Anthos Therapeutics Inc.’s phase II study of abelacimab in treating atrial fibrillation in patients at moderate to high risk of stroke has met its primary endpoint. The data monitoring committee stopped the study early as the fully human monoclonal antibody targeting factor XI/XIa reduced bleeding when compared to a leading standard of care, direct oral anticoagulant, Xarelto (rivaroxaban, Johnson & Johnson).
Galimedix Therapeutics Inc. plans to move its lead compound, GAL-101, into a phase IIa proof-of-concept trial next year, in order to test an intriguing hypothesis associated with certain retinal degeneration conditions. GAL-101 selectively binds misfolded amyloid beta species, and the company believes that this mechanism may benefit patients with the dry form of age-related macular degeneration or with glaucoma.
Hanmi Science Co. Ltd. is rolling out a new obesity pipeline with five candidates under its relatively new leadership with Lim Ju-hyun, the eldest daughter of Hanmi Pharmaceutical Co. Ltd. founder Lim Sung-ki, who serves as president of Hanmi’s global strategy division. Songpa-gu, Seoul-based Hanmi Science is the holding group of its main drug development and production arm, Hanmi Pharmaceutical, and its wholesaler arm, Online Pharm.
Though data won’t be available for a few years, the disclosure in mid-July that Grifols SA completed enrollment in the phase III study called Sparta caused some ears to perk up in the alpha-1-antitrypsin deficiency (AATD) space, where a number of contenders are busy.
The combination of new U.S. FDA phase II study guidance and a $175 million underwritten public offering sent gene therapy developer Rocket Pharmaceuticals Inc.’s stock soaring on Sept 13. Shares (NASADQ:RCKT) closed 38.8% upward to $21.23 each on Sept. 13.
One hepatitis delta virus player (HDV) has dropped out after Eiger Biopharmaceuticals Inc.’s phase III effort with peginterferon lambda turned up safety issues, while others remain busy in a space highlighted during last November’s meeting of the American Association for the Study of Liver Diseases. Shares of Palo Alto, Calif.-based Eiger (NASDAQ:EIGR) closed Sept. 13 at 41 cents, down 28 cents, or 40.6%, on word that the company is stopping the Limt-2 study in patients with chronic HDV.
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The data showed higher rates of patency, a measure of the lack of vascular obstruction, when compared to synthetic graft benchmarks.
Acelyrin Inc.’s shares tumbled after its interleukin-17A inhibitor, izokibep, failed to reachstatistical significance in part B of a phase IIb/III trial inmoderate to severe hidradenitis suppurativa (HS), but the company remains undeterred with its plans to advance the drug for the inflammatory skin condition.
Neurocrine Biosciences Inc.’s positive top-line data from the phase III study called Cahtalyst in classic congenital adrenal hyperplasia (CAH) further whetted Wall Street’s appetite for soon-to-come results in the same indication from Spruce Therapeutics Inc.
HLB Co. Ltd. is ready to take half of the liver cancer treatment market with its potential first-line treatment, rivoceranib, currently undergoing U.S. FDA review, company chairman Jin Yang-gon said, backed by positive survival data that beat out competitors by three months.