Aug. 30 Clinical Quick Takes: Pharnext falls on FDA request for second Phase III study, plus Genentech, Novartis and Seqirus
Pharnext shares sag on regulatory slowdown
Shares of Pharnext S.A. (Euronext:ALPHA) lost €4.99 (41%) to €7.16 on Friday after the company said FDA advised it to conduct a second Phase III study of PXT3003 prior to submitting an NDA for the candidate to treat Charcot-Marie-Tooth 1A disease. The company had been planning to submit an NDA for the oral solution of baclofen, naltrexone and sorbitol after it met the primary endpoint of its first Phase III trial, but Pharnext said Friday FDA is concerned about an "unexpected intercurrent formulation event" in that study. PXT3003 is under review in China (see "Pharnext Planning Submissions").
Three-month delay for Tecentriq sBLA in 1L NSCLC
Genentech Inc. disclosed Friday that FDA is extending by three months its review of an sBLA for Tecentriq atezolizumab in combination with chemotherapy for first-line metastatic non-squamous non-small cell lung cancer. The new PDUFA date is Dec. 2, which Genentech said will enable FDA to review additional information requested to support the application...