Cybin Continues To Expect To Commence Phase 3 Pivotal Program In Late Summer; It Had Type B Initial Breakthrough Therapy Meeting With FDA Late Last Week
Portfolio Pulse from Benzinga Newsdesk
Cybin is set to commence its Phase 3 pivotal program for CYB003 in late summer, following a Type B Initial Breakthrough Therapy meeting with the FDA. The company has selected 30 clinical sites across the US and Europe. In Phase 2, CYB003 showed a 75% remission rate from depression four months after two 16mg doses. Cybin expects to report 12-month efficacy data from Phase 2 in Q4 this year.
August 13, 2024 | 11:37 am
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Cybin is preparing to start its Phase 3 pivotal program for CYB003 in late summer, following a positive Type B Initial Breakthrough Therapy meeting with the FDA. The Phase 2 study showed promising results with a 75% remission rate from depression. The company will report 12-month efficacy data in Q4.
The news of Cybin commencing its Phase 3 pivotal program and the positive results from the Phase 2 study are likely to boost investor confidence and positively impact the stock price in the short term. The upcoming 12-month efficacy data report in Q4 adds further anticipation.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100