Clovis Gears Up for NDA Discussion in April
Clovis Oncology traded down on Friday after the company said the FDA scheduled the New Drug Application for rociletinib for discussion by the Oncologic Drugs Advisory Committee on April 12.
Clovis Oncology Inc. (NASDAQ: CLVS) traded down in Friday’s session on a U.S. Food and Drug Administration (FDA) announcement. The company said that the FDA scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12.
Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
Ultimately, the ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.
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Patrick J. Mahaffy, president and CEO of Clovis, commented:
We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib. New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.
Shares of Clovis were trading down almost 3% at $18.08 Friday morning, with a consensus analyst price target of $34.13 and a 52-week trading range of $17.76 to $116.75.
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Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics. Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications. A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.
