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. 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 AGRX Twirla contraceptive patch was approved by the FDA. Bellerophon Therapeutics Inc 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 LLY sNDA for Cyramza injection for intravenous use in combination with Roche Holdings AG's Basel ADR 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 KDMN will present at the TCT Meetings expanded Phase 2 data for KD025 in chronic graft-versus-host disease (Sunday).

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

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

Earnings

Monday

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

Tuesday

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

Wednesday

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

Thursday

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