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

Shanthi Rexaline

March 16, 2019 at 8:35 AM

Biotech stocks had an upweek, with the release of clinical trial results and the positive broader market sentiment offering ample support.

Here are some key catalysts that can move biotech stocks in the unfolding week.

Conferences

2019 American College of Cardiology meeting – March 16-18, in New Orleans, Louisiana
The Society of Gynecologic Oncology's 2019 annual meeting – March 16-19, in Honolulu, Hawaii
3rd World Congress on Embryology and In Vitro Fertilization - March 18-19, in New York
16th World Hematology Congress - March 18-19, in Rome, Italy
7th International Conference on HIV/AIDS, STDs and STIs - March 18-19, in New York
23rd International Conference on Neurology & Neurophysiology - March 18-19, in Edinburgh, U.K.
20th Annual World Congress on Pediatrics - March 18-19, in Chicago
Oppenheimer 29th Annual Healthcare Conference – March 19-20, in New York
10th Euro Breast Cancer Summit - March 20-21, in Paris, France
6th World Congress on Mental Health, Psychiatry and Well-being - March 20-21, in New York
9th International Conference and Exhibition on Advanced Cell and Gene Therapy - March 21-22, in Rome
ENDO 2019 – March 23-26 in New Orleans, Louisiana

PDUFA Dates

The FDA is set to rule Monday on Roche Holdings AG Basel ADR (OTC: RHHBY)'s sBLA for Tecentriq, in combination with carboplatin and etoposide (chemotherapy) for first-line treatment of people with extensive-stage small cell lung cancer, or SCLC.

SAGE Therapeutics Inc (NASDAQ: SAGE) and Ligand Pharmaceuticals Inc. (NASDAQ: LGND) await FDA decision on their NDA for Brexanolone in the treatment of postpartum depression. The -day is set for Tuesday.

On Wednesday, the FDA will rule on Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)'s NDA for JZP-110, its treatment candidate for excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.

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Sanofi SA (NASDAQ: SNY) and Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) await FDA verdict on their oral diabetic drug Zynquista, chemically Sotagliflozin on Friday.

Clinical Trial Results

PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) is scheduled to present Phase 1 data for PB2452, its reversal agent for tricagrelor, at the American College of Cardiology meeting.

AstraZeneca plc (NYSE: AZN) on Monday is due to present Phase 3 data for its Type-2 diabetes candidate Farxiga.

Amarin Corporation plc (NASDAQ: AMRN) on Monday will release new Phase 3 data for Vascepa, its treatment candidate for high triglycerides with mixed dyslipidemia, at the American College of Cardiology meeting.

Leap Therapeutics Inc (NASDAQ: LPTX) on Monday is due to present Phase 2 data for its endometrial cancer treatment candidate DKN-01 and Paclitaxel at the Society of Gynecologic Oncology meeting.

Strongbridge Biopharma plc (NASDAQ: SBBP) on Saturday is expected to present already-released Phase 3 data for COR-003 that is being evaluated for endogenous Cushing's syndrome at ENDO 2019.

Earnings Monday, March 18

Aclaris Therapeutics Inc (NASDAQ: ACRS) (before the market open)
Akebia Therapeutics Inc (NASDAQ: AKBA) (after the market close)
Innovate Biopharmaceuticals Inc (NASDAQ: INNT) (after the market close)
Novavax, Inc. (NASDAQ: NVAX) (after the market close)

Tuesday, March 19

Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (before the market open)
Provention Bio Inc (NASDAQ: PRVB) (after the market close)

Thursday, March 21

Aptinyx Inc (NASDAQ: APTX) (before the market open)
Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) (before the market open)

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