About two months after reporting that enrollment of its phase II/III study with buntanetap in Alzheimer’s disease had completed enrollment, Annovis Bio Inc. disappointed Wall Street by saying that findings from the phase III in Parkinson’s disease – hoped for by the end of this month – would be delayed for data-cleaning reasons.
Inhibrx Inc. and Sanofi SA have agreed to a deal worth up to $2.2 billion, whereby the latter’s Aventis Inc. subsidiary will acquire INBRX-101, an optimized, recombinant alpha-1 antitrypsin (AAT) augmentation therapy undergoing a registrational trial for AAT deficiency (AATD), an inherited genetic disorder caused by single nucleotide variants in the SERPINA1 gene.
Analysts from the hosting firm talked up their takeaways on biopharma from the J.P. Morgan (JPM) Healthcare Conference and looked ahead to 2024, anticipating a generally better year than those in the recent past.
With one approved myosin inhibitor on the market and another coming up fast, researchers such as those at Tenaya Therapeutics Inc. are casting for new strategies to treat hypertrophic cardiomyopathy (HCM).
After the U.S. FDA granted clearance in March 2023, sales began promptly of Acadia Pharmaceuticals Inc.’s new Rett syndrome therapy, Daybue (trofinetide), and questions during the recent J.P. Morgan Healthcare Conference in San Francisco had to do with – among other matters – sales guidance from the firm, which is hardly alone in seeking treatments for the disease. Other players include Anavex Life Sciences Corp., Neurogene Inc. and Taysha Gene Therapies Inc.
Kriya Therapeutics Inc.’s unveiling of its new gene therapy program for thyroid eye disease (TED), KRIYA-586, added yet another player to the burgeoning space, where a handful of developers have reached the phase III stage.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
Xenon Pharmaceuticals Inc. took to the stage this week at the J.P. Morgan Healthcare Conference to talk up its pipeline, including the phase III program testing XEN-1101 in focal-onset seizures (FOS), due to complete enrollment in the second half of this year. It’s an indication where such other players as Biohaven Ltd. are busy, too. Several million adults are afflicted with FOS in the U.S., with close to a half-million pediatric patients.
Among the firms updating progress at the J.P. Morgan Healthcare Conference (JPM) in San Francisco this week was Relay Therapeutics Inc., coming off a $30 million financing to boost its Dynamo platform and candidates.
GSK plc is plunking down $1 billion cash to take over Aiolos Bio Inc., with the promise of as much as $400 million in regulatory milestone payments along with tiered royalties. The deal gives London-based GSK asthma candidate AIO-001, a phase II-ready, long-acting antibody that binds to the human thymic stromal lymphopoietin (TSLP) ligand to inhibit TSLP signaling and relieve inflammation. GSK said AIO-001 could redefine the standard of care in asthma via the prospect of dosing every six months.
