→ Citing Allergan’s “chronic underperformance” under Brett Saunders — the current board chairman and CEO — investor David Tepper has once again called for the two roles to be split up. Tepper, founder and president of the hedge fund Appaloosa, suggested in an open letter that a seasoned independent chair “could exert a favorable influence on executive decision-making, the record for which has been fraught with ill-considered initiatives and self-inflicted wounds for several years now.” Appaloosa holds about 1% of the company.
→ Zogenix has officially shipped off its marketing applications in both the US and Europe for ZX008, the much-anticipated looming rival for GW Pharma’s pioneering cannabis-derived drug. The submissions are based on Phase III data suggested the drug led to a dramatic reduction in seizures for children with Dravet syndrome — one of two indications GW’s Epidiolex is approved for.
→ With some help from the FDA, Axsome has locked in a Phase III plan that it believes can lead its migraine drug straight to an NDA. The biotech, which enjoyed a stock rally $AXSM on cheerful mid-stage depression data just days ago, says that the FDA seems to agree it only needs one registrational trial (developed under a special protocol assessment) to file for approval of AXS-07, a combo of the 5-HT receptor agonist rizatriptan and a reformulated version of meloxicam. Notably, the trial will be limited to patients who have responded inadequately to prior migraine treatments. Topline data are expected in the first quarter of 2020, a year after the trial begins.
→ AstraZeneca has scored an orphan drug designation for Fasenra, its to-be blockbuster asthma drug that it’s clearly keen on pushing to new indications despite some setbacks in COPD. The FDA’s orphan badge is for the treatment of hypereosinophilic syndrome, where high numbers of a type of white blood cells called eosinophils cause progressive damage to organs.
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