Tonix Shares Up After Minutes From FDA Meeting on Long Covid

By Michael Dabaie

Tonix Pharmaceuticals Holding Corp. shares were higher in premarket trading after the company received the minutes from a pre-investigational new drug application meeting with the U.S. Food and Drug Administration.

The meeting was for TNX-102 SL as a potential treatment for Long Covid Syndrome. Tonix said it believes the minutes provide a path to an agreement on the design of a Phase 2 study and the overall clinical development plan for TNX-102 SL in a subset of patients affected by Long Covid.

Shares were up 16% to 80 cents premarket.

The company said it is planning to submit the IND in the fourth quarter to support a Phase 2 study for the management of a subset of Long Covid patients whose symptoms overlap with fibromyalgia.

Although most people recover from Covid-19 within weeks of the acute illness, a substantial portion develop a chronic syndrome called Long Covid, the company said. These individuals experience symptoms long past the time of recovery, which can include fatigue, sleep disorders, pain, fevers, shortness of breath, cognitive impairment described as "brain fog" or memory disturbance, gastrointestinal symptoms, anxiety, and depression.

"Based on our positive fibromyalgia Phase 3 RELIEF study in which TNX-102 SL showed activity in addressing persistent pain, sleep disturbance, memory, fatigue and energy, we are hopeful that TNX-102 SL might provide a unique treatment opportunity for the symptoms of Long Covid in patients whose symptoms overlap with those of fibromyalgia," said Chief Medical Officer Gregory Sullivan.

TNX-102 SL is in mid-Phase 3 development for the treatment of fibromyalgia.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

August 24, 2021 08:32 ET (12:32 GMT)

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