The Week Ahead In Biotech (Oct. 18-23): J&J, Biogen Kickstart Big Pharma Earnings, Regeneron-Sanofi, Roche Await FDA Decisions And IPOs

Biotech stocks rebounded in the week ended Oct. 15, bouncing from third straight weekly losses. The strength came amid a broader market rally and some sector-specific news.

Moderna, Inc. MRNA and Johnson & Johnson JNJ posted gains for the week after a Food and Drug Administration panel recommended approval of a third booster dose of their respective COVID-19 vaccines.

Avadel Pharmaceuticals plc AVDL faced a setback after the FDA extended the review period for its new drug application for FT218, which is being evaluated for excessive daytime sleepiness. However, Ocular Therapeutix, Inc. OCUL received early approval for its supplemental NDA for Dextenza in allergic conjunctivitis.

Jasper Therapeutics, Inc. JSPR was among the biggest advancers of the week, although there was no notable catalyst to justify the move. Protagonist Therapeutics, Inc. PTGX shares swelled after the FDA removed the clinical hold on its experimental cancer drug.

Here are the key catalysts that could impact trading in biotech stocks in the unfolding week:

Conferences:

American Neurological Association, or ANA, Annual Meeting (virtual): Oct. 17-19

National Association for Rare Disorders, or NORD, Rare Summit (virtual): Oct. 18-19

28th Annual Congress of the European Society of Gene and Cell Therapy, ESGCT (virtual): Oct. 19-22

53rd Congress of the International Society of Pediatric Oncology, or SIOP (virtual): Oct. 21-24

PDUFA Dates

Sanofi SNY & Regeneron Pharmaceuticals, Inc. REGN await FDA ruling on their sNDA for Dupixent, which is being evaluated as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The PDUFA date is set for Thursday.

The FDA is also scheduled to announce its decision on Roche Holding AG RHHBY's BLA for Port Delivery System with ranibizumab for neovascular or wet age-related macular degeneration by the PDUFA action date of Saturday.

Clinical Readouts/Presentations

ESGCT Congress Presentations

Tenaya Therapeutics, Inc. TNYA: New preclinical data for TN-201, its AAV-based gene therapy product candidate for patients carrying mutations of the MYBPC3 gene (Wednesday)

Sio Gene Therapies Inc. SIOX: Phase 1/2 data for AXO-AAV-GM1 gene therapy for the treatment of infantile- and juvenile-onset GM1 Gangliosidosis and data from the Phase 1/2 dose evaluation study of AXO-Lenti-PD gene therapy for Parkinson's disease (Thursday)

Abeona Therapeutics Inc. ABEO: data from the Phase 1/2 study of ABO-102 investigational gene therapy for Sanfilippo syndrome Type A (Mucopolysaccharidosis IIIA) (Thursday)

AVROBIO, Inc. AVRO: new safety data on the eight patients in Phase 2 clinical trial who have been treated with AVR-RD-01, an investigational gene therapy for Fabry disease, and data from the phase 1/2 study of AVR-RD-02 ex-vivo lentiviral vector, autologous gene therapy for Gaucher disease (Friday)

NORD Summit Presentations

Soligenix, Inc. Inc. SNGX: positive Phase 3 results with HyBryte (hypericin ointment 0.25%) in the context of the broader cutaneous T-cell lymphoma treatment landscape (Monday)

Related Link: Merck's Oral COVID-19 Treatment Could Be Game-Changer: BofA Analyst

SIOP Congress Presentations

Turning Point Therapeutics, Inc. Inc. TPTX: results from the Phase 1/2 study of repotrectinib in pediatric and young adult patients with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations (Saturday, at 8:40, am – 9:40 a.m)

Earnings

Johnson & Johnson (Tuesday, before the market open)

Intuitive Surgical, Inc. ISRG (Tuesday, after the close)

Abbott Laboratories ABT (Wednesday, before the market open)

Biogen Inc. BIIB (Wednesday, before the market open)

Quest Diagnostics Incorporated DGX (Thursday, after the close)

Plus Therapeutics, Inc. PSTV (Thursday, after the close)

IPOs

IPO Pricing

California-based Ventyx Biosciences, Inc. VTYX has filed a preliminary prospectus with the SEC to offer 7.8125 million shares in an initial public offering. The clinical-stage biopharma focusing on therapies for patients with inflammatory diseases and autoimmune disorders expects the offering to be priced between $15 and $17. It has applied for listing its shares on the Nasdaq under the ticker symbol "VTYX."

Minerva Surgical, Inc. UTRS, a commercial-stage Medtech company focused on developing minimally invasive solutions to meet the distinct uterine healthcare needs of women, is proposing to offer 6.25 million shares in an IPO, with an estimated price range of $15 and $17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "UTRS."

Woburn, Massachusetts-based Biofrontera, Inc. BFRI, the U.S. unit of German-based Biofrontera AG, is offering 3 million shares in an IPO. Biofrontera is a U.S.-based biopharma specializing in the commercialization of pharmaceutical products to treat dermatological conditions. Immediately following the offering, the parent company will own approximately 72.7% of the outstanding shares of common stock. It is currently estimated that the IPO price per share of the common stock will be between $5 and $7. The company has applied for listing the shares under the symbol "BFRI."

IPO Quiet Period Expiry

Cue Health Inc. HLTH

Related Link: NanoViricides COVID-19 Treatment Candidate Found Effective Against Coronavirus Variants In Lab Study

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