The Week Ahead In Biotech: ASCO Presentations In The Spotlight

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. 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 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 NVS's gene therapy candidate Zolgensma for spinal muscular atrophy Type 1.

Allergan plc 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 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 TMDX

Trevi Therapeutics Inc TRVI

See Also: 5 ASCO Abstracts That Moved Stocks

ASCO Presentations

Friday, May 31

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

Saturday, June 1

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

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

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

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

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

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

Sierra Oncology Inc 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. CGEN: Phase 1 data for COM701 (solid tumors)

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

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

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

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

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

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

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

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

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

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

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

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

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

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