The Week Ahead In Biotech (April 24-April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Decisions, Big Pharma Earnings, IPOs And More

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Biotech shares prolonged their loses in the 7 days ending April 22. The sector took cues from the broader market place, which reacted to the lackluster get started of the first-quarter reporting period and lingering amount hike fears.

On the M&A front, Regeneron Pharmaceuticals, Inc. REGN introduced a offer to purchase Checkmate Prescribed drugs, Inc. CMPI for $250 million.

Johnson & Johnson, Inc. JNJ kickstarted the pharma reporting time with blended 1st-quarter final results. The firm withdrew its COVID-19 vaccine direction for the 12 months, citing global supply surplus and need uncertainty.

Here are the crucial catalysts for the unfolding 7 days:

Conferences

2022 American Modern society of Cataract and Refractive Medical procedures, or ASCRS, Yearly Assembly: April 23-26, in Washington, D.C.

2022 Tandem Conferences – Transplantation & Mobile Treatment Meetings Of American Modern society for Transplantation and Cellular Remedy, or ASTCT, and Centre for International Blood and Marrow Transplant Research, or CIBMTR: April 23-26, in Salt Lake City, Utah

32nd European Congress of Scientific Microbiology and Infectious Disorders, or ECCMID: April 23-26, being held practically and in Lisbon, Portugal

American Academy of Neurology, or AAN, Annual Conference: April 24-26, in Seattle, Washington

The 2022 Food and drug administration/DIA Oligonucleotide-primarily based Therapeutics Meeting, or Oligo22: April 25-27, in Rockville, Maryland

2022 Mixed Otolaryngology Spring Conferences, or COSM: April 27 – May possibly 1, in Dallas, Texas.

PDUFA Dates

The Food stuff and Drug Administration is scheduled to announce its verdict on Bristol-Myers Squibb Company’s BMY new drug application for heart failure cure mavacamten. The determination is due on Thursday, April 28.

Supernus Pharmaceuticals, Inc.’s SUPN supplemental new drug software to grow the label of Qelbree to include adult sufferers with focus deficit hyperactivity problem has a PDUFA aim day of Friday, April 29.

The Fda is also scheduled to rule on HUTCHMED (China) Limited’s HCM NDA for surufatinib as a treatment method possibility for pancreatic and further-pancreatic neuroendocrine tumors. The determination is anticipated by Saturday, April 30.

Axsome Therapeutics, Inc. AXSM has a PDUFA objective day of Friday for its NDA for meloxicam-rizatriptan in acute migraine.

The drug regulator is also envisioned to announce its decision on Coherus BioSciences, Inc.’s CHRS biologic license software for toripalimab in nasopharyngeal cancer. The PDUFA goal date is Saturday.

Related Link: Consideration Biotech Investors: Mark Your Calendar For April PDUFA Dates

Medical Readouts/Shows

Nkarta, Inc. NKTX is scheduled to host a convention call on Monday, at 8 am ET, to assessment scientific details from the Section 1 clinical trials evaluating two direct medical packages, NKX101 and NKX019. The former is remaining evaluated for acute myeloid leukemia/myelodysplastic syndromes and the latter for B-cell malignancies.

Arrowhead Prescribed drugs, Inc. ARWR will current at the Oligo22 conference Phase 1b facts for ARO-HIF2 in distinct mobile renal mobile carcinoma.

Ocuphire Pharma, Inc. OCUP will existing at the ASCRS meeting Section 2 facts for Nyxol in presbyopia. (Monday)

Cidara Therapeutics, Inc. CDTX is scheduled to existing at the ECCMID conference Section 2/3 facts for rezafungin in candidemia. (Monday)

Magenta Therapeutics, Inc. MGTA will present at the TCT assembly Section 2 data for MGTA-145, in blend with plerixafor, in numerous myeloma people. (Tuesday)

Merck & Organization, Inc. MRK is owing to current at the ECCMID assembly Stage 3 information for oral COVID capsule Lagevrio, previously molnupiravir, in COVID-19 clients.

Lyra Therapeutics, Inc. LYRA will present at the COSM conference Period 2 info for LYR-210 in serious rhinosinusitis. (Thursday)

Tarsus Prescribed drugs, Inc. TARS expects to release Stage 3 topline details for TP-03 in Demodex blepharitis in April.

Earnings

The earnings record presented is not comprehensive. Click on below to obtain Benzinga’s earnings calendar for the comprehensive routine

Tuesday

NeuroMetrix, Inc. NURO (right before the market place open)

Wednesday

Boston Scientific Corporation BSX (in advance of the market open)
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Alkermes plc ALKS (right before the market open)
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Integra LifeSciences Holdings Corporation IART (in advance of the industry open)
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Amgen Inc. AMGN (following the near)
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BioMarin Pharmaceutical Inc. BMRN (after the shut)

Thursday

Merck (ahead of the industry open up)
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Eli Lilly & Company LLY (just before the sector open up)
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Alnylam, Inc. ALNY (prior to the sector open)

Friday

AbbVie, Inc. ABBV (in advance of the sector open)
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Birstol-Myers Squibb (in advance of the sector open up)

IPOs

IPO Pricing

San Diego, California-primarily based Belite Bio, Inc. BLTE, a clinical-stage biopharma concentrated on therapies for retinal ailments, has filed to offer 6 million shares in an first community presenting. This Cayman Islands exempted keeping business expects to rate the supplying among $5.50 and $6.50 for every Ads. The business has applied for listing its ADSs on the Nasdaq.

Health-related system firm Tenon Healthcare, Inc. TNON ideas to give 4 million shares in an IPO, with the approximated price array at $4.50-$5.50 per share. The Los Gatos, California-based organization expects to list its shares on the Nasdaq beneath the ticker image TNON.

Associated Url: Biogen Fails To Influence Rewards Of Alzheimer’s Drug To European Regulator

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