Context Therapeutics rises on FDA fast track status for lead asset

[US Food and Drug Administration (FDA)]

Context Therapeutics (CNTX [https://seekingalpha.com/symbol/CNTX]) added ~11% on Thursday after the cancer drug developer said that the U.S. Food and Drug Administration (FDA) issued its Fast Track Designation to CTIM-76, the lead asset of the company.

The designation covers the development work related to CTIM-76 in patients with platinum-resistant ovarian cancer who have undergone all available standard of care drugs.

A Phase 1b trial for the T cell-engaging bispecific antibody for patients with CLDN6-positive advanced or metastatic ovarian, endometrial, and testicular cancers is currently underway, with its interim data expected in June.

The FDA's fast-track designation permits expedited development and review of drugs targeting serious conditions with unmet medical needs. It enables developers to communicate frequently with the regulator regarding their plans for clinical studies.

Subject to certain conditions, companies with fast-track designations can secure the FDA's accelerated approval and priority review, paving the way for a swifter market launch of their products [https://seekingalpha.com/pr/20460542-context-therapeutics-announces-ctimminus-76-receives-fda-fast-track-designation-for-the].

MORE ON CONTEXT THERAPEUTICS

* Seeking Alpha’s Quant Rating on Context Therapeutics [https://seekingalpha.com/symbol/CNTX/ratings/quant-ratings]
* Historical earnings data for Context Therapeutics [https://seekingalpha.com/symbol/CNTX/earnings]
* Financial information for Context Therapeutics [https://seekingalpha.com/symbol/CNTX/income-statement]