The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs - Merck & Co (NYSE:MRK), iShares Biotechnology ETF (NASDAQ:IBB), Eli Lilly and Co (NYSE:LLY), Pfizer (NYSE:PFE)

Biotech earnings news flow accelerated in last week, with Pfizer Inc. PFE and Sanofi SA SNY among the noteworthy releases of the week.

With the earnings news flow set to continue, these are some of the catalysts biotech investors should watch for in the upcoming week.

Conferences

28th World Congress on Cardiology and Heart Diseases: Nov. 5-6 in Amsterdam, Netherlands
5th International Conference on Depression, Anxiety and Stress Management: Nov. 5-6 in Bangkok, Thailand
23rd Annual Congress on Pediatrics & Neonatology: Nov. 5-6 in Bangkok
International Conference on Bipolar Disorder: Depression and Psychiatry: Nov. 5-6 in Abu Dhabi, UAE
World Summit on Liver Cirrhosis and Hepatitis: Nov. 7-8 in Singapore City
Global Congress on Asthma, Allergy and Immunology: Nov. 7-8 in Singapore City
International Conference on Frontiers in Gynecologic Cancers: Nov. 7-8 in Singapore City
Global Congress on Asthma, Allergy and Immunology: Nov. 7-8 in Singapore City
The Society for Immunotherapy of Cancer, or SITC Annual Meeting: Nov. 7-11 in Washington, D.C.
24th Asia-Pacific Dermatology Conference: Nov. 8-9 in Sydney, Australia
American Medical Association 2018 Interim Meeting: Nov. 8-13 in National Harbor, Maryland
2nd Annual Summit on Cell Therapy, Tissue Science and Regenerative Medicine: Nov. 9-10 in Atlanta
2nd Annual Summit on Stem Cell Research, Cell and Gene Therapy: Nov. 9-10 in Atlanta
The American Association for the Study of Liver Diseases, or AASLD, 2018 Liver Meeting: Nov. 9-13 in San Francisco

PDUFA Dates

Merck & Co., Inc. MRK, which recently announced FDA approval for its Keytruda in combination with chemotherapy drugs for metastatic squamous non-small cell lung cancer, or NSCLC, has another tryst with the FDA on Friday, Nov. 9. The regulatory body will announce its verdict on Keytruda as a monotherapy for hepatocellular carcinoma. The sBLA was submitted based on the KEYNOTE-224 study.

Clinical Trial Results

BioMarin Pharmaceutical Inc. BMRN will release Phase 2 longer-term 42-month data on its achondroplasia treatment Vosoritide Wednesday, Nov. 7.

Novartis AG NVS will present Phase 3 data for its heart failure pipeline candidate Entresto at the AHA 2018 meeting to be held between Nov. 10 and 12.

Eidos Therapeutics Inc EIDX will release Phase 2 data for AG10, its treatment candidate for transthyretin amyloidosis, on Saturday, Nov. 10.

SITC 2018 Meeting Presentations

Iovance Biotherapeutics Inc IOVA: update on Phase 2 program for LN-144 for treating refractory metastatic melanoma (Nov. 9).

Aduro BioTech Inc ADRO: initial Phase 1b data for its ADU-S100 for treating solid tumors as well as lymphoma (Nov. 9).

TESARO Inc TSRO: Phase 1 data for its solid tumor treatment combo TSR-022 plus TSR-042 (Nov. 9) as well as Phase 1 data for another solid tumor treatment candidate, TSR-033 (Nov. 7-11).

Nektar Therapeutics NKTR: Updated Phase 1/2 data for NKTR-214 plus Bristol-Myers Squibb Co BMY's Opdiva for melanoma and renal cell carcinoma and NSCLC (Nov. 9).

Corvus Pharmaceuticals Inc CRVS: Phase 2 data for its solid tumor treatment candidate CPI-444 (Nov. 10).

Leap Therapeutics Inc LPTX: Interim Phase 1 data for its TRX518 in combination with KEYTRUDA or Opdivo for treating advanced solid tumors (Nov. 7-11).

Earnings

Monday

Amicus Therapeutics, Inc. FOLD (before the market open)
Avadel Pharmaceuticals PLC AVDL (before the market open)
Galmed Pharmaceuticals Ltd GLMD (before the market open)
Alder Biopharmaceuticals Inc ALDR (after the market close)
Alimera Sciences Inc ALIM (after the market close)
Akcea Therapeutics Inc AKCA (after the market close)
Neurocrine Biosciences, Inc. NBIX (after the market close)
Dynavax Technologies Corporation DVAX (after the market close)
PTC Therapeutics, Inc. PTCT (after the market close)
Insys Therapeutics Inc INSY (after the market close)
Infinity Pharmaceuticals Inc. INFI (after the market close)
Taro Pharmaceutical Industries Ltd. TARO (after the market close)
Kura Oncology Inc KURA (after the market close)
Mylan NV MYL (after the market close)
Dicerna Pharmaceuticals Inc DRNA (after the market close)
Xencor Inc XNCR (after the market close)
Evolus Inc EOLS (after the market close)
Sunesis Pharmaceuticals, Inc. SNSS (after the market close)
Otonomy Inc OTIC (after the market close)
Ultragenyx Pharmaceutical Inc RARE (after the market close)

Tuesday

ANI Pharmaceuticals Inc ANIP (before the market open)
Eli Lilly And Co LLY (before the market open)
Becton Dickinson and Co BDX (before the market open)
BioCryst Pharmaceuticals, Inc. BCRX (before the market open)
Chimerix Inc CMRX (before the market open)
InspireMD Inc NSPR (before the market open)
SAGE Therapeutics Inc SAGE (before the market open)
Spark Therapeutics Inc ONCE (before the market open)
Regeneron Pharmaceuticals Inc REGN (before the market open)
Mallinckrodt PLC MNK (before the market open)
Neuronetics Inc STIM (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
Ionis Pharmaceuticals Inc IONS (before the market open)
Haemonetics Corporation HAE (before the market open)
Eyepoint Pharmaceuticals Inc EYPT (before the market open)
Adaptimmune Therapeutics PLC ADAP (before the market open)
Aquestive Therapeutics Inc AQST (after the market close)
Accelerate Diagnostics Inc AXDX (after the market close)
Aclaris Therapeutics Inc ACRS (after the market close)
Audentes Therapeutics Inc BOLD (after the market close)
Aerie Pharmaceuticals Inc AERI (after the market close)
CytomX Therapeutics Inc CTMX (after the market close)
Iovance Biotherapeutics Inc IOVA (after the market close)
Theravance Biopharma Inc TBPH (after the market close)
Cara Therapeutics Inc CARA (after the market close)
Xenon Pharmaceuticals Inc XENE (after the market close)
Rigel Pharmaceuticals, Inc. RIGL (after the market close)
Jazz Pharmaceuticals PLC JAZZ (after the market close)
Five Prime Therapeutics Inc FPRX (after the market close)
Genomic Health, Inc. GHDX (after the market close)
Myriad Genetics, Inc. MYGN (after the market close)
Halozyme Therapeutics, Inc. HALO (after the market close)
Inspire Medical Systems Inc INSP (after the market close)
Paratek Pharmaceuticals Inc PRTK (after the market close)
Supernus Pharmaceuticals Inc SUPN (after the market close)
CytomX Therapeutics Inc CTMX (after the market close)
Immune Design Corp IMDZ (after the market close)
CymaBay Therapeutics Inc CBAY (after the market close)
DexCom, Inc. DXCM (after the market close)
Fulgent Genetics Inc FLGT (after the market close)

Wednesday

Aerpio Pharmaceuticals Inc ARPO (before the market open)
Affimed NV AFMD (before the market open)
Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
Amneal Pharmaceuticals Inc AMRX (before the market open)
Protalix Biotherapeutics Inc PLX (before the market open)
Intra-Cellular Therapies Inc ITCI (before the market open)
Evofem Biosciences Inc EVFM (before the market open)
Melinta Therapeutics Inc MLNT (before the market open)
Recro Pharma Inc REPH (before the market open)
Charles River Laboratories Intl. Inc CRL (before the market open)
Reata Pharmaceuticals Inc RETA (before the market open)
Momenta Pharmaceuticals, Inc. MNTA (before the market open)=
Horizon Pharma PLC HZNP (before the market open)
Miragen Therapeutics Inc MGEN (before the market open)
Pieris Pharmaceuticals Inc PIRS (before the market open)
Merrimack Pharmaceuticals Inc MACK (before the market open)
TRACON Pharmaceuticals Inc TCON (after the market close)
Zafgen Inc ZFGN (after the market close)
MacroGenics Inc MGNX (after the market close)
G1 Therapeutics Inc GTHX (after the market close)
Regenxbio Inc RGNX (after the market close)
Viking Therapeutics Inc VKTX (after the market close)
Arena Pharmaceuticals, Inc. ARNA (after the market close)
Achieve Life Sciences Inc ACHV (after the market close)
Avalara Inc AVLR (after the market close)
Arbutus Biopharma Corp ABUS (after the market close)
Aileron Therapeutics Inc ALRN (after the market close)
Calithera Biosciences Inc CALA (after the market close)
Kindred Biosciences Inc KIN (after the market close)
Nektar Therapeutics NKTR (after the market close)
Vanda Pharmaceuticals Inc. VNDA (after the market close)
Immunomedics, Inc. IMMU
Glaukos Corp GKOS (after the market close)
Editas Medicine Inc EDIT (after the market close)
Flexion Therapeutics Inc FLXN (after the market close)
Ocular Therapeutix Inc OCU (after the market close)
Hologic, Inc. HOLX (after the market close)
Pfenex Inc PFNX (after the market close)
Voyager Therapeutics Inc VYGR (after the market close)
Portola Pharmaceuticals Inc PTLA (after the market close)
TherapeuticsMD Inc TXMD (after the market close)

Thursday

Karyopharm Therapeutics Inc KPTI (before the market open)
Histogenics Corp HSGX (before the market open)
Ligand Pharmaceuticals Inc. LGND (before the market open)
Obseva SA OBSV (before the market open)
Eloxx Pharmaceuticals Inc ELOX (before the market open)
Endo International PLC ENDP (before the market open)
Foamix Pharmaceuticals Ltd FOMX (before the market open)
Misonix, Inc. MSON (after the market close)
Assertio Therapeutics Inc ASRT (after the market close)
BioDelivery Sciences International, Inc. BDSI (after the market close)
BioTime, Inc. BTX (after the market close)
Coherus Biosciences Inc CHRS (after the market close)
CareDx Inc CDNA (after the market close)
Synthetic Biologics Inc SYN (after the market close)
Vermillion, Inc. VRML (after the market close)
ICU Medical, Incorporated ICUI (after the market close)
Inovio Pharmaceuticals Inc INO (after the market close)
Transenterix Inc TRXC (after the market close)
Collegium Pharmaceutical Inc COLL (after the market close)
DENTSPLY SIRONA Inc XRAY (after the market close)
HTG Molecular Diagnostics Inc HTGM (after the market close)
Organovo Holdings Inc ONVO (after the market close)

Friday

SurModics, Inc. SRDX (before the market open)
PLx Pharma Inc PLXP (before the market open)

IPO Quiet Period Expiry

Allogene Therapeutics, Inc. ALLO

Equillium, Inc. EQ

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