treatment-resistant depression

11 articles
Investing.comInvesting.com··Nathan Reiff

Trump's Psychedelic Order Ignites Biotech Rally, But Valuations Raise Caution

Trump's April 2026 executive order grants FDA priority vouchers to psychedelic biotech firms, triggering stock surges for Compass Pathways, AtaiBeckley, and Definium Therapeutics amid speculative valuations.
DFTXCMPSPSILbiotechclinical trials
The Motley FoolThe Motley Fool··Howard Smith

Compass Pathways Surges 40% on White House Push for Psychedelic Drug Approvals

Compass Pathways stock surges 40% following White House Executive Order accelerating FDA approval of its COMP360 psychedelic therapy for treatment-resistant depression.
CMPSFDA approvaltreatment-resistant depression
The Motley FoolThe Motley Fool··Matthew Benjamin

Trump's Psychedelic Fast-Track Order Opens New Frontier for FDA Approvals

Trump executive order accelerates psychedelic drug approvals from 6-10 months to 1-2 months, allocates $50M for research, benefiting biotech companies.
DFTXCMPStreatment-resistant depressionmental health
The Motley FoolThe Motley Fool··Motley Fool Staff

Psychedelic Therapy Emerges as Disruptive Mental Health Treatment Model

Psychedelic therapy advances as clinical treatment for depression and PTSD, with companies like Compass Pathways pursuing FDA approvals. The investment opportunity centers on $10,000-$20,000 treatment services rather than drugs.
JNJABBVCMPStreatment-resistant depressionpsilocybin
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley CEO to Present at Needham Conferences as Psychedelic Drug Advances

AtaiBeckley will showcase its FDA-designated breakthrough therapy BPL-003 at Needham conferences in April, advancing toward Phase 3 trials in 2026.
ATAItreatment-resistant depressionFDA Breakthrough Therapy Designation
GlobeNewswire Inc.GlobeNewswire Inc.··Johnson & Johnson

J&J's SPRAVATO Shows Durable Depression Relief in Real-World Study

Johnson & Johnson's SPRAVATO demonstrates sustained effectiveness for treatment-resistant depression in 570-patient European study, with benefits persisting 6 months post-treatment.
JNJtreatment-resistant depressionreal-world evidence
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley's BPL-003 Shows Durable Antidepressant Benefits in Treatment-Resistant Depression

AtaiBeckley's BPL-003 nasal spray demonstrates rapid and sustained antidepressant effects in treatment-resistant depression Phase 2a trial, advancing toward Phase 3 launch in Q2 2026.
ATAIPhase 3 clinical trialtreatment-resistant depression
GlobeNewswire Inc.GlobeNewswire Inc.··Ataibeckley Inc.

AtaiBeckley Secures FDA Nod for Phase 3 Depression Trial, Eyes 2029 Runway

AtaiBeckley advances psychedelic depression treatment to Phase 3 with $220.7M cash runway through early 2029, plus positive anxiety trial data.
ATAIPhase 3 clinical trialFDA approval
BenzingaBenzinga··Prnewswire

Psychedelic Drug Developers Entering Final Testing Phase for Mental Health Treatments

Five biotech firms advance psychedelic therapies to Phase 3 trials for depression and anxiety, with multiple readouts expected in 2026, marking progress toward regulatory approval.
ATAIDFTXGHRSLBRXpsychedelic biotechnologyPhase 3 trials
BenzingaBenzinga··Prnewswire

Psilocybin Pipeline Expands as Regulatory Support Strengthens for CNS Applications

Psilocybin gains regulatory momentum with first Phase 3 success in treatment-resistant depression. DEA increases production quota 67%, while five pharma companies advance psychedelic programs across multiple CNS indications.
CMPSRLMDANROAXSMFDA approvalPhase 3 trials
The Motley FoolThe Motley Fool··Howard Smith

Compass Pathways Surges on Positive Phase 3 Psilocybin Trial Results

Compass Pathways stock surged 44% after positive Phase 3 trial results for psilocybin depression therapy. FDA application expected by end of 2024.
CMPSFDA approvaltreatment-resistant depression