FDA Events for Context Therapeutics (CNTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Context Therapeutics (CNTX).
Over the past two years, Context Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CT-95. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CT-95 - FDA Regulatory Timeline and Events
CT-95 is a drug developed by Context Therapeutics for the following indication: For mesothelin-expressing cancers.
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:
- CT-95
- Announced Date:
- April 30, 2025
- Indication:
- For mesothelin-expressing cancers.
Announcement
Context Therapeutics Inc. announced preclinical and translational data regarding the Company's clinical asset, CT-95, a mesothelin x CD3 TCE was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL.
AI Summary
Context Therapeutics Inc. presented new preclinical and translational data for CT-95, its mesothelin x CD3 T cell engager, at the American Association for Cancer Research Annual Meeting 2025 in Chicago. The data highlighted how CT-95 binds to a unique, membrane-proximal region of mesothelin, which is overexpressed on several cancer types such as pancreatic, ovarian, and mesothelioma. This specific binding helps avoid the issues associated with shed mesothelin fragments that can act as decoys. Additionally, the studies demonstrated CT-95’s strong anti-tumor activity and its ability to activate T cells without triggering broad cytokine release, all while being well tolerated in various models. This promising data supports the ongoing Phase 1 clinical trial of CT-95, and initial clinical results are expected to be shared in mid-2026.
Read Announcement- Drug:
- CT-95
- Announced Date:
- April 9, 2025
- Indication:
- For mesothelin-expressing cancers.
Announcement
Context Therapeutics Inc. announced that the first patient has been dosed in the Phase 1 clinical trial of CT-95, a mesothelin ("MSLN") x CD3 T cell engaging ("TCE") bispecific antibody designed to target mesothelin-expressing cancers. The Company anticipates sharing initial data for the CT-95 Phase 1 trial in mid-2026.
AI Summary
Context Therapeutics Inc. announced that the first patient has been dosed in its Phase 1 clinical trial of CT-95, a new mesothelin x CD3 bispecific antibody designed to target cancers that overexpress mesothelin. Mesothelin is a protein found in about 30% of cancers, which includes pancreatic, ovarian, and mesothelioma tumors. CT-95’s unique design directs T cells to attack cancer cells displaying mesothelin, aiming to overcome the challenges of decoy molecules that can interfere with treatment.
The open-label trial will evaluate the safety, tolerability, and potential anti-tumor effects of CT-95 in patients with advanced solid tumors. Context expects to share initial clinical data from this study in mid-2026, marking an important step forward in developing next-generation precision immunotherapies for solid tumors.
Read Announcement
Context Therapeutics FDA Events - Frequently Asked Questions
As of now, Context Therapeutics (CNTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Context Therapeutics (CNTX) has reported FDA regulatory activity for CT-95.
The most recent FDA-related event for Context Therapeutics occurred on April 30, 2025, involving CT-95. The update was categorized as "Presentation," with the company reporting: "Context Therapeutics Inc. announced preclinical and translational data regarding the Company's clinical asset, CT-95, a mesothelin x CD3 TCE was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL. "
Currently, Context Therapeutics has one therapy (CT-95) targeting the following condition: For mesothelin-expressing cancers..
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:CNTX) was last updated on 7/13/2025 by MarketBeat.com Staff
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