Nov. 18 Quick Takes: Provention prices first-ever therapy to delay diabetes progression

Provention Bio Inc. (NASDAQ:PRVB) Chief Commercial Officer Jason Hoitt told a conference call Friday that the company has priced Tzield teplizumab-mzwv, its newly approved therapy to delay the onset of Type I diabetes, at $13,850 per vial, or $193,900 per 14-day treatment course. The company is launching the product alongside Sanofi (Euronext:SAN; NASDAQ:SNY), which entered a co-promotion deal with the biotech last month. FDA approved the therapy for patients with stage 2 disease; in a pivotal study, a single course of treatment with the anti-CD3 mAb delayed progression to stage 3 by a median of 25 months compared with placebo, representing the first clinical evidence that a therapeutic intervention can do so. Provention was off $0.16 to $8.08 on Friday; partner MacroGenics Inc. (NASDAQ:MGNX), which is due a $60 million milestone tied to approval, was off $0.08 to $6.48.

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) added about $780 million in market cap Friday after it said FDA had accepted its amended NDA for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration, giving it a new PDUFA date of Feb. 26, 2023. The application now includes 24-month data from two Phase III studies showing sustained efficacy. Investors appeared to interpret the acceptance as a signal that FDA is more likely to approve the therapy rather than issue a complete response letter, removing an overhang on the stock. Although Apellis’ shares rose $7.21 (17%) to $50.45 on Friday, they haven’t fully recovered to their level at $60.05 at close on Nov. 3, before the company said a major amendment to the NDA would extend the agency’s review...