The psychedelic and psychedelic-like drug space made another stride as Ataibeckley Inc. disclosed positive top-line data from a double‑blind, placebo‑controlled, first-in-patient phase IIa study testing oral R-MDMA therapy EMP‑01 in adults with social anxiety disorder (SAD).
Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
Sensorium Therapeutics Inc. has reported that the U.S. FDA has cleared the IND application for SNTX-2643 (SENS-01), its lead anxiety program. First-in-human dosing begins in Q3 2025.
Privately held Beckley Psytech Ltd. is to be taken over by Atai Life Sciences in an all-share deal that values the U.K. psychedelic drug specialist at $370 million. After making a $50 million investment in January 2024, Berlin-based Atai already owns 36% of Beckley. It will now issue 105 million new shares to its fellow Beckley investors, giving them 34% ownership of the merged company.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
Wall Street cheered Vistagen Therapeutics Inc.’s first positive phase III trial with a drug for social anxiety disorder (SAD) in 15 years and sent the South San Francisco-based firm’s shares (NASDAQ:VTGN) on a rocket ride to close Aug. 7 at $13.05, up $11.37, or 677%. Vistagen unveiled top-line data from the phase III study called Palisade-2 testing the efficacy, safety, and tolerability of lead asset fasedienol (PH-94B) nasal spray in adults with SAD.
Bionomics Ltd. is gearing up for an end-of-phase-II meeting with the U.S. FDA later this year to discuss the full results from the phase II study called Prevail in social anxiety disorder (SAD) with BNC-210, which missed its primary endpoint but yielded encouraging signs. Top-line data were disclosed last December. An oral alpha-7 nicotinic acetylcholine receptor negative allosteric modulator, BNC-210 fell short in change from baseline to the average of the Subjective Unites of Distress Scale (SUDS) during a five-minute public speaking challenge.
Top-line results from Vistagen Therapeutics Inc.’s Palisade-1 phase III study of PH-94B for treating social anxiety disorder showed the therapy fell shy of the primary endpoint. The South San Francisco-based company’s stock (NASDAQ:VTGN) fell dramatically on the results July 22 as shares closed 86% lower at 15 cents each.
