Healthcare Business

5 Critical Biotech Drug Dates and Events for December

Jon C. Ogg, Chris Lange

At least five upcoming dates could be big days in December, for better or worse, for individual biotech stocks. These events refer to reviews and decisions by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). We have included the details on each with references made to New Drug Application (NDA) or a supplemental New Drug Application (sNDA), along with the Prescription Drug User Fee Act (PDUFA) dates for each.

24/7 Wall St. has also looked at each company’s shares versus analyst expectations and trading history over the past year. We have also included total revenue expectations and a relative market cap for each company. The one caveat that needs to be mentioned is that biotech dates can change with no explanation given — and it is always possible that extensions or changes can occur even up to hours or days ahead of the event.

These key biotech review events are listed in chronological order rather than alphabetically.

Incyte

Incyte Corp. (NASDAQ: INCY) has its PDUFA date for the sNDA for ruxolitinib set for December 5, 2014. The company announced in August that the FDA had accepted for filing the sNDA for ruxolitinib as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA included results from the RESPONSE Phase 3 trial, which had been presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.

Shares of Incyte were trading around $74.25, versus a consensus analyst price target of $81.08 and a 52-week trading range of $40.30 to $76.37. One analyst said that Incyte was worth a whopping 70% more back in September. Incyte’s market cap was over $12 billion on last look. The company’s projected annual sales for the full year 2014 are $531.19 million and for the full year 2015 are $688.45 million.

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Cubist Pharmaceuticals

Cubist Pharmaceuticals Inc. (NASDAQ: CBST) has a PDUFA action date set as December 21, 2014. Back in June, the company announced that the FDA had accepted its NDA for its investigational antibiotic ceftolozane/tazobactam with Priority Review. Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. Cubist’s NDA is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the FDA and the EMA specified primary endpoints. The company said back in June that results of the secondary analyses were consistent with and supportive of the primary outcomes.

Shares of Cubist were trading around $75.50, with a consensus analyst price target of $81.27 and a 52-week trading range of $58.50 to $82.12. It has a market cap of over $5 billion. The projected annual total revenues for the company for the full year 2014 are $1.2 billion and for the full year 2015 are $1.41 billion. Cubist was named back in April as one company betting on the next 10 blockbuster drugs.