Group 1 - BioMarin Pharmaceutical Inc. is set to acquire Amicus Therapeutics in an all-cash transaction valued at approximately $4.8 billion, with a share price of $14.50 per Amicus share [2][3] - The acquisition is expected to close in Q2 2026, pending regulatory clearances and stockholder approval [2] - This strategic move is aimed at stabilizing long-term cash flows and expanding BioMarin's leadership in rare diseases by adding two marketed therapies for lysosomal storage disorders, which generated a combined revenue of $599 million over the last four quarters [3] Group 2 - H.C. Wainwright raised BioMarin's price target to $60 from $55, maintaining a Neutral rating, indicating that Voxzogo will remain the primary driver of stock value until peak sales materialize in the 2030s [1][3] - The acquisition includes US rights to DMX-200, a Phase 3 investigational small molecule targeting focal segmental glomerulosclerosis, a rare kidney disease [3] - BioMarin develops and commercializes therapies for life-threatening rare diseases and medical conditions across various regions including the US, Europe, and Asia Pacific [4]

MannKind Corporation (NASDAQ:MNKD) is one of the best NASDAQ stocks to buy in 2026. On December 23, MannKind Corporation secured FDA approval for the FUROSCIX On-body Infusor to treat pediatric patients weighing 43 kg or more. This expands the treatment’s existing reach beyond adults with chronic heart failure/CHF and chronic kidney disease/CKD, providing a home-based option for managing fluid buildup/edema. Earlier on December 1, MannKind Corporation (NASDAQ:MNKD) announced that the US FDA accepted for ...

Core Insights - The article discusses the author's long-term positive outlook on Rigel Pharmaceuticals (RIGL) and its product TAVALISSE, highlighting the company's promising pipeline and potential for growth [1]. Group 1: Company Overview - Rigel Pharmaceuticals has been under observation for seven years, with a focus on its innovative therapies and pipeline developments [1]. - The company is recognized for its commitment to developing breakthrough therapies in the biotech sector [1]. Group 2: Investment Perspective - The author expresses a bullish sentiment towards RIGL, indicating a potential buy opportunity noted in early 2019 [1]. - The investment strategy revolves around identifying innovative companies with catalysts for potential acquisitions, which aligns with Rigel's profile [1].

Group 1 - The stock market ended 2025 on a low note, but the overall uptrend in stocks remains intact, indicating a shift of investment focus away from Big Tech [4] - December's trading activity showed evidence of capital flowing into sectors outside of major technology companies, suggesting diversification in investment strategies [4] - Axsome Therapeutics experienced a significant stock price increase after the FDA granted priority review for its Alzheimer's agitation drug, highlighting positive developments in the biotech sector [5] Group 2 - The upcoming challenges for major tech companies like Google, Microsoft, Oracle, and Meta are expected to center around their cloud growth as earnings per share (EPS) slow down [7] - The AI sector is facing a critical moment, with the success or failure of companies like OpenAI being pivotal for investor confidence and market performance [9] - The stock market has seen record highs driven by companies like Nvidia and Google, alongside positive GDP data, indicating strong economic performance [9]

Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 As filed with the Securities and Exchange Commission on December 31, 2025 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REDHILL BIOPHARMA LTD. (Exact name of Registrant as specified in its charter) Not Applicable (Translation of Registrant's name into English) (Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices) RedHill Biopharma In ...

USD 100 million senior term loan facility with a 2-year maturityStrengthens liquidity to support execution across Alvotech’s R&D pipeline and global product launches through 2026Led by GoldenTree Asset Management REYKJAVIK, ICELAND (December 31, 2025) — Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a USD 100 million senior term loan facility with maturity in December 2027 aimed at stren ...

Core Insights - Replimune Group's shares have increased by 131.1% over the last three months due to positive regulatory developments [1] - The FDA has accepted the resubmission of the biologics license application (BLA) for Replimune's lead candidate RP1 in combination with Bristol Myers' Opdivo for advanced melanoma, with a target action date set for April 10, 2026 [1][5] Regulatory Developments - The BLA resubmission follows a complete response letter (CRL) issued in July 2025, which raised concerns about data heterogeneity in the IGNYTE study population [2] - The FDA indicated that the IGNYTE study was not considered adequate for providing substantial evidence of effectiveness [2] - Replimune has engaged with the FDA to address the feedback from the CRL, and the FDA confirmed that the resubmission adequately addresses the previous concerns [3] Clinical Data - The RP1/Opdivo combination achieved a 44% response rate and an 11.9-month median response duration in patients with acral melanoma from the IGNYTE study [5][9] - Replimune is continuing a larger phase III study evaluating the RP1/Opdivo combination against the physician's choice of treatment for melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapies [9] Market Performance - Replimune's shares have declined by 19.6% over the past year, contrasting with the industry's growth of 20.2% [4] - The acceptance of the resubmitted BLA has alleviated investor concerns regarding the RP1/Opdivo combination, leading to increased visibility and confidence in the candidate's approval path [6] Additional Pipeline Information - RP1 is also being evaluated as a monotherapy for solid organ transplant recipients with skin cancers [12] - Replimune has a second oncolytic immunotherapy candidate, RP2, currently in mid-stage to large-stage studies for metastatic uveal melanoma and hepatocellular carcinoma [12]

Core Insights - Axsome Therapeutics shares experienced a significant increase, closing the year with a rise of over 20% following the announcement of key developments [1] Group 1: FDA Approvals and Designations - The U.S. FDA granted priority review designation for Axsome's AXS-05 drug, aimed at treating agitation in Alzheimer's disease, which addresses a significant unmet medical need [3][4] - AXS-05 is already approved for major depressive disorder (MDD) and has seen a 69% year-over-year sales growth in Q3, contributing to 80% of Axsome's revenue for that quarter [3][8] - The FDA has set a target action date of April 30, 2026, for AXS-05, providing a clear timeline for potential market entry [4] Group 2: Pipeline Developments - Axsome's AXS-12, a drug for treating narcolepsy, is also progressing, with FDA meeting minutes indicating that the regulatory data package is acceptable for a new drug application (NDA) submission expected next month [5][6] - The positive news regarding both AXS-05 and AXS-12 has led to increased investor interest in Axsome stock [6]

Halozyme Therapeutics, Inc. (NASDAQ:HALO) is one of the best affordable stocks with good earnings growth for 2026. Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced on December 18 that Johnson & Johnson received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO, co-formulated with ENHANZE® for people with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer. RYBREVANT FASPRO holds approval across all indications of RYBREVAN ...

Gilead Sciences Inc. (NASDAQ:GILD) is one of the best stocks for the next decade. On December 12, Morgan Stanley raised the firm’s price target on Gilead to $151 from $147 with an Overweight rating on the shares. The firm informed investors that the regulatory and political uncertainties currently weighing on biopharma are expected to subside. As these policy overhangs fade, Morgan Stanley anticipates a shift in market attention back to the industry’s core financial and operational performance. Later, on ...