18 Key Biopharma Catalysts To Keep An Eye On In Q3

Biopharma stocks underperformed in the first half of 2021, and several of these stocks could be in for a rebound in the coming months.

Needham analyst Serge Belanger highlighted companies in the firm's coverage universe that have key catalysts in the third quarter.

PDUFA Events: PDUFA goal dates are key binary events that can make or break stocks. The date denotes the end of the review period for the regulatory application filed with the Food and Drug Administration.

A standard review takes 10 months from the date of filing of the application, while a priority review takes up to six months.

Revance Therapeutics, Inc. RVNC: Daxi, or daxibotulinumtoxin A, for glabellar lines will likely clear the FDA hurdle by the middle of the third quarter, 

Verrica Pharmaceuticals Inc. VRCA: Ycanth, or VP-102, for molluscum contagiosum has a PDUFA date of Sept. 23.

Clinical Trial Readouts: Another stock-moving catalyst for biopharma stocks is clinical readouts. A drug goes through several stages of testing, starting with preclinical testing, before its efficacy and safety can be established.

Xenon Pharmaceuticals Inc. XENE: Data from the Phase 2b study, dubbed 2b X-TOLE, of XEN-101 in adult focal epilepsy is due mostly in the late third quarter.

Aerie Pharmaceuticals, Inc. AERI: Results from a phase 2b trial of AR-15512 in dry eye patients.

Revance: results from the open-label safety trial of daxi in cervical dystonia patients are expected in the second half.

Clearside Biomedical, Inc.'s CLSD collaboration partner REGENXBIO Inc. RGNX: Data from the first cohort of a Phase 2 AAVIATE study evaluating suprochoroidally-injected RGX-314 in wet age-related macular degeneration patients.

Related Link: Biotech Losers In 2021 That Could Bounce Big In The Second Half

Regulatory Filings: Filing a new drug application or a biologic license approval is considered a major milestone in the drug approval process.

Zogenix, Inc. ZGNX: The biopharma is due to complete an sNDA filing for Fintepla, seeking a label expansion to include Lennox-Gastaut Syndrome patients.

Acer Therapeutics Inc. ACER: The company plans to file an NDA for ACER-001 as a treatment for urea cycle disorder in the third quarter.

Regulatory Development Updates: Among Needham's coverage universe, KalVista Pharmaceuticals, Inc. KALV and Zynerba Pharmaceuticals, Inc. ZYNE are due to meet with the FDA to gain clarity on advancing their programs to the next development step.

Belanger also looks ahead to Amphastar Pharmaceuticals, Inc. AMPH, Heron Therapeutics, Inc. HRTX and Zogenix to provide development updates, including potential filing and approval timelines, on their late-stage programs. The intellectual property rights proceedings that could impact Liquidia Corporation's LQDA LIQ861 for pulmonary arterial hypertension could also be important, he added.

Launch Progression Updates: The main product launch updates that investors are likely to keep an eye on, include BioCryst Pharmaceuticals, Inc.'s BCRX Orladeyo for hereditary angioedema, Revance's RHA filler and HintMD platform, and Zogenix's Fintepla for Dravet Syndrome, Belanger said. The next launch of significant interest is Heron's Zynrelef, which became commercially available on July 1, he added.