Aug. 3 Quick Takes: CymaBay gains on PBC readout; plus expanded labels for Epidiolex, Spravato, Voyager-AbbVie deal ends, Immunic and more

CymaBay plans to re-start pivotal trial
Shares of CymaBay Therapeutics Inc. (NASDAQ:CBAY) rose $1.33 (37%) to $4.88 Monday after 78.2% of primary biliary cholangitis (PBC) patients on its seladelpar met the primary composite outcome of the Phase III ENHANCE study after three months, compared with 12.5% of patients on placebo. The company also reported improvements in ALP and pruritus compared with placebo, and similar safety and tolerability profiles between the two groups. CymaBay said it would re-initiate a Phase III registrational study of PPARδ agonist in PBC; last year, the company faced a series of safety and efficacy misses for the therapy, including a clinical hold, that sent its stock tumbling (see “More Woes for CymaBay”).

Expanded label for GW’s Epidiolex
FDA expanded the label for Epidiolex cannabidiol from GW Pharmaceuticals plc (NASDAQ:GWPH), approving the drug to treat seizures associated with tuberous sclerosis complex in patients one year of age and older. In 2018, the agency approved Epidiolex for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years or older; the age range for both indications is now expanded to include patients one and up...