Oct. 9 Quick Takes: Sobi’s Phase III miss; plus Alkermes, COVAX, Warp Speed-AZ, Lilly-Gates, Pfizer, Everest and Affamed-Kissei

Sobi’s avatrombopag misses in Phase III for chemotherapy-induced thrombocytopenia 
Swedish Orphan Biovitrum AB (SSE:SOBI) sank 18% on Friday, shedding $1.3 billion in market cap, after CD110 agonist Doptelet avatrombopag missed the composite primary endpoint in a placebo-controlled Phase III study to treat chemotherapy-induced thrombocytopenia in patients with solid tumors. Doptelet has gained approval from FDA and EMA to treat thrombocytopenia associated with chronic liver disease, and from FDA to treat chronic immune thrombocytopenic purpura (ITP). Sobi acquired the drug’s rights via its $915 million takeout of Dova Pharmaceuticals Inc. last year. 

FDA panel: labeling sufficient to mitigate Alkermes antipsychotic’s risks
FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 11-6 that labeling language would be sufficient to mitigate risks associated with opioid antagonist action of samidorphan, one of the components of ALKS 3831 from Alkermes plc (NASDAQ:ALKS). The committees also voted 16-1 that samidorphan meaningfully mitigates olanzapine-associated weight gain, and 13-3 with one abstention that ALKS 3831's safety profile has been adequately characterized. ALKS 3831, which combines samidorphan with olanzapine, is under review for schizophrenia and bipolar I disorder; its PDUFA date is Nov. 15...