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Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.
More than 75 industry executives and experts gazed into the crystal ball and shared with Scrip their predictions around transformative technologies. Perhaps unsurprisingly, AI was the dominant theme – but gene editing, cell therapies and new targeting modalities were also among the highlights.
Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.
Plus deals involving Menarini/VenatoRx, Orion/Glykos, Roche/MOMA, Janssen/Elektrofi, Galapagos/BridGene along with 13 other transactions.
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