The Week Ahead In Biotech: Adcom Test Awaits FibroGen, Data Readouts, IPOs In The Mix

Biopharma stocks closed the holiday-shortened week lower amid a lack of any significant news flow.

On the drug approval front, Provention Bio, Inc. PRVB faced a setback, as its diabetes drug failed to get the FDA nod. The stock shed over 20% in reaction to the adverse outcome. Expectedly, the review period for ChemoCentryx, Inc.'s CCXI avacopan as a treatment option for small blood vessel damage was extended. The stock reacted positively to the outcome.

Alector, Inc. ALEC was among the biggest gainers of the week, buoyed by an immuno-neurology deal it struck with GlaxoSmithKline plc GSK.

Biogen, Inc. BIIB was under the scanner as the FDA narrowed the Aduhelm label and also called for an investigation into the interactions between FDA staffers and the company in the run-up to the approval.

Here are the key catalytic events that can impact trading in biotech stocks in the unfolding week:

Conferences

European Academy of Allergy and Clinical Immunology, or EAACI, Annual Congress 2021, to be held virtually: July 10-16
Ladenburg Thalmann Annual Healthcare Conference: July 13-14
William Blair Biotech Focus Conference 2021: July 14-15

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

Adcom Calendar

FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet July 15 to discuss the NDA for FibroGen, Inc.'s FGEN roxadustat for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. FibroGen is partnering with AstraZeneca PLC AZN for Roxadustat. Roxadustat is already approved in Japan and China.

Clinical Readouts/Presentations

KalVista Pharmaceuticals, Inc. KALV will present at the EAACI Congress results of a phase 2 study of KVD900 as a treatment option for patients with hereditary angioedema. The presentation is scheduled for Monday.

AVEO Oncology AVEO will host a key opinion leader webinar focusing on Fotivda, its oral, once-daily, differentiated vascular endothelial growth factor receptor tyrosine kinase inhibitor, for the treatment of adult patients with relapsed or refractory renal cell carcinoma following two or more prior systemic therapies. The event is scheduled for Friday afternoon.

Earnings

AngioDynamics, Inc. ANGO (Tuesday, before the market open)

IPOs

IPO Pricing

Utah-based Sera Prognostics, Inc. is proposing to offer 4.69 million shares of its Class A common stock in an initial public offering at an estimated price range of $15-$17 apiece. Sera is a women's health diagnostic company utilizing its proprietary proteomics and bioinformatics platform to discover clinically meaningful and economically impactful biomarker tests, with an initial focus on improving pregnancy outcomes. The company has applied to list the shares on the Nasdaq under the ticker symbol SERA.

Sight Sciences, Inc., a medical device company that focuses on development of proprietary devices that target the underlying causes of eye diseases, has filed for offering 6.98 million shares in an IPO. The California-based company expects to price the offering between $20 and $23 per share. The company has applied for listing its shares on the Nasdaq under the ticker symbol SGHT.

Related Link: 14 Biotech Stocks To Watch Over The Next 6 Months

IPO Quiet Period Expiry

Molecular Partners AG MOLN
Verve Therapeutics, Inc. VERV
Lyell Immunopharma, Inc. LYEL
Ambrx Biopharma Inc. AMAM
Century Therapeutics, Inc. IPSC
Codex DNA, Inc. DNAY
Cyteir Therapeutics, Inc. CYT
Atai Life Sciences N.V. ATAI