Biotech stocks came under pressure in the week ended May 7 as traders digested a slew of earnings news flow and a handful of clinical trial readouts. COVID-19 vaccine stocks came under pressure following the U.S. government's decision to support for taking vaccine technology and intellectual property off patent.
ChemoCentryx, Inc. (NASDAQ:CCXI) shares went from $48.32 to $10.46 over the week, a pullback of over 78% on the back of a negative Adcom verdict.
Pfizer, Inc. (NYSE:PFE) reported strong quarterly results and raised its guidance, standing out from the rest of the big pharma pack.
Two biopharma companies debuted on Wall Street this week, raising combined gross proceeds of $171 million.
Here are the key catalytic events for the unfolding week:
Conferences
BofA Securities 2021 Healthcare Conference: May 10-13
American Society of Gene and Cell Therapy, ASGCT, 2021 Virtual Meeting: May 11-14
American Thoracic Society, or ATS, 2021 meeting: May 14-19
American College of Cardiology, or ACC, Annual Scientific Session and Expo: May 15-17
PDUFA Dates
The Food and Drug Administration is scheduled to rule on Heron Therapeutics, Inc.'s (NASDAQ:HRTX) new drug application for HTX001, which is being evaluated for postoperative pain, by the PDUFA date of Wednesday, May 12. This is Heron's third attempt at gaining approval for the investigational drug.
Apellis Pharmaceuticals, Inc.'s (NASDAQ:APLS) NDA for pegcetacoplan, being evaluated for paroxysmal nocturnal hemoglobinuria, has a PDUFA goal date of Friday, May 14.
Clinical Readouts
ASGCT Meeting Presentations
AVROBIO, Inc. (NASDAQ:AVRO): Updated results from a Phase 1/2 clinical trial evaluating hematopoietic stem cell lentiviral gene therapy AVR-RD-04 for cystinosis (Tuesday)
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT): Interim results from a Phase 1/2 study of a gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I (Tuesday), updated results of a global Phase 1 study of a gene therapy for pyruvate kinase deficiency (Wednesday)
Flexion Therapeutics, Inc. (NASDAQ:FLXN): Preliminary data from a Phase 1 trial of FX201, an intra-articular gene therapy candidate, for osteoarthritis (Tuesday)
Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE): Updated results from a Phase 1/2 study of AAV8 gene therapy as a potential treatment in adults with late-onset ornithine transcarbamylase deficiency (Tuesday); updated results from a Phase 1/2 study of a gene therapy for a type of glycogen storage disease
Sio Gene Therapies, Inc. (NASDAQ:SIOX): Preliminary results from the Phase 1/2 trial of AXO-AAV-GM1 for the treatment of GM1 gangliosidosis (Thursday); new data on AXO-Lenti-PD gene therapy for Parkinson's disease (Thursday)
REGENXBIO Inc. (NASDAQ:RGNX): Interim analysis of the Phase 1 study of RGX-121 gene therapy for the treatment of severe mucopolysaccharidosis Type II (Friday)
Athenex, Inc. (NASDAQ:ATNX): Additional GINAKIT2 Phase I data in neuroblastoma (Friday)
ATS Meeting Presentations
Amgen Inc. (NASDAQ:AMGN) and AstraZeneca PLC (NASDAQ:AZN): Additional data from the pivotal NAVIGATOR study evaluating Tezepelumab in patients with severe uncontrolled asthma
Acceleron Pharma Inc. (NASDAQ:XLRN): Updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept in patients with pulmonary arterial hypertension
Standalone Presentations
Graybug Vision, Inc. (NASDAQ:GRAY) will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial Wednesday, at 8 a.m. The mid-stage trial is evaluating its investigational asset GB-102 in for certain types of macular degeneration.
Fate Therapeutics, Inc. (NASDAQ:FATE) is scheduled to release interim Phase 1 data from its FT516 and FT538 programs at an investor event scheduled for Thursday. Both are iPSC-derived NK cell therapeutic candidates being evaluated for the treatment of relapsed or refractory acute myeloid leukemia.
Earnings
Monday
Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates
Tuesday
Wednesday
Thursday
Friday
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX) (before the market open)
PLx Pharma Inc. (NASDAQ:PLXP) (before the market open)
IPOs
IPO Quiet Period Expiry
Akoya Biosciences, Inc. (NASDAQ:AKYA)
Biomea Fusion, Inc. (NASDAQ:BMEA)
Recursion Pharmaceuticals, Inc. (NASDAQ:RXRX)
Related Link: Why This Pfizer Analyst Is Sidelined After Beat-And-Raise Q1
Photo by Diana Polekhina on Unsplash.
© 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
To add Benzinga News as your preferred source on Google, click here.
