FDA Rulings Lift Celcuity but Sink Telix and Outlook Therapeutics Stocks

The U.S. Food and Drug Administration issued three materially different rulings on Wednesday that sent shares of the affected biotechnology companies in opposite directions. Celcuity said it will begin submitting a rolling new drug application for gedatolisib in PIK3CA wild-type, hormone receptor-positive/HER2-negative advanced breast cancer under the agency’s Real-Time Oncology Review program. The move, which could shorten review timelines, lifted the Minneapolis-based company’s stock about 8% in pre-market trading after an earlier 13% jump in the after-hours session. In contrast, Australia’s Telix Pharmaceuticals disclosed that the FDA found deficiencies in its application for Zircaix, a PET imaging agent intended to detect clear-cell renal cell carcinoma, and requested additional data to show the commercial manufacturing process matches that used in trials. Telix said it would address the concerns immediately, but its U.S.-listed shares fell roughly 17% pre-market after sliding as much as 19% in Sydney trading. Meanwhile, Outlook Therapeutics received a complete response letter for its resubmitted biologics license application for ONS-5010, an ophthalmic formulation of bevacizumab for retinal diseases. The regulator said the submission lacked substantial evidence of effectiveness because the drug failed to meet the primary endpoint in the NORSE EIGHT study, and recommended additional confirmatory data. Outlook’s shares plunged about 64% ahead of the opening bell.