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Veru outlines 72-week Phase IIb PLATEAU study targeting obesity plateau population following FDA guidance (NASDAQ:VERU)
Seeking Alpha· 2025-12-17 17:01
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New Study Shows Extended-Release Buprenorphine Safely Delivers Rapid, Clinically Meaningful Reductions in Opioid Use and Supports Abstinence in High-Risk Populations
Prnewswire· 2025-12-17 16:30
RICHMOND, Va., Dec. 17, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq: INDV) today announced results from a randomized, double-blind clinical trial published in JAMA Network Open. The study found that both the 100-mg and 300-mg monthly maintenance doses of SUBLOCADE® (extended- release buprenorphine) rapidly reduced opioid use and improved opioid abstinence and were well tolerated, with no new safety signals in individuals with moderate-to-severe opioid use disorder (OUD). Participants across both dose groups e ...
Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma
Businesswire· 2025-12-17 16:20
Core Viewpoint - Incyte has received approval from the European Commission for Minjuvi® (tafasitamab) to treat relapsed or refractory follicular lymphoma, marking a significant advancement in the company's oncology portfolio [1] Group 1: Company Developments - The approval of Minjuvi® is a pivotal milestone for Incyte, enhancing its position in the oncology market [1] - This treatment option is specifically aimed at patients with relapsed or refractory follicular lymphoma, addressing an unmet medical need in this patient population [1] Group 2: Industry Impact - The approval is expected to contribute positively to the treatment landscape for follicular lymphoma, potentially improving patient outcomes [1] - This development may influence competitive dynamics within the oncology sector, as companies seek to address similar patient needs with innovative therapies [1]
Pfizer Issues Soft 2026 View: What Does It Mean for the Stock's Future?
ZACKS· 2025-12-17 16:01
Core Viewpoint - Pfizer's financial outlook for 2026 has disappointed investors, leading to a more than 3% drop in shares, primarily due to declining demand for COVID-19 products and increasing loss of exclusivity across its portfolio [2][10]. Financial Outlook - Pfizer expects total revenues for 2026 to be between $59.5 billion and $62.5 billion, including $5 billion from COVID-19 product sales, which indicates modest growth compared to the revised 2025 revenue expectation of around $62 billion [3]. - The adjusted EPS guidance for 2026 is set at $2.80-$3.00, falling short of the Zacks Consensus Estimate of $3.08 per share [4]. - Adjusted R&D expenses are projected to be between $10.5 billion and $11.5 billion, while adjusted selling, informational, and administrative (SI&A) spending is targeted between $12.5 billion and $13.5 billion [4]. Cost Management - Pfizer has exceeded its cost-saving targets for 2025 and aims for cumulative cost reductions of $7.2 billion by 2027, with most savings expected in 2026 [5]. Growth Projections - Beyond 2026, Pfizer does not anticipate a return to robust growth until late in the decade, with COVID-19 product sales expected to decline by approximately $1.5 billion in 2026 [7]. - The company faces a significant patent cliff, with projected revenue losses exceeding $3 billion in 2027 and more than $6 billion in 2028 due to loss of exclusivity [8]. Strategic Focus - Pfizer is concentrating on two key growth areas: obesity and oncology, with the recent acquisition of Metsera aimed at building an early-stage obesity pipeline [11]. - In oncology, Pfizer is prioritizing the development of a PD-1×VEGF bispecific antibody, although competition in this area is intensifying [13]. Valuation and Market Performance - Pfizer's shares have underperformed the industry year to date, trading at a price/earnings ratio of 8.19 times forward earnings, which is lower than the industry average of 17.18 and its own 5-year mean of 10.41 [16]. - EPS estimates for 2025 and 2026 have declined over the past 30 days, indicating a downward trend in market expectations [18].
Evoke Pharma and QOL Medical Announce Expiration of Tender Offer
Prnewswire· 2025-12-17 15:50
SOLANA BEACH, Calif., and VERO BEACH, Fla., Dec. 17, 2025 /PRNewswire/ -- Evoke Pharma, Inc. (formerlyNASDAQ: EVOK) ("Evoke") and QOL Medical, LLC ("QOL Medical") today announced that the tender offer (the "Offer") by QOL-EOS Merger Sub, Inc., a Delaware corporation and a direct wholly owned subsidiary of QOL Medical (the "Merger Sub"), to acquire all of the outstanding shares of common stock, par value $0.0001 per share (the "Shares"), of Evoke, in exchange for $11.00 in cash per share (the "Offer Price"), ...
Pfizer, Merck Are Boring Again — And That's Exactly Why 2026 Investors Are Circling Back
Benzinga· 2025-12-17 15:14
Pfizer Inc (NYSE:PFE) and Merck & Co Inc (NYSE:MRK) aren't exciting stocks anymore — and after a bruising reset, that's starting to look intentional. Pfizer's stock has been back in focus this month after the company laid out a cautious 2026 outlook, acknowledging that the post-COVID reset isn't over yet. Track PFE stock here.Management flagged flat-to-low single-digit growth expectations, with COVID product declines continuing to fade out of the base. The market's response was telling: shares slipped, but ...
SHAREHOLDER ALERT: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Rezolute
Prnewswire· 2025-12-17 15:11
Rezolute, Inc. shares tumbled sharply on December 11, 2025, as investors reacted to disappointing topline results from its Phase 3 sunRIZE clinical trial for ersodetug, its lead drug candidate for treating congenital hyperinsulinism. The study failed to meet both its primary and key secondary endpoints, with the highest dose showing reductions in hypoglycemia events that were not statistically significant versus placebo, To learn more about the Rezolute investigation, go to www.faruqilaw.com/RZLT or call F ...
Billionaire With 30 Years of 30% CAGR Gains Dumped Nvidia, Palantir, and Eli Lilly
247Wallst· 2025-12-17 15:05
Core Viewpoint - Stanley Druckenmiller, a renowned investor, has achieved significant returns without holding major AI stocks like Nvidia, Palantir, and Eli Lilly, indicating a strategic shift in his investment approach [1][2]. Group 1: Investment Strategy - Druckenmiller's portfolio has shown a 9.07% increase in Q3 2025, with 62 holdings, reflecting a diversified investment strategy [1]. - His top holdings are not concentrated in AI stocks, with Taiwan Semiconductor being his only AI investment, suggesting a unique approach compared to other hedge funds [2]. Group 2: Nvidia (NVDA) - Druckenmiller began acquiring Nvidia shares in late 2022 but sold his last shares in Q3 2024 when the stock was nearly $135, indicating a strategic exit as the stock price increased [4]. - Despite Nvidia's current price of $178, Druckenmiller's decision to sell appears to be based on valuation concerns and the identification of better investment opportunities [5]. Group 3: Palantir (PLTR) - Druckenmiller has had a fluctuating relationship with Palantir, selling over half his shares in Q3 2021, then re-entering in early 2022, and ultimately selling 94.6% of his holdings by Q3 2024 [6][7]. - Although he missed out on Palantir's gains, his strategy to shift into "safer" stocks with greater upside potential has proven effective, as his top holdings have outperformed Palantir significantly [8][10]. Group 4: Eli Lilly (LLY) - Druckenmiller has a history of trading Eli Lilly, having bought shares in 2022 and selling all holdings by Q3 2025, realizing substantial profits [11][12]. - His re-entry into Eli Lilly in Q4 2024 was followed by a complete exit in Q3 2025, coinciding with a price drop from the $900s to the $700s, but he missed subsequent gains as the stock rose to $1,054 [12][13].
FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug
ZACKS· 2025-12-17 14:46
Core Insights - Adagene Inc. (ADAG) received Fast Track designation from the FDA for its lead immuno-oncology candidate, muzastotug (ADG126), in combination with Merck's Keytruda for treating adult patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC) without active liver metastases [1][6] - Following the announcement, ADAG shares increased by 13.8% [1][7] - The Fast Track designation aims to expedite the development and review of therapies for serious diseases with unmet medical needs [2] Company Overview - Muzastotug is a next-generation anti-CTLA-4 antibody developed using proprietary SAFEbody masking technology, which may improve survival and quality of life compared to conventional therapies [5][7] - The ongoing phase II study has primary and secondary endpoints focused on overall response rate, duration of response, progression-free survival, and overall survival [6][8] - A phase III study is planned to start in 2027, contingent on continued positive clinical results [8] Market Performance - Over the past year, ADAG's shares have declined by 6.9%, contrasting with a 16.3% rise in the industry [4] - The Fast Track designation allows for more frequent interactions with the FDA and potential rolling reviews of future marketing applications [8]
X @The Wall Street Journal
The Wall Street Journal· 2025-12-17 14:39
The Justice Department indicted Adderall startup Done Global a month after its founder and top doctor were both convicted for a conspiracy to distribute controlled substances https://t.co/5PHM5UaKqc ...