Immuneering Corp.’s phase IIa data from an ongoing trial in pancreatic cancer disclosed June 17 impressed Wall Street and brought renewed attention to the perennially difficult indication, at which drug developers continue to fling themselves with varied mechanisms.
An 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat.
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.
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