Jefferies on Compass Pathways (CMPS): 'We remain 75-85%+ confident the FDA approves COMP360 (oral psilocybin) around YE:26/early 2027'

Jefferies analyst Andrew Tsai reiterated a Buy rating and $18.00 price target on Compass Pathways (NASDAQ: CMPS)

The analyst comments "Building on COMP360's (oral psilocybin) prior Phase III findings with a single upfront dose (Study '005), Study '006 (2x upfront doses) shares consistent 26- week efficacy data suggesting an infrequent dosing paradigm of 2-4x per year - competitive to Spravato's paradigm of up to 56x/year (guided to $5B+ at peak). CMPS will now complete the rolling NDA in Q4:26. An existing CNPV voucher could support an approval around YE:26 for a launch by H1:27. Big picture: We remain 75-85%+ confident the FDA approves COMP360 (oral psilocybin) around YE:26/early 2027 for TRD depression (affects 4M+ US patients), as the compound has already been derisked by 3 large (+) Phase II/III datasets (all stat-sig). The gating factor to COMP360's rolling NDA completion in Q4:26 is the 26-week dataset of Study '006 (vs 9-week data previously). To be clear, we've viewed the 26-week data as more of a procedural/housekeeping requirement for FDA approval (e.g., the Street had no "bar" on efficacy) since the original Week 6 primary endpoint achieved stat-sig already. In any case, we foresee a pot'l launch by H1:27 and think 2027 cons of $60M is achievable, as the only other approved TRD therapy that is currently used is JNJ's Spravato (intranasal esketamine), which is dosed up to 52-56x/year (2-hour sessions each time."

For an analyst ratings summary and ratings history on Compass Pathways click here. For more ratings news on Compass Pathways click here.

Shares of Compass Pathways closed at $12.84 yesterday.

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