Context Therapeutics (CNTX) FDA Approvals

Context Therapeutics' Drug in the FDA Approval Process

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.

Poster Presentation - November 7,2025

• Drug: CT-95
• Announced Date: November 7, 2025
• Indication: For mesothelin-expressing cancers.

Context Therapeutics Inc. shared two posters discussing the Company's CT-95 and CT-202 programs at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, being held November 7–9, 2025 in National Harbor, MD.

Context Therapeutics Inc. presented two posters on its CT-95 and CT-202 programs at the Society for Immunotherapy of Cancer’s 40th Annual Meeting (Nov. 7–9, 2025). The posters highlighted recent progress and near-term milestones for both therapies.

CT-95 is a mesothelin×CD3 bispecific antibody aimed at solid tumors. In the Phase 1 trial, six patients are enrolled. Cohort 3 doses are 0.18 µg/kg priming and 0.6 µg/kg full. No severe cytokine release syndrome or dose-limiting toxicity has occurred. Preclinical data predict target dose exposure will be reached at Cohort 4. Dose escalation continues, with initial Phase 1a data due mid-2026.

CT-202 is a Nectin-4×CD3 bispecific TCE with strong preclinical activity and a favorable safety profile. Regulatory filings to support a first-in-human trial are expected in Q2 2026. Presentation materials are on the company website.

Poster Presentation - October 6,2025

• Drug: CT-95
• Announced Date: October 6, 2025
• Indication: For mesothelin-expressing cancers.

Context Therapeutics Inc. announced two posters will be presented at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting, being held November 7–9, 2025, at the Gaylord National Resort and Convention Center in National Harbor, MD.

Context Therapeutics Inc. announced that it will present two posters at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting, taking place November 7–9, 2025, at the Gaylord National Resort and Convention Center in National Harbor, Maryland.

The first poster, “Trial in Progress: A Phase 1, First-in-Human Study of CT-95, a Mesothelin (MSLN)-Directed Bispecific T Cell Engager (TCE) in Subjects with Advanced Solid Tumors,” will be shown on Saturday, November 8 at 10:00 AM ET (Abstract 586). The second, “CT-202: a Dual pH-Dependent Nectin-4 x CD3 Bispecific T Cell Engager,” will be presented on Friday, November 7 at 10:00 AM ET (Abstract 963). Both sessions will be held in the Prince George ABC Exhibit Halls.

CT-95 is designed to bind to mesothelin on tumor cells and engage T cells to kill cancer, while avoiding interference from shed mesothelin. CT-202 targets Nectin-4, a protein common in many solid tumors, and is engineered to be more active in the acidic tumor microenvironment. These presentations highlight Context’s progress in developing bispecific antibodies for solid tumors.

Presentation - April 30,2025

• Drug: CT-95
• Announced Date: April 30, 2025
• Indication: For mesothelin-expressing cancers.

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.

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.

Dose Update - April 9,2025

Phase 1

• Drug: CT-95
• Announced Date: April 9, 2025
• Indication: For mesothelin-expressing cancers.

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.

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.