DUBLIN – Aelis Farma SAS is banking $30 million up front as part of a strategic collaboration and option license deal with Indivior plc involving AEF-0117, its candidate drug for treating cannabis-related disorders, including addiction and psychosis. It could receive another $100 million, should Invidior trigger the option on completion of a phase IIb trial in the U.S.
During a conference call with investors, Biogen Inc. officials defended the price of Aduhelm (aducanumab) for Alzheimer’s disease (AD), with CEO Michel Vounatsos saying the $56,000 per year price tag was based on “the value it is expected to bring to patients, caregivers, and society.”
By granting accelerated approval for Biogen Inc.’s Aduhelm (aducanumab) for Alzheimer’s disease (AD), the FDA is “essentially confirming that the beta-amyloid hypothesis has been validated,” Mizuho analyst Salim Syed said in an alert to investors. Shares of Cambridge, Mass.-based Biogen (NASDAQ:BIIB) closed $395.85, up $109.71, or 38.3%, as Wall Street hailed the first new AD therapy to reach the market since 2003.
DUBLIN – Ronopterin (VAS-203) failed to meet the primary endpoint of a phase III trial in traumatic brain injury (TBI), but developer Vasopharm GmbH is nevertheless convinced that it has an active drug on its hands. It has also received backing from the study’s data monitoring committee, which has provided, Vasopharm said, a “positive benefit-risk assessment” on the basis of the efficacy signals detected and the drug’s known safety profile.
LONDON – In a sizeable seed round for a U.K. biotech, Transine Therapeutics Ltd. has raised £9.1 million (US$12.9 million) to take forward a novel method for up-regulating endogenous protein production using a naturally occurring class of long noncoding RNAs.
The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven.
The brakes have now been pumped twice at Larimar Therapeutics Inc. as the FDA placed a clinical hold on its CTI-1601 Friedreich’s ataxia (FA) clinical program, and the company won’t close on a planned $95 million private placement financing. Larimar’s stock (NASDAQ:LRMR) took a battering May 26 as shares slumped 33.46% to close at $8.99.
Shares of Annovis Bio Inc. (NYSE:ANVS) leapt 127.3% to $60 May 21 on news that, following 25 days of treatment with its lead candidate, ANVS-401 (posiphen), 14 early Alzheimer's disease patients enrolled in its ongoing phase IIa study showed cognitive improvement of 22% vs. those who received placebo. Pending successful completion of the study, the company is targeting advancement to late-stage studies later this year.
There’s been a change of plans. Following a preliminary review of briefing materials for a type C meeting, the FDA told Reata Pharmaceuticals Inc. that a pre-NDA meeting is instead the next best step in the development of omaveloxolone (RT-408) for treating Friedreich’s ataxia (FA).
LONDON – Technology commercialization specialist Eurekare SA has arrived on the scene after raising a $60 million series A, with which it plans to seed fund the formation of microbiome and synthetic biology startups and invest in later-stage rounds of companies specializing in those two fields.
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