TRACON Pharmaceuticals (TCON) Stock Pops On FDA Clearance

TRACON Pharmaceuticals TCON Stock News

TRACON Pharmaceuticals Inc (NASDAQ: TCON) is running for the top in the market this morning after announcing that it has received clearance from the FDA to move forward with a pivotal study. Here’s what’s going on:

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TCON Stock Climbs On FDA Trial Approval

In the press release, TRACON Pharmaceuticals announced that the FDA has provided clearance for the pivotal ENVASARC protocol. The protocol was filed with the United States FDA as part of an Investigational New Drug Application on July 15.

As a result of the approval, TCON said that it expects to initiate enrollment in the pivotal ENVASARC trial at 25 sites in the United States in the fourth quarter of this year.

Only patients who have received one or two prior cancer therapies, but have not received prior immune checkpoint inhibitor therapy will be enrolled in the trial. The gaol is to enroll 160 patients. 80 of these patients will be enrolled into cohort A and treated with single agent envafolimib. The other 80 patients will be enrolled in cohort B and treated with a combination of envafolimib and Yervoy.

Through the study, the company plans to further validate strong efficacy and safety data that it has seen throughout the development of the drug. In a statement, James Freddo, M.D., CMO at TCON, had the following to offer:

We are pleased to receive clearance from the FDA to initiate the pivotal ENVASARC trial of envafolimab in sarcoma and look forward to dosing the first patient in the fourth quarter of this year. Immunotherapy has radically changed the treatment paradigm for a number of cancers and our hope is envafolimab will do the same for sarcoma patients who have few treatment options.

This Is Big News

The news released by TRACON Pharmaceuticals proved to be overwhelmingly positive. The company is moving forward with a pivotal trial. This means that if the trial ends in positive results, the company may be on its way to having an approved therapy in oncology.

Moreover, the treatment being studied has the potential to treat a multitude of cancers. So, should it be effective and safe, it could become the goose that lays the golden eggs for the company and its investors. As such, TCON stock is one for the watchlist.

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