Healthcare Business

Major Biopharma Catalysts on October's FDA Calendar

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 the month 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 of these 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.

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.

Valeant Pharmaceuticals International Inc. (NYSE: VRX) has a PDUFA action date set for October 5 for its Jemdel (halobetasol propionate 0.01%) (IDP-122) lotion. If approved, Jemdel will be the first high-potency topical steroid treatment for plaque psoriasis with dosing for as long as eight weeks.

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.

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.

AVEO Pharmaceuticals Inc. (NASDAQ: AVEO) will be presenting additional data from its Phase 2 data 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.

Akcea Therapeutics Inc. (NASDAQ: AKCA) has a PDUFA goal date of October 6 for Tegsedi. For some quick background, Tegsedi (inotersen) works to treat the stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis.

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.

AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) announced the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA has a meeting to revenue the company’s New Drug Application (NDA) for Dsuvia for the management of moderate-to-severe acute pain in medically supervised settings in adult patients. The PDUFA date is set for November 3.

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