Biotech and pharmaceutical companies generally are 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. 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 the remainder of October.
It’s worth mentioning 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, while 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.
AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) will be presenting additional data from its Phase 2 results from its tivozanib and nivolumab trial at the European Society of Medical Oncology (ESMO) on October 22. The study is looking to treat advanced renal cell carcinoma.
Mirati Therapeutics Inc. (NASDAQ: MRTX) will be presenting an update from its Phase 2 study of sitravatinib for the treatment of non-small cell lung cancer at the ESMO on October 22.
Neon Therapeutics Inc. (NASDAQ: NTGN) is another presenter at the ESMO. The company will be presenting updated data from NT-001, its ongoing Phase 1b clinical trial in metastatic melanoma, lung cancer and bladder cancer.
Tricida Inc. (NASDAQ: TCDA) will present Phase 3 data from its TRCA-301 clinical trial of TRC101 designed to treat metabolic acidosis in patients with chronic kidney disease. The data will be presented at Kidney Week 2018, the annual meeting of the American Society of Nephrology on October 23 to 28.
TG Therapeutics Inc. (NASDAQ: TGTX) has final Phase 2 data from its trial of ublituximab (TG-1101) in relapsing forms of multiple sclerosis in October. The company will make an oral presentation at the upcoming 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which will be held on October 10 to 12.
RegenXBio Inc. (NASDAQ: RGNX) is expected to present Phase 1 clinical trial data evaluating RGX-314 for the treatment of wet age-related macular degeneration later this month. On October 26, the firm will present the interim results at the American Academy of Ophthalmology 2018 Annual Meeting.
Merus N.V. (NASDAQ: MRUS) has Phase 1/2 data for MCLA-128 due at the ESMO with other cohort data due in the fourth quarter of this year. MCLA-128 has a few indications to treat gastric, ovarian, endometrial and non-small cell lung cancer.
Merck & Co. Inc. (NYSE: MRK) has a PDUFA target action date of October 6, for its Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), the company’s 9-valent HPV vaccine. The application is seeking approval for an expanded age indication for Gardasil 9 for use in women and men ages 27 to 45 for the prevention of certain cancers and diseases caused by the nine HPV types covered by the vaccine.
Trevena Inc. (NASDAQ: TRVN) previously announced that the FDA has scheduled a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee on October 11 to discuss the safety and efficacy of oliceridine injection for the management of moderate to severe acute pain. The company has a PDUFA target date of November 2.