ABVC Biopharma Inc. entered a multiyear, global licensing agreement for its CNS drugs to treat major depressive disorder and attention deficit hyperactivity disorder. The license deal with Aibtl Biopharma Inc. would cover clinical trial, registration, manufacturing, supply and distribution rights. The products were valued at $667 million by a third party, according to ABVC.
Bioxcel Therapeutics Inc. said a third-party audit of data from its Tranquility II phase III study came back clean, potentially positioning the firm to submit the statistically significant results in a supplemental NDA seeking approval of BXCL-501 in treating agitation associated with dementia in probable Alzheimer’s disease.
Royalty monetization is a financing tactic that is becoming increasingly popular during challenging times, and PTC Therapeutics Inc. is the latest firm to leverage a marketed drug to pay off debt and fuel its development pipeline. The South Plainfield, N.J.-based company agreed to sell up to $1.5 billion of its Evrysdi (risdiplam) royalty stream to Royalty Pharma plc, of New York. Evrysdi is a survival motor neuron 2 RNA splicing modifier approved by the U.S. FDA in 2020 to treat spinal muscular atrophy.
Monte Rosa Therapeutics Inc. has cut a deal with Roche Holding AG that brings the molecular glue degrader-based medicines developer an up-front $50 million and the possibility of more than $2 billion in milestone payments. The Boston-based company coupled the deal by releasing positive interim data from the phase I dose-escalation portion of its phase I/II open-label, multisite study of MRT-2359 in Myc-driven solid tumors.
The EMA is standing firm on its refusal to recommend approval of the amyotrophic lateral sclerosis (ALS) treatment Albrioza in Europe after re-examining Amylyx Pharmaceuticals Inc.’s marketing authorization application and remaining unconvinced that the main study demonstrated the drug effectively slows disease progression.
With shares dropping again, this time more than 15% on Oct. 13, Cassava Sciences Inc. has found itself entangled in a mess involving short-sellers, data that were allegedly mishandled involving its oral Alzheimer’s disease (AD) candidate simufilam, and a leaked investigation report from the City University of New York (CUNY).
Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down.
In a race with Karuna Therapeutics Inc. to get its schizophrenia drug to market, Cerevel Therapeutics Holdings Inc. has priced an underwritten public offering at $22.81 per share. The offering is worth of about $450 million, with the company estimating sales of the 19.7 million shares will yield net proceeds of about $433.6 million.
For most psychiatric illnesses, the precipitating event is mysterious. Many conditions are thought to result from a mix of genetic risk and environmental factors, but the specific trigger remains unknown. In post-traumatic stress disorder (PTSD), the environmental trigger is usually clear. In many cases, it is all the affected individuals can think about. “Intrusive reliving” of the triggering situation is one of the core features of PTSD.
After rising significantly pre-market on Oct. 5 – when positive phase IIa results with Lomecel-B in Alzheimer’s disease (AD) were made public – shares of Longeveron Inc. (NASDAQ:LGVN) sank during the day and again Oct. 6 to close at $1.75, down 34 cents, or 16%.
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