Tonix jumps on rejigged phase III for PTSD drug; MeiraGTx scores another NIH deal; OpGen, Qiagen join hands to detect superbugs

→ After a Phase III trial testing its PTSD drug, Tonmya, involving patients that suffered trauma during military service since 2001, was prematurely halted following a futility analysis, Tonix Pharma $TXNP went to the FDA armed with a subgroup analysis that showed patients with fresher trauma had benefitted from the drug. On Wednesday, the company said it had convinced the US health regulator to give it another shot with a new late-stage study in this category of patients, as well as those that have experienced civilian trauma. Tonix has also changed the trial’s goalposts, saying it will determine whether the primary endpoint has been met at week 4, versus week 12. Shares of tiny Tonix, whose breakthrough therapy Tonmya has endured multiple trial setbacks, jumped about 22% on the announcement. CEO Seth Lederman remains bullish about drug’s prospects, but told Endpoints News that he will need to raise more capital to take the drug to the finish line.

→ Gene therapy developer MeiraGTx $MGTX has scored an exclusive licensing agreement with the NIH, in which the company gets the rights to an experimental drug for Sjögren’s syndrome — a systemic autoimmune disorder that impairs one’s ability to secrete fluids such as saliva and tears that affects an estimated 4 million Americans. The two entities have already partnered on two other R&D programs.

→ Genomic analysis company OpGen $OPGN is collaborating with molecular diagnostics company Qiagen $QGEN to develop diagnostics to detect multidrug resistant bacterial pathogens. OpGen’s stock rose about 7% on the announcement, in which financial terms of the deal were unspecified.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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