The Week Ahead In Biotech (June 5-11): Adcom Test For Novavax, ASCO Presentations, Enzo Biochem Earnings And More
Biotech stocks reversed course along with the broader market and closed the week ending June 3 lower. The sector's lean run thus got extended.
Genocea Biosciences, Inc. (NASDAQ:GNCA), which announced on May 24 plans to wind down of operations, continued to see weakness, ending the week down over 66%. The company is awaiting delisting of its stock from Nasdaq.
Aeglea Biotherapeutics, Inc. (NASDAQ:AGLE) shares also came under intense selling pressure after it announced the Food and Drug Administration's decision to issue a refusal-to-file letter for its Arginase 1 deficiency treatment candidate.
The week witnessed some activity on the M&A front. GlaxoSmithKline plc (NYSE:GSK) confirmed the spin-off of the consumer healthcare business it jointly owns with Pfizer, Inc. (NYSE:PFE). Bristol-Myers Squibb Company (NYSE:BMY) announced a deal to buy precision oncology company Turning Point Therapeutics, Inc. (NASDAQ:TPTX) for $4.1 billion.
Here are the key catalysts scheduled for the unfolding week:
Conferences
2022 American Society of Clinical Oncology, or ASCO, Annual Meeting: June 3-7, held in Chicago, Illinois & virtually
Jefferies Healthcare Conference: June 8-10, in New York
PDUFA Dates
The FDA is scheduled to rule on the new drug application filed by Acer Therapeutics, Inc. (NASDAQ:ACER) and partner Relief Therapeutics Holding AG (OTC:RLFTF) for ACER-001 as a treatment option for urea cycle disorders. The PDUFA goal date was set for Sunday, June 5.
Regeneron Pharmaceuticals, Inc. and (NASDAQ:REGN) & Sanofi (NASDAQ:SNY) await the nod for an expanded indication for their Dupixent, this time around, as an add-on maintenance treatment for children, aged 6 months to 5 years, with moderate-to-severe atopic dermatitis. The PDUFA goal date is Wednesday, June 8.
Adcom Calendar
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on Tuesday, June 7 to discuss Novavax, Inc.'s (NASDAQ:NVAX) emergency use authorization request for its vaccine to prevent COVID-19 in individuals 18 years of age and older. A briefing document released on Friday showed that FDA staffers were concerned about possible heart inflammation risk stemming from vaccinating with the company's COVID-19 shot. This sent the company's stock down by over 20%.
Related Link: Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates
Clinical Readouts/Presentations
ASCO Presentations
Alkermes, Plc (NASDAQ:ALKS): data from Phase 2 study of nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma
AstraZeneca plc (NASDAQ:AZN): study of Durvalumab and with or without tremelimumab and chemotherapy (CT) in first-line metastatic non-small cell lung cancer; durvalumab plus platinum-etoposide in extensive-stage small cell lung cancer; data from the Phase 2 study of osimertinib in combination with platinum plus pemetrexed in patients with EGFR-mutated, advanced non–small cell lung cancer; Phase 3 data for abiraterone combined with olaparib in patients with metastatic castration-resistant prostate cancer
Delcath Systems, Inc. (NASDAQ:DCTH): Phase 3 data for percutaneous hepatic perfusion with melphalan for patients with ocular melanoma liver metastases
Eli Lilly and Company (NYSE:LLY): data from Phase 1a/b trial of imlunestrant in ER-positive advanced breast cancer and endometrial endometrioid cancer
Adicet Bio, Inc. (NASDAQ:ACET): updated data from the Phase 1 study of ADI-001 for the potential treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma
Veru Inc (NASDAQ:VERU): Phase 3 data for enobosarm and abemaciclib combination for the second-line treatment of AR+ ER+ HER2- metastatic breast cancer in patients that have previously received palbociclib and estrogen blocking agent; final analysis of Phase 1b/2 data for sabizabulin in men with metastatic castration resistant prostate cancer
Earnings
Enzo Biochem, Inc. (NYSE:ENZ): Thursday, after the market close
IPOs
IPO Quiet Period Expiry
OKYO Pharma Limited (NASDAQ:OKYO)
Related Link: GSK Confirms Consumer Healthcare Unit Spin-off: What Investors Should Know