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Latest From COMPASS Pathways
MindMed Ready To Take LSD Therapy Into Phase III For Anxiety
Mind Medicine’s LSD product MM120 will move into Phase III in the second half of 2024 after it showed efficacy in generalized anxiety disorder out to 12 weeks with a single administration in Phase IIb.
Lykos’ MDMA NDA Leads Upcoming Tests Of US FDA’s Psychedelics Draft Guidance
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.
For Psychedelics, US FDA Is Open To Creative Thinking But Firm On Approval Standards
Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.
Finance Watch: Novartis Sets October Separation Date For Sandoz Spin-Off
Novartis revealed detailed terms and a 4 October spin-off date for Sandoz’s standalone debut. Also, MIRA launched a small IPO, but two firms plan to go public in SPAC mergers. Also, Mirati’s $345m offering leads follow-ons offerings and Sangon Biotech raised $290m in venture capital.
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