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. 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. THERF's BLA for its multi-drug resistant HIV-infection treatment candidate Ibalizumab is due on April 3.

Friday, April 6

Clovis Oncology Inc 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 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) 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. RIGL - Phase 2 data from the second cohort of the trial evaluating Fostamatinib for IgA nephropathy

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

ImmunoGen, Inc. 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 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 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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