Ionis Pharmaceuticals Inc. CEO Brett Monia predicted that diagnoses of familial chylomicronemia syndrome (FCS) will “accelerate fairly quickly” now that the firm has gained U.S. FDA clearance for Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with the rare form of severe hypertriglyceridemia (sHTG) that can lead to life-threatening acute pancreatitis (AP). Read More
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome. Read More
The first acellular tissue engineered vessel for adults with vascular trauma in a bodily extremity has been approved by the U.S. FDA. Symvess, which comes from regenerative tissue developer Humacyte Inc., can be used to repair an arterial injury that could be life threatening and require immediate attention. Read More
In a deal worth $100 million up front and up to $1.25 billion in milestone payments, Bioarctic AB licensed its pyroglutamate-amyloid-β (pyroglutamate-Aβ) antibody program to Bristol Myers Squibb Co. to advance treatments for Alzheimer’s disease. Read More
The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16.92% rise in September and peak of 25.19% in August. The BBI has now fallen behind the Nasdaq Biotechnology Index, which posted a 6.27% year-to-date gain, and the Dow Jones Industrial Average, up 19.16% at the end of the month. Read More
Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting. Read More
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18. Read More
Biopharmas raising money in public or private financings, including: Assembly, Circio, Clene, Gilead, Hervolution, Gangagen, Marker, Umecrine. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alk-Abello, Aurion, Cognition, Corvus, Ena, Exegi, Hansa, Krystal, Metavia, Mendus, Quoin, Sensorion, Transcode, Viatris, Verastem. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abilita, Certa, Deepcure, Henlius, NGM, Palleon, Orion, Occurx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Betta, Biogencell, Limmatech, Mesoblast, Nurix, Ocuphire, PTC, Sapience , Savara, Ultragenyx, Xcovery. Read More
