A shortage of efficacy compared to placebo in a phase II study of treating cognitive impairment has put Aptinyx Inc. on the defensive. The company’s oral, small-molecule NMDA receptor modulator, NYX-458, was being studied in 99 patients with mild cognitive impairment or mild dementia associated with Parkinson’s disease or Lewy body dementia. Based on the results, Aptinyx has decided to stop the therapy’s development, along with closing its phase IIb study of another oral, small molecule, NYX-783, for treating post-traumatic stress disorder. Read More
If clinical efforts pan out, gamma delta T-cell specialist TC Biopharm plc could plant the space’s first U.S. regulatory flag. Founded 10 years ago, the Glasgow, U.K.-based firm is marching ahead with phase IIb work testing main asset Omnimmune, an allogeneic unmodified cell therapy, in acute myeloid leukemia (AML). Read More
Armed with $193 million in combined series A and B rounds, Aera Therapeutics aims to address current challenges with delivering gene-based therapies via a self-assembling human-derived protein platform it has in-licensed from a well-known Harvard scientist’s lab. Read More
In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice spelling out how licensed providers can obtain the drugs through the agency’s special access program on a case-by-case basis. Read More
Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen. Read More
Biocytogen Pharmaceuticals Co. Ltd.’s wholly owned subsidiary, Eucure Biopharma Co. Ltd., licensed exclusive greater China rights to YH-008 to Chipscreen Biosciences Co. Ltd. in a ¥596 million (US$86 million) deal. Chipscreen subsidiary, Chipscreen Newway Biosciences Co. Ltd., will develop and commercialize the bispecific antibody in mainland China, Hong Kong, Macau and Taiwan. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Blueprint, Celldex, Chiesi, Clene, Elpiscience, Evelo, Hutchmed, Imunon, Levation, Maze, Mitsubishi Tanabe, Nexcella, Sanofi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Amarin, Catalyst, CSL, DMK, GC, Pfizer, Redhill, Sunshine, Tempus, Tevard, Theravance, Vertex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks. Read More
