Clarity Pharmaceuticals shares soar on FDA review
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More news: Clarity Pharmaceuticals was comfortably the best performer across the ASX 200 index in early trading, after the clinical stage radiopharmaceutical company said it received a second fast track designation from the US Food and Drug Administration for its novel prostate cancer diagnostic Cu-SAR-bisPSMA.
Clarity shares were up 7.9% to $4.38 by 10:30am AEDT, extending gains of more than 90% over the last 12 months.
Clarity Pharma receives second FDA review for prostate cancer diagnostic
The news: Sydney-based Clarity Pharmaceuticals has received a second fast track designation (FTD) from the US Food and Drug Administration (FDA) for its imaging agent Cu-SAR-bisPSMA, a novel diagnostic option for patients with prostate cancer.
The context: The FDA has granted the FTD for Cu-SAR-bisPSMA for patients with biochemical recurrence of prostate cancer following definitive therapy. Clarity received its first FTD for the diagnostic last year, for patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy.
Clarity said the two FTDs enable the company to accelerate the development of its comprehensive diagnostic program with the product.
The FDA's FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs.
What they said: "This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA," said Clarity's executive chair Alan Taylor.
"The designation will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostics."
The source: ASX announcement
