Core Insights - BioVaxys Technology Corp. announced positive findings from a Phase 2 clinical study of maveropepimut-S (MVP-S) in combination with pembrolizumab and low-dose cyclophosphamide for advanced or metastatic bladder cancer, reinforcing the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications [1][4] Group 1: Clinical Study Findings - The Phase 2 study assessed the safety, tolerability, and clinical activity of the combination regimen in patients with metastatic bladder cancer, including those who had progressed on prior anti-PD1/PD-L1 therapies [2] - Key findings indicate that combining MVP-S with checkpoint inhibitors can expand antigen-specific T cell responses, reduce regulatory T-cell activity, and amplify anti-tumor activity [2] - Of 17 evaluable subjects, five showed objective responses, including 2 confirmed complete responses (CRs) and 3 partial responses (PRs), with notable responses in patients previously resistant to checkpoint inhibitors [5] Group 2: MVP-S Mechanism and Composition - MVP-S is a DPX-based immunotherapy that includes multiple survivin-derived peptides, a T-helper peptide, and an innate immune stimulant, promoting efficient antigen uptake and robust T-cell activation [3] - The DPX platform employs a novel, non-aqueous, lipid-in-oil formulation that mimics natural immune processes, resulting in durable immune responses without systemic release at the injection site [3] Group 3: Market Context and Future Opportunities - The encouraging results from the Phase 2 study support advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications [4] - Major anti-PD1 therapies, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo, are approaching significant patent expirations by 2028, creating opportunities for MVP-S in a competitive market [4] - BioVaxys continues to advance its oncology pipeline, with MVP-S demonstrating consistent tolerability and immune activation across various cancer indications [6]

Beam Therapeutics Inc. (NASDAQ:BEAM)  is among the Growth Stock Portfolio: 12 Stock Picks By Cathie Wood. Bernstein Maintains an Outperform Rating on Beam Therapeutics Inc. (BEAM) On January 7, 2026, TheFly reported that Bernstein maintained its Outperform rating. It increased its price objective for Beam Therapeutics Inc. (NASDAQ:BEAM) from $37 to $41. The company’s Alpha-1 Antitrypsin Deficiency program received a favorable regulatory update before the change. The latest regulatory action was Bernstein ...

Core Viewpoint - Unicycive Therapeutics has received FDA acceptance for the resubmission of its New Drug Application for oxylanthanum carbonate (OLC), an investigational oral phosphate binder aimed at treating hyperphosphatemia in chronic kidney disease patients on dialysis, with a target action date set for June 27, 2026 [1][9]. Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney diseases, with its lead investigational treatment being oxylanthanum carbonate [8]. - The company also has a second investigational treatment, UNI-494, which is intended for conditions related to acute kidney injury and has received orphan drug designation from the FDA [8]. Product Details - OLC is designed to reduce the number and size of pills required for treating hyperphosphatemia, potentially improving patient adherence compared to existing treatments [4]. - The NDA for OLC is supported by data from three clinical studies and various preclinical studies, with no concerns raised by the FDA regarding the safety or efficacy data [2]. Financial Position - As of the end of 2025, the company reported an unaudited cash position of $41.3 million, which is expected to support its commercial launch activities and provide a cash runway into 2027 [3][9]. Regulatory Pathway - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, backed by a strong global patent portfolio that includes exclusivity until 2031, with potential extensions until 2035 [5]. Market Context - Hyperphosphatemia is a critical condition affecting nearly all patients with End Stage Renal Disease, with over 450,000 individuals in the U.S. requiring medication annually to manage phosphate levels [6].

Revita-treated patients experienced sustained weight maintenance, improved cardiometabolic profile, and reduced food cravings at 6 months compared with sham, with continued excellent safety and tolerability Patients with above median GLP-1-associated weight loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6- ...

Drugmaker Eli Lilly is partnering with Repertoire Immune Medicines in a deal worth up to $1.93 billion to develop therapies for multiple autoimmune diseases, the Massachusetts-based biotech said on Th... ...

LONDON, Jan. 29, 2026 /PRNewswire/ -- LifeArc Ventures, the venture capital arm of the medical research organisation, LifeArc, had its most active year to date in 2025, announcing investments in four new innovative life sciences portfolio companies and further funding and supporting its portfolio, which stood at 20 companies at year end. Since its inception in 2020, the portfolio has grown through Seed and Series A investments, expanding its investments into Series B in 2025. LifeArc Ventures participated i ...

Core Insights - Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all patent disputes related to its biosimilar of Eylea, which is approved for marketing in several regions [1][2][3] Group 1: Licensing and Market Entry - The settlement allows Alvotech to market and sell the biosimilar starting January 1, 2026, in the UK and Canada, and in Japan from May 1, 2026, excluding diabetic macular edema [2] - The biosimilar will be available in the European Economic Area and other countries (excluding the U.S.) from May 1, 2026, and in Japan with all approved indications from November 1, 2026 [2] Group 2: Commercial Partnerships - Alvotech's commercial partners for the Eylea biosimilar in Europe include Advanz Pharma (UK/EEA), STADA (Germany), and Biogaran (France), with Fuji Pharma Ltd. as the partner in Japan [4] - The biosimilar is marketed under the names Mynzepli and Afiveg in Europe and as AFLIBERCEPT BS in Japan [5] Group 3: Product Information - AVT06, the biosimilar to Eylea, inhibits vascular endothelial growth factors (VEGF), which are crucial in treating various retinal diseases [5] - Aflibercept remains a widely used treatment for retinal diseases, and Alvotech aims to support its commercial partners in launching the product successfully [3]

Core Insights - OSE Immunotherapeutics has selected chronic pouchitis and hidradenitis suppurativa as new clinical indications for lusvertikimab, aligning with its strategic plan for 2026-2028 to target high-value immune-mediated diseases [2][5] - The development of these indications is contingent on financing, with the first Phase 2 clinical trial expected to start in the second half of 2026 [2][15] Group 1: Indications and Rationale - Chronic pouchitis and hidradenitis suppurativa both show strong translational alignment with IL-7R biology, indicating a significant unmet medical need [3][9] - Chronic pouchitis affects approximately 70% of patients who undergo proctocolectomy for ulcerative colitis, with about 45,000 patients in the EU, North America, and Japan developing chronic pouchitis, highlighting a significant management challenge [6] - Hidradenitis suppurativa affects around 1% of the general population, equating to approximately 9.5 million individuals in the same regions, and is associated with a long diagnostic delay and severe quality of life impacts [7][9] Group 2: Development Strategy - The company aims to leverage the capital-efficient nature of chronic pouchitis as a rare disease opportunity while also pursuing the larger dermatology market for hidradenitis suppurativa [5][10] - The first Phase 2 clinical trial is designed to provide clear evidence of differentiated clinical efficacy and safety, supporting a fast, data-driven proof-of-concept strategy [10][11] - OSE plans to advance the ulcerative colitis indication alongside these new indications, developing a subcutaneous formulation of lusvertikimab to enhance its market potential [11]

Recursion Pharmaceuticals (NASDAQ: RXRX) is a small-cap biotech with a mission. The company is looking to revolutionize the way we develop drugs through the use of artificial intelligence (AI). However, the company has had little success so far. Last year, Recursion Pharmaceuticals' shares fell significantly. Could the company bounce back this year? Image source: Getty Images. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now, when yo ...

The past few years have been challenging for Moderna (NASDAQ: MRNA) as the biotech has failed to maintain strong revenue growth from its coronavirus vaccine. The company's shares have significantly lagged the market since 2022. However, the biotech is off to a strong start in 2026. Moderna stock is already trading up 58% this year. Could this finally be the start of a sustained bull run for the pharmaceutical stock? Where to invest $1,000 right now? Our analyst team just revealed what they believe are the ...