Foamix stock bubbles higher on latest acne PhIII; Concentric Analgesic gets an FDA 'breakthrough'
→ Shares of Foamix Therapeutics $FOMX soared Tuesday night on news that their third Phase III study of a new acne med succeeded in delivering significant benefits. The numbers may not be overwhelming, with investigators noting that a “mean reduction in inflammatory lesion count at Week 12 relative to baseline was -16.93 for the FMX101 treatment group and -13.40 for the vehicle treatment group (p<0.0001).” But investors loved it. Shares rocketed up more than 50% in after-market trading and were still up 23% in early morning trading Wednesday.
→ A San Francisco-based biotech called Concentric Analgesics has won the FDA’s breakthrough drug designation for a non-opioid pain therapy. The injectable therapy is designed to desensitize nerve fibers without causing numbness, converting to capsaicin, a TRPV1-agonist. “Receiving Breakthrough Therapy designation for CA-008 is significant at this early stage of clinical development, and firmly supports the compelling data we have seen to date in post-surgical pain,” said CEO Frank Bellizzi.
→ Zai Lab is partnering with Novocure on their cancer therapy Optune, which uses electric fields to disrupt call division for cancer patients. The Shanghai-based Zai Lab plans to accelerate development work for China, saying it’s pleased to add a commercial-stage therapy to the pipeline.
→ Shire — soon to be melded into Takeda — says the European Commission has OK’d their application for Veyvondi, a new treatment for bleeding events in adults with von Willebrand disease.