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

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

Biotech stocks continued to be in the red this week, with the losses worse than what the broader market suffered.

Here's a list of key events associated with biotech stocks one needs to focus on, in the upcoming week.

PDUFA Dates

Tuesday, April 3

The FDA is scheduled to pronounce its verdict on Merck & Co., Inc. (NYSE: MRK)'s Supplemental Biologic License Application, or sBLA for a new indication - relapsed primary mediastinal large B-cell Lymphoma - for its immuno-oncology drug Keytruda.

The PDUFA action date for Theratechnologies Inc. (OTC: THERF)'s BLA for its multi-drug resistant HIV-infection treatment candidate Ibalizumab is due on April 3.

Friday, April 6

Clovis Oncology Inc (NASDAQ: CLVS) awaits FDA verdict on its sNDA for its Rucaparib, which is being tested as a maintenance treatment in patients with recurrent epithelial, ovarian, fallopian tube, or primary peritoneal cancer, who are platinum sensitive, and in a complete, or partial response to platinum-based chemotherapy.

The FDA will also announce its decision concerning Pacira Pharmaceuticals Inc (NASDAQ: PCRX)'s sNDA for Exparel, seeking an expansion in label to include administration via nerve block for prolonged regional analgesia.

Clinical Trial Results

Novartis AG (ADR) (NYSE: NVS) is scheduled to present the abstract of 52-week results from the Phase 3 study of its AIN457 (Cosentyx) at the Panamerican League of Associations for Rheumatology Congress scheduled between April 7 and 10.

A Few With an April Schedule With No Set Date

Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) - Phase 2 data from the second cohort of the trial evaluating Fostamatinib for IgA nephropathy

vTv Therapeutics Inc (NASDAQ: VTVT) – Phase 3 data from the Part A study of Azeliragon to treat mild Alzheimer's.

ImmunoGen, Inc. (NASDAQ: IMGN) – Futility analysis based on a Phase 3 trial – dubbed FORWARD I - of Mirvetuximab for treating ovarian cancer and relapsed endometrial cancer.

Edge Therapeutics Inc (NASDAQ: EDGE) – Interim Phase 3data analysis for EG-1962, the company's treatment candidate for improving patient outcome following aneurysmal subarachnoid hemorrhage.

IPO Quiet Period Expirations

BioXcel Therapeutics Inc (NASDAQ: BTAI) - The company with focus on neuroscience and immuno-oncology, priced its 5.45 million share offering at $11 on March 8.

Conferences

  • Sixth Biennial Schizophrenia International Research Society Conference – April 4-8 in Florence, Italy
  • Anxiety And Depression Association of America 38th Annual Conference, or ADAA 2018 – April 5-8 at the Marriott Wardman Park in Washington, DC
  • Panamerican League of Associations for Rheumatology Congress – April 7-11 at Hotel Hilton, Buenos Aires, Argentina

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