Latest news with #TectonicTherapeutic
Yahoo
17-05-2025
- Business
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Tectonic Therapeutic Presents Complete Results for Positive Phase 1b Clinical Trial of TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF in Late-Breaking Presentation at ESC Heart Failure 2025
Data confirmed TX45's tolerability profile and improvements in left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF') In new echocardiographic analysis, TX45 treatment resulted in sustained hemodynamic effects for 29 days TX45 improved cardiac and pulmonary hemodynamics in PH-HFpEF patients across a range of left ventricular ejection fractions ('LVEF'), including LVEF≥50% and LVEF 41-49% WATERTOWN, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) ('Tectonic') today announced the complete results from Part A of the Phase 1b clinical trial of TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF'), which are being presented in a late-breaking, oral session at the European Society of Cardiology (ESC) Heart Failure 2025 Congress being held in Belgrade, Serbia. The results include the full cohort of 19 patients in Part A of the Phase 1b trial of TX45, Tectonic's lead asset and a long-acting relaxin therapy. Interim data for 16 patients in the Phase 1b trial was previously reported in a press release on January 30, 2025. The complete data from Part A of the Phase 1b clinical trial confirmed the tolerability and hemodynamic effects of TX45 in patients with PH-HFpEF previously reported in the interim data. Based on the complete dataset in PH-HFpEF, a single intravenous dose of TX45 was well tolerated, with no serious or severe adverse events. In the overall study population, TX45 achieved a 19.0% reduction in pulmonary capillary wedge pressure ('PCWP'), an endpoint known to correlate with exercise capacity, morbidity and mortality in patients with heart failure. In the subpopulation with combined pre- and post-capillary pulmonary hypertension ('CpcPH') who have an elevated Pulmonary Vascular Resistance ('PVR') and more severe disease, TX45 demonstrated >30% reduction in PVR, which along with PCWP is correlated to exercise capacity and mortality in this patient population. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to the ongoing APEX Phase 2 clinical trial ( NCT06616974). APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026. New hemodynamic data reported today from the Phase 1b clinical trial include the following: Echocardiograms were evaluated at baseline and at Days 2, 15 and 29. Following the administration of TX45, sustained improvements in echocardiogram endpoints were observed consistent with improved hemodynamics. Increased tricuspid annular plane systolic excursion/systolic pulmonary artery pressure (TAPSE/SPAP), a marker of PVR, and right ventricular fractional area of change (RVFAC), a marker of right ventricular function, were observed on all days post treatment compared to baseline demonstrating a sustained effect for 29 days after single dose administration. In the clinical trial, hemodynamics were analyzed across a range of left ventricular ejection fractions ('LVEF'), including LVEF≥50% and LVEF 41-49%. Both subpopulations showed similar improvements in PCWP (19.7% and 18.4%, respectively) and cardiac output (18.3% and 18.7%, respectively), as well as improvement in pulmonary hemodynamics following administration of TX45. Cardiac output increased numerically more in response to TX45 in patients with higher baseline PVR, with 16.8% improvement in patients with baseline PVR<2 wood units, 20.5% with baseline PVR≥2 and 24.5% with baseline PVR≥3. 'We are enthusiastic about the potential of TX45 as a treatment for patients with Group 2 pulmonary hypertension. In particular, we are very encouraged that the echocardiographic analysis demonstrated sustained hemodynamic effects of TX45 out to 29 days,' said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. 'Additionally, the positive and consistent hemodynamic effects across a range of LVEF confirmed that TX45 is well positioned to address the full spectrum of PH-HFpEF patients. We look forward to the topline data from Part B of the Phase 1b study in another type of pulmonary hypertension patients, those with Heart Failure with reduced Ejection Fraction (HFrEF), expected in the second half of 2025.' Marcella K. Ruddy, M.D., Chief Medical Officer of Tectonic commented, 'These results from the Phase 1b study show the promising therapeutic profile of TX45, offering patients a potential best-in-class therapy for Group 2 pulmonary hypertension, a disease with high morbidity, mortality and no approved treatments. Additionally, these data continue to support our hypothesis that TX45 may provide the greatest benefit to patients with CpcPH, based on data showing strong improvement in pulmonary hemodynamics and cardiac output relative to baseline PVR.' Highlights from complete Phase 1b Part A results Within the cohort of 19 patients with PH-HFpEF enrolled in the Phase 1b open label clinical trial of TX45, 9 patients had CpcPH, as measured by PVR>2 Wood units. Hemodynamic measures evaluating left ventricular function included PCWP, Cardiac Output ('CO') and Stroke Volume ('SV'). Hemodynamic measures evaluating the pulmonary vasculature included PVR, Total Pulmonary Resistance ('TPR') and mean Pulmonary Artery Pressure ('mPAP'). Safety Results: TX45 was well tolerated with no serious or severe adverse events, discontinuations, infusion reactions or drug-related adverse events. There were no clinically significant changes in vital signs, physical exam or safety laboratory values. Transient asymptomatic decreases in blood pressure were observed over the first 24 hours after TX45 dosing. Hemodynamic Results: TX45 administration resulted in meaningful improvement in both left ventricular function and pulmonary hemodynamics, representing a differentiated profile for TX45 compared to other PAH drugs that are pulmonary vasodilators but have not shown improvement in left ventricular function and have not shown efficacy in PH-HFpEF. TX45 achieved the following improvements in left ventricular function: PCWP decreased 19.0% [95% CI, -26.1% to -11.9%]. CO increased 18.5% [95% CI, 10.2% to 26.9%]. TX45 achieved the following improvements in pulmonary hemodynamics: PVR decreased 32.0% [95% CI, -35.9% to -28.1%] and 35.5% (95%CI, -38.6% to -32.5%) in the subgroup of patients with baseline PVR≥2 and baseline PVR≥3, respectively. TPR decreased 28.7% [95% CI, -34.1% to -22.1%] in the overall population. Mean pulmonary artery pressure decreased 16.8% [95% CI, -20.8% to -12.8%] in the overall population. As a relaxin therapeutic, the differentiated mechanism of TX45 improved both left ventricular function and pulmonary hemodynamics, which most strongly matches the more severe pathophysiology of patients with CpcPH. About the TX45 Phase 1b clinical trial in Group 2 pulmonary hypertension The Phase 1b open label clinical trial is designed to evaluate the safety and hemodynamic effect of single doses of TX45 in patients with Group 2 pulmonary hypertension. Part A evaluated the effect of TX45 in PH-HFpEF and Part B will evaluate effects of TX45 in Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction ('PH-HFrEF'). The design of the clinical trial is as follows: after obtaining informed consent, a right heart catheter, which is the gold standard for the measurement of cardiopulmonary hemodynamics, is inserted and baseline measurements are obtained, an intravenous dose of TX45 is administered, and hemodynamic effects are evaluated over 8 hours post dose. Participants are then followed for 45 days post dose for safety and exploratory biomarker endpoints. Part A of the trial has completed. Part B enrollment is ongoing with topline data expected in the second half of 2025. About Group 2 Pulmonary Hypertension in HFpEF The World Health Organization has defined 5 groups of pulmonary hypertension ('PH'). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF'). In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH ('IpcPH') and Combined pre- and post-capillary PH ('CpcPH'). CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in Pulmonary Vascular Resistance ('PVR'). Although several Group 1 PH (Pulmonary Arterial Hypertension, 'PAH') medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About TX45, a long-acting Fc-relaxin fusion protein TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About Tectonic Tectonic is a biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors ('GPCRs'). Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit and follow on LinkedIn. Forward-Looking StatementsThis press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are 'forward-looking statements.' These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic's product candidates, including the ongoing Phase 1b and Phase 2 clinical trials for its lead program, TX45, in Group 2 PH-HFpEF. These forward-looking statements are based on Tectonic's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic's ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading 'Risk Factors' in Tectonic's Quarterly Report on Form 10-Q filed with the SEC on May 8, 2025, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit and LinkedIn. CONTACT: Contacts: Investors: Dan Ferry LifeSci Advisors daniel@ (617) 430-7576 Media: Kathryn Morris The Yates Network kathryn@ (914) 204-6412Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-05-2025
- Business
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Tectonic Therapeutic Presents Complete Results for Positive Phase 1b Clinical Trial of TX45 in Patients with Group 2 Pulmonary Hypertension in HFpEF in Late-Breaking Presentation at ESC Heart Failure 2025
Data confirmed TX45's tolerability profile and improvements in left ventricular function and pulmonary hemodynamics in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF') In new echocardiographic analysis, TX45 treatment resulted in sustained hemodynamic effects for 29 days TX45 improved cardiac and pulmonary hemodynamics in PH-HFpEF patients across a range of left ventricular ejection fractions ('LVEF'), including LVEF≥50% and LVEF 41-49% WATERTOWN, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) ('Tectonic') today announced the complete results from Part A of the Phase 1b clinical trial of TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF'), which are being presented in a late-breaking, oral session at the European Society of Cardiology (ESC) Heart Failure 2025 Congress being held in Belgrade, Serbia. The results include the full cohort of 19 patients in Part A of the Phase 1b trial of TX45, Tectonic's lead asset and a long-acting relaxin therapy. Interim data for 16 patients in the Phase 1b trial was previously reported in a press release on January 30, 2025. The complete data from Part A of the Phase 1b clinical trial confirmed the tolerability and hemodynamic effects of TX45 in patients with PH-HFpEF previously reported in the interim data. Based on the complete dataset in PH-HFpEF, a single intravenous dose of TX45 was well tolerated, with no serious or severe adverse events. In the overall study population, TX45 achieved a 19.0% reduction in pulmonary capillary wedge pressure ('PCWP'), an endpoint known to correlate with exercise capacity, morbidity and mortality in patients with heart failure. In the subpopulation with combined pre- and post-capillary pulmonary hypertension ('CpcPH') who have an elevated Pulmonary Vascular Resistance ('PVR') and more severe disease, TX45 demonstrated >30% reduction in PVR, which along with PCWP is correlated to exercise capacity and mortality in this patient population. The Phase 1b trial enrolled a patient population and evaluated hemodynamic endpoints which are similar to the ongoing APEX Phase 2 clinical trial ( NCT06616974). APEX is a 24-week clinical trial in PH-HFpEF with topline results expected in 2026. New hemodynamic data reported today from the Phase 1b clinical trial include the following: Echocardiograms were evaluated at baseline and at Days 2, 15 and 29. Following the administration of TX45, sustained improvements in echocardiogram endpoints were observed consistent with improved hemodynamics. Increased tricuspid annular plane systolic excursion/systolic pulmonary artery pressure (TAPSE/SPAP), a marker of PVR, and right ventricular fractional area of change (RVFAC), a marker of right ventricular function, were observed on all days post treatment compared to baseline demonstrating a sustained effect for 29 days after single dose administration. In the clinical trial, hemodynamics were analyzed across a range of left ventricular ejection fractions ('LVEF'), including LVEF≥50% and LVEF 41-49%. Both subpopulations showed similar improvements in PCWP (19.7% and 18.4%, respectively) and cardiac output (18.3% and 18.7%, respectively), as well as improvement in pulmonary hemodynamics following administration of TX45. Cardiac output increased numerically more in response to TX45 in patients with higher baseline PVR, with 16.8% improvement in patients with baseline PVR<2 wood units, 20.5% with baseline PVR≥2 and 24.5% with baseline PVR≥3. 'We are enthusiastic about the potential of TX45 as a treatment for patients with Group 2 pulmonary hypertension. In particular, we are very encouraged that the echocardiographic analysis demonstrated sustained hemodynamic effects of TX45 out to 29 days,' said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic. 'Additionally, the positive and consistent hemodynamic effects across a range of LVEF confirmed that TX45 is well positioned to address the full spectrum of PH-HFpEF patients. We look forward to the topline data from Part B of the Phase 1b study in another type of pulmonary hypertension patients, those with Heart Failure with reduced Ejection Fraction (HFrEF), expected in the second half of 2025.' Marcella K. Ruddy, M.D., Chief Medical Officer of Tectonic commented, 'These results from the Phase 1b study show the promising therapeutic profile of TX45, offering patients a potential best-in-class therapy for Group 2 pulmonary hypertension, a disease with high morbidity, mortality and no approved treatments. Additionally, these data continue to support our hypothesis that TX45 may provide the greatest benefit to patients with CpcPH, based on data showing strong improvement in pulmonary hemodynamics and cardiac output relative to baseline PVR.' Highlights from complete Phase 1b Part A results Within the cohort of 19 patients with PH-HFpEF enrolled in the Phase 1b open label clinical trial of TX45, 9 patients had CpcPH, as measured by PVR>2 Wood units. Hemodynamic measures evaluating left ventricular function included PCWP, Cardiac Output ('CO') and Stroke Volume ('SV'). Hemodynamic measures evaluating the pulmonary vasculature included PVR, Total Pulmonary Resistance ('TPR') and mean Pulmonary Artery Pressure ('mPAP'). Safety Results: TX45 was well tolerated with no serious or severe adverse events, discontinuations, infusion reactions or drug-related adverse events. There were no clinically significant changes in vital signs, physical exam or safety laboratory values. Transient asymptomatic decreases in blood pressure were observed over the first 24 hours after TX45 dosing. Hemodynamic Results: TX45 administration resulted in meaningful improvement in both left ventricular function and pulmonary hemodynamics, representing a differentiated profile for TX45 compared to other PAH drugs that are pulmonary vasodilators but have not shown improvement in left ventricular function and have not shown efficacy in PH-HFpEF. TX45 achieved the following improvements in left ventricular function: PCWP decreased 19.0% [95% CI, -26.1% to -11.9%]. CO increased 18.5% [95% CI, 10.2% to 26.9%]. TX45 achieved the following improvements in pulmonary hemodynamics: PVR decreased 32.0% [95% CI, -35.9% to -28.1%] and 35.5% (95%CI, -38.6% to -32.5%) in the subgroup of patients with baseline PVR≥2 and baseline PVR≥3, respectively. TPR decreased 28.7% [95% CI, -34.1% to -22.1%] in the overall population. Mean pulmonary artery pressure decreased 16.8% [95% CI, -20.8% to -12.8%] in the overall population. As a relaxin therapeutic, the differentiated mechanism of TX45 improved both left ventricular function and pulmonary hemodynamics, which most strongly matches the more severe pathophysiology of patients with CpcPH. About the TX45 Phase 1b clinical trial in Group 2 pulmonary hypertension The Phase 1b open label clinical trial is designed to evaluate the safety and hemodynamic effect of single doses of TX45 in patients with Group 2 pulmonary hypertension. Part A evaluated the effect of TX45 in PH-HFpEF and Part B will evaluate effects of TX45 in Pulmonary Hypertension in Heart Failure with reduced Ejection Fraction ('PH-HFrEF'). The design of the clinical trial is as follows: after obtaining informed consent, a right heart catheter, which is the gold standard for the measurement of cardiopulmonary hemodynamics, is inserted and baseline measurements are obtained, an intravenous dose of TX45 is administered, and hemodynamic effects are evaluated over 8 hours post dose. Participants are then followed for 45 days post dose for safety and exploratory biomarker endpoints. Part A of the trial has completed. Part B enrollment is ongoing with topline data expected in the second half of 2025. About Group 2 Pulmonary Hypertension in HFpEF The World Health Organization has defined 5 groups of pulmonary hypertension ('PH'). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction ('PH-HFpEF'). In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH ('IpcPH') and Combined pre- and post-capillary PH ('CpcPH'). CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in Pulmonary Vascular Resistance ('PVR'). Although several Group 1 PH (Pulmonary Arterial Hypertension, 'PAH') medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About TX45, a long-acting Fc-relaxin fusion protein TX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About Tectonic Tectonic is a biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors ('GPCRs'). Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit and follow on LinkedIn. Forward-Looking StatementsThis press release contains 'forward-looking statements' within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are 'forward-looking statements.' These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic's product candidates, including the ongoing Phase 1b and Phase 2 clinical trials for its lead program, TX45, in Group 2 PH-HFpEF. These forward-looking statements are based on Tectonic's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic's clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic's ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic's actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading 'Risk Factors' in Tectonic's Quarterly Report on Form 10-Q filed with the SEC on May 8, 2025, and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit and LinkedIn. CONTACT: Contacts: Investors: Dan Ferry LifeSci Advisors daniel@ (617) 430-7576 Media: Kathryn Morris The Yates Network kathryn@ (914) 204-6412Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
07-05-2025
- Business
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Tectonic Therapeutic To Present on May 15th, 2025 at the Bank of America Securities Health Care Conference
Tectonic Therapeutic WATERTOWN, Mass., May 07, 2025 (GLOBE NEWSWIRE) -- Tectonic Therapeutic, Inc. (NASDAQ: TECX) ('Tectonic'), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors ('GPCRs'), today announced that Alise Reicin, MD, President and Chief Executive Officer, will present at the Bank of America Securities 2025 Health Care Conference taking place in Las Vegas on May 12-15, 2025. Bank of America Securities Health Care Conference Date: Thursday, May 15th, 2025 Time: 9:20am PDT Format: Corporate Presentation Presenter: Alise Reicin, MD, President and Chief Executive Officer Webcast: Link The Tectonic management team will host one-on-one meetings at the conference. Interested investors should contact their Bank of America Securities representative to schedule meetings. The live webcast can also be accessed under 'Events & Presentations' on the Investors section of the Tectonic website at Once the conference has concluded, a replay of the webcast will be available on the Company's website for approximately 90 days. About Tectonic Tectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit and follow us on LinkedIn. CONTACT: Investors: Dan Ferry LifeSci Advisors daniel@ (617) 430-7576 Media: Kathryn Morris The Yates Network kathryn@ (914) 204-6412
Yahoo
02-05-2025
- Business
- Yahoo
TipRanks' ‘Perfect 10' Picks: 2 Top-Scoring Stocks Earning Wall Street's Seal of Approval
Building a strong portfolio naturally hinges on choosing the right stocks. The tricky part? Finding them. With thousands of publicly traded companies and a flood of investment 'methods' floating around, it's no wonder even seasoned investors can feel overwhelmed. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. The biggest problem with sorting through that array of stocks comes from the sheer volume of data that needs to be examined. Those thousands of stocks are traded by thousands of investors – and there are tens of millions of daily transactions, every one of which adds another bit to the flow of raw market data. No human can keep up with that kind of volume – but AI can. That's where TipRanks' Smart Score steps in. This powerful algorithm, built on AI and natural language processing, cuts through the chaos. It sifts through vast amounts of market data, analyst insights, and technical indicators, distilling it all into a simple, actionable rating. Every stock gets a score from 1 to 10 – based on factors statistically tied to future outperformance – making it easier than ever to identify potential winners and sidestep the duds. The 'Perfect 10' scores indicate stocks that definitely deserve a closer look. We've opened up the database at TipRanks to find out what Wall Street thinks of 2 top-scoring stocks; here's a closer look. Tectonic Therapeutic (TECX) The first 'Perfect 10' stock we'll look at here is a biopharmaceutical research firm, Tectonic Therapeutic. Tectonic is working at both the preclinical and clinical stages, focusing its efforts on the development of G-Protein Coupled Receptors, or GPCRs, into a line of new drug candidates. GPCRs have an important role, as receptor molecules, as regulators in several human biological functions. They appear on cell surfaces and are actively involved in regulating such vital functions as blood pressure regulation, glucose metabolism, immune function, and neuronal signalling. Molecules with such varied actions in the human body are bursting with potential for medical research – and Tectonic is working to unlock that potential. The company has created a proprietary drug development platform, dubbed GEODe, which it uses in its discovery efforts for new biologic medicines to add to its research pipeline. Currently, Tectonic has several lines in the preclinical discovery stage, and one, TX45, in the human trial clinic. TX45 is under investigation as a potential treatment for high blood pressure in the circulatory system of the lungs, a dangerous condition known as pulmonary hypertension. The drug candidate is an 'Fc-relaxin fusion protein,' with potential to become the best in its class, and Tectonic is studying its efficacy in the treatment of Group 2 pulmonary hypertension. The drug's action leverages vasodilatory and anti-fibrotic properties of relaxin. Tectonic has had some success with TX45 in the clinical studies. In September of last year, the company released favorable data from the Phase 1a study, and in January of this year it followed that data with another set of favorable interim results, on the Phase 1b stage of the study, in patients with Group 2 pulmonary hypertension in HFpEF. This coming May, the company will present additional Phase 1b data to the European Society of Cardiology (ESC) Heart Failure 2025 Congress. The drug is currently undergoing a Phase 2 clinical trial, with results expected next year. We should note that, despite these successes in the trial clinic, shares in TECX are down 56% so far this year. The stock's decline began in January, after the pharma giant Eli Lilly terminated the clinical studies of its kidney disease drug candidate volenrelaxin. The termination was due to concerns that the drug was not proving efficacious; the negative impact on TECX shares came because volenrelaxin is in the same class of drugs, relaxin mimetics, as TX45. The failure of volenrelaxin has caused analysts and investors to worry about the efficacy of Tectonic's lead candidate – worries that only a series of positive trial results will allay. Despite concerns surrounding the broader relaxin drug class, Mizuho analyst Uy Ear sees substantial promise in the company's TX45 candidate and argues that the market is drastically undervaluing its potential. 'We like TECX as we believe: (1) The stock price reflects near zero value for TX45, which we believe has $3.3B unadjusted/$1.2B adjusted peak sales potential in CpCPH with HFpEF alone. There are also multiple scenarios for TX45 to treat the larger Group 2 PH, which would lead to significant upside; (2) While there are concerns about the ineffectiveness of the relaxin class, we see limited read-through from Lilly terminating volenrelaxin's Phase 2 for futility, given the different conditions (heart failure vs TX45's Group 2 PH) and continued validation of the MoA from AstraZeneca's ongoing AZD3427 Phase 2 in Group 2 PH; (3) The consistency and clinically relevant magnitude of the improvements — left ventricular function and pulmonary hemodynamics — observed in the Phase 1b hemodynamic data will likely translate to clinical benefit in PH-HFpEF; and (4) Strong cash position (~$326M in 1Q25) with runway into 4Q28 and to complete the Phase 2 trial for TX45 and the Phase 1 and Phase 2 trials for TX2100, provide additional potential catalysts for the stock,' Ear opined. With that, Ear rates the shares as Outperform (i.e., Buy) and sets a $51 price target—implying the stock could soar by 152% over the next year. (To watch Ear's track record, click here) Overall, there are 5 recent analyst reviews of this stock, and they are all unanimously positive – giving TECX shares a Strong Buy consensus rating. The stock's $20.23 trading price and $74.25 average target price together suggest a hefty 267% one-year upside potential. (See TECX stock forecast) AeroVironment (AVAV) The second 'Perfect 10' we'll look at here is a defense contractor, AeroVironment. This company, which was founded in 1971, has a historical specialization in applied robots, in the form of unmanned aerial vehicles (UAVs) and uncrewed aircraft systems (UASs) – that is, drones. Today, AeroVironment has moved beyond drone aircraft and, in addition, designs and produces unmanned ground vehicles (UGVs) and high-altitude pseudo-satellites (HAPS). These lines of uncrewed vehicles are designed to give military users superior reconnaissance capabilities without risking human crews. In a more offensive-minded design, the company also produces loitering munition systems (LMSs), capable of hovering over a battlefield and providing both offensive and defensive fire support. AeroVironment focuses on giving its customers 'solutions that work,' based on the bedrock fact that there is minimal margin for error in most military applications. The company takes part in every aspect of product development, from the design and production of prototypes to the deployment of regular production models. AeroVironment is always looking for ways to improve the ease of use and effectiveness of its drone aircraft and vehicles. In recent weeks, AeroVironment has made several important expansionary moves. Probably the most important of these is the April 1 stockholder approval of the company's acquisition of Blue Halo. Blue Halo is a defense contractor working in various high-tech fields, including directed energy weapons, electronic warfare, AI, and counter-measures to uncrewed vehicles and aircraft. AeroVironment's acquisition of Blue Halo is valued at $4.1 billion, as an all-stock transaction. In addition, AeroVironment has scored two important European contracts in recent weeks. In March, the company was awarded the contract to deliver 41 large uncrewed ground vehicles to the German military, with deliveries running from summer of this year into 2027. And on April 21, AeroVironment announced it had won a $46.6 million contract with the Italian Defense Ministry to deliver the JUMP 20 vertical takeoff and landing (VTOL) medium uncrewed aircraft system. The five-year contract includes delivery of the drone aircraft, as well as engineering services and initial sustainment and technical support. On the financial side, AeroVironment missed the forecasts on both revenue and earnings in its last report, which covered fiscal 3Q25. In that quarter, which ended on January 25, the company had a top line of $167.6 million, down 10% year-over-year and falling short of the analysts' forecast of $188.2 million. At the bottom line, AeroVironment's non-GAAP EPS of $0.30 was 36 cents per share less than had been anticipated. Looking forward, however, AeroVironment reported having a funded backlog of $763.5 million as of January 25; this figure was a company record. For Raymond James analyst Brian Gesuale, the key here is this company's ability to disrupt the defense industry. He is impressed by the Blue Halo transaction, too, and writes of AeroVironment, 'We see ~15% upside to consensus estimates over NTM, see valuation as compelling, and believe the standalone AVAV as well as its pending acquisition of Blue Halo position it as one of the elder statesmen of the Defense Disruptors. This cohort that includes Anduril, Palantir, Shield AI, and several other non-traditional defense names is poised to take significant share in the growing DOD budget over the next decade.' Gesuale rates AVAV shares as a Strong Buy and he complements that with a $200 price target, implying a one-year gain for the shares of 30.5%. (To watch Gesuale's track record, click here) As with TECX above, there are 5 recent reviews on record here and they are all positive – for a unanimous Strong Buy consensus rating. AVAV stock is priced at $153.24 and its $190.25 average price target suggests a 12-month upside potential of 24%. (See AVAV stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. 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