All articles tagged with #breakthrough therapy
Daiichi Sankyo and Merck's investigational drug ifinatamab deruxtecan has received FDA Breakthrough Therapy Designation for treating pretreated extensive-stage small cell lung cancer, based on promising clinical trial data, aiming to accelerate its development and approval.
The FDA has granted breakthrough therapy status to an LSD formulation, MM120, for treating generalized anxiety disorder, with promising results from a Phase 2 trial showing significant symptom improvement and remission in patients. This designation is expected to bring in a substantial investment for further development, and MindMed plans to begin Phase 3 trials later this year.
A single dose of a new LSD formulation, MM120, has shown promising results in treating generalized anxiety disorder, leading to a 48% remission rate and significant improvement for 65% of patients within three months. The drug has received breakthrough therapy status from the FDA, and the biopharmaceutical company, Mind Medicine Inc., is developing it. The study's results also indicate potential benefits for depression symptoms. This marks the first time LSD has been studied in a medical setting in over 40 years, and the breakthrough designation will facilitate the drug's development process.