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
TX2100 and TX45. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TX2100 FDA Regulatory Events
TX2100 is a drug developed by Tectonic Therapeutic for the following indication: Treatment of Hereditary Hemorrhagic Telangiectasia (HHT).
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:
- TX2100
- Announced Date:
- September 29, 2026
- Indication:
- Treatment of Hereditary Hemorrhagic Telangiectasia (HHT)
Announcement
Tectonic Therapeutic, Inc announced favorable topline results from its Phase 1a clinical trial evaluating TX2100, an investigational VHH-Fc fusion antagonist antibody targeting the APJ (apelin) receptor, in healthy adult volunteers.
Read Announcement
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:
- June 10, 2026
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, 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").
AI Summary
Tectonic Therapeutic announced that it has completed enrollment in the APEX trial, a 24-week Phase 2 study of TX45. The trial is testing the drug’s safety and effectiveness in patients with pulmonary hypertension linked to heart failure with preserved ejection fraction, also called PH-HFpEF. This condition is serious and can make it hard for the heart and lungs to work properly, leading to symptoms like shortness of breath and low energy.
With enrollment now finished, the company can move closer to learning whether TX45 may help this patient group. The APEX trial is an important step because it will provide more data on how well the treatment works and how safe it is over the study period. Tectonic said the trial remains on track as it continues evaluating TX45 in this difficult-to-treat disease area.
Read Announcement- Drug:
- TX45
- Announced Date:
- October 29, 2025
- Indication:
- For the treatment of patients with Group 2 PH-HFpEF.
Announcement
Tectonic Therapeutic, announced positive topline results from the Phase 1b Part B acute hemodynamic clinical trial of TX45, a long-acting, Fc-relaxin fusion protein, in patients with Group 2 PH‑HFrEF.
AI Summary
Tectonic Therapeutic announced positive topline results from its Phase 1b Part B acute hemodynamic trial of TX45, a long-acting Fc-relaxin fusion protein, in patients with Group 2 pulmonary hypertension and heart failure with reduced ejection fraction (PH-HFrEF). A single intravenous dose of TX45 was well tolerated, with no serious or severe adverse events, no clinically significant blood pressure changes and no immune-related reactions.
TX45 treatment led to meaningful improvements in left heart function and pulmonary hemodynamics. Pulmonary capillary wedge pressure (PCWP) fell by 29.2%, pulmonary vascular resistance (PVR) dropped by nearly 20% in patients with PVR over 3 Wood units, total pulmonary resistance decreased by 29.2%, and mean pulmonary artery pressure fell by 19.3%. Cardiac output rose by 17.3%.
Echocardiography at day 29 showed sustained benefits, including a 19.4% increase in left ventricular ejection fraction, 20.3% improvement in right ventricular contractile function, and a 36.3% increase in the TAPSE/SPAP ratio. These results support expanding TX45 into the PH-HFrEF population and guide the ongoing APEX Phase 2 trial.
Read Announcement- 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
