The BioWorld Cancer Index (BCI) finished July down 3.94% for the year, maintaining its downward trend after reaching a high of 11.07% at the end of February and closing in March with a 3.92% gain. In comparison, the BCI underperformed the Nasdaq Biotechnology Index, which climbed 10.82%, and the Dow Jones Industrial Average, which posted an 8.37% increase over the first seven months of the year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS Pharma, Ascendis, Crispr, Humacyte, Sandoz, Scpharmaceuticals, Shanghai Junshi, Vertex, Wave Life.
Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
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