In the quest for regulatory approval for their COVID-19 vaccine, Sanofi SA and Glaxosmithkline plc (GSK) said they plan to submit their phase III and booster efficacy study data showing it induced a significant increase in neutralizing antibodies after a primary series of mRNA or adenovirus vaccines.
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
Marker Therapeutics Inc.’s update from the safety lead-in stage of its phase II study of MT-401 in treating post-transplant acute myeloid leukemia saw response in one of the six participants. The results from the study of the multitumor-associated antigen-specific T-cell product also known as zelenoleucel saw firms such as Oppenheimer cut its target price for Marker to $5 from $8 and Piper Sandler to cut its target price from $5.50 to $4.
A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
Immunogen Inc. and Eli Lilly and Co., having already seen a collaboration collapse in 2018, will try it again. Immunogen granted the exclusive rights to research, develop and commercialize antibody-drug conjugates (ADCs) that are directed toward targets Lilly will select. Waltham, Mass.-based Immunogen will receive $13 million up front from Lilly and is eligible to receive another $32.5 million in exercise fees if Lilly licenses all the targets. Down the road, Immunogen could receive as much as $1.7 billion in exercise fees and milestones payments.
Collegium Pharmaceutical Inc. said it plans to acquire all outstanding shares of Biodelivery Sciences International Inc. for $5.60 each, putting the price tag at about $604 million. At the heart of the deal are Biodelivery Sciences' Belbuca (buprenorphine buccal film), a schedule III opioid, and Elyxyb (celecoxib), an oral migraine treatment that gives Collegium a foothold into the neurology market.
Proqr Therapeutics NV stock lost three-quarters of its value as word got out that its pivotal phase II/III study of sepofarsen in treating a tough, rare and genetic retinal disease failed to hit the primary endpoint. CEO Daniel de Boer said he was “shocked by the unexpected outcome” based on data from earlier studies. He added that he is unsure if Proqr will continue developing its therapy for treating CEP290-mediated Leber congenital amaurosis 10 until it understands the new results.
Curevo Vaccine Inc. closed on a $60 million series A financing designed to take the company through releasing top-line data for its phase IIb study of CRV-101 for treating shingles in older adults. That means taking on a blockbuster, Shingrix from Glaxosmithkline plc.
