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On Tuesday, Noble Capital reaffirmed its Outperform rating and $70.00 price target on Tonix Pharma (NASDAQ:TNXP), which currently has a market capitalization of $181 million. The firm’s analyst, Robert LeBoyer, highlighted the recent development regarding the U.S. Food and Drug Administration’s (FDA) decision not to require an Advisory Committee Meeting for the approval of Tonix’s drug candidate Tonmya (TNX-102 SL). According to InvestingPro data, the stock has shown significant momentum, posting a 132% return over the past six months. This decision is often indicative of a smooth review process, suggesting that the clinical trial data has not raised significant questions about patient use or other concerns that would typically be addressed in such a meeting.
The FDA’s choice to skip the Advisory Committee step is seen as a positive sign for Tonix, as it implies there may not be any outstanding concerns regarding the efficacy or safety of the drug that would necessitate further discussion. This development comes as the company maintains a strong liquidity position, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 6.5x, though investors should note the company is currently burning through cash at a significant rate. Advisory Committee hearings are typically convened to evaluate and provide insights into clinical trial data, where experts in clinical practice, research, or statistical analysis review a company’s analysis of the trial data alongside the FDA’s assessment.
Tonix’s Tonmya has the potential to transform the treatment of fibromyalgia, a condition characterized by chronic pain, insomnia, depression, fatigue, and cramps. Currently, patients rely on a mix of medications to manage these symptoms. However, Tonmya is the first drug to demonstrate strong efficacy across a broad range of fibromyalgia symptoms, indicating a significant step forward in treatment options.
The drug candidate successfully met its primary endpoint and all six secondary endpoints with high statistical significance in two Phase 3 trials. The New Drug Application (NDA) for TNX-102 SL was submitted in October 2024, and it has been assigned a Prescription Drug User Fee Act (PDUFA) date of August 15, 2025. Due to the Fast Track Review designation it has received, there is a possibility that approval could be granted before the PDUFA date.
In conclusion, Noble Capital anticipates that the approval of Tonix’s product will likely occur on or before the set PDUFA date, and they expect the stock to start reflecting potential future sales of TNX-102 SL. The firm remains steadfast in its Outperform rating and $70 price target for Tonix Pharma shares. InvestingPro analysis indicates the stock is currently trading above its Fair Value, with analyst targets ranging from $50 to $1,100 per share. Subscribers can access 12 additional ProTips and comprehensive financial metrics to make more informed investment decisions.
In other recent news, Tonix Pharmaceuticals Holding Corp. reported fourth-quarter earnings and revenue that fell short of analyst expectations. The company posted a loss of $9.77 per share, significantly wider than the anticipated $3.91 loss, with revenue reaching $2.58 million, below the consensus estimate of $3.2 million. Despite the earnings miss, Tonix is making strides with its investigational drug TNX-102 SL for fibromyalgia, as the FDA will not require an Advisory Committee meeting for its New Drug Application. This decision could expedite the review process, with a Prescription Drug User Fee Act (PDUFA) goal date set for August 15, 2025. The drug has also been granted Fast Track designation, highlighting its potential to address unmet medical needs in fibromyalgia treatment. CEO Seth Lederman expressed optimism about a potential commercial launch in the fourth quarter of 2025, pending FDA approval. Tonix’s development pipeline also includes treatments for other central nervous system disorders, immunology, and infectious diseases. Despite the earnings setback, the company maintains $98.8 million in cash, which it expects will support operations beyond the PDUFA date.
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