Clinical Trials
Doctors and biopharma executives discussed the opportunities and challenges for researching and administering combination therapy at the Clinical Trials on Alzheimer’s Disease meeting.
The company says that clascoterone presents the first potential innovation in over 30 years in male hair loss.
Bayer has begun a Phase III trial evaluating its intrauterine device for non-atypical endometrial hyperplasia, a condition with no approved medical treatments.
Novo Nordisk presented topline results from its Phase III semaglutide studies at the Clinical Trials on Alzheimer’s Disease meeting, Lilly SVP Ronald DeMattos advocated for anti-amyloid brain shuttles to reduce ARIA and Eisai presented subcutaneous Leqembi data.
Pharvaris’s oral bradykinin B2 antagonist hit all endpoints in a Phase III study in hereditary angioedema attacks, meaning the drug could be competing soon with Kalvista’s Ekterly.
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.
The pivotal Phase III trial met the primary and secondary endpoints, showing skeletal and cardiac benefits and supporting deramiocel as a treatment for Duchenne cardiomyopathy.
Janux wowed last year with first data from its ‘masked’ T-cell engager, JANX007, but investors have been spooked by newly updated results for the product. Analysts, however, still think it can compete with rivals from Amgen and J&J.
If approved, VER-01 would be the first cannabinoid-based therapy for chronic low back pain.
At the Clinical Trials On Alzheimer’s Disease meeting, Novo explained why it tested semaglutide in AD a day before the company’s Phase III EVOKE/EVOKE+ presentation, Roche updated Phase Ib/IIa results for its anti-amyloid trontinemab and UCB’s bepranemab remains in limbo.
In the head-to-head Phase III HARMONY trial in metformin-failed type 2 diabetes, HighTide's HTD1801 yielded a mean 1.12% reduction in HbA1c from baseline at 24 weeks, versus 0.93% for AstraZeneca’s Farxiga.
The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.
Akeso’s first-in-class PD-1/VEG-F bispecific ivonescimab is a landmark achievement for China’s biotech sector, but the firm is already expanding its ambitions in oncology and beyond, including a challenge to Roche in Alzheimer’s.
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Promising Phase III results could help tinlarebant become the first approved treatment for the genetic eye disorder, with planned US FDA filing in 2026.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The growth of China’s biopharma sector has been perhaps the most significant sector trend this year – Scrip outlines five themes that have emerged during 2025 and in discussions at the recent Jefferies conference in London.
New Phase II data in type 2 diabetes for Novo Nordisk’s GLP-1/amylin agonist amycretin shows significant weight loss and HbA1c-lowering potential. A Phase III trial is planned.
The biotech will present data at the upcoming ASH meeting on three patients who achieved PRs or VGPRs with minimal residual disease negativity and no cases of neurotoxicity.
Having built its reputation as the ‘Gateway to China’ for global firms, Zai is going global itself, moving its potential first-in-class ADC into Phase III development.