The Week Ahead In Biotech: J&J Earnings Kickstarts Pharma Earnings, More IPOs In The Pipeline

Biotech stocks advanced along with the broader market in the week ended Oct. 9, although the news flow was quite light.

Antibody treatment for COVID-19 took the spotlight during the week, with both Eli Lilly And Co LLY and Regeneron Pharmaceuticals Inc. REGN requesting for emergency use authorizations. Regeneron was in the news even ahead of the EUA request, as President Trump was administered the company's antibody cocktail after he was diagnosed COVID-19 positive.

In a major breakthrough in the coronavirus vaccine space, Pfizer Inc. PFE and BioNTech SE – ADR BNTX began rolling submission of the BLA for their jointly-developed mRNA vaccine - BNT16b2 in Europe.

Pre-announcement season kickstarted, with most companies reporting above-consensus preliminary revenues for the quarter ended Sept. 30.

A multi-billion-dollar deal was announced during the week, with Bristol-Myers Squibb Co. BMY agreeing to buy Myokardia Inc. MYOK for $13.1 billion.

The week also witnessed 3 biotechs debuting on Wall Street following their IPOs, which raised a cumulative $390.04 million in gross proceeds.

Here're the key catalysts for the unfolding week:

Conferences

• United European Gastroenterology, or UEG, Week 2020: Oct. 11-13
• Cell & Gene Meeting on the Mesa 2020: Oct. 12-16
• Joint 49th Child Neurology Society Annual Meeting/16th International Child Neurology Congress: Oct. 12-23
• European Society for Immunodeficiencies, or ESID, 2020 Meeting: Oct. 14-17
• Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

Clinical Readouts

Bristol-Myers Squibb is scheduled to host a virtual investor event at 8 a.m. ET Monday to present results from the Phase 3 True North trial evaluating Zeposia in patients with moderate to severe ulcerative colitis. The data will subsequently be presented at the UEG Week.

Rocket Pharmaceuticals Inc. RCKT is scheduled to present at the ESID meeting an update on data from the Phase 1 portion of the Phase 1/2 clinical trial of RP-L201, lentiviral-mediated ex-vivo gene therapy, for leukocyte adhesion deficiency-I. The company will also present an e-poster consisting of preclinical study data on RP-L401 for infantile malignant osteopetrosis.

Earnings

• Johnson & Johnson JNJ (Tuesday, before the market open)
• Enzo Biochem Inc. ENZ (Tuesday, after the close)
• Brainstorm Cell Therapeutics Inc. BCLI (Thursday, before the market open)
• Intuitive Surgical Inc. ISRG (Thursday, after the close)

IPOs

Cambridge, Massachusetts-based Codiak BioSciences has filed with the SEC a preliminary prospectus to offer 5 million shares of its common stock at an estimated price range of $14-$16. The clinical-stage biopharma focused on pioneering the development of exosome-based therapeutics said it has applied for listing its shares on the Nasdaq under the ticker symbol CDAK.

Praxis Precision Medicines Inc., also from Cambridge in Massachusetts, is planning a 7.4-million-share IPO at an estimated price range of $16-$18. The company, which translates genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, is expected to list its shares on the Nasdaq under the ticker symbol PRAX.

Carlsbad, California-based Spinal Elements Holdings Inc., a medical device company developing comprehensive portfolio of systems, products and technologies for spine surgery procedures, said it has filed to offer 7.7 million shares in an IPO at an estimated price range of $13-$15. The company has applied for listing its shares on the Nasdaq under the ticker symbol SPEL.

IPO Quiet Period Expiry

• Metacrine Inc MTCR
• Dyne Therapeutics Inc DYN
• Athira Pharma Inc ATHA
• Outset Medical Inc OM

Related Link: FDA's COVID-19 Vaccine Guidance Shows 'Substantial' Obligations For Developers: Analyst