The Week Ahead In Biotech (April 10-April 16): Regeneron FDA Decision, Cancer Conference Presentations And More

Zinger Key Points
  • The FDA is scheduled to rule on Regeneron Pharmaceuticals's biologic license application for REGEN-COV.
  • The American Association for Cancer Research Annual Meeting is being held April 8-13 in New Orleans.
The Week Ahead In Biotech (April 10-April 16): Regeneron FDA Decision, Cancer Conference Presentations And More

Biotech stocks managed to carve out modest gains for the week ending April 8, defying the broader market weakness. The defensive nature of the stocks make them appealing in times of risk aversion.

Data readouts triggered some stock-specific reactions. Phio Pharmaceuticals, Inc. PHIO was among the best performers for the week after reporting positive preclinical data on an RNAi therapeutic candidate meant to enhance the efficacy of anti-PD-1 antibody therapies.

On the regulatory front, BioXcel Therapeutics, Inc. BTAI received FDA approval for its BXCL501, an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine for the treatment of agitation associated with neuropsychiatric disorders. Novartis AG's NVS Vijoice was greenlighted as a treatment option for adult and pediatric patients with severe manifestations of PIK3CA-related Overgrowth Spectrum who require systemic therapy.

Pfizer, Inc. PFE was also in the spotlight following its announcement regarding a $525 million deal to buy respiratory syncytial vaccine company ReViral.

Here are the key catalysts for the unfolding week:

Conferences

American Association for Cancer Research, or AACR, Annual Meeting 2022: April 8-13, in New Orleans, Louisiana

Society for Inherited Metabolic Disorders, or SIMD, Annual Meeting: April 10-13, in Orlando, Florida

Annual Needham Virtual Healthcare Conference: April 11-14

PDUFA Dates:

The FDA is scheduled to rule on Regeneron Pharmaceuticals, Inc.'s REGN biologic license application for REGEN-COV as a prophylactic treatment for COVID-19. The PDUFA goal date is Wednesday, April 13.

Related Link: Merck Continues to See Executive Exodus; Here's A Look At All Recent Departures

Clinical Readouts/Presentations

AACR Meeting Presentations

Vaccinex, Inc. VCNX: data from the Phase 1/2 study of pepinemab, in combination with Merck, Inc.'s MRK Keytruda as first-line treatment of recurrent or metastatic head and neck cancer (Monday)

IN8bio, Inc. INAB: Phase 1 data for temozolomide in primary high-grade gliomas (Monday)

Bicycle Therapeutics plc BCYC: interim Phase I results from the Phase 1/2 trial of BT8009 in solid tumors (Monday)

Repare Therapeutics Inc. RPTX: clinical data from the Phase 1/2 trial of RP-3500 in solid tumors (Monday)

Eli Lilly and Company (LLY: data from Phase 1b study of pirtobrutinib, in combination with venetoclax ± rituximab in relapsed/refractory chronic lymphocytic leukemia (Monday)

Kintara Therapeutics, Inc. KTRA: Phase 2 data for dianhydrogalactitol (VAL-083) for the treatment of glioblastoma multiforme (Monday)

Celsion Corporation CLSN: data from the Phase 1b dose-escalating study of GEN-1 in the neoadjuvant treatment of patients with Stage III/IV ovarian cancer (Monday)

C4 Therapeutics, Inc. CCCC: data from the Phase 1/2 study of CFT7455 in multiple myeloma (Tuesday)

Checkmate Pharmaceuticals, Inc. CMPI: biomarker signature data from the Phase 1b study of vidutolimod in combination with Keytruda in melanoma (Tuesday)

Gracell Biotechnologies Inc. GRCL: early results of a safety and efficacy study of allogeneic TruUCAR GC502 in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (Tuesday)

Alpine Immune Sciences, Inc. ALPN: results from the dose escalation portion of a Phase 1 clinical trial of davoceticept (ALPN-202) as monotherapy in advanced malignancies (Tuesday)

HOOKIPA Pharma Inc. HOOK: Phase 1/2 data for HB-201 and HB-202 for the treatment-refractory HPV16+ cancers (Tuesday)

Kura Oncology, Inc. KURA: data from the Phase 1/2 trial of tipifarnib and alpelisib for patients with HRAS-overexpressing and/or PIK3CA mutated/amplified recurrent/metastatic head and neck squamous cell carcinoma (Wednesday)

SIMD Meeting Presentations

Aeglea BioTherapeutics, Inc. AGLE: additional data from the PEACE Phase 3 study of pegzilarginase for the treatment of patients with Arginase 1 Deficiency (Monday, 10-11 pm ET)

Travere Therapeutics, Inc. TVTX: initial results from the Phase 1/2 study of pegtibatinase, an investigational enzyme replacement therapy, for the treatment of classical homocystinuria (Monday, 8-10 pm ET)

Earnings

Theratechnologies Inc. THTX (Wednesday, before the market open)
BeyondSpring, Inc. BYSI (Thursday, before the market open)

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

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