Tonix Pharmaceuticals stock halted ahead of FDA approval news
CAMBRIDGE - Vedanta Biosciences’ experimental treatment for ulcerative colitis, VE202, failed to meet its primary endpoint in a Phase 2 clinical trial, the company announced Wednesday.
The COLLECTiVE202 study, which evaluated VE202 in patients with mild-to-moderate ulcerative colitis, showed no statistically significant difference in endoscopic response rates between the treatment group and placebo. The trial enrolled 114 patients across sites in the United States, Europe, and Australia.
Despite the setback, the microbiome-based therapy demonstrated a favorable safety profile with no treatment-related serious adverse events reported. Most adverse events were mild to moderate in intensity, according to the company’s press release.
Bernat Olle, CEO of Vedanta Biosciences, expressed disappointment in the results but emphasized the company’s commitment to advancing microbiome science. "We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option," Olle said.
Following these results, Vedanta will redirect its resources toward its lead program, VE303, currently in Phase 3 testing for the prevention of recurrent Clostridioides difficile infection. The company noted that VE303 previously demonstrated positive Phase 2 results with a 30.5% absolute risk reduction in C. difficile recurrence compared to placebo. InvestingPro analysis reveals PureTech maintains a healthy balance sheet with more cash than debt, though investors should note the company is currently burning through cash rapidly. Get access to 10+ additional ProTips and comprehensive financial metrics with an InvestingPro subscription.
The company is also advancing VE707, designed to prevent infections caused by multidrug-resistant organisms, with an investigational new drug application planned for the first half of 2026.
PureTech Health plc (PRTC), which founded Vedanta, currently holds a 4.2% ownership stake in the company on a fully diluted basis. According to InvestingPro data, PureTech maintains a strong financial position with a current ratio of 9.33, indicating robust liquidity. The company’s market capitalization stands at $4.31 billion, with analysts forecasting significant revenue growth of 462% for the current fiscal year.
Vedanta plans to share additional analyses from the COLLECTiVE202 study at upcoming scientific meetings. With PureTech’s next earnings report due on August 27, investors can access detailed financial analysis and Fair Value estimates through InvestingPro’s comprehensive suite of tools and metrics.
In other recent news, PureTech Health has launched Celea Therapeutics, a new venture aimed at developing treatments for serious respiratory diseases. The company has appointed Sven Dethlefs, the former CEO of Teva North America, to lead this initiative. Celea’s primary focus will be on deupirfenidone (LYT-100), a therapeutic candidate ready for Phase 3 trials, targeting idiopathic pulmonary fibrosis. Discussions with the U.S. Food and Drug Administration regarding the Phase 3 trial design are expected by the end of the third quarter. Additionally, PureTech Health announced that Raju Kucherlapati, PhD, has stepped down as Chair of the Board after nearly two decades of service. Sharon Barber-Lui, currently the Audit Committee Chair, has been named Interim Chair of the Board. Barber-Lui will oversee the search for a new Board Chair and engage with shareholders to discuss board evolution. These developments highlight significant leadership changes and strategic advancements within PureTech Health.
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