atai Life Sciences: A Leading Candidate in the Treatment-Resistant Depression Market with Intranasal 5-MeO-DMT BPL-003

atai Life Sciences is poised to lead the treatment-resistant depression market with its psychedelic candidate BPL-003. Jefferies analysts maintain a "Buy" rating and $7 price target, citing the company's potential to leapfrog rival GH Research and earn New Chemical Entity exclusivity. BPL-003 has advanced regulatory status, a more robust trial design, and a precise intranasal delivery system. Jefferies believes these advantages support a $1 billion-plus opportunity in TRD.

Atai Life Sciences (NASDAQ:ATAI, ETR:9VC) is making significant strides in the psychedelics space, poised to lead the treatment-resistant depression (TRD) market with its intranasal 5-MeO-DMT candidate BPL-003. Jefferies analysts maintain a 'Buy' rating and a $7 price target, nearly double the stock's current price, citing the company's potential to leapfrog rival GH Research (NASDAQ:GHRS) and earn New Chemical Entity (NCE) exclusivity from the FDA [1].

Jefferies argues that atai has the opportunity to get ahead of GH Research and earn NCE exclusivity due to the more advanced regulatory status of BPL-003 compared to GHRS's GH001. While GH001 remains under an FDA clinical hold due to inhalation toxicology studies, atai and its partner Beckley Psytech are moving forward with BPL-003, including the recent release of positive Phase 2b trial results [1].

The analysts noted that atai’s trial design is more robust, featuring an 8-week blinded treatment phase followed by an 8-week open-label extension, compared to GHRS’s shorter 8-day blinded period and 6-month extension. Additionally, BPL-003 benefits from a more precise intranasal delivery system using Aptar technology, similar to Johnson & Johnson's FDA-approved esketamine nasal spray Spravato, whereas GH001 relies on a vaporized device requiring multiple breaths [1].

Looking ahead, atai plans to release new 8-week open-label extension data and two-dose induction results in Q3 2025, followed by a pivotal FDA meeting in the second half of the year. Jefferies believes these milestones could support a breakthrough therapy designation from the FDA and enable initiation of a Phase 3 program in 2026 [1].

The analysts conclude that BPL-003 has best-in-class potential, supporting a $1 billion-plus opportunity in TRD. Over the past year, atai’s stock has surged approximately 71.10%, significantly outpacing the S&P 500’s price return of 12.69% [3].

References:
[1] https://www.proactiveinvestors.com.au/companies/news/1075313/atai-life-sciences-poised-to-lead-treatment-resistant-depression-market-with-psychedelic-candidate-bpl-003-1075313.html
[3] https://www.ainvest.com/news/semiconductor-stocks-tumble-texas-instruments-falls-12-q3-outlook-2507/