/covis-pharma-to-withdraw-only-fda-approved-treatment-to-prevent-preterm-births" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">October 2022</a>.</li>
<li>In October, the FDA&#39;s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/10/29337799/citing-ineffectiveness-fda-panel-recommends-taking-down-famed-preterm-birth-drug-from-market" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">study failed to show that it was effective</a>.&nbsp;</li>
<li>Wall Street Journal&nbsp;<a class="editor-rtfLink" href="https://www.wsj.com/articles/fda-forces-the-only-drug-for-preterm-births-to-leave-market-a0e92b24?mod=latest_headlines" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">writes</a>&nbsp;that Makena has possible side effects, including blood clots, depression, and allergic reactions.&nbsp;</li>
<li>Covis said previously that the drug has a strong safety record and that adverse events are rare, but the FDA has said some evidence suggests there may be long-term risks that aren&#39;t yet well understood.</li>
</ul>

FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits

<ul>
<li>U.S. District Judge Matthew Kacsmaryk questioned President Joe Biden&#39;s administration lawyers on whether the federal regulatory approval of the abortion pill mifepristone was proper.</li>
<li>The judge is reportedly considering a request by anti-abortion groups to ban sales of the drug nationwide.</li>
<li>The judge raised the possibility of keeping the drug on the market but re-imposing some restrictions lifted by Biden&#39;s administration, including requiring it to be dispensed in person rather than by mail.&nbsp;</li>
<li>Kacsmaryk said he would rule &quot;as soon as possible.&quot;</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/government/23/03/31297156/new-york-governor-attorney-general-ask-three-pharmacy-operators-commitment-over-abortion-drug-access" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">New York Governor, Attorney General Ask Three Pharmacy Operators&#39; Commitment Over Abortion Drug Access</a>.</li>
<li>The anti-abortion groups sued the FDA in November, accusing the agency followed an improper process to approve mifepristone in 2000. It did not adequately consider the drug&#39;s safety when used by girls under 18.</li>
<li>The plaintiffs are asking Kacsmaryk for a preliminary order halting sales of mifepristone nationwide - even in states where abortion is legal - while their lawsuit proceeds.</li>
<li>Lawyers for the U.S. Justice Department and an attorney for mifepristone&#39;s manufacturer, Danco Laboratories, argued that the plaintiffs had no standing and that mifepristone has an impressive safety and efficacy record,&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/legal/texas-judge-consider-banning-abortion-pill-us-2023-03-15/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Reuters</a>&nbsp;reported.</li>
<li>Major medical organizations have weighed in on the side of the FDA, saying mifepristone &quot;has been thoroughly studied and is conclusively safe.&quot;</li>
<li>Photo via Wikimedia Commons</li>
</ul>

Regulations

US Judge Weighs Nationwide Ban On Abortion Pills

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/news-events/press-announcements/fda-takes-action-restrict-unlawful-import-xylazine" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA issued</a>&nbsp;an &quot;import alert&quot; about the animal tranquilizer xylazine, also called &quot;tranq,&quot; &quot;tranq dope,&quot; and &quot;zombie drug.&quot;&nbsp;</li>
<li>The notice allows agents to seize shipments of xylazine and &quot;unapproved finished drug products&quot; containing it without physically examining the shipments.&nbsp;</li>
<li>The FDA said it will scrutinize incoming xylazine shipments to ensure they are &quot;properly labeled, not adulterated, and for legitimate veterinary use.&quot;&nbsp;</li>
<li>Xylazine, a tranquilizer used on large animals, is not approved for human consumption in the U.S., but so far, tranq dope has reportedly spread to at least 39 states, Washington D.C., and Puerto Rico.&nbsp;</li>
<li>Xylazine can depress breathing, blood pressure, heart rate, and body temperature to critical levels.&nbsp;</li>
<li>Additionally, people who inject drugs containing xylazine can develop severe skin wounds and patches of dead and rotting tissue that easily become infected.</li>
<li>These wounds can develop in areas of the body away from the injection site.</li>
<li>The chemical xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs and has increasingly been detected in overdose deaths.</li>
<li>Xylazine is not an opioid, and it&#39;s often mixed with other drugs.</li>
<li>It has been identified as a contaminant found in combination with opioids such as illicit fentanyl and other illicit products that contain stimulants such as methamphetamine and cocaine.&nbsp;</li>
<li>Xylazine is typically sold as a liquid when used for veterinary purposes.&nbsp;</li>
<li>However, according to some reports, several online vendors sell powder forms of xylazine. One China-based seller reportedly said xylazine had become a &quot;hot&quot; product among Americans in 2021.</li>
<li>An October Drug Enforcement Administration&nbsp;<a class="editor-rtfLink" href="https://www.dea.gov/sites/default/files/2022-12/The%20Growing%20Threat%20of%20Xylazine%20and%20its%20Mixture%20with%20Illicit%20Drugs.pdf" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">report</a>&nbsp;found that a kilogram of xylazine powder can be bought from Chinese suppliers from $6-$20 per kilogram.&nbsp;</li>
<li>People who use illicit drugs may not be aware of the presence of xylazine.</li>
<li>Photo by Diamond Rehab Thailand via Pixaby</li>
</ul>

FDA Takes Action To Restrict Unlawful Import Of Animal Tranquilizer 'Tranq' Or ''Zombie Drug'

The coronavirus pandemic that began in 2020 and is persisting today has led many investors to hold poor market expectations. But maybe they shouldn&rsquo;t be so pessimistic.
What Happened: That&rsquo;s according to a new RSM report stating the U.S. economy grew by over 6% in the second quarter of 2021, making the start of a&nbsp;business cycle as good as things were prior to the pandemic&rsquo;s onset.
In fact, this last quarter&rsquo;s growth is the best second-quarter growth recorded since 1983.
&ldquo;The composition of growth in the second quarter of the year was nothing short of virtuous,&rdquo; RSM economist Joe Brusuelas wrote in the report.
Technological innovations will begin to be enacted in various industries as the pandemic recedes, and bottleneck issues will generally fade, he said.&nbsp;
&ldquo;[I] would not be surprised at all to see jumps in productivity across medical services, which has long been a target of potential digital disruption,&rdquo; he wrote in an email to Benzinga.
Why It Matters: Several biotechnology and health care funds have&nbsp;made gains Thursday, including ARK Innovation ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arkk#NASDAQ">ARKK</a>), ARK Genomic Revolution (BATS: <a class="ticker" href="https://www.benzinga.com/stock/arkg#BATS">ARKG</a>) and First Trust Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>).

Economics

ARKG

ARKK

Q2 Growth 'Nothing Short Of Virtuous': Economist

For the first time in 18 years, there was a new treatment for Alzheimer&rsquo;s Disease approved by the FDA.
Aducanumab from Biogen Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/biib#NASDAQ">BIIB</a>) was <a href="https://www.benzinga.com/general/biotech/21/06/21455132/biogen-gets-fda-nod-for-controversial-alzheimers-drug-first-treatment-approval-for-the-disease-in">approved </a>as a drug that can reduce the clinical decline of dementia. The FDA concluded using Aduhelm (the marketing name of Aducanumab) for Alzheimer&rsquo;s patients outweighs the risk of therapy.
The result saw Biogen shares halted for hours Monday before reopening for trade at $449, significantly above the 52-week high of $363.92. Investors sent shares of ETFs with Biogen up higher prior to shares of Biogen resuming trade.
Here is a look at five ETFs with large exposure to Biogen shares (data as of June 4 from <a href="https://etfdb.com/stock/BIIB/">ETFdb.com</a> and the company&rsquo;s websites).
Invesco Dynamic Biotechnology &amp; Genome ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pbe#NYSE">PBE</a>): +5.1%
The <a href="https://www.invesco.com/us/financial-products/etfs/product-detail?audienceType=Investor&amp;ticker=PBE">Invesco Dynamic Biotechnology &amp; Genome ETF</a> follows the Dynamic Biotech &amp; Genome index, investing at least 90% of assets in securities found in the index. The index includes 30 companies in the sector. The ETF rebalances quarterly in February, May, August and November.
Biogen is the second largest weighted stock in the PBE ETF at 5.23% of assets. Eight of the 31 holdings in the ETF have a weighting of 4.8% or more including Illumina Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ilmn#NASDAQ">ILMN</a>), Gilead Sciences (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gild#NASDAQ">GILD</a>), Bio-Techne (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tech#NASDAQ">TECH</a>), Alexion Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alxn#NASDAQ">ALXN</a>), Amgen Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>), Catalent Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ctlt#NYSE">CTLT</a>) and Qiagen (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>).
VanEck Vectors Biotech ETF: (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NASDAQ">BBH</a>): +4.6%
The VanEck Vectors Biotech ETF <a href="https://www.vaneck.com/us/en/investments/biotech-etf-bbh/">follows</a> the MVIS Us Listed Biotech 25 Index, which tracks the performance of companies involved in genetic analysis and diagnostics equipment.
Biogen is the eighth largest holding in the ETF at 4.8% of assets. The ETF&rsquo;s top holdings are Amgen, Moderna Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) and BioNTech (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>) at 9%, 7.2% and 5.8% of assets respectively.
Related Link: <a href="https://www.benzinga.com/analyst-ratings/21/05/21178928/where-biogen-stands-with-analysts">Where Biogen Stands With Analysts</a>
Invesco BuyBack Achievers ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pkw#NASDAQ">PKW</a>): +2%
Along with several biotechnology sector ETFs, the<a href="https://www.invesco.com/us/financial-products/etfs/product-detail?audienceType=Investor&amp;ticker=PKW"> Invesco BuyBack Achievers ETF</a> was up on news from Biogen&rsquo;s approval. The ETF, which has 109 holdings, is based on the Nasdaq US BuyBack Achievers Index. The Index tracks companies that have a net reduction in shares outstanding of 5% or more over the last trailing twelve months. The ETF is rebalanced quarterly in January, April, July and October.
Biogen is the fifth largest holding in the ETF at 3.5% of assets and the top held health care stock in the fund. Top holdings in the ETF include Oracle Corp (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/orcl#NYSE">ORCL</a>), Charter Communications (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/chtr#NASDAQ">CHTR</a>), eBay Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ebay#NASDAQ">EBAY</a>) and Allstate Corp (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/all#NYSE">ALL</a>).
First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>): +4.3%
The First Trust NYSE Arca Biotechnology Index Fund <a href="https://www.ftportfolios.com/Retail/etf/etfsummary.aspx?Ticker=FBT">tracks </a>an index of 30 holdings that cover several areas of the sector. The ETF has 30 holdings and due to the equal weighting the top 10 holdings represent 3.5% to 4.0% of assets.
Biogen is the eighth largest holdings at 3.5% of assets. The fund rebalances in January, April, July and October to get components to equal weighting.
iShares Nasdaq Biotechnology ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ibb#NASDAQ">IBB</a>): +4.4%
With $10.1 billion assets under management, the<a href="https://www.ishares.com/us/products/239699/ishares-nasdaq-biotechnology-etf"> iShares Nasdaq Biotechnology ETF</a> is one of the largest in the sector and could have a great impact from the Biogen news. The ETF has 277 holdings and tracks an index that covers companies listed on the Nasdaq in both the biotechnology and pharmaceutical fields.
Biogen represents 3.5% of assets and is the seventh largest holding. Top holdings in the ETF are Amgen, Gilead and Moderna at weightings of 8.7%, 7.1% and 6.9%, respectively.
Price Action: Shares of Biogen are up 42% to $405 at the time of writing.&nbsp;

Sector ETFs

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ALXN

AMGN

BNTX

CHTR

CTLT

EBAY

GILD

ILMN

MRNA

ORCL

QGEN

TECH

5 Top ETFs With Exposure To Biogen

The biotechnology space is always fertile territory for mergers and acquisitions, and that theme was on display over the weekend when AstraZeneca (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/azn#NYSE">AZN</a>) <a href="https://www.benzinga.com/general/biotech/20/12/18763050/astrazeneca-to-buy-rare-disease-specialist-drugmaker-alexion-for-39-billion">announced a $39-billion takeover</a> of&nbsp;Alexion Pharmaceuticals (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alxn#NASDAQ">ALXN</a>).
U.K.-based AstraZeneca, which is one of the prime players in the COVID-19 vaccine race, is valuing Alexion at $175 per&nbsp;share in this year&#39;s biggest pharmaceuticals takeover.
&ldquo;Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology. We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients,&rdquo; AstraZeneca CEO Pascal Soriot said&nbsp;<a href="https://finance.yahoo.com/news/astrazeneca-acquire-alexion-accelerating-companys-124800374.html">in a release</a>.
As of the Dec. 11 close, Alexion had a market value of just over $26 billion, meaning it&#39;s a decent-sized player in a variety of <a href="https://www.benzinga.com/trading-ideas/long-ideas/20/12/18764597/new-etf-from-adasina-social-capital-gets-to-heart-of-social-justice-investing">exchange traded funds</a>. Here are a few &ldquo;Alexion ETFs&rdquo; that could be in for a big day&nbsp;Monday.
Invesco Dynamic Biotechnology &amp; Genome ETF (PBE)
The Invesco Dynamic Biotechnology &amp; Genome ETF (NYSEARCA: PBE) <a href="https://www.invesco.com/us/financial-products/etfs/product-detail?productId=ETF-PBE">has a 4.55% weight</a> to Alexion as of Dec. 11, putting the fund in the upper tiers of ETFs in terms of weight to Astra&#39;s new target. That makes Alexion PBE&#39;s eighth-largest holding.
The $250.5-million PBE, which is 15.5 years old, holds 30 stocks with an average market capitalization of $25.23 billion, meaning there are other credible takeover targets in this ETF.
PBE tracks the Dynamic Biotech &amp; Genome Intellidex Index, which is &ldquo;based on a variety of investment merit criteria, including price momentum, earnings momentum, quality, management action, and value,&rdquo; according to Invesco.
VanEck Biotech ETF (BBH)
The VanEck Biotech ETF (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bbh#NASDAQ">BBH</a>) has a 4.71% Alexion weight as of Dec. 11, making the stock the fund&#39;s fifth-largest holding. That&#39;s decent Alexion exposure among ETFs, but the tails that wag the BBH dog are Amgen (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amgn#NASDAQ">AMGN</a>) and Moderna (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>), which combine for 24.42% of the fund&#39;s weight.
Along with Moderna, BBH has some other coronavirus vaccine exposure, helping the fund to a year-to-date gain of almost 23%. In other words, the Alexion takeover news is just gravy for BBH.
First Trust NYSE Arca Biotechnology Index Fund (FBT)
The First Trust NYSE Arca Biotechnology Index Fund (NYSEARCA: FBT) allocates just over 3% of its weight to Alexion, putting it third by that metric behind the aforementioned PBE and BBH.
FBT is home to 30 stocks. Moving beyond the Alexion news, a case can be made that up to half of FBT holdings are legitimate takeover targets and probably 10%, or slightly more, of the fund&#39;s components are realistic buyers.

Long Ideas

Pre-Market Outlook

3 ETFs For AstraZeneca's $39B Alexion Pharmaceuticals Takeover

Biotechnology exchange-traded funds were hot until they weren&#39;t. History indicates recent weakness in the previously high-flying group be a symptom of election year jitters and investors shouldn&#39;t ignore these funds for too long.
Take the case of the First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>).
What Happened: FBT, one of the largest funds in this category, flirted with $181 in mid-July. On Tuesday, it closed just under $151.
&ldquo;However, since peaking on July 20th, the NYSE Arca Biotechnology Index has declined by 12.7%, while the S&amp;P 500 Index has advanced by 8.7% (through 9/1/20),&rdquo; said First Trust Senior Vice President Ryan Issakanien <a href="https://www.ftportfolios.com/Commentary/Insights/2020/9/4/how-have-presidential-elections-impacted-biotechnology-stocks">in a recent note</a>.
&ldquo;While there are many possible explanations for biotech&rsquo;s recent underperformance, I believe one important factor is the upcoming presidential election. Rising health care costs in the U.S. have been a go-to wedge issue for Democratic party candidates in election campaigns, especially over the past two decades (Affordable Care Act passed in 2010). But if history repeats, this pullback may represent an attractive buying opportunity.&rdquo;
Why It&#39;s Important: FBT and its peers <a href="https://www.benzinga.com/general/biotech/20/09/17402721/this-baby-biotech-etf-has-big-potential">were bid higher this year</a> due in large part to the coronavirus pandemic. While that&#39;s a credible catalyst, investors need to prepare for life when COVID-19 is defeated.
That could include streamlined regulatory approvals and more consolidation, depending upon the outcome Election Day.
For those considering FBT today, it&#39;s worth noting that over the past four presidential election cycles, the only time the ETF&#39;s underlying index traded higher two months before Election Day was in 2004. Two months after those elections, FBT&#39;s benchmark was higher in three of those four years with 2008 being the exception.
What&#39;s Next: &quot;During the last four presidential elections (2004, 2008, 2012&nbsp;and 2016), biotechnology stocks performed poorly heading into election day. On average, the NYSE Arca Biotechnology Index had a -6.4% return during the prior 2 months,&rdquo; according to First Trust. &ldquo;However, biotech stocks also rebounded nicely following these elections, regardless of which candidate was elected. While Democratic and Republican presidential candidates split these four elections evenly, the average return 2 months after election day was 4.9%, and the average return 12 months after election day was 34.6%.&rdquo;
As for what&#39;s next, investors are likely hoping history repeats because FBT&#39;s index traded higher by deep double-digit margins a year after each of the past four presidential elections.

Politics

Election History Says Buy Biotech Dip

These days, it&#39;s not hard to find winners among health care exchange-traded funds and that&#39;s true of both <a href="https://www.benzinga.com/general/biotech/20/08/16935750/hey-junior-new-biotech-etf-goes-small-in-search-of-big-winners">established and rookie players</a>.
What Happened: Obviously, the primary catalyst driving many health care ETFs this year, <a href="https://www.benzinga.com/general/biotech/20/08/16911373/labu-snaps-back-after-rough-end-to-july">particularly biotechnology</a> and pharmaceutical funds, is the fight against the coronavirus. Still, investors evaluating biotech ETFs today need to ensure the funds they&#39;re considering will be viable in a post-pandemic world.
The First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>), one of the largest biotech ETFs by assets, is an example of a fund from this category that is viable today and should continue delivering for investors after COVID-19 is defeated.
Why It&#39;s Important:&nbsp;Up 10.64% year to date, the $2.18 billion FBT follows the NYSE Arca Biotechnology Index. Relative to some rivals, the fund&#39;s performance this year is subdued because Moderna (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>) isn&#39;t among its 30 holdings and its overall coronavirus exposure is low. However, that doesn&#39;t diminish the long-term thesis for the fund.
&ldquo;The COVID-19 crisis has further stimulated improvements in regulatory efficiency, representing one of the most important long-term consequences of the crisis for biotechnology companies, in our view,&rdquo; <a href="https://www.ftportfolios.com/Commentary/Insights/2020/6/12/the-post-pandemic-opportunity-for-biotech">said First Trust in a recent note</a>. &ldquo;The urgency of the crisis forced regulators to reevaluate potentially outdated methods and consider new ways to streamline clinical trials. In the years ahead, these adaptations may enable biotechnology and other health care companies to bring new products to market more quickly, improving outcomes for both patients and shareholders.&rdquo;
That&#39;s good news for FBT because while the ETF isn&#39;t the most direct play on COVID-19 testing and vaccine development, many of its member firms have robust pipelines and are working innovative therapies that could benefit patients and investors.
What&#39;s Next: Consolidation is often a credible consideration when evaluating biotech ETFs and the pandemic is cementing that notion.
&ldquo;Over the past several months, numerous companies have entered into new partnerships, seeking to accelerate innovation and leverage one another&rsquo;s strengths,&rdquo; according to First Trust. &quot;As they discover the benefits of these synergies, some may choose to make them more permanent via mergers &amp; acquisitions. While near-term liquidity needs could delay certain deals from being proposed, several large health care companies have ample cash to consider such transactions, in our opinion. The ten largest pharmaceutical and biotech companies in the S&amp;P 500 held an average of $10.7 billion in cash on their balance sheets, as of 6/9/20.&rdquo;
That&#39;s another positive for FBT because plenty of its components are qualified buyers and plenty are legitimate targets.

Post-Pandemic Stars Could Align For This Biotech ETF

Due to the coronavirus outbreak, a slew of companies are making negative earnings revisions and the carnage isn&#39;t limited to withdrawn guidance by some big name technology companies.
Some exchange traded funds have large concentrations of components that are making downward revisions. For example, the Amplify Advanced Battery Metals and Materials ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/batt#NYSE">BATT</a>) downbeat earnings revision tally is close to 48%, <a href="https://www.etfrc.com/index.php">according to the ETF Research Center</a>.
&ldquo;Estimate revisions are an important metric we monitor because they tell us how the analysts who follow companies the closest are changing their thinking,&rdquo; says ETFRC. &ldquo;Analysts being an optimistic bunch, they tend to overestimate a company&#39;s earnings at the start of each year, so negative estimate revisions as the year progresses are normal and widespread.&rdquo;
Here are three other ETFs chock full of negative earnings guidance.
See Also: <a href="https://www.benzinga.com/trading-ideas/long-ideas/20/02/15418441/3-safe-etfs-if-a-stock-market-correction-comes-calling">3 Safe Harbor ETFs</a>
<h3>First Trust NYSE Arca Biotechnology Index Fund (FBT)</h3>
Investors thinking the coronavirus would be a salve for biotechnology stocks and ETFs have learned a hard lesson and the First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fbt#NYSE">FBT</a>) has proved as much. FBT, one of the largest biotech ETFs, is lower by almost 6% over the past week, far worse than 4.15% shed by the NASDAQ Biotechnology Index over the same period.
The negative earnings revision tally for FBT is 35%, second only to BATT.
<h3>Invesco Dynamic Energy Exploration &amp; Production ETF (PXE)</h3>
The only thing surprising about the inclusion of the Invesco Dynamic Energy Exploration &amp; Production ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pxe#NYSE">PXE</a>) on this list is that there are several ETFs in between it and the worst spot. The downbeat earnings revision tally for the moribund PXE is 17.2%, according to ETFRC.
The fund is down 17.73% over the past week and almost 35% year-to-date and entered Thursday 47.2% below its 52-week high. As <a href="https://finviz.com/quote.ashx?t=PXE&amp;ty=c&amp;ta=1&amp;p=d">the chart indicates</a>, PXE is in a death spiral.
<h3>First Trust Natural Gas ETF (FCG)</h3>
Death spiral part II with the First Trust Natural Gas ETF (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/fcg#NYSE">FCG</a>), which is to say don&#39;t be fooled by the 4.34% yield on this fund. If the 14.4% negative earnings revisions doesn&#39;t scare an investor away, the 35% year-to-date decline should.
Following FCG&#39;s close at $7.83 on Wednesday, further losses from here make a reverse split a very real possibility.

Earnings

Short Ideas

Commodities

BATT

First Trust ISE-Revere Natural Gas Index Fund

PowerShares ETF Trust Dynamic Energy Exploration & Production Port

3 ETFs Chock Full Of Companies With Negative Earnings Revisions

So far, it&#39;s been a good year for biotech stocks with the Nasdaq Biotechnology Index soaring 19.6% year to date. This is in sharp contrast to last year&#39;s performance when the Index was down 19.1% with several factors including the drug pricing controversy weighing on the sector.
2016 was disappointing from an R&amp;D perspective as well with a fewer number of drugs managing to gain FDA approval and quite a few companies suffering from high-profile pipeline failures. Mixed results, slower-than-expected new product launches and increasing competition were some of the other challenges for the sector. &nbsp;(Read: <a href="https://www.zacks.com/stock/news/282691/time-to-buy-global-low-volatility-etfs">Time to Buy Global Low Volatility ETFs?</a>)
However, ramp up in new product sales, R&amp;D success and innovation, strong results, a higher number of FDA approvals and continued strong performance from key products are some of the factors that have helped the sector recover this year. Moreover, investors now seem more comfortable with the drug pricing scenario and are focusing more on the fundamentals of the sector.
Increasing Threat from Biosimilars
Although biosimilars are yet to pick pace, they remain a major threat for biotech stocks specially companies that are set to lose patent protection for major blockbuster drugs in the next few years. While a relatively new area, the market for biosimilars is huge and highly lucrative with several blockbuster biologics including Humira and Lantus slated to lose patent protection by 2020. Biosimilars are expected to reduce healthcare costs and provide a large number of patients with access to much needed biologic treatments. Biosimilars are also gaining acceptance across formularies.
According to information provided by Express Scripts, about $250 billion could be saved in the next decade (2014 &ndash; 2024) if biosimilars for 11 products including Neupogen, Avastin, Epogen, Humira, Neulasta, Remicade and Rituxan are approved. According to the company, Neupogen and Remicade biosimilars alone represent potential savings of more than $22 billion.
Mergers and Acquisitions (M&amp;As) Yet to Pick Pace
Although expectations were high that M&amp;A activity would pick up in 2017, this did not happen. While several small deals were announced, big-ticket M&amp;A activity was more or less limited with major acquisition news including Johnson &amp; Johnson&#39;s&nbsp;$30 billion acquisition of Actelion and&nbsp;Gilead&#39;s&nbsp;$11.9 billion acquisition of Kite. (Read: <a href="https://www.zacks.com/stock/news/281883/7-topranked-tech-etfs-on-unstoppable-rally">7 Top-Ranked Tech ETFs on Unstoppable Rally</a>)
The sector will receive an additional boost if more M&amp;A deals are announced, though companies are likely to adopt a &quot;wait and see&quot; stance as they await more clarity on the drug pricing situation and tax reforms. Another major deterrent could be high valuations with companies remaining wary of bidding wars leading to over-priced deals.
Higher Number of Drugs Approved So Far in 2017
So far in 2017, the FDA has granted approval to 34 novel drugs, surpassing last year&#39;s total tally of 22. Key approvals in the biotech sector this year include Gilead&#39;s Yescarta (CAR-T therapy for certain types of large B-cell lymphoma) and Vosevi (hepatitis C virus), Puma&#39;s Nerlynx (to reduce the risk of breast cancer returning), Regeneron/Sanofi&#39;s Kevzara (rheumatoid arthritis) and eczema treatment, Dupixent, TESARO&#39;s PARP inhibitor, Zejula and BioMarin&#39;s Brineura (treatment of a specific form of Batten disease) among others. Quite a few of these drugs have blockbuster potential.
The FDA is working on streamlining the development process for drugs for rare diseases as well as for targeted cancer therapies. The agency is also working on clearing up a backlog of orphan drug applications. (Read: <a href="https://www.zacks.com/stock/news/282424/top-ranked-tech-etfs-for-long-term-investors">Top Ranked Tech ETFs for Long Term Investors</a>)
Innovative Pipelines &amp; Catalysts
Biotech companies continue to work on bringing innovative new treatments to market, and there could be significant catalysts in the coming quarters in the form of important new product approvals as well as major data read-outs especially in key therapeutic areas like immuno-oncology, Alzheimer&#39;s, central nervous system disorders, and immunology/inflammation.
ETFs in Focus
Highlighted below are some biotech ETFs -- ETFs present a low-cost and convenient way to get a diversified exposure to the sector.
iShares Nasdaq Biotechnology&nbsp;(IBB)&nbsp;&nbsp;
IBB, launched in February 2001 by BlackRock Investments LLC, tracks the Nasdaq Biotechnology Index. The fund mainly covers biotech stocks (81.9%) with pharma accounting for 9.3%. The top 3 holdings include Amgen (8.4%), Biogen Inc. (8.28%) and Gilead Sciences, Inc. (7.85%). The total assets of the fund as of Oct 30, 2017 were $9.65 billion representing 159 holdings. The fund&#39;s expense ratio is 0.47% while dividend yield is 0.22%. The trading volume is roughly 1,268,319 shares per day.
SPDR S&amp;P Biotech ETF&nbsp;(XBI)
XBI, launched in January 2006 by State Street Global Advisors, tracks the S&amp;P Biotechnology Select Industry Index. The fund covers health care stocks only. Key holdings include Juno Therapeutics, Inc. (2.61%), Sarepta Therapeutics (2.51%), and Exelixis, Inc. (2.42%). The total assets of the fund as of Oct 30, 2017 were $4 billion representing 102 holdings. The fund&#39;s expense ratio is 0.35% while dividend yield is 0.22%. The trading volume is roughly 4,782,719 shares per day.
First Trust NYSE Arca Biotech ETF&nbsp;(FBT)
FBT, launched in June 2006 by First Trust Advisors, tracks the NYSE Arca Biotechnology Index. The top 3 holdings include Alnylam Pharmaceuticals, Inc. (3.68%), Juno Therapeutics, Inc. (3.64%), and Neurocrine&nbsp;Biosciences, Inc. (3.61%). The total assets of the fund as of Oct 27, 2017 were $1.2 billion representing 30 holdings. The fund&#39;s expense ratio is 0.56% while dividend yield is nil. The trading volume is roughly 33,108 shares per day.
VanEck Vectors Biotech ETF&nbsp;(ETF:BBH)
BBH, launched in December 2011 by Van Eck, tracks the Market Vectors US Listed Biotech 25 Index. The fund covers health care stocks. The top 3 holdings include Amgen (11.62%), Celgene Corporation (11.26%) and Gilead Sciences Inc. (11.18%). The total assets of the fund as of Oct 30, 2017 were $668.8 million representing 25 holdings. The fund&#39;s expense ratio is 0.35% while dividend yield is 0.2%. The trading volume is roughly 43,186 shares per day.
PowerShares Dynamic Biotech &amp; Genome ETF&nbsp;(PBE)
PBE, launched in June 2005 by Invesco PowerShares, tracks the Dynamic Biotech &amp; Genome Intellidex Index. The top 3 holdings include Illumina, Inc. (5.31%), Biogen (5.29%), and Gilead Sciences, Inc. (5.11%). The total assets of the fund as of Oct 30, 2017 were $237 million representing 31 holdings. The fund&#39;s expense ratio is 0.58% while dividend yield is 0.84%. The trading volume is roughly 13,247 shares per day.
Conclusion
Although the sector may face some volatility due to the drug pricing issue, pipeline success in innovative and important therapeutic areas, cost-cutting, share buybacks, new products, increased pipeline visibility and appropriate utilization of cash should help maintain investor confidence in this sector.&nbsp;
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Biotech ETFs: What Lies Ahead?

With the <a href="https://www.benzinga.com/trading-ideas/long-ideas/16/10/8590026/this-catalyst-could-reinvigorate-low-volatility-etfs">low volatility, quality and value</a> investment factors outperforming this year, it might be logical to assume momentum is struggling.
<h3>FV: Gauging The Momentum Factor</h3>
If the once beloved First Trust Exchange Traded Fund VI (NASDAQ: <a class="ticker" href="/stock/fv#NASDAQ">FV</a>) is an accurate gauge, yes, momentum is struggling. Still, FV&#39;s 3.3 percent year-to-date loss is not staggering and it cannot be ignored that the ETF is up more than 15 percent off its February lows.
Although FV is considered a passively managed ETF, relative strength analysis of its constituent ETFs is conducted weekly, meaning if one (or more) of the holdings tumble enough, they can be removed from FV and replaced with other First Trust sector and industry funds displaying better relative strength traits.
Data suggest FV can outperform the S&amp;P 500, but it potentially does with more volatility.
<h3>A Look Back At FV's 'Wild Ride'</h3>
FV &ldquo;has been on a wild ride since its inception. From March 31, 2014, through Aug. 31, 2016, FV&rsquo;s annualized total return was 8.95 percent, marginally higher than that experienced by Vanguard 500 Index Fund (NYSE: <a class="ticker" href="/stock/voo#NYSE">VOO</a>),&rdquo; said Morningstar <a href="http://beta.morningstar.com/articles/776047/fickle-investors-have-missed-out-on-this-etfs-momentum-strategy.html">in a recent note</a>. &ldquo;However, FV&rsquo;s standard deviation of monthly returns during that span was 14.9 percent, versus just 11.1 percent for VOO. Also, FV&rsquo;s maximum drawdown during the period was 18.7 percent, more than twice that suffered by VOO shareholders (8.4 percent).&rdquo;
Again, FV is a passive ETF that can and does alter its holdings. Some investors can quibble with how the ETF sends its holdings packing and adds new ones. They might have a point. For example, FV dumped the First Trust NYSE Arca Biotchnlgy Indx Fd (NYSE: <a class="ticker" href="/stock/fbt#NYSE">FBT</a>) <a href="http://www.benzinga.com/trading-ideas/long-ideas/16/02/6224696/popular-etf-of-etfs-gets-defensive-after-market-slide">earlier this year </a>in favor of the First Trust Utilities AlphaDEX Fnd (ETF) (NYSE: <a class="ticker" href="/stock/fxu#NYSE">FXU</a>).
FV held onto FBT through a major decline and by sending the ETF packing when it did, FV has missed out on a biotech rebound only to be holding FXU while utilities stocks are giving up big chunks of the gains accrued earlier this year.
FV has been propped by the First Trust DJ Internet Index Fund (ETF)(NYSE: <a class="ticker" href="/stock/fdn#NYSE">FDN</a>), which is FV&#39;s largest holding at over 23 percent of the momentum fund&#39;s weight. FDN, the largest U.S. internet ETF, has recently been making a series of all-time highs.
That has not been enough to keep investors interested as highlighted by the $1.57 billion that has been yanked from FV this year.
&ldquo;While FV returned nearly 9 percent annualized, its investor return over the period in question was actually negative 2.3 percent! While FV kept pace with the S&amp;P 500, the average dollar invested in the fund actually lost money. Momentum strategies have merit, but investors&rsquo; ability to effectively harness this fickle factor correlates directly with their intestinal fortitude,&rdquo; added Morningstar.

Broad U.S. Equity ETFs

Specialty ETFs

First Trust Dow Jones Internet Index Fund

Once Beloved Momentum ETF Loses Its Momo

Drug pricing has been one of the hot topics of the year. As Citron Research&#39;s controversial executive editor Andrew Left <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/09/8496510/andrew-left-on-valeant-eliminating-price-gouging-is-sole">said</a> last month, &ldquo;Regulating the price of pharmaceuticals and eliminating price gouging might be the only issue that Trump and Hillary both agree on.&rdquo;
Conversing with SunTrust Robinson Humphrey Managing Director and Senior Biotechnology Analyst Edward Nash and Associate Biotechnology Analyst Mike Guo, Benzinga had the chance to discuss drug pricing, an issue that goes well beyond Valeant Pharmaceuticals Intl Inc (NYSE: <a class="ticker" href="/stock/vrx#NYSE">VRX</a>), Mylan NV (NASDAQ: <a class="ticker" href="/stock/myl#NASDAQ">MYL</a>) or Martin Shkreli.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/10/8570470/exclusive-suntrust-top-analysts-explain-fatty-liver-dise">Exclusive: SunTrust Top Analysts Explain Fatty Liver Diseases, Galmed&#39;s Potential In The Space</a></bzrelatedlink>
&ldquo;If you look at what we&rsquo;ve seen in the last year-and-a-half or two years, the issues that have popped up around pricing, have always been with older drugs that have been out there for a while, which have been rebranded, or had their patents extended, or just don&rsquo;t have any competition&hellip; and they&rsquo;ve had their prices dramatically increased overnight,&rdquo; Nash explained. So, controversy in these cases is quite easy to understand.
However, the expert added, this is not considered biotech. &ldquo;At some point, that is going to be the low hanging fruit&hellip; and that kind of gouging (if you want to call it that, which in some cases, it is) is where I think we would start to see the first, initial attempts to make some type of pricing changes there.&rdquo;
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/analyst-ratings/analyst-color/16/10/8564634/exclusive-suntrust-managing-director-goes-over-sarepta-t">Exclusive: SunTrust Managing Director Goes Over Sarepta Therapeutics&#39; Story</a></bzrelatedlink>
Nonetheless, he went on:
<ul>
<ol>
<li>&ldquo;Any changes that would come about&hellip; won&rsquo;t happen overnight&hellip; It takes time and a lot of work.&rdquo;</li>
<li>Companies in the biotech space, developing drugs that are the first approved for an indication, or drugs that target orphan indications, or drugs that offer much higher levels of efficacy or safety than pre-existing treatments, will always be able to charge a premium.</li>
</ol></ul>
&ldquo;So, normal biotech, while it does get affected by rumors and talk [about price gouging],&rdquo; would not feel a big impact over the near or longer term. Instead, Nash concluded, this is something that would have a larger impact on specialty pharmaceuticals and generics pharmaceuticals first.
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	Disclosure: Javier Hasse holds no interest in any of the securities or entities mentioned above.

	&nbsp;

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Exclusive: SunTrust Managing Director Shares Thoughts On Drug Pricing, Impact On Biotech

Hillary Clinton, Democratic presidential nominee, introduced a new plan to address the "unjustified" price increases on life-savings drugs that have become commonplace among some drug makers over the past few years.
According to <a href="http://www.reuters.com/article/us-usa-election-clinton-drugs-idUSKCN1181DM">Reuters,</a> Clinton plans on creating an oversight panel that will be tasked with protecting consumers from price increases on life-saving drugs. She also pledged to import alternative drugs and treatments if necessary to do so.
Clinton said that the panel will be provided with an "aggressive new set of enforcement tools" as well as the ability to slap drug makers with fines and even impose penalties for any "unjustified" price hikes.
The panel would consist of representatives from already existing public health and consumer protection agencies.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/general/biotech/16/09/8417318/10-conditions-that-could-soon-be-treated-with-cannabis-from-menstrual-">10 Conditions That Could Soon Be Treated With Cannabis: From Menstrual Cramps To Autism</a></bzrelatedlink>
"Over the past year, we've seen far too many examples of drug companies raising prices excessively for long-standing, life-saving treatments with little or no new innovation or R&amp;D," Reuters quoted Clinton as saying in a statement.
There may be one problem with Clinton's proposal: She would need the blessing of the U.S. Congress to implement key measures of her proposals, including levying fines and fees.
Reuters also noted that lawmakers have historically resisted any motion to introduce controls on pharmaceutical prices. Lawmakers argued that lowering or limiting drug prices would interfere with drug markers' ability to invest in research and develop new therapies.
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Clinton's Proposal To Combat Drug Price Hikes

Radio frequencies frequently emitted by cellphones can cause cancer, according to partial findings of a government study on rats, reported the <a href="http://www.wsj.com/articles/cellphone-cancer-link-found-in-government-study-1464324146">Wall Street Journal</a>.
The National Toxicology Program (NTP) has carried out extensive toxicology and carcinogenesis <a href="http://biorxiv.org/content/early/2016/05/26/055699.full.pdf">studies of radiofrequency radiation (RFR)</a> in rats over multiple years. The studies involved observing the effects of frequencies and modulations found in the U.S. telecommunications industry on the rodents, paying particular attention to the potential of cancer-cell developments.
<h3>The Study</h3>
The peer-reviewed study found "the occurrences of two tumor types in male Harlan Sprague Dawley rats exposed to RFR (radiofrequency radiation), malignant gliomas in the brain and schwannomas of the heart," according to <a href="http://www.nbcnews.com/health/health-news/possible-cellphone-link-cancer-rat-study-launches-new-debate-n581621">the research team</a>.
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/news/16/05/8040684/astrazeneca-remains-committed-to-development-of-zs-9-despite-letter-from-fda">AstraZeneca Remains Committed To Development of ZS-9 Despite Letter From FDA</a></bzrelatedlink>
"Given the widespread global usage of mobile communications among users of all ages, even a very small increase in the incidence of disease resulting from exposure to [radio-frequency radiation] could have broad implications for public health," the <a href="http://www.wsj.com/articles/cellphone-cancer-link-found-in-government-study-1464324146">Wall Street Journal</a> quoted a report of partial findings from the study.
Under these studies, rats and mice were exposed to radio-frequency "with two signal modulations [Code Division Multiple Access (CDMA) and Global System for Mobile Communications (GSM)] at two frequencies (900 MHz for rats and 1900 MHz for mice)," the <a href="http://biorxiv.org/content/biorxiv/early/2016/05/26/055699.full.pdf">NTP</a> wrote.
The study also found that "the tumors in the brain and heart observed at low incidence in male rats exposed to GSM and CDMA-modulated cell phone RFR in this study are of a type similar to tumors observed in some epidemiology studies of cell phone use."
"All RF exposures were conducted over a period of approximately 18 hours using a continuous cycle of 10 minutes on (exposed) and 10 minutes off (not exposed), for a total daily exposure time of approximately 9 hours a day, 7 days/week," according to the study.
<h3>What Does It All Mean?</h3>
"Where people were saying there's no risk, I think this ends that kind of statement," the <a href="http://www.wsj.com/articles/cellphone-cancer-link-found-in-government-study-1464324146">Wall Street Journal</a> report said, quoting Ron Melnick, who ran the NTP project until his retirement in 2009.
The Journal said, "It's not clear how the results may impact the government's cellphone safety recommendations."
"Scientific evidence always informs FCC rules on this matter," an FCC spokesman told the Journal. "We will continue to follow all recommendations from federal health and safety experts including whether the FCC should modify its current policies and RF exposure limits."

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Government Study: Cellphone Radiation Linked To Cancer

The First Trust Dorsey Wright Focus 5 ETF (NASDAQ: <a class="ticker" href="/stock/fv#NASDAQ">FV</a>), one of the most popular funds using the ETF of ETFs strategy, recently made another change among its five holdings.

	FV&#39;s<a href="http://www.ftportfolios.com/Retail/Etf/EtfHoldings.aspx?Ticker=FV"> holdings page </a>shows the First Trust Energy AlphaDEX Fund (NYSE: <a class="ticker" href="/stock/fxn#NYSE">FXN</a>) as FV&#39;s fifth-largest holding at a weight of 19.8 percent. That means FV has sent the First Trust Health Care AlphaDEX Fund (NYSE: <a class="ticker" href="/stock/fxh#NYSE">FXH</a>) packing.&nbsp;

	Flows data confirm as much. From March 23 through March 29, FXN added $680.1 million in new assets, more than any other ETF over that period, according to <a href="http://www.etf.com/etfanalytics/etf-fund-flows-tool">ETF.com</a> data. Conversely, FXH lost $562.3 million in assets during that stretch, more than all but one ETF.&nbsp;

	FV turned two earlier this month and had not changed its lineup until last month when it dumped the First Trust NYSE Arca Biotechnology Index Fund (NYSE: <a class="ticker" href="/stock/fbt#NYSE">FBT</a>) for the First Trust Utilities AlphaDEX Fund (NYSE: <a class="ticker" href="/stock/fxu#NYSE">FXU</a>). That move came after a massive decline for FBT.

	A similar though not as drastic scenario is seen with FV&#39;s healthcare-for-energy swap with FXN replacing FXH. FXH, the healthcare ETF, has long had a significant portion of its lineup in biotech stocks. Like more traditional, diversified healthcare ETFs, FXH was not immune to the biotech sector&#39;s tumble that started last year. Even with a 4.6 percent gain over the past month, FXH is down nearly 19 percent over the past year.

	That means the ETF is still close to meeting the definition of a bear market. While FV is not a market timing ETF, it is not unreasonable to assume of the fund&#39;s devotees, of which there are plenty given its $3.4 billion in assets, are wondering why it takes so long to part with losing positions like FBT and FXH. Frankly, those positions got worse and worse <a href="http://www.benzinga.com/trading-ideas/long-ideas/16/02/6224696/popular-etf-of-etfs-gets-defensive-after-market-slide">before FV moved out of them</a>.

	Those are just two examples and here is another. From its 2015 peak to its 2016 trough, the First Trust Dow Jones Internet Index Fund (NYSE: <a class="ticker" href="/stock/fdn#NYSE">FDN</a>), FV&#39;s largest holding, lost more than 28 percent but the Internet fund was not removed from FV.

	In fact, since FV debuted, FDN has experienced multiple corrections (defined as a drop of 10 percent or more) and at least one bear market (albeit temporary) and the Internet fund has never left FV.

Intraday Update

Focus 5 ETF Makes Another Change

The First Trust Dorsey Wright Focus 5 ETF (First Trust Exchange Traded Fund VI (NASDAQ: <a class="ticker" href="/stock/fv#NASDAQ">FV</a>)), one of the stars of 2014&#39;s crop of rookie exchange-traded funds, now has a dynamic counterpart with last week&#39;s launch of the First Trust Dorsey Wright Dynamic Focus 5 ETF (NASDAQ: FVC).
Like FV, the First Trust Dorsey Wright Dynamic Focus 5 ETF holds, in order, the First Trust Consumer Disry Alpha Fnd (ETF) (NYSE: <a class="ticker" href="/stock/fxd#NYSE">FXD</a>), First Trust DJ Internet Index Fund (ETF) (NYSE: <a class="ticker" href="/stock/fdn#NYSE">FDN</a>), First Trust Cnsumer Stapl Alpha Fd (ETF) (NYSE: <a class="ticker" href="/stock/fxg#NYSE">FXG</a>), First Trust Utilities AlphaDEX Fnd (ETF) (NYSE: <a class="ticker" href="/stock/fxu#NYSE">FXU</a>) and the First Trust Health Care AlphaDEX Fd(ETF) (NYSE: <a class="ticker" href="/stock/fxh#NYSE">FXH</a>).
<bzrelatedlink>Related Link: <a href="http://www.benzinga.com/trading-ideas/long-ideas/16/03/7665385/a-new-muti-asset-etf-of-etfs">A New Multi-Asset ETF Of ETFs</a></bzrelatedlink>
<h3>The Differences Between FV And FVC</h3>
While those ETFs represent all of FV&#39;s lineup, they combine for about 60 percent of the new FVC. The rest of FVC&#39;s lineup is allocated to <a href="http://www.ftportfolios.com/Retail/Etf/EtfHoldings.aspx?Ticker=FVC">short-term U.S. T-bills</a>.
The relative strength analysis for FVC&#39;s equity ETFs is conducted on a bi-monthly basis as is the analysis for the ETF&#39;s cash holdings, according to Illinois-based <a href="http://www.ftportfolios.com/LoadContent/gr3ukptsgaho">First Trust</a>.
Though FV is considered a passively managed ETF, relative strength analysis of its constituent ETFs is conducted weekly, meaning if one (or more) of the holdings tumble enough, they can be removed from FV and replaced with other First Trust sector and industry funds displaying better relative strength traits.
FV&#39;s ability to change holdings was on display earlier this year when it dumped the First Trust NYSE Arca Biotchnlgy Indx Fd (NYSE: <a class="ticker" href="/stock/fbt#NYSE">FBT</a>) in favor of FXU. However, that move left many FV investors what took so long as FV endured a massive slide in biotech stocks before parting ways to with FBT.
FVC has its work cut out for it when it comes to competing with FV, which has over $3.4 billion in assets under management. However, the new FVC is slightly less expensive than FV, as the former charges 0.79 percent per year, or $79 for each $10,000 invested, compared with FV&#39;s annual expense ratio of 0.89 percent.
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