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Morning. A hard weekend for those backing MDMA-assisted psychotherapy: First, the FDA rejects a treatment from Lykos Therapeutics. Now a journal is retracting three MDMA papers, citing data integrity issues. Also, a nasal epinephrine spray gets an FDA approval, and more.
The need-to-know this morning
- Halda Therapeutics, a privately held developer of cancer medicines, raised $126 million in new financing. The money will be used to advance an experimental drug for prostate cancer into its first clinical trial next year.
- The FDA approved a new hormone treatment for hypoparathyroidism in adults. The drug, called Yorvipath, is made by Ascendis Pharma.
- The FDA extended its review of lab-grown blood vessels made by Humacyte. The agency had been expected to make an approval decision on Aug. 10. Humacyte did not say how long the extended review would take to complete.
Journal retracts papers on MDMA-assisted psychotherapy
The journal Psychopharmacology retracted three papers on MDMA-assisted psychotherapy, involving authors affiliated with MAPS and its spinout Lykos Therapeutics, due to “protocol violations amounting to unethical conduct,” particularly those related to a Phase 2 trial where an unlicensed therapist was accused of sexual assault.
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