Phase II
The FDA placed 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced Thursday.
The discovery of novel Alzheimer’s biomarkers is enabling better trial selection, earlier pipeline decision making and new targets for therapeutics.
Novartis is cleaning house, cutting its Huntington’s disease program along with several others. The company announced multiple program stops and delays in its full-year 2022 report Wednesday.
The FDA asked Taysha Gene Therapies to dose more patients in a double-blinded, placebo-controlled trial before submitting a BLA for its giant axonal neuropathy candidate.
uniQure inked a deal with Apic Bio to gain development and commercialization rights to APB-102, a gene therapy for a rare, genetic form of ALS.
Vera Therapeutics released a 36-week per-protocol analysis of the Phase IIb trial assessing atacicept in IgA nephropathy.
XyloCor Therapeutics reported positive topline results Thursday from Phase II of the Phase I/II trial of its gene therapy for refractory angina.
Ocuphire Pharma’s oral diabetic retinopathy drug missed the primary endpoint of an improvement in patient scores on the diabetic retinopathy severity scale.
Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
Following the death of a patient, Magenta Therapeutics placed a hold on Phase I/II dose-escalation trial of its acute myeloid leukemia therapy.
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