Ocugen OCGN Stock News

Ocugen Inc (NASDAQ: OCGN) is running for the top in the market this morning, and for good reason. The company announced that the FDA has granted one of its candidates Orphan Drug Designation. Here’s what’s going on:

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OCGN Stock Soars On Orphan Drug Designation

In a press release issued early this morning, Ocugen announced that it has received its third Orphan Drug Designation from the FDA. This particular ODD came in regard to OCU400, a treatment being developed as a potential options for patients with RHO mutation-associated retinal degeneration.

In the release, OCGN said that RHO mutation is part of the Retinitis Pigmentosa group of rare, genetic disorders that involve the breakdown and loss of cells in the retina. Unfortunately, this leads to visual impairment and blindness.

Importantly, the RHO mutation is one of the larger mutations within the RP class. In fact, it represents about 12% of RP patients in the United States.

OCU400 is being developed under the belief that it has broad potential to be effective in restoring retinal integrity and function across a range of genetically diverse inherited retinal diseases.

In a statement, Dr. Shankar Musunuri, CEO and Co-Founder at OCGN, had the following to offer:

Our third ODD for OCU400 from the FDA is an important step towards developing a broad-spectrum treatment for RP and getting a therapy faster to patients who are in desperate need of rescue. Orphan designation for this indication supports the goal of our Modifier Gene Therapy Platform to treat a variety of inherited retinal diseases with a single gene therapy product. There are currently no approved treatments which slow or stop the progression of multiple forms of RP, which is why we’re excited to have a platform that can potentially address multiple mutations, including mutations in the Rhodopsin gene, with one therapy.

This News Is Huge

The news released by Ocugen today is overwhelmingly positive. As mentioned in the press release, the ODD announced today represents the third received by the company.

Orphan Drug Designation is an important step when developing drugs for rare conditions. With the ODD, OCGN will enjoy more frequent communication with the FDA throughout development, potentially shorter review periods, and longer exclusivity periods should the drug be approved.

Ultimately, the news today only expands the idea that an investment in OCGN is an investment well made.

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