Major Biopharma Catalysts on the December FDA Calendar

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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 December.

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.

Biogen Inc. (NASDAQ: BIIB) is scheduled to release full results of new aducanumab data on December 5. This comes ahead of its presentation at the Annual American Society of Hematology (ASH) meeting on December 7-10.

G1 Therapeutics, Inc. (NASDAQ: GTHX) will present additional data from its Phase 1b/2a study of lerociclib (+ faslodex) in ER+, HER2- breast cancer on December 11 at the San Antonio Breast Cancer Symposium (SABCS).

Syros Pharmaceuticals, Inc. (NASDAQ: SYRS) will make a presentation on metastasis in triple-negative breast cancer (TNBC) at the SABCS as well.

MacroGenics, Inc. (NASDAQ: MGNX) is another presenter at the SABCS. The firm will give a comprehensive update from its 2nd interim analysis of its Phase 3 Sophia trial in HER2-positive metastatic breast cancer.

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) announced that the presentation of the results from its Phase 3 HARMONY study of pimavanserin in dementia-related psychosis has been accepted for a late-breaking oral communication at the upcoming 12th Clinical Trials on Alzheimer’s Disease (CTAD) meeting on December 4-7. The trial was stopped early in September after meeting the primary endpoint.

Alector, Inc. (NASDAQ: ALEC) will be presenting Phase 1 data from its AL002 treatment for Alzheimer’s disease at the CTAD meeting on December 6.

Epizyme, Inc. (NASDAQ: EPZM) is on track to submit its New Drug Application (NDA) for tazemetostat as a monotherapy for relapsed or refractory follicular lymphoma (FL) patients in December. Separately, Epizyme will present Phase 2 data on its FL treatment at ASH on December 7.

Avadel Pharmaceuticals plc (NASDAQ: AVDL) previously announced that the FDA has accepted the NDA for the company’s fourth Hospital Product, AV001. The FDA assigned a PDUFA target action date of September 15, but this was extended 3 months to December 15.

Bausch Health Companies Inc. (NYSE: BHC) has a PDUFA target action date scheduled on December 22 for IDP-123 Lotion. If approved, IDP-123 will be the first tazarotene acne treatment available in a lotion form.

Amarin Corp. PLC (NASDAQ: AMRN) previously announced that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa to reduce the risk of cardiovascular events in high-risk patients. The FDA is not bound by the recommendations of an advisory committee. A PDUFA target action date is scheduled for December 28.

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