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Health professional recording info from patient

Phase III wins in July include Apnimed, Livzon, Takeda

Sep. 2, 2025
By Amanda Lanier
No Comments
In July 2025, BioWorld recorded 140 clinical trial updates spanning phases I through III, a significant drop from 254 updates tracked in June. Of the July data, 16 trials reported successful phase III results, while four studies were reported as failures.
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Triglycerides in blood vessel

Ionis reports sHTG win while Arrowhead inks Novartis deal

Sep. 2, 2025
By Randy Osborne
No Comments
Acute pancreatitis took center stage as Wall Street took heed of phase III data from Ionis Pharmaceuticals Inc. with olezarsen for severe hypertriglyceridemia (sHTG), while another player in the space, Arrowhead Pharmaceuticals Inc., signed a sizeable deal in a separate therapeutic area with Novartis AG.
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Tyvaso nebulizer

United’s Tyvaso surprise in IPF potentially opens $4B market

Sep. 2, 2025
By Karen Carey
No Comments
Following positive data from competitors earlier this year, United Therapeutics Corp. rolled out impressive and unexpected phase III results of nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF), setting the stage for an sNDA filing with the U.S. FDA next year.  If approved for the indication, United, of Silver Spring, Md., and Research Triangle Park, N.C., could tap into what analysts say is a $4 billion-plus market.
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Cervical cancer cell

Antiva looks to cut cervical cancer off before it starts

Aug. 29, 2025
By Brian Orelli
No Comments
Antiva Biosciences Inc. has developed an intravaginal topical treatment, ABI-2280, for high-risk cervical infections with human papillomavirus (HPV). In a phase Ib/II study, after two weeks of treatment at the highest dose of the DNA polymerase inhibitor, 46% of patients were negative for high-risk HPV at week 12, compared to just 16% of patients treated with placebo.
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Kidney disease illustration

Vor and Remegen post another phase III win

Aug. 27, 2025
By Lee Landenberger
No Comments
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
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Lung cancer illustration

PD-1/VEGF bispecific hits survival endpoint in lung cancer trial

Aug. 27, 2025
By Jennifer Boggs
No Comments
Summit Therapeutics Inc.’s presentation for bispecific antibody ivonescimab in non-small-cell lung cancer could draw some extra attention at next month’s World Conference on Lung Cancer meeting thanks to promising overall survival data from partner Akeso Pharmaceuticals Inc.’s China study of the PD-1/VEGF candidate.
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Igalmi sublingual film

Trying this at home: Bioxcel steps closer to an sNDA for Igalmi

Aug. 27, 2025
By Lee Landenberger
No Comments
With new and positive phase III data in treating agitation in patients – at home instead of in a clinic – with bipolar disorders or schizophrenia, Bioxcel Therapeutics Inc. is preparing to submit an sNDA in the first quarter of 2026 to expand the label of the company’s Igalmi (BXCL-501). These data also bring the company closer to having the first such treatment that is approved by the U.S. FDA for home use. The unmet need for patients is huge, Vimal Mehta, the CEO of Bioxcel, told the BioWorld Insider podcast. Watch the interview, below.
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Illustration of the spine with ankylosing spondylitis

Akeso’s gumokimab, manfidokimab meet phase III endpoints

Aug. 26, 2025
By Tamra Sami
No Comments
Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.
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Woman receiving vaccine

France’s Osivax wins $19.5M BARDA award for universal flu vaccine

Aug. 26, 2025
By Nuala Moran
No Comments
French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.
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Oral medication

Lilly’s oral GLP-1 respectable vs. injectables, filing soon

Aug. 26, 2025
By Randy Osborne
No Comments
Eli Lilly and Co.’s regulatory ducks are lined up nicely with the latest positive top-line results from the phase III Attain-2 trial testing orforglipron, an oral glucagon-like peptide 1 (GLP-1) receptor agonist, in adults with obesity or overweight and type 2 diabetes.
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