Phase II
Tetra Discovery Partners announced that the FDA had given its Investigational New Drug application the go-ahead for Fragile X Syndrome and potentially other autism spectrum disorders.
AMO Pharma reported that patients treated with its Phase II neuromuscular treatment for onset myotonic dystrophy type 1 experienced clinical benefits such as an improvement in cognitive function and an increased ability to perform daily tasks.
A U.S. Food and Drug Administration announced their decision to slap a clinical hold on Solid Biosciences Inc.’s experimental gene therapy treatment for Duchenne muscular dystrophy.
Here’s a look at eight biopharma companies with upcoming catalysts.
Protalix BioTherapeutics believes it’s on the right track in developing an oral medicine for ulcerative colitis that could potentially replace current TNF-inhibitor therapies that are administered via injection or infusion.
Aeglea BioTherapeutics announced new repeat dose data from its Phase I/II trial of AEB1102 (pegzilarginase) in patients with Arginase 1 Deficiency.
The U.S. Food and Drug Administration granted Proteostasis Therapeutics’ investigational cystic fibrosis add-on therapy the Breakthrough Therapy Designation.
The FDA placed a hold on Advaxis’ Phase I/II trial following the death of a patient.
The FDA accepted Merck & Co.’s supplemental Biologics License Application and granted Priority Review for Keytruda in advanced cervical cancer.
Biogen is buying Pfizer’s PF-04958242, a first-in-class, Phase IIb-ready drug to treat several neurological and psychiatric diseases, including schizophrenia.
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