공고 • Jun 11
Tectonic Therapeutic, Inc. Completes Enrollment in TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients Tectonic Therapeutic, Inc. announced the completion of enrollment for the APEX trial, a 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”). The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”)>3 Wood Units (“WU”) at baseline. The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR>3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. In the APEX clinical trial, the mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR>3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Tectonic expects topline results from the APEX clinical trial in early First Quarter 2027. The APEX Phase 2 clinical trial is a global, randomized, double-blind, placebo-controlled, proof-of-concept trial designed to evaluate the safety and efficacy of two dose regimens of TX45 administered subcutaneously (“SC”) in patients with PH-HFpEF, enriched for patients with CpcPH. Patients were randomized to receive 300 mg SC (2 ml injection) once monthly of TX45, 300 mg SC every other week of TX45, or a placebo. Change from baseline in PVR in the PVR>3 WU population is the primary endpoint of the trial. 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 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 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 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. 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. 공고 • Apr 27
Tectonic Therapeutic, Inc., Annual General Meeting, Jun 08, 2026 Tectonic Therapeutic, Inc., Annual General Meeting, Jun 08, 2026. 공고 • Apr 26
Tectonic Therapeutic, Inc. Appoints Jessica Chutter to Board of Directors, Effective June 8, 2026 Tectonic Therapeutic, Inc. announced it has appointed Jessica Chutter to its Board of Directors, effective June 8, 2026. Ms. Chutter brings more than four decades of experience in global healthcare investment banking, with deep expertise advising biotechnology and pharmaceutical companies on strategic positioning, mergers and acquisitions, and capital markets execution. She is widely recognized as a pioneer in investment banking in the biotechnology sector and has served as a trusted advisor to CEOs and boards across the industry. Ms. Chutter spent her career at Morgan Stanley, where she served as Managing Director from 1998 to February 2026 and helped build its biotechnology investment banking practice. Most recently, she was Vice Chair of Healthcare Investment Banking from 2020 to February 2026 and Chair of Biotechnology Investment Banking from 2010 to February 2026. Earlier in her tenure, she served as Co-Head of Biotechnology Investment Banking and held various roles in healthcare investment banking. Over the course of her career, Ms. Chutter advised biotechnology and pharmaceutical companies on strategic and capital markets initiatives and was involved in approximately $80 billion in capital raising transactions and $85 billion in strategic transactions. Ms. Chutter currently serves on the Board of Directors of PTC Therapeutics. She is also on the Board of The Hospital for Sick Children and the Toronto Innovation Acceleration Partners, a not-for-profit organization focused on translating health science research into commercial opportunities. She holds an M.B.A. from Harvard Business School and a Bachelor of Arts in Commerce and Honors Economics from McGill University. 공고 • Feb 24
Tectonic Therapeutic, Inc. Announces Board and Committees Changes Tectonic Therapeutic, Inc. announced it has appointed François Nader, M.D., MBA, as an independent director to its Board of Directors, and as a member of the Nominating and Corporate Governance Committee, effective April 1, 2026, at which time he will also assume the role of Chair of the Board. Dr. Nader brings more than 30 years of leadership experience across the biotechnology and pharmaceutical industry and currently serves as an Independent Director of Moderna, Inc. . Upon Dr. Nader assuming the role as independent director to the Board of Directors, Terrance McGuire on February 23, 2026, notified the Board of his intent to (i) resign as Chair of the Board, effective as of April 1, 2026 and (ii) resign from the Board, including its committees, effective as of the Company’s 2026 annual stockholder meeting. In order to provide for a smooth leadership transition, Mr. McGuire will remain a member of the Board of Directors until Tectonic’s 2026 Annual Meeting of Stockholders, which is anticipated to be in June 2026. Dr. Nader was appointed as an Independent Director of Moderna in 2019, where he chairs both the Talent & Compensation Committee and the Nominating & Governance Committee. He has served as Chairman, Executive Chairman, and/or Independent Director of numerous biotechnology companies which culminated in significant strategic transactions, including Acceleron Pharma (acquired by Merck), Alexion Pharmaceuticals (acquired by AstraZeneca), Prevail Therapeutics (acquired by Eli Lilly), Clementia Pharmaceuticals (acquired by Ipsen), Advanced Accelerator Applications (acquired by Novartis), Baxalta (acquired by Shire), NPS Pharmaceuticals (acquired by Shire), and Noven Pharmaceuticals (acquired by Hisamitsu). He also previously served as President and Chief Executive Officer of NPS Pharmaceuticals, where he led the company’s transformation into a global rare disease leader. Earlier in his career, he held senior leadership roles spanning medical, regulatory, and commercial functions at Aventis and its predecessor companies. Dr. Nader earned his French Doctorate in Medicine from St. Joseph University in Lebanon and a Physician Executive MBA from the University of Tennessee. 
