Abeona Therapeutics (ABEO) Stock: Gaining Big On Orphan Drug Designation In Europe


Abeona Therapeutics Inc (NASDAQ: ABEO)

Abeona Therapeutics is having an incredible day in the market today, and for good reason. In an early morning press release, the company informed investors that it has received the Orphan Drug Designation in the EU for a key clinical stage treatment. Today, we’ll talk about the designation, how the stock reacted to the news, and what we can expect to see from ABEO ahead.

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ABEO Receives Orphan Drug Designation

As mentioned above, Abeona Therapeutics is having a strong day in the market today after announcing that it has received Orphan Drug Designation in the European Union. The designation surrounds the company’s clinical stage treatment known as ABO-102. This is a gene therapy designed for the treatment of Sanfilippo Syndrome Type A.

This isn’t the first bit of good news that ABEO has received with regard to the ABO-102 clinical program. In fact, the company has received Orphan Product Designation in he United States for the treatment from the US FDA. On top of that, the FDA has granted the treatment the Rare Pediatric Disease Designation as a pre-requisite part of the Priority Review Voucher Process.

What Orphan Drug Designation Means

At this point, we know that ABEO has achieved orphan drug designation in the US and EU for ABO-102. However, what does that really mean? The truth is that Orphan Drug Designation is a great achievement. The designation is only given to treatments that affect small percentages of the population. Once the designation is offered, it comes with reduced regulatory fees, increased guidance from regulatory agencies, and more protection from market competition.

In a statement, Timothy J. Miller, Ph.D., President and CEO of Abeona Therapeutics, had the following to say about the EU’s decision to grant Orphan Drug Designation:

Receiving European Union (EU) orphan drug designation is an important milestone that delivers significant commercial benefits to our company as we advance our innovative portfolio of gene therapy products… The benefits and incentives associated with the designations, including marketing exclusivity, are strategically important from a regulatory and commercial perspective and potentially value-creating for shareholders.”

How The Stock Reacted To The News

As investors, we know that the news moves the market. The news released with regard to ABEO was overwhelmingly positive. So, it’s only natural that we’re seeing a positive reaction. Currently, (12:13), the stock is trading at $7.78 per share after a gain of $0.98 per share (14.41%) thus far today.

What We Can Expect To See Moving Forward

CNA Finance Chief Strategic Analyst Kenny Soulstring has rated ABEO as a “Strong Buy,” citing strengths that include a strong clinical stage pipeline, promising clinical results, endorsements, and designations granted by regulatory agencies. To read Kenny’s full analysis on ABEO, click here.

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