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BioWorld - Tuesday, May 13, 2025
Home » Topics » Clinical

Clinical
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Heart, DNA and ECG

Nuevocor draws $45M series B for gene therapy in rare heart disease

May 6, 2025
By Nuala Moran
Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy.
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Actuate posts improved phase II data in pancreatic cancer

May 6, 2025
By Lee Landenberger
Actuate Therapeutics Inc. said its lead candidate, elraglusib, in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to convince investors.
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Woman using eyedrops

Aldeyra DED phase III hits but reproxalap field goal fumbled

May 6, 2025
By Randy Osborne
Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution.
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Head and neck anatomy

Immutep’s efti shows strong survival data in head and neck cancer

May 5, 2025
By Tamra Sami
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1.
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Dorsal striatum and its neurons in Huntington's disease

Associate degree: PTC’s hints of phase II HD efficacy studied

May 5, 2025
By Randy Osborne
PTC Therapeutics Inc. CEO Matthew Klein said the firm “achieved all we set out to [achieve] in phase II” with PTC-518 in Huntington’s disease (HD), but it wasn’t enough to excite Wall Street, as some questioned whether the level of associations between trial findings and efficacy would appease the U.S. FDA. Shares (NASDAQ:PTCT) ended May 5 at $40.65, down $9.30, or 18.6%. Warren, N.J.-based PTC rolled out the most recent data from the Pivot-HD effort in stage 2 and stage 3 HD with PTC-518, an oral, centrally as well as peripherally distributed huntingtin (HTT) pre-mRNA splicing modifier.
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Bladder

AUA hoorays in bladder cancer for J&J, Urogen, more

May 1, 2025
By Randy Osborne
Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
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AACR 2025: D3 Bio, Immvira present solid tumor, brain cancer data

April 30, 2025
By Tamra Sami
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine.
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3D heart in chest
Heart Rhythm 2025

PFA continues to set EP hearts aflutter

April 29, 2025
By Annette Boyle
Pulsed field ablation dominated discussions and scientific sessions at Heart Rhythm 2025 in San Diego with researchers and manufacturers touting new applications in persistent atrial fibrillation, atrial flutter and addressing specific challenges for existing systems.
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Wearoptimo microwearable hydration sensor

Wearoptimo’s hydration sensor outperforms gold standard tests

April 29, 2025
By Tamra Sami
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
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Green approved stamp

Akeso hot with FDA cancer win, nods in China, new data

April 29, 2025
By Randy Osborne
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
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