May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam
Complete response letter for Heron’s non-opioid pain therapy
Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative pain. The agency requested additional CMC and non-clinical information for the long-acting formulation of bupivacaine in a fixed-dose combination with meloxicam. Shares of Pacira Pharmaceuticals Inc. (NASDAQ:PCRX), which markets extended-release Exparel bupivacaine for postoperative pain, appeared to benefit from the news, gaining $6.43 (16%) to $46.25.
Setback for Nabriva's Contepo
Shares of Nabriva Therapeutics plc (NASDAQ:NBRV) also tumbled Wednesday after FDA issued a complete response letter for its NDA for broad-spectrum antibiotic Contepo fosfomycin to treat complicated urinary tract infections (cUTIs). The agency wants the company to address problems related to facility inspections and manufacturing deficiencies at one of its contract manufacturing organizations. Nabriva was off $0.82 (27%) to $2.17...