Natera Inc., a developer of cell-free DNA testing, provided an update on its product portfolio at the J.P. Morgan Healthcare Conference on Jan. 15. The company disclosed a new version of the Signatera assay that leverages the genome. Natera said the test, now available for research and clinical use, enables bespoke assay design from a whole genome sequence of a patient’s tumor.
Esocap AG aims to transform the treatment of eosinophilic esophagitis with its drug delivery technology, ESO-101, designed to increase mucosal contact time and drug deposition in the esophagus. Data from the recent ACESO study showed that ESO-101 was safe and well tolerated and improved both histologic and endoscopic outcomes in patients with active eosinophilic esophagitis.
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched.
Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC).
Day two of the J.P Morgan Healthcare Conference rolled on with positive data from Sling Therapeutics Inc. that is leading the company to a phase III study in treating thyroid eye disease. The privately held company posted top-line efficacy and safety results from a phase IIb/III study of its lead candidate, linsitinib, which hits its primary endpoint with statistical significance at the twice-daily, 150-mg oral dose.
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
As 2025 makes its debut, one of the topics gaining momentum in health care is the diagnosis and potential treatment of neurodegenerative diseases, a scourge that threatens to overwhelm society and drain treatment budgets around the world. One company looking to find solutions to the oncoming neurodegenerative disease tsunami is privately held Sunbird Bio Inc., which is developing blood-based diagnostic platform for neurological diseases like Alzheimer’s and Parkinson’s disease.
Shares of Phio Pharmaceuticals Corp. soared 291% Jan. 13 on news that two patients with cutaneous squamous cell carcinoma had a complete response following treatment with the company’s Intasyl siRNA gene silencing candidate PH-762.
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender.
Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic dystrophy type 1 treatment after reviewing new results from a phase I/II study. DYNE-101, an oligonucleotide antisense and DMPK gene modulator, produced results on disease biomarkers that included DMPK and splicing correction, disease progression reversal on several functional endpoints and a favorable safety profile. The accelerated approval submission could come in the first half of 2026.
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