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Saturday, May 26, 2018 - 11:07am
Photo from Pixabay.

Biotech shares put up a lackadaisical show this week, as reflected by the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB). With earnings season winding down, FDA decisions and data presentations at conferences served as catalysts for stocks in the week.

Here're are the key catalytic events in the upcoming week biotech investors need to be mindful about.

Medical/Healthcare/Biotech Conferences

  • European Society of Cardiology, or ESC, World Congress on Acute Heart Failure – May 26-May 29, in Vienna, Austria
  • 2018 American Society of Clinical Oncology Annual Meeting – June 1-5, McCormick Place, Chicago, Illinois

PDUFA Dates

Sunday, May 27

TherapeuticsMD Inc (NASDAQ: TXMD), which was mired in a controversy over a website error following an erroneous post about FDA approval for its vaginal pain treatment candidate TX-004HR, awaits the FDA ruling on May 27.

The candidate was handed a complete response letter, or CRL, on May 8, 2017, citing a lack of long-term endometrial safety. Following a resubmission and FDA's acceptance of the resubmission on Dec. 19, 2017, the new PDUFA action date was set.

Thursday, May 31

The FDA is set to announce its verdict on KITOV PHARMA LT/S ADR (NASDAQ: KTOV)'s osteoarthritis and hypertension treatment candidate KIT-302 on May 31.

Clinical Trial Outcomes

ABIOMED, Inc. (NASDAQ: ABMD) is due to make an oral presentation of the Phase 2b data for its chronic heart failure treatment candidate gencaro at the ESC World Congress on Acute Heart Failure on Sunday, May 27. The data released in February didn't show any benefit in overall population.

ASCO Presentations

Friday, June 1

Incyte Corporation (NASDAQ: INCY) – The company will make an oral presentation of the Phase 1 data for its relapsed/refractory multiple myeloma treatment candidate ruxolitinib at 3:45 p.m. ET.

bluebird bio Inc (NASDAQ: BLUE) – Celgene and bluebird bio will present additional Phase 1 data for their relapsed/multiple myeloma treatment candidate bb2121 at 3:45 p.m. ET. Preliminary Phase 1 data released at the American Society of Hematology 2017 meeting showed overall response rate of 94 percent and complete response of 56 percent.

Celgene Corporation (NASDAQ: CELG) – The company will present Phase 3 data for its refractory multiple myeloma treatment candidate MM-007. Data released in Febraury showed that the study, dubbed OPTIMISMM, met the primary endpoint of progression free survival.

See Also: Cara Therapeutics Shares Jump On Licensing Deal For Pruritis Treatment

Saturday, June 2

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) – The company will make a poster presentation of its solid tumor pipeline candidate entinostat.

Loxo Oncology Inc (NASDAQ: LOXO) – The company is set to present Phase 1 data for its LOXO-292, for treating RET-fusion non-small cell lung cancer, or NSCLC, medullary thyroid cancer and other tumors.

Exelixis, Inc. (NASDAQ: EXEL) – Exelixis will present Phase 1 data on its urothelial carcinoma treatment combo cabometyx and nivolumab-ipilimumab combined.

Karyopharm Therapeutics Inc (NASDAQ: KPTI) is due to release Phase 2/3 data for selinexsor for treating dedifferentiated liposarcoma.

Endocyte, Inc. (NASDAQ: ECYT) – The company will present Phase 3 data for its metastatic castration-resistant prostate cancer treatment candidate Lu-PSMA-617.

Celldex Therapeutics, Inc. (NASDAQ: CLDX - 2) – The company will present a poster of the Phase 2 data for its recurrent/metastatic head and neck squamous cell cancer candidate CDX-3379 at 1:15 pm CT. The company is also scheduled to make a oral presentation of Phase 2 data for its combo solid tumor treatment candidate varlilumab and nivolumab.

Jounce Therapeutics Inc (NASDAQ: JNCEO) – The company will present preliminary Phase 1/2 data for its solid tumor candidate JTX-2011. When the abstract data was publish on May 17, the stock slumped about 35 percent, with analyst attributing the stock decline to underwhelming objective response rate shown by the study.

Nektar Therapeutics (NASDAQ: NKTR) & Bristol-Myers Squibb Co (NYSE: BMY) – The companies will present preliminary Phase 1/2 data on NKTR-214-Opdivo combo from a study dubbed PIVOT-02. The combo is being evaluated for treating a variety of cancers, including melanoma, renal cell carcinoma and NSCLC.

Earnings

Wednesday, May 30

  • Ascendis Pharma A/S (NASDAQ: ASND)

Thursday, May 31

  • Organovo Holdings Inc (NASDAQ: ONVO)

IPOs

Quiet Period Expirations

Inspire Medical Systems Inc (NYSE: INSP) – Priced at $15 on May 3

Unity Biotechnology Inc (NASDAQ: UBX) – Priced at $17 on May 3

Aslan Pharmaceuticals (NASDAQ: ASLN) – Priced at $7.03 on May 4


Saturday, May 26, 2018 - 11:06am
Photo from Pixabay.

One of the most well-known hedge fund managers on Wall Street, Greenlight Capital’s David Einhorn, has hit a rough patch with his investing over the past several years. Einhorn made his reputation by correctly predicting some high-profile market downfalls and delivering a 26-percent average annual return for Greenlight investors over the first 10 years of its existence.

However, Einhorn has produced an average annual return of just 4.7 percent since 2009, and Greenlight’s assets under management have shrunk from $11.8 billion to just $6.4 billion since 2014 as investors lost faith in his ability.

The Decline Of Value Investing

Einhorn’s performance has dropped as value investing has gone out of style during the current bull market, according to Institutional Investor. Einhorn has always been a strict value investor, taking long positions only in stocks with discounted cash flow multiples or other metrics that meet certain standards. Einhorn has also taken short positions in stocks with extremely high market valuations.

As a result, Institutional Investor said Einhorn has ended up limiting his long bets to low-quality stocks such as General Motors (NYSE: GM) and exposing Greenlight investors to short bets on high-flying stocks such as Amazon.com, Inc. (NASDAQ: AMZN), Netflix, Inc. (NASDAQ; NFLX) and Tesla, Inc. (NASDAQ: TSLA).

The nine-year-old bull market has ushered in a rise in quantitative analysis, ETFs, index funds and momentum trading — none of which are incorporated in Einhorn’s value strategy.

Going Down With The Ship?

Even Einhorn himself seems to recognize the problem, but is sticking to his value investing guns for now.

“Bubbles do pop, you know,” Einhorn recently joked at the Sohn Conference. “Or at least they used to.”

Critics have blasted Einhorn for his stubbornness and arrogance, while supporters say Einhorn is simply committed to his value methodology and point to his humble lifestyle as an example of his down-to-earth thinking.

For what it’s worth, Einhorn’s comments to investors after another disappointing quarter in Q1 of 2018 suggest he still sees a comeback in value investing and is prepared to go down with the ship if he’s wrong.

“Our investment theses remain intact,” he said in his shareholder letter. “Despite recent results, our portfolio should perform well over time.”

Top Einhorn Stock Picks

For investors who agree with Einhorn that value investing is poised for a comeback, here’s an overview of Greenlight’s largest long positions:

  • General Motors
  • Brighthouse Financial Inc (NASDAQ: BHF)
  • AerCap Holdings N.V. (NYSE: AER)
  • Mylan NV (NASDAQ: MYL)
  • Green Brick Partners Inc (NASDAQ: GRBK)

Related Links:

Q1 13F Roundup: How Buffett, Einhorn, Ackman And Others Adjusted Their Portfolio

Greenlight's Q4 Letter Reveals Another Tough Quarter For David Einhorn


Saturday, May 26, 2018 - 10:59am
Photo by Maurizio Pesce via Wikimedia.

The odds of running a $1 billion business are slim to none.

Unless you’re Elon Musk. Then you run a few.

The CEO of Tesla Inc (NASDAQ: TSLA), SpaceX and the Boring Co. is now known to head two firms that are both valued north of $25 billion.

With Tesla’s $46-billion market cap and SpaceX’s estimated worth af about $28 billion, Musk is working to cement his fortune and legacy as this century’s Cornelius Vanderbilt.

A Solid Investment

Interestingly, Vanderbilt also made his money in diverse transportation ventures. The shipping and railroad tycoon, together with railroad magnate Andrew Carnegie, proved the industry to be historically lucrative.

The market continues to testify to transportation’s profitability.

SPDR S Tr/S&P TRANSN ETF (NYSE: XTN) trades up 150.5 percent from its 2011 debut price, and iShares Dow Jones Transport. Avg. (ETF) (BATS: IYT) is up 141 percent from its 2003 offering.

A Common Interest

Musk’s contemporaries have transportation assets of their own.

Jeff Bezos, CEO of Amazon.com, Inc. (NASDAQ: AMZN) and owner of The Washington Post, founded Blue Origin for commercial space travel and is an Uber investor. 

Berkshire Hathaway Inc. Class A (NYSE: BRK-A) (NYSE: BRK-B) CEO Warren Buffett counts BNSF Railway, Berkshire Hathaway Automotive and Precision Castparts, an aerospace parts producer, in his portfolio.

Richard Branson, who formerly owned Virgin Atlantic and Virgin Mobile, founded space travel company Virgin Galactic and rail company Virgin Trains. He also invested in Hyperloop One.

Microsoft Corporation (NASDAQ: MSFT) cofounder Paul Allen launched Stratolaunch and funds SpaceShipOne for commercial space travel.

Related Links:

Master Of All Trades: Every Industry Jeff Bezos Has A Hand In

6 Things Elon Musk Is Working On Other Than Tesla

Photo by Maurizio Pesce via Wikimedia. 


Friday, May 25, 2018 - 4:54pm

Benzinga’s Weekly Movers For The Week Of May 25, 2018 

The data presented below was compiled using a Screener widget and a Newsfeed widget on the Benzinga Pro platform. The Screener is customizable and is available for the pre-market and after-hours sessions in addition the the intraday session. To try out these widgets, sign up for a trial of the Benzinga Pro platform.

Percentage changes in prices below refer to total weekly change.

Biggest Gainers

  • Cytori Therapeutics Inc (NASDAQ: CYTX): Up 768.1 percent after the stock began trading on an adjusted basis following 1-for-10 reverse split.
  • Achieve Life Sciences Inc (NASDAQ: ACHV): Up 753 percent after the stock began trading on adjusted basis following 1-for-10 reverse split.
  • Fibrocell Science Inc (NASDAQ: FCSC): Up 278 percent after 1-for-5 reverse split took effect. The company reported Monday that FCX-007 was well-tolerated and showed "positive" trends.
  • VistaGen Therapeutics Inc (NASDAQ: VTGN): Up 47.5 percent after Oppenheimer initiated coverage Thursday with an Outperform rating and $6 PT, implying 520-percent upside. The firm’s stance was based on a positive outlook on the company’s AV-101 antidepressant.

Biggest Losers

  • China Lodging Group Ltd (NASDAQ: HTHT): Down 75.6 percent on no apparent news.
  • Recro Pharma Inc (NASDAQ: REPH): Down 65.5 percent after the FDA issued a CRL on Thursday saying it could not approve meloxicam in its current form.
  • Zoe's Kitchen Inc (NYSE: ZOES): Down 47.8 percent after the company on Thursday reported a Q1 earnings miss and cut FY18 sales guidance. The company said Q1 results were “challenged” due to declining comps and decelerating dine-in traffic.
  • ZEA Inc (NASDAQ: IZEA): Down 26.2 percent after reporting a Q1 miss Tuesday.

Friday, May 25, 2018 - 4:44pm
Photo from Pixabay.

Splunk Inc (NASDAQ: SPLKreported Thursday with a first-quarter non-GAAP loss per share of 7 cents on revenue of $311.6 million, up 37 percent year-over-year.

The results exceeded consensus expectations, which called for a loss of 9 cents on revenue of $297.67 million.

The revenue guidance for the second quarter as well as fiscal 2019 were also above expectations.

The Analysts

  • Bank of America Merrill Lynch analyst Kash Rangan reiterated a Buy rating and increased the price target from $124 to $128.
  • Bernstein analyst Mark Moerdler maintained an Outperform rating and raised the price target from $117 to $136.
  • JMP Securities analyst Greg McDowell maintained a Market Perform rating and hiked the price target from $108 to $120.
  • KeyBanc Capital Markets analyst Rob Owens maintained an Overweight rating and $120 price target.
  • Morgan Stanley analyst Melissa Franchi maintained an Equal-weight rating and increased the price target from $100 to $109.
  • Stifel analyst Brad Reback reiterated a Buy rating and $120 price target.

BofA Sees Accelerating Growth Story

BofA Merrill Lynch's Rangan said he's constructive on Splunk's quarter for the following reasons: 

  • The 37-percent post-ASC 606 revenue growth.
  • The faster growth rate of software revenue relative to total revenue growth.
  • Better-than-expected cash flow from operations and free cash flow.
  • The maintenance of the 11.5-percent operating margin guidance for fiscal 2019. 

Splunk is an accelerating growth story, Rangan said in the note. 

3 Positives Takeaways From Splunk's Q1

Splunk is a beneficiary of continuing momentum, as it remains poised to benefit in the years ahead — especially in the security arena, Bernstein's Moerdler said.

Customers are scaling to multiple use cases across multiple departments with the same data, resulting in strong increases in revenue per customer, the analyst said. 

Splunk is taking steps to accelerate new customer growth, according to Bernstein. 

See also: Splunk Is A Security 'Must-Have,' Wedbush Says In Upgrade

JMP Recommends Stock 

Splunk's leadership in its space; large and expanding total addressable market; more predictable revenue model; and long runway to sustain double-digit growth all render the shares attractive, JMP's McDowell said.

The analyst attributed the negative stock reaction to the below-consensus Q2 operating margin guidance and confusion around billings under ASC 606.

KeyBanc: Buy The Dip 

Security dominates Splunk's story, with the orchestration and automation capabilities that came with the Phantom acquisition extending the value proposition in the high-demand security analytics arena, KeyBanc's Owens said.

The analyst views the quarter as a strong one from the perspective of releases as well as customer additions.

"We would be opportunistic buyers should shares begin to see any meaningful pullback," Owens said.

Morgan Stanley Stays Neutral 

License revenue growth of 35-percent-plus, strength in Splunk Cloud and outperformance in cash flow are among the items Morgan Stanley's Franchi liked in Splunk's Q1 print. 

A slowdown in billings growth that came despite the metric exceeding expectations was a negative, Franchi said. Slow customer additions and the reiteration of cash flow guidance despite the revenue guidance being nudged higher were also downsides, the analyst said. 

Stifel Projects Continued Growth

With the headwinds associated with Splunk's transition to a cloud business model in the rearview mirror, Stifel's Reback said the company can sustain healthy growth, The company can also improve profitability and cash flow generation over the next several years, the analyst said.

The Price Action

Splunk shares have gained about 40 percent year-to-date through Thursday. 

The stock was down 5.2 percent at $110.26 at the close Friday. 

Related Link:

3 Reasons To Get Positive On Splunk After An Impressive Q2


Friday, May 25, 2018 - 4:21pm
Photo from Pixabay.

Cryptocurrencies finished another difficult week Friday, with most major cryptocurrencies trading lower by more than 1 percent. Here’s a look at some of the headlines that were moving the cryptocurrency market today — and which currencies were on the move.

Headlines

One day after the U.S. Justice Department said it has launched a probe into potential price manipulation in the bitcoin market, the U.K. Financial Conduct Authority said Friday that it is investigating 24 businesses that deal with cryptocurrencies. The FCA said it has opened up seven new investigations this year thanks to whistleblower reports of potential misconduct.

A cryptocurrency publicity stunt turned deadly this week when a Nepalese Sherpa accompanying a group of Mount Everest climbers organized by Ukranian social network ASKfm died during a climb. ASKfm sponsored a group of four people to climb Everest and bury a hard drive containing an estimated $50,000 in digital tokens. The plan was to encourage other Everest climbers to claim the crypto prize, which has a value based on an “estimate of their value once the pre-sale and ICO launch,” ASKfm said.

On Thursday, the Anti-Phishing Working Group released a new study that found $1.2 billion in cryptocurrency has been stolen since the beginning of 2017. Cryptocurrency bulls often cite the security of the blockchain verification process, but the reports found that cryptocurrency investors have still lost billions to scams, hackers and frauds.

Price Action

The Bitcoin Investment Trust GBTC (OTC: GBTC) traded at $12.22, down 0.1 percent.

Here’s how several top crypto investments fared Friday. Prices are as of 3:45 p.m. ET and reflect the previous 24 hours.

  • Bitcoin declined 2.1 percent to $7,420;
  • Ethereum declined 1.7 percent to $582;
  • Ripple declined 4.8 percent to 60 cents;
  • Bitcoin Cash declined 4.6 percent to $1,006;
  • EOS declined 0.7 percent to $12.11.

The three cryptocurrencies with at least $1-million market caps that have made the biggest gains over the past 24 hours are:

  • Photon: $2-million market cap, 87.4-percent gain.
  • MUSE: $17.4-million market cap, 42.9-percent gain.
  • Carboncoin: $1.6-million market cap, 39.2-percent gain.

The three cryptocurrencies hit hardest in the past 24 hours were:

  • BunnyCoin: $1.9-million market cap, 69-percent decline.
  • Jiyo: $3.8-million market cap, 31.4-percent decline.
  • LiteDoge: $1.2-million market cap, 31.1-percent decline.

Related Links:

Today In Cryptocurrency: Crypto Market Hits One-Month Low, India Mulls New Taxes

Riot Blockchain's 10-Q Sheds Light On Crypto Mining Operation


Friday, May 25, 2018 - 3:59pm
Photo by Karlis Dambrans/Wikimedia.

The White House informed lawmakers Friday it has reached a deal to put the Chinese telecom company ZTE back in business, according to a New York Times report.

Since April 16, ZTE has been banned from purchasing components from American firms for seven years. The denial order — issued as punishment for violating U.S. sanctions against Iran and North Korea — has crippled the company and threatened the jobs of thousands of Chinese workers.

In exchange for lifting the ban, ZTE would pay a heavy fine, make changes to its management team and hire American compliance officers.

Challenges From All Sides

President Donald Trump has been working on a deal to save ZTE since at least May 13, when he tweeted he was working with Chinese President Xi Jinping to save the lost jobs.

The fate of ZTE has been perceived as a major stumbling block in trade negotiations with China. ZTE’s death would be a major embarrassment to the country, which has been pushing to become a global leader in technology. Should the White House succeed, this act of good faith could go a long way toward easing trade tensions.

That success will likely be hard-fought. Members of Congress from both parties have stated their firm opposition to a deal that saves ZTE on the grounds that its products present a national security threat.

On Thursday, the House passed a bill that would prevent the administration from easing up on the company, and the Senate has been working on its own measures to keep the pressure on.

US Stocks React

Shares of several American companies with exposure to ZTE rallied on the news.

Acacia Communications, Inc. (NASDAQ: ACIA) shares — which had previously led stocks higher on the initial Trump-ZTE tweet — were trading up 5.4 percent at $33.92 at time of publication.

Others included Qualcomm, Inc. (NASDAQ: QCOM), Oclaro Inc (NASDAQ: OCLR) and Xilinx, Inc. (NASDAQ: XLNX).

Related Links:

Trump Reverses Course On ZTE And Optical Stocks Follow

Trump Tweets 'Nothing Has Happened With ZTE Except As It Pertains To The Larger Trade Deal'

Photo by Karlis Dambrans/Wikimedia. 


Friday, May 25, 2018 - 3:52pm
Photo courtesy of TradingView.

TradingView, winner of Best Analysis Tool at Benzinga’s 2017 Fintech Awards, announced Monday that it closed a $37-million round of Series B financing meant to expand its software suite and international reach.

The seven-year-old company operates one of the market’s largest financial and social platforms meant to democratize trading among self-directed investors.

With more cash on hand, TradingView intends to expand over the next six to 12 months by:

  • Moving its headquarters to the financial hub of New York;
  • Expanding charting and analytics data with the potential addition of options;
  • Adding more U.S. and international brokers, such as Robinhood, E*TRADE Financial Corp (NADSAQ: ETFC) and TD Ameritrade Holding Corp. (NASDAQ: AMTD);
  • Incorporating big crypto exchanges; and
  • Building out mobile and app platforms.

It also plans to improve international interactions.

"There's a lot of things to be done in terms of visibility in each region," TradingView COO Stan Bokov told Benzinga. "China is huge in the trading world, and it requires Weibo, QQ and Alipay integrations, etc. so we'll be focusing a lot on local needs, what kind of news they need, data, experience, pricing, etc."

TradingView's products appeal largely to millennials but also support institutional clients such as CME Group, Investopedia, Zacks and national exchanges.

"TradingView has clearly emerged as the preeminent charting platform and social network for active traders," Peter Johnson, vice president at Jump Capital, said in a press release. "Their tools have become an invaluable resource to the trading community, as demonstrated by their rapid growth to over 8 million monthly users and integrations into thousands of leading exchanges and financial applications."

In its early days, TradingView got a boost from TechStars Chicago and secured $3.7 million from TechStars, Irish Angels, iTech Capital and other angel investors. Its latest round of financing was led by Insight Venture Partners with contributions from Jump Capital and DRW Venture Capital.

Related Links:

'Trading Is The Ultimate Goal': Fintech Is Dictating The Development Of Cryptocurrency

For Traders, The Right Charting Software Is Critical

Photo courtesy of TradingView.


Friday, May 25, 2018 - 3:26pm
Public domain photo via Wikimedia.

Gamers could be one step closer to getting their hands on a relaunch of the Nintendo 64.

The Japanese video game giant filed for a trademark of an image of a Nintendo 64 controller, indicating that a mini N64 could be in the works. Nintendo ADR filed similar trademarks before launching mini retro versions of its original NES and Super Nintendo consoles to an extremely strong reception. 

Nintendo appears to have cornered the market on retro and modern gaming, with its newest console, The Switch, becoming the fastest-selling gaming console of all time in 2017. In 2016, the company launched a mini classic NES console and sold over 2.3 million units amid supply constraints.

The following year the company released a mini SNES console to strong demand.

The NES classic is set to relaunch in stores June 29

A repurposed N64 could be the most popular console of all, being home to some of the most beloved games of a generation — despite being outsold by its rival Playstation in its original go-round. The gaming world seems excited about the possibility of playing "Mario Kart" in 2018.

A new N64 isn't a done deal, though, as video game news site IGN pointed out

"More often than not, these [trademark] applications are filed in order to simply maintain control of a company's intellectual property rather than release anything new," the site said in a Wednesday report.

The games that would accompany a new N64 console are a matter of speculation. "Goldeneye 007," considered one of the best videos games of all time, was made by Rare, a British video game developer owned by Microsoft Corporation (NASDAQ: MSFT). A new deal would likely need to be struck between the two companies.

Related Links:

Nintendo Continues Nostalgia Gaming Trend With Super NES Release

Nintendo Resurrects The NES...What's Next?

Public domain photo via Wikimedia. 

IGN, MSFT, NTDOY, Media

Friday, May 25, 2018 - 3:03pm
Photo courtesy of Tesla.

Tesla Inc. (NASDAQ: TSLA) is shutting down Model 3 production starting Saturday in an effort to make changes to improve its production process and alleviate the bottlenecks that have caused the company to miss their production targets in recent quarters. The planned event is part of the 10 days of shutdowns Tesla previously announced for the quarter, and one analyst said in a Friday note that it had better be the last. 

The Analyst

GBH Insights head of technology research Daniel Ives reiterated an Attractive rating on Tesla with a $320 price target.

The Thesis

Tesla is on track to hit its near-term production target of 5,000 Model 3s per week by early July, Ives said in the note. (See the analyst's track record here.)

Tesla has taken a lot of heat for repeatedly missing its Model 3 production targets, but the company is still in a good spot if it can get on track in the near future, the analyst said. 

On the other hand, Ives said investors may not have the patience for any further delays.

“Any further shutdowns and bottlenecks could be the straw that broke the camel’s back toward hitting the 5,000 target, which remains the key risk to the story along with the cash burn situation [and] potentially raising capital in 2019,” Ives said.

The coming months are pivotal for Tesla stock, as the company either proves it can push past its temporary production problems or demonstrates its execution issues are here to stay, Ives said. 

Price Action

Tesla stock was down 0.32 percent at the time of publication Friday and is now down 21.3 percent in the past three months.

Related Links:

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Photo courtesy of Tesla.