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Why Tonix Pharmaceuticals Stock Is Crashing Today

By Keith Speights – Jul 26, 2021 at 10:56AM

Key Points

  • Tonix won't enroll any additional patients in a late-stage study of TNX-102 SL in treating fibromyalgia.
  • The decision came after the study's Independent Data Monitoring Committee's interim analysis found the drug wasn't likely to provide a significant improvement.
  • Tonix plans to move forward with the study for participants who are already enrolled.

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The company is stopping enrollment in a late-stage study for its lead pipeline candidate.

What happened

Shares of Tonix Pharmaceuticals (TNXP 3.96%) were crashing 28.3% lower as of 10:24 a.m. EDT on Monday. The big decline came after Tonix announced on Friday following the market close that it is halting enrollment in a late-stage clinical study evaluating TNX-102 SL in treating fibromyalgia.

So what

Tonix made the decision to stop enrollment in its late-stage study of TNX-102 SL after the study's Independent Data Monitoring Committee (IDMC) completed an interim analysis. The IDMC recommended stopping the study after concluding that TNX-102 SL was unlikely to demonstrate a statistically significant clinical improvement for patients with fibromyalgia.

Physician's hand held up in a halting gesture.

Image source: Getty Images.

CEO Seth Lederman said that the company was "surprised and disappointed" by the interim analysis findings. That's understandable, especially considering that TNX-102 SL met the primary endpoint of a previous late-stage study that was similar in design.

TNX-102 SL is Tonix's lead pipeline candidate. In addition to being evaluated in treating fibromyalgia, the company also has hopes for the drug in treating post-traumatic stress disorder-related sleep disturbance, agitation in patients with Alzheimer's disease, and alcohol use disorder.

Now what

What's next for the biotech company? Tonix isn't throwing in the towel on TNX-102 SL in fibromyalgia yet. The company plans to move forward with its late-stage study targeting fibromyalgia with the patients who are already enrolled. Top-line results are expected in the fourth quarter of this year, after which Tonix will decide the next steps it will take with the program.

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Stocks Mentioned

Tonix Pharmaceuticals Holding Stock Quote
Tonix Pharmaceuticals Holding
TNXP
$0.39 (3.96%) $0.01

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