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The Week Ahead In Biotech: ASCO Presentations In The Spotlight

Shanthi Rexaline

After two successive weeks of losses, biotech stocks slowly clawed back. Multiple conference presentations, independent clinical trial readouts and a few FDA decisions marked the key events in the biotech space.

Among the notable biotech movers of the week: BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX), which suffered a severe setback despite a positive readout from a late-stage trial of its investigational drug for preventing hereditary angioedema.

The massive four-day rally in Outlook Therapeutics Inc (NASDAQ: OTLK) took a break.

The following are catalysts that could set the tone for trading in biotech stocks in the upcoming week.

Conferences

  • The American Society of Clinical Pyschopharmacology 2019 Annual Meeting: May 28-31 in Scottsdale, Arizona.
  • 27th Annual Congress on Cell Signaling, Cancer Science and Therapeutics: May 30-31 in Orlando, Florida.
  • The American Society of Clinical Oncology, or ASCO, 2019 Annual Meeting: May 31–June 4 in Chicago, Illinois.

PDUFA Dates

The FDA is likely to issue its verdict on Novartis AG (NYSE: NVS)'s gene therapy candidate Zolgensma for spinal muscular atrophy Type 1.

Allergan plc (NYSE: AGN) awaits the FDA's nod for an expanded indication for its schizophrenia drug cariprazine. The company is now seeking approval for depressive episodes associated with bipolar disorder in adults.

Clinical Trial Readouts

Concert Pharmaceuticals Inc (NASDAQ: CNCE) is due to present Phase 1 data for single-dose CTP-692, its schizophrenia treatment candidate, at the 2019 annual meeting of the American Society of Clinical Pyschopharmacology on Tuesday, May 28.

IPOs

IPO Quiet Period Expiry

TransMedics Group Inc (NASDAQ: TMDX)

Trevi Therapeutics Inc (NASDAQ: TRVI)

See Also: 5 ASCO Abstracts That Moved Stocks

ASCO Presentations

Friday, May 31

Jazz Pharmaceuticals PLC (NASDAQ: JAZZ): Phase 1/2 data for CPX-351 (acute myeloid leukemia)

Saturday, June 1

Five Prime Therapeutics Inc (NASDAQ: FPRX): initial Phase 1b data for FPA150 (solid tumors)

Blueprint Medicines Corp (NASDAQ: BPMC): Phase 1 data for Avapritinib BLU-285 (gastrointestinal stromal tumors with specific mutations)

Iovance Biotherapeutics Inc (NASDAQ: IOVA): Phase 2 data for lifileucel (refractory metastatic melanoma) and poster presentation of Phase 2 data for LN-145 (cervical cancer)

Athenex Inc (NASDAQ: ATNX): poster presentation of Phase 1 data for Oratecan (solid tumors)

Bellicum Pharmaceuticals Inc (NASDAQ: BLCM): initial Phase 1 data for BPX-601 (pancreatic cancer)

Corvus Pharmaceuticals Inc (NASDAQ: CRVS): poster presentation of Phase 1/1b data for CPI-006 (solid tumors)

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Sierra Oncology Inc (NASDAQ: SRRA): preliminary Phase 1/2 data for SRA737 (advanced solid tumors or non-Hodgkin lymphoma) and preliminary Phase 1/2 data for SRA737 plus Low-Dose chemotherapy medication gemcitabine (solid tumors)

Compugen Ltd. (NASDAQ: CGEN): Phase 1 data for COM701 (solid tumors)

CytomX Therapeutics Inc (NASDAQ: CTMX): updated Phase 1/2 data for CX-072 (solid tumors)

G1 Therapeutics Inc (NASDAQ: GTHX): additional Phase 2 data for trilaciclib (second- or third-line small-cell lung cancer)

Celldex Therapeutics, Inc. (NASDAQ: CLDX): Phase 2 data for CDX-3379 (metastatic head and neck squamous cell cancer)

Mersana Therapeutics Inc (NASDAQ: MRSN): Phase 1 data for XMT-1536 (ovarian cancer and non-small cell lung cancer)

ImmunoGen, Inc. (NASDAQ: IMGN): Phase 1b/2 data for mirvetuximab soravtansine (ovarian cancer and relapsed endometrial cancer)

Moderna Inc (NASDAQ: MRNA): Phase 1 data for mRNA-4650 (autologous cancer) and updated Phase 1 data for mRNA-4157 (personalized cancer vaccine)

Arcus Biosciences Inc (NYSE: RCUS): initial Phase 1 data for AB928 plus AB122 (solid tumors)

MEI Pharma Inc (NASDAQ: MEIP): final Phase 1 data for ME-344 (HER-negative breast cancer)

Beigene Ltd (NASDAQ: BGNE): initial Phase 3 data from China for tislelizumab (nasopharyngeal cancer)

Genocea Biosciences Inc (NASDAQ: GNCA): Phase 1/2 initial immunogenicity data for GEN-009 vaccine (multiple cancers)

Repligen Corporation (NASDAQ: RGEN): Phase 1/2 data for RP1 in combination with Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo (solid tumors)

Vaccinex Inc (NASDAQ: VCNX): initial Phase 1/2 data for VX15 in combination with Merck & Co., Inc. (NYSE: MRK)'s fully human monoclonal antibody avelumab (non-small cell lung cancer)

Dynavax Technologies Corporation (NASDAQ: DVAX): Phase 1/2 data for SD-101 in combination with Merck's Keytruda (melanoma and head and neck squamous cell carcinoma)

Incyte Corporation (NASDAQ: INCY) & Imv Inc (NASDAQ: IMV): DPX-Survivac and epacadostat (ovarian cancer)

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