Draig Therapeutics Ltd. launched with a $140 million series A and an AMPA receptor modulator program that has completed phase I and will start a phase II trial in major depressive disorder later in 2025. The series A also will enable the company to advance two small-molecule GABA receptor modulators that have the potential to treat a range of neuropsychiatric disorders, into the clinic in 2026.
On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Ark, Averoa, Celltrion, Centessa, Circle, Kalvista, MBX, Milestone, Ocugen, Solascure.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antares, Crescent, Endo, Fosun, Glycomimetics, Help, Incyte, Mallinckrodt, Nextcure, Pierre Fabre, Poltreg, Qiagen, Simcere, Teva.
Shares of Nextcure Inc. (NASDAQ:NXTC) dropped 26.27% on news of a potential $745 million partnership with Simcere Zaiming for Simcere’s cadherin-6 antibody-drug conjugate (ADC) candidate. Shares ended at 50 cents apiece June 16.
The revised trial protocol that means a delay in filing for U.S. approval of DYNE-101 to treat myotonic dystrophy type 1 (DM1) dented shares of Dyne Therapeutics Inc. (NASDAQ:DYN), which closed June 17 at $10.86, down $2.96, or 21%.
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