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Clovis Oncology Shares Plummet on FDA Request for More Data

Xconomy Boulder/Denver — 

Clovis Oncology has hit another bump in the road—causing the company’s stock to fall to its lowest price since 2013—in developing a therapy for a type of lung cancer that pharmaceutical giant AstraZeneca is also targeting.

The Boulder, CO-based company announced today that potential approval may be delayed because Clovis must now submit additional clinical data related to the efficacy of its drug, CO-1686 (rociletinib). Clovis said it would submit new data to the Food and Drug Administration by the end of the day.

Shareholders responded poorly to the news, dropping the price of Clovis stock (NASDAQ: CLVS)  by 69 percent to $30.44 per share by midday Monday. That’s the lowest price since April 2013, and the largest decline in the company’s history.

The company has had its share of ups and downs, and yet has been able to pique investor interest. Interim results for the Phase II trial of rocilentinib, which seeks to treat people with non-small cell lung cancer who are resistant to existing drugs, underwhelmed analysts and investors after it didn’t blow AstraZeneca’s competing therapy, AZD9291 (osimertinib), out of the water.

Clovis raised $240 million in a public stock offering in June 2013, just shy of two years after its $130 million initial public offering. The company’s stock was trading at around $100 per share before it released the news about the FDA request.

Some of the data that Clovis previously included was based on responses to its treatment that were not confirmed—meaning that brain metastasis either caused continued progression of the cancer or that brain scans didn’t show the tumor shrank more than 30 percent. The FDA said it would only consider the efficacy of confirmed responses, and the original new drug application included some unconfirmed response rates.

AstraZeneca has its drug in Phase II trials, and released some positive data in September.