Company Product Description Indication Status
Incyte Corp., of Wilmington, Del. Pemigatinib FGFR inhibitor Cholangiocarcinoma FDA accepted for priority review NDA seeking approval for use in patients with previously treated, locally advanced or metastatic disease with FGFR2 fusions or rearrangements
Tonix Pharmaceuticals Holding Corp., of New York Tonmya (TNX-102 SL) Cyclobenzaprine sublingual tablets Post-traumatic stress disorder Received official minutes from type B meeting with FDA; phase III study design changes are being implemented after agency indicated importance of showing persistence of treatment effect at week 12 in a pivotal study; ongoing Recovery trial has more than 50% target enrollment, with interim analysis expected in first quarter of 2020 and top-line data in second quarter of 2020
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin 0.7% topical solution) Blistering agent Molluscum contagiosum NDA accepted for filing by FDA; PDUFA date of July 13, 2020

Notes

For more information about individual companies and/or products, see Cortellis.

No Comments