Usona’s Potential FDA Filing Puts Pressure on Compass Pathways and Other Psychedelic Developers
Usona’s potential FDA filing for psilocybin makes the competitive landscape more real for Compass, Definium, Helus Pharma and GH Research, analyst says.
Usona’s potential FDA filing for psilocybin makes the competitive landscape more real for Compass, Definium, Helus Pharma and GH Research, analyst says.
Open-label Part C data showed extra MADRS improvement and ~30% remission after another 25 mg dose. Safety was unchanged. Launch targeted for H1 2027.
Compass Pathways reports strong Q2: Phase 3 wins for COMP360 in TRD, $433M cash, rolling NDA, and commercial launch planned for first half 2027.
Wells Fargo sees a booming psychedelic depression market, with new treatments challenging Spravato and creating big opportunities for biotech firms.
The deal would boost Lilly’s psychedelic pipeline for treatment-resistant depression.
Positive six-month COMP360 results trigger analyst upgrades and higher price targets for Compass Pathways. Strong durability data clears path to potential 2027 FDA approval in treatment-resistant depression.