Free Trial

Tectonic Therapeutic (TECX) FDA Events

Tectonic Therapeutic logo
$21.09 -0.46 (-2.13%)
As of 02:33 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
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.

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

  • 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
From Our Partners