The Week Ahead In Biotech (May 9-15): Heron, Apellis FDA Decisions, Presentations and Earnings

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. 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. 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 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 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. 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. 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. FLXN: Preliminary data from a Phase 1 trial of FX201, an intra-articular gene therapy candidate, for osteoarthritis (Tuesday)

Ultragenyx Pharmaceutical Inc. 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. 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. RGNX: Interim analysis of the Phase 1 study of RGX-121 gene therapy for the treatment of severe mucopolysaccharidosis Type II (Friday)

Athenex, Inc. ATNX: Additional GINAKIT2 Phase I data in neuroblastoma (Friday)

ATS Meeting Presentations

Amgen Inc. AMGN and AstraZeneca PLC AZN: Additional data from the pivotal NAVIGATOR study evaluating Tezepelumab in patients with severe uncontrolled asthma

Acceleron Pharma Inc. XLRN: Updates from the PULSAR and SPECTRA Phase 2 trials of sotatercept in patients with pulmonary arterial hypertension

Standalone Presentations

Graybug Vision, Inc. 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. 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

ImmunoGen, Inc. IMGN (before the market open)
Intersect ENT, Inc. XENT (before the market open)
Eagle Pharmaceuticals, Inc. EGRX (before the market open)
Constellation Pharmaceuticals, Inc. CNST (before the market open)
Viatris Inc. VTRS (before the market open)
TG Therapeutics, Inc. TGTX (before the market open)
BioNTech SE BNTX (before the market open)
Intra-Cellular Therapies, Inc. ITCI (before the market open)
Matinas BioPharma Holdings, Inc. MTNB (before the market open)
Biohaven Pharmaceutical Holding Company Ltd. BHVN (before the market open)
Sesen Bio, Inc. SESN (before the market open)
BioXcel Therapeutics, Inc. BTAI (before the market open)
Avadel Pharmaceuticals plc AVDL (before the market open)
Amicus Therapeutics, Inc. FOLD (before the market open)
Axsome Therapeutics, Inc. AXSM (before the market open)
Akebia Therapeutics, Inc. AKBA (before the market open)
Zai Lab Limited ZLAB (before the market open)
Adamas Pharmaceuticals, Inc. ADMS (after the close)
Arcturus Therapeutics Holdings Inc. ARCT (after the close)
Aligos Therapeutics, Inc. ALGS (after the close)
AVEO Pharmaceuticals, Inc. AVEO (after the close)
Forte Biosciences, Inc. FBRX (after the close)
Pulse Biosciences, Inc. PLSE (after the close)
Castle Biosciences, Inc. CSTL (after the close)
Omeros Corporation OMER (after the close)
Cara Therapeutics, Inc. CARA (after the close)
Veracyte, Inc. VCYT (after the close)
ShockWave Medical, Inc. SWAV (after the close)
Inovio Pharmaceuticals, Inc. INO (after the close)
Revance Therapeutics, Inc. RVNC (after the close)
Mersana Therapeutics, Inc. MRSN (after the close)
Novavax, Inc. NVAX (after the close)
Catalyst Pharmaceuticals, Inc. CPRX (after the close)
Geron Corporation GERN (after the close)
FibroGen, Inc. FGEN (after the close)
Organogenesis Holdings Inc. ORGO (after the close)
Halozyme Therapeutics, Inc. HALO (after the close)

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

Tuesday

InspireMD, Inc. NSPR (before the market open)
Myovant Sciences Ltd. MYOV (before the market open)
Taysha Gene Therapies, Inc. TSHA (before the market open)
Xtant Medical Holdings, Inc. XTNT (before the market open)
Vascular Biogenics Ltd. VBLT (before the market open)
Royalty Pharma plc RPRX (before the market open)
Kindred Biosciences, Inc. KIN (after the close)
Navidea Biopharmaceuticals, Inc. NAVB (after the close)
ClearPoint Neuro, Inc. CLPT (after the close)
Prothena Corporation plc PRTA (after the close)
Cumberland Pharmaceuticals Inc. CPIX (after the close)
EDAP TMS S.A. EDAP (after the close)
Exagen Inc. XGN (after the close)
Syndax Pharmaceuticals, Inc. SNDX (after the close)
Otonomy, Inc. OTIC (after the close)
Ra Medical Systems, Inc. RMED (after the close)
Opiant Pharmaceuticals, Inc. OPNT (after the close)
Inari Medical, Inc. NARI (after the close)
Lyra Therapeutics, Inc. LYRA (after the close)

Wednesday

PolyPid Ltd. PYPD (before the market open)
Minerva Neurosciences, Inc. NERV (before the market open)
IMV Inc. IMV (before the market open)
Veru Inc. VERU (before the market open)
Strongbridge Biopharma plc SBBP (before the market open)
Apyx Medical Corporation APYX (before the market open)
Curis, Inc. CRIS (after the close)
Acutus Medical, Inc. AFIB (after the close)
ADMA Biologics, Inc. ADMA (after the close)
Biocept, Inc. BIOC (after the close)
Cyclacel Pharmaceuticals, Inc. CYCC (after the close)
MannKind Corporation MNKD (after the close)
Eyenovia, Inc. EYEN (after the close)
Flexion Therapeutics, Inc. FLXN (after the close)
Panbela Therapeutics, Inc. PBLA (after the close)
Repro Med Systems, Inc. KRMD (after the close)
STRATA Skin Sciences, Inc. SSKN (after the close)
Salarius Pharmaceuticals, Inc. SLRX (after the close)
Marker Therapeutics, Inc. MRKR (after the close)

Thursday

Galmed Pharmaceuticals Ltd. GLMD (before the market open)
Synlogic, Inc. SYBX (before the market open)
Wave Life Sciences Ltd. WVE (before the market open)
UroGen Pharma Ltd. URGN (before the market open)
Selecta Biosciences, Inc. SELB (before the market open)
PDS Biotechnology Corporation PDSB (before the market open)
Haemonetics Corporation HAE (before the market open)
Osmotica Pharmaceuticals plc OSMT (after the close)
ImmuCell Corporation ICCC (after the close)
Achieve Life Sciences, Inc. ACHV (after the close)
Daré Bioscience, Inc. DARE (after the close)
BioLife Solutions, Inc. BLFS (after the close)
Atea Pharmaceuticals, Inc. AVIR (after the close)
Anavex Life Sciences Corp. AVXL (after the close)
AbCellera Biologics Inc. ABCL (after the close)
aTyr Pharma, Inc. LIFE (after the close)
Aptinyx Inc. APTX (after the close)
Brickell Biotech, Inc. BBI (after the close)
Bionano Genomics, Inc. BNGO (after the close)
Co-Diagnostics, Inc. CODX (after the close)
Capricor Therapeutics, Inc. CAPR (after the close)
Dyadic International, Inc. DYAI (after the close)
DermTech, Inc. DMTK (after the close)
Lineage Cell Therapeutics, Inc. LCTX (after the close)
HTG Molecular Diagnostics, Inc. HTGM (after the close)
Eledon Pharmaceuticals, Inc. ELDN (after the close)
Eton Pharmaceuticals, Inc. ETON (after the close)
ThermoGenesis Holdings, Inc. THMO (after the close)
ProPhase Labs, Inc. PRPH (after the close)
Spectrum Pharmaceuticals, Inc. SPPI (after the close)
TFF Pharmaceuticals, Inc. TFFP (after the close)
Regulus Therapeutics Inc. RGLS (after the close)
Infinity Pharmaceuticals, Inc. INFI (after the close)
Marinus Pharmaceuticals, Inc. MRNS (after the close)
PolarityTE, Inc. PTE (after the close)

Friday

Forma Therapeutics Holdings, Inc. FMTX (before the market open)
PLx Pharma Inc. PLXP (before the market open)

IPOs

IPO Quiet Period Expiry

Akoya Biosciences, Inc. AKYA
Biomea Fusion, Inc. BMEA
Recursion Pharmaceuticals, Inc. RXRX

Related Link: Why This Pfizer Analyst Is Sidelined After Beat-And-Raise Q1

Photo by Diana Polekhina on Unsplash.