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BioWorld - Friday, November 14, 2025
Breaking News: FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld, Clinical
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Single strand RNA

Backtrack to GalNAc: Korro AATD strategy Rewrite post-fizzle

Nov. 13, 2025
By Randy Osborne
No Comments
Korro Bio Inc.’s latest update on RNA editing prospect KRRO-110 may mean one less competitor in alpha-1 antitrypsin deficiency (AATD), and shares of the firm (NASDAQ:KRRO) closed Nov. 13 at $6.50, down $24.92, or 79%. As part of the third-quarter earnings report, Korro said KRRO-110 produced functional protein in AATD patients but fell short of projected levels of functional protein after a single administration.
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Mosquito

With malaria numbers rising, Novartis has phase III success

Nov. 13, 2025
By Lee Landenberger
No Comments
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
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Doctor-patient consultation

J&J pushes to elevate patient voices in Asia

Nov. 13, 2025
By Tamra Sami
No Comments
Up to 77% of patients with non-small-cell lung cancer in Asia-Pacific rely almost entirely on their physicians to decide their treatment, even though 69% of physicians say they encourage shared decision-making. That disconnect remains one of the region’s biggest obstacles to improving outcomes, Anthony Elgamal, vice president of Oncology Asia Pacific at Johnson & Johnson Innovative Medicine, told BioWorld.
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Female doctor and patient
FT Global Pharma and Biotech Summit

Could restricting diversity efforts stall women’s health research?

Nov. 12, 2025
By Nuala Moran
No Comments
Recent progress in redressing the historical underfunding and neglect of women’s health could be undermined by the backlash against diversity, equity and inclusion (DEI) initiatives, according to executives participating in the FT Global Pharma and Biotech Summit 2025 in London Nov. 11-12.
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Man falling asleep in car

Alkermes’ alixorexton hits endpoints in narcolepsy phase II

Nov. 12, 2025
By Lee Landenberger
No Comments
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
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Liver anatomy with virus

Bluejay way: Positive phase II data for treating hepatitis D

Nov. 11, 2025
By Lee Landenberger
No Comments
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
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Art concept for bladder

Up the bladder ladder, Engene tweak means phase II bell rung

Nov. 11, 2025
By Randy Osborne
No Comments
Engene Holdings Inc.’s protocol amendment to its phase II trial with detalimogene voraplasmid in bladder cancer worked out in a big way, and shares of the firm closed Nov. 11 at $8.82, up $2.81, or 47%. Engene rolled out additional preliminary data from the pivotal cohort of the ongoing Legend study testing the nonviral gene therapy in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without concomitant papillary disease.
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Stomach cross-section on scientific background

A second win for Cogent pushes the company toward two NDAs

Nov. 10, 2025
By Lee Landenberger
No Comments
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
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Liver over digital lens background

MASH prospects from Rivus, Metavia show promise in phase II

Nov. 7, 2025
By Karen Carey
No Comments
Phase II data being presented at the American Association for the Study of Liver Diseases annual meeting indicate drug development in the field of metabolic dysfunction-associated steatohepatitis (MASH) is making steady progress.
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Kidneys, pills and chart line

Eledon tego for phase III in transplant despite midstage miss

Nov. 7, 2025
By Randy Osborne
No Comments
A primary endpoint failure but with outstanding estimated glomerular filtration rates and impressive safety data in the phase II trial called Bestow are adding up to plans for later-stage work with Eledon Pharmaceuticals Inc.’s tegoprubart (tego) for preventing rejection in de novo kidney transplant.
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