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 May.
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.
Valeant Pharmaceuticals International Inc. (NYSE: VRX) has a PDUFA date set for May 13. Specifically, this is for its New Drug Application for Plenvu (NER1006), which was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market. Plenvu is a next-generation bowel cleansing preparation for colonoscopies.
Voyager Therapeutics Inc. (NASDAQ: VYGR) will be presenting at the American Society of Gene and Cell Therapy annual meeting taking place May 16 to 19, 2018, in Chicago. The firm will be releasing data from its lead clinical program for Parkinson’s disease, its preclinical programs targeting a monogenic form of amyotrophic lateral sclerosis (ALS) called SOD1, Huntington’s disease and Friedreich’s ataxia, and its gene therapy vector platform including novel adeno-associated virus capsid optimization efforts and manufacturing capabilities.
Amgen Inc. (NASDAQ: AMGN) is waiting for the FDA to review its Biologics License Application (BLA) for Aimovig (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. The FDA has set a PDUFA date for May 17.
GTx Inc. (NASDAQ: GTXI) will present additional data demonstrating duration of response following completion of treatment for its Phase 2 proof-of-concept clinical trial evaluating enobosarm 3 mg in postmenopausal women with stress urinary incontinence at the upcoming 2018 American Urological Association meeting on May 18.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) has a PDUFA date scheduled for May 28 for its investigational therapy pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine levels in adult patients with phenylketonuria who have uncontrolled blood phenylalanine levels on existing management.
Esperion Therapeutics Inc. (NASDAQ: ESPR) is scheduled to release top-line results from its pivotal Phase 3 Study 3 (1002-046) later this month. Specifically, the is the study of bempedoic acid in atherosclerotic cardiovascular disease patients on background therapy of less than approved daily starting doses of statins (high CV risk patients considered statin intolerant).
Keep in mind that the annual meeting of the American Society of Clinical Oncology (ASCO) is just around the corner (early June) and we can expect abstracts coming out later this month in anticipation.