FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, has received constructive feedback from the U.S. Food and Drug Administration (FDA) regarding its TFF TAC clinical program, the company announced today. This follows the submission of a briefing book to the FDA in April 2024, aimed at guiding the next steps in the development of TFF TAC, an inhaled dry powder formulation of the immunosuppressive drug tacrolimus.
The FDA's response highlighted the potential therapeutic benefit of mitigating or preventing tacrolimus-associated toxicities, particularly in lung allografts, without increasing risk. The feedback is not expected to significantly alter the program's timelines or estimated costs.
Dr. Zamaneh Mikhak, Chief Medical Officer at TFF Pharmaceuticals, indicated that the initial FDA feedback has provided additional clarity on advancing TFF TAC toward registrational testing. A more detailed regulatory update is anticipated in the third quarter of 2024 after further guidance from the FDA.
TFF TAC aims to deliver tacrolimus directly to the lungs using an easy-to-use dry powder inhaler, potentially improving lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus. This could enhance efficacy and decrease systemic toxicities such as kidney toxicity. The ongoing Phase 2 trial involves lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity and includes a 12-week treatment period followed by an optional safety extension.
TFF Pharmaceuticals' proprietary Thin Film Freezing (TFF) technology platform is at the core of this development. It allows for the transformation of drugs into dry powder formulations suitable for various delivery routes, including inhalation. The TFF process generates powders that can be administered directly to the target organ, such as the lung, potentially reducing unwanted toxicities and side effects.
This news article is based on a press release statement from TFF Pharmaceuticals, Inc.
In other recent news, TFF Pharmaceuticals has been making significant strides in its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC), aimed at preventing lung transplant rejection. The company reported accelerated patient enrollment with 10 patients now participating in the study. Notably, all six patients who completed the initial 12-week treatment opted to continue therapy in the safety extension phase.
Jones Trading, however, has adjusted its outlook on TFF Pharmaceuticals' shares, lowering the 12-month price target significantly to $4.00 from the previous $13.00. This adjustment reflects concerns about the long-term risks associated with TFF Pharmaceuticals' reliance on the development of a single clinical asset, TFF TAC. Despite this, the firm maintained a Buy rating on the stock, expressing continued belief in the potential of TFF Pharmaceuticals' formulation technology and the clinical and commercial prospects for TFF TAC.
In financial developments, TFF Pharmaceuticals has launched a public offering of shares and warrants, expecting to raise approximately $4.8 million in gross proceeds. The company intends to allocate the net proceeds for working capital and general corporate purposes.
Furthermore, the company announced positive data from its ongoing Phase 2 study evaluating TFF TAC for organ rejection prevention in lung transplant recipients. The data presented showed that TFF TAC could prevent rejection with lower doses and systemic exposure compared to oral tacrolimus. Based on these findings, TFF Pharmaceuticals plans to pursue an Investigational New Drug (IND) application in the United States to explore TFF TAC's use immediately post-transplant, in preparation for a registrational trial.
InvestingPro Insights
As TFF Pharmaceuticals (NASDAQ:TFFP) navigates the clinical development of its innovative TFF TAC program, investors are closely monitoring the company's financial health and market performance. Recent data from InvestingPro provides critical insights into the company's financial standing and stock activity.
InvestingPro data reveals a market capitalization of $5.39 million USD, reflecting the current valuation of the company in the market. Interestingly, despite the challenging financial metrics, TFF Pharmaceuticals holds more cash than debt on its balance sheet, which is a positive sign for investors concerned about the company's liquidity and financial resilience.
However, the company's stock has experienced significant volatility. It has taken a substantial hit over the last week, with a one-week price total return of -9.84%, and the trend extends further with a -21.27% return over the past month. This is consistent with the broader pattern of decline over the last year, culminating in a -85.35% return, which might raise concerns among investors regarding the stock's short-term prospects.
Analysts are also anticipating a sales decline in the current year, which could be a reflection of the company's investment in research and development for its clinical programs, such as TFF TAC. Moreover, TFF Pharmaceuticals does not pay a dividend, which may influence the investment decisions of those seeking regular income from their holdings.
For investors looking for more in-depth analysis and additional InvestingPro Tips, such as the implications of weak gross profit margins or the company's cash burn rate, TFF Pharmaceuticals' detailed profile on InvestingPro provides valuable insights. There are 11 additional tips available, which can help investors make more informed decisions. To access these tips, visit https://www.investing.com/pro/TFFP and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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