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BioWorld - Saturday, July 19, 2025
Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

New IBD strategies promising: Abivax, Shattuck, more

July 18, 2025
By Randy Osborne
No Comments
As Wall Street awaits key phase III data from Abivax SA with microRNA-124 (miR-124)-targeting obefazimod in ulcerative colitis, due this quarter, the inflammatory bowel disease (IBD) space – which also takes in Crohn’s disease – continues to grow and shift with new findings across varied fronts.
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Sarepta CEO: Third same-vector gene therapy death ‘not material’

July 18, 2025
By Randy Osborne
No Comments
Sarepta Therapeutics Inc. made known a third gene therapy death, this time with SRP-9004 for limb-girdle muscular dystrophy. The patient was a late-stage, non-ambulatory 51-year-old man participating in the phase I Discovery trial, who expired about a month ago of acute liver failure, as did the two previous subjects who passed away after they were treated with Elevidys (delandistrogene moxeparvovec), Cambridge, Mass.-based Sarepta’s gene product for Duchenne muscular dystrophy.
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Multiple myeloma and antibodies

Blenrep misstep? ODAC cites tox, GSK dosing neglect in MM

July 17, 2025
By Randy Osborne
No Comments
The rough ride presaged by briefing documents came to pass for GSK plc with the drug first approved by the U.S. FDA as Blenrep (belantamab mafodotin, bel-maf), as the agency’s Oncologic Drugs Advisory Committee (ODAC) appraised the possibility that the antibody-drug conjugate could return to market for relapsed/refractory multiple myeloma (r/r MM).
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Brain with clock hands, day and night background

Takeda phase IIIs win; Street still wants a visual on narcolepsy

July 15, 2025
By Randy Osborne
No Comments
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
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Multiple myeloma illustration

Adcom briefing docs eye toxicity of GSK’s Blenrep

July 15, 2025
By Randy Osborne
No Comments
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
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Brain with clock hands, day and night background

Takeda phase IIIs win; Street still wants a visual on narcolepsy

July 14, 2025
By Randy Osborne
No Comments
Takeda Pharmaceutical Co. Ltd.’s dual phase III victories in narcolepsy type 1 (NT1) with oral orexin receptor 2 (OX2R)-selective agonist oveporexton (also known as TAK-861) had Wall Street mulling what the outcome might mean for others trying the mechanism of action, and questions linger about side effects on eyesight.
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Up-tempo phase II Rhythm data in obesity sweeten bivamelagon

July 9, 2025
By Randy Osborne
No Comments
Rhythm Pharmaceuticals Inc. will be sitting down with regulators in the U.S. and Europe to discuss phase III plans in the wake of positive phase II data from the study testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity.
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B cell-activating factor (BAFF)

Wheat from chaff in BAFF: APRIL’s advent for Aurinia?

July 8, 2025
By Randy Osborne
No Comments
Tickling Wall Street’s already strong interest in the mechanism of action was Aurinia Pharmaceuticals Inc., which June 30 made public positive results from the phase I single ascending-dose study with aritinercept (AUR-200), the company’s dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL).
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Mast cell

Cogent makes lucid phase II mastocytosis case for bezuclastinib

July 7, 2025
By Randy Osborne
No Comments
Cogent Biosciences Inc. is eyeing an NDA submission to the U.S. FDA by the end of this year in the wake of positive top-line results from the registration-directed second part of the Summit phase II trial testing bezuclastinib in non-advanced systemic mastocytosis (SM). The data show clinically meaningful and highly statistically significant improvements in SM across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.
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A lot to (not) be desired: Jasper CSU drug batch under scrutiny

July 7, 2025
By Randy Osborne
No Comments

Jasper Therapeutics Inc.’s otherwise upbeat data with subcutaneous briquilimab was hamstrung by apparent trouble with one lot of drug used in the phase Ib/II Beacon study in chronic spontaneous urticaria. Shares of the Redwood Calif.-based firm (NASDAQ:JSPR) closed July 7 at $3.04, down $3.73, or 55%.


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