The Week Ahead In Biotech: Biopharma Earnings Pick Up Pace

Biotech stocks turned in a lackadaisical performance last week amid earnings releases by smid-cap stocks, a few clinical readouts and data presentations at conferences and a handful of FDA verdicts.

Merck & Co., Inc. (NYSE:MRK) faced a regulatory setback, with the sNDA for Keytruda dosing updation receiving a thumbs down from the FDA. Meanwhile, after two rejections, Agile Therapeutics Inc's (NASDAQ:AGRX) Twirla contraceptive patch was approved by the FDA. Bellerophon Therapeutics Inc (NASDAQ:BLPH) was among the biggest gainers of the week following a positive clinical readout.

Here are the key catalysts that could impact trading in biotech stocks in the unfolding week.

Conferences

2020 Transplantation and Cellular Therapy, or TCT, Meetings: Feb. 19-23 in Orlando, Florida
9th Annual SVB Leerink Global Healthcare Conference: Feb. 25-27 in New York

Adcom Meeting

FDA's Oncologic Drugs Advisory Committee is scheduled to discuss Eli Lilly And Co's (NYSE:LLY) sNDA for Cyramza injection for intravenous use in combination with Roche Holdings AG's Basel ADR (OTC:RHHBY) Tarceva for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations.

See Also: Why Merck Has Had Underwhelming Start To 2020

Clinical Trials

Kadmon Holdings Inc (NYSE:KDMN) will present at the TCT Meetings expanded Phase 2 data for KD025 in chronic graft-versus-host disease (Sunday).

Imv Inc (NASDAQ:IMV) is scheduled to present Phase 2 top-line data for DPX – Survivac and epacadostat – in ovarian cancer (Tuesday).

Menlo Therapeutics Inc (NASDAQ:MNLO) is due to present Phase 2 data for serlopitant for the treatment of chronic pruritus of unknown origin (February).

Earnings

Monday

• Epizyme Inc (NASDAQ:EPZM) (before the market open)
• AxoGen, Inc (NASDAQ:AXGN) (after the close)
• T2 Biosystems Inc (NASDAQ:TTOO) (after the close)
• Theravance Biopharma Inc (NASDAQ:TBPH) (after the close)
• Clovis Oncology Inc (NASDAQ:CLVS) (after the close)
• Tandem Diabetes Care Inc (NASDAQ:TNDM) (after the close)
• Guardant Health Inc (NASDAQ:GH) (after the close)
• Halozyme Therapeutics, Inc. (NASDAQ:HALO) (after the close)
• Medpace Holdings Inc (NASDAQ:MEDP) (after the close)
• Orthofix Medical Inc (NASDAQ:OFIX) (after the close)
• Retrophin Inc (NASDAQ:RTRX) (after the close)
• Merit Medical Systems, Inc. (NASDAQ:MMSI) (after the close)
• Revance Therapeutics Inc (NASDAQ:RVNC) (after the close)
• Xencor Inc (NASDAQ:XNCR) (after the close)

Tuesday

• Avanos Medical Inc (NYSE:AVNS) (before the market open)
• Strongbridge Biopharma plc (NASDAQ:SBBP) (before the market open)
• Gamida Cell Ltd (NASDAQ:GMDA) (before the market open)
• Vericel Corp (NASDAQ:VCEL) (before the market open)
• MannKind Corporation (NASDAQ:MNKD) (before the market open)
• Chimerix Inc (NASDAQ:CMRX) (before the market open)
• Lantheus Holdings Inc (NASDAQ:LNTH) (before the market open)
• Insmed Incorporated (NASDAQ:INSM) (before the market open)
• Intercept Pharmaceuticals Inc (NASDAQ:ICPT) (before the market open)
• Mallinckrodt PLC (NYSE:MNK) (before the market open)
• Amarin Corporation plc (NASDAQ:AMRN) (after the close)
• Adamas Pharmaceuticals Inc (NASDAQ:ADMS) (after the close)
• Akcea Therapeutics Inc (NASDAQ:AKCA) (after the close)
• Aclaris Therapeutics Inc (NASDAQ:ACRS) (after the close)
• Iovance Biotherapeutics Inc (NASDAQ:IOVA) (after the close)
• Insulet Corporation (NASDAQ:PODD) (after the close)
• Nevro Corp (NYSE:NVRO) (after the close)
• Exelixis, Inc. (NASDAQ:EXEL) (after the close)
• GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) (after the close)
• Inspire Medical Systems Inc (NYSE:INSP) (after the close)
• Repro-Med Systems, Inc. (NASDAQ:KRMD) (after the close)
• Veracyte Inc (NASDAQ:VCYT) (after the close)
• MacroGenics Inc (NASDAQ:MGNX) (after the close)
• Supernus Pharmaceuticals Inc (NASDAQ:SUPN) (after the close)
• Paratek Pharmaceuticals Inc (NASDAQ:PRTK) (after the close)
• Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) (after the close)
• Kura Oncology Inc (NASDAQ:KURA) (after the close)
• Jazz Pharmaceuticals PLC (NASDAQ:JAZZ) (after the close)

Wednesday

• Harvard Bioscience, Inc. (NASDAQ:HBIO) (before the market open)
• United Therapeutics Corporation (NASDAQ:UTHR) (before the market open)
• Ionis Pharmaceuticals Inc (NASDAQ:IONS) (before the market open)
• Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) (before the market open)
• Endo International PLC (NASDAQ:ENDP) (before the market open)
• Horizon Therapeutics PLC (NASDAQ:HZNP) (before the market open)
• Amneal Pharmaceuticals Inc (NYSE:AMRX) (before the market open)
• Moderna Inc (NASDAQ:MRNA) (before the market open)
• Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) (after the close)
• Alimera Sciences Inc (NASDAQ:ALIM) (after the close)
• ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) (after the close)
• BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) (after the close)
• Adaptive Biotechnologies Corp (NASDAQ:ADPT) (after the close)
• Global Blood Therapeutics Inc (NASDAQ:GBT) (after the close)
• BioTelemetry Inc (NASDAQ:BEAT) (after the close)
• Cyclacel Pharmaceuticals Inc (NASDAQ:CYCC) (after the close)
• Portola Pharmaceuticals Inc (NASDAQ:PTLA) (after the close)
• Silk Road Medical Inc (NASDAQ:SILK) (after the close)
• Editas Medicine Inc (NASDAQ:EDIT) (after the close)
• G1 Therapeutics Inc (NASDAQ:GTHX) (after the close)
• Opko Health Inc. (NASDAQ:OPK) (after the close)
• Viking Therapeutics Inc (NASDAQ:VKTX) (after the close)

Thursday

• Atara Biotherapeutics Inc (NASDAQ:ATRA) (before the market open)
• ANI Pharmaceuticals Inc (NASDAQ:ANIP) (before the market open)
• Adaptimmune Therapeutics PLC – ADR (NASDAQ:ADAP) (before the market open)
• Allogene Therapeutics Inc (NASDAQ:ALLO) (before the market open)
• IVERIC bio Inc (NASDAQ:ISEE) (before the market open)
• Concert Pharmaceuticals Inc (NASDAQ:CNCE) (before the market open)
• Radius Health Inc (NASDAQ:RDUS) (before the market open)
• SAGE Therapeutics Inc (NASDAQ:SAGE) (before the market open)
• Intellia Therapeutics Inc (NASDAQ:NTLA) (before the market open)
• Obalon Therapeutics Inc (NASDAQ:OBLN) (before the market open)
• NeoGenomics, Inc. (NASDAQ:NEO) (before the market open)
• Orchard Therapeutics PLC – ADR (NASDAQ:ORTX) (before the market open)
• Athenex Inc (NASDAQ:ATNX) (before the market open)
• Aimmune Therapeutics Inc (NASDAQ:AIMT) (after the market close)
• Acceleron Pharma Inc (NASDAQ:XLRN) (after the market close)
• Coherus Biosciences Inc (NASDAQ:CHRS) (after the market close)
• Cara Therapeutics Inc (NASDAQ:CARA) (after the market close)
• Glaukos Corp (NYSE:GKOS) (after the market close)
• CareDx Inc (NASDAQ:CDNA) (after the market close)
• CytomX Therapeutics Inc (NASDAQ:CTMX) (after the market close)
• Collegium Pharmaceutical Inc (NASDAQ:COLL) (after the market close)
• Dicerna Pharmaceuticals Inc (NASDAQ:DRNA) (after the market close)
• Five Prime Therapeutics Inc (NASDAQ:FPRX) (after the market close)
• Otonomy Inc (NASDAQ:OTIC) (after the market close)
• Immunomedics, Inc. (NASDAQ:IMMU) (after the market close)
• Zynex Inc. (NASDAQ:ZYXI) (after the market close)
• Tricida Inc (NASDAQ:TCDA) (after the market close)
• Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) (after the market close)
• Myokardia Inc (NASDAQ:MYOK) (after the market close)
• TRACON Pharmaceuticals Inc (NASDAQ:TCON) (after the market close)
• Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) (after the market close)
• ICU Medical, Incorporated (NASDAQ:ICUI) (after the market close)
• Mylan NV (NASDAQ:MYL) (after the market close)
• Nektar Therapeutics (NASDAQ:NKTR) (after the market close)

IPO

Passage Bio, which is developing gene therapies for central nervous system disorders, has filed to offer 7.4 million shares in an IPO to be priced between $16 and $18. The company has applied to list the shares on the Nasdaq under the ticker symbol "PASG."

IPO Quiet Period Expiry

Annovis Bio Inc (NYSE:ANVS)
AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ:ANPC)
Black Diamond Therapeutics Inc (NASDAQ:BDTX)
Arcutis Biotherapeutics Inc (NASDAQ:ARQT)