In the wake of Sage Therapeutics Inc.’s recent phase II fizzle with SAGE-324 in essential tremor, Wall Street is waiting for better news in the indication, which has racked up failures across several developers. Among those finding favor lately is Praxis Precision Medicines Inc. with Nav-targeting ulixacaltamide, also known as PRAX-628, which Oppenheimer analyst Francois Brisebois said “warrants particular attention.”
Stocks tumbled on Aug. 5, with the Dow Jones Industrial Average falling more than 1,000 points amid a disappointing jobs report released by the U.S. Labor Department on Aug. 2. The BioWorld Stock Index, which tracks approximately 510 U.S. biopharma stocks, was up 17.27% for the year on July 26 before closing Aug. 5 up only 3.47%, representing a significant drop. Likewise, the Nasdaq Biotechnology Index fell as much as 200 points that day. Despite the downturn, the biopharma industry remains well-positioned to outshine other sectors during challenging economic times.
Biopharma financings soared to $73.76 billion in the first seven months of 2024, marking a substantial 102% jump compared to the $36.47 billion accumulated in the same period in 2023. This amount places 2024 just behind the record-setting years of 2020 ($80.42 billion) and 2021 ($80.74 billion) in terms of funds raised through July. The $2.04 billion secured in July also is an increase from the $1.87 billion raised in June.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.
The BioWorld Drug Developers Index (BDDI) continued to track closely with the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), maintaining its trend upward after a decline at the end of April. BDDI increased by 2.14% through the end of June, following a 1.82% rise through May, after ending April down 4.8% from the start of the year.
In June 2024, BioWorld covered 221 clinical trial updates, compared to 298 in May. BioWorld recorded 23 phase III trial successes in June, seven failures, and one with mixed results.
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