Market Herald logo


Be the first with the news that moves the market
  • WPD Pharmaceuticals (CSE:WBIO) and Moleculin Biotech’s Annamycin drug has received FDA approval for Fast Track Designation.
  • Annamycin is a drug which may become a possible treatment for specific types of leukemia.
  • The Fast Track Designation will make the drug eligible for Accelerated Approval, if it meets the relevant criteria.
  • WPD’s share price is up by 18.71 per cent, with shares trading at $1.65 apiece.

WPD Pharmaceuticals’ (WBIO) Annamycin drug has been approved for Fast Track Designation by the U.S. Food and Drug Administration (FDA).

Tests are currently underway, to study Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia (AML).

WPD gained the Fast Track Designation through their development partner Moleculin Biotech.

The Fast Track Designation will make Annamycin eligible for a number of privileges, including more frequent communication from the FDA.

The FDA will meet with WPD and Moleculin to discuss the drug development plan, proposed clinical trials design, use of biomarkers, and collection of appropriate data for drug approval.

Annamycin’s developers may also be able to complete a Rolling Review. A Rolling Review allows a drug company to submit its New Drug Application for FDA review in sections, rather than when the entire application is finished.

The Fast Track Designation may also make Annamycin eligible for Accelerated Approval and Priority Review, if it meets the relevant criteria.

WPD CEO Mariusz Olejniczak welcomed the approval from the FDA, which he described as “an important validation of the significant unmet need that we are collectively trying to address with our partners at Moleculin.”

WPD’s share price is up by 18.71 per cent, with shares trading at $1.65 apiece.

More From The Market Herald
The Market Herald Video

" Algernon Pharmaceuticals (CSE:AGN) files for approval for Phase 1 DMT Human Stroke Study

Algernon (AGN) has filed a Clinical Trials of Investigational Medicinal Products and Ethics Approval application with the UK MHRA.

" Telo Genomics (TSXV:TELO) advances lead product and Implements automation to workflow

Telo Genomics (TELO) has announced a study for its lead product for smoldering multiple myeloma (SMM) patients and completed research and development projects.

" Cardiol Therapeutics (TSX:CRDL) appoints leaders in cardiovascular medicine to scientific advisory board

Cardiol Therapeutics (CRDL) has appointed Dr. Paul M. Ridker, Dr. Bruce McManus, and Dr. Joseph A. Hill to its scientific advisory board.