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BioWorld - Wednesday, December 31, 2025
Home » Topics » Clinical

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Person scratching arm

Sanofi’s amlitelimab hits phase III endpoints in atopic dermatitis

Sep. 4, 2025
By Lee Landenberger
No Comments
Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.
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Thyroid anatomy illustration

Batoclimab data in Graves’ could signal bigger Immunovant win

Sep. 4, 2025
By Randy Osborne
No Comments
Roivant Sciences Ltd.’s Immunovant Inc. unit unveiled phase II data in Graves’ disease with batoclimab, whetting appetites on Wall Street for the results with next-generation prospect IMVT-1402 from two potentially registrational trials that are enrolling now.
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Heart scientific overlay

ESC 2025: From heart failure to hypertension, research advances

Sep. 3, 2025
By Nuala Moran
No Comments
There have been numerous improvements in the treatment of cardiovascular disease since the European Society of Cardiology (ESC) first met in 1950, but unmet medical need remains and the science continues to advance, as delegates heard at the 75th annual meeting in Madrid, Spain, Aug. 29-Sept. 1.
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Stock table, gold arrow pointing down

Argenica’s stock drops 56% on mixed phase II results

Sep. 3, 2025
By Tamra Sami
No Comments
Argenica Therapeutics Ltd. saw its stock drop 56% following mixed results for its ARG-007 phase II Seancon trial in acute ischemic stroke patients undergoing endovascular revascularization, or thrombectomy.
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Liver and lungs

Wave Life says data are positive but stock wavers

Sep. 3, 2025
By Lee Landenberger
No Comments
As Wave Life Sciences Ltd. released more results from its ongoing phase Ib/IIa study of small interfering RNA editing oligonucleotide WVE-006 for treating alpha-1 antitrypsin deficiency, the company’s stock (NASDAQ:WVE) dropped by 16.8% to close at $8 on Sept. 3.
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Impella

Impella pump use continues to reduce male mortality at 10 years

Sep. 2, 2025
By Annette Boyle
The Danish-German Cardiogenic Shock trial found that men implanted with Johnson & Johnson’s Impella CP after experiencing a heart attack with cardiogenic shock gain 600 days of life, on average, compared to usual care at 10 years. The study demonstrated no benefit for women.
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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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Kidney disease illustration

Vor and Remegen post another phase III win

Sep. 2, 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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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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