Week Ahead In Biotech (May 2-8): ChemoCentryx Adcom, Ophthalmology Conference Presentations, Earnings Deluge

Biopharma stocks experienced volatility in the week ended April 30, as stocks reacted to earnings, data readouts and a handful of FDA decisions.

Earnings prints from big name pharma companies, including Merck & Co., Inc. MRK, Amgen Inc. AMGN, Eli Lilly and Company LLY and Novartis AG NVS, were uninspiring.

Among Food and Drug Administration decisions scheduled for the week, Sol-Gel Technologies Ltd. SLGL said the FDA is yet to get back on a decision, Protalix BioTherapeutics, Inc. PLX received a complete response letter, and Ardelyx, Inc. ARDX) communicated a three-month delay.

Adverum Biotechnologies, Inc. ADVM suffered a setback following the reporting of a serious adverse event in a study evaluating its investigational gene therapy for diabetic macular edema.

Two biopharma companies debuted on the Nasdaq, raising a combined $230.5 million in gross proceeds.

Here are the key catalysts for the unfolding week:


The American Society for Aesthetic Plastic Surgery, or ASAPS, Aesthetic Meeting 2021 (Miami, Florida): April 29-May 3

American Psychiatric Association, APA, 2021 Annual Meeting (virtual): May 1-3

Association for Research In Vision and Ophthalmology, or ARVO, 2021 Virtual Meeting: May 1-7

World Vaccine Congress Washington (virtual meeting): May 4-6

European Society for Medical Oncology, ESMO, Breast Cancer Virtual Congress 2021: May 5-8

Adcom Calendar

FDA's Arthritis Advisory Committee is scheduled to meet Thursday to discuss ChemoCentryx, Inc.'s CCXI NDA for avacopan oral capsules, for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis. The meeting is scheduled between 10 a.m. and 4:15 p.m.

Clinical Readouts

Vaxart, Inc. VXRT is scheduled to present on Monday new data comparing the T-cell responses generated from its VXA-CoV2-1 vaccine with those of other vaccines. (12 p.m.)

ARVO Presentations

Ocular Therapeutix, Inc. OCUL: Phase 1 data for an intracameral travoprost hydrogel-based implant for the treatment of primary open angle glaucoma and ocular hypertension (Monday, 11:15 a.m. to 1 p.m.)



Adverum: Phase 1 data for intravitreal gene therapy with ADVM-022 for neovascular age-related macular degeneration (Monday, 4:30-6 p.m.)

Applied Genetic Technologies Corporation AGTC: six-month findings from a Phase 1/2 clinical study of subretinal gene therapy drug AGTC-501 for X-Linked retinitis pigmentosa (Monday, 4:30-6 p.m.) and 12-month findings from 2 Phase 1/2 clinical studies of subretinal gene therapy drugs for achromatopsia (Thursday, 5:15-6:45 p.m.)

Palatin Technologies, Inc. PTN: data from the Phase 2 study of PL9643 in dry eye disease (Thursday, 11:15 a.m. to 1 p.m.)

ESMO Meeting

Veru Inc. VERU: Clinical results from the Phase 2 clinical study of enobosarm in heavily pretreated women with AR+ER+HER2- advanced breast cancer


Karyopharm Therapeutics Inc. KPTI (before the market open)
GlycoMimetics, Inc. GLYC (before the market open)
SI-BONE, Inc. SIBN (after the close)
Myriad Genetics, Inc. MYGN (after the close)
Ligand Pharmaceuticals Incorporated GND (after the close)
QIAGEN N.V. QGEN (after the close)


Pfizer Inc. PFE (before the market open)
Seres Therapeutics, Inc. MCRB (before the market open)
Sage Therapeutics, Inc. SAGE (before the market open)
Jounce Therapeutics, Inc. JNCE (before the market open)
Incyte Corporation INCY (before the market open)
Concert Pharmaceuticals, Inc. CNCE (before the market open)
Repligen Corporation RGEN (before the market open)
Catalent, Inc. CTLT (before the market open)
Lantheus Holdings, Inc. LNTH (before the market open)
Neuronetics, Inc. STIM (before the market open)
Bausch Health Companies Inc. BHC (before the market open)
Zimmer Biomet Holdings, Inc. ZBH (before the market open)
Pacira BioSciences, Inc. PCRX (before the market open)
Agile Therapeutics, Inc. AGRX (after the close)
Aquestive Therapeutics, Inc. AQST (after the close)
Atara Biotherapeutics, Inc. ATRA (after the close)
Aptose Biosciences Inc. APTO (after the close)
Aziyo Biologics, Inc. AZYO (after the close)
Arrowhead Pharmaceuticals, Inc. ARWR (after the close)
Theravance Biopharma, Inc. TBPH (after the close)
Exact Sciences Corporation EXAS (after the close)
Jazz Pharmaceuticals plc JAZZ (after the close)
Silk Road Medical, Inc SILK (after the close)
Ultragenyx Pharmaceutical Inc. RARE (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Sangamo Therapeutics, Inc. SGMO (after the close)
Penumbra, Inc. PEN (after the close)
Inspire Medical Systems, Inc. INSP (after the close)
Globus Medical, Inc. GMED (after the close)
Esperion Therapeutics, Inc. ESPR (after the close)
Deciphera Pharmaceuticals, Inc. DCPH (after the close)
Cerus Corporation CERS (after the close)
Cytosorbents Corporation CTSO (after the close)
Invitae Corporation NVTA (after the close)
DURECT Corporation DRRX (after the close)


Horizon Therapeutics Public Limited Company HZNP (before the market open)
EyePoint Pharmaceuticals, Inc. EYPT (before the market open)
Editas Medicine, Inc. EDIT (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Clovis Oncology, Inc. CLVS (before the market open)
Vericel Corporation VCEL (before the market open)
10x Genomics, Inc. TXG (before the market open)
Passage Bio, Inc. PASG (before the market open)
Ionis Pharmaceuticals, Inc. IONS (before the market open)
NeoGenomics, Inc. (NEO) (before the market open)
OraSure Technologies, Inc. OSUR (after the close)
Ampio Pharmaceuticals, Inc. AMPE (after the close)
Arbutus Biopharma Corporation ABUS (after the close)
Aerie Pharmaceuticals, Inc. AERI (after the close)
Arena Pharmaceuticals, Inc. ARNA (after the close)
Aeglea BioTherapeutics, Inc. AGLE (after the close)
Allogene Therapeutics, Inc. ALLO (after the close)
Adaptive Biotechnologies Corporation ADPT (after the close)
AxoGen, Inc. AXGN (after the close)
ACADIA Pharmaceuticals Inc. ACAD (after the close)
Global Blood Therapeutics, Inc. GBT (after the close)
Synthetic Biologics, Inc. SYN (after the close)
Neurocrine Biosciences, Inc. NBIX (after the close)
Sarepta Therapeutics, Inc. SRPT (after the close)
REGENXBIO Inc. RGNX (after the close)
Rigel Pharmaceuticals, Inc. RIGL (after the close)
Vanda Pharmaceuticals Inc. VNDA (after the close)
Ocular Therapeutix, Inc. OCUL (after the close)
Glaukos Corporation GKOS (after the close)
Celcuity Inc. CELC (after the close)
CareDx, Inc CDNA (after the close)
Nevro Corp. NVRO (after the close)
Tandem Diabetes Care, Inc. TNDM (after the close)
OrthoPediatrics Corp. KIDS (after the close)
DiaMedica Therapeutics Inc. DMAC (after the close)
Turning Point Therapeutics, Inc. TPTX (after the close)
Outset Medical, Inc. OM (after the close)
TRACON Pharmaceuticals, Inc. TCON (after the close)
Lumos Pharma, Inc. LUMO (after the close)
NuVasive, Inc. NUVA (after the close)
Supernus Pharmaceuticals, Inc. SUPN (after the close)

Related Link: Why This Bristol-Myers Squibb Stock Analyst Is Turning Bullish On The Pharma Company's Pipeline


Moderna, Inc. MRNA (before the market open)
Intellia Therapeutics, Inc. NTLA (before the market open)
Intercept Pharmaceuticals, Inc. ICPT (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
Insmed Incorporated INSM (before the market open)
Fulcrum Therapeutics, Inc. FULC (before the market open)
Endo International plc ENDP (before the market open)
Bio-Techne Corporation TECH (before the market open)
Harvard Bioscience, Inc. HBIO (before the market open)
Athenex, Inc. ATNX (before the market open)
Zoetis Inc. ZTS (before the market open)
Aldeyra Therapeutics, Inc. ALDX (before the market open)
Syros Pharmaceuticals, Inc. SYRS (before the market open)
Albireo Pharma, Inc. ALBO (before the market open)
BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
Regeneron Pharmaceuticals, Inc. REGN (before the market open)
Autolus Therapeutics plc AUTL (before the market open)
BioDelivery Sciences International, Inc. BDSI (before the market open)
Adaptimmune Therapeutics plc ADAP (before the market open)
Axcella Health Inc. AXLA (before the market open)
Antares Pharma, Inc. ATRS (before the market open)
Agenus Inc. AGEN (before the market open)
ADC Therapeutics SA ADCT (before the market open)
Reata Pharmaceuticals, Inc. RETA (before the market open)
Epizyme, Inc. EPZM (before the market open)
Coherus BioSciences, Inc. CHRS (after the close)
Dicerna Pharmaceuticals, Inc. DRNA (after the close)
Chiasma, Inc. CHMA (after the close)
Aurinia Pharmaceuticals Inc. AUPH (after the close)
Athersys, Inc. ATHX (after the close)
Acorda Therapeutics, Inc. ACOR (after the close)
Acceleron Pharma Inc. XLRN (after the close)
Axonics, Inc. AXNX (after the close)
Puma Biotechnology, Inc. PBYI (after the close)
Twist Bioscience Corporation TWST (after the close)
T2 Biosystems, Inc. TTOO (after the close)
ICU Medical, Inc. ICUI (after the close)
Travere Therapeutics, Inc. TVTX (after the close)
NovaBay Pharmaceuticals, Inc. NBY (after the close)
Kura Oncology, Inc. KURA (after the close)
Natera, Inc. NTRA (after the close)
Zogenix ZGNX (after the close)
Nektar Therapeutics NKTR (after the close)
Eiger BioPharmaceuticals, Inc. EIGR (after the close)
Vir Biotechnology, Inc. VIR (after the close)
Iovance Biotherapeutics, Inc. IOVA (after the close)
Evofem Biosciences, Inc. EVFM (after the close)
Caladrius Biosciences, Inc. CLBS (after the close)
Quidel Corporation QDEL (after the close)
Corcept Therapeutics Incorporated CORT (after the close)
Insulet Corporation PODD (after the close)
Fluidigm Corporation FLDM (after the close)
Cardiovascular Systems, Inc. CSII (after the close)
CytomX Therapeutics, Inc. CTMX (after the close)
Cytokinetics, Incorporated CYTK (after the close)
Dynavax Technologies Corporation DVAX (after the close)
Collegium Pharmaceutical, Inc. COLL (after the close)
Enanta Pharmaceuticals, Inc. ENTA (after the close)
Fulgent Genetics, Inc. FLGT (after the close)
Chembio Diagnostics, Inc. CEMI (after the close)
Guardant Health, Inc. GH (after the close)
Tricida, Inc. TCDA (after the close)
Neovasc Inc. NVCN (after the close)
Spero Therapeutics, Inc. SPRO (after the close)
Misonix, Inc. MSON (after the close)


Elanco Animal Health Incorporated ELAN (before the market open)
Amneal Pharmaceuticals, Inc. AMRX (before the market open)
ANI Pharmaceuticals, Inc. ANIP (before the market open)
Avanos Medical, Inc. AVNS (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)
Radius Health, Inc. RDUS (before the market open)

IPO Pricing

Valneva SE, a French company focused on prophylactic vaccines for infectious diseases, intends to offer 7.083 million of its ordinary shares. The offering will comprise an initial public offering of ADSs, each representing two ordinary shares, in the U.S., and a concurrent private placement of ordinary shares in certain jurisdictions outside of the U.S.

The company has applied to list its ADSs on the Nasdaq under the ticker symbol VALN. The ADS offering is expected to be priced at $28.24 per ADS, based on the last reported sale price of its ordinary shares on Euronext Paris on April 27.

Lakeway, Texas-based Anebulo Pharmaceuticals, Inc. is proposing to offer 3 million shares of its common stock in an IPO, with the price estimated in the range of $6-$8. The clinical-stage biotechnology company is working on products for people suffering from cannabinoid overdose and substance addiction. It has applied for listing its shares on the Nasdaq under the ticker symbol ANEB.

IPO Quiet Period Expiry

VectivBio Holding AG VECT
Reneo Pharmaceuticals, Inc. (NASDAQ: RPHM

Related Link: Exclusive: BioSig's Cardiac Signal Processing System Now Used At Mayo Clinic's Phoenix Campus

Photo by Christina Victoria Craft on Unsplash.


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