Insmed Inc (NASDAQ:INSM) on Friday outlined a commercial and clinical roadmap for 2026, highlighting strong momentum from its respiratory portfolio and a series of upcoming trial readouts and launches that could shape the company's growth over the next 18 months. • Insmed stock is gaining positive traction. Why are INSM shares climbing?Speaking ahead of Insmed's presentation at the J.P. Morgan Healthcare Conference, Will Lewis, chair and CEO, said 2025 marked a turning point for the company as it translated ...

BOTHELL, Wash., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today announced that it has changed its name to LeonaBio, Inc. The name change aligns with the Company's transformative acquisition of rights to develop and commercialize lasofoxifene, a promising late-stage clinical asset for the potential treatment of metastatic breast cancer, currently ...

New name to reflect recent transformative acquisition of rights to Phase 3 program in metastatic breast cancer and commitment to continued leadership, resilience and innovationBOTHELL, Wash., Jan. 09, 2026 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, today announced that it has changed its name to LeonaBio, Inc. The name change aligns with the Company’s transfo ...

Core Insights - Eupraxia Pharmaceuticals announced positive results from the RESOLVE trial, showing significant improvements in tissue health and symptom management for patients with eosinophilic esophagitis (EoE) after treatment with EP-104GI [1][2] Group 1: Clinical Trial Results - The RESOLVE trial is a Phase 1b/2a study evaluating EP-104GI, which has shown compelling evidence of addressing the underlying pathology of EoE at the tissue level [2][9] - At week 12, patients receiving the highest dose of EP-104GI demonstrated a near-complete normalization of tissue health, with an EoEHSS Grade improvement of -0.57 (94% improvement) and Stage improvement of -0.63 (97% improvement) [6] - Clinical remission was achieved by 58% of patients at week 12, 79% at week 24, and 67% at week 52, indicating sustained efficacy [7] Group 2: Safety and Tolerability - Over 200 patient-months of follow-up have been reported with no serious adverse events (SAEs) and no cases of oral candidiasis, indicating a favorable safety profile for EP-104GI [5][15] - The treatment has been well tolerated across all dose levels, including the highest dose of 8mg/site [15] Group 3: Future Developments - Eupraxia plans to disclose additional data from the RESOLVE trial in the coming months, with the Phase 2b part of the trial currently recruiting participants [9][10] - The top-line data from the Phase 2b trial is expected in Q3 2026, which will further assess the efficacy and safety of EP-104GI [10]

Core Insights - Denali Therapeutics Inc. (DNLI) has outlined its roadmap for 2026, focusing on investigational therapies for neurodegenerative diseases and lysosomal storage disorders, with an emphasis on the anticipated FDA approval and commercial launch of tividenofusp alfa for Hunter syndrome [1][9] Regulatory Developments - The company submitted a biologics license application (BLA) for tividenofusp alfa under the FDA's accelerated approval pathway, based on phase I/II study data [4] - The FDA extended the review timeline for the BLA to April 5, 2026, due to the submission of updated clinical pharmacology information, not related to efficacy or safety [5][6] Clinical Trials and Studies - Denali is conducting a phase II/III COMPASS study for tividenofusp alfa, with data expected to support global regulatory submissions [6] - The company is also evaluating DNL126 for Sanfilippo syndrome type A, with initial data set to be presented at the 2026 WORLDSymposium [7] - Ongoing studies include DNL593 for frontotemporal dementia in partnership with Takeda, and BIIB122 for early-stage Parkinson's disease in collaboration with Biogen, with readouts expected in 2026 [8][11] Financial Position - As of September 30, 2025, Denali held approximately $872.9 million in cash and marketable securities, and raised an additional $200 million through equity financing [14] - The company secured a royalty funding agreement worth up to $275 million based on future sales of tividenofusp alfa, providing necessary capital for regulatory activities and clinical trials [14] Future Outlook - The potential FDA approval of tividenofusp alfa in 2026 could transform Denali into a commercial-stage biotech, with positive data from ongoing studies likely to boost stock performance [15]

Alumis (NASDAQ:ALMS), which develops targeted therapies for immune-mediated diseases, closed Tuesday’s session at $16.23, up 95.31%. Trading volume reached 64.1 million shares, coming in about 3,077% above its three-month average of 2 million shares.Tuesday's move followed Phase 3 psoriasis data for envudeucitinib, which investors are treating as a potential commercial inflection point. The focus is now watching New Drug Application (NDA) timing and competitive dynamics in oral TYK2 inhibitors. How the ma ...

Phase 1 results confirm investigational drug-candidate G1090N has a favorable safety and tolerability profile, supporting further clinical evaluationCompelling anti-inflammatory activity of G1090N was evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors, showing inhibition of pro-inflammatory pathwayFindings provide a solid foundation for advancing G1090N into Phase 2 proof-of-concept studies across the ACLF continuum Lille (France), Cambridge (Massachuse ...

Today, Novo Nordisk A/S ( NVO ) has launched a pill version of Wegovy in the U.S., the news that many investors were waiting for. They’re now offering a 30-day supply at just $149 forI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific foundation gave me an appreciation for the rigor and challenges behind ...

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]

Key Takeaways Ionis Pharmaceuticals surged 127.6% in 2025 on progress across wholly-owned programs.GPCR jumped on phase II data showing up to 15.3% placebo-adjusted weight loss for oral GLP-1 aleniglipron.KOD rallied as late-stage tarcocimab and KSI-501 advance, with multiple phase III readouts slated for 2026.After a weak first half, the drug and biotech sector regained momentum in the latter part of 2025, setting the stage for a strong year for select stocks. Improved policy clarity following most large d ...