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Tourmaline Bio, Inc. (TRML) is a late-stage clinical biotechnology company dedicated to developing groundbreaking medicines for patients with severe immune diseases. Headquartered in Boston, MA, and Louisville, KY, Tourmaline Bio is at the forefront of biotechnological advancements with a focus on transformative cell therapies. The company's mission is to significantly enhance patients' lives by offering treatments that can potentially eradicate the need for chronic immunosuppression in organ transplant recipients and induce lasting remissions in individuals with severe autoimmune and immune-mediated disorders.
The centerpiece of Tourmaline Bio's innovation is TOUR006, a fully human monoclonal antibody that targets interleukin-6 (IL-6), a crucial proinflammatory cytokine implicated in numerous autoimmune and inflammatory diseases. The IL-6 antibody class, including anti-IL-6 and anti-IL-6 receptor (IL-6R) antibodies, has a proven track record spanning over two decades, serving more than a million patients globally. TOUR006 harnesses this extensive clinical and commercial experience to offer potential new treatments for life-altering conditions.
Founded on pioneering technology developed by Dr. Suzanne Ildstad, Tourmaline Bio operates its own state-of-the-art cell processing facility in Louisville. The company is backed by top-tier life sciences investors such as Blackstone Life Sciences, Longitude Capital, and Qiming Venture Partners USA, underscoring its robust financial foundation.
Tourmaline Bio is committed to advancing its clinical programs and is currently navigating the complex pathways of regulatory approvals and clinical trials. Despite the inherent uncertainties and potential delays in the biotech sector, the company remains steadfast in its vision. Tourmaline Bio continually engages in forward-looking statements, understanding the risks and challenges ahead, including the need for substantial additional capital and achieving successful clinical outcomes.
For the latest updates and developments, investors and stakeholders can refer to Tourmaline Bio's periodic filings with the Securities and Exchange Commission (SEC), including the detailed 'Risk Factors' section in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023.
Tourmaline Bio (NASDAQ: TRML) announced key updates at its Investor Day, highlighting progress in its cardiovascular inflammation programs. The company's Phase 2 TRANQUILITY trial has exceeded its enrollment target with 143 patients, surpassing the original 120-patient goal. Topline data is expected in Q2 2025.
The company expanded its Cardiovascular Scientific Advisory Board with two new appointments: Dr. Deepak L. Bhatt as Chair and Dr. Dipender Gill. Additionally, Tourmaline nominated abdominal aortic aneurysm (AAA) as a second cardiovascular indication for its drug pacibekitug, with plans for a Phase 2 proof-of-concept trial after TRANQUILITY results.
Regarding its Thyroid Eye Disease program, the initiation of Phase 3 trials will depend on results from the ongoing Phase 2b spiriTED trial, with topline data expected in H2 2025.
Tourmaline Bio (NASDAQ: TRML) has announced its upcoming virtual Investor Day scheduled for December 10, 2024, at 10 a.m. ET. The event will feature presentations from the company's leadership team and special guest Dr. Marc Bonaca, a distinguished cardiologist and Executive Director of CPC Clinical Research. Dr. Bonaca, who serves on Tourmaline's Cardiovascular Scientific Advisory Board, will join discussions about the company's development plans for pacibekitug, their therapeutic candidate aimed at addressing unmet needs in immune and inflammatory diseases.
Tourmaline Bio reported Q3 2024 financial results with a net loss of $20.2 million ($0.78 per share), compared to $5.6 million in Q3 2023. The company maintains a strong cash position of $314.4 million, providing runway into 2027. Research and development expenses increased to $19.3 million from $3.8 million year-over-year, while general and administrative expenses rose to $5.1 million from $2.9 million.
The company remains on track to report topline data from its Phase 2 TRANQUILITY trial in first half of 2025 and formed a Cardiovascular Scientific Advisory Board in October 2024. Additionally, Tourmaline expects topline data from the pivotal spiriTED Phase 2b trial in TED in second half of 2025.
Tourmaline Bio (NASDAQ: TRML) has announced its participation in two upcoming investor conferences. Dr. Sandeep Kulkarni, Co-Founder and CEO, will participate in the Truist Securities BioPharma Symposium in New York on November 7, 2024, speaking on a panel about cardiac and skeletal muscle illnesses at 2:35 pm ET. He will also join a fireside chat at the Guggenheim Securities Healthcare Innovation Conference in Boston on November 12, 2024, at 1:30 pm ET.
Live webcasts and replays will be accessible through the company's investor relations website at ir.tourmalinebio.com under 'Events and Presentations.'
Tourmaline Bio (NASDAQ: TRML) is set to host a webinar titled 'Understanding the Genetic Validation for IL-6 Inhibition in Cardiovascular Disease' on Friday, November 1, 2024, at 9:30 AM ET. The event will feature Dr. Dipender Gill, CEO and Founder of Sequoia Genetics, a renowned expert in leveraging human genetics for drug discovery and development.
The webinar will explore recent advancements in using human genetics to inform therapeutic strategies targeting IL-6 signaling pathways. Dr. Gill, with over 250 published papers and significant contributions to Mendelian randomization research, will discuss how genetic insights are guiding new approaches for treating high-risk cardiovascular patients.
As cardiovascular disease remains a leading cause of global morbidity and mortality, this webinar aims to shed light on innovative approaches beyond traditional treatments. Interested participants can register through the Tourmaline Bio website, where a replay will also be available after the event.
Tourmaline Bio (NASDAQ: TRML) has announced its plans to present two posters at the 19th Annual Cardiometabolic Health Congress (CMHC) in Boston, MA, from October 17-19, 2024. The presentations highlight the company's commitment to understanding inflammatory cardiovascular risk and potential therapeutic mechanisms of IL-6 inhibition.
The first poster, titled 'Utilization of High-Sensitivity C-Reactive Protein Testing in Primary and Secondary ASCVD Prevention', involves collaborations with Atropos Health and Wake Forest University School of Medicine. The second poster, 'Effect of IL-6 Inhibition on Lipoprotein(a) Levels: A Systematic Review and Meta-Analysis', is a joint effort with Wake Forest University School of Medicine and an independent researcher from Toronto.
These presentations underscore Tourmaline Bio's focus on developing transformative medicines for patients with life-altering immune and inflammatory diseases.
Tourmaline Bio, Inc. (NASDAQ: TRML) has announced the formation of its Cardiovascular Scientific Advisory Board (CV SAB). This board of leading experts will provide strategic guidance for the development of pacibekitug, Tourmaline's treatment for cardiovascular diseases. The CV SAB is expected to support Tourmaline as it advances towards potential Phase 3 clinical trial readiness in 2025.
The advisory board comprises academic and industry veterans with extensive experience in cardiovascular medicine, clinical trial design, and therapeutic innovation. Their expertise will be important in shaping the strategic direction of Tourmaline's cardiovascular program, including the ongoing TRANQUILITY Phase 2 clinical trial, for which topline data is expected in the first half of 2025.
Tourmaline Bio (NASDAQ: TRML), a late-stage clinical biotech company, has announced its participation in two upcoming investor conferences. CEO Sandeep Kulkarni is scheduled to present at:
- H.C. Wainwright 26th Annual Global Investor Conference in New York on September 9, 2024 at 12:00 pm ET
- Cantor Global Healthcare Conference in New York on September 17, 2024 at 3:40 pm ET
Both presentations will be available via live webcast on the company's website under the 'Events and Presentations' section. Replays will be archived on the site after each event. Tourmaline Bio focuses on developing transformative medicines for immune and inflammatory diseases.
Tourmaline Bio (NASDAQ: TRML) reported its Q2 2024 financial results and business highlights. Key points include:
- First patient dosed in Phase 2 TRANQUILITY trial for cardiovascular risk in May 2024
- On track to initiate Phase 3 trial for Thyroid Eye Disease (TED) in H2 2024
- Added to Russell 2000® and Russell 3000® Indexes in June 2024
- Cash position of $334.4 million as of June 30, 2024, providing runway into 2027
- Q2 2024 net loss of $17.5 million, or $0.68 per share
- R&D expenses increased to $15.7 million, G&A expenses rose to $6.2 million
The company continues to advance its clinical programs for pacibekitug in TED and cardiovascular diseases, with key data readouts expected in 2025.
Tourmaline Bio (NASDAQ: TRML) presented the design of its Phase 2 TRANQUILITY study at the American Society of Preventive Cardiology Congress 2024. The study evaluates TOUR006's ability to reduce high-sensitivity C-reactive protein (hs-CRP) in patients with chronic kidney disease (CKD) and elevated hs-CRP, who are at higher risk of atherosclerotic cardiovascular disease (ASCVD).
The trial involves 120 patients with CKD stage 3 or 4 and hs-CRP ≥2 and <15 mg/L, randomized to receive subcutaneous TOUR006 at various doses or placebo. The primary endpoint is the change in hs-CRP levels. Topline data is expected in the first half of 2025, potentially advancing TOUR006 toward Phase 3 readiness for ASCVD and other cardiovascular diseases.
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