FDA Postpones Verdict on Syndax's Leukemia Medication; Shares Take a Hit
The FDA has postponed its approval decision on Syndax Pharmaceuticals' leukemia drug after requesting additional data, causing a significant drop in the company's stock price.
Bill McColl brings over 25 years of expertise as a senior producer and writer across television, radio, and digital platforms, leading teams of anchors, reporters, and editors to deliver impactful news coverage on major events.
Highlights
- The FDA has delayed its approval timeline for Syndax Pharmaceuticals' leukemia treatment following a request for more comprehensive information.
- The biopharmaceutical firm announced a three-month extension beyond the original September 26 decision date.
- Syndax's stock experienced a sharp decline following the announcement.
Syndax Pharmaceuticals (SNDX) saw its shares tumble during Monday's trading session after the FDA postponed its decision on the approval of revumenib, an experimental therapy targeting acute leukemia.
The company revealed that the FDA extended the Prescription Drug User Fee Act (PDUFA) date for the New Drug Application (NDA) of revumenib to allow regulators additional time to thoroughly evaluate supplementary data submitted by Syndax.
This extension pushes the original action date, previously set for September 26, back by three months.
CEO Emphasizes Strong Trial Data Supporting Approval
Michael Metzger, CEO of Syndax, highlighted that revumenib has the potential to become the first approved treatment for patients suffering from KMT2A-rearranged acute leukemia, a condition associated with poor survival outcomes. He described the patient group as having "significant unmet medical needs" and expressed confidence that both earlier clinical trials and the newly provided data robustly support FDA approval.
Following the FDA's announcement, Syndax's stock price dropped nearly 13%, closing at $21.36 by 2:40 p.m. ET on Monday, marking a downturn for the company in 2024.
If you have news tips for Investopedia journalists, please contact us at tips@investopedia.com.
Explore useful articles in Markets News as of 22-06-2024. The article titled " FDA Postpones Verdict on Syndax's Leukemia Medication; Shares Take a Hit " offers in-depth analysis and practical advice in the Markets News field. Each article is carefully crafted by experts to provide maximum value to readers.
The " FDA Postpones Verdict on Syndax's Leukemia Medication; Shares Take a Hit " article expands your knowledge in Markets News, keeps you informed about the latest developments, and helps you make well-informed decisions. Each article is based on unique content, ensuring originality and quality.