Even More Biopharma and FDA Catalysts Coming in October
As the markets continue to hit all-time highs, biotech and pharmaceutical companies have been part of these massive gains. There is a very positive sentiment in the health care sector as it’s been one of the best performing this year, second to technology in the S&P 500.
Biotech and pharmaceutical companies are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk to a great amount of risk involved, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.
24/7 Wall St. has collected a few more catalysts that are coming up on the calendar in October and added some color, along with the trading range and price target. We previously highlighted some other catalysts to keep an eye on. Note that, due to many outside and internal factors, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters if a company is not 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.
Aerie Pharmaceuticals Inc. (NASDAQ: AERI) has a PDUFA meeting with the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee on Friday of next week to review the company’s New Drug Application (NDA) for Rhopressa (netarsudil) ophthalmic solution for the treatment of patients with open-angle glaucoma or ocular hypertension.
Spark Therapeutics Inc. (NASDAQ: ONCE) is set to meet with the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee on Thursday for its PDUFA review to discuss the Biologics License Application (BLA) for Luxturna for the treatment of inherited retinal disease. Although Wedbush expects approval to be recommended, the firm sees upside from the event as priced in to the stock.
Fennec Pharmaceuticals Inc. (NASDAQ: FENC) has Phase 3 data of Pedmark for the prevention of platinum-induced ototoxicity in pediatric patients due on October 14, at the International Society of Paediatric Oncology. Preliminary data was released in mid-September that showed significantly reduced incidences of cisplatin-induced hearing loss without any evidence of tumor protection. In simpler terms, preliminary data was promising.
Antares Pharma Inc. (NASDAQ: ATRS) has a PDUFA review date set for October 20, for the company’s NDA for Quickshot Testosterone, a drug-device combination product for the delivery of testosterone enanthate use a subcutaneous auto injector.
Loxo Oncology Inc. (NASDAQ: LOXO) is scheduled to present initial clinical data for Loxo-292 at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer, which will be held October 15 to 18 in Japan. Loxo-292 is a selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection kinase.