Generally speaking, 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 consider that 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 midstage trial or even achieving as much as a Fast Track designation from the U.S. Food and Drug Administration (FDA).
Basically, these updates within the industry have the potential to make or break these 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.
Sierra Oncology Inc. (NASDAQ: SRRA) previously announced that it will provide an update on the SRA737 development program sometime in February and remains on track to report interim clinical results at a medical conference in the second half of 2018. SRA737 works to treat advanced solid tumors or non-Hodgkin’s lymphoma. The drug is currently being investigated in two Phase 1 trials. Shares of Sierra Oncology closed most recently at $2.90, with a consensus price target of $4.33 and a 52-week trading range of $1.10 to $4.09.
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 last trading at $5.80, with a consensus price target of $9.25 and a 52-week range of $2.45 to $6.75.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) is expected to report its most recent quarterly results on February 22. The consensus estimates from Thomson Reuters are calling for a net loss of $0.24 per share on $357.49 million in revenue. The same period of last year had a net loss of $0.53 per share and $300.09 million in revenue. Shares of BioMarin were last seen at $84.98, with a consensus price target of $110.32 and a 52-week range of $78.50 to $100.51.
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 $37.20, with a consensus price target of $57.11 and a 52-week range of $15.97 to $40.65.
NocoCure Ltd. (NASDAQ: NVCR) is scheduled to release its fourth-quarter earnings report on February 22 as well. The consensus estimates call for a net loss of $0.11 per share and $53.52 million in revenue. The same period of last year had a net loss of $0.26 per share and $30.24 million in revenue. Shares of Novocure most recently closed at $21.50, with a consensus price target of $27.00 and a 52-week range of $6.75 to $24.15.