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The Week Ahead In Biotech (April 25-May 1): FDA Decisions For Sol-Gel, Protalix Bio, Ardelyx

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The Week Ahead In Biotech April 25-May 1: FDA Decisions For Sol-Gel, Protalix Bio, Ardelyx

Biopharma stocks came back from the weakness seen in the first two sessions to close the week ended April 23 higher. Johnson & Johnson (NYSE: JNJ) and Roche Holding AG (OTC: RHHBY) each reported fairly robust results.

Four healthcare stocks, including biotechs and medical device makers, debuted on Wall Street this week, raising $413.3 million in gross proceeds.

Ocugen, Inc. (NASDAQ: OCGN) was among the biggest gainers of the week, having advanced over 110% on the back of a positive clinical readout for a partnered COVID-19 vaccine candidate.

Here are the key catalysts for the unfolding week:

Conferences

International Organization for Medical Physics', or IOMP, International Medical Physics Week: April 26-30
UBS Asia Virtual Healthcare Summit: April 27-29
B. Riley's Neuroscience Investor Conference: April: April 28—29
2021 Society of Biological Psychiatry, or SOBP, annual meeting: April 29-May 1
Association for Research In Vision and Ophthalmology, or ARVO, 2021 Virtual Meeting: May 1-7

PDUFA Dates

The Food and Drug Administration is scheduled to announce its verdict on Sol-Gel Technologies Ltd.'s (NASDAQ: SLGL) new drug application for Epsolay in the treatment of inflammatory lesions of rosacea. The PDUFA date, or the deadline for announcing the decision, is Monday.

The FDA will also rule on Protalix BioTherapeutics, Inc.'s (NYSE: PLX) biologic license application for pegunigalsidase alfa in Fabry disease. The PDUFA date is set for Tuesday.

By Thursday, the regulatory agency is mandated to make a decision on Ardelyx, Inc.'s (NASDAQ: ARDX) new drug application for tenapanor in hyperphosphatemia.

Related Link: BofA Says GlaxoSmithKline's Decision To Halt Feladilimab Studies Is Disappointing

Clinical Readouts/Presentations

Nanobiotix S.A. (NASDAQ: NBTX) is scheduled to present at the IOMP's physics week, further data from the Phase 1 expansion data for NBTXR3 in head and neck cancer.

Cyclerion Therapeutics, Inc. (NASDAQ: CYCN) will host a webinar at 8 a.m., Tuesday, to provide a corporate update on clinical programs for its CY6463 in Alzheimer's disease with vascular pathology and mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes.

Trillium Therapeutics Inc. (NASDAQ: TRIL) will host its virtual R&D Day for analysts and investors at 10:00 am – 1:00 pm on Wednesday, wherein it will provide a clinical update for TTI-622 in refractory lymphoma or multiple myeloma, and TTI-621 in diffuse Large B-cell Lymphoma (DLBCL), cutaneous T-cell lymphoma.

Aptinyx Inc. (NASDAQ: APTX) is due to present at the SOBP annual meeting, data from the Phase 2a exploratory study of NYX-783 in posttraumatic stress disorder.

Annovis Bio, Inc. (NYSE: ANVS) is scheduled to release in April interim data for ANVS401 in Alzheimer's and Parkinson's diseases.

Lineage Cell Therapeutics, Inc. (NYSE: LCTX) is set to present at the ARVO annual meeting updated interim results from a Phase 1/2a study of its lead product candidate, OpRegen, a retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration.

Earnings

Monday

Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) (before the market open)
Masimo Corporation (NASDAQ: MASI) (after the close)

Tuesday

Eli Lilly and Company (NYSE: LLY) (before the market open)
AtriCure, Inc. (NASDAQ: ATRC) (after the close)
Amgen Inc. (NASDAQ: AMGN) (after the close)
Illumina, Inc. (NASDAQ: ILMN) (after the close)

Wednesday

Boston Scientific Corporation (NYSE: BSX) (before the market open)
Surmodics, Inc. (NASDAQ: SRDX) (before the market open)
Integra LifeSciences Holdings Corporation (NASDAQ: IART) (before the market open)
Alkermes plc (NASDAQ: ALKS) (before the market open)
Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) (after the close)
Alimera Sciences, Inc. (NASDAQ: ALIM) (after the close)
OPKO Health, Inc. (NASDAQ: OPK) (after the close)
Hologic, Inc. (NASDAQ: HOLX) (after the close)
Viking Therapeutics, Inc. (NASDAQ: VKTX) (after the close)

Thursday

Syneos Health, Inc. (NASDAQ: SYNH) (before the market open)
NovoCure Limited (NASDAQ: NVCR) (before the market open)
West Pharmaceutical Services, Inc. (NYSE: WST) (before the market open)
Merck & Co., Inc. (NYSE: MRK) (before the market open)
Evelo Biosciences, Inc. (NASDAQ: EVLO) (before the market open)
Baxter International Inc. (NYSE: BAX) (before the market open)
Bristol-Myers Squibb Company (NYSE: BMY) (before the market open)
Blueprint Medicines Corporation (NASDAQ: BPMC) (before the market open)
Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
Laboratory Corporation of America Holdings (NYSE: LH) (before the market open)
Abiomed, Inc. (NASDAQ: ABMD) (before the market open)
Amarin Corporation plc (NASDAQ: AMRN) (before the market open)
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) (before the market open)
ResMed Inc. (NYSE: RMD) (after the close) (after the close)
MiMedx Group, Inc. (NASDAQ: MDXG) (after the close)
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close)
Pacific Biosciences of California, Inc. (NASDAQ: PACB) (after the close)
Bio-Rad Laboratories, Inc. (NYSE: BIO) (after the close)
Emergent BioSolutions Inc. (NYSE: EBS) (after the close)
ChemoCentryx, Inc. (NASDAQ: CCXI) (after the close)
DexCom, Inc. (NASDAQ: DXCM) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
Merit Medical Systems, Inc. (NASDAQ: MMSI) (after the close)
LeMaitre Vascular, Inc. (NASDAQ: LMAT) (after the close)
MacroGenics, Inc. (NASDAQ: MGNX) (after the close)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
Seagen Inc. (NASDAQ: SGEN) (after the close)

Friday

AbbVie Inc. (NYSE: ABBV) (before the market open)

IPOs Quiet Period Expiries

Achilles Therapeutics plc (NASDAQ: ACHL)

Related Link: Why This Bristol-Myers Squibb Stock Analyst Is Turning Bullish On The Pharma Company's Pipeline

 

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