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The Week Forward In Biotech (April 24-April 30): Bristol-Myers Squibb, Supernus, Hutchmed, Axsome, Coherus FDA Selections, Large Pharma Earnings, IPOs And Extra

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Biotech shares prolonged their loses within the week ending April 22. The sector took cues from the broader market, which reacted to the lackluster begin of the first-quarter reporting season and lingering fee hike fears.

On the M&A entrance, Regeneron Prescription drugs, Inc. REGN introduced a deal to purchase Checkmate Prescription drugs, Inc. CMPI for $250 million.

Johnson & Johnson, Inc. JNJ kickstarted the pharma reporting season with combined first-quarter outcomes. The corporate withdrew its COVID-19 vaccine steering for the yr, citing international provide surplus and demand uncertainty.

Listed here are the important thing catalysts for the unfolding week:

Conferences

2022 American Society of Cataract and Refractive Surgical procedure, or ASCRS, Annual Assembly: April 23-26, in Washington, D.C.

2022 Tandem Conferences – Transplantation & Mobile Remedy Conferences Of American Society for Transplantation and Mobile Remedy, or ASTCT, and Heart for Worldwide Blood and Marrow Transplant Analysis, or CIBMTR: April 23-26, in Salt Lake Metropolis, Utah

thirty second European Congress of Scientific Microbiology and Infectious Ailments, or ECCMID: April 23-26, being held just about and in Lisbon, Portugal

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

The 2022 FDA/DIA Oligonucleotide-based Therapeutics Convention, or Oligo22: April 25-27, in Rockville, Maryland

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

PDUFA Dates

The Meals and Drug Administration is scheduled to announce its verdict on Bristol-Myers Squibb Firm’s BMY new drug utility for coronary heart failure therapy mavacamten. The choice is due on Thursday, April 28.

Supernus Prescription drugs, Inc.’s SUPN supplemental new drug utility to develop the label of Qelbree to incorporate grownup sufferers with consideration deficit hyperactivity dysfunction has a PDUFA aim date of Friday, April 29.

The FDA can also be scheduled to rule on HUTCHMED (China) Restricted’s HCM NDA for surufatinib as a therapy possibility for pancreatic and extra-pancreatic neuroendocrine tumors. The choice is anticipated by Saturday, April 30.

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

The drug regulator can also be anticipated to announce its resolution on Coherus BioSciences, Inc.’s CHRS biologic license utility for toripalimab in nasopharyngeal most cancers. The PDUFA aim date is Saturday.

Associated Hyperlink: Consideration Biotech Buyers: Mark Your Calendar For April PDUFA Dates

Scientific Readouts/Shows

Nkarta, Inc. NKTX is scheduled to host a convention name on Monday, at 8 am ET, to assessment scientific knowledge from the Part 1 scientific trials assessing two lead scientific packages, NKX101 and NKX019. The previous is being evaluated for acute myeloid leukemia/myelodysplastic syndromes and the latter for B-cell malignancies.

Arrowhead Prescription drugs, Inc. ARWR will current on the Oligo22 convention Part 1b knowledge for ARO-HIF2 in clear cell renal cell carcinoma.

Ocuphire Pharma, Inc. OCUP will current on the ASCRS assembly Part 2 knowledge for Nyxol in presbyopia. (Monday)

Cidara Therapeutics, Inc. CDTX is scheduled to current on the ECCMID assembly Part 2/3 knowledge for rezafungin in candidemia. (Monday)

Magenta Therapeutics, Inc. MGTA will current on the TCT assembly Part 2 knowledge for MGTA-145, together with plerixafor, in a number of myeloma sufferers. (Tuesday)

Merck & Firm, Inc. MRK is because of current on the ECCMID assembly Part 3 knowledge for oral COVID tablet Lagevrio, previously molnupiravir, in COVID-19 sufferers.

Lyra Therapeutics, Inc. LYRA will current on the COSM assembly Part 2 knowledge for LYR-210 in continual rhinosinusitis. (Thursday)

Tarsus Prescription drugs, Inc. TARS expects to launch Part 3 topline knowledge for TP-03 in Demodex blepharitis in April.

Earnings

The earnings checklist offered will not be complete. Click on right here to entry Benzinga’s earnings calendar for the entire schedule

Tuesday

NeuroMetrix, Inc. NURO (earlier than the market open)

Wednesday

Boston Scientific Company BSX (earlier than the market open)

Alkermes plc ALKS (earlier than the market open)

Integra LifeSciences Holdings Company IART (earlier than the market open)

Amgen Inc. AMGN (after the shut)

BioMarin Pharmaceutical Inc. BMRN (after the shut)

Thursday

Merck (earlier than the market open)

Eli Lilly & Firm LLY (earlier than the market open)

Alnylam, Inc. ALNY (earlier than the market open)

Friday

AbbVie, Inc. ABBV (earlier than the market open)

Birstol-Myers Squibb (earlier than the market open)

IPOs

IPO Pricing

San Diego, California-based Belite Bio, Inc. BLTE, a clinical-stage biopharma targeted on therapies for retinal issues, has filed to supply 6 million shares in an preliminary public providing. This Cayman Islands exempted holding firm expects to cost the providing between $5.50 and $6.50 per ADS. The corporate has utilized for itemizing its ADSs on the Nasdaq.

Medical machine firm Tenon Medical, Inc. TNON plans to supply 4 million shares in an IPO, with the estimated worth vary at $4.50-$5.50 per share. The Los Gatos, California-based firm expects to checklist its shares on the Nasdaq beneath the ticker image TNON.

Associated Hyperlink: Biogen Fails To Persuade Advantages Of Alzheimer’s Drug To European Regulator

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