Health and Healthcare

Major Biopharma Catalysts on February's FDA Calendar

Chris Lange

Published: February 3, 2018 8:50 am

Last Updated: January 12, 2020 3:46 am

Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to great, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.

In simpler terms, these updates within the industry have the potential to make or break biopharma companies.

Here 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in February. We have added some color, a recent trading history and a consensus analyst price target.

It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and some can be disasters if a company is deeply financed.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) is undergoing a priority review of its New Drug Application (NDA) for tezacaftor/ivacaftor combination in the treatment of cystic fibrosis. The FDA has a PDUFA date set for February 28. Shares of Vertex last closed at $166.24, with a consensus price target of $191.28 and a 52-week trading range of $84.39 to $174.96.

Kadmon Holdings Inc. (NYSE: KDMN) is expecting to report six-month data from its Phase 2 study of KD025 for idiopathic pulmonary fibrosis (IPF) sometime in the month of February. IPF is a specific form of progressive fibrosing interstitial lung disease that can cause pneumonia, and it generally comes with a low life expectancy. Shares of Kadmon recently traded at $5.14, with a consensus price target of $10.67 and a 52-week range of $2.05 to $5.86.

Apricus Biosciences Inc. (NASDAQ: APRI) has a PDUFA goal date for completion of the FDA’s review of the Vitaros NDA set on February 17. Vitaros is a novel, on-demand topical cream for the treatment of erectile dysfunction (ED) and a new potential entrant into the U.S. ED treatment market. So far Vitaros has been approved in Canada, Mexico and certain countries in Europe, Latin America and the Middle East. Shares of Apricus were last seen at $2.22, with a 52-week range of $0.86 to $3.49 and a consensus price target of $3.50.

Celgene Corp. (NASDAQ: CELG) will present its full Phase 2 data set for Otezla at the 13th Congress of the European Crohn’s and Colitis Organization (ECCO) on February 14 to 17. Otezla is used to treat ulcerative colitis. Celgene recently traded at $99.80 a share, with a consensus price target of $124.51 and a 52-week range of $94.55 to $147.17.

Aimmune Therapeutics Inc. (NASDAQ: AIMT) is looking for Phase 3 data for in its Palisade trial of AR101 in February. Specifically, this trial is looking to treat peanut allergies. Shares closed most recently at $36.18, with a consensus price target of $57.38 and a 52-week range of $15.97 to $40.65.

Johnson & Johnson (NYSE: JNJ) has a few catalysts in the works for the month of February. The firm is looking to present at the American Society of Clinical Oncology Genitourinary (ASCO GU) 2018 Cancers Symposium taking place February 8 to 10. Specifically, the company is presenting new data for Zytiga and Apalutamide for the treatment of prostate cancer. It is announcing Phase 2 data for Erdafitinib in the treatment of urothelial cancer at ASCO GU as well. Shares were last trading at $137.68, with a consensus price target of $149.68 and a 52-week range of $112.62 to $148.32.

Amicus Therapeutics Inc. (NASDAQ: FOLD) has a couple of presentations highlighting its development programs for lysosomal storage disorders will be included at the 14th Annual WORLDSymposium 2018, to be held February 5 to 9. The main presentation will be on Pompe disease, with updated results from its Phase 1/2 study of ATB200. Amicus shares were last seen at $16.40, with a consensus analyst target of $19.21 and a 52-week trading range of $5.51 to $17.40.

Gilead Sciences Inc. (NASDAQ: GILD) has a PDUFA date for its HIV-1 treatment, bictegravir in combination with emtricitabine/tenofovir alafenamide, set on February 12. Shares of Gilead traded at $81.73 apiece, with a consensus price target of $87.79 and a 52-week range of $63.76 to $89.54.

KemPharm Inc. (NASDAQ: KMPH) has a PDUFA date for Apadaz set on February 23. Note that Apadaz is intended to provide short-term management of acute pain. KemPharm was trading at $6.35 per share, with a consensus price target of $9.25 and a 52-week range of $2.45 to $6.75.