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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 (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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. (NASDAQ: 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 (NASDAQ: AXGN) (after the market close)
Pulse Biosciences Inc (NASDAQ: PLSE) (after the market close)
PAVmed Inc (NASDAQ: PAVM) (after the market close)
Revance Therapeutics Inc (NASDAQ: RVNC) (after the market close)
Plus Therapeutics Inc (NASDAQ: PSTV) (after the market close)

Tuesday

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

Wednesday

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

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

Thursday

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

Friday

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

IPO Quiet Period Expiries

Ortho Clinical Diagnostics Holdings PLC (NASDAQ: OCDX)
NLS Pharmaceutics AG (NASDAQ: NLSP)

Other Events

Viatris Inc (NASDAQ: 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 (NYSE: 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

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