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AXSM's 2025 Revenue Surge Largely Driven by Auvelity: What's Ahead?
ZACKS· 2026-03-13 16:41
Core Insights - Axsome Therapeutics (AXSM) is experiencing significant growth driven by its lead drug, Auvelity (AXS-05), which is approved for major depressive disorder and has contributed substantially to the company's revenue since its U.S. launch in 2022 [1][9]. Sales Performance - In 2025, Auvelity achieved sales of $507.1 million in the U.S., reflecting a year-over-year increase of approximately 74% [2][9]. - The sales growth is attributed to an increase in unit sales volume, with expectations for continued momentum into 2026 [2]. - Sunosi, another drug in Axsome's portfolio, generated $124.8 million in sales in 2025, marking a 32% increase year-over-year [5][9]. - Axsome's newest product, Symbravo, launched in June 2025, recorded $6.6 million in sales in its first year [5]. Regulatory Developments - The FDA has accepted Axsome's supplemental new drug application (sNDA) for AXS-05 to treat Alzheimer's disease agitation, with a priority review and a decision expected by April 30, 2026 [3]. Clinical Development - Axsome plans to initiate a pivotal phase II/III study of AXS-05 for smoking cessation in the second quarter of 2026 [4]. Competitive Landscape - The CNS market remains competitive, with Acadia Pharmaceuticals' Nuplazid generating $691.9 million in sales in 2025, up 14.7% year-over-year [7]. - Sunosi may face competition from Jazz Pharmaceuticals' sleep disorder drugs, while Symbravo is expected to compete with established migraine treatments from Pfizer and AbbVie [8]. Valuation and Market Performance - Year-to-date, Axsome's shares have declined by 15.6%, contrasting with a 5.7% increase in the industry [10]. - Axsome's price-to-sales (P/S) ratio stands at 12.22, significantly higher than the industry average of 2.45, although below its five-year mean of 14.41 [11]. Earnings Estimates - The Zacks Consensus Estimate for 2026 has shifted from earnings of $0.34 per share to a projected loss of $1.29 per share, with 2027 estimates also decreasing from $5.85 to $5.12 [12].
Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non-muscle-invasive bladder cancer
Prnewswire· 2026-03-13 16:35
Core Insights - Johnson & Johnson announced promising results for Erda-iDRS, a targeted treatment for early-stage bladder cancer, showing an 89% complete response rate in intermediate-risk patients with durable responses over 18 months [1][2] Group 1: Study Results - The Phase 1 study evaluated Erda-iDRS in patients with intermediate-risk and high-risk non-muscle-invasive bladder cancer (NMIBC) with specific FGFR alterations [1] - In the intermediate-risk cohort, the complete response rate was 89% (95% CI, 78-95), with a median duration of complete response of 18 months (95% CI, 14-25) [1] - In the high-risk cohort, the median recurrence-free survival was 20 months (95% CI, 15-30), with a 12-month recurrence-free survival rate of 83% (95% CI, 62-93) [1] Group 2: Safety Profile - Treatment was generally well tolerated, with no dose-limiting toxicities; the most common treatment-related adverse events were hematuria (32%) and dysuria (22%) [1] - Serious treatment-related adverse events occurred in 2% of patients, and 9% discontinued treatment due to adverse events [1] Group 3: Future Development - Ongoing Phase 2 and Phase 3 studies are set to further evaluate Erda-iDRS in various risk settings, including the MoonRISe program [1] - The program includes studies targeting both intermediate-risk and high-risk NMIBC patients, focusing on adjuvant and ablative settings [1]
Allogene Therapeutics Posts Narrower-Than-Expected Loss in Q4
ZACKS· 2026-03-13 16:25
Core Insights - Allogene Therapeutics (ALLO) reported a narrower fourth-quarter 2025 loss of 17 cents per share, compared to the Zacks Consensus Estimate of a loss of 25 cents and a loss of 28 cents in the same quarter last year [1][5] - The company's shares have increased by 80% year-to-date, significantly outperforming the industry average growth of 4% [1] Financial Performance - Research and development (R&D) expenses for Q4 2025 were $28.6 million, a decrease of 36% from the previous year [3] - General and administrative (G&A) expenses fell by 11% year-over-year to $13.8 million [3] - Allogene ended 2025 with $258.3 million in cash and cash equivalents, down from $277 million as of September 30, 2025, which is expected to fund operations into the first quarter of 2028 [3] Annual Results - For the full year 2025, Allogene did not record any revenues and reported a loss of 87 cents per share, an improvement from the loss of $1.32 per share in the previous year [4] 2026 Guidance - The company anticipates full-year operating expenses to be around $210 million, including nearly $35 million in non-cash stock-based compensation [6] - Cash burn for the full year is expected to be approximately $150 million [6] Pipeline Updates - Allogene's primary focus is on the pivotal phase II ALPHA3 study evaluating cema-cel for treating newly diagnosed large B-cell lymphoma patients, with data expected in April 2026 [7] - The company has initiated the phase I RESOLUTION basket study for ALLO-329 in various autoimmune diseases, with initial data expected in June 2026 [8] - Allogene is also developing ALLO-316, currently in the phase I TRAVERSE study for advanced renal cell carcinoma, and is exploring partnership opportunities for its development [9]
GSK's RSV Vaccine, AREXVY, Approved in US for Expanded Age Indication in Adults Aged 18–49 Years at Increased Risk
Businesswire· 2026-03-13 15:44
Core Viewpoint - GSK's RSV vaccine, AREXVY, has received approval in the US for an expanded age indication, now including adults aged 18–49 years who are at increased risk [1] Group 1 - The approval of AREXVY marks a significant milestone for GSK in addressing respiratory syncytial virus (RSV) in a broader adult population [1] - The vaccine is specifically targeted at adults aged 18–49 years who are considered to be at increased risk, expanding its potential market [1]
US stock market today (March 13, 2026): Wall Street slips amid Iran war oil shock; inflation worries, volatile trading keep investors cautious
The Times Of India· 2026-03-13 15:31
Market Overview - The S&P 500 slipped 0.2% after an earlier rise of 0.9%, while the Dow Jones Industrial Average was up 34 points (0.1%) and the Nasdaq composite declined 0.4% [4][6] - Major indices are on track for a third consecutive weekly loss due to market turbulence [4][6] Energy Market - Brent crude traded above $100 per barrel, slightly lower than Thursday's close of $100.46, with prices surging over 37% this month [6] - US crude rose 0.1% to $95.83 per barrel, up approximately 43% this month [6] - Analysts warn that if disruptions in oil supply persist, prices could rise to around $150 per barrel [6] - The International Energy Agency announced a record release of 400 million barrels from emergency reserves, but some economists believe this may provide limited reassurance [5][6] Economic Data - Consumer prices rose 2.8% year-on-year in January, with core inflation climbing to 3.1%, the highest level in nearly two years [5][6] - Consumer spending and incomes increased by 0.4% during the month [5][6] - Job openings rose to nearly 7 million in January, exceeding economists' expectations [5][6] - The US economy grew at a subdued annual rate of 0.7% in the October-December quarter, revised down from earlier estimates [5][6] Sector Performance - Financial and healthcare stocks supported the broader market, with JPMorgan rising 1.1% and Eli Lilly gaining 1.6% [5][6] - Software firm Adobe dropped 6% despite beating revenue and profit forecasts, while Ulta Beauty tumbled 10.5% after reporting weaker-than-expected quarterly earnings [5][6] - Bitcoin climbed 4.6% to around $72,777, positively impacting shares of cryptocurrency-linked companies like Coinbase Global and Strategy [5][6] Bond Market - The yield on the 10-year Treasury eased to 4.25% from 4.26%, remaining higher than the 3.97% level seen before the conflict began [5][6] International Markets - European indices showed modest gains, with Britain's FTSE 100, Germany's DAX, and France's CAC 40 all moving higher [6] - In Asia, Japan's Nikkei 225 fell 1.2%, with technology stocks among the biggest losers, including a 4.5% decline in SoftBank Group [6]
CORT ALERT: Hagens Berman Alerts Corcept Therapeutics (CORT) Investors to Securities Class Action Following FDA Rejection and Federal Court Patent Loss
Globenewswire· 2026-03-13 15:16
Core Viewpoint - A securities class action has been filed against Corcept Therapeutics, with a deadline for investors to move for Lead Plaintiff by April 21, 2026, following significant stock losses related to the company's lead drug candidate, relacorilant [1][4]. Group 1: Lawsuit Details - The lawsuit, titled Allegheny County Employees' Retirement System v. Corcept Therapeutics Inc., was filed in the U.S. District Court for the Northern District of California, seeking to recover losses for those who purchased Corcept common stock between October 31, 2024, and December 30, 2025 [2]. - The allegations center around a failure to disclose critical information regarding the FDA's concerns about relacorilant, which the company allegedly misrepresented to investors [3][4]. Group 2: Allegations Summary - The complaint alleges that Corcept made materially false and misleading statements about relacorilant, failing to disclose that the FDA had warned the company about insufficient evidence of effectiveness during pre-submission meetings in 2024 and early 2025 [7]. - Despite knowing the FDA viewed the clinical data as fundamentally flawed, Corcept continued to promote positive Phase 3 results [7]. - On December 31, 2025, Corcept disclosed it received a Complete Response Letter (CRL) from the FDA, indicating an unfavorable benefit-risk assessment due to an "insufficient" evidentiary record, leading to a 50% drop in stock price from $70.20 to $34.80, erasing nearly $2.5 billion in market capitalization in one day [7].
Jim Cramer on Eli Lilly: “We’re Not Budging, We’d Buy More If It Really Got Hit”
Yahoo Finance· 2026-03-13 15:15
Group 1 - Eli Lilly and Company (NYSE: LLY) is highly regarded by analysts, with a strong recommendation to hold and potentially buy more shares if the stock price declines [1][3] - The company is a leading developer of GLP-1 medications, which have shown significant promise beyond weight loss and diabetes treatment, including potential applications for alcohol and tobacco addiction [3] - Eli Lilly's market position is strengthened by its joint venture with NVIDIA, focusing on developing treatments for hard-to-treat diseases, which could lead to long-term growth opportunities [3] Group 2 - Eli Lilly's success is impacting its main competitor, Novo Nordisk, as it continues to capture market share [3] - While Eli Lilly is recognized for its potential, some analysts suggest that certain AI stocks may offer greater upside potential with less risk [4]
ImmunityBio Stock Soars 295% YTD: Time to Buy, Hold or Sell?
ZACKS· 2026-03-13 15:05
Core Viewpoint - ImmunityBio's stock (IBRX) has surged nearly 300% year to date, significantly outperforming the industry and S&P 500, driven by strong demand for its product Anktiva [2][9]. Financial Performance - ImmunityBio reported net product revenues of $113 million for the full year 2025, reflecting a 700% increase year over year, primarily due to repeat prescriptions of Anktiva [7][9]. - The ongoing shortage of Bacillus Calmette-Guérin (BCG) has created treatment bottlenecks, further boosting demand for Anktiva [8]. Product Development and Regulatory Approvals - Anktiva has received regulatory approvals in the EU and Saudi Arabia for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [11]. - The company is pursuing additional label expansions for Anktiva, including a recent resubmission to the FDA for a combination therapy with BCG [10][12]. - ImmunityBio is also exploring Anktiva's potential in non-small cell lung cancer (NSCLC) and other oncology indications, with ongoing clinical studies aimed at expanding its therapeutic applications [12][14][15]. Competitive Landscape - ImmunityBio faces significant competition from established pharmaceutical companies like Merck, Bristol Myers, and Roche, which have well-established products and resources in the oncology market [18][19]. - The competitive pressure may challenge ImmunityBio's market penetration despite the promising growth trajectory of Anktiva [26]. Valuation and Market Position - ImmunityBio's stock is trading at a premium, with a price-to-sales (P/S) ratio of 32.59, compared to the industry average of 2.00 [22]. - Despite the high valuation, the early commercial performance of Anktiva suggests potential for continued revenue growth [26].
X @Bloomberg
Bloomberg· 2026-03-13 14:48
Leo Pharma has invited investment bankers to vie for roles in a potential initial public offering, sources say, as the more-than-a-century-old Danish drugmaker edges closer to going public https://t.co/W2VqOkk6OS ...
Zoetis (ZTS) Loses 8.1% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2026-03-13 14:35
Core Viewpoint - Zoetis (ZTS) has experienced significant selling pressure, resulting in an 8.1% decline over the past four weeks, but analysts anticipate better earnings than previously expected, indicating potential for recovery [1]. Group 1: Technical Analysis - The Relative Strength Index (RSI) is utilized to determine if ZTS is oversold, with a current reading of 29.54, suggesting that selling pressure may be exhausting and a rebound could occur [2][5]. - RSI is a momentum oscillator that measures price movement speed and change, typically indicating oversold conditions when below 30 [2][3]. Group 2: Fundamental Indicators - Analysts have raised earnings estimates for ZTS by 3.2% over the last 30 days, which often correlates with price appreciation in the near term [7]. - ZTS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, further supporting the potential for a turnaround [8].