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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 (NASDAQ: ENDP) cellulite treatment, while Merck & Co., Inc. (NYSE: MRK)-Eisai Co., Ltd's (OTC: ESALY) combo therapy was rejected by the FDA as a first-line treatment option for liver cancer.
Unum Therapeutics Inc (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: 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 (NYSE: 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. (NASDAQ: SGEN). (Tuesday)
The Cardiovascular and Renal Drugs Advisory Committee is scheduled to discuss Mallinckrodt PLC's (NYSE: 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 (NASDAQ: 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 (NASDAQ: INMB) will report interim data from its Phase Ib clinical study of XPro1595 in Alzheimer's disease. (Tuesday)