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BioWorld - Sunday, March 29, 2026
Home » Topics » Clinical

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Feet and scale

Pfizer M&A prospect Metsera heads to phase III with lead GLP-1

Sep. 30, 2025
By Karen Carey
No Comments
Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion.
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Eye chart and teen with laser over eye

Magnum Opus: Street drinks in LCA5 gene therapy phase I/II data

Sep. 30, 2025
By Randy Osborne
No Comments
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
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Pacbio Revio sequencing plate

Pacbio’s Puretarget simplifies carrier screening

Sep. 29, 2025
By Annette Boyle
Up to 71% of people carry at least one pathogenic variant that could contribute to development of a heritable disorder in offspring, but until now, prospective parents often had to undergo multiple tests to understand their risks. Pacific Biosciences of California Inc. (Pacbio)’s expanded Puretarget portfolio provides a quicker and more streamlined solution as it covers all challenging tier 3 genes identified in the American College of Medical Genetics technical standard.
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Generic injection pens

Larimar above par in FA despite anaphylaxis penalty

Sep. 29, 2025
By Randy Osborne
No Comments
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
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Dollar arrows pointing upward

Enanta’s stock nearly doubles on strong RSV data

Sep. 29, 2025
By Lee Landenberger
No Comments
Enanta Pharmaceuticals Inc.’s phase IIb study of zelicapavir missed its primary endpoint in treating respiratory syncytial virus (RSV) but mined enough positive results to get the company to talk about advancing the once-daily oral treatment into further, larger studies.
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Financial chart, downward arrow

Moonlake shares crash on phase III sonelokimab data for HS

Sep. 29, 2025
By Nuala Moran
No Comments

Bar what it described as a “placebo wobble,” Moonlake Therapeutics AG turned in positive results from the phase III trials of sonelokimab in treating hidradenitis suppurativa (HS), only to see its share price take a complete battering. The stock (Nasdaq:MLTX) fell 90%, or $55.75, to close Sept. 29 at $6.24, after the Zug Switzerland-based company published 16-week data from two identical trials, Vela-1 and Vela-2.


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Ultromics

Ultromics' Echogo improves cardiac amyloidosis diagnosis

Sep. 26, 2025
By Annette Boyle
A month after raising $55 million to advance its AI-enhanced ultrasound diagnostics for cardiovascular disease, Ultromics Ltd. presented strong results for its U.S. FDA-cleared AI analysis of echocardiograms at the American Society of Echocardiography's 2025 Scientific Sessions in Nashville, Tenn. Ultromics' Echogo Amyloidosis was able to detect cardiac amyloidosis earlier and more accurately than traditional methods, missing fewer cases without increasing unnecessary testing.
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aXess vascular access conduit

Xeltis’ Axess conduit shows transformative potential

Sep. 26, 2025
By Shani Alexander
Xeltis BV reported successful clinical data from the Axess EU pivotal trial which demonstrated the transformative potential of its restorative vascular access conduit, Axess, in hemodialysis treatment.
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Phase HPV urine test

Phase launches largest urine-based HPV screening study

Sep. 26, 2025
By Tamra Sami
Phase Scientific International Ltd. launched China’s largest clinical study for urine-based cervical cancer screening. If successful, the blood-based test could be the first non-invasive test for HPV.
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Head and neck anatomy

Real-world data illuminates Rakuten's Alluminox solid tumor platform

Sep. 26, 2025
By Marian (YoonJee) Chu
No Comments
Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.
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