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. 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. 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 GSK confirmed the spin-off of the consumer healthcare business it jointly owns with Pfizer, Inc. PFE. Bristol-Myers Squibb Company BMY announced a deal to buy precision oncology company Turning Point Therapeutics, Inc. 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. ACER and partner Relief Therapeutics Holding AG 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 REGN & Sanofi 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 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 ALKS: data from Phase 2 study of nemvaleukin alfa monotherapy in patients with advanced mucosal and cutaneous melanoma

AstraZeneca plc 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. DCTH: Phase 3 data for percutaneous hepatic perfusion with melphalan for patients with ocular melanoma liver metastases

Eli Lilly and Company LLY: data from Phase 1a/b trial of imlunestrant in ER-positive advanced breast cancer and endometrial endometrioid cancer

Adicet Bio, Inc. 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 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. ENZ: Thursday, after the market close

IPOs

IPO Quiet Period Expiry

OKYO Pharma Limited OKYO

Related Link: GSK Confirms Consumer Healthcare Unit Spin-off: What Investors Should Know