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.

BioCryst Pharmaceuticals

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) is expecting an FDA decision by December 23, 2014, on the intravenous peramivir NDA as a treatment for influenza. This company has most recently been known for its news around Ebola. In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst had previously said that it had reached agreement with FDA regarding all requirements for a complete NDA submission, which included results in over 2,700 subjects treated with peramivir in 27 clinical trials. BioCryst had also previously said that peramivir has been approved in Japan and Korea.

BioCryst shares were down over 4% at $10.35 with less than three hours left in regular trading. The stock has a consensus analyst price target of $17.73 and a 52-week trading range of $5.63 to $14.62. The market cap is $743 million. The projected annual sales for the full year 2014 are $11.1 million and for the full year 2015 are $43.3 million.

Vertex Pharmaceuticals

In October, Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee voted 13 to two to recommend approval of KALYDECO in people with cystic fibrosis ages 6 and older who have the R117H mutation in the cystic fibrosis transmembrane regulatory gene, which is the indication being reviewed by the FDA. The FDA is expected to make a decision on the approval of ivacaftor by December 30, 2014. Vertex gave the same disclosure that most biotech companies give when they receive panel backing: Advisory committees provide the FDA with independent scientific and medical advice on safety, effectiveness and appropriate use of potential new medicines, but the FDA is not bound by the committee’s recommendation.

Vertex shares were recently trading around at $117.25, with a consensus analyst price target of $122.05 and a 52-week trading range of $59.79 to $120.91. Vertex was recently named as a top pick for 2015 by RBC Capital Markets. Vertex has a market cap of $28 billion. The projected annual sales for the full year 2014 are $566 million and for the full year 2015 are $1.3 billion.

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POZEN

POZEN Inc. (NASDAQ: POZN) has its NDA resubmission ongoing, and an FDA decision on PA8140/PA32540 as a secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers is due by December 30, 2014. The company has just freshly announced that it and Sanofi (NYSE: SNY), via Sanofi US, have mutually agreed to terminate their agreement for commercialization of the investigational products, PA8140 and PA32540 effective November 29, 2014. All licenses granted to Sanofi US will be terminated and all rights to the products will revert to POZEN. POZEN stuck with its December 30 PDUFA date in the press release, confirming that the Sanofi pact was off. It said:

Our goal at POZEN continues to be to maximize shareholder return. Management and the Board of Directors are taking this opportunity to evaluate all strategic options for YOSPRALA and POZEN. As we continue to work with the FDA during these final weeks leading up to our December 30th PDUFA date, we are very happy with the current FDA-proposed package insert. With respect to how well YOSPRALA may perform in the marketplace, we believe that the clinical profile of the drug, as described in the current FDA-proposed package insert, will meet or exceed the assumptions we made when we started our development and evaluated the commercial potential for this product. Given that the target population for YOSPRALA could exceed 20 million patients in the US, we will be fully engaged in the near term evaluating strategic options available to the company.

Shares of POZEN were down about 16% at $7.47 with less than three hours left in regular trading on Monday. The stock has a consensus analyst price target of $11.00 and a 52-week trading range of $5.96 to $9.90. The market cap is $239 million. The projected annual sales for the full year 2014 are $40.10 million and for the full year 2015 are $38.60 million.

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