Roivant Sciences (NASDAQ:ROIV) Stock, Quote.Headers.trade-ideas

Roivant Sciences

Roivant Sciences Ltd is a commercial-stage biopharmaceutical company dedicated to improving the delivery of healthcare to patients. It also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. Its drug candidate VTAMA (tapinarof) is a treatment of plaque psoriasis in adult patients and is in its commercial stage. The other drug candidates in their different stages of development are; Batoclimab, IMVT-1402, Brepocitinib, Namilumab, and others.

ROIV

Biotech

News

Health Care

Movers

Trading Ideas

General

Organon is set to acquire Roivant Sciences&#39; Dermavant Sciences, known for developing immuno-dermatology treatments, including FDA-approved Vtama cream for plaque psoriasis. The deal, valued up to $1.2 billion.

Roivant Sciences Offloads Psoriasis Medicine Maker To Organon For Up To $1.2B

Large Cap

Contracts

BAYRY

Roivant Sciences has licensed worldwide rights to develop and commercialize Bayer&#39;s mosliciguat for an upfront payment of $14 million and up to $280 million in future milestone payments.

Roivant Sciences Unveils New &#39;Vant&#39; Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer

IMVT

Immunovant reports promising Phase 2a trial results for batoclimab in treating Graves&#39; Disease, showing a high response rate and significant IgG reduction. A pivotal trial is expected to start by the end of 2024.

What&#39;s Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday?

Roivant Sciences Ltd

ROIVANT SCIENCES LTD WT EXP

Takeda ((<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;,%20url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&amp;,%20esheet=54124287&amp;,%20newsitemid=20240918509211&amp;,%20lan=en-US&amp;,%20anchor=TSE%3A4502%2FNYSE%3ATAK&amp;,%20index=1&amp;,%20NYSE:%3Ca%20class=">TAK</a>) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.
The approval is based primarily on the results of the FRESCO-2 trial, a global Phase 3 clinical trial conducted in the United States, Europe, Japan and Australia. The trial compared FRUZAQLA plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic colorectal cancer (mCRC). The FRESCO-2 trial met all primary and key secondary efficacy endpoints and demonstrated consistent benefits in patients who received FRUZAQLA, regardless of the types of therapy the patients had previously received. FRUZAQLA demonstrated a manageable safety profile in the FRESCO-2 trial, with the incidence of adverse events leading to discontinuation being 21% in the placebo plus BSC arm compared to 20% in the FRUZAQLA plus BSC arm.1 The data from the FRESCO-2 trial were <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flancet%2Farticle%2FPIIS0140-6736%252823%252900772-9%2Fabstract&amp;esheet=54124287&amp;newsitemid=20240918509211&amp;lan=en-US&amp;anchor=published&amp;index=2&amp;md5=4ae4f0cb6c84175356b3a0226e262316">published</a> in The Lancet in June 2023.
Dr. Takayuki Yoshino, deputy director of hospital, head, Division for the Promotion of Drug and Diagnostic Development, and chief, Department of Gastrointestinal Oncology at the National Cancer Center Hospital East, who served on the FRESCO-2 study Steering Committee, said, "Although the mortality rate of colorectal cancer has been going down in recent years due to early screening and advances in treatment, the 5-year survival rate for metastatic colorectal cancer remains low and new treatment options are much in need. The approval of FRUZAQLA in Japan offers new hope for patients and families of patients with metastatic colorectal cancer, as well as for healthcare personnel involved in colorectal cancer treatment. I feel that it is of great clinical significance."
"For more than a decade, Takeda has been a leader in advancing the treatment of metastatic colorectal cancer in Japan. With this approval of FRUZAQLA, we are able to further support patients living with this debilitating disease," said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. "FRUZAQLA is now approved in the U.S., European Union, Japan and a number of other countries around the world, and we remain committed to bringing this treatment to additional patients with metastatic colorectal cancer around the world who urgently need new therapeutic options."

Government

Regulations

Takeda's FRUZAQLA Capsules Approved in Japan for Advanced Colorectal Cancer Treatment

Oportun (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPRT#NASDAQ">OPRT</a>), a mission-driven financial services company, today announced the closing of an amendment and extension to its long-term warehouse facility. Features of this facility include: &nbsp;
<ul>
<li>$306 million total commitment</li>
<li>Goldman Sachs as senior lender – and Jefferies, as mezzanine lender – both existing, longstanding lenders to Oportun</li>
<li>A new two-year revolving period</li>
<li>Collateralized by Oportun's unsecured and secured personal loan originations &nbsp;</li>
</ul>
"This warehouse facility extension expands on Oportun's longstanding lending relationships", said Jonathan Coblentz, Chief Financial Officer of Oportun. "With the support of our lenders at Goldman Sachs and Jefferies, this committed financing will help drive Oportun's responsible growth in the years ahead."
Oportun maintains a diverse set of capital sources including committed warehouse facilities, asset-backed securitizations, corporate-level debt financing, and whole loan sales.

OPRT

Reported Earlier, Oportun Secures $306M Financing Extension With Goldman Sachs and Jefferies

With U.S. stock futures trading mixed this morning on Tuesday, some of the stocks that may grab investor focus today are as follows:
<ul>
<li>Wall Street expects AutoZone, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZO#NYSE">AZO</a>) to report quarterly earnings at $53.53 per share on revenue of $6.22 billion before the opening bell, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>. AutoZone shares fell 0.7% to $3,027 in after-hours trading.</li>
<li>AAR Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AIR#NYSE">AIR</a>) posted better-than-expected results for its first quarter on Monday. The company reported quarterly earnings of 85 cents which beat the analyst consensus estimate of 82 cents per share. AAR shares gained 3.4% to $71.44 in the after-hours trading session.</li>
<li>Analysts expect THOR Industries, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/THO#NYSE">THO</a>) to post quarterly earnings at $1.30 per share on revenue of $2.47 million before the opening bell. THOR Industries shares gained 1.6% to $104.83 in the after-hours trading session.</li>
</ul>
Check out our <a href="https://www.benzinga.com/premarket/">premarket coverage here</a>
<ul>
<li>Snowflake Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNOW#NYSE">SNOW</a>) announced a $2 billion private placement of senior convertible notes. Snowflake shares fell 3.1% to $109.71 in the after-hours trading session.</li>
<li>Analysts are expecting KB Home (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/KBH#NYSE">KBH</a>) to post quarterly earnings at $2.06 per share on revenue of $1.73 billion. The company will release earnings after the closing bell. KB Home shares gained 1.1% to close at $88.20 on Monday.</li>
</ul>
Check This Out:
<ul>
<li><a href="https://www.benzinga.com/news/24/09/40980672/top-3-financials-stocks-that-may-plunge-in-september">Top 3 Financial Stocks That May Plunge In September</a></li>
</ul>
Photo courtesy: Shutterstock

Earnings

Pre-Market Outlook

Markets

SNOW

AutoZone, Thor Industries And 3 Stocks To Watch Heading Into Tuesday

Excelerate Energy, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EE#NYSE">EE</a>) (the "Company" or "Excelerate"), a leading provider of floating storage and regasification units (FSRUs) and liquefied natural gas (LNG) solutions, and PetroVietnam Technical Services Corporation (PTSC), a subsidiary of Vietnam Oil and Gas Group (PetroVietnam) and the leading provider of oil &amp; gas and industrial services in Vietnam, have signed a strategic partnership agreement to jointly study FSRU based technical solutions for LNG imports into Vietnam.
Through this strategic alliance, Excelerate and PTSC will leverage their unique strengths and combined resources to deliver affordable and reliable energy solutions that address Vietnam's growing energy demands while supporting the country's transition to carbon neutrality.
Under the partnership agreement, the two companies will conduct joint feasibility studies to assess the viability of FSRU opportunities in Vietnam. The studies aim to optimize existing natural gas infrastructure and augment domestic supply with regasified LNG to help meet the growing demand for natural gas and stimulate the development of a regional gas market.

Reported Earlier, Excelerate Energy and PetroVietnam Partner To Boost Vietnam's LNG Imports

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.firstam.com&amp;esheet=54126266&amp;newsitemid=20240923810819&amp;lan=en-US&amp;anchor=First+American+Financial+Corporation&amp;index=1&amp;md5=70ff5a7d15f2af52f7e408adc440e753">First American Financial Corporation</a> (NYSE: <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.firstam.com%2Finvestor&amp;esheet=54126266&amp;newsitemid=20240923810819&amp;lan=en-US&amp;anchor=FAF&amp;index=2&amp;md5=42d3b12043586201743f4291dde8c059">FAF</a>), a premier provider of title, settlement and risk solutions for real estate transactions, today announced the pricing of a public offering of $450 million of its 5.450 percent senior notes due 2034. The offering is expected to close on September 30, 2024, subject to customary conditions.
The notes will be general senior unsecured obligations of the company and will rank equally in right of payment with the company's existing and future senior unsecured indebtedness. Interest will be paid semi-annually on March 30 and September 30, beginning March 30, 2025. The company intends to use the net proceeds from the sale of the notes for repayment at maturity of the company's 4.60% senior notes due 2024 and for general corporate purposes, which may include, among other possible uses, acquisitions, funding for working capital, repurchase of the company's capital stock and other capital expenditures. The company may also use the net proceeds for temporary investments until it needs them for general corporate purposes.

Offerings

Reported Earlier, First American Financial Raised $450M Via Senior Notes Offering For Debt Repayment

Bank of America has identified crucial dates for the stock market leading up to the <a href="https://www.benzinga.com/markets/equities/24/09/40974512/stifel-warns-of-12-market-drop-by-end-of-2024-as-s-p-500-faces-high-valuations-and-speculative-r">November Presidential election</a>.
What Happened: In a note released on Monday, Bank of America highlighted several key dates. The bank used options prices to predict potential movements in the S&amp;P 500 index. The most significant date is Nov. 6, the day after the election, with an estimated 2.5% move in either direction, <a href="https://markets.businessinsider.com/news/stocks/stock-market-most-important-daysstock-market-between-now-and-election-2024-9">reported</a> Business Insider.
Other important dates include Oct. 4 and Nov. 1, when nonfarm payroll reports are released. These dates could see a 1% move in the S&amp;P 500. Oct. 21 is another critical date, marking the start of major tech companies&#8217; third-quarter earnings announcements.
Additionally, Oct. 10 is noted for the release of the September CPI data, though its impact is expected to be less significant compared to labor market data. The Federal Reserve&#8217;s recent interest rate cut has shifted focus from inflation to labor market indicators.
See Also: <a href="https://www.benzinga.com/news/24/09/40972893/trumps-mars-landing-promise-gets-slammed-by-peter-schiff-even-as-elon-musk-says-spacex-plans-5-launc?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Trump&#8217;s Mars Landing Promise Gets Slammed By Peter Schiff Even As Elon Musk Says SpaceX Plans 5 Launches To Red Planet In 2 Years</a>
Why It Matters: The stock market is on edge as it approaches the November election, with several analysts predicting significant volatility. 
Stifel recently warned of a <a href="https://www.benzinga.com/markets/equities/24/09/40974512/stifel-warns-of-12-market-drop-by-end-of-2024-as-s-p-500-faces-high-valuations-and-speculative-r">potential 12% market drop by the end of 2024</a>, citing high valuations and speculative risks. Chief equity strategist Barry Bannister pointed out that the S&amp;P 500 could experience a correction to the low 5,000s by the fourth quarter.
In early September, Tom Lee, a <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40701071/market-bull-warns-of-up-to-10-september-pullback-urges-caution-but-stresses-be-read">prominent equity strategist</a>, anticipated a 7%-10% market pullback, urging caution but also advising investors to be ready to &#8220;buy that dip.&#8221; Lee noted that September has historically been the weakest month for stocks, with the S&amp;P 500 averaging a 0.7% loss every September since 1950.
Additionally, market strategist Jay Woods discussed the potential impacts of the election year and Federal Reserve rate cuts on the stock market. In an interview, Woods mentioned that the Fed&#8217;s expected rate cut in September comes as investors try to predict market movements <a href="https://www.benzinga.com/etfs/broad-u-s-equity-etfs/24/08/40533318/exclusive-market-strategist-on-small-cap-rally-election-year-fed-cuts-and-whats-next-i">amid the 2024 presidential election</a>. Woods says the Fed was late to raise rates and has been late to cut rates.
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/news/24/09/40969619/trump-ally-sarah-huckabee-sanders-jabs-kamala-harris-for-not-having-biological-children-doesnt-have?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">Trump Ally Sarah Huckabee Sanders Jabs Kamala Harris For Not Having Biological Children: &#8220;Doesn&#8217;t Have Anything Keeping Her Humble!&#8221;</a></li>
</ul>
Image Via Shutterstock 
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a>

Equities

Global

Key Stock Market Dates Predicting Major Swings Revealed Ahead Of 2024 Election, According To Bank Of America

Nova Minerals Limited ("Nova" and the "Company") (Nasdaq NVA, NVAWW) (ASX: NVA), (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NVAAF#OTC">NVAAF</a>)(FSE: QM3)), a gold and critical minerals exploration stage company focused on advancing the Estelle Gold Project in Alaska, U.S.A., today announced the pricing of an underwritten public offering of 430,000 American Depository Shares ("ADS"), with an ADS-to-ordinary-share ratio of 1 to 60, at a price to the public of $5.00 per ADS, for gross proceeds of $2,150,000, before deducting underwriting discounts and offering expenses. In addition, Nova has granted the underwriters a 45-day option to purchase up to an additional 43,000 ADSs to cover over-allotments, if any. &nbsp;
The Company intends to use the proceeds for resource and exploration field programs, including additional drilling and exploration, feasibility studies, and general working capital.

NVAAF

Reported Earlier, Nova Minerals Raised $2.15M Via Secondary Offering Of 0.43M ADS At $5/ADS

T-Mobile US, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TMUS#NASDAQ">TMUS</a>) ("T-Mobile") announced today that T-Mobile USA, Inc., its direct wholly-owned subsidiary ("T-Mobile USA" or the "Issuer"), has agreed to sell $700,000,000 aggregate principal amount of its 4.200% Senior Notes due 2029 (the "2029 Notes"), $900,000,000 aggregate principal amount of its 4.700% Senior Notes due 2035 (the "2035 Notes") and $900,000,000 aggregate principal amount of its 5.250% Senior Notes due 2055 (the "2055 Notes," and collectively with the 2029 Notes and the 2035 Notes, the "notes") in a registered public offering.
The offering of the notes is scheduled to close on September 26, 2024, subject to satisfaction of customary closing conditions. T-Mobile USA intends to use the net proceeds from the offering for general corporate purposes, which may include among other things, share repurchases, any dividends declared by T-Mobile's Board of Directors and refinancing of existing indebtedness on an ongoing basis.

TMUS

Reported Earlier, T-Mobile To Raise $2.5B Via Senior Notes Offering

New Mountain Finance Corporation (the "Company," "we," "us" or "our") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NMFC#NASDAQ">NMFC</a>) today announced that it has priced an underwritten public offering of $300 million in aggregate principal amount of 6.200% unsecured notes due 2027 (the "Notes").
The Notes will mature on October 15, 2027, and may be redeemed in whole or in part at the Company's option at any time prior to October 15, 2027, at par plus a "make-whole" premium plus accrued interest. The Notes will bear interest at a rate of 6.200% per year payable semi-annually on April 15 and October 15 of each year, beginning April 15, 2025.
The offering is expected to close on September 26, 2024, subject to the satisfaction of customary closing conditions.

NMFC

Reported Earlier, New Mountain Finance Raised $300M Via Secondary Offering Of Unsecured Notes Due 2027

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.lnw.com%2F&amp;esheet=54126322&amp;newsitemid=20240923020206&amp;lan=en-US&amp;anchor=Light+%26amp%3B+Wonder%2C+Inc.&amp;index=1&amp;md5=b86e6598104a68d63d8555273b511202">Light &amp; Wonder, Inc.</a> (NASDAQ and ASX: LNW) (together with its subsidiaries "Light &amp; Wonder," "L&amp;W" or the "Company") today received an order from the U.S. District Court for the District of Nevada granting Aristocrat a preliminary injunction relating to L&amp;W's Dragon Train game. We respectfully disagree with the judge's decision and will promptly file an appeal. We will continue to vigorously defend against Aristocrat's claims, including presenting our defenses to a jury at a trial.
Light &amp; Wonder reaffirms its 2025 $1.4 billion Targeted Consolidated AEBITDA(1). We expect continued strong growth across all our businesses. The Company is moving forward on a number of key initiatives to mitigate the immediate impact and any continuing business disruption from today's order. Our pre-ruling estimate of 2025 Consolidated AEBITDA(1) for Dragon Train was less than 5%(2) of the $1.4 billion.
We have a diversified portfolio of successful game franchises that are driving our strong performance and growth, of which Dragon Train is only one. Increased investment in our R&amp;D engine has and continues to deliver innovative, engaging content that gives us a continuing competitive advantage not tied to any one game or franchise.
Light &amp; Wonder has the #1 share(3) and #1 performance position overall for top new sold games and has the top performing game in all 5 for sale categories in North America(4). Additionally, Light &amp; Wonder has 8 of the top 25 premium leased and wide-area progressive parent theme games(4). Our chart-topping game performance continues to be underpinned by our franchises such as ULTIMATE FIRE LINK&#x2122;, INVADERS, our hit Asian-themed games 88 FORTUNES&#xAE; and DANCING DRUMS&#xAE;, stepper favorites QUICK HIT&#x2122; and TRIPLE BLAZING 7s&#x2122;, and Huff N' Puff&#xAE;, where we recently launched a new game extension Huff N' Puff Money Mansion&#xAE; as a leased game. Our market-leading game franchises will continue to drive our Company's strong growth over the long term. We are also already working on new iterations of the Dragon Train franchise consistent with the terms of the Court's ruling.
"We have the best game design talent in the industry, and they are creating great games across all our channels," said Matt Wilson, President and CEO of Light &amp; Wonder. "We are excited about the new games we will be featuring at the Global Gaming Expo in October. We expect our strong growth trajectory to continue, notwithstanding this decision. We have built an amazing business and a solid financial foundation over the last several years with great teams driving our success and are highly confident in our future of continuing innovation and ability to achieve our stated 2025 $1.4 billion Targeted Consolidated AEBITDA(1)."
Our robust capital management strategy remains unchanged. We continue to allocate capital where we can achieve the best shareholder returns, including share repurchases pursuant to our recently approved $1 billion program along with value accretive organic and inorganic investments.

Guidance

Legal

Reported Earlier, Light & Wonder Confirms $1.4B 2025 Consolidated AEBITDA After Court Ruling On Dragon Train Game

BioVie Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIVI#NASDAQ">BIVI</a>), ("BioVie" or the "Company"), a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders, today announced the pricing of a best efforts public offering of 1,960,800 shares of its common stock (or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) and warrants to purchase up to 1,960,800 shares of common stock at a combined offering price of $1.53 per share (or Pre-funded Warrant) and associated warrant. The warrants will have an exercise price of $1.53 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the offering are expected to be approximately $3,000,000, before deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes. All of the shares of common stock (or Pre-funded Warrants) and associated warrants are being offered by the Company. The offering is expected to close on September 25, 2024, subject to satisfaction of customary closing conditions. &nbsp;

BIVI

Reported Earlier, BioVie Raised $3M VIa Secondary Stock Offering Of 1.96M Shares At $1.53/Share

InvenTrust Properties Corp. ("InvenTrust" or the "Company") (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IVT#NYSE">IVT</a>) today announced it has priced an underwritten registered public offering of 8,000,000 shares of its common stock at a price to the public of $28.00 per share for total gross proceeds of $224.0 million. As part of the offering, the Company also granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of the Company's common stock at the public offering price, less the underwriting discount. The offering is expected to close on September 25, 2024 subject to customary closing conditions.
J.P. Morgan, BofA Securities, and Wells Fargo Securities are acting as joint-book-running managers for the public offering. Jefferies and KeyBanc Capital Markets are acting as additional bookrunners for the public offering. BTIG and Fifth Third Securities are acting as co-managers for the public offering.
The Company intends to use the net proceeds for general corporate purposes, including, but not limited to, funding the acquisition of additional properties, repayment of short-term and long-term indebtedness (including mortgage loans, including a $72.5 million loan with Bank of America, N.A, and amounts outstanding from time to time under the Company's revolving credit facility) and providing for working capital.

Reported Earlier, InvenTrust Properties Raised $224M Via Upsized Secondary Stock Offering Of 8M Shares (Prior $6.5M Shares) At $28/Share

Hawaiian Electric Industries, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HE#NYSE">HE</a>) ("HEI" or the "Company") today announced that it has priced its previously announced public offering of 54,054,054 shares of its common stock at a price of $9.25 per share. The offering is expected to close on September 25, 2024, subject to customary closing conditions.
The Company has granted the underwriters of the offering an option to purchase up to an additional 8,108,108 shares of common stock at the public offering price less underwriting discounts and commissions.
HEI intends to use the net proceeds from the offering to fund its contribution to the expected Maui wildfire tort litigation settlement and for general corporate purposes.

Hawaiian Electric Industries Raised $500M Via Secondary Stock Offering Of 54M Shares At $9.25/Share

<a href="https://www.globenewswire.com/Tracker?data=QOxRsnrI4lIcPvAJOHMkqpD2ZCcXLqncOnt8jZtYl5Orntqk98Ug6cXUt26iWYSQ">UCB</a> (Euronext Brussels: UCB) and <a href="https://www.globenewswire.com/Tracker?data=dQmAuZ_6afdr57GCMIz_bBuykaXWwgeC4T9F0-q_hAYdmPT_oUGMDy50CId7wM1j4bYykSMNSRmZ3zuqKQjiUA==">Biogen Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) today announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe systemic lupus erythematosus (SLE). Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks versus placebo in addition to SOC. Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.
The safety profile of dapirolizumab pegol was generally consistent with previous studies and with that expected in study participants with systemic lupus erythematosus receiving an immunomodulator.
"These positive results with dapirolizumab pegol represent encouraging progress in the development of medicines that can improve the lives of those living with lupus, an area that remains one of high unmet medical need and where women are disproportionately affected," said Fiona du Monceau, Head of Patient Evidence at UCB. "We have confidence in the unique mode of action of dapirolizumab pegol which targets multiple inflammatory pathways involved in the pathogenesis of SLE. As we pursue the next steps in the clinical development of this potentially differentiated treatment, we extend our appreciation to the patients, study investigators and the clinical community for their ongoing support and participation in this important research."
Based on the successful outcome of the PHOENYCS GO study, UCB and Biogen are initiating a second Phase 3 trial of dapirolizumab pegol in 2024, PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
"Our hypothesis is that impacting the CD40L pathway, a central mechanism in immune response, would translate to significant impact on SLE disease burden. These results demonstrate that dapirolizumab pegol has the promise to provide meaningful benefit in this serious, chronic, and often devastating disease," said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. "We are committed to delivering new treatment options for this autoimmune disease and believe the overall efficacy and safety seen in PHOENYCS GO support further development of dapirolizumab pegol in SLE."
PHOENYCS GO (n= 321) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of dapirolizumab pegol as an add on therapy to standard of care compared to placebo with standard of care. The primary outcome measure was improvement of moderate-to-severe disease activity at Week 48 using BICLA, an established, composite primary efficacy endpoint for measurement of clinical disease activity based on patient medical history, clinical examination and laboratory tests.
Detailed results from the PHOENYCS GO study will be presented at an upcoming medical congress.

BIIB

UCB And Biogen Report Results In Phase 3 Lupus Drug Trial

CRH plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CRH#NYSE">CRH</a>), the leading provider of building materials solutions, announces that Albert Manifold has decided to retire as Chief Executive Officer at the end of 2024 and that he is to be succeeded by Jim Mintern.
&nbsp;
Mr. Mintern is currently CRH's Chief Financial Officer and has been a director of its board since June 2021. He has over 30 years of experience in the building materials industry and 22 years with CRH, serving in various senior leadership roles. Mr. Mintern has deep industry knowledge, has led a variety of operational businesses, and is an accomplished developer of teams and people. He also has extensive portfolio management, financial and capital markets expertise. Most recently, Mr. Mintern led the strategic transition of CRH's primary listing to the New York Stock Exchange.
Mr. Manifold has held varied responsibilities with CRH since he joined in 1998. He was appointed Chief Executive Officer in January 2014. Mr. Manifold will step down from the board and relinquish his executive responsibilities on December 31, 2024. He will continue as an advisor to CRH for a further 12 months.
&nbsp;

Management

CRH Names CFO Jim Mintern As CEO, Effective 2024 End, Succeeding Albert Manifold

As Tesla Stock Sneaks Into Positive Territory For Year Fund Manager Says Not 10/10 Robotaxi Event But This Would Strengthen Fledgling Recovery (alt HL)
Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) <a href="https://www.benzinga.com/news/24/09/40992274/what-happened-with-tesla-stock-today">shares climbed nearly 5% Monday</a> and settled at a psychological resistance of $250, with optimism concerning third-quarter deliveries outperformance fueling much of the upside. Amid the stock surge, a fund manager weighed in on the potential impact of the upcoming Oct. 10 Robotaxi launch event on the stock.
10/10 Stock Mover? Future Fund LLC Managing Partner Gary Black is not convinced that Oct. 10 would be a catalyst for the stock, although he didn&#8217;t rule the possibility out. He said his apprehension stemmed from the fact that Tesla&#8217;s full self-driving technology is not yet close to the 99.99% efficacy needed for unsupervised autonomy.
Most analysts have discounted supervised FSD in their models, assuming a 15-20% take rate for the existing fleet and current deliveries. Also, analysts have assumed that supervised FSD with 97% efficacy will sell more Teslas, he added.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Many <a href="https://twitter.com/search?q=%24TSLA&amp;src=ctag&amp;ref_src=twsrc%5Etfw">$TSLA</a> bulls keep talking about the robotaxi event on 10/10 as a catalyst for TSLA stock. It may be. TSLA FSD is not yet close to the 99.99% efficacy needed for unsupervised autonomy. Supervised FSD is already in most analysts' models at a 15-20% take rate x the existing… <a href="https://t.co/PFVs6IWZtz">pic.twitter.com/PFVs6IWZtz</a>
&mdash; Gary Black (@garyblack00) <a href="https://twitter.com/garyblack00/status/1838261891912572954?ref_src=twsrc%5Etfw">September 23, 2024</a></blockquote>
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See Also: <a href="https://www.benzinga.com/money/how-to-buy-tesla-stock">How To Buy Tesla (TSLA) Stock</a>
Upbeat On Low-End Model: Black reiterated his optimism regarding the $25,000-$30,000 compact car from Tesla&#8217;s stable. The optimism is premised on what happened in 2019-2020 to the fundamentals and the stock after the Model Y launch, he said.
The Model Y was launched in 2019 amid shorts&#8217; high skepticism but the vehicle &#8220;ushered in a whole new TAM by vaulting TSLA into the fast-growing CUV category,&#8221; he added.
The fund manager said that the launch of a sub-$30K car on Oct. 10 is not very certain, but if it does, that&#8217;s more of a reason to buy the stock. He said that an affordable electric vehicle will allow Tesla to leverage its brand, higher range, superior tech, and better performance in the large compact category, where Toyota Motor Corp.&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TM#NYSE">TM</a>) Corolla is the leader.
&#8220;Similar to 2019-2020, $TSLAQ shorts don't understand the incremental TAM math where most TSLA Compact volume will be incremental, and not cannibalized from Model 3, which competes in an entirely different category (affordable sedans),&#8221; Black said.
Although <a href="https://www.benzinga.com/quote/TSLA/short-interest">Tesla&#8217;s short interest is far lower </a>currently compared to 2019-2020, the likely change in the current trajectory of earnings estimates from very negative to positive will change the Tesla investment narrative, the Tesla bull said. He sees Tesla&#8217;s volumes rising again, driving earnings estimates higher, which in turn will propel the stock price higher.
Tesla ended Monday&#8217;s session up 4.93% to $250, according to <a href="https://benzinga.grsm.io/register174">Benzinga Pro data.</a> With the recent rally, the stock has turned to black for the year and is up 0.61%.
Check out more of Benzinga&#8217;s Future Of Mobility coverage by&nbsp;<a href="http://www.benzinga.com/topic/mobility" target="_blank" rel="noreferrer noopener">following this link</a>.
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Analyst Color

Long Ideas

TSLA

Tesla Bull Dampens Enthusiasm Regarding 10/10 Robotaxi Event But Here's What Would Take To Strengthen Fledgling Stock Recovery

Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) senior executive Ashok Elluswamy on Monday hinted that the company is rushing to deploy its full self-driving (FSD) driver assistance technology on Cybertrucks, with a GIF from the 1980 movie &#8220;Airplane!&#8221;
What Happened: Tesla said earlier this month that FSD will be deployed on the <a href="https://www.benzinga.com/news/24/09/40724069/tesla-fsd-rollout-in-china-europe-planned-for-q1-2025">Cybertruck this month with other improvements</a> in the software. 
&#8220;Waiting,&#8221; Tesla wrote on its official account dedicated to Cybertruck updates on Monday. 
Elluwamy responded with a gif from &#8216;Airplane!&#8217; showing Robert Hays, who acted as the protagonist of the film, sweating through as he struggles to land a plane and implying that the team is hard at work to deploy the technology on the stainless steel truck.
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true"> <a href="https://t.co/MFYDKKLUPk">pic.twitter.com/MFYDKKLUPk</a>
&mdash; Ashok Elluswamy (@aelluswamy) <a href="https://twitter.com/aelluswamy/status/1838338402997223861?ref_src=twsrc%5Etfw">September 23, 2024</a></blockquote>
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Tesla CEO Elon Musk and Cybertruck lead engineer Wes Morrill also responded humorously to Elluswamy. 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">&#x1f602;
&mdash; Elon Musk (@elonmusk) <a href="https://twitter.com/elonmusk/status/1838351437694173364?ref_src=twsrc%5Etfw">September 23, 2024</a></blockquote>
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">driving lastest build tonight <a href="https://t.co/iZr8WNl3Pu">pic.twitter.com/iZr8WNl3Pu</a>
&mdash; Wes (@wmorrill3) <a href="https://twitter.com/wmorrill3/status/1838387591521116303?ref_src=twsrc%5Etfw">September 24, 2024</a></blockquote>
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Why It Matters: Tesla deployed <a href="https://www.benzinga.com/news/24/09/40791286/tesla-ceo-elon-musk-considers-making-steering-yoke-stationary-while-cybertruck-parks-itself">parking assistance features</a> on the Cybertruck and actually smart summon feature on other Tesla vehicles this month as part of its plans to enhance the capability of the FSD software to eventually drive autonomously without driver supervision.
However, FSD is yet to be deployed on the Cybertruck as of date.
Tesla is known for delaying its provided timelines. Musk has been saying for years that Tesla vehicles will be able to drive autonomously but FSD software still requires active driver supervision. 
Check out more of Benzinga's Future Of Mobility coverage by&nbsp;<a href="https://www.benzinga.com/topic/mobility" target="_blank" rel="noreferrer noopener">following this link</a>.
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Photo courtesy: Shutterstock

Tech

Tesla Team Working Hard At Deploying FSD On Cybertruck, Senior Exec Implies

The U.S. Commerce Department has proposed banning key Chinese software and hardware in connected vehicles on American roads, citing national security concerns.
What Happened: The proposed regulation would effectively bar nearly all Chinese cars from entering the U.S. market. The Biden administration has expressed worries about data collection by Chinese companies on U.S. drivers and infrastructure through connected vehicles, Reuters reported on Monday.
The White House has ordered an investigation into potential dangers, including foreign manipulation of internet-connected and navigation systems in vehicles. The prohibitions would also prevent Chinese automakers from testing self-driving cars on U.S. roads.
Commerce Secretary Gina Raimondo highlighted the risks, stating, &#8220;When foreign adversaries build software to make a vehicle that means it can be used for surveillance, can be remotely controlled, which threatens the privacy and safety of Americans on the road.&#8221;
White House National Security Adviser Jake Sullivan added that the proposal would effectively ban all existing Chinese light-duty cars and trucks from the U.S. market, though Chinese automakers could seek specific authorizations for exemptions.
The proposal calls for software prohibitions to be effective in the 2027 model year, while the hardware ban would take effect in the 2030 model year or January 2029. The Commerce Department is allowing 30 days for public comment and aims to finalize the rules by Jan. 20.
See Also: <a href="https://www.benzinga.com/news/24/09/40935722/spacex-ceo-elon-musk-says-anyone-can-go-to-mars-with-spacex-but-journey-would-be-like-a-long-sea-voy?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">SpaceX CEO Elon Musk Says Anyone Can Go To Mars With SpaceX But Journey Would Be Like A &#8216;Long Sea Voyage In Centuries Past&#8217;</a>
Why It Matters: The proposed ban on Chinese vehicles comes amid escalating trade tensions between the U.S. and China. Just last week, the Biden administration<a href="https://www.benzinga.com/markets/asia/24/09/40886450/50-of-new-car-sales-in-china-are-electric-but-in-the-us-its-only-10-are-protectionist-policies-widen"> imposed steep tariffs</a> on Chinese goods, including a 100% tax on electric vehicles made in China. The tariffs also cover Chinese solar panels, EV batteries, steel, aluminum, and other crucial minerals. This move aims to boost U.S. manufacturing and jobs, particularly in battleground states like Michigan, which is central to the American auto industry.
Additionally, former President Donald Trump has<a href="https://www.benzinga.com/news/24/09/40913456/trump-vows-200-tariffs-on-chinese-made-cars-in-mexico-warns-of-us-auto-industry-collapse-if-kamala-h"> vowed to impose 200% tariffs</a> on Chinese-made cars produced in Mexico, further intensifying the trade war rhetoric. Trump warned that if Kamala Harris wins the 2024 election, the U.S. auto industry could collapse within two to three years due to EV production moving to China.
On the other side, China has advised its automakers to keep <a href="https://www.benzinga.com/news/24/09/40825946/china-wants-automakers-to-safeguard-their-ev-technology-and-keep-it-within-the-country-as-companies">advanced EV technology </a>within the country, even as they expand factories abroad to avoid heavy tariffs. This strategy includes exporting knock-down kits for assembly at foreign plants, ensuring key components are still produced in China.
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Photo courtesy: Shutterstock
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Pooja-Rajkumari" target="_blank" rel="noreferrer noopener">Pooja Rajkumari</a>

US Proposes Ban On Vehicles Equipped With Chinese Software As Team Biden Cracks Down On 'Foreign Adversaries' Threatening 'Privacy And Safety Of Americans On The Road'

Bernard Arnault, the CEO of LVMH Moët Hennessy Louis Vuitton (OTC:<a class="ticker" href="https://www.benzinga.com/stock/LVMHF#OTC">LVMHF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/LVMUY#OTC">LVMUY</a>), has seen his net worth drop by $54 billion, moving him from the world&#8217;s richest person to nearly fifth place.
What Happened: Arnault&#8217;s fortune peaked at $231 billion in March, placing him ahead of Elon Musk and Jeff Bezos on the Bloomberg Billionaires Index. However, his net worth has since fallen to $177 billion as of Wednesday&#8217;s close.
This significant drop makes Arnault the biggest wealth loser among the top 500 individuals on Bloomberg&#8217;s list, with a $30 billion decrease this year alone. He is now only $1 billion ahead of Larry Ellison, co-founder of Oracle.
Forbes&#8217; rankings also reflect this decline, showing Arnault&#8217;s net worth at $175 billion, placing him behind Musk, Bezos, Ellison, and Mark Zuckerberg.
The decline in Arnault&#8217;s wealth is largely due to a 16% drop in LVMH&#8217;s stock price, which has hit its lowest level in two years. The company has faced challenges, including a mere 2% increase in underlying revenues and an 8% drop in income from recurring operations in the first half of the year.
See Also: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/40989179/meta-connect-2024-preview-cheaper-vr-expected-analysts-see-augmented-reality-and-ai">Meta Connect 2024 Preview: Cheaper VR Expected, Analysts See Augmented Reality And AI As Major Focus</a>
Why It Matters: The dramatic decline in Arnault&#8217;s net worth underscores the volatility in the luxury goods market. This comes after a series of strategic moves by Arnault and LVMH to navigate market challenges. In August, Arnault invested <a href="https://www.benzinga.com/news/24/08/40480056/king-of-luxury-bernard-arnault-goes-ai-shopping-channelling-over-300m-in-ai-startups-as-lvmh-navigat">over $300 million in artificial intelligence startups</a> through his family office, Aglaé Ventures.
Earlier this year, Arnault&#8217;s son set his sights on <a href="https://www.benzinga.com/markets/equities/24/02/36927006/bernard-arnaults-son-sets-sights-on-30b-watch-market-with-high-end-reinvented-pieces-after-lvmh-">the $30 billion luxury watch market</a>, launching a new division within LVMH to capture a larger share of this lucrative sector. The company&#8217;s jewelry and watch division recorded sales of $11.8 billion in 2023, representing a 7% organic growth, according to IMARC Group.
Additionally, Arnault has been involved in high-profile discussions with industry leaders like Musk. In July, Arnault revealed that he and Musk once discussed a potential collaboration between SpaceX and Louis Vuitton, highlighting the <a href="https://www.benzinga.com/news/24/07/39997764/elon-musk-bernard-arnault-once-discussed-potential-spacex-louis-vuitton-collab-im-afraid-he-will-ask">innovative approaches that he considers</a>.
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Image Via Shutterstock 
This story was generated using <a href="https://www.benzinga.com/author/benzinga-neuro">Benzinga Neuro</a> and edited by <a href="https://www.benzinga.com/topic/Kaustubh-Bagalkote" target="_blank" rel="noreferrer noopener">Kaustubh Bagalkote</a>

Eurozone

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LVMUY

Musk, Bezos, Ellison, And Zuckerberg Skip Ahead Of Bernard Arnault In Billionaire Rankings After LVMH CEO's Wealth Takes A $54B Dip: What Happened?

The former executive of the collapsed cryptocurrency exchange FTX, Caroline Ellison, is set to be sentenced on Tuesday for her role in the sensational fraud case.
What Happened: Prosecutors have requested a lighter sentence for Ellison, highlighting her &#8220;extraordinary cooperation&#8221; in the investigation, according to a <a href="https://apnews.com/article/caroline-ellison-ftx-sentencing-18ebfcdee1af8527511e30c9b45de045">report </a>by AP News on Monday. Her legal team has also sought leniency, citing her testimony and the emotional distress caused by her on-and-off romantic relationship with disgraced founder Sam Bankman-Fried (SBF). However, they stressed that Ellison is not avoiding accountability for her actions.
Ellison, who confessed her guilt nearly two years ago, <a href="https://www.benzinga.com/markets/cryptocurrency/23/10/35168021/caroline-ellison-points-finger-at-ftxs-sam-bankman-fried-in-crypto-fraud-trial">provided crucial testimony </a>against SBF in a trial last November. Her evidence played a significant role in SBF&#8217;s conviction for fraud, resulting in his <a href="https://www.benzinga.com/markets/cryptocurrency/24/03/37988324/sam-bankman-fried-sentenced-to-25-years-judge-points-to-ambition-political-manipulation">25-year prison sentence</a>.
See Also: <a href="https://www.benzinga.com/markets/cryptocurrency/24/09/40971599/well-its-crypto-its-ai-its-some-of-the-other-things-says-donald-trump-unsure-of-what-his-n?itm_source=parsely-api" target="_blank" rel="noreferrer noopener">&#8216;Well, It&#8217;s Crypto, It&#8217;s AI, It&#8217;s Some Of The Other Things,&#8217; Says Donald Trump, Unsure Of What His New Crypto Project Even Is</a>
Ellison held the CEO position at Alameda Research, a cryptocurrency hedge fund controlled by Bankman-Fried that processed some customer funds from FTX. Her professional relationship with Bankman-Fried was further complicated by a romantic involvement, which her lawyers characterized as &#8220;erratic and manipulative.&#8221;
Why It Matters: FTX, once a leading player in the cryptocurrency exchange market, collapsed in 2022 following accusations of <a href="https://www.benzinga.com/markets/cryptocurrency/23/10/35445270/the-true-cost-of-the-ftx-collapse-how-much-did-sam-bankman-fried-really-make">misappropriation of customer accounts</a>, illegal political donations, and luxury Caribbean real estate purchases by SBF and his accomplices.
The collapse precipitated the cryptocurrency winter, causing Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>), the market&#8217;s leading cryptocurrency, to plunge to lows of $16,000.
Ellison&#8217;s testimony against Bankman-Fried implicated him in directing fraudulent activities.
According to a popular prediction market, Polymarket, bettors leaned toward the possibility of Ellison <a href="https://polymarket.com/event/caroline-ellison-prison-time?tid=1727154078940">avoiding prison time</a>, with 47% odds in favor of such an outcome. On the other hand, bets in favor of a 1–11 month sentencing reached 23% as of this writing.
Apart from SBF&#8217;s 25-year prison sentence, Ryan Salame, another prominent figure involved in the operations of the now-defunct platform, <a href="https://www.benzinga.com/markets/cryptocurrency/24/05/39044786/former-ftx-executive-ryan-salame-sentenced-to-over-7-years-in-prison">was awarded 90 months</a> in prison.
Photo by Sergei Elagin on Shutterstock
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Disclaimer:&nbsp;This content was partially produced with the help of&nbsp;<a href="https://www.benzinga.com/author/benzinga-neuro" target="_blank" rel="noreferrer noopener">Benzinga Neuro</a>&nbsp;and was reviewed and published by Benzinga editors.

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