The private British biotech announced positive results from its Phase IIa study of BPL-003, which it said support its Phase IIb study of the same DMT-based drug.

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.

US FDA’s drugs center posted one of its lowest monthly approval counts of original applications in January, but new indications filled the gap, including new claims for Merck’s Keytruda, Takeda immunoglobulins, and Sanofi/Regeneron’s Dupixent.

Public Company Edition: Syndax grossed $230m in a follow-on public offering based on positive results for its menin inhibitor in leukemia, but the FOPO was an outlier relative to other companies, which relied on private placements, debt and other options to raise cash in a tough market.