The Week Ahead In Biotech: J&J Kickstarts Pharma Earnings, Relay Therapeutics IPO

Biotech stocks advanced in the week ended July 10 amid mixed news flow emerging out of the sector.

FDA approved a few drugs, including Endo International PLC's ENDP cellulite treatment, while Merck & Co., Inc. MRK-Eisai Co., Ltd's ESALY combo therapy was rejected by the FDA as a first-line treatment option for liver cancer.

Unum Therapeutics Inc UMRX was the biggest gainer for the week, with the shares reacting to an acquisition and fund buying. In major COVID-19 updates, Novavax, Inc. NVAX announced $1.6 billion federal funding for its coronavirus vaccine program.

The week also saw three biotechs testing the IPO waters. The three issues raised a combined $583.7 million from the offerings.

Here are the key catalysts for the unfolding week.

Conferences

Annual Biomarkers for Alzheimer's Disease Summit (digital event): July 15

PDUFA Dates

The FDA is set to rule on Verrica Pharmaceuticals Inc's VRCA NDA for VP-102, a topical solution, being reviewed as a potential treatment option for molluscum contagiosum. Updating on the regulatory review, the company said in late June it received a letter from the FDA stating there are deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The PDUFA date is set for Monday.

Adcom Meetings

FDA's Oncologic Drugs Advisory Committee will discuss GlaxoSmithKline plc's GSK biologic license application for belantamab mafodotin for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The drug linker technology for the product candidate was licensed from Seattle Genetics, Inc. SGEN. (Tuesday)

The Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Mallinckrodt PLC's MNK new drug application for terlipressin, lyophilized powder for solution for injection, for the proposed indication of treatment of hepatorenal syndrome Type 1. (Wednesday)

Related Link: Gilead's Remdesivir Data Shows Improved Clinical Recovery, Reduced Death Rate

Clinical Readouts/Presentations

Gritstone Oncology Inc GRTS is scheduled to present data from the ongoing Phase 1 studies of its immunotherapy product candidates GRANITE and SLATE. The company also said it would discuss Phase 2 study plans. (Monday)

INmune Bio Inc INMB will report interim data from its Phase Ib clinical study of XPro1595 in Alzheimer's disease. (Tuesday)

Cassava Sciences Inc SAVA said its lead neuroscientist, Lindsay Burns will give a keynote presentation at the Biomarkers for Alzheimer's Disease Summit, with the presentation focusing on SavaDx, the company's investigational diagnostic to detect Alzheimer's disease with a simple blood test. (Wednesday)

Earnings

• Abbott Laboratories ABT (Thursday, before the market open)
• AngioDynamics, Inc. ANGO (Thursday, before the market open)
• Johnson & Johnson JNJ (Thursday, before the market open)

IPOs

Cambridge, Massachusetts-based Relay Therapeutics has filed with the SEC for offering 14.7 million shares to be priced between $16 and $18. Repare is a clinical-stage precision medicine company transforming the drug discovery process with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. The company has applied for listing its shares on the Nasdaq under the ticker symbol RLAY.

IPO Quiet Period Expirations

• Repare Therapeutics Inc RPTX
• Progenity Inc PROG
• Genetron Holdings Ltd – ADR GTH
• Forma Therapeutics Holdings Inc FMTX