Companies in 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 can spell disaster for a stock, comes great reward as well. Some companies can see 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).
In simpler terms, these updates within the industry have the potential to make or break biopharma companies.
Here, 24/7 Wall St. includes a calendar of a few of the biggest companies expecting clinical trial and FDA updates in April. We have added some color, a recent trading history and a consensus analyst price target to each.
Note that these dates may be subject to change due to various outside and internal factors, or some of these dates may have changed already. Some date 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.
Merck & Co. Inc. (NYSE: MRK) is scheduled for a PDUFA target action date on April 3 for the review of its supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma, or who have relapsed after two or more prior lines of therapy. Shares of Merck were last seen at $54.47, with a consensus analyst price target of $66.50 and a 52-week trading range of $52.97 to $66.41.
Pacira Pharmaceuticals Inc. (NASDAQ: PCRX) announced back in February that the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of Exparel (bupivacaine liposome injectable suspension) as a nerve block to produce regional analgesia. As a result, the FDA is considering it in its review of the company’s sNDA seeking expansion of the Exparel label. The PDUFA date for completion of the review is April 6. Shares of Pacira were last trading at $31.15, with a consensus price target of $43.00 and a 52-week range of $27.80 to $52.48.
Keep in mind that the European Association for the Study of the Liver (EASL) is poised to have its annual congress in Paris on April 11 to 15. We can expect numerous abstracts and presentations to come from this event. Some of the companies to watch include Eiger BioPharmaceuticals Inc. (NASDAQ: EIGR), Galectin Therapeutics Inc. (NASDAQ: GALT) and Alnylam Pharmaceuticals Inc. (NASDAQ: ALNY).
There is another major medical conference going on at this time as well. The American Association for Cancer Research will be hosting its annual meeting April 14 to 18 in Chicago. Some of the big names to watch for this conference are Bluebird Bio Inc. (NASDAQ: BLUE), Blueprint Medicines Corp. (NASDAQ: BPMC), Endocyte Inc. (NASDAQ: ECYT), Epizyme Inc. (NASDAQ: EPZM), Fate Therapeutics Inc. (NASDAQ: FATE) and G1 Therapeutics Inc. (NASDAQ: GTHX).
As we get closer to these conferences, we will go more in depth for each.