Cybin completes FDA Type B meeting and plans CYB003 Phase 3 program for major depressive disorder
- Cybin held a Type B Initial Breakthrough Therapy Meeting with the FDA.
- Plans to initiate Phase 3 pivotal trial of CYB003 for MDD in late summer 2024.
- Phase 3 trial will include 30 clinical sites across the U.S. and Europe.
- Phase 2 study showed 75% of patients in remission four months after two 16mg doses.
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Leqembi approved for the treatment of Alzheimer's disease in the United Arab Emirates
- The Ministry of Health and Prevention in the UAE has approved Leqembi (lecanemab) for treating Alzheimer's disease.
- Leqembi is indicated for patients with mild cognitive impairment or mild dementia stages of Alzheimer's disease.
- Approval is based on the Phase 3 Clarity AD study, where Leqembi met all primary and key secondary endpoints.
- Leqembi is also approved in the U.S., Japan, China, South Korea, Hong Kong, and Israel, with ongoing applications in 11 other countries and regions.
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Otsuka Precision Health and Click Therapeutics launch Rejoyn for MDD treatment
- Rejoyn, the first FDA-cleared prescription digital therapeutic for MDD, is now commercially available.
- Patients can obtain Rejoyn via prescription from their provider or through a virtual consultation.
- Rejoyn includes cognitive emotional brain training exercises and CBT-based therapy lessons.
- The FDA clearance was based on the Mirai study, showing significant improvement in depression symptoms.
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Cingulate reports second quarter 2024 financial results and provides development update on major milestones achieved
- FDA clears Cingulate to file for marketing approval of CTx-1301, targeting NDA submission in 1H 2025.
- Completed manufacturing of twelve registration batches for CTx-1301.
- Exploring additional licensing arrangements for CTx-1301 both inside and outside the US.
- Raised $1.6 million through a warrant inducement offer.
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Alto Neuroscience reports second quarter 2024 financial results and recent business highlights
- Completed enrollment of 301 patients in Phase 2b study of ALTO-100 for major depressive disorder (MDD).
- Initiated Phase 2b study of ALTO-100 in bipolar depression (BPD) with $11.7 million funding from Wellcome Trust.
- Ongoing Phase 2b study of ALTO-300 in MDD with topline data expected in 1H 2025.
- Initiated Phase 2 proof-of-concept studies for ALTO-101 in cognitive impairment associated with schizophrenia (CIAS) and ALTO-203 in MDD with anhedonia.
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NeuroPace reports second quarter 2024 financial results and increases 2024 revenue guidance
- Revenue grew to $19.3 million in Q2 2024, a 17% increase over Q2 2023.
- Increased full-year 2024 revenue guidance to $76 million to $78 million.
- Gross margin expanded to 73.4% in Q2 2024 from 72.5% in Q2 2023.
- Decreased cash burn to $4.0 million in Q2 2024 compared to $4.4 million in Q2 2023.
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