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BioWorld - Monday, December 29, 2025
Breaking News: BioWorld 2025 Year in ReviewBreaking News: BioWorld MedTech 2025 Year in ReviewBreaking News: Trump administration impacts continue to roil the life sciences sector
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BioWorld, Clinical
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Test tubes, capsules, dropper
Biopharma clinical updates June 2025

Biopharma busy with numerous clinical successes last month

July 25, 2025
By Amanda Lanier
No Comments
In June 2025, BioWorld tracked 254 clinical trial updates across phases I to III, up from 223 in May, 151 in April and 197 in March. Of the June updates, 24 trials reported positive phase III results, while only one was reported as a failure.
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Kidneys

Memo's potravitug reduces BK viral load in kidney transplant

July 25, 2025
By Nuala Moran
No Comments
Memo Therapeutics AG is laying plans to advance its BK polyomavirus neutralizing monoclonal antibody potravitug into phase III development after reporting positive phase II results in treating infections in immunocompromised kidney transplant patients.
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Silhouette of child and brain

Rett bet set includes Neurogene, Taysha gene therapies

July 24, 2025
By Randy Osborne
No Comments
Neurogene Inc.’s disclosure June 30 of its registrational trial design in Rett syndrome (RS) added spice to the space, where Taysha Gene Therapies Inc. is another closely watched player. The New York-based firm said Embolden will test NGN-401, a gene therapy for the treatment of females age 3 and older with RS. U.S. regulators have signed off regarding key aspects of Embolden’s structure.
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Autoantibodies bond to receptor blocking the acetylcholine transmitters in myasthenia gravis

Phase III MG settee: Astrazeneca perched pretty with gefurulimab

July 24, 2025
By Randy Osborne
No Comments
Astrazeneca plc seems on the way to expanding its presence in myasthenia gravis (MG) with positive “high-level” results from a global, randomized, double-blind, placebo-controlled phase III trial with once-weekly, self-administered gefurulimab in adults with anti-acetylcholine receptor antibody-positive, generalized disease.
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AI-generated image of man sleeping

Apnimed loses no sleep over new phase III apnea results

July 23, 2025
By Lee Landenberger
No Comments
Apnimed Inc.’s lead oral therapy for obstructive sleep apnea has delivered a second round of positive phase III data, bringing a potential U.S. FDA filing closer. Top-line results taken from the second pivotal late-stage study show AD-109 (aroxybutynin 2.5mg/atomoxetine 75 mg) hit its primary endpoint with clinically meaningful and statistically significant drops in airway obstruction at 26 weeks.
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Stock chart, upward arrow

Abivax’s obefazimod wows investors; stock climbs 500%+

July 23, 2025
By Nuala Moran
No Comments
Abivax SA is positioning to change the treatment landscape in ulcerative colitis after delivering positive results and a favorable safety profile in two phase III trials of its orally available miRNA-124 enhancer, obefazimod. Abivax stock rocketed in Europe and the U.S. on news of the data. Shares (Paris:ABVX) rose €45.40, or 510%, to close at €54.30 July 23. In the U.S., shares (NASDAQ:ABVX) leapt 586%, or $58.60, to close at $68.60.
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Skin irritation on hands

Livzon’s IL-17A/F meets phase III endpoints in plaque psoriasis ​

July 22, 2025
By Tamra Sami
No Comments
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
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Single strand RNA
Newco news

In ongoing mRNA evolution, SML Biopharm sights new cancer vaccines

July 21, 2025
By Marian (YoonJee) Chu
No Comments
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
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New non-opioid approach for pain: Tafalgie reports phase I data

July 21, 2025
By Nuala Moran
No Comments
After two decades of research elucidating the basic science, Tafalgie Therapeutics SA has delivered the first clinical data for its non-opioid analgesic.
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Lungs

Still no scare for Ohtuvayre: Roche IL-33 COPD data mixed

July 21, 2025
By Randy Osborne
No Comments
The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
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