The U.S. Food and Drug Administration (FDA) has accepted New York-based biotechnology company Regeneron Pharmaceuticals’ (REGN) supplemental Biologics License Application (sBLA) for metastatic cervical cancer treatment Libtay for priority review. The target action date has been set for January 30, 2022.
The sBLA is also under review for the FDA’s Project Orbis initiative, which will allow for concurrent review by participating health authorities in Switzerland, Canada, Brazil and Australia. The company has planned additional regulatory submissions, including in the European Union, by the end of the year.
The sBLA is backed by the results of a Phase III trial, which is being conducted in collaboration with NRG Oncology-Japan, the European Network for Gynecological Oncological Trial groups (ENGOT) and The GOG Foundation.
Shares of the company closed 2.3% lower on Tuesday and lost another 0.2% in extended trade to end the day at $604. (See Regeneron stock chart on TipRanks)
Regeneron used its proprietary VelocImmune technology to invent Libtay to treat patients with metastatic or recurrent cervical cancer whose disease progressed after or during chemotherapy. The company has a global collaboration agreement with Sanofi-Aventis SA (SNY) for the joint development of the drug.
Last week, Oppenheimer analyst Hartaj Singh reiterated a Buy rating on Regeneron with a price target of $825 (36.4% upside potential).
The analyst said, “The stock has been outperforming the NBI Index (larger-cap) and the XBI ETF (SMID-cap weighted) since April. As we continue to highlight a company firing on all commercial and pipeline cylinders, we stay bullish.”
Overall, the stock has a Moderate Buy consensus rating based on 10 Buys and 4 Holds. The average Regeneron Pharmaceuticals price target of $710.77 implies 17.5% upside potential. Shares have gained 25.6% over the past six months.
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