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The Week Ahead In Biotech: Earnings, Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Shanthi Rexaline

Earnings and U.S. midterm polls continued to positively influence biotech stocks, with the sector notching gains for the second straight week.

These are some of the upcoming week's catalysts that could sway biotech stocks.

Conferences

  • The Society for Immunotherapy of Cancer, or SITC, 2018 Annual Meeting – Nov. 7-11, in Washington D.C.
  • The American Association for the Study of Liver Diseases, or AASLD, 2018 Liver Meeting – Nov. 9-13, in San Francisco
  • The American Heart Association, or AHA, Scientific Sessions 2018 – Nov. 10-12, in Chicago, Illinois
  • Credit Suisse 27th Annual Healthcare Conference – Nov. 12-15, at the Phoenician Resort in Scottsdale, Arizona
  • Stifel Healthcare Conference – Nov. 13-14, at the Lotte Palace Hotel in New York City
  • 30th European Organisation for Research and Treatment of Cancer, or EORTC, the National Cancer Institute, or NCI, and the American Association for Cancer Research, or AACR, symposium – Nov. 13-16, in Dublin, Ireland
  • Jefferies 2018 London Healthcare Conference – Nov. 14-15, in London
  • Connective Tissue Oncology Society, or CTOS, 2018 Annual Meeting – Nov. 14-17, in Rome, Italy
  • Society for Neuro-Oncology, or SNO, 2018 annual meeting – Nov. 15-18, in New Orleans, Louisiana
  • Life Sciences + Pharmaceuticals CEO Symposium – Nov. 16, in Midtown Manhattan, New York City

PDUFA Dates

Theravance Biopharma Inc (NASDAQ: TBPH) and Mylan NV (NASDAQ: MYL) await FDA decision on their chronic obstructive pulmonary disorder treatment candidate Revefenacin Tuesday, Nov. 13.

Adcom Schedule

Mallinckrodt PLC (NYSE: MNK)'s generic unit SpecGx's NDA for an immediate-release oral tablet formulation of oxycodone - MNK-812 - will be discussed by a joint committee of Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee Nov. 14.

This pipeline asset is intended to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The joint committee will also determine whether the sponsor company demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved.

Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates

Clinical Trial Results

Novartis AG (NYSE: NVS) will present Phase 3 data for its heart failure pipeline candidate Entresto, at the AHA 2018 meeting.

Mesoblast limited (NASDAQ: MESO) is due to present Phase 2b data for MPC-150-IM, its treatment candidate for end-stage heart failure with LVADs, at the AHA 2018 meeting.

Mirati Therapeutics Inc (NASDAQ: MRTX) is scheduled to present Phase 2 biomarker analysis for its Sitravatinib in combination with nivolumab for treating non-small cell lung cancer, Nov.11 at the SITC 2018 annual meeting.

CymaBay Therapeutics Inc (NASDAQ: CBAY) is scheduled to release 52-week data for its primary biliary cholangitis treatment candidate Seladelpar, Monday, Nov. 12 at the AASLD.

Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) is due to present initial Phase 1 data for its hepatitis B treatment candidate ARO-HBV, Monday, Nov. 12 at the AASLD.

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) will present Phase 2 data for its non-alcoholic steatohepatitis, or NASH, treatment candidate MGL-3196, Nov. 12 at the AASLD.

Viking Therapeutics Inc (NASDAQ: VKTX) is due to Phase 2 data for hypercholesterolemia and non-alcoholic fatty liver disease candidate VK2809, Nov. 12 at the AASLD.

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Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) is set to present 12-month Phase 2b data for Aramchol, its treatment candidate for NASH, Nov. 13 at the AASLD.

TRACON Pharmaceuticals Inc (NASDAQ: TCON) will present Phase 2 data for TRC102 and Temodar, evaluated for Glioblastoma, at the SNO 2018 annual meeting.

Zymeworks Inc (NYSE: ZYME) is expected to present updated Phase 1 data for ZW25, its candidate for HER2-expressing cancers such as ovarian, breast and gastric, Nov. 14 at the EORTC-NCI-AACR.

Blueprint Medicines Corp (NASDAQ: BPMC) will present updated Phase 1 data for Avapritnib BLU-285 being evaluated for PDGFRα driven gastrointestinal stromal tumors, Nov. 15 at the CTOS 2018 annual meeting.

Syros Pharmaceuticals Inc (NASDAQ: SYRS) is due to present Phase 1 data for its solid tumor treatment candidate SY-1365, Nov. 15, at the EORTC-NCI-AACR.

Beigene Ltd (NASDAQ: BGNE) will present Phase 1/2 data for its glioblastoma treatment candidate Pamiparib, Nov. 16, at the SNO 2018 annual meeting.

ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) is set to present updated Phase 1 data for the Ad-RTS-hIL-12 + veledimex combo being tested for Glioblastoma Multiforme, Nov. 16, at the SNO 2018 annual meeting.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) is due to present Phase 1/2 data for Varlilumab and nivolumab that are being evaluated for solid tumors, Nov. 17, at the SNO 2018 annual meeting.

Earnings

Monday, Nov. 12

  • Fibrocell Science Inc (NASDAQ: FCSC) (before the market open)
  • Urogen Pharma Ltd (NASDAQ: URGN) (before the market open)
  • Asterias Biotherapeutics Inc (NYSE: AST) (after the market close)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) (after the market close)
  • Unum Therapeutics Inc (NASDAQ: UMRX) (after the market close)
  • Urovant Sciences Ltd (NASDAQ: UROV) (after the market close)

Tuesday, Nov. 13

  • Albireo Pharma Inc (NASDAQ: ALBO) (before the market open)
  • Dare Bioscience Inc (NASDAQ: DARE) (before the market open)
  • Jounce Therapeutics Inc (NASDAQ: JNCE) (before the market open)
  • Eyenovia Inc (NASDAQ: EYEN) (before the market open)
  • OptiNose Inc (NASDAQ: OPTN) (before the market open)
  • Onconova Therapeutics Inc (NASDAQ: ONTX) (before the market open)
  • Capricor Therapeutics Inc (NASDAQ: CAPR) (after the market close)
  • Biocept Inc (NASDAQ: BIOC) (after the market close)
  • OncoCyte Corp (NYSE: OCX) (after the market close)
  • RA Medical Systems Inc (NYSE: RMED) (after the market close
  • Synlogic Inc (NASDAQ: SYBX) (after the market close
  • Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) (after the market close
  • Rubius Therapeutics Inc (NASDAQ: RUBY)

Wednesday, Nov. 14

  • Athenex Inc (NASDAQ: ATNX) (before the market open)
  • Aldeyra Therapeutics Inc (NASDAQ: ALDX) (before the market open)
  • AIT Therapeutics Inc (OTC: AITB) (after the market close)
  • Reshape Lifesciences Inc (NASDAQ: RSLS) (after the market close)
  • Edap Tms SA (NASDAQ: EDAP) (after the market close)
  • Cesca Therapeutics Inc (NASDAQ: KOOL) (after the market close)
  • RXi Pharmaceuticals Corp (NASDAQ: RXII) (after the market close)

Thursday, Nov. 15

  • PAVmed Inc (NASDAQ: PAVM) (after the market close)
  • NantHealth Inc (NASDAQ: NH) (after the market close)

IPOs

Vapotherm, which manufactures non-invasive breathing aids to treat respiratory distress, is set to offer 4 million shares in an IPO, with an estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol VAPO.

Centrexion Therapeutics, which develops non-opioid therapies for pain, is expected to offer 5 million shares in an IPO, priced between $14 and $16. The company plans to list the shares are on the Nasdaq under the ticker symbol CNTX.

IPO Quiet Period Expiry

  • LogicBio Therapeutics Inc (NASDAQ: LOGC)
  • Osmotica Pharmaceuticals PLC (NASDAQ: OSMT)
  • PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS)
  • SI-Bone Inc (NASDAQ: SIBN)

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