Wall Street nicked shares of Karyopharm Therapeutics Inc. after the firm offered top-line results from the 263-subject phase III study with Xpovio (selinexor) in advanced or recurrent endometrial cancer (EC). Shares (NASDAQ:KPTI) closed at $8.19, down $2.05, or 20%, having dropped as low as $7.66. Read More
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S. Read More
Congruence Therapeutics Inc. has closed on a $50 million series A financing to design small molecules to treat rare diseases with protein misfolding. Montreal-based Congruence uses structural bioinformatics, computational chemistry and machine learning in its in silico platform that detects key biophysical features on proteins. That data are used to then design drugs. Read More
Witnesses at a Feb. 8 hearing in the U.S. Congress emphasized that the proposed Advanced Research Projects Agency – Health (ARPA-H) must be an independent agency to avoid a crippling case of bureaucratic torpor. However, several members of Congress and one of the witnesses made the case that ARPA-H would increase duplicative taxpayer spending without providing a commensurate increase in productive research in the life sciences, signaling that establishment of this new DARPA-like agency is anything but guaranteed. Read More
Xanadu Bio, a Yale University spinout developing an intranasal SARS-CoV-2 mRNA vaccine booster, has secured an exclusive license from the school for a polymeric nanoparticle delivery platform to support the project. The delivery tech could potentially have future applications for influenza, respiratory syncytial virus and even cystic fibrosis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Active Biotech, Actuate, Acurx, Antengene, Biomarin, Canbridge, Eubiologics, Evelo, Lysogene, Maplight, Nanoscope, Neoimmunetech, Pop, Tearclear, Uniqure.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arbor, Askbio, Bayer, Biogen, Edigene, Healx, Merakris, Merck, Orange Grove, Ovid, Ridgeback, Touchlight, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Azurity, Biogen, Celltrion, Everest, Gilead, GW, Jazz, NGM, Obseva, RDIF, Sanofi, Sinomab. Read More
