Dernières nouvelles pour Bristol-Myers Squibb (NYSE:BMY) Stock

Bristol-Myers Squibb

Bristol-Myers Squibb discovers, develops, and markets drugs for various therapeutic areas, such as cardiovascular, cancer, and immune disorders. A key focus for Bristol is immuno-oncology, where the firm is a leader in drug development. Bristol derives close to 70% of total sales from the U.S., showing a higher dependence on the U.S. market than most of its peer group.

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb Co

BRISTOL-MYERS SQUIBB $2PR by Bristol-Myers Squibb Co.

In the Phase 3b/4 PSORIATYK SCALP trial Sotyktu was superior to placebo across all primary and secondary endpoints at Week 16, with patients reporting significantly greater improvement in symptoms
Safety profile in PSORIATYK SCALP was consistent with the established safety profile of Sotyktu
In the real-world RePhlect registry of patients, six months of Sotyktu treatment was consistent with the efficacy outcomes observed in the POETYK clinical studies for psoriasis
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com%2F&amp;esheet=54127020&amp;newsitemid=20240925005092&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=bea69efca57c5230176a4c6a25a3865c">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced positive results from the Phase 3b/4 PSORIATYK SCALP trial evaluating Sotyktu (deucravacitinib) for the treatment of patients with moderate-to-severe scalp psoriasis, including those with less extensive overall psoriasis. The primary endpoint was met, with a statistically significant improvement in the scalp-specific Physician's Global Assessment (ss-PGA) response of 0 or 1 (clear/almost clear) at 16 weeks, with more than three times as many patients achieving ss-PGA 0/1 with Sotyktu treatment compared to those on placebo (48.5% versus 13.7%, respectively; p&lt;0.0001).
The new PSORIATYK SCALP efficacy and safety results (oral presentation FC04.07, abstract #5627), patient-reported outcomes (oral presentation FC06.06, abstract #5390) and 23 additional abstracts are being presented at the European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, Netherlands taking place September 25-28, 2024.

Biotech

News

General

Bristol Myers Squibb Presents New Data From 2-Trials Demonstrating Sotyktu Efficacy In both Moderate-To-Severe Scalp Psoriasis And In A Real-World Setting; In The Phase 3b/4 PSORIATYK SCALP Sotyktu Was Superior To Placebo Across All Primary And Secondary Endpoints At Week 16, With Patients Reporting Significantly Greater Improvement In Symptoms

BMO Capital analyst Evan Seigerman maintains Bristol-Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) with a Market Perform and raises the price target from $48 to $53.

Price Target

Analyst Ratings

BMO Capital Maintains Market Perform on Bristol-Myers Squibb, Raises Price Target to $53

In August, the Federal Reserve's preferred inflation gauge, the <a href="https://www.benzinga.com/news/econ-s/24/09/41066122/feds-preferred-inflation-gauge-comes-in-below-expectations-for-august-easing-concerns-about-rising-p">Personal Consumption Expenditures </a>(PCE) Price Index, rose 2.2% year-over-year, coming in below analyst expectations of 2.3%. That&#8217;s down from July's 2.5%.
The core PCE, which excludes volatile food and energy prices, increased by 2.7% year-over-year, matching forecasts and slightly higher than July's 2.6%.
This decline in overall inflation, despite steady core inflation, suggests a potential easing of price pressures, even as costs for services like housing and financial services continue to rise.
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Following Friday&#8217;s PCE report, these 14 stocks showed strong momentum in premarket trading, according <a href="https://pro.benzinga.com/">to Benzinga Pro:</a>
<ul>
<li>Bristol-Myers Squibb Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) rises 3.6% to $51.94.</li>
<li>PPD Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PDD#NASDAQ">PDD</a>) climbs 3.8% to $134.14.</li>
<li>JD.com Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JD#NASDAQ">JD</a>) is up 3.3% to $39.38.</li>
<li>Equinor ASA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EQNR#NYSE">EQNR</a>) gains 2.8% to $24.89.</li>
<li>Anheuser-Busch InBev SA/NV (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BUD#NYSE">BUD</a>) advances 1.5% to $66.52.</li>
<li>NetEase Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NTES#NASDAQ">NTES</a>) lifts 1.7% to $92.69.</li>
<li>Nu Holdings Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NU#NYSE">NU</a>) jumps 1.3% to $14.00.</li>
<li>Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) rockets 1.1% to $257.16.</li>
<li>Alibaba Group Holding Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BABA#NYSE">BABA</a>) moves 0.9% higher to $105.80.</li>
<li>BP p.l.c. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BP#NYSE">BP</a>) ticks up 0.9% to $31.07.</li>
<li>PayPal Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PYPL#NASDAQ">PYPL</a>) soars 1.1% to $81.03.</li>
<li>General Motors Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GM#NYSE">GM</a>) inches up 0.9% to $46.24.</li>
<li>Lennar Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LEN#NYSE">LEN</a>) posts a rise of 1.07% to $185.01.</li>
<li>Micron Technology Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MU#NASDAQ">MU</a>) registers a boost of 0.7% to $110.69.</li>
</ul>
Rising costs in services, particularly in housing, financial services, and insurance, were the key drivers of inflation, pushing the overall PCE index higher. While service prices surged, goods prices saw a slight decline, helping to offset some of the inflationary pressure. Meanwhile, falling energy prices, especially gasoline, provided additional relief compared to previous periods of stronger inflationary impact from energy.
Food prices increased modestly, primarily in off-premises consumption like groceries, but their effect on inflation was smaller compared to services. 
Core inflation, which excludes food and energy, remained steady due to ongoing price increases in durable goods and essential services. Despite minor declines in goods prices, rising service costs <a href="https://www.benzinga.com/topic/inflation">kept core inflation elevated</a>.
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Photo: Shutterstock.

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14 Stocks Gain Momentum As August Inflation Comes In Below Expectations

On Thursday, the FDA approved Bristol Myers Squibb&nbsp;&amp; Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b41059140/u-s-food-and-drug-administration-approves-bristol-myers-squibbs-cobenfy-xanomeline-and-trospium-ch" rel="noreferrer noopener">schizophrenia in adults</a>.
Bristol-Myers added the treatment via Karuna Therapeutics deal for $330 per share in cash for a total equity <a target="_blank" href="https://www.benzinga.com/markets/equities/23/12/36388646/bristol-myers-acquisition-of-karuna-therapeutics-paves-way-for-aggressive-global-marketing-of-ka" rel="noreferrer noopener">value of $14 billion</a>.
Cobenfy represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1&nbsp;and M4&nbsp;receptors in the brain without blocking D2&nbsp;receptors.
&#8220;Today&#8217;s landmark approval of our <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40964682/bristol-myers-acquired-drug-karxt-poised-for-fda-approval-as-first-new-type-of-schizophrenia-trea" rel="noreferrer noopener">first-in-class treatment</a> for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,&#8221; said&nbsp;Chris Boerner, board chair and CEO at Bristol Myers Squibb.
Schizophrenia is estimated to impact approximately 2.8 million people in the U.S.
The FDA approval of Cobenfy is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of COBENFY for up to one year.
In Phase 3 EMERGENT-2 and EMERGENT-3 trials, Cobenfy met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five.
Cobenfy demonstrated a 9.6-point reduction (-21.2 Cobenfy vs. -11.6 placebo) and an 8.4-point reduction (-20.6 Cobenfy vs. -12.2 placebo) in PANSS total score compared to placebo at week five in EMERGENT-2 and EMERGENT-3, respectively.
In EMERGENT-2, Cobenfy demonstrated a statistically significant improvement in illness from baseline to week five.
Cobenfy was invented at PureTech Health Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTC#NASDAQ">PRTC</a>). FDA approval triggers two separate milestone payments to PureTech <a href="https://www.benzinga.com/pressreleases/24/09/b41060406/puretech-invented-karxt-receives-u-s-food-and-drug-administration-approval-for-the-treatment-of-sc" target="_blank" rel="noreferrer noopener">totaling $29 million</a>.
Price Action: BMY stock is up 6.34% at $53.30 during the premarket session at last check Friday.
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Photo via Shutterstock

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Schizophrenia Treatment Revolution: FDA Approves Bristol Myers Squibb's Cobenfy As First New Class Of Treatment In More Than 3 Decades

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Bristol-Myers Squibb shares are trading higher after the company announced the FDA approved COBENFY for treatment of schizophrenia

Shares of Establishment Labs Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ESTA#NASDAQ">ESTA</a>) rose sharply in today's pre-market as the company received U.S. FDA approval for Motiva Implants.
Establishment Labs Holdings shares jumped 28.3% to $52.88 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Fangdd Network Group Ltd.  (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DUO#NASDAQ">DUO</a>) rose 51.3% to $1.62 in pre-market trading after jumping 110% on Thursday.</li>
<li>Onconetix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONCO#NASDAQ">ONCO</a>) shares rose 40.1% to $4.75 in pre-market trading. Onconetix recently announced a 1-for-40 reverse stock split.</li>
<li>The Real Good Food Company, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGF#NASDAQ">RGF</a>) gained 38.9% to $0.5140 in pre-market trading after announcing debt refinancing transactions with PMC Financial Services and Emblem Investment Fund for a $60 million new term loan.</li>
<li>Expion360 Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XPON#NASDAQ">XPON</a>) rose 30.2% to $0.0840 in pre-market trading after declining around 23% on Thursday.</li>
<li>Cardio Diagnostics Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDIO#NASDAQ">CDIO</a>) shares rose 26.5% to $0.3162 in pre-market trading after falling around 5% on Thursday.</li>
<li>Mercurity Fintech Holding Inc.  (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MFH#NASDAQ">MFH</a>) shares surged 16% to $1.60 in pre-market trading after falling around 4% on Thursday.</li>
<li>Sonim Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SONM#NASDAQ">SONM</a>) shares gained 10.1% to $3.27 in pre-market trading. Sonim Technologies recently announced a strategic distribution partnership with TCCM.</li>
<li>IonQ, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IONQ#NASDAQ">IONQ</a>) gained 7% to $8.62 in pre-market trading after the company said it inked $54.5 million contract with the United States Air Force Research Lab.</li>
<li>Bristol-Myers Squibb Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) shares jumped 6.3% to $53.29 in pre-market trading as the company said the U.S. FDA has approved COBENFY&#x2122; (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Volato Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SOAR#NYSE">SOAR</a>) shares dipped 19% to $0.4156 in pre-market trading after jumping 83% on Thursday.</li>
<li>enVVeno Medical Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVNO#NASDAQ">NVNO</a>) fell 16.4% to $3.76 in pre-market trading after announcing a proposed public offering.</li>
<li>Momentus Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNTS#NASDAQ">MNTS</a>) shares fell 16% to $0.4504 in pre-market trading after the company received non-compliance notice from Listing Qualifications Department of Nasdaq.</li>
<li>Mustang Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MBIO#NASDAQ">MBIO</a>) fell 13.8% to $0.2058 in pre-market trading after gaining more than 7% on Thursday.</li>
<li>Telesis Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TBIO#NASDAQ">TBIO</a>) shares declined 12.8% to $3.48 in pre-market trading. Telesis Bio shares jumped 72% on Thursday after the company announced a partnership with Beckman Coulter Life Sciences to revolutionize DNA and mRNA synthesis.</li>
<li>Theriva Biologics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TOVX#NASDAQ">TOVX</a>) shares fell 11.8% to $1.80 in pre-market trading after the company announced the pricing of $2.5 million public offering.</li>
<li>Cassava Sciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAVA#NASDAQ">SAVA</a>) declined 10.8% to $28.40 in pre-market trading after the SEC charged the company, two former executives for misleading claims about Alzheimer&#8217;s clinical trial.</li>
<li>AtlasClear Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATCH#NASDAQ">ATCH</a>) shares declined 9.8% to $0.2643 in pre-market trading.</li>
<li>Gryphon Digital Mining, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRYP#NASDAQ">GRYP</a>) fell 9.6% to $0.5533 in today's pre-market trading after gaining 10% on Thursday.</li>
<li>HP Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HPQ#NYSE">HPQ</a>) shares fell 3.2% to $35.70 in pre-market trading after gaining over 2% on Thursday.</li>
</ul>
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Why Establishment Labs Shares Are Trading Higher By Around 28%; Here Are 20 Stocks Moving Premarket

Sentiment has soured ahead of the <a href="https://www.benzinga.com/trading-ideas/previews/24/09/41054701/inflation-data-will-be-watched-like-a-hawk-friday-after-feds-interest-rate-cuts">key inflation data that is due ahead of the market open </a>on Friday, with the index futures pointing to a modestly lower opening. A fairly benign data could keep the upward trajectory intact ahead of next week&#8217;s key labor market data. Stocks are on track to finish September, a seasonally weaker month, on a positive note, and election uncertainty could weigh down on the market in the upcoming month. The focus would shift to the third-quarter reporting season in the latter half of October.
<figure class="wp-block-table is-style-stripes"> 
<table>
<tbody>
<tr>
<td>Futures</td>
<td>Performance (+/-)</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>-0.18%</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>-0.07%</td>
</tr>
<tr>
<td>Dow</td>
<td>-0.03%</td>
</tr>
<tr>
<td>R2K</td>
<td>+0.31%</td>
</tr>
</tbody>
</table>
</figure>
In premarket trading on Friday,&nbsp;the SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) edged up 0.03% to $572.46 and the&nbsp;Invesco QQQ ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>) fell 0.08% to $489.09, according to&nbsp;<a href="https://benzinga.grsm.io/lxquj26b2sag" target="_blank" rel="noreferrer noopener">Benzinga Pro data</a>.
Cues From Last Session:
U.S. stocks advanced on Thursday as traders digested a slew of economic data, Chinese stimulus that set the Asian markets on fire and Micron Technology, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MU#NASDAQ">MU</a>) earnings. A sharp drawdown in the shares of Super Micro Computer, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMCI#NASDAQ">SMCI</a>) on the back of the news of a Department of Justice probe tempered optimism toward the tech stocks.
The major indices opened sharply higher after separate reports showed jobless claims fell in the recent reporting week, durable goods orders remained flat, belying expectations for a decline, and the second-quarter GDP data was left unrevised at 3%.
The indices squandered the early gains but remained mostly above the unchanged line for the rest of the session before closing higher for the day.
The S&amp;P 500 scored another record intraday and closing highs, with nine of the 11 S&amp;P 500 sector classes closing higher. Material stocks advanced notably, while energy stocks came under significant selling pressure. 
<figure class="wp-block-table is-style-stripes"> 
<table>
<tbody>
<tr>
<td>Index</td>
<td>Performance (+/)</td>
<td>Value</td>
</tr>
<tr>
<td>Nasdaq Composite</td>
<td>+0.60%</td>
<td>18,190.29</td>
</tr>
<tr>
<td>S&amp;P 500 Index</td>
<td>+0.40%</td>
<td>5,745.37</td>
</tr>
<tr>
<td>Dow Industrials</td>
<td>+0.62%</td>
<td>42,175.11</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>+0.57%</td>
<td>2,209.87</td>
</tr>
</tbody>
</table>
</figure>
Insights From Analysts:
LPL Chief Economist Jeffrey Roach said in a note he anticipates a period of higher volatility among both bonds and equities during the present period of global uncertainty and softer growth outlook. &#8220;We expect volatility to remain elevated over the next few months, and believe a better entry point back into the longer-term bull market is likely,&#8221; he said.
The economist said the long and variable lag of monetary policy is not perfectly symmetrical, and it could take time for the monetary stimulus to filter down from Wall Street to Main Street. &#8220;Portfolio allocators should consider keeping a domestic bias during these periods of flux,&#8221; he added.
With just two sessions to go for September, the S&amp;P 500 is up about 17.2% for the month-to-date period. Carson Group Chief Investment Strategist Ryan Detrick underlined a positive aspect of it. If the index finishes September in the green, it would mark gains for eight of the nine months of 2024. Going back into history, this has occurred nine other times and in those years, the index posted gains for the fourth quarter all nine times. The average gain is a decent 6.7%.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
<div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">No September isn&#39;t over yet, but if the S&amp;P 500 finishes higher in September that would be 8 of the first 9 months of &#39;24 higher. I found 9 other times that happened in history. Q4? Up 9 times and up 6.7% on avg.
&mdash; Ryan Detrick, CMT (@RyanDetrick) <a href="https://twitter.com/RyanDetrick/status/1839388702646161483?ref_src=twsrc%5Etfw">September 26, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
See also: <a href="https://www.benzinga.com/money/best-futures-trading-software">Best Futures Trading Software</a>
Upcoming Economic Data:
<ul>
<li>The Bureau of Economic Analysis is due to release a personal income and spending report for August at 8:30 a.m. EDT. Economists, on average, expect personal income and spending to have increased by 0.4% and 0.3% month-over-month, respectively, in August. This compares to the July rates of 0.3% and 0.5%, respectively. The price consumption expenditure index may have edged up 0.1% compared to July&#8217;s 0.2% increase. Annually, the rate of increase in the PCEI is expected to have slowed from 2.5% in July to 2.3% in August. The monthly and annual rates of the core PCEI are estimated at 0.2% and 2.7%, respectively, for August, compared to July&#8217;s 0.2% and 2.6% rates.</li>
<li>The advanced trade balance report for August will be released by the Commerce Department at 8:30 a.m. EDT. The consensus estimate calls for a deficit of $100.60 billion for August compared to a deficit of $102.84 billion in July. The Commerce Department will also release advance wholesale and retail inventory data at 8:30 a.m. EDT.</li>
<li>The University of Michigan&#8217;s final consumer sentiment index for September is scheduled to be released at 10 a.m. EDT. The headline consumer sentiment index is expected to be revised from the flash reading of 69 to 69.3, marking an increase from 67.9 in August. The one-year and five-year inflation expectations readings will likely come in at 2.7% and 3.1%, respectively,</li>
<li>Atlanta Fed GDPNow for the third quarter, due at 10:30 a.m. EDT, is expected to show 2.9% growth.</li>
<li>Federal Reserve Governor Michelle Bowman is scheduled to speak at 1:15 p.m. EDT.</li>
</ul>
Stocks In Focus:
<ul>
<li>BlackBerry Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BB#NYSE">BB</a>) fell over 1.50% <a href="https://www.benzinga.com/premarket">in premarket trading</a> following the company&#8217;s earnings announcement, and Costco Wholesale Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COST#NASDAQ">COST</a>) was down about 1.30% on earnings.</li>
<li>Bristol Myers Squibb&nbsp;Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) shares rose over 6% after the FDA approved Cobenfy, an oral medication for the treatment of schizophrenia in adults.</li>
</ul>
Commodities, Bonds And Global Equity Markets:
Crude oil futures are weaker yet again, although more modestly than in the previous two sessions, and gold futures retreated modestly and traded just shy of the record. Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) rallied over 3% over the past 24 hours and is fast approaching the next psychological resistance of $66K.
The yield on the 10-year Treasury note remained almost flattish with a slight negative bias at 3.785%.
In Asia, stocks in Hong Kong, Japan and China rose strongly and the Australian averages gained modestly, but major indices elsewhere settled mostly lower. China&#8217;s optimism continued to buoy sentiment in the mainland markets.
The European markets advanced in early trading as traders digested inflation data from some key countries in the region and other data. 
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</ul>
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SMCI

Wall Street On Wait-And-Watch Mode Ahead Of Inflation Data, Bitcoin Holds Above 65.5K: Analyst Says Volatility Ahead Providing Better Entry Point Into Long-term Bull Market

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bms.com&amp;esheet=54127503&amp;newsitemid=20240925382351&amp;lan=en-US&amp;anchor=Bristol+Myers+Squibb&amp;index=1&amp;md5=4c5782a9cae61ff07bf3f46354780c2f">Bristol Myers Squibb</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) today announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY&#x2122; (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.1 COBENFY represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia by selectively targeting M1 and M4 receptors in the brain without blocking D2 receptors.2,3,4
This press release features multimedia. View the full release here: <a href="https://www.businesswire.com/news/home/20240925382351/en/">https://www.businesswire.com/news/home/20240925382351/en/</a>
<img src="https://mms.businesswire.com/media/20240925382351/en/2254707/4/COBENFY%E2%84%A2_Product_Image.jpg" alt="Product Image (Photo: Bristol Myers Squibb)" />
Product Image (Photo: Bristol Myers Squibb)
"Today's landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm," said <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.bms.com%2Fabout-us%2Fleadership%2Fleadership-team%2Fchris-boerner.html&amp;esheet=54127503&amp;newsitemid=20240925382351&amp;lan=en-US&amp;anchor=Chris+Boerner%2C+PhD&amp;index=2&amp;md5=6642d2f3554dd82aeef370702f1e3416">Chris Boerner, PhD</a>, board chair and chief executive officer at Bristol Myers Squibb. "As we reenter the field of neuropsychiatry, we are dedicated to changing the conversation around serious mental illness, beginning with today's approval in schizophrenia."
Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels and behaves.5 It is estimated to impact approximately 2.8 million people in the United States.6 Symptoms typically first appear in early adulthood and present differently in each person, making symptoms difficult to diagnose and manage.6 While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy.7
"For people living with schizophrenia, it's often difficult to find a treatment that works for them. Having a variety of treatment options gives patients and healthcare providers the tools to help manage this serious condition," said Gordon Lavigne, chief executive officer of the Schizophrenia &amp; Psychosis Action Alliance. "People living with schizophrenia want and deserve more. Today's approval provides a new option as people with schizophrenia move forward with proper support to rebuild their lives."
The FDA approval of COBENFY is supported by data from the EMERGENT clinical program, which includes three placebo-controlled efficacy and safety trials and two open-label trials evaluating the long-term safety and tolerability of COBENFY for up to one year. In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, COBENFY met its primary endpoint, demonstrating statistically significant reductions of schizophrenia symptoms compared to placebo, as measured by the Positive and Negative Syndrome Scale (PANSS) total score change from baseline to week five. COBENFY demonstrated a 9.6-point reduction (-21.2 COBENFY vs. -11.6 placebo, p&lt;0.0001) and an 8.4-point reduction (-20.6 COBENFY vs. -12.2 placebo; p&lt;0.0001) in PANSS total score compared to placebo at week five in EMERGENT-2 and EMERGENT-3, respectively. In EMERGENT-2, COBENFY demonstrated a statistically significant improvement in illness from baseline to week five, as measured by the Clinical Global Impression-Severity (CGI-S) score, a secondary endpoint in the trial.1
The safety and tolerability profile of COBENFY has been established across acute and long-term trials. In the Phase 3 EMERGENT-2 and EMERGENT-3 trials, the most common adverse reactions (≥5% and at least twice placebo) were nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness and gastroesophageal reflux disease.1 COBENFY does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.
"Due to its heterogeneous nature, schizophrenia is not a one-size-fits-all condition, and people often find themselves in a cycle of discontinuing and switching therapies," said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials and investigator in the EMERGENT program. "The approval of COBENFY is a transformative moment in the treatment of schizophrenia because, historically, medicines approved to treat schizophrenia have relied on the same primary pathways in the brain. By leveraging a novel pathway, COBENFY offers a new option to manage this challenging condition."
The Company today also announced the launch of COBENFY Cares&#x2122;, a program designed to support patients who have been prescribed COBENFY. Patients will be able to enroll in the COBENFY Cares program in late October corresponding with product availability. The COBENFY Cares phone number is 1-877-COBENFY.

Government

Regulations

FDA Approves Bristol Myers Squibb's COBENFY, First New Schizophrenia Drug in Decades

Today, the U.S. Food and Drug Administration approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the standard of care.

FDA Earlier Announced Approval Of Bristol-Myers Squibb's Cobenfy With New Mechanism Of Action For Treatment Of Schizophrenia

On Thursday, 26 September, the FDA's Oncologic Drugs Advisory Committee will discuss the use of immune checkpoint inhibitors in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma and esophageal <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534057/cancer-medicines-from-merck-bristol-myers-and-beigene-in-question-as-fda-committee-to-discuss-lim" rel="noreferrer noopener">squamous cell carcinoma</a>.
The FDA <a target="_blank" href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-26-2024-meeting-oncologic-drugs-advisory-committee-meeting-announcement-09262024" rel="noreferrer noopener">notes</a> that the current labeling for approved checkpoint inhibitors in this indication reflects broad approvals in the intent to treat patient populations agnostic of programmed death cell ligand-1 (PD-L1) expression.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534057/cancer-medicines-from-merck-bristol-myers-and-beigene-in-question-as-fda-committee-to-discuss-lim" rel="noreferrer noopener">Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer</a>.
Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity.
The review includes existing approvals for&nbsp;Bristol Myers Squibb Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>)&nbsp;Opdivo (nivolumab) and Yervoy (ipilimumab),&nbsp;Merck &amp; Co Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)&nbsp;Keytruda (pembrolizumab), and pending applications for&nbsp;BeiGene Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BGNE#NASDAQ">BGNE</a>)&nbsp;Tevimbra (tislelizumab).
In a&nbsp;<a target="_blank" href="https://www.fda.gov/media/182138/download" rel="noreferrer noopener">briefing document</a>, the FDA indicated that combining immune checkpoint inhibitors (ICIs) with standard chemotherapy does not seem to offer benefits for patients with PD-L1 expression below 1%. Patients with PD-L1 levels of 10% or higher experience the most significant benefit.
The advantages remain unclear for those with PD-L1 levels between 1% and 10%, and interpreting the data is difficult.
Given that patients with low or absent PD-L1 expression are unlikely to benefit, administering anti-PD-1 therapy may introduce risks, including severe immune-related adverse effects, which can further diminish the quality of life in individuals already dealing with malignancy.
"Although these results are exploratory &#8230; strong evidence does not appear to support the use of anti-PD-L1 drugs in patients with low PD-L1 expression," the FDA <a target="_blank" href="https://www.fda.gov/media/182143/download" rel="noreferrer noopener">said</a>.
Read Next:
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<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/09/41028913/bristol-myers-2seventy-bio-halt-phase-3-trial-for-abecma-in-newly-diagnosed-myeloma" target="_blank" rel="noreferrer noopener">Bristol Myers-2seventy Bio Halt Phase 3 Trial For Abecma In Newly Diagnosed Myeloma Patients, Speeds Path To Profitability</a>.</li>
</ul>
Image by PDPics from Pixabay

BGNE

FDA Casts Doubt On Use Of Merck, Bristol Myers' PD-1 Cancer Drugs For Certain Type Of Gastric Cancer Patients

2seventy bio, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSVT#NASDAQ">TSVT</a>)&nbsp;and its partner Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), will discontinue enrollment in its ongoing Phase 3 KarMMa-9 study of Abecma&nbsp;(idecabtagene vicleucel; ide-cel) with lenalidomide maintenance versus lenalidomide maintenance alone for newly diagnosed multiple myeloma (NDMM) who have suboptimal response to autologous <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b41020153/2seventy-bio-provides-update-on-karmma-9-study-and-previews-anticipated-strong-third-quarter-reven" rel="noreferrer noopener">stem cell transplant</a>.
"Consistent with our focus on capital allocation and creating value for all stakeholders, we anticipate this decision will conserve over $80 million in near-term expenditures and accelerate our path to breakeven in 2025," said Chip Baird, CEO of 2seventy bio.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38114915/fda-approves-bristol-myers2seventy-bios-abecma-for-earlier-use-in-pretreated-blood-cancer-patient" rel="noreferrer noopener">FDA Approves Bristol-Myers/2seventy Bio's Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer</a>.
2seventy also reported continued positive momentum in&nbsp;Abecma's expected return to growth in the earlier line setting following the FDA's approval in April 2024.
The company expects third-quarter&nbsp;Abecma&nbsp;U.S. revenue growth of approximately 30%&nbsp;from second-quarter revenue of $54 million. Demand, as measured by new patients undergoing apheresis in the third quarter, is also expected to reflect double-digit growth compared to the second quarter of 2024.
William Blair says while expectations for Abecma are generally low for investors at this point, the ability to maximize the opportunity in the current label would offset concerns about the fixed costs of the cell therapy franchise.
2seventy bio and BMS share equally in all profits and losses related to the development, manufacturing, and commercialization of&nbsp;Abecma&nbsp;in the U.S.
Overall, the announcement suggests moving CAR-T therapies into the earliest lines of treatment may have headwinds given the strong current standard of care. Therefore, we think thoughtful trial designs that reflect the changing standard of care will have the greatest potential of maximizing the CAR-T total addressable market."
Recently, Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) acquired the Hemophilia A program and rights to 2seventy's in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39532373/novo-nordisk-buys-2seventys-hemophilia-a-program-divestiture-supports-exclusive-focus-on-abecma" rel="noreferrer noopener">cells for autoimmune disease</a>.
2seventy bio will focus exclusively on the commercialization and continued development of&nbsp;Abecma.
Price Action: TSVT stock is down 7.65% at $4.41, and BMY stock is down 2.90% at $49.47 at last check Wednesday.
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Analyst Color

TSVT

Bristol Myers-2seventy Bio Halt Phase 3 Trial For Abecma In Newly Diagnosed Myeloma Patients, Speeds Path To Profitability

&quot;With a greatly improved NDMM treatment landscape and following our rigorous review of the business case for the KarMMa-9 study, we have decided to discontinue enrollment in this Phase 3 study,&quot; said Chip Baird, chief executive officer, 2seventy bio.&nbsp;

2seventy bio, Bristol Myers Squibb Discontinue Enrollment In Phase 3 KarMMa-9 Study

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders often look for circumstances when the market estimation of an option diverges away from its normal worth. Abnormal amounts of trading activity could push option prices to hyperbolic or underperforming levels. 
Below are some instances of options activity happening in the Health Care sector: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>PFE</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/17/25</td>
<td>$32.50</td>
<td>$70.5K</td>
<td>38.1K</td>
<td>2.5K</td>
</tr>
<tr>
<td>BMY</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>10/04/24</td>
<td>$51.00</td>
<td>$32.5K</td>
<td>829</td>
<td>797</td>
</tr>
<tr>
<td>BNTX</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>10/18/24</td>
<td>$120.00</td>
<td>$34.5K</td>
<td>1.3K</td>
<td>625</td>
</tr>
<tr>
<td>CI</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/27/24</td>
<td>$355.00</td>
<td>$71.7K</td>
<td>16</td>
<td>505</td>
</tr>
<tr>
<td>TGTX</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>01/17/25</td>
<td>$40.00</td>
<td>$137.7K</td>
<td>2</td>
<td>383</td>
</tr>
<tr>
<td>JNJ</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>12/20/24</td>
<td>$175.00</td>
<td>$45.4K</td>
<td>513</td>
<td>382</td>
</tr>
<tr>
<td>BHVN</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>10/18/24</td>
<td>$45.00</td>
<td>$48.4K</td>
<td>74</td>
<td>365</td>
</tr>
<tr>
<td>VKTX</td>
<td>CALL</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>11/15/24</td>
<td>$60.00</td>
<td>$189.7K</td>
<td>4.5K</td>
<td>172</td>
</tr>
<tr>
<td>GMED</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>12/20/24</td>
<td>$70.00</td>
<td>$31.6K</td>
<td>7</td>
<td>122</td>
</tr>
<tr>
<td>MNKD</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>11/15/24</td>
<td>$3.50</td>
<td>$30.0K</td>
<td>121</td>
<td>100</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These itemized elaborations have been created using the accompanying table. 
• For PFE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), we notice a call option sweep that happens to be bullish, expiring in 116 day(s) on January 17, 2025. This event was a transfer of 1500 contract(s) at a $32.50 strike. This particular call needed to be split into 47 different trades to become filled. The total cost received by the writing party (or parties) was $70.5K, with a price of $47.0 per contract. There were 38163 open contracts at this strike prior to today, and today 2583 contract(s) were bought and sold. 
• Regarding BMY (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), we observe a call option sweep with bearish sentiment. It expires in 11 day(s) on October 4, 2024. Parties traded 500 contract(s) at a $51.00 strike. This particular call needed to be split into 24 different trades to become filled. The total cost received by the writing party (or parties) was $32.5K, with a price of $65.0 per contract. There were 829 open contracts at this strike prior to today, and today 797 contract(s) were bought and sold. 
• Regarding BNTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), we observe a call option sweep with bullish sentiment. It expires in 25 day(s) on October 18, 2024. Parties traded 150 contract(s) at a $120.00 strike. This particular call needed to be split into 19 different trades to become filled. The total cost received by the writing party (or parties) was $34.5K, with a price of $230.0 per contract. There were 1345 open contracts at this strike prior to today, and today 625 contract(s) were bought and sold. 
• Regarding CI (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>), we observe a put option sweep with bullish sentiment. It expires in 4 day(s) on September 27, 2024. Parties traded 239 contract(s) at a $355.00 strike. This particular put needed to be split into 15 different trades to become filled. The total cost received by the writing party (or parties) was $71.7K, with a price of $300.0 per contract. There were 16 open contracts at this strike prior to today, and today 505 contract(s) were bought and sold. 
• For TGTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TGTX#NASDAQ">TGTX</a>), we notice a put option sweep that happens to be bearish, expiring in 116 day(s) on January 17, 2025. This event was a transfer of 82 contract(s) at a $40.00 strike. This particular put needed to be split into 12 different trades to become filled. The total cost received by the writing party (or parties) was $137.7K, with a price of $1680.0 per contract. There were 2 open contracts at this strike prior to today, and today 383 contract(s) were bought and sold. 
• For JNJ (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), we notice a call option sweep that happens to be bearish, expiring in 88 day(s) on December 20, 2024. This event was a transfer of 329 contract(s) at a $175.00 strike. This particular call needed to be split into 11 different trades to become filled. The total cost received by the writing party (or parties) was $45.4K, with a price of $138.0 per contract. There were 513 open contracts at this strike prior to today, and today 382 contract(s) were bought and sold. 
• For BHVN (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BHVN#NYSE">BHVN</a>), we notice a put option trade that happens to be bearish, expiring in 25 day(s) on October 18, 2024. This event was a transfer of 149 contract(s) at a $45.00 strike. The total cost received by the writing party (or parties) was $48.4K, with a price of $325.0 per contract. There were 74 open contracts at this strike prior to today, and today 365 contract(s) were bought and sold. 
• Regarding VKTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VKTX#NASDAQ">VKTX</a>), we observe a call option trade with neutral sentiment. It expires in 53 day(s) on November 15, 2024. Parties traded 150 contract(s) at a $60.00 strike. The total cost received by the writing party (or parties) was $189.7K, with a price of $1265.0 per contract. There were 4588 open contracts at this strike prior to today, and today 172 contract(s) were bought and sold. 
• For GMED (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GMED#NYSE">GMED</a>), we notice a put option sweep that happens to be bearish, expiring in 88 day(s) on December 20, 2024. This event was a transfer of 102 contract(s) at a $70.00 strike. This particular put needed to be split into 31 different trades to become filled. The total cost received by the writing party (or parties) was $31.6K, with a price of $310.0 per contract. There were 7 open contracts at this strike prior to today, and today 122 contract(s) were bought and sold. 
• For MNKD (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>), we notice a call option sweep that happens to be bullish, expiring in 53 day(s) on November 15, 2024. This event was a transfer of 100 contract(s) at a $3.50 strike. This particular call needed to be split into 5 different trades to become filled. The total cost received by the writing party (or parties) was $30.0K, with a price of $300.0 per contract. There were 121 open contracts at this strike prior to today, and today 100 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

BHVN

BNTX

GMED

MNKD

TGTX

VKTX

10 Health Care Stocks With Whale Alerts In Today's Session

BMO Capital analyst Evan Seigerman maintains Bristol-Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) with a Market Perform and maintains $48 price target.

BMO Capital Maintains Market Perform on Bristol-Myers Squibb, Maintains $48 Price Target

The experimental drug KarXT, developed by Karuna Therapeutics, is expected to receive FDA approval later this month (Sept. 26), marking a significant breakthrough in schizophrenia treatment.
If approved, KarXT would become the first novel schizophrenia drug in over 70 years, offering new hope for patients and medical professionals alike.
Schizophrenia, a mental disorder that affects approximately 3.8 million adults in the U.S., is often characterized by severe symptoms such as social isolation, memory issues and psychotic episodes.
Last year, Bristol-Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) acquired Karuna Therapeutics for $330 per share in cash for a total equity value of $14 billion, or $12.7 billion net of <a href="https://www.benzinga.com/markets/equities/23/12/36388646/bristol-myers-acquisition-of-karuna-therapeutics-paves-way-for-aggressive-global-marketing-of-ka" target="_blank" rel="noreferrer noopener">estimated cash acquired</a>. 
The Financial Times <a target="_blank" href="https://www.ft.com/content/427d37df-e2e9-4b67-87be-29f2a258de00" rel="noreferrer noopener">highlights</a> that existing treatments, mainly focused on blocking dopamine receptors, often come with serious side effects, including weight gain and involuntary movements.
Despite the enthusiasm surrounding KarXT, the complexity and financial constraints of the U.S. health care system could limit access to this new treatment.
High drug pricing could also hinder access; the Institute for Clinical and Economic Review has suggested KarXT be priced at up to $20,000 per year.
In August, AbbVie Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) completed the acquisition of Cerevel Therapeutics, another company focused on developing drugs for neurological disorders, for a total equity value of approximately $8.7 billion, or <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/12/36138732/abbvies-new-9b-neuroscience-space-deal-might-attract-ftc-scrutiny-analyst-signals" rel="noreferrer noopener">$45 per share in cash</a>.
The challenges extend beyond the cost and availability of medications, the Financial Times report adds. Many individuals with mental health conditions, particularly schizophrenia, encounter law enforcement rather than health care professionals during crises.
While KarXT&#8217;s approval could represent a crucial step forward, many experts, including Michael Thompson, a criminal justice expert, say that more systemic changes are needed to ensure mental health care is accessible and effective, especially for vulnerable populations like the homeless, according to FT. 

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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<li><a href="https://www.benzinga.com/general/biotech/24/09/40963228/zevra-therapeutics-drug-becomes-first-fda-approved-treatment-for-ultra-rare-neurodegenerative-dis" target="_blank" rel="noreferrer noopener">Zevra Therapeutics&#8217; Drug Becomes First FDA-Approved Treatment For Ultra-Rare Neurodegenerative Disease</a></li>
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Photo via Pixabay.

ABBV

Bristol-Myers Acquired Drug KarXT Poised For FDA Approval As First New Type Of Schizophrenia Treatment In 70 Years

Wednesday, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) announced new data from the Phase 3 Daybreak trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with Zeposia (ozanimod) for relapsing <a href="https://www.benzinga.com/pressreleases/24/09/b40915829/new-long-term-zeposia-ozanimod-data-demonstrate-durable-efficacy-and-consistent-safety-in-relapsin" target="_blank" rel="noreferrer noopener">forms of multiple sclerosis</a>.
These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: Radiance, −0.27; Sunbeam, −0.35).
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534057/cancer-medicines-from-merck-bristol-myers-and-beigene-in-question-as-fda-committee-to-discuss-lim" rel="noreferrer noopener">Cancer Medicines From Merck, Bristol Myers, And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer</a>.
Additionally, findings from a separate Daybreak OLE safety analysis demonstrated declining or stable incidence rates of treatment-emergent adverse events (TEAEs), with relatively low rates of infections, serious infections and opportunistic infections over more than eight years of treatment with Zeposia.
These will be presented at the 40th&nbsp;Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
The Daybreak OLE trial included 2,257 patients from the Sunbeam and Radiance Phase 3 trials and evaluated rates of brain volume loss.
Switching from interferon beta-1a (IFN-β) to Zeposia treatment consistently reduced rates of WBV loss (annualized LSM% change from Radiance baseline to Month 24 and Daybreak baseline to Month 24: −0.48 and −0.19, respectively, with a similar pattern observed in Sunbeam).
Additionally, similar reductions were observed for changes in thalamic volume loss.
High annualized LSM% reductions in cortical grey matter volume (CGMV) were observed with IFN-β (annualized change at Month 12 relative to Sunbeam baseline: −1.02; annualized change at Month 24 relative to RADIANCE baseline: −0.59), but this trend reversed 12 months after switching to Zeposia in Daybreak (annualized LSM% increase relative to Daybreak baseline: patients from Sunbeam, 0.10; patients from Radiance, 0.20), with low annualized LSM% CGMV loss observed after that.
Price Action: BMY stock is up 0.40% at $49.69 during the premarket session at last check Wednesday.
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Image: Shutterstock

Bristol Myers Squibb Presents Data For Multiple Sclerosis Drug Zeposia, Shows Long-Term Efficacy

Bristol Myers Says New Data From Phase 3 DAYBREAK Trial Showed Decreased Rates Of Brain Volume Loss Were Sustained In Open-label Extension For Patients Treated With Zeposia (Ozanimod) For Relapsing Forms Of Multiple Sclerosis

8 analysts have expressed a variety of opinions on Bristol-Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) over the past quarter, offering a diverse set of opinions from bullish to bearish.
The table below offers a condensed view of their recent ratings, showcasing the changing sentiments over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th style="text-align: right;">Bullish</th>
<th style="text-align: right;">Somewhat Bullish</th>
<th style="text-align: right;">Indifferent</th>
<th style="text-align: right;">Somewhat Bearish</th>
<th style="text-align: right;">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">6</td>
<td style="text-align: right;">2</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">3</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">1</td>
<td style="text-align: right;">0</td>
<td style="text-align: right;">0</td>
</tr>
</tbody>
</table>
In the assessment of 12-month price targets, analysts unveil insights for Bristol-Myers Squibb, presenting an average target of $46.0, a high estimate of $53.00, and a low estimate of $41.00. Witnessing a positive shift, the current average has risen by 0.26% from the previous average price target of $45.88.
<img src="https://www.benzinga.com/files/images/story/2024/1726520462_0.png" alt="price target chart" />
<h2>Interpreting Analyst Ratings: A Closer Look</h2>
A clear picture of Bristol-Myers Squibb's perception among financial experts is painted with a thorough analysis of recent analyst actions. The summary below outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Olivia Brayer</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Neutral</td>
<td>$50.00</td>
<td>$50.00</td>
</tr>
<tr>
<td>Akash Tewari</td>
<td>Jefferies</td>
<td>Raises</td>
<td>Hold</td>
<td>$51.00</td>
<td>$49.00</td>
</tr>
<tr>
<td>Carter Gould</td>
<td>Barclays</td>
<td>Raises</td>
<td>Underweight</td>
<td>$42.00</td>
<td>$41.00</td>
</tr>
<tr>
<td>Steve Scala</td>
<td>TD Cowen</td>
<td>Raises</td>
<td>Hold</td>
<td>$53.00</td>
<td>$45.00</td>
</tr>
<tr>
<td>Carter Gould</td>
<td>Barclays</td>
<td>Maintains</td>
<td>Underweight</td>
<td>$41.00</td>
<td>$41.00</td>
</tr>
<tr>
<td>James Shin</td>
<td>Deutsche Bank</td>
<td>Lowers</td>
<td>Hold</td>
<td>$45.00</td>
<td>$53.00</td>
</tr>
<tr>
<td>Olivia Brayer</td>
<td>Cantor Fitzgerald</td>
<td>Maintains</td>
<td>Neutral</td>
<td>$45.00</td>
<td>$45.00</td>
</tr>
<tr>
<td>Carter Gould</td>
<td>Barclays</td>
<td>Lowers</td>
<td>Equal-Weight</td>
<td>$41.00</td>
<td>$43.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts frequently update their recommendations based on evolving market conditions and company performance. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Bristol-Myers Squibb. This information provides a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Delving into assessments, analysts assign qualitative values, from 'Outperform' to 'Underperform'. These ratings communicate expectations for the relative performance of Bristol-Myers Squibb compared to the broader market.</li>
<li>Price Targets: Gaining insights, analysts provide estimates for the future value of Bristol-Myers Squibb's stock. This comparison reveals trends in analysts' expectations over time.</li>
</ul>
Understanding these analyst evaluations alongside key financial indicators can offer valuable insights into Bristol-Myers Squibb's market standing. Stay informed and make well-considered decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/BMY/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Bristol-Myers Squibb analyst ratings.</a>
<h2>Get to Know Bristol-Myers Squibb Better</h2>
Bristol-Myers Squibb discovers, develops, and markets drugs for various therapeutic areas, such as cardiovascular, cancer, and immune disorders. A key focus for Bristol is immuno-oncology, where the firm is a leader in drug development. Bristol derives close to 70% of total sales from the U.S., showing a higher dependence on the U.S. market than most of its peer group.
<h3>Bristol-Myers Squibb's Financial Performance</h3>
Market Capitalization Analysis: Falling below industry benchmarks, the company's market capitalization reflects a reduced size compared to peers. This positioning may be influenced by factors such as growth expectations or operational capacity.
Revenue Growth: Bristol-Myers Squibb's revenue growth over a period of 3 months has been noteworthy. As of 30 June, 2024, the company achieved a revenue growth rate of approximately 8.69%. This indicates a substantial increase in the company's top-line earnings. As compared to its peers, the revenue growth lags behind its industry peers. The company achieved a growth rate lower than the average among peers in Health Care sector.
Net Margin: Bristol-Myers Squibb's net margin is impressive, surpassing industry averages. With a net margin of 13.77%, the company demonstrates strong profitability and effective cost management.
Return on Equity (ROE): Bristol-Myers Squibb's ROE is below industry averages, indicating potential challenges in efficiently utilizing equity capital. With an ROE of 10.03%, the company may face hurdles in achieving optimal financial returns.
Return on Assets (ROA): The company's ROA is a standout performer, exceeding industry averages. With an impressive ROA of 1.73%, the company showcases effective utilization of assets.
Debt Management: Bristol-Myers Squibb's debt-to-equity ratio is below the industry average at 3.17, reflecting a lower dependency on debt financing and a more conservative financial approach.
<h2>How Are Analyst Ratings Determined?</h2>
Experts in banking and financial systems, analysts specialize in reporting for specific stocks or defined sectors. Their comprehensive research involves attending company conference calls and meetings, analyzing financial statements, and engaging with insiders to generate what are known as analyst ratings for stocks. Typically, analysts assess and rate each stock once per quarter.
Some analysts publish their predictions for metrics such as growth estimates, earnings, and revenue to provide additional guidance with their ratings. When using analyst ratings, it is important to keep in mind that stock and sector analysts are also human and are only offering their opinions to investors.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

What Analysts Are Saying About Bristol-Myers Squibb Stock

Cantor Fitzgerald analyst Olivia Brayer reiterates Bristol-Myers Squibb (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) with a Neutral and maintains $50 price target.

Reiteration

Cantor Fitzgerald Reiterates Neutral on Bristol-Myers Squibb, Maintains $50 Price Target

<ul>
<li>Objective response rate (ORR) 29%, confirmed ORR (cORR) 25%, disease control rate (DCR) of 53% and tumor shrinkage rate of 53% in the efficacy population treated with relevant IMA401 doses and MAGEA4/8 target levels.</li>
<li>Objective responses observed in head and neck squamous cell carcinoma, neuroendocrine tumor, cutaneous and mucosal melanoma including durable ongoing partial responses of up to 13+ months and deep responses (tumor shrinkage of ≥50%).</li>
<li>Pharmacokinetics data indicate a median terminal half-life of over two weeks, supporting the current q2w (once every two weeks) schedule and the pursuit of future dosing schedules of up to q4w.</li>
<li>Immatics to regain full clinical development and commercialization rights to IMA401 due to ongoing portfolio prioritization efforts within Bristol Myers Squibb; Phase 1 dose escalation trial with IMA401 is ongoing and will continue to be conducted by Immatics.</li>
</ul>

IMTX

Immatics Presented The Proof-of-concept Clinical Data For TCER IMA401 (MAGEA4/8) At The ESMO Congress

Biggest stock movers Friday: BB, BMY, and more

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In a report released today, Srikripa Devarakonda from Truist Financial assigned a Buy rating to Bristol-Myers Squibb (BMY – Research Report). The c...

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Bristol-Myers Squibb: Cobenfy Approval A Major Coup For The Dealmaker (Upgrade)

BMEA

BMYMP

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Screenshot 2024-02-29 at 7.16.11 PM

ATNM

COEP

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Press Releases

Bristol Myers Squibb Employees to Relay Nearly 3,000 Miles Cross-Country Aspiring to Raise Over $1 Million for the V Foundation for Cancer Research

Bristol Myers Squibb to Present Data at ESMO Demonstrating Ongoing Leadership in Immuno-Oncology and Progression of Assets from Its Differentiated Research Platforms

Bristol Myers Squibb Announces Dividend

Bristol Myers Squibb to Report Results for Third Quarter 2024 on October 31, 2024

Bristol Myers Squibb Presents Landmark 10-Year Follow-Up Data from CheckMate -067 Which Showed Continued Durable Long-Term Survival Benefit with Opdivo® plus Yervoy® in Advanced Melanoma

Immatics Presents Clinical Proof-of-Concept Data from Ongoing Phase 1 Dose Escalation Trial with TCR Bispecific Molecule TCER® IMA401 Targeting MAGEA4/8 at ESMO 2024 and Provides Development Update

New Long-Term Zeposia (ozanimod) Data Demonstrate Durable Efficacy and Consistent Safety in Relapsing Forms of Multiple Sclerosis

U.S. Food and Drug Administration Approves Bristol Myers Squibb's COBENFY™ (xanomeline and trospium chloride), a First-In-Class Muscarinic Agonist for the Treatment of Schizophrenia in Adults

PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults

Bristol Myers Squibb Presents New Data from Two Trials Demonstrating Sotyktu (deucravacitinib) Efficacy in both Moderate-to-Severe Scalp Psoriasis and in a Real-World Setting

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