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The Week Ahead In Biotech: ASCO Presentations Dominate The Headlines

The Week Ahead In Biotech: ASCO Presentations Dominate The Headlines

A few FDA approvals and the impending 2018 American Society of Clinical Oncology annual meeting gave some impetus to the biotech space in the week ending June 1.

The FDA greenlighted Pfizer Inc. (NYSE: PFE)'s sNDA for Xeljanz, while TherapeuticsMD Inc (NASDAQ: TXMD) finally secured a FDA nod for its vaginal pain medication Imvexxy.

The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) has been higher for the week.

Here are a few catalytic events biotech investors should watch in the unfolding week:

Medical, Health Care And Biotech Conferences

  • 2018 American Society of Clinical Oncology Annual Meeting: June 1-5, McCormick Place, Chicago. 
  • Jefferies 2018 Global Healthcare Conference: June 5-8 in New York City.
  • American Society for Microbiology 2018 meeting: June 7-11 in Atlanta.

Clinical Trial Outcomes

  • Cidara Therapeutics Inc (NASDAQ: CDTX) is due to present Phase 2 data for its candidemia treatment rezafungin IV at the ASM meeting at 11 a.m. on Friday, June 8. The data from Cidara's STRIVE study released in March showed that the study met the primary objectives.

ASCO Presentations Pick Up Steam

Sunday, June 3

  • Merck & Co., Inc. (NYSE: MRK) is presenting the following:
  • Phase 3 data from KEYNOTE-042 study for non-small cell lung cancer, or NSCLC.
  • Phase 2 data for a Keytruda and chemo combo for first-line non-squamous NSCLC.
  • Data for Keytruda and carboplatin-paclitaxel or nab-paclitaxel from the KEYNOTE-407 study evaluating the combo for squamous NSCLC.
  • Data for MK-3475-189 from the KEYNOTE-180 study that evaluated the pipeline candidate for treating first-line metastatic non-squamous NSCLC.
  • Celgene Corporation (NASDAQ: CELG): Updated Phase 1 data for Lico-cel in B cell non-Hodgkin lymphoma
  • Novartis AG (ADR) (NYSE: NVS): Phase 3 data for LEE011 from MONALEESA-3 study that evaluated for breast cancer in post-menopausal women.
  • TESARO Inc (NASDAQ: TSRO): Phase 1 data for niraparib-keytruda combo for treating triple-negative breast cancer or ovarian cancer.
  • Calithera Biosciences Inc (NASDAQ: CALA): Phase 1/2 data for CB-839 and panitumumab for treating colorectal cancer.
  • MacroGenics Inc (NASDAQ: MGNX): Phase 2 data for margetuximab in combination with Keytruda to treat gastric cancer.
  • Incyte Corporation (NASDAQ: INCY): Phase 1 data for DPX-survivac vaccine therapy and epacadostat for recurrent ovarian cancer.
  • ARMO Biosciences Inc (NASDAQ: ARMO): Phase 1b data for AM0010 in solid tumors
  • Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) is presenting the following: 
  • Phase 3 data for venclexta for treating relapsed or refractory chronic lymphocytic leukemia.
  • Updated Phase 3 data for alecensa for treating ALK-positive metastatic NSCLC.
  • Pfizer is presenting the following: 
  • Phase 3 data for ibrance from the PALOMA-3 study in breast cancer patients.
  • Phase 2 data for ibrance in treating head and neck squamous cell carcinoma.
  • Other companies due to present data June 3 include:
  • Immunomedics, Inc. (NASDAQ: IMMU)
  • Epizyme Inc (NASDAQ: EPZM)
  • Exelixis, Inc. (NASDAQ: EXEL)
  • NewLink Genetics Corp (NASDAQ: NLNK)
  • AbbVie Inc (NYSE: ABBV)
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX)
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • FibroGen Inc (NASDAQ: FGEN)
  • Tyme Technologies Inc (NASDAQ: TYME)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX)
  • Zai Lab Ltd (NASDAQ: ZLAB)

See also: Labs Are 'Relative Safe Havens' In Health Care Services, Morgan Stanley Says In Quest Diagnostics Upgrade

Monday, June 4

  • Roche is presenting:
  • Phase 3 data for tecentriq and cb and pac/nab-pac from the Impower 131 study that evaluated for squamous NSCLC. 
  • Phase 3 data for tecentriq from the Impower 150 study in patients with non-squamous NSCLC.
  • Infinera Corp. (NASDAQ: INFN): Phase 1 study of IPI-549 and opdivo for treating solid tumors.
  • Agenus Inc (NASDAQ: AGEN): A Phase 1/2 study of AGEN2034 in cervical cancer and Phase 1 data for AGEN1884 in solid cancers.
  • Acceleron Pharma Inc (NASDAQ: XLRN): Phase 2 study of luspatercept for myelodysplastic syndromes.
  • Nektar Therapeutics (NASDAQ: NKTR): Phase 1/2 data for NKTR-214 and tecentriq in solid tumors.
  • Eli Lilly And Co (NYSE: LLY): Phase 3 data from the REACH-2 study that evaluated its ramucirumab for hepatocellular carcinoma.
  • ImmunoGen, Inc. (NASDAQ: IMGN): Phase 1/2 data for mirvetuximab soravtansine in the FORWARD II study that evaluated it in ovarian cancer and relapsed endometrial cancer.
  • Bristol-Myers Squibb Co (NYSE: BMY) is presenting:
  • Phase 3 data of CM-227 (opdivo-yervoy combo) for first-line NSCLC.
  • Phase 2 data for opdivo and rubraca in castration-resistant prostate cancer, along with Clovis Oncology Inc (NASDAQ: CLVS).
  • AstraZeneca plc (ADR) (NYSE: AZN) – Phase 2 data for lyparza and Keytruda for castration-resistant prostate cancer.
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN) & Sanofi SA (ADR) (NYSE: SNY): Phase 1 data for cemiplimab in NSCLC
  • Celgene and Acceleron: Phase 2 data for luspatercept in myelofibrosis.
  • Pfizer: Phase 3 data on dacomitinib for treating NSCLC.

Other companies due to present data on June 4 include:

  • Stemline Therapeutics Inc (NASDAQ: STML)
  • Verastem Inc (NASDAQ: VSTM)
  • CytomX Therapeutics Inc (NASDAQ: CTMX)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Corcept Therapeutics Incorporated (NASDAQ: CORT)
  • Protalix Biotherapeutics Inc (NYSE: PLX)
  • MEI Pharma Inc (NASDAQ: MEIP)
  • Portola Pharmaceuticals Inc (NASDAQ: PTLA)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO)
  • Molecular Templates Inc (NASDAQ: MTEM)
  • Mersana Therapeutics Inc (NASDAQ: MRSN)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Calithera Biosciences
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • AbbVie Inc
  • Dynavax Technologies Corporation (NASDAQ: DVAX)
  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)
  • Tesaro
  • TG Therapeutics Inc common stock (NASDAQ: TGTX)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • Merrimack Pharmaceuticals Inc (NASDAQ: MACK)
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA)


Thursday, June 7

  • Advaxis, Inc. (NASDAQ: ADXS)

IPO Calendar

MeiraGTx Holdings, a gene therapy company that focuses on disorders of the eye and salivary gland, is set offer 5 million shares at an estimated price range of $14-$16.

The company seeks to list its shares on the Nasdaq under the ticker symbol MGTX.

Quiet Period Expirations

Evelo Biosciences Inc (NASDAQ: EVLO) listed its shares on the Nasdaq on May 8, with the stock closing its debut session at its offer price of $16. The stock is currently trading at a discount to the offer price.

Related Link:

'Right To Try' Law Signed By Trump Increases Patient Access To Experimental Drugs


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