Delivers real-time biopharma news and signals — powered by AI, curated for professionals.
Vigil Neuroscience's experimental drug for a rare brain disease has failed to meet its primary endpoints in a phase 2 study, casting doubt on its future development. Despite this setback, the company's pending acquisition by pharmaceutical giant Sanofi remains unaffected.
In a flurry of recent announcements, pharmaceutical companies have made significant strides in obesity treatments, neuroscience collaborations, and gene therapy advancements. This comprehensive update covers the latest developments from industry leaders and emerging biotech firms.
Johnson & Johnson (J&J) has revised its projected tariff impact for 2025 following recent developments in U.S.-China trade relations. The pharmaceutical giant now anticipates a potentially softer hit to its bottom line, according to statements made by Chief Financial Officer Joseph Wolk at the recent Bernstein investor conference.
Antheia, a biomanufacturing company specializing in biosynthesis technology, has successfully raised $56 million in a Series C funding round. The California-based firm, known for producing a key ingredient in the opioid overdose treatment Narcan, plans to utilize this capital infusion to expand its manufacturing operations in the United States and launch new strategic innovation programs in Singapore.
Vividion Therapeutics, a subsidiary of Bayer, has announced a significant development in its oncology portfolio by acquiring global rights to the world's only clinical-stage Werner helicase (WRN) inhibitor from its partner Roche. This move marks a crucial step in the advancement of novel cancer treatments targeting DNA repair mechanisms.
Ascletis Pharma has announced positive results from a phase 3 trial of its oral acne treatment, denifanstat, positioning the company for a potential regulatory submission in China. The once-daily pill demonstrated significant efficacy in treating moderate to severe acne vulgaris, potentially offering a new oral option in a market dominated by topical treatments.
Gilead Sciences is poised to enter the lucrative multiple myeloma CAR-T market, setting the stage for a fierce competition with Johnson & Johnson's established Carvykti. The pharmaceutical giant is targeting a 2026 launch for its new cell therapy, anitocabtagene autoleucel (anito-cel), which it believes could expand the market through outpatient use and potentially superior safety profile.
The pharmaceutical industry has witnessed a significant surge in merger and acquisition (M&A) activity, with major players like Sanofi, Bristol Myers Squibb, and Eli Lilly making notable moves. After a relatively quiet first quarter, the sector has seen a flurry of deals, particularly focusing on smaller biotech companies.
The biotech venture capital landscape has completed a full ecosystem cycle from 2012 to 2024, marking the end of a boom-and-bust period and ushering in a new era of more sustainable investing. A recent report from Pitchbook suggests that the industry is entering a phase of more measured capital deployment, with VC firms continuing to create and invest in companies, albeit with increased caution and focus on capital efficiency.
Kura Oncology, in partnership with Kyowa Kirin, has announced that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for ziftomenib with priority review. The drug is being developed for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with specific mutations. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of November 30, 2025, for this application.
Kymera Therapeutics has reported encouraging Phase I results for its experimental protein degrader KT-621, positioning the drug as a potential oral competitor to Sanofi and Regeneron's blockbuster injectable, Dupixent. The news has sparked significant interest in the pharmaceutical industry, with Kymera's shares soaring by nearly 50% following the announcement.
The Food and Drug Administration (FDA) has granted de novo authorization to Clairity Breast, the first artificial intelligence tool designed to predict patients' five-year breast cancer risk from routine mammograms. Developed by Boston-based startup Clairity, this groundbreaking technology marks a significant shift in breast cancer risk assessment and early detection strategies.
