Biogen said it plans to channelize resources allocated to Aduhelm to advance Leqembi, which was approved for the treatment of AD in January this year, and to develop new treatment modalities.
DetailsFDA Requires Label Updates with Black Box Warnings for CAR-T Therapies
FDA demands a black box warning as “T-cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies”.
DetailsSagimet Biosciences Announces Positive Topline Results From Phase 2b FASCINATE-2 Trial Of Denifanstat on NASH
Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis.
DetailsGilead Sciences’ Phase 3 EVOKE-01 Trial for NSCLC Fails To Meet Its Primary Endpoint
Gilead plans to discuss results with regulators and to present the data at an upcoming medical meeting.
DetailsAgenus’ NEST-1 Study on Botensilimab Shows Unprecedented Tumor Regression in Colorectal Cancer Patients
The study showed significant tumor regression after only a single dose of BOT and two doses of BAL with complete elimination of ctDNA in 100% of patients tested.
DetailsSolid Biosciences Receives Orphan Drug Designation by FDA for DMD Gene Therapy SGT-003
This therapy uses a novel capsid and a muscle tropic vector delivering a microdystrophin that incorporates a neuronal Nitric Oxide Synthase (nNOS) binding domain.
DetailsDyne Therapeutics Reports Positive Initial Clinical Data from Its ACHIEVE and DELIVER Trials on Muscle Diseases
DYNE-101 demonstrated a dose-dependent splicing correction and increase in muscle delivery and DMPK knockdown while also showing functional improvement in myotonia.
DetailsLongboard Pharma Announces Positive Results From Phase 1b/2a Trial of Bexicaserin for Developmental and Epileptic Encephalopathies (DEES)
Bexicaserin achieved a median seizure reduction of 53.3 percent in countable motor seizures compared to 20.8 percent in the placebo group.
DetailsBioXcel Reports Positive OS Data From Phase 2 Trial of BXCL701 in Patients with SCNC
In the trial, evaluable patients with SCNC as of a data cutoff of September 6 showed a median OS of 13.6 months, and a 12-month survival rate of 56.5%.
DetailsInovio Pharma Receives FDA Feedback on BLA Submission for INO-3107 to Treat RRP
If approved, INO-3107 would be the first DNA medicine in the U.S. and the first INOVIO candidate to receive regulatory approval.
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