The Week Ahead In Biotech: J&J Vaccine Adcom Meeting, Sarepta FDA Decision And Plenty Of Earnings

Biotech stocks pulled back along with the broader market in the holiday-shortened week ended Feb 19. Earnings news flow was light before picking up pace in the unfolding week.

Bluebird bio Inc BLUE was among the worst performers of the week after the company temporarily stalled its gene therapy studies in sickle cell disease.

A day after bluebird bio shared the negative tidings, Novartis AG NVS announced an agreement with the Bill & Melinda Gates Foundation for funding the development of a single-administration, in-vivo gene therapy to cure sickle cell disease.

The week also witnessed the forging of a few alliances and partnerships, a slew of follow-on offerings and some vaccine updates.

Here are the key catalytic events for the coming week:

Conferences:

Annual SVB Leerink Global Healthcare Conference (virtual event): Feb. 22-26

Citi Healthcare Services Virtual Conference (virtual event): Feb. 24-25

Americas Committee for Treatment and Research in Multiple Sclerosis, or ACTRIMS, Forum (virtual event): Feb. 25-27

PDUFA Dates

The Food and Drug Administration is scheduled to rule on Sarepta Therapeutics Inc's SRPT new drug application for casimersen, a treatment for patients with Duchenne muscular dystrophy who have certain genetic mutations. The PDUFA goal date is Thursday, Feb. 25.

Clinical Readouts

ACTRIMS Presentation:

Clene Inc. CLNN: updated interim Phase 2 data from the REPAIR-MS study evaluating CNM-Au8 in relapsing multiple sclerosis and updated blinded interim Phase 2 data from the VISIONARY-MS study of CNM-Au8 in chronic optic neuropathy

Earnings

Monday

AxoGen, Inc Common Stock AXGN (after the market close)
Pulse Biosciences Inc PLSE (after the market close)
PAVmed Inc PAVM (after the market close)
Revance Therapeutics Inc RVNC (after the market close)
Plus Therapeutics Inc PSTV (after the market close)

Tuesday

Rubius Therapeutics Inc RUBY (before the market open)
Epizyme Inc EPZM (before the market open)
Clovis Oncology Inc CLVS (before the market open)
Adamas Pharmaceuticals Inc ADMS (after the close)
Arena Pharmaceuticals, Inc. ARNA (after the close)
AtriCure Inc. ATRC (after the close)
Theravance Biopharma Inc TBPH (after the close)
Masimo Corporation MASI (after the close)
Insulet Corporation PODD (after the close)
Esperion Therapeutics Inc ESPR (after the close)
Myriad Genetics, Inc. MYGN (after the close)
Halozyme Therapeutics, Inc. HALO (after the close)
Inspire Medical Systems Inc INSP (after the close)
Penumbra Inc PEN (after the close)
Xencor Inc XNCR (after the close)
Jazz Pharmaceuticals PLC JAZZ (after the close)
MacroGenics Inc MGNX (after the close)
Medtronic PLCMDT (after the close)

Wednesday

SAGE Therapeutics Inc SAGE (before the market open)
Merit Medical Systems, Inc. MMSI (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Xtant Medical Holdings Inc XTNT (before the market open)
Horizon Therapeutics PLC HZNP (before the market open)
Repligen Corporation RGEN (before the market open)
Kura Oncology Inc KURA (before the market open)w
NeoGenomics, Inc. NEO (before the market open)
Ionis Pharmaceuticals Inc IONS (before the market open)
PPD Inc PPD (before the market open)
Vericel Corp VCEL (before the market open)
Harvard Bioscience, Inc. HBIO (before the market open)
Adaptive Biotechnologies Corp ADPT (after the close)
ACADIA Pharmaceuticals Inc. ACAD (after the close)
Alimera Sciences Inc ALIM (after the close)
Global Blood Therapeutics Inc GBT (after the close)
Coherus Biosciences Inc CHRS (after the close)
Nevro Corp NVRO (after the close)
CareDx Inc CDNA (after the close)
CytomX Therapeutics Inc CTMX (after the close)
Sangamo Therapeutics, Inc. SGMO (after the close)
Paratek Pharmaceuticals Inc PRTK (after the close)
Tandem Diabetes Care Inc TNDM (after the close)
Guardant Health Inc GH (after the close)
G1 Therapeutics Inc GTHX (after the close)

Related Link: Vir Biotech Expands Vaccine Collaboration With GlaxoSmithKline: What You Need to Know

Thursday

Chimerix Inc CMRX (before the market open)
Concert Pharmaceuticals Inc CNCE (before the market open)
Kala Pharmaceuticals Inc KALA (before the market open)
Jounce Therapeutics Inc JNCE (before the market open)
Intellia Therapeutics Inc NTLA (before the market open)
Moderna Inc MRNA (before the market open)
Radius Health Inc RDUS (before the market open)
Insmed Incorporated INSM (before the market open)
Intercept Pharmaceuticals Inc ICPT (before the market open)
Editas Medicine Inc EDIT (before the market open)
Mediwound Ltd MDWD (before the market open)
Novocure Ltd NVCR (before the market open)
Glaukos Corp GKOS (before the market open)
BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
Pacira Biosciences Inc PCRX (before the market open)
Provention Bio Inc PRVB (before the market open)
Albireo Pharma Inc ALBO (before the market open)
Amarin Corporation plc AMRN (before the market open)
Adaptimmune Therapeutics PLC – ADR ADAP (before the market open)
Akebia Therapeutics Inc AKBA (before the market open)
Agios Pharmaceuticals Inc AGIO (before the market open)
Aerie Pharmaceuticals Inc AERI (after the close)
Apellis Pharmaceuticals Inc APLS (after the close)
Acceleron Pharma Inc XLRN (after the close)
Allogene Therapeutics Inc ALLO (after the close)
Puma Biotechnology Inc PBYI (after the close)
BioMarin Pharmaceutical Inc. BMRN (after the close)
Caladrius Biosciences Inc CLBS (after the close)
Iovance Biotherapeutics Inc IOVA (after the close)
Intra-Cellular Therapies Inc ITCI (after the close)
Nektar Therapeutics NKTR (after the close)
Natera Inc NTRA (after the close)
ICU Medical Inc ICUI (after the close)
Zogenix, Inc. ZGNX (after the close)
NuVasive, Inc. NUVA (after the close)
ZIOPHARM Oncology Inc. ZIOP (after the close)
PRA Health Sciences Inc PRAH (after the close)
Endo International PLC ENDP (after the close)
Lantheus Holdings Inc LNTH (after the close)
TRACON Pharmaceuticals Inc TCON (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
LeMaitre Vascular Inc LMAT (after the close)
Voyager Therapeutics Inc VYGR (after the close)
Natus Medical Inc NTUS (after the close)
Cerus Corporation CERS (after the close)
Dynavax Technologies Corporation DVAX (after the close)
Cytokinetics, Inc. CYTK (after the close)
Collegium Pharmaceutical Inc COLL (after the close)
GenMark Diagnostics, Inc GNMK (after the close)
Dicerna Pharmaceuticals Inc DRNA (after the close)
Vir Biotechnology Inc VIR (after the close)

Friday

Amneal Pharmaceuticals Inc AMRX (before the market open)
Orthofix Medical Inc OFIX (before the market open)

IPO Quiet Period Expiries

Ortho Clinical Diagnostics Holdings PLC OCDX
NLS Pharmaceutics AG NLSP

Other Events

Viatris Inc VTRS has scheduled a conference call Monday, at 8 a.m., to discuss the generic pharma company's 2021 guidance.

FDA's Vaccine & Related Biological Products Committee is scheduled to meet Friday, Feb. 26, between 9 a.m. and 5:30 p.m., to discuss Johnson & Johnson JNJ unit Janssen's emergency use authorization application for its COVID-19 vaccine.

Related Link: Lilly Strikes Licensing Deal With Rigel In Push Toward Neurological, Immunological Therapies