Biopharmaceutical companies continue to enjoy a banner year, and the sector as a whole remains a favorite with investors, a fact confirmed by Jefferies analyst Michael Yee, who wrote that "the biotech sector [is] seeing an increase in money flow and better performance vs. the broader market and other health care sectors."
Harmony Biosciences LLC, a new company created by entrepreneur Jeff Aronin's Paragon Biosciences, has acquired exclusive U.S. rights to a drug already EMA-approved for adults with narcolepsy, from France's Bioprojet Societe Civile de Recherche. Harmony is fueling the deal with a $270 million equity financing that it said will also help accelerate its ability to advance other treatments for central nervous system disorders. Meanwhile, it intends to establish an expanded access program for the medicine, called pitolisant, in the U.S. in early 2018 and to submit an FDA new drug application for it during the first half of 2018.
Backed by strong data and boasting a mechanism of action that avoids the opioid route, Zilretta (FX006, triamcinolone acetonide with a poly lactic-co-glycolic acid matrix) – the pain drug for osteoarthritis of the knee from Flexion Therapeutics Inc. – won FDA approval smack on its PDUFA date.