18 key biopharmaceutical catalysts to watch in Q3 – iShares Nasdaq Biotechnology Index Fund (IBB)


Biopharmaceuticals stocks underperformed in the first half of 2021, and several of these stocks could rebound in the coming months.

Needham analyst Serge Bélanger highlighted companies in the company’s coverage universe that have key enablers in the third quarter.

PDUFA Events: PDUFA deadlines are key binary events that can make or break actions. The date indicates 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, while a priority review takes up to six months.

Revance Therapeutics, Inc. (NASDAQ: RVNC): Daxi, or daxibotulinumtoxin A, for glabellar lines will likely pass the FDA hurdle by the middle of the third trimester,

Verrica Pharma inc. (NASDAQ: VRCA): Ycanth, or VP-102, for molluscum contagiosum has a PDUFA date of September 23.

Clinical trial readings: Clinical readings are another catalyst for stock movement for biopharmaceutical stocks. A drug goes through several stages of testing, starting with preclinical testing, before its efficacy and safety can be established.

Xenon Pharmaceuticals Inc. (NASDAQ: XENE): Data from the phase 2b study, dubbed 2b X-TOLE, of XEN-101 in focal epilepsy in adults is mainly expected at the end of the third trimester.

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

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

Clearside Biomedical, Inc. (NASDAQ: CLSD) collaboration partner REGENXBIO inc. (NASDAQ: RGNX): Data from the first cohort of a phase 2 AAVIATE study evaluating RGX-314 injected via the suprachoroidal route in patients with age-related macular degeneration.

Related Link: Biotech Losers in 2021 Who Could Bounce Big in Second Half

Regulatory deposits: Filing a new drug application or biologic license approval is considered an important step in the drug approval process.

Zogenix, Inc. (NASDAQ: ZGNX): Biopharma to complete an sNDA dossier for Fintepla, seeking label extension to include patients with Lennox-Gastaut syndrome.

Acer Therapeutics Inc. (NASDAQ: ACER): The company plans to file an NDA for ACER-001 as a treatment for third trimester urea cycle disorder.

Regulatory Development Updates: Among Needham’s cover universe, KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) and Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) are scheduled to meet with the FDA to seek clarification on the progress of their programs to the next stage of development.

Bélanger is also considering Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH), Heron Therapeutics, Inc. (NASDAQ: HRTX) and Zogenix to provide development updates, including potential filing and approval timelines, on their late stage programs. Procedures relating to intellectual property rights that could have an impact Liquidia Corporation (NASDAQ: LQDA) LIQ861 for pulmonary arterial hypertension could also be important, he added.

Launch progress updates: Top product launch updates that investors are likely to watch out for include by BioCryst Pharmaceuticals, Inc. (NASDAQ: 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.


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