Tonix Pharma Stock’s Retail Chatter Explodes After FDA Nod For New Drug Application
By Stocktwits Inc | First Published Dec 18, 2024, 7:29 PM ISTThe drug already received Fast Track designation in July 2024, expediting the review process due to its potential to address an unmet medical need.
Tonix Pharmaceuticals was the most active symbol on Stocktwits before the bell on Wednesday as shares of the clinical-stage biopharmaceutical company surged over 35% in premarket after witnessing a significant decline on Tuesday.
The spike followed news that the U.S. Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, a chronic pain condition affecting over 10 million adults in the U.S.
Latest Videos
Tonix announced that the FDA will issue a “Day 74 Letter” — i.e. within 74 days of the NDA submission.
This letter will confirm the Prescription Drug User Fee Act (PDUFA) target action date and whether the drug qualifies for Priority Review.
The drug already received Fast Track designation in July 2024, expediting the review process due to its potential to address an unmet medical need.
Tonix CEO Seth Lederman expressed optimism, stating, “The fibromyalgia community, comprised of patients and their families and support groups, has been waiting for a new drug for over 15 years.”
“Analysis of insurance claims in the U.S., commissioned by Tonix, have shown that 18 months after diagnosis, fibromyalgia patients were more likely to be prescribed addictive opioids than all three of the FDA-approved drugs combined.],” he added.
Tonix shares fell 37% on Tuesday, with retail investors speculating that broader market factors, such as anticipation of the Federal Reserve’s rate decision, contributed to the decline.
However, retail sentiment for Tonix remained 'bullish' early Wednesday, after Stocktwits message volume soared 164% in the previous session, hitting “extremely high” levels.
Tonix Pharmaceuticals also garnered attention in October after receiving its first payment from the Defense Threat Reduction Agency (DTRA), a U.S. Department of Defense initiative.
The agency awarded Tonix up to $34 million over five years to develop broad-spectrum antiviral agents for military personnel in biological threat environments.
While Wednesday’s premarket surge signals renewed optimism, Tonix Pharma shares remain down over 97% year-to-date.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
subscribe to Asianet Newsable WhatsApp channel by clicking here. For more reliable and latest news
subscribe to Asianet Newsable Telegram channel by clicking here.