CLVS - Clovis Oncology downgraded to neutral at Wainwright on Rubraca ovarian cancer uncertainty

H.C. Wainwright has downgraded Clovis Oncology (NASDAQ:CLVS) to neutral from buy over concerns about a potential launch of Rubraca (rucaparib) as a first-line ovarian cancer treatment. Shares are down 30% in Friday afternoon trading. Analyst Edward White noted that the company recently received notification from the U.S. FDA that it should wait for additional maturity in terms of overall survival data from the ATHENA-SOLO trial before submitting an sNDA for Rubraca in the first-line ovarian cancer setting. White added that the company has stated achieving 50% maturity as FDA requested would take two years. Due to the uncertainty of this sNDA, he has removed the first-line indication from his Rubraca model and also lowered sales estimates for the drug from 2022-2024. Clovis (CLVS) shares have plummeted ~97% since reporting Q1 earnings before the opening bell on Wednesday.

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Clovis Oncology downgraded to neutral at Wainwright on Rubraca ovarian cancer uncertainty