Tonix Pharmaceuticals stock halted ahead of FDA approval news
NEW YORK - Tourmaline Bio, Inc. (NASDAQ: TRML), a biotechnology company focused on developing treatments for immune and inflammatory diseases, announced today the establishment of a Cardiovascular Scientific Advisory Board (CV SAB). This team of experts is set to provide strategic guidance as the company progresses its cardiovascular drug, pacibekitug, towards a potential Phase 3 clinical trial readiness in 2025.
The CV SAB comprises a panel of seasoned professionals from both academic and industry backgrounds, specializing in cardiovascular medicine, clinical trial design, and therapeutic innovation. The advisory board's role is expected to be crucial in the strategic planning for pacibekitug, especially as Tourmaline Bio anticipates the release of topline data from the TRANQUILITY Phase 2 clinical trial in the first half of 2025.
Pacibekitug, also known as TOUR006, is a long-acting anti-IL-6 monoclonal antibody that has been previously studied in approximately 450 participants across six completed clinical trials. The drug is being developed for multiple indications, including thyroid eye disease (TED) and atherosclerotic cardiovascular disease (ASCVD), with the potential to expand into additional diseases.
Dr. Emil deGoma, Senior Vice President of Medical Research at Tourmaline, expressed his honor in welcoming the distinguished group to the advisory board. He highlighted the importance of their collective expertise in areas such as atherosclerotic cardiovascular disease, heart failure, and vascular medicine, which will be invaluable in advancing pacibekitug.
The formation of the CV SAB marks a significant step for Tourmaline Bio as it seeks to redefine standards of care for patients at high risk of cardiovascular diseases. The company's mission is to develop transformative medicines that dramatically improve the lives of patients with life-altering diseases.
While Tourmaline Bio is optimistic about the therapeutic potential of IL-6 inhibition in cardiovascular diseases, it is important to note that the development of pacibekitug is subject to the inherent risks and uncertainties of drug development and regulatory approval processes.
The information regarding the formation of the CV SAB and the development of pacibekitug is based on a press release statement from Tourmaline Bio, Inc.
In other recent news, biotechnology firm Tourmaline Bio has made significant amendments to its corporate bylaws and changed its fiscal year. Recent developments include the promotion of Ryan Robinson to the role of Chief Financial Officer and Treasurer, as well as the launch of a Phase 2 clinical trial, named TRANQUILITY, for its drug candidate TOUR006. The trial aims to treat atherosclerotic cardiovascular disease and other cardiovascular conditions. Tourmaline Bio's ongoing cardiovascular studies have also seen advancements, with data readouts expected in 2025. Analyst firms Truist Securities and Piper Sandler have maintained their positive ratings for Tourmaline Bio, expressing confidence in the potential of the company's product, TOUR006. The bylaw amendments are designed to streamline governance and shareholder engagement processes. These recent developments reflect the company's continued commitment to progress and innovation in the biotechnology sector.
InvestingPro Insights
As Tourmaline Bio (NASDAQ: TRML) advances its cardiovascular drug pacibekitug towards potential Phase 3 clinical trials, investors should consider some key financial metrics and insights from InvestingPro.
Despite the company's ambitious plans, InvestingPro data reveals that Tourmaline Bio is not currently profitable, with a negative P/E ratio of -13.87 for the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year. This is not uncommon for biotechnology companies in the development stage, as they often incur significant research and development expenses before generating revenue from their products.
However, it's worth noting that Tourmaline Bio's stock has shown strong performance recently. InvestingPro data shows a remarkable 144.59% price total return over the past year, and a 73.68% return in the last month alone. This suggests that investors are optimistic about the company's prospects, possibly due to the progress of pacibekitug and the formation of the Cardiovascular Scientific Advisory Board.
An important InvestingPro Tip highlights that Tourmaline Bio holds more cash than debt on its balance sheet. This financial stability could be crucial as the company prepares for potential Phase 3 trials, which are typically costly endeavors in drug development.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Tourmaline Bio, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.