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BioWorld - Friday, July 18, 2025
Home » Topics » Clinical

Clinical
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Mental illness art concept

Compass Pathways succeeds in phase III depression study; stock slides

June 23, 2025
By Lee Landenberger
No Comments
Hitting the primary endpoint on Compass Pathways plc’s Comp005 study of synthetic psilocybin, which the company billed as the first classic psychedelic to report phase III efficacy data, produced only a shrug from investors.
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Xia Jin, CEO and co-founder of Immuno Cure, and Dan Mallon, senior vice president of corporate development for Pharmajet

Immuno Cure, Pharmjet partner on needle-free HIV vaccine trial

June 20, 2025
By Tamra Sami
No Comments
Immuno Cure Biotech Ltd. is collaborating with Pharmajet Inc. to evaluate the safety and immunogenicity of its HIV therapeutic DNA vaccine, Icvax, delivered via Pharmajet's innovative Tropis needle-free injection system.
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Rezdiffra

CHMP recommends approval of Rezdiffra, Ogsiveo and others

June 20, 2025
By Nuala Moran
No Comments
One year after the FDA’s nod, the EMA is following on and recommending conditional approval of Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) as the first drug in Europe for treating noncirrhotic metabolic dysfunction-associated steatohepatitis.
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Cheering Immuneering, Street hopes high in pancreatic

June 18, 2025
By Randy Osborne
No Comments
Immuneering Corp.’s phase IIa data from an ongoing trial in pancreatic cancer disclosed June 17 impressed Wall Street and brought renewed attention to the perennially difficult indication, at which drug developers continue to fling themselves with varied mechanisms.
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Stock chart, upward arrow

An early stage 85% remissions rate in AML drives Aptevo’s stock surge

June 18, 2025
By Lee Landenberger
No Comments
An 85% remissions rate was found in updated results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat.
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Red and blue bispecific antibodies

3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

June 17, 2025
By Marian (YoonJee) Chu
No Comments
3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
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Dyne vHOT in DM1 but shares cool on endpoint switch

June 17, 2025
By Randy Osborne
No Comments
The revised trial protocol that means a delay in filing for U.S. approval of DYNE-101 to treat myotonic dystrophy type 1 (DM1) dented shares of Dyne Therapeutics Inc. (NASDAQ:DYN), which closed June 17 at $10.86, down $2.96, or 21%.
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Hands holding mobile phone

‘Be Part of Research,’ UK government urges with NHS app

June 16, 2025
By Nuala Moran
No Comments
The U.K. government has announced the latest measures to speed up and expand clinical trials, launching Be Part of Research, a central national register where people can search and sign up to take part in studies.
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Sarepta signage

Elevidys’ second liver death hits Sarepta, sends DMD ripples

June 16, 2025
By Randy Osborne
No Comments
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene moxeparvovec), cleared for Duchenne muscular dystrophy (DMD). Shares of Cambridge, Mass.-based Sarepta (NASDAQ:SRPT) closed June 16 at $20.94, down $15.24, or 42%, as Wall Street digested the news.
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Enterome raises $19M to advance non-Hodgkin lymphoma therapy

June 13, 2025
By Nuala Moran
No Comments
As it prepares to present the latest data from the phase I/II clinical trial of EO-2463, Enterome SA has secured $19 million to expand and complete the study, and to scope phase III development of the microbiome-derived off-the-shelf immunotherapy in the treatment of non-Hodgkin lymphoma.
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