The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
Axovant, one of Vivek Ramaswamy’s biotech companies, is replenishing its pipeline with a licensing deal with Australian company Benitec Biopharma.
Rockville, Md.-based REGENXBIO snagged $100 million from Novartis under its license agreement with gene-therapy company AveXis, which the Swiss company acquired for $8.7 billion earlier in 2018.
Protagonist Therapeutics Inc. discontinued a Phase IIb study for the experimental ulcerative colitis treatment PTG-100 following a review from an Independent Data Monitoring Committee (DMC).
Ghent, Belgium-based Ablynx NV announced the price of its U.S. initial public offering (IPO) at $17.50.
Exelixis’s Cabometyx (cabozantinib) hit key endpoints of overall survival in its Phase III liver cancer trial.
Trovagene Inc., a precision medicine biotechnology company, announced that the U.S. Food and Drug Administration granted an orphan drug designation to PCM-075 for the treatment of patients with acute myeloid leukemia (AML).
Motif Bio’s Phase III drug candidate iclaprim hit primary endpoints in treating patients with acute bacterial skin and skin structure infections (ABSSSI).
Shares of beleaguered Dimension Therapeutics Inc. soared more than 160 percent in premarket trading after gene therapy company Regenxbio Inc. announced its acquisition via an all-stock deal.
FDA granted orphan-drug exclusivity for Haegarda for the prevention of hereditary angioedema attacks.