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BioWorld - Saturday, May 16, 2026
Home » Topics » North America » U.S.

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Sarepta’s gene therapy gets boost with FDA platform designation

June 4, 2025
By Mari Serebrov
No Comments
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
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US Fed Circuit rules in favor of Moderna in patent squabble

June 4, 2025
By Mari Serebrov
No Comments
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
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Kymera’s phase I data lead big week for STAT6 space

June 4, 2025
By Jennifer Boggs
No Comments
It’s a good week to be working on drugs targeting STAT6. Kymera Therapeutics Inc.’s, KT-621, the first oral STAT6 degrader candidate to enter the clinic, surpassed expectations with impressive safety, pharmacokinetic and biomarker data from a phase I trial, while potential fast-followers from Nurix Therapeutics Inc. and Recludix Pharma Inc. advanced via respective partnerships with Sanofi SA.
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Immuno-oncology

Epimab sells bispecific T-cell engager to Juri in $210M deal

June 4, 2025
By Marian (YoonJee) Chu
No Comments
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
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Illustration of kidneys with DNA double helix

Vantive to invest $1B in digital kidney support therapies

June 3, 2025
By Annette Boyle
Vantive Health LLC, formerly the kidney care business of Baxter International Inc., plans to invest $1 billion over the next five years in development of digitally enabled dialysis products, innovation in acute organ support therapy options and expanding production capacity.
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Epimab sells bispecific T-cell engager to Juri in $210M deal

June 3, 2025
By Marian (YoonJee) Chu
No Comments
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal.
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Daiichi and Merck pull accelerated approval BLA for ADC

June 3, 2025
By Lee Landenberger
No Comments
Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. have voluntarily pulled the BLA for accelerated approval tied to their HER3-directed antibody-drug conjugate (ADC) in treating EGFR-mutated non-small-cell lung cancer. The partnership in the expanding ADC space began nearly two years ago in a $22 billion deal.
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Nibec stock soars 30% on $435M peptide deal with US biotech

June 3, 2025
By Marian (YoonJee) Chu
No Comments
Nibec Co. Ltd. announced May 28 the signing of a potential $435 million license deal for NP-201, its phase II-ready peptide-based pulmonary fibrosis therapy candidate, with an undisclosed U.S.-based biotech company.
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Regeneron boosts obesity pipeline with Hansoh’s GLP-1/GIP for $2B

June 3, 2025
By Tamra Sami
No Comments
Regeneron Pharmaceuticals Inc. is adding to its obesity pipeline by in-licensing Hansoh Biomedical Co. Ltd.’s phase III dual glucagon-like peptide 1 (GLP-1)/gastric inhibitory polypeptide (GIP) receptor agonist, HS-20094, for up to $2 billion.
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Next IgAN contenders line up; Vera preps a BLA for atacicept

June 3, 2025
By Karen Carey
No Comments
With a 42% placebo-adjusted reduction in proteinuria at week 36, Vera Therapeutics Inc. met its primary endpoint in the Origin phase III trial with BAFF and APRIL dual inhibitor atacicept in treating immunoglobulin A nephropathy (IgAN) in adults.
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