Clinical Trials
Although the data are from a small bridging study, MeiraGTx plans to discuss Phase III options for AAV-GAD in Parkinson’s disease after showing efficacy on a disease rating scale and a quality-of-life measure.
The IL-23 antagonist Omvoh is under FDA/EMA review for Crohn’s disease; Lilly reported new Phase III data showing the drug is better than Stelara on multiple endpoints of histologic response.
Until the full data are released, it is difficult to weigh ANCHOR.
The Swiss company is aiming to regain its innovator status and expand its offering across all breast cancer settings. Approval of Itovebi is just the start.
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 French major and partner Denali's attempts to validate RIPK1 as a promising target have once again foundered as oditrasertib comes up short in a multiple sclerosis trial months after a failure in amyotrophic lateral sclerosis.
Recent major developments in the Korean biotech sector include Orum Therapeutics’ IPO plan and HLB’s US resubmission for the approval of rivoceranib in combination with camrelizumab for first-line liver cancer.
The TCR therapy showed strong efficacy and durability in patients with previously treated melanoma. A Phase III pivotal trial is due to start in December.
An overall survival benefit for patients in TALAPRO-2 could pave the way for a broader label for the combination in metastatic prostate cancer.
While vatiquinone may have missed its primary endpoint in a Phase III trial, PTC is ready to file the drug for the debilitating, life-shortening disorder after showing that it slowed disease progression over 144 weeks.
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.
Arexvy has become the first RSV vaccine to show it can provide protection over three years – but that might mean lower market uptake than originally expected.
Purespring has just raised $105m from an investor syndicate who are betting it can develop the first gene therapy for kidney disease and learn from setbacks experienced in the space.
Dalzanemdor missed its primary endpoint in a Phase II Parkinson’s study, Sage announced, following April’s Phase II miss in Alzheimer’s. Phase II data in Huntington’s are still expected this year.
A US regulatory filing for the drug/device combination product in earlier stages of bladder cancer remains on track for early 2025.
As broad stock markets finished the third quarter of 2024 on a high, two large biotech companies battled on more than one front. Despite both announcing positive news in the last week of the quarter, neither seemed to be a clear winner over that period.
Phase III success positions Scholar Rock’s selective myostatin inhibitor for regulatory filings in early 2025. Analysts see a blockbuster opportunity for additive therapy in spinal muscular atrophy.
The FDA has placed zetomipzomib on clinical hold a year after Kezar decided to focus solely on the product.