Hopes raised by the phase IIb Harmony study with FGF21 analogue efruxifermin (EFX) in pre-cirrhotic nonalcoholic steatohepatitis (NASH), which appeared in a scientific journal last week, were less than fulfilled as Akero Therapeutics Inc. rolled out disappointing 36-week results from another, same-stage trial called Symmetry in NASH patients with cirrhosis. The company is forging ahead with U.S. FDA talks to figure out how a phase III effort might be designed. Read More
While Ventyx Biosciences Inc.’s oral S1P1 receptor modulator, VTX-002, achieved primary and secondary endpoints in a phase II ulcerative colitis (UC) trial, the company’s shares (NASDAQ:VTYX) fell 25.9%, or $7.78, closing Oct. 10 at $22.22, possibly due to a higher-than-expected placebo response and a clinical remission rate that was similar to Pfizer Inc.’s etrasimod.
Hoping to find a niche where it can be a pacesetter in biopharma development, the Canadian government is investing CA$49 million (US$36 million) in the new Conscience Open Science Drug Discovery Network. The investment will be used to accelerate drug R&D “by leveraging Canadian strengths in artificial intelligence and employing open science principles to drive efficiencies in building Canadian innovation capacity and delivering the medicines that Canadians need,” François-Philippe Champagne, minister of Innovation, Science and Industry, said in announcing the funding Oct. 5. Read More
Qyuns Therapeutics Co. Ltd. has filed to list on the Hong Kong Exchange to fund its autoimmune and allergic disease therapy pipeline, including lead assets QX-002N for ankylosing spondylitis and QX-005N for multiple indications including atopic dermatitis. Read More
Arbele Ltd. founder and CEO John Luk identified and patented cadherin-17 as a therapeutic cancer target, and the company was founded to develop immunotherapies for gastrointestinal cancers, which are prevalent in Asia Pacific. Read More
New hires and promotions in the biopharma industry, including: Aatec, Astrivax, Blue Water, Medicenna, Neumora, Pacira, Pheon, Renovaro, Sibylla, Specific, Zevra. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaptysbio, Atom, Avidity, Bridgebio, Coya, Eloxx, Innovent, Janssen, MBX, Newron, Reneo, Samsung, Tenaya, Salubris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Almirall, Berlin Cures, Biomap, Canariabio, Centrient, Couragen, GPCR, Hikma, Kamada, Ocugen, Pharmenable, Salipro, Sosei, Stem, Theramex, Venatorx, Verge, XNK. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acousia, Alnylam, Aquestive, Canbridge, Jasper, Novartis, Okyo, Radiopharm, Tonix, Ultimovacs. Read More
