Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Achieve, Brainchild, Denali, Hoth, Imbrium, Immuneering, Johnson & Johnson, MBX, Metsera, Pharmaessentia, Raphael.
New hires and promotions in the biopharma industry, including: Actio, Aicuris, Alltrna, Antag, Avidity, Cardurion, Centessa, Commit, Corrixr, Eyepoint, Gain, Kailera, Noema, Odyssey, Sionna, Tarsier, Trisalus, Unnatural Products, Vor.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Alivegen, Bayer, Calico, Dizal, GSK, Interius, Orion, Restem, Vergent.
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future.
What does it mean for a confirmatory trial to be “underway”? That’s a question that’s been plaguing some drug sponsors, especially those in the ultra-rare disease space, since the U.S. Congress, in 2023, gave the FDA the authority to require that a confirmatory trial be underway at the time accelerated approval is granted.
Strong interim safety and efficacy data from Hoth Therapeutics Inc.’s phase IIa study of HT-001 helped boost the company’s stock (NASDAQ:HOTH) on Jan. 7 as shares rose 178% to close at $2.28 each.
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