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Oncopeptides Wins Fast-Track Status for First PDC Trial in Glioblastoma

Story Highlights
  • Oncopeptides gained Norwegian fast-track status and Nordic regulatory alignment for a small, first-of-its-kind glioblastoma study using its Peptide Drug Conjugate platform.
  • The Window-of-Opportunity trial could validate brain penetration, extend Oncopeptides’ technology beyond multiple myeloma and position it for the growing glioblastoma market.
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Oncopeptides Wins Fast-Track Status for First PDC Trial in Glioblastoma

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The latest announcement is out from Oncopeptides AB ( (SE:ONCO) ).

Oncopeptides has secured fast-track designation from Norway’s medicines regulator for a planned Window-of-Opportunity study of its Peptide Drug Conjugate platform in glioblastoma, following regulatory alignment with Swedish authorities on the trial design. The study, to be conducted in Norway in about 10 patients using an already approved Oncopeptides drug, will be the first clinical test of a PDC in glioblastoma and is intended to rapidly demonstrate brain penetration in a cost-efficient way.

Management describes the agreement and fast-track status as a strategic milestone that extends its PDC platform beyond multiple myeloma and could strengthen its position in a global glioblastoma market forecast to exceed $8 billion by 2035. By directly sampling tumor tissue, the trial aims to validate the mechanism of brain tumor targeting in an indication with profound unmet need, potentially de-risking future dose-finding and larger studies and offering new hope to patients facing limited treatment options and poor survival outcomes.

The most recent analyst rating on (SE:ONCO) stock is a Hold with a SEK3.00 price target. To see the full list of analyst forecasts on Oncopeptides AB stock, see the SE:ONCO Stock Forecast page.

More about Oncopeptides AB

Oncopeptides AB is a Swedish biotechnology company focused on researching, developing and commercializing targeted therapies for difficult-to-treat cancers. It leverages its proprietary Peptide Drug Conjugate and SPiKE technology platforms to deliver cytotoxic agents selectively into cancer cells, and commercializes its flagship drug in Europe with partnerships across South Korea, the Middle East, Africa and other regions.

Average Trading Volume: 2,199,510

Technical Sentiment Signal: Sell

Current Market Cap: SEK613.6M

See more insights into ONCO stock on TipRanks’ Stock Analysis page.

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