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BioWorld - Saturday, February 14, 2026
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Face with digital focus on eye

HS dropout as math favors Acelyrin’s TED course with lonigutamab

Aug. 14, 2024
By Randy Osborne
With favorable data from the phase III trial testing izokibep, a small protein therapeutic designed to inhibit IL-17A, in hidradenitis suppurativa (HS), Acelyrin Inc. CEO Mina Kim said the firm will “look at all the options and do what’s best for the program.” The phase III trial hit its primary endpoint of Hidradenitis Suppurativa Clinical Response 75 at 12 weeks. At the same time, the Los Angeles-based firm made known a refocused pipeline strategy that prioritizes lonigutamab in thyroid eye disease (TED) and is projected to extend its cash runway.
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Red and white blood cells

Ascentage moves BCL-2 inhibitor into fourth phase III

Aug. 14, 2024
By Tamra Sami
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
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Regulatory actions for Aug. 14, 2024

Aug. 14, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Daiichi Sankyo, Cybin, Galderma, Insignis, Kyverna and Mabwell.
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Other news to note for Aug. 14, 2024

Aug. 14, 2024
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boundless, Citius, Lexicon, Novartis, Ovid.
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Financings for Aug. 14, 2024

Aug. 14, 2024
Biopharmas raising money in public or private financings, including: Actuate, Elicio, Regenics, Santhera.
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In the clinic for Aug. 14, 2024

Aug. 14, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Appollomics, Dare, Rivus, Syros, Xgene.
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Appointments and advancements for Aug. 14, 2024

Aug. 14, 2024
New hires and promotions in the biopharma industry, including: Abeona, Immpact, Omega.
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Syros halts enrollment in phase II AML study

Aug. 13, 2024
By Lee Landenberger
Data from an interim analysis have convinced Syros Pharmaceuticals Inc. to stop enrollment in its phase II study of treating newly diagnosed acute myeloid leukemia (AML) and retinoid alpha receptor agonist gene overexpression. Analysts seemed unconcerned about the repercussions for Syros’ phase III study in myelodysplastic syndrome.
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Man scratching arm

Dupixent atopic of talk as Galderma’s Nemluvio cleared in PN

Aug. 13, 2024
By Randy Osborne
Aiming to offer an advantage over Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), dermatology-focused Galderma Holding SA won clearance from the U.S. FDA for Nemluvio (nemolizumab) as a prefilled pen providing a subcutaneous injection to treat adults with prurigo nodularis (PN).
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Thyroid anatomy

Visen’s palopegteriparatide hits endpoints in hypoparathyroidism

Aug. 13, 2024
By Tamra Sami
Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.
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