Intra-Cellular Therapies 주식 (NASDAQ: ITCI)

에 대한 최신 뉴스 Intra-Cellular Therapies (NASDAQ:ITCI) 주식

Intra-Cellular Therapies

Intra-Cellular Therapies Inc is a biopharmaceutical company that develops novel drugs for treating diseases of the central nervous system. The company is focused on the delivery and clinical development of small-molecule drugs that address needs in neuropsychiatric and neurological disorders. Intra-Cellular maintains proprietary chemistry platforms to develop drugs for neurodegenerative diseases. The company's business segment is discovering and developing drugs for the treatment of neurological and psychiatric disorders.

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1월 13일부터 1월 17일까지 지난주 최고의 성과를 낸 대형주 11종목은 다음과 같다. 여러분의 포트폴리오에도 포함되어 있는지 확인해 보자.  마이크로스트레티지, 소파이 테크놀로지스, 카바나, 인트라 셀룰라, 로빈후드, 베이진, JD닷컴, 빌더스 퍼스트소스, 심보틱, 샤오펑, 유나이티드 렌탈스

마이크로스트레티지, 소파이 테크놀로지스, 카바나 등 지난주 급등한 대형주 (1월 13일~17일)

CTTAF

FTAI

NVDA

RPRX

SNAP

이들 10개 대형주는 지난주 최고의 성과를 거두었다. 그것들이 당신의 포트폴리오에 있나요? 1. 월그린스 부츠 얼라이언스(NASDAQ:WBA)의 주가가 회사가 예상보다 나은 1분기 재무결과를 발표한 후 27.97% 상승했다.

월그린스, 마이크론 및 델타 항공은 지난주 최고 성과를 보여준 10개 대형주 중 일부 (1월 6일-10일)

AMKR

BILI

BRFS

IBRX

IRTC

OLLI

RKLB

TALO

이들 중형주들은 지난주 최고의 성과를 거두었다. 그것들이 당신의 포트폴리오에 있나요? 빌리빌리(NASDAQ:BILI)의 주가는 지난주 &#39;산구오: 무딩티엔샤(San Guo: Mou Ding Tian Xia)&#39; 발표 이후 23.32% 상승했다. 또한 JP모건 애널리스트 다니엘 첸(Daniel Chen)은 중국의 빌리빌리를 중립에서 비중확대로 상향 조정하고 21달러 가격 목표를 발표했다. 

빌리빌리와 올리즈 바겐은 지난주 최대 성과를 보인 10개 중형주 중 일부 (6월 16일-6월 22일)

Intra-Cellular Therapies Inc. - Common Stock

Intra-Cellular Therapies Inc

These eleven large-cap stocks were the best performers in the last week. Are they in your portfolio?
<ol>
<li>Intra-Cellular Therapies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) stock surged 33.02% after Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) entered into a definitive agreement to acquire the company for $132 per share in cash, valuing <a href="https://www.benzinga.com//node/42959061" target="_blank" rel="noreferrer noopener">it at approximately $14.6 billion</a>. A couple of analysts <a href="https://www.benzinga.com/quote/itci/analyst-ratings" target="_blank" rel="noreferrer noopener">downgraded the stock</a>.</li>
<li>MicroStrategy Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSTR#NASDAQ">MSTR</a>) stock grew 20.92% on <a href="https://www.benzinga.com//node/43062726" target="_blank" rel="noreferrer noopener">Bitcoin's continued upward momentum</a>.</li>
<li>Robinhood Markets, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HOOD#NASDAQ">HOOD</a>) stock upped 20.13% after announcing a $45 million <a href="https://www.benzinga.com//node/42971991" target="_blank" rel="noreferrer noopener">settlement with the SEC</a>.</li>
<li>Carvana Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVNA#NYSE">CVNA</a>) stock rose 19.39% after Hindenburg Research, which previously issued a short report on the stock, <a href="https://www.benzinga.com//node/43034961" target="_blank" rel="noreferrer noopener">announced it would close down</a>.</li>
<li>BeiGene, Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONC#NASDAQ">ONC</a>) shares gained 18.88% last week.</li>
<li>JD.com, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JD#NASDAQ">JD</a>) shares were up 17.82% on the acceleration of China's economic activity, beating expectations for the last quarter of 2024 <a href="https://www.benzinga.com//node/43062957" target="_blank" rel="noreferrer noopener">as stimulus measures kicked in</a>.</li>
<li>Builders FirstSource, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BLDR#NYSE">BLDR</a>) stock upped 17.26%.</li>
<li>SoFi Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SOFI#NASDAQ">SOFI</a>) shares escalated 16.61%. The company disclosed a personal loan securitization agreement <a href="https://www.benzinga.com//node/43037459" target="_blank" rel="noreferrer noopener">with a global fixed-income manager on Thursday</a>.</li>
<li>Symbotic Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SYM#NASDAQ">SYM</a>) shares increased 16.30% after the company announced an agreement to acquire Walmart Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WMT#NYSE">WMT</a>) <a href="https://www.benzinga.com//node/43026684" target="_blank" rel="noreferrer noopener">Advanced Systems and Robotics business</a>. Northland Capital Markets maintained an Outperform rating while raising the price <a href="https://www.benzinga.com/quote/sym/analyst-ratings" target="_blank" rel="noreferrer noopener">forecast to $41 from $35</a>.</li>
<li>XPeng Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XPEV#NYSE">XPEV</a>) stock gained 15.63% last week after China's central bank <a href="https://www.benzinga.com//node/42974632" target="_blank" rel="noreferrer noopener">reportedly indicated</a> it would take measures to support economic growth. China's GDP growth data also <a href="https://www.benzinga.com//node/43062957" target="_blank" rel="noreferrer noopener">fueled optimism</a>.</li>
<li>United Rentals, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/URI#NYSE">URI</a>) stock upped 14.91% after announcing <a href="https://www.benzinga.com//node/42974291" target="_blank" rel="noreferrer noopener">it would acquire</a> H&amp;E Equipment Services, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HEES#NASDAQ">HEES</a>) for $4.8 billion. Additionally, Baird upgraded the stock <a href="https://www.benzinga.com/quote/uri/analyst-ratings" target="_blank" rel="noreferrer noopener">from Underperform to Neutral</a>.</li>
</ol>
Photo by JOCA_PH on Shutterstock

MicroStrategy, SoFi Technologies And Carvana Are Among Top Large-Cap Gainers Last Week (Jan 13-Jan 17): Are The Others In Your Portfolio?

Piper Sandler analyst David Amsellem downgrades Intra-Cellular Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) from Overweight to Neutral and raises the price target from $107 to $132.

Downgrades

Price Target

Analyst Ratings

Piper Sandler Downgrades Intra-Cellular Therapies to Neutral, Raises Price Target to $132

<h3>Gainers</h3>
<ul>
<li>Salarius Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>) stock increased by 185.6% to $4.47 during Monday's pre-market session. The market value of their outstanding shares is at $6.4 million. </li>
<li>Phio Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) stock moved upwards by 141.42% to $4.08. The market value of their outstanding shares is at $7.0 million. </li>
<li>Agape ATP (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATPC#NASDAQ">ATPC</a>) stock moved upwards by 69.84% to $2.14. The company's market cap stands at $8.5 million. </li>
<li>Sage Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) stock increased by 38.01% to $7.66. The company's market cap stands at $468.5 million. </li>
<li>Intra-Cellular Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) stock moved upwards by 34.76% to $127.85. The market value of their outstanding shares is at $13.5 billion. </li>
<li>Kairos Pharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/KAPA#AMEX">KAPA</a>) shares rose 34.02% to $1.3. The market value of their outstanding shares is at $16.7 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>AirSculpt Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AIRS#NASDAQ">AIRS</a>) stock fell 31.4% to $4.1 during Monday's pre-market session. The company's market cap stands at $237.3 million. </li>
<li>NAYA Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAYA#NASDAQ">NAYA</a>) shares fell 27.47% to $0.59. The company's market cap stands at $2.9 million. </li>
<li>GT Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTBP#NASDAQ">GTBP</a>) shares decreased by 21.51% to $2.08. The market value of their outstanding shares is at $4.6 million. </li>
<li>Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) shares decreased by 21.02% to $33.37. The market value of their outstanding shares is at $12.8 billion. </li>
<li>Dyadic International (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DYAI#NASDAQ">DYAI</a>) stock fell 19.4% to $1.33. The market value of their outstanding shares is at $39.3 million. </li>
<li>AEON Biopharma (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AEON#AMEX">AEON</a>) shares decreased by 19.19% to $0.15. The market value of their outstanding shares is at $11.9 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

AEON

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ATPC

DYAI

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SLRX

12 Health Care Stocks Moving In Monday's Pre-Market Session

Shares of Intra-Cellular Therapies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) are trading higher Monday after Johnson &amp; Johnson agreed to <a href="https://www.benzinga.com/pressreleases/25/01/g42940221/johnson-johnson-strengthens-neuroscience-leadership-with-acquisition-of-intra-cellular-therapies-i">acquire the company</a>.
What To Know: Johnson &amp; Johnson on Monday entered into a definitive agreement to acquire all outstanding shares of Intra-Cellular Therapies for $132 per share in cash in a deal that values the company at approximately $14.6 billion. 
The acquisition is expected to strengthen Johnson &amp; Johnson&#8217;s presence in neuroscience, and includes Intra-Cellular Therapies&#8217; CAPLYTA (lumateperone), a once-daily oral treatment approved by the FDA for schizophrenia and depressive episodes linked to bipolar I and II disorder.
Johnson &amp; Johnson also gains a pipeline, including ITI-1284, which is being tested for generalized anxiety disorder and Alzheimer's-related psychosis and agitation.
In December 2024, Intra-Cellular Therapies submitted a supplemental new drug application for CAPLYTA as an adjunctive treatment for major depressive disorder. If approved, the drug could become a key player in treating common depressive disorders, potentially generating over $5 billion in annual sales.
The transaction is expected to close later this year, pending regulatory and shareholder approvals. Once completed, Intra-Cellular Therapies&#8217; stock will be delisted from the Nasdaq. Johnson &amp; Johnson plans to fund the acquisition with cash on hand and debt. Johnson &amp; Johnson is also expected to provide commentary on any potential impact to adjusted earnings when it reports financial results on Jan. 22. 
ITCI Price Action: Intro-Cellular shares were up 34.2% at $127.27 at the time of writing Monday, according to <a href="https://pro.benzinga.com/dashboard?new_user=False&amp;backend=google-oauth2">Benzinga Pro.</a>
<figure class="wp-block-image size-large is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent011325&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="1024" height="523" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08-1024x523.png" alt="" class="wp-image-731191" style="width:493px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08-1024x523.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08-300x153.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08-768x392.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08-1536x784.png 1536w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/13142141/Screenshot-2025-01-13-at-14.15.08.png 1546w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
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Photo by solarseven on Shutterstock.

Intra-Cellular Therapies Stock Is Surging Monday: What's Going On?

U.S. stocks traded mixed toward the end of trading, with the Nasdaq Composite falling around 150 points on Monday.
The Dow traded up 0.64% to 42,206.46 while the NASDAQ dipped 0.79% to 19,010.47. The S&amp;P 500 also fell, dropping, 0.11% to 5,820.34.
Check This Out: <a href="https://www.benzinga.com/news/earnings/25/01/42944267/how-to-earn-500-a-month-from-fastenal-stock-ahead-of-q4-earnings">How To Earn $500 A Month From Fastenal Stock Ahead Of Q4 Earnings</a>
Leading and Lagging Sectors Energy shares rose by 1.6% on Monday.
In trading on Monday, utilities shares tumbled by 1.8%.
Top Headline
U.S. consumer inflation expectations for the year ahead came in unchanged at 3% in December, the same as in the previous month.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) shares shot up 426% to $6.43 after the company reported promising results of second cohort from its ongoing clinical study of PH-762.</li>
<li>Shares of Salarius Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>)got a boost, surging 159% to $4.04. Salarius Pharmaceuticals and Decoy Therapeutics announced a definitive merger agreement.</li>
<li>Intra-Cellular Therapies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) shares were also up, gaining 34% to $127.42 after Johnson &amp; Johnson agreed to acquire the company for $132.00 per share in cash for a total equity value of approximately $14.6 billion.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) shares dropped 20% to $33.67 after the company updated its 2025 expected revenue range to $1.5 billion to $2.5 billion, below analyst estimates of $2.951 billion.</li>
<li>Shares of Abercrombie &amp; Fitch Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ANF#NYSE">ANF</a>) were down 18% to $132.09 after issuing mixed fourth-quarter and FY24 guidance.</li>
<li>Comtech Telecommunications Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMTL#NASDAQ">CMTL</a>) was down, falling 48% to $2.15 after the company announced downbeat quarterly results.</li>
</ul>
Commodities In commodity news, oil traded up 2.7% to $78.66 while gold traded down 1.4% at $2,677.60.
Silver traded down 3.1% to $30.345 on Monday, while copper rose 0.4% to $4.3195.
Euro zone
European shares closed lower today. The eurozone's STOXX 600 declined 0.55%, Germany's DAX 40 fell 0.41% and France's CAC 40 dipped 0.30%. Spain's IBEX 35 Index fell 0.28%, while London's FTSE 100 slipped 0.29%.
Asia Pacific Markets
Asian markets closed lower on Monday, with China's Shanghai Composite Index falling 0.25%, Hong Kong's Hang Seng Index declining 1% and India's BSE Sensex falling 1.36%.
Economics
U.S. consumer inflation expectations for the year ahead came in unchanged at 3% in December, the same as in the previous month.
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</ul>

Earnings

Eurozone

Commodities

Intraday Update

Markets

CMTL

Gold Down Over 1%; Salarius Pharmaceuticals Shares Surge

U.S. stocks traded mixed midway through trading, with the Dow Jones index gaining around 50 points on Monday.
The Dow traded up 0.13% to 41,992.95 while the NASDAQ dipped 1.42% to 18,888.78. The S&amp;P 500 also fell, dropping, 0.70% to 5,786.44.
Check This Out: <a href="https://www.benzinga.com/news/earnings/25/01/42944267/how-to-earn-500-a-month-from-fastenal-stock-ahead-of-q4-earnings">How To Earn $500 A Month From Fastenal Stock Ahead Of Q4 Earnings</a>
Leading and Lagging Sectors Energy shares rose by 2.2% on Monday.
In trading on Monday, utilities shares tumbled by 1.9%.
Top Headline 
Sage Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) confirmed that Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) submitted an unsolicited, nonbinding proposal to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen for $7.22 per share.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) shares shot up 418% to $8.76 after the company reported promising results of second cohort from its ongoing clinical study of PH-762.</li>
<li>Shares of Salarius Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLRX#NASDAQ">SLRX</a>)got a boost, surging 277% to $5.87. Salarius Pharmaceuticals and Decoy Therapeutics announced a definitive merger agreement.</li>
<li>Intra-Cellular Therapies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) shares were also up, gaining 35% to $127.72 after Johnson &amp; Johnson agreed to acquire the company for $132.00 per share in cash for a total equity value of approximately $14.6 billion.</li>
</ul>
<ul>
<li>Equities Trading DOWN</li>
<li>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) shares dropped 22% to $33.13 after the company updated its 2025 expected revenue range to $1.5 billion to $2.5 billion, below analyst estimates of $2.951 billion.</li>
<li>Shares of Abercrombie &amp; Fitch Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ANF#NYSE">ANF</a>) were down 20% to $129.03 after issuing mixed fourth-quarter and FY24 guidance.</li>
<li>Comtech Telecommunications Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMTL#NASDAQ">CMTL</a>) was down, falling 47% to $2.1901 after the company announced downbeat quarterly results.</li>
</ul>
Commodities In commodity news, oil traded up 3.1% to $78.93 while gold traded down 1.1% at $2,685.60.
Silver traded down 3% to $30.37 on Monday, while copper rose 0.8% to $4.3365.
Euro zone
European shares were lower today. The eurozone's STOXX 600 declined 0.45%, Germany's DAX 40 fell 0.26% and France's CAC 40 dipped 0.11%. Spain's IBEX 35 Index fell 0.23%, while London's FTSE 100 slipped 0.19%.
Asia Pacific Markets
Asian markets closed lower on Monday, with China's Shanghai Composite Index falling 0.25%, Hong Kong's Hang Seng Index declining 1% and India's BSE Sensex falling 1.36%.
Economics
Data on consumer inflation expectations will be released today.
Now Read This: 
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<li><a href="https://www.benzinga.com/25/01/42947348/tesla-to-rally-around-9-here-are-10-top-analyst-forecasts-for-monday">Tesla To Rally Around 9%? Here Are 10 Top Analyst Forecasts For Monday</a></li>
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BIIB

Crude Oil Surges 3%; Abercrombie & Fitch Shares Plunge

U.S. stocks were mixed, with the Dow Jones index gaining over 200 points on Monday.
Shares of Intra-Cellular Therapies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) rose sharply during Monday's session after Johnson &amp; Johnson agreed to acquire the company for $132.00 per share in cash for a total equity value of <a href="https://www.benzinga.com/general/biotech/25/01/42948170/like-bristol-myers-squibb-and-abbvie-johnson-johnson-seeks-to-bolster-neuropsychiatric-portfolio-with-15-billion-deal">approximately $14.6 billion</a>.
With this agreement, Johnson &amp; Johnson adds Intra-Cellular Therapies' Caplyta (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate.
Intra-Cellular Therapies shares jumped 34.6% to $127.62 on Monday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>Sage Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) shares jumped 35.5% to $7.52. On Friday, Sage Therapeutics confirmed that Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) submitted an unsolicited, nonbinding proposal to acquire all of the outstanding shares of Sage Therapeutics not already owned by Biogen for $7.22 per share.</li>
<li>Standard BioTools Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LAB#NYSE">LAB</a>) gained 24% to $2.0250 after the company announced preliminary fourth-quarter and FY24 financial results.</li>
<li>LSB Industries, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LXU#NYSE">LXU</a>) rose 21% to $9.00 after Piper Sandler upgraded the stock from Underweight to Overweight and raised its price target from $9 to $11.</li>
<li>agilon health, inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AGL#NYSE">AGL</a>) gained 17% to $2.86.</li>
<li>SI-BONE, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SIBN#NASDAQ">SIBN</a>) rose 14.1% to $15.66 after the company announced preliminary revenue for the fourth quarter and full year 2024.</li>
<li>Critical Metals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRML#NASDAQ">CRML</a>) climbed 13.9% to $8.85.</li>
<li>Trump Media &amp; Technology Group Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DJT#NASDAQ">DJT</a>) rose 13% to $39.92.</li>
<li>Radiopharm Theranostics Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RADX#NASDAQ">RADX</a>) climbed 12.2% to $6.00.</li>
<li>Nu Skin Enterprises, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NUS#NYSE">NUS</a>) gained 11.4% to $6.93 as the company announced fourth-quarter preliminary revenue at high end of guidance.</li>
<li>Blueprint Medicines Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BPMC#NASDAQ">BPMC</a>) rose 10.4% to $96.43 after the company reported a year-over-year increase in FY24 AYVAKIT revenue results.</li>
<li>Radiopharm Theranostics Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RADX#NASDAQ">RADX</a>) gained 10.3% to $5.90. Radiopharm Theranostics announced it will execute a private placement and will raise $5 million in proceeds.</li>
<li>United States Steel Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/X#NYSE">X</a>) gained 8.5% to $37.15 amid a report that Cleveland-Cliffs will partner with Nucor to make a potential bid for the company.</li>
<li>Humana Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>) gained 6.6% to $286.90.</li>
<li>CF Industries Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CF#NYSE">CF</a>) rose 6.3% to $94.35. Piper Sandler analyst Charles Neivert upgraded CF Industries Holdings from Underweight to Overweight and raised the price target from $79 to $105.</li>
</ul>
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<li><a href="https://www.benzinga.com/25/01/42947348/tesla-to-rally-around-9-here-are-10-top-analyst-forecasts-for-monday">Tesla To Rally Around 9%? Here Are 10 Top Analyst Forecasts For Monday</a></li>
</ul>

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CRML

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Intra-Cellular Therapies, Standard BioTools, SI-BONE And Other Big Stocks Moving Higher On Monday

Needham analyst Ami Fadia downgrades Intra-Cellular Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) from Buy to Hold and maintains the price target from $100 to $100.

Needham Downgrades Intra-Cellular Therapies to Hold, Maintains Price Target to $100

On Monday, Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) agreed to acquire Intra-Cellular Therapies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) for $132.00 per share in cash for a total equity value of <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42940221/johnson-johnson-strengthens-neuroscience-leadership-with-acquisition-of-intra-cellular-therapies-i" rel="noreferrer noopener">approximately $14.6 billion</a>.
Intra-Cellular Therapies is a biopharmaceutical company focused on developing and commercializing therapeutics for central nervous system (CNS) disorders.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41752158/intra-cellular-therapies-treatment-reduces-schizophrenia-relapse-risk-63" rel="noreferrer noopener">Intra-Cellular Therapies&#8217; Treatment Reduces Schizophrenia Relapse Risk 63%</a>
With this agreement, Johnson &amp; Johnson adds Intra-Cellular Therapies&#8217; Caplyta&nbsp;(lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder (bipolar depression), as a monotherapy and adjunctive therapy with lithium or valproate.
The acquisition also includes ITI-1284, a promising Phase 2 compound being studied in generalized anxiety disorder (GAD) and Alzheimer&#8217;s disease-related psychosis and agitation, as well as a clinical-stage pipeline that further complements and strengthens Johnson &amp; Johnson&#8217;s current areas of focus.
In December 2024, Intra-Cellular Therapies submitted a marketing application to the FDA for Caplyta&nbsp;as an adjunctive treatment for adults with major depressive disorder (MDD).
In two global Phase 3 studies, Caplyta, as an adjunctive treatment to antidepressants, demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms, as measured by both clinician-rated and patient-reported outcomes.
If approved, Caplyta&nbsp;has the potential to be the first treatment approved for MDD and depressive symptoms associated with bipolar I and II in more than 15 years.
Additional Phase 3 trials are underway with Caplyta in bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania).
Johnson &amp; Johnson expects to fund the transaction through cash on hand and debt.
In 204, Bristol-Myers Squibb&nbsp;&amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) added an oral medication for&nbsp;schizophrenia via Karuna Therapeutics deal for $330 per share in cash for a total equity&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41064867/schizophrenia-treatment-revolution-fda-approves-bristol-myers-squibb-cobenfy-as-new-class-of-trea" rel="noreferrer noopener">value of $14 billion</a>.
In November, AbbVie&nbsp;Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) released data from its two Phase 2 EMPOWER trials of&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41881546/abbvie-9billion-schizophrenia-studies-bristol-myers-stock-surges" rel="noreferrer noopener">emraclidine for schizophrenia</a>.
The patients experienced an acute exacerbation of psychotic symptoms and did not meet their primary endpoint of showing a statistically significant improvement in the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo group at week 6.
AbbVie added emraclidine via the approximately $8.7 billion acquisition of Cerevel Therapeutics.
Price Action: JNJ stock is up 0.86% at $143.28, and ITCI stock is up 34.5% at $127.62 at the last check on Monday.
Read Next:
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<li><a href="https://www.benzinga.com/25/01/42945266/why-department-store-chain-macys-stocks-are-sliding-on-monday-premarket" target="_blank" rel="noreferrer noopener">Why Is Department Store Chain Macy&#8217;s Stock Sliding Today?</a></li>
</ul>
Photo by Tada Images via Shutterstock

Biotech

Health Care

General

ABBV

Like Bristol-Myers Squibb And AbbVie, Johnson & Johnson Seeks To Bolster Neuropsychiatric Portfolio With $15 Billion Deal

<h3>Gainers</h3>
<ul>
<li>Agape ATP (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATPC#NASDAQ">ATPC</a>) shares increased by 81.0% to $2.28 during Monday's pre-market session. The company's market cap stands at $9.0 million. </li>
<li>Sage Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) shares moved upwards by 36.93% to $7.6. The company's market cap stands at $464.9 million. </li>
<li>Intra-Cellular Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) shares rose 35.56% to $128.61. The company's market cap stands at $13.6 billion. </li>
<li>GlucoTrack (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GCTK#NASDAQ">GCTK</a>) stock rose 32.73% to $0.16. The market value of their outstanding shares is at $2.4 million. </li>
<li>CytoMed Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GDTC#NASDAQ">GDTC</a>) stock moved upwards by 27.53% to $3.52. The market value of their outstanding shares is at $40.6 million. </li>
<li>GT Biopharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTBP#NASDAQ">GTBP</a>) shares increased by 26.03% to $3.34. The market value of their outstanding shares is at $7.4 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Ocular Therapeutix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCUL#NASDAQ">OCUL</a>) stock fell 14.7% to $7.0 during Monday's pre-market session. The company's market cap stands at $1.1 billion. </li>
<li>Indaptus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INDP#NASDAQ">INDP</a>) shares declined by 13.69% to $0.82. The market value of their outstanding shares is at $9.8 million. </li>
<li>Aligos Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALGS#NASDAQ">ALGS</a>) shares decreased by 12.7% to $29.43. The market value of their outstanding shares is at $105.5 million. </li>
<li>NovaBay Pharmaceuticals (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/NBY#AMEX">NBY</a>) stock fell 12.49% to $0.61. The market value of their outstanding shares is at $2.9 million. </li>
<li>AirSculpt Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AIRS#NASDAQ">AIRS</a>) stock declined by 12.21% to $5.25. The company's market cap stands at $303.8 million. </li>
<li>NAYA Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAYA#NASDAQ">NAYA</a>) stock declined by 12.11% to $0.71. The market value of their outstanding shares is at $3.5 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Johnson &amp; Johnson expects to fund the transaction through a combination of cash on hand and debt. Johnson &amp; Johnson expects to maintain a strong balance sheet and to continue to support its stated capital allocation priorities of R&amp;D investment, competitive dividends, value-creating acquisitions, and strategic share repurchases.
Johnson &amp; Johnson will provide commentary on any potential impact to Adjusted Earnings Per Share (EPS) from the transaction when it provides its initial full year 2025 guidance during the fourth quarter earnings call on Wednesday, January 22, 2025.
 &nbsp;

Johnson & Johnson Says Intra-Cellular Acquisition Includes CAPLYTA (Lumateperone), The First And Only US FDA-Approved Treatment For Bipolar I And II Depression As An Adjunctive And Monotherapy

WIIM

Intra-Cellular Therapies shares are trading higher after Johnson & Johnson agreed to acquire the company for $132.00 per share in cash.

Johnson & Johnson Agrees To Acquire Intra-cellular Therapies For $132.00 Per Share In Cash For Total Equity Value Of $14.6B

Johnson & Johnson Has Agreed To Acquire Intra-cellular Therapies For $132.00 Per Share In Cash For A Total Equity Value Of Approximately $14.6B

Shares of Sage Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAGE#NASDAQ">SAGE</a>) rose sharply in today's pre-market trading after the company confirmed the receipt of Biogen&#8217;s nonbinding $7.22/share <a href="https://www.benzinga.com/quote/SAGE">acquisition proposal</a>.
Sage Therapeutics shares jumped 34.2% to $7.45 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>Agape ATP Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATPC#NASDAQ">ATPC</a>) gained 86.5% to $2.35 in pre-market trading after gaining 8% on Friday.</li>
<li>GlucoTrack, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GCTK#NASDAQ">GCTK</a>) gained 62.3% to $0.1899 in pre-market trading after dipping over 15% on Friday.</li>
<li>Algorhythm Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIME#NASDAQ">RIME</a>) gained 47% to $0.1981 in pre-market trading after falling 18% on Friday.</li>
<li>Traws Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRAW#NASDAQ">TRAW</a>) rose 29.3% to $10.45 in pre-market trading. Expert Systems and Traws Pharma reported a breakthrough in H5N1Bird Flu Antiviral Program.</li>
<li>Cooper-Standard Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CPS#NYSE">CPS</a>) gained 26.3% to $16.69 in pre-market trading.</li>
<li>Intra-Cellular Therapies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) gained 22.3% to $116.00 in pre-market trading after Bloomberg Reported that J&amp;J is exploring a bid for the company.</li>
<li>Black Diamond Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDTX#NASDAQ">BDTX</a>) gained 18.5% to $2.29 in pre-market trading following a 5% decline on Friday.</li>
<li>QMMM Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QMMM#NASDAQ">QMMM</a>) gained 18% to $1.05 in pre-market trading.</li>
<li>Arcutis Biotherapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARQT#NASDAQ">ARQT</a>) rose 14.1% to $15.75 in pre-market trading after reporting preliminary unaudited fourth quarter product revenue and full-year 2024 product revenues.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>SEALSQ Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LAES#NASDAQ">LAES</a>) fell 24.8% to $4.31 in pre-market trading after gaining 9% on Friday.</li>
<li>Vision Marine Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VMAR#NASDAQ">VMAR</a>) fell 20.5% to $1.71 in today's pre-market trading after jumping 41% on Friday.</li>
<li>Direct Digital Holdings, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DRCT#NASDAQ">DRCT</a>) fell 19.5% to $1.32 in pre-market trading after jumping around 38% on Friday.</li>
<li>Castellum, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CTM#NYSE">CTM</a>) shares fell 18.6% to $0.8458 in pre-market trading after the company files for mixed shelf offering up to $100 million.</li>
<li>LeddarTech Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LDTC#NASDAQ">LDTC</a>) shares dipped 18.5% to $0.9624 in pre-market trading after declining around 14% on Friday.</li>
<li>Rigetti Computing, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGTI#NASDAQ">RGTI</a>) fell 17% to $7.41 in pre-market trading after dipping 11% on Friday.</li>
<li>D-Wave Quantum Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QBTS#NYSE">QBTS</a>) dipped 14.5% to $4.93 in pre-market trading.</li>
<li>ScanTech AI Systems Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/STAI#NASDAQ">STAI</a>) shares fell 14.5% to $1.95 in pre-market trading after gaining around 5% on Friday.</li>
<li>Mercury General Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MCY#NYSE">MCY</a>) declined 13.4% to $42.00 in pre-market trading. Mercury General shares dipped around 20% on Friday after the company announced it anticipates wildfire losses in Southern California to surpass $150 million in reinsurance retention levels.</li>
<li>Tredegar Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TG#NYSE">TG</a>) shares tumbled 8.1% to $6.82 in pre-market trading.</li>
</ul>
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</ul>

Pre-Market Outlook

ARQT

BDTX

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LDTC

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QMMM

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TRAW

VMAR

Why Sage Therapeutics Shares Are Trading Higher By Over 34%; Here Are 20 Stocks Moving Premarket

<a href="https://www.bloomberg.com/news/articles/2025-01-12/johnson-johnson-exploring-bid-for-intra-cellular?embedded-checkout=true" title="https://www.bloomberg.com/news/articles/2025-01-12/johnson-johnson-exploring-bid-for-intra-cellular?embedded-checkout=true">https://www.bloomberg.com/news/articles/2025-01-12/johnson-johnson-exploring-bid-for-intra-cellular?embedded-checkout=true</a>

Bloomberg Reported Sunday, J&J Explores Bid For Intra-Cellular Therapies

These ten large-cap stocks were the best performers in the last week. Are they in your portfolio?
<ol>
<li>Walgreens Boots Alliance, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WBA#NASDAQ">WBA</a>) stock gained 27.97% last week after the company <a href="https://www.benzinga.com//node/42912519" target="_blank" rel="noreferrer noopener">reported better-than-expected</a> first-quarter financial results.</li>
<li>Constellation Energy Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CEG#NASDAQ">CEG</a>) stock jumped 25.80% after the company announced an agreement to acquire Calpine Corp., an electricity generation company, in a cash and stock <a href="https://www.benzinga.com//node/42916941" target="_blank" rel="noreferrer noopener">deal valued at $16.4 billion</a>.</li>
<li>FTAI Aviation Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FTAI#NASDAQ">FTAI</a>) shares escalated by 20.48%.</li>
<li>TD SYNNEX Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SNX#NYSE">SNX</a>) stock was up 15.05% after the company reported better-than-expected <a href="https://www.benzinga.com//node/42915528" target="_blank" rel="noreferrer noopener">fourth-quarter financial results</a>.</li>
<li>Aurora Innovation, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AUR#NASDAQ">AUR</a>) shares grew 14.59% after the company announced a partnership with NVIDIA Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) and Continental AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/CTTAF#OTC">CTTAF</a>) to scale driverless trucks using NVIDIA's <a href="https://www.benzinga.com//node/42841305" target="_blank" rel="noreferrer noopener">next-gen DRIVE Thor SoC</a>.</li>
<li>Royalty Pharma plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RPRX#NASDAQ">RPRX</a>) shares are up 14.35% after the company announced it <a href="https://www.benzinga.com//node/42902266" target="_blank" rel="noreferrer noopener">increased its quarterly dividend</a>.</li>
<li>Micron Technology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MU#NASDAQ">MU</a>) shares rose 13.75%. The company announced an expansion of its collaboration with Pure Storage to develop high-capacity, energy-efficient <a href="https://www.benzinga.com//node/42853369" target="_blank" rel="noreferrer noopener">solutions using Micron G9 QLC NAND</a>.</li>
<li>Delta Air Lines, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DAL#NYSE">DAL</a>) stock upped 13.34% after the company reported better-than-expected<a href="https://www.benzinga.com//node/42912208" target="_blank" rel="noreferrer noopener"> results and issued 2025 guidance</a>.</li>
<li>Intra-Cellular Therapies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) stock gained 12.62%, entering into a settlement agreement with Sandoz and resolving a patent litigation related to CAPLYTA Patent.</li>
<li>United Airlines Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UAL#NASDAQ">UAL</a>) surged 12.24% in sympathy with Delta Air Lines, which rose after reporting strong <a href="https://www.benzinga.com//node/42919651" target="_blank" rel="noreferrer noopener">fourth-quarter financial results</a>.</li>
</ol>
Photo by VanderWolf via Shutterstock

Walgreens Boots Alliance, Aurora Innovation And Delta Air Lines Are Among Top Large Cap Gainers Last Week (Jan 6-10): Are The Others In Your Portfolio?

The settlement agreement&nbsp;permits&nbsp;Sandoz&nbsp;to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances.
Similar patent litigation brought by Intra-Cellular Therapies against other parties remains pending in the U.S. District Court for the District of New Jersey.&nbsp;

Legal

Intra-Cellular Therapies Enters Settlement Agreement With Sandoz Resolving Patent Litigation Related To CAPLYTA Patent; No Terms Disclosed

Intra-cellular Therapies Says It Has Entered Into A Settlement Agreement With Sandoz Inc. Resolving Patent Litigation Related To Intra-cellular Therapies' Product Caplyta (Lumateperone)

On Monday, Axsome Therapeutics, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42719707/axsome-therapeutics-announces-successful-completion-and-results-of-phase-3-clinical-program-of-axs" rel="noreferrer noopener">Alzheimer's disease agitation</a>.
The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation, demonstrating a 3.6-fold lower risk of relapse compared to placebo.
AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001). Further, AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to the placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42221091/axsome-therapeutics-axs-12-data-for-sleeping-disorder-boosts-confidence-in-approval-and-market-potential-analyst-says" rel="noreferrer noopener">Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says</a>
The ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint in delaying the time to relapse of agitation from baseline to Week 5, with reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively.
However, results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.
AXS-05 was safe and well tolerated in both controlled studies.
The long-term safety and tolerability of AXS-05 were also evaluated in more than 300 subjects treated for at least 6 months and more than 100 treated for at least 12 months.
In the controlled and long-term studies in subjects with Alzheimer's disease, AXS-05 was not associated with an increased risk of falls, cognitive decline, or sedation.
In the clinical program for AXS-05 in Alzheimer's disease agitation, there have been no deaths in subjects receiving AXS-05.
Axsome plans to submit an NDA for AXS-05 in Alzheimer's disease agitation to the FDA in the second half of 2025.
William Blair writes that the data from the trials represent a mixed scenario for investors to digest how regulators will interpret the total pivotal data package for AXS-05 in Alzheimer's disease agitation.
The analyst notes that neuropsychiatry drugs have been approved based on their overall data, even if they faced setbacks in key trials.
Examples include Intra-Cellular Therapies Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITCI#NASDAQ">ITCI</a>) Caplyta and Johnson &amp; Johnson's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) esketamine.
William Blair notes the approval of Otsuka Holdings Co Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/OTSKY#OTC">OTSKY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/OTSKF#OTC">OTSKF</a>) Rexulti for Alzheimer's-related agitation, despite mixed trial results, is a strong comparison for Axsome's AXS-05.
However, a key difference is that Rexulti's approval relied on placebo-controlled parallel group studies, while Axsome is expected to depend on results from the ADVANCE-1 and ACCORD-1/2 trials to meet the FDA's requirement for two well-controlled studies.
The analyst remains optimistic about AXS-05's approval, highlighting that the FDA's continued designation of AXS-05 as a breakthrough therapy reflects the high unmet need in this area, which could work in Axsome's favor.
Price Action: AXSM stock is up 2.62% to $87.00 premarket at the last check on Tuesday.
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Axsome Reveals Data From Alzheimer's Studies, Analyst Sees Hope Despite Mixed Trial Results

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Press Releases

Intra-Cellular Therapies Settles CAPLYTA® (lumateperone) Patent Litigation with Sandoz

Johnson & Johnson Strengthens Neuroscience Leadership with Acquisition of Intra-Cellular Therapies, Inc.

ITCI Stock Alert: Halper Sadeh LLC Is Investigating Whether the Sale of Intra-Cellular Therapies, Inc. Is Fair to Shareholders

$HAREHOLDER ALERT: The M&A Class Action Firm Investigates the Merger of Intra-Cellular Therapies, Inc. - ITCI

SHAREHOLDER NOTICE: Halper Sadeh LLC Investigates ENFN, ITCI, EDBL on Behalf of Shareholders

Shareholder Alert: Ademi LLP investigates whether Intra-Cellular Therapies, Inc. is obtaining a Fair Price for its Public Shareholders

INTRA-CELLULAR THERAPIES INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Intra-Cellular Therapies, Inc. - ITCI

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates ENFN, ITCI, EDBL on Behalf of Shareholders

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates ENFN and ITCI on Behalf of Shareholders

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Intra-Cellular Therapies

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