LONDON – The largest study to date, involving 236,379 confirmed cases, shows that 1 in 3 survivors of COVID-19 was diagnosed with a neurological or psychiatric condition within six months of contracting the infection. For 13% of those patients, it was their first such diagnosis.
New top-line data from Scholar Rock Holding Group’s phase II Topaz trial of apitegromab (SRK-015) in patients with type 2 and type 3 spinal muscular atrophy generated enough proof-of-concept results for the company to plan on initiating a phase III for later this year. But the 12-month data didn’t stop the Cambridge, Mass.-based company’s stock (NASDAQ:SRRK) from struggling mightily on April 6 as shares closed 20.3% lower at $35.97 each.
Acadia Pharmaceuticals Inc. President Serge Stankovic said the company was “kept completely in [the] dark” by the FDA regarding specifics about what the agency found wrong a month ago with the sNDA for Nuplazid (pimavanserin) – until, that is, the agency’s complete response letter (CRL) landed on the firm’s desk.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
In an unusual move, three members of the Nov. 6 FDA advisory committee that voted against recommending approval of Biogen Inc.’s high profile Alzheimer’s disease candidate, aducanumab, have doubled down on their argument in an editorial published in JAMA on March 31.
Scribe Therapeutics Inc. raised $100 million in a series B round to continue its engineering-intensive approach to developing CRISPR-based therapies that employ custom-designed CasX enzymes.
Sage Therapeutics Inc. on March 17 disclosed another batch of positive phase III data with zuranolone, its oral, once-daily, two-week therapy for the treatment of major depressive disorder (MDD) and postpartum depression. News regarding the GABAA receptor-positive allosteric modulator came the same day that Praxis Precision Medicines Inc. reported fourth-quarter and full-year financial results, updating investors on PRAX-114, its drug in the same class for MDD.
Bridgene Biosciences Inc., a company using an in-house chemoproteomic platform to find and develop small molecules for hard-to-drug targets, has signed its first major pharma partnership with Takeda Pharmaceutical Co. Ltd. for an undisclosed up-front payment.
It’s a first for Larry Miller. In his 30 years of working in pharma, he has never run a company that didn’t have a pack of near competitors scrambling to develop a therapy. “Not even close,” he told BioWorld. Miller, the CEO of Apnimed Inc., just saw the company close on a $25 million series B to help drive its lead program, a once-daily, oral obstructive sleep apnea (OSA) therapy, into a phase III registrational trial.
Eliem Therapeutics Inc. is old-fashioned in the useful ways. The company is going after extremely large indications, including chronic pain and major depression. “We’re really passionate about these large markets,” Eliem President and CEO Bob Azelby told BioWorld. “These patients live in the shadows… There’s so many people suffering.”
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