FDA Events for Tectonic Therapeutic (TECX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Tectonic Therapeutic (TECX).
Over the past two years, Tectonic Therapeutic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TX45. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TX45 - FDA Regulatory Timeline and Events
TX45 is a drug developed by Tectonic Therapeutic for the following indication: For the treatment of patients with Group 2 PH-HFpEF.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TX45
- Announced Date:
- May 17, 2025
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic 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.
AI Summary
Tectonic Therapeutic announced the complete results from Part A of its Phase 1b clinical trial of TX45, a long-acting relaxin therapy, in patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF). The trial, which included 19 patients, showed that TX45 was well tolerated with no serious or severe side effects. The data demonstrated meaningful improvements in both left ventricular function and pulmonary hemodynamics, including a 19% decrease in pulmonary capillary wedge pressure (PCWP), a key marker linked to exercise capacity and patient outcomes, and significant enhancements in cardiac output.
An echocardiographic analysis revealed sustained hemodynamic benefits for up to 29 days after a single TX45 dose, with consistent improvements seen across various left ventricular ejection fraction ranges. These promising results are set to be presented during a late-breaking oral session at the ESC Heart Failure 2025 Congress in Belgrade, Serbia.
Read Announcement- Drug:
- TX45
- Announced Date:
- April 15, 2025
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that it will make a late-breaking oral presentation at the European Society of Cardiology (ESC) Heart Failure 2025 Congress.
AI Summary
Tectonic Therapeutic recently announced that it will deliver a late-breaking oral presentation at the European Society of Cardiology Heart Failure 2025 Congress in Belgrade, Serbia, from May 17 to 20, 2025. The presentation will focus on Phase 1b clinical data for TX45, the company’s lead asset. TX45 is a long-acting Fc-relaxin fusion protein that shows promise as a best-in-class therapy for patients with Group 2 pulmonary hypertension related to heart failure with preserved ejection fraction (PH-HFpEF).
During the session titled “Hemodynamic effects of TX45, a long-acting Fc-relaxin fusion, in Group 2 pulmonary hypertension patients,” Dr. Anthony Muslin, Chief Development Officer, will share comprehensive results from the PH-HFpEF cohort. This detailed presentation will provide further insights into TX45’s potential to improve patient outcomes and address this challenging condition.
Read Announcement- Drug:
- TX45
- Announced Date:
- January 30, 2025
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced positive interim data from the Phase 1b acute hemodynamic clinical trial of its lead product candidate, TX45, a long-acting, Fc-relaxin fusion protein.
AI Summary
Tectonic Therapeutic announced positive interim data from its Phase 1b trial of TX45, a long-acting Fc-relaxin fusion protein. In this study focused on patients with Group 2 Pulmonary Hypertension in Heart Failure with preserved Ejection Fraction (PH-HFpEF), a single IV dose of TX45 improved key heart functions. Researchers observed a 17.9% decrease in pulmonary capillary wedge pressure (PCWP), an important measure related to exercise capacity and overall heart health. In patients with the more severe combined pre- and post-capillary PH (CpcPH), TX45 reduced pulmonary vascular resistance (PVR) by over 30%. The treatment was well tolerated, with no serious or severe adverse events noted. These encouraging results support the hemodynamic endpoints targeted in the ongoing APEX Phase 2 trial and offer new hope for patients facing high mortality with few existing treatment options.
Read Announcement- Drug:
- TX45
- Announced Date:
- December 3, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, Inc announced it will host a virtual key opinion leader (KOL) event on Thursday, December 12, 2024 from 4:00 PM to 6:00 PM ET.
AI Summary
Tectonic Therapeutic, Inc. has announced that it will host a virtual key opinion leader (KOL) event on Thursday, December 12, 2024, from 4:00 PM to 6:00 PM ET. At this online session, distinguished experts, including Dr. John R. Teerlink from UCSF and Dr. Raymond L. Benza from the Icahn School of Medicine at Mount Sinai, will discuss current treatment challenges in Group 2 Pulmonary Hypertension due to heart failure with preserved ejection fraction (HFpEF). The speakers will explore the unmet medical needs of patients in this area and provide insights into Tectonic’s development of TX45, an investigational Fc-relaxin fusion protein designed to activate the RXFP1 receptor. The discussion will highlight TX45’s potential benefits as indicated by ongoing Phase 1b and Phase 2 clinical studies, and a live question and answer session will follow the presentations to engage attendees directly.
Read Announcement- Drug:
- TX45
- Announced Date:
- September 19, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced favorable Phase 1a topline data for its lead asset TX45, a long-acting, potentially best-in-class relaxin. TX45 is being developed for the treatment of Group 2 PH-HFpEF.
AI Summary
Tectonic Therapeutic announced positive Phase 1a topline results for its lead asset TX45, a long-acting relaxin being developed for treating Group 2 PH-HFpEF. In this early study, TX45 was well-tolerated with no signs of immunogenicity. The trial showed a strong pharmacokinetic and pharmacodynamic (PK/PD) relationship, which helped in selecting the appropriate doses for the upcoming global Phase 2 clinical trial. These results also matched observations from preclinical models, further bolstering confidence in TX45’s potential as a best-in-class therapy. The favorable data supports the continued development of TX45 to address the unmet needs of patients with Group 2 PH-HFpEF, a condition for which there are currently no approved treatments.
Read Announcement- Drug:
- TX45
- Announced Date:
- September 19, 2024
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that Phase 1b single dose hemodynamic proof-of-concept clinical trial in Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) escalated to the highest dose of TX45 (3 mg/kg) based on favorable tolerability profile observed at lower doses, with topline trial results expected in the second quarter of 2025
AI Summary
Tectonic Therapeutic announced encouraging progress in its Phase 1b clinical trial for TX45 in patients with Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF). The single dose hemodynamic proof-of-concept study has now escalated to the highest dose of 3 mg/kg after lower doses were well tolerated with no signs of immunogenicity. Researchers are evaluating TX45’s impact on pulmonary hemodynamics and other safety markers. Topline trial results are expected in the second quarter of 2025, which will help guide dose selection for a planned Phase 2 clinical study. This advancement offers hope for a condition where there are currently no approved treatments, marking a significant step toward potentially improving care for patients with PH-HFpEF.
Read Announcement - Drug:
- TX45
- Announced Date:
- September 19, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic Results to be presented at the American Heart Association (AHA) Scientific Sessions in November 2024,
AI Summary
Tectonic Therapeutic, Inc. announced that favorable Phase 1a trial results for its lead program TX45 will be shared at the American Heart Association (AHA) Scientific Sessions in November 2024. TX45, a long-acting fusion protein in development for treating Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF), showed minimal adverse effects and no signs of immune response. These findings demonstrated a strong pharmacokinetic and pharmacodynamic relationship, which helped the company select the appropriate doses for the global Phase 2 clinical trial. The study used both intravenous and subcutaneous doses, with the highest dose of 3 mg/kg well-tolerated in healthy volunteers. Tectonic’s ability to translate preclinical success into the clinic provides a promising path forward for patients with PH-HFpEF, a condition with currently limited treatment options, and the full trial outcomes will be discussed at the upcoming AHA sessions.
Read Announcement- Drug:
- TX45
- Announced Date:
- July 30, 2024
- Estimated Event Date Range:
- September 1, 2024 - September 30, 2024
- Target Action Date:
- September 1, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that Phase 1a topline trial results of TX45 in healthy volunteers are expected to be released this September, with detailed data to be subsequently presented at a scientific meeting
AI Summary
Tectonic Therapeutic announced promising news regarding its experimental treatment, TX45, an Fc-relaxin fusion protein designed to treat Group 2 pulmonary hypertension (PH) caused by heart failure with preserved ejection fraction (HFpEF). The company expects to release the topline results from its Phase 1a clinical trial in healthy volunteers this September. Following this initial report, more detailed data will be presented at a scientific meeting, offering further insights into the safety, pharmacokinetics, and pharmacodynamics of TX45. This early phase study is an important step in the drug’s development, as TX45 is engineered to potentially improve both pulmonary and systemic vasodilation, as well as cardiac function. The results will also help guide future research and the design of upcoming trials, moving closer to addressing the significant unmet medical need for effective treatments among patients with PH-HFpEF in the U.S.
Read Announcement- Drug:
- TX45
- Announced Date:
- July 30, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, nnounced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TX45, an Fc-relaxin fusion protein being evaluated for the treatment of patients with Group 2 PH-HFpEF.
AI Summary
Tectonic Therapeutic announced that the FDA has cleared its Investigational New Drug (IND) application for TX45, an Fc-relaxin fusion protein being developed to treat patients with Group 2 Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction (PH-HFpEF). TX45 is designed to improve blood flow by promoting vasodilation in the lungs and the rest of the body and may help improve heart function by addressing diastolic dysfunction and potentially remodeling both pulmonary vessels and cardiac muscle. The clearance supports the company’s plan to start a global, 24-week Phase 2 clinical trial in the third quarter of 2024, which will assess the drug’s effectiveness in a large group of PH-HFpEF patients. Early clinical studies in healthy volunteers and patients are also underway to evaluate safety and pharmacologic responses, with further results expected in the coming years.
Read Announcement- Drug:
- TX45
- Announced Date:
- July 30, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that Phase 1b hemodynamic trial evaluating single doses of TX45 in subjects with Group 2 PH-HFpEF continues to enroll as planned, with topline study results expected in mid-2025
AI Summary
Tectonic Therapeutic announced that its Phase 1b hemodynamic trial evaluating single doses of TX45 in subjects with Group 2 pulmonary hypertension due to HFpEF is continuing to enroll as planned. Topline study results from this trial are expected to be available by mid-2025. TX45 is an Fc‐relaxin fusion protein being developed to address the unmet needs of patients suffering from this serious condition, which currently has no approved therapies. The trial aims to assess the safety, tolerability, and acute hemodynamic effects of the drug, including its impact on pulmonary and systemic vascular resistance. These efforts build on promising early data and support the continued development of TX45, potentially improving exercise capacity and overall heart function in patients with PH-HFpEF.
Read Announcement- Drug:
- TX45
- Announced Date:
- July 30, 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that topline trial results expected in 2026
AI Summary
Tectonic Therapeutic announced that it expects topline results from its global Phase 2 clinical trial in 2026. The trial is designed to evaluate TX45, an Fc-relaxin fusion protein for treating patients with Group 2 Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction (HFpEF). The study will last for 24 weeks, during which patients will receive TX45 via subcutaneous injections. Up to 180 patients, including a subgroup with a more severe form of the disease, will be enrolled to examine changes in pulmonary vascular resistance and other hemodynamic endpoints, as well as improvements in exercise capacity measured by the six-minute walk distance.
The announcement highlights the company’s commitment to addressing the unmet needs of patients with PH-HFpEF. Prior trial plans include additional studies to assess TX45’s safety and initial efficacy, further supporting the potential of this novel therapeutic approach.
Read Announcement- Drug:
- TX45
- Announced Date:
- July 30, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced that Planned initiation of global, 24-week Phase 2 clinical trial to evaluate TX45 administered subcutaneously in subjects with Group 2 PH due to HFpEF (PH-HFpEF) in the third quarter of 2024,
AI Summary
Tectonic Therapeutic announced plans to start a global Phase 2 clinical trial for TX45 in the third quarter of 2024. The study will run for 24 weeks and focus on patients with Group 2 pulmonary hypertension caused by heart failure with preserved ejection fraction (HFpEF). TX45, an Fc-relaxin fusion protein, is designed to improve heart and lung function by promoting vasodilation and reducing cardiac dysfunction. The trial will enroll up to 180 subjects who will receive TX45 by subcutaneous injection, compared with a placebo group. Researchers hope that the treatment will lead to better exercise capacity and improved pulmonary and systemic hemodynamics in these patients. Topline results from this study are expected by 2026, potentially offering a new therapeutic option for the more than 600,000 patients in the U.S. affected by this serious condition.
Read Announcement
Tectonic Therapeutic FDA Events - Frequently Asked Questions
As of now, Tectonic Therapeutic (TECX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Tectonic Therapeutic (TECX) has reported FDA regulatory activity for TX45.
The most recent FDA-related event for Tectonic Therapeutic occurred on May 17, 2025, involving TX45. The update was categorized as "Results," with the company reporting: "Tectonic Therapeutic 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."
Currently, Tectonic Therapeutic has one therapy (TX45) targeting the following condition: For the treatment of patients with Group 2 PH-HFpEF..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TECX) was last updated on 7/10/2025 by MarketBeat.com Staff
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