Companies that reside within the biotech and pharmaceutical industries are subject to a sizable amount of risk with regards to their drug candidates passing clinical trials and gaining regulatory approval. But with the risk of failure, which could spell disaster for a stock, comes great reward as well. Some companies can see a massive upside just from winning a single mid-stage trial or even achieving as much as a Fast Track designation from the U.S. Food and Drug Administration (FDA).
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 a few of the biggest companies expecting clinical trial and 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.
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 trading most recently at $37.13, with a consensus price target of $55.50 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 $145.33, with a consensus price target of $149.50 and a 52-week range of $111.90 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. Shares of Amicus were last seen at $16.20, with a consensus analyst target of $19.21 and a 52-week trading range of $5.07 to $17.40.
AMAG Pharmaceuticals Inc. (NASDAQ: AMAG) has a PDUFA date set for its drug Feraheme for the treatment of iron deficiency anemia in patients who have an intolerance or unsatisfactory response to oral iron. The date is set for February 2. Shares of AMAG were trading at $14.45, in a 52-week range of $11.93 to $25.20 and with a consensus price target of $18.00.
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 were last seen at $85.46, with a consensus price target of $86.54 and a 52-week range of $70.05 to $85.49.
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. Shares of KemPharm were trading at $5.75, with a consensus price target of $9.25 and a 52-week range of $2.45 to $6.43.