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The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Readouts

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The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Readouts

Biotech stocks staged a steady recovery last week. ASCO presentations dominated the headlines, with Iovance Biotherapeutics Inc (NASDAQ: IOVA) and Mirati Therapeutics Inc (NASDAQ: MRTX) among the biggest gainers. The IPO calendar was empty and there were a slew of clinical trial readouts that swayed stocks.

The following are key catalysts expected in the unfolding week.

Conferences

  • American Diabetes Association 79th Scientific Sessions: June 7-11 in San Francisco, California.
  • 24th World Congress of Dermatology: June 10-15 in Milan, Italy.
  • Goldman Sachs 40th Annual Global Healthcare Conference: June 11-13 in Rancho Palos Verdes, California.
  • The Annual European Congress of Rheumatology of the European League Against Rheumatism: June 12-16 in Switzerland.
  • 24th European Hematology Association Congress: June 13-16 in Amsterdam, Netherlands.

PDUFA Dates

Merck & Co., Inc. (NYSE: MRK) awaits the FDA's ruling on its sBLA for Keytruda as a first-line treatment option for patients with recurrent or metastatic head and neck squamous cell carcinoma. The PDUFA date is set for June 10.

Clinical Trial Readouts

American Diabetes Association 79th Scientific Sessions Presentations

NGM Biopharmaceuticals Inc (NASDAQ: NGM): updated Phase 1b data for NGM313/MK-3655 (NASH and Type 2 diabetes)on June 9. 

EULAR Annual European Congress Of Rheumatology Presentations

GALAPAGOS NV/S ADR (NASDAQ: GLPG) and Gilead Sciences, Inc. (NASDAQ: GILD): already-released Phase 3 data for Filgotinib from FINCH 1 study (rheumatoid arthritis), June 12; Phase 3 data for Filgotinib from FINCH 3 study (rheumatoid arthritis), June 15.

Nektar Therapeutics (NASDAQ: NKTR): Phase 1b data for NKTR-358 (systemic lupus erythematosus), June 13.

Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP): Phase 2 open-label data for Lenabasum (dermatomyositis), June 14; Phase 2 open-label data for Lenabasum (systemic sclerosis).

Kezar Life Sciences Inc (NASDAQ: KZR): already-released initial Phase 1b topline data for KZR-616 (lupus), June 14.

24th European Hematology Association Congress Presentations

Kura Oncology Inc (NASDAQ: KURA): Additional Phase 2 data for Tipifarnib (relapsed or refractory peripheral T-cell lymphoma), June 13.

bluebird bio Inc (NASDAQ: BLUE): Phase 3 data for LentiGlobin in HGB-212 (transfusion-dependent beta thalassemia), June 14; updated Phase 1/2 data for LentiGlobin in HGB-204 (beta-thalassemia), June 14; updated Phase 3 data for LentiGlobin in HGB-207 (non-β0/β0 transfusion-dependent thalassemia), June 14.

Beigene Ltd (NASDAQ: BGNE): updated Phase 1 data for Zanubrutinib (Waldenström's macroglobulinemia), June 14; Phase 2 data for Tislelizumab (relapsed or refractory classical Hodgkin lymphoma), June 14.

Global Blood Therapeutics Inc (NASDAQ: GBT): Phase 3 data for GBT440 (sickle cell disease), June 14.

Blueprint Medicines Corp (NASDAQ: BPMC): updated Phase 1 data for Avapritinib BLU-285 (advanced Systemic mastocytosis), June 14.

ArQule, Inc. (NASDAQ: ARQL): Phase 1a data for ARQ 531 (B-cell malignancies), June 14.

Regeneron Pharmaceuticals Inc (NASDAQ: REGN): updated Phase 1 data for REGN1979 (non-Hodgkin lymphoma).

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS): updated Phase 1/2 data for SNS-062 ( advanced B-cell malignancies).

Sutro Biopharma Inc (NASDAQ: STRO): Phase 1 initial safety data for STRO-001 (non-Hodgkin lymphoma), June 15.

Forty Seven Inc (NASDAQ: FTSV): Phase 2 data for 5F9 + rituximab (non-Hodgkin lymphoma), June 15.

Geron Corporation (NASDAQ: GERN) : updated Phase 2 data for Imetelstat (Myelodysplastic syndromes), June 15.

24th World Congress of Dermatology Presentations

Incyte Corporation (NASDAQ: INCY): Phase 2 data for ruxolitinib (atopic dermatitis), June 14; Phase 2 data for ruxolitinib (vitiligo), June 15

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