8-K - Context Therapeutics Inc. | StockGist

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Context Therapeutics Inc. announced that the FDA granted Fast Track designation to its investigational drug CTIM-76 for platinum-resistant ovarian cancer, with interim Phase 1a trial data expected in June 2026.

Key Takeaways

1FDA granted Fast Track designation to CTIM-76 for platinum-resistant ovarian cancer in patients who have received all standard of care therapies.

2CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody currently in a Phase 1 clinical trial for CLDN6-positive advanced or metastatic cancers.

3Interim data from the CTIM-76 Phase 1a trial is expected in June 2026, which will evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity.

4The Fast Track designation is designed to expedite development and review timelines for drugs treating serious conditions with unmet medical needs.

5CTIM-76 targets CLDN6, which is enriched in various solid tumors including ovarian, endometrial, lung, gastric, and testicular cancers.

Current Report Details

Event Type

Regulation Fd

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

, and Exhibit 99.1 attached hereto, are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, a

Regulation Fd

8.01

. Other Events. On April 2, 2026, the Company issued a press release announcing that the FDA has granted Fast Track designation to CTIM-76, the Company’s invest

Other Event

9.01

. Financial Statements and Exhibits. (d) Exhibits Exhibit No.: 99.1 | Description: Press Release issued by Context Therapeutics Inc., dated April 2, 2026 Exhibi

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1