Psychedelics guidance from the FDA set to benefit developers, including AtaiBeckley, Jefferies says

The US Food and Drug Administration's finalized guidance on psychedelic drug development signals the agency remains receptive to helping developers navigate the approval process, a development that Jefferies said could benefit companies including Compass Pathways (NASDAQ:CMPS), AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC), Cybin Inc. (NYSE-A:CYBN, FRA:R7E), GH Research (NASDAQ:GHRS), Awakn Life Sciences (NEO:AWKN) and others in the sector. The firm wrote on Monday that the final guidance, alongside the FDA's plans to hold a public hearing on September 14, points to a more supportive regulatory environment that could reduce regulatory risk for psychedelic drug developers.

Proactive Investors • 20 hours ago

Compass Pathways Eyes 2027 Launch as Psilocybin Depression Data Holds Up

Compass Pathways NASDAQ: CMPS said new 26-week data from its Phase 3 COMP006 trial further support the durability and safety profile of COMP360, its investigational psilocybin therapy for treatment-resistant depression, as the company works toward a potential U.S. launch in the first half of 2027.

MarketBeat • Jul 10, 2026

Compass Pathways: 'Strong Buy' COMP360 Trial Wins And Q4 NDA Full Submission

Compass Pathways: 'Strong Buy' COMP360 Trial Wins And Q4 NDA Full Submission

Seeking Alpha • Jul 8, 2026

Why Psychedelics-Tied Compass Pathways Isn't Getting High

Compass Pathways stock crumbled Tuesday despite seemingly positive test results for its psychedelic drug in treatment-resistant depression.

Investors Business Daily • Jul 7, 2026

Compass Pathways Highlights Long-Term Data from Resistant Depression, Backs 2027 Launch Timeline

Compass Pathways plc (NASDAQ:CMPS) on Wednesday reported 26-week results from Part B of its Phase 3 COMP006 trial, reinforcing the rapid and durable efficacy of COMP360, its synthetic psilocybin therapy for treatment-resistant depression (TRD).

Benzinga • Jul 7, 2026

COMPASS Pathways plc (CMPS) Discusses Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile in Depression Transcript

COMPASS Pathways plc (CMPS) Discusses Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile in Depression Transcript

Seeking Alpha • Jul 7, 2026

Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile

LONDON & NEW YORK--(BUSINESS WIRE)---- $CMPS #Biotech--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the 26-week results (Part B) from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which confirm COMP360's rapid onset and durable profile. The 26-week findings in nearly 600 patients build on previously reported resul.

Business Wire • Jul 7, 2026

Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

LONDON & NEW YORK--(BUSINESS WIRE)---- $CMPS #Biotech--Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of emplo.

Business Wire • Jul 2, 2026

A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year

Issued on behalf of Helus Pharma™ Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., says its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in Q4 2026. NEW YORK and TORONTO, June 26, 2026 /PRNewswire/ -- USA News Group News Commentary, In drug development, enrollment is the quiet variable that decides whether a promising therapy ever reaches a data readout on schedule.

PRNewsWire • Jun 26, 2026

3 Companies Redefining Healthcare Innovation

The Healthcare Technology and Innovation index (HTEC) was launched back in 2019 with a specific purpose in mind: to allow investors to participate in the evolution of healthcare needed to address critical societal challenges.

ETF Trends • Jun 24, 2026