Moleculin Biotech Inc (NASDAQ: MBRX) is screaming for the top in the market this morning, and for good reason. The company announced that the FDA has approved its request for a Rare Pediatric Disease designation on three indications for an experimental treatment. Here’s what’s happening.
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MBRX Stock Screams For The Top On Rare Pediatric Disease Designations
As mentioned above, Moleculin Biotech broke some pretty big news this morning. The company announced that the United States Food and Drug Administration has approved its request for a Rare Pediatric Disease designationfor its drug candidate WP1066.
In the release, MBRX said that the designation allows the company to receive a transferrable Priority Review Voucher upon New Drug Approval for each of three indications. The indications include diffuse intrinsic pontine glioma (DIPG), medulloblastoma, and atypical teratoid rhabdoid tumor.
In a statement, Walter Klemp, Chairman and CEO at MBRX, had the following to offer:
The early activity we are seeing in WP1066 is both unexpected and encouraging. The approval of these three Rare Pediatric Disease designations is a reminder of just how important our efforts are to potentially help children with brain tumors.
It is also important for investors to understand the implications of the PRVs or Priority Review Vouchers. These vouchers are issued upon drug approval of the rare disease indication from the FDA and, once issued, can be transferred to other drug developers. These PRVs have historically had tremendous value and have been recently sold for up to $100 million or more. For Moleculin to have the potential for three of them is noteworthy indeed.
This News Is Huge
The news released by Moleculin Biotech this morning proved to be overwhelmingly positive. Think about it, rare pediatric disease designation does quite a bit for the company:
- Validation. First and foremost, the fact that the FDA provided the designation serves to validate the hard work the company has put into developing this drug candidate.
- Priority Review. The Rare Pediatric Disease designation provides the company with the ability to move forward with priority revew, reducing the review to approval time.
- Increased FDA Communication. Finally, Rare Pediatric Disease designation will increase the communication between MBRX and the FDA, helping to reduce inefficiencies in the development process.
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The Bottom Line
The bottom line here is that with the Rare Pediatric Disease designation, Moleculin Biotech is clearly onto something with WP1066. As the company continues to develop the treatment, it will now benefit from various perks afforded by the FDA to the company. All in all, MBRX stock is one to watch closely!
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