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 3.85% 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 11.06% avacopan as a treatment option for small blood vessel damage was extended. The stock reacted positively to the outcome.
Alector, Inc. ALEC 5.67% was among the biggest gainers of the week, buoyed by an immuno-neurology deal it struck with GlaxoSmithKline plc GSK 0.45%.
Biogen, Inc.
BIIB 2.95% 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
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 0.23% 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 0.62% for Roxadustat. Roxadustat is already approved in Japan and China.
Clinical Readouts/Presentations
KalVista Pharmaceuticals, Inc. KALV 0.17% 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 5.69% 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 2.89% (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.
IPO Quiet Period Expiry
Molecular Partners AG MOLN 0.37%
Verve Therapeutics, Inc. VERV 0.54%
Lyell Immunopharma, Inc. LYEL 4.13%
Ambrx Biopharma Inc. AMAM 0.78%
Century Therapeutics, Inc. IPSC 4.27%
Codex DNA, Inc. DNAY 0.99%
Cyteir Therapeutics, Inc. CYT 3.62%
Atai Life Sciences N.V. ATAI 4.62%
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