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BioWorld - Wednesday, December 31, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld, Clinical
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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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Kidney disease illustration

Prokidney produces positive phase II CKD data, thunderous stock surge

July 8, 2025
By Lee Landenberger
No Comments
A mixed bag of top-line phase II data prompted stellar stock results for Prokidney Corp. and its chronic kidney disease (CKD) and diabetes therapy, rilparencel. The results came from two arms of the study, each with its own treatment regime. The market heartily took to the results as the company’s stock (NASDAQ:PROK) closed 515% upward at $3.73 per share after starting the day under $1 each.
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Apogee’s Apex phase II reads out for APG-777 in atopic dermatitis

July 7, 2025
By Brian Orelli
No Comments
Apogee Therapeutics Inc. plans to enter a crowded atopic dermatitis market with established drugs, such as Dupixent (dupilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) and Ebglyss (lebrikizumab-lbkz, Eli Lilly and Co.), which are sold by much larger competitors. But the company thinks it can compete with its anti-IL-13 antibody, APG-777, thanks to the drug’s 77 day half-life that may allow it to be dosed only two to four times a year in the maintenance phase, compared to 13 to 26 injections per year for the established competitors.
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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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Woman receiving chemotherapy

Chemotherapy-induced mutations are not universal phenomenon

July 3, 2025
By Nuala Moran
No Comments
The first systematic whole genome sequencing study of how chemotherapy damages healthy tissues has shown that many, but not all, of these agents cause mutations and premature aging of normal blood cells.
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Zanza time trickle in ESMO hourglass: more Exelixis CRC data?

July 3, 2025
By Randy Osborne
No Comments
Exelixis Inc.’s positive phase III top-line data June 22 with zanzalintinib (zanza) in colorectal cancer had Wall Street speculating anew about the odds with the tyrosine kinase inhibitor in an important indication.
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AI-generated image of illustration of MRI of lungs with fibrosis

Tweaked pirfenidone, other strategies in the works for IPF

July 2, 2025
By Randy Osborne
No Comments
Puretech Health plc’s rollout May 20 of more phase IIb data with deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF) perked optimism for that compound – a deuterated form of p38 MAP kinase inhibitor pirfenidone – as well as others in the busy therapeutic space.
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Digital lungs illustration

Bioversys, Shionogi in CHF529M lung infection collaboration

July 2, 2025
By Nuala Moran
No Comments
Antibiotics specialist Bioversys AG has sealed a potential CHF529 million (US$667.5 million) deal with Shionogi Co. Ltd., in which they will work together on novel ansamycins for treating multidrug-resistant lung infections caused by non-tuberculous mycobacteria.
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Beckley Atai deal to go forth on positive phase IIb depression data

July 1, 2025
By Nuala Moran
No Comments
The joining of psychedelic specialists Beckley Psytech Ltd. and Atai Life Sciences can now go ahead after the pair announced positive top-line results from the phase IIb study of BPL-003, an intranasal formulation of 5-MeO-DMT benzoate.
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