The Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The Spotlight

Biotech stocks ended the holiday-shortened week ended April 1 in the green, catalyzed by the broader market rebound and a slew of company-specific news flow. Buoyed by hopes of a U.S. government infrastructure spending program, the S&P 500 Index closed above the 4,000 level for the first time ever during the week.

The Pfizer Inc. PFE-BioNTech SE BNTX duo had a double dose of positive tidings. Their vaccine candidate BNT162b2 showed positive results in a late-stage study in adolescents, while follow-up data from the late-stage study was positive enough to support a filing for full approval.

Humanigen, Inc. HGEN was among the best performers of the week, the catalyst being a late-stage readout for its COVID-19 treatment candidate.

U.K.-based immuno-oncology company Achilles Therapeutics plc ACHL made its Wall Street debut after raising $175.5 million in an initial public offering.

Here are the key catalytic events for the unfolding week:

Conferences

American Association of Cancer Research, or AACR, Annual Meeting 2021 (virtual event): April 10-15

PDUFA Dates

The FDA is scheduled to rule on Regeneron Pharmaceuticals, Inc. REGN and Sanofi SA's SNY supplemental biologic license application for Praluent in treating homozygous familial hypercholesterolemia in adults. Familial hypercholesterolemia is a genetic disorder that renders the body unable to remove bad cholesterol from the blood. The PDUFA date is fixed for Sunday, April 4.

The agency will also announce by early April its verdict on Supernus Pharmaceuticals, Inc.'s SUPN new drug application for SPN-812, which is being evaluated for the treatment of attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age.

Related Link: Immunic Gets Bullish Rating On Multiple Sclerosis Drug Prospect

Clinical Readouts/Presentations

GlycoMimetics, Inc. GLYC: Interim analysis of a Phase 1b proof-of-concept study of GMI-1359 in bone-metastatic breast cancer

Molecular Templates, Inc. MTEM: Interim Phase 1 data for MT-5111 in in patients with HER-2+ tumors

Cardiff Oncology, Inc. CRDF: Phase 1/2 data for onvansertib for treatment of patients with KRAS-mutant metastatic colorectal cancer

Iovance Biotherapeutics, Inc. IOVA: Durable duration of response at 28-month from the Phase 2 study of lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte therapy, in patients with advanced melanoma

IPOs

IPO Quiet Period Expiry

TCR2 Therapeutics Inc. TCRR: Phase 1 data from the Phase 1/2 clinical trial of the potential cancer drug gavo-cel, for treating refractory mesothelin-expressing solid tumors

Codiak BioSciences, Inc. CDAK: Phase 1 trial of exoIL-12, a treatment for cutaneous T cell lymphoma

Alpine Immune Sciences, Inc. ALPN: Data from the Phase 1 study of ALPN-202 in advanced malignancies

Agenus Inc. AGEN: New data from the Phase 1/2 clinical study of AGEN1181, alone and in combination with PD-1 antibody balstilimab, in colon cancer

Greenwich LifeSciences, Inc. GLSI: Phase 3 data of GP2 + GM-CSF as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer

Oncolytics Biotech Inc. ONCY: Phase 2 data for Holding AG's RHHBY Tecentriq and the oncolytic virus pelareorep in early breast cancer

Eli Lilly and Company LLY: Phase 1/2 data highlighting safety and efficacy data of Retevmo in the treatment of RET fusion-positive cancers outside of lung and thyroid cancer

Zentalis Pharmaceuticals, Inc. ZNTL: Clinical activity of a single-agent ZN-c3 in a Phase 1 dose-escalation trial in patients with advanced solid tumors

iTeos Therapeutics, Inc. ITOS: Initial data from the Phase 1/2a trial of EOS-448 in solid tumors

Pieris Pharmaceuticals, Inc. PIRS: Additional data from the Phase 1/2 study of PRS-343 in HER2-positive solid tumors

Prometheus Biosciences, Inc. RXDX
Longboard Pharmaceuticals, Inc. LBPH

Related Link: Amgen Bets On Regenerative Immunology With Rodeo Therapeutics Acquisition

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