The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
Multiple datasets are due to roll out soon in the Prader-Willi syndrome (PWS) space, where contenders are trying varied mechanisms of action to tackle the rare genetic disorder characterized by insatiable hunger, or hyperphagia. In the mix are Aardvark Therapeutics Inc., Acadia Pharmaceuticals Inc., Rhythm Pharmaceuticals Inc. and Soleno Therapeutics Inc.
The BioWorld Biopharmaceutical Index (BBI) showed signs of recovery after hitting its lowest point of the year in late May, when it closed the month down 7.02%. While still negative overall, the index improved to -5.11% by the end of June and finished July down 3.57%. Similarly, the Nasdaq Biotechnology Index and the Dow Jones Industrial Average bottomed out at the end of May but posted stronger rebounds, closing July up 3.49% and 3.73%, respectively.
Biopharma deal activity (excluding M&As) has surged to record-breaking levels in the first seven months of 2025, reaching $164.03 billion, well above prior years and a 36% jump over the same period in 2024.
In part one of this story on Elysium Therapeutics Inc., published Aug. 14, company officials explained the rationale and technology behind the plan to formulate a longer-lasting opioid-overdose rescue agent – one that remedies the problem of fentanyl rebound, or re-narcotization, which happens when the standard reverser wears off and the culprit drug stays active, potentially killing the patient.
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