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BioWorld - Thursday, May 7, 2026
Breaking News: Read BioWorld's AACR 2026 coverageBreaking News: Best of BioWorld: Q1
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BioWorld, Clinical
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Hand held near armpit

Abdakibart phase II graded, puts Avalo in HS upper class

May 6, 2026
By Randy Osborne
No Comments
Avalo Therapeutics Inc. may have designed in lead asset abdakibart, a drug for hidradenitis suppurativa (HS) that offers a novel mechanism of action, wide dosing interval, and more-than-satisfying outcomes on the Hidradenitis Suppurativa Clinical Response 75 endpoint, just what the doctor – and Wall Street – ordered.
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Symani system

MMI’s Symani system treats Alzheimer’s patient in IDE study

May 5, 2026
By Shani Alexander
No Comments
Medical Microinstruments Inc.’s (MMI) Symani surgical system was used to treat a patient with Alzheimer’s disease as part of a study evaluating robotic-enabled microsurgery for the condition. The procedure investigated whether restoring lymphatic drainage pathways in the deep cervical lymph nodes could improve the clearance of harmful neurotoxins believed to contribute to the progression of Alzheimer’s.
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Heart illustration

Cytokinetics metrics satisfy in nHCM phase III

May 5, 2026
By Randy Osborne
No Comments
Thanks to a trial design that, according to Evercore ISI analyst Cory Kasimov, “played out exactly as drawn up,” Cytokinetics Inc. hit both of the phase III co-primary endpoints with aficamten in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
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Eye with digital overlay

Viridian’s Reveal-2 beats expectations with elegrobart in TED

May 5, 2026
By Karen Carey
No Comments
Top-line data from the Reveal-2 phase III trial of elegrobart to treat chronic thyroid eye disease (TED) drove Viridian Therapeutics Inc.’s stock up by 33.6%, positioning the company for a BLA filing in the first quarter of 2027. The trial met both primary endpoints at week 24: proptosis responder rate, as measured by exophthalmometry, required for a filing with the U.S. FDA; and the overall responder rate, required for an EMA filing. Doses every four weeks or every eight weeks achieved 50% and 54% PRR, respectively, compared to 15% for placebo. The doses also achieved 47% and 54% ORR vs. 15% for placebo. ORR included those with both proptosis and Clinical Activity Score response, defined as no worsening from baseline in the study eye, without deterioration in the fellow eye.
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Breast cancer illustration

Celcuity rises on gedatolisib on top-line data in breast cancer

May 4, 2026
By Jennifer Boggs
No Comments
As Celcuity Inc. awaits a U.S. FDA approval decision for gedatolisib in HER-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, the company already is setting its sights on a supplemental NDA filing, based on a top-line readout of the multi-target PAM inhibitor in a PIK3CA-mutant breast cancer cohort.
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Liver disease

Up to BAT in PSC, Mirum base case proven with phase IIb

May 4, 2026
By Randy Osborne
No Comments
Entering what Mirum Pharmaceuticals Inc. CEO Chris Peetz called “a new phase of growth and value creation,” the company plans to submit an NDA to the U.S. FDA in the second half of this year, based on phase IIb data from the Vistas trial with oral ileal bile acid transporter (IBAT) inhibitor volixibat in primary sclerosing cholangitis (PSC).
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Pancreas

Sonire starts US study of cancer HIFU after $18M series A

May 1, 2026
By Marian (YoonJee) Chu
No Comments
Sonire Therapeutics Inc. initiated a U.S.-based Sunrise II study of Suizenji, its novel ultrasound-guided high-intensity focused ultrasound (HIFU) system designed to ablate pancreatic tumors, after closing an $18 million series A financing round April 15.
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Xray showing lung cancer on tablet

How to Summit up? Dis-Harmoni on ivonescimab NSCLC phase III

May 1, 2026
By Randy Osborne
No Comments
Wall Street pundits were divided about the likely fate of ivonescimab, Summit Therapeutics Inc.’s bispecific antibody partnered with Akeso Pharmaceuticals Inc., of Hong Kong, and undergoing phase III testing in first-line squamous non-small-cell lung cancer (NSCLC).
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British pound symbol

Enterobiotix raises $25.7M for phase IIb of microbiome pill in IBS

April 29, 2026
By Nuala Moran
No Comments
Microbiome specialist Enterobiotix Ltd. has raised £19 million (US$25.7 million) to fund phase IIb development of its lead program EBX-102-02 in the treatment of irritable bowel syndrome with constipation (IBS-C).
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AI generated image for researcher developing antisense oligonucleotides

Bio Korea 2026 kicks off with spotlight on oligonucleotides

April 29, 2026
By Marian (YoonJee) Chu
No Comments
Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.
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