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Invion Secures FDA Orphan Drug Designation for Anal Cancer Treatment

Story Highlights
  • Invion received FDA Orphan Drug Designation for INV043, enhancing its market position.
  • The designation offers exclusive rights and incentives, boosting Invion’s strategic appeal.
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Invion Secures FDA Orphan Drug Designation for Anal Cancer Treatment

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An announcement from Invion ( (AU:IVX) ) is now available.

Invion Limited has received Orphan Drug Designation from the US FDA for its lead cancer drug candidate, INV043, for the treatment of anal cancer. This designation provides Invion with several benefits, including seven years of exclusive marketing rights in the US, financial incentives, and a potentially faster path to market. The designation is a significant milestone, enhancing Invion’s clinical program and positioning it favorably in the industry. The company plans to conduct a clinical trial in collaboration with the Peter MacCallum Cancer Centre, leveraging promising preclinical data that showed approximately 80% tumor control in mouse models. This development may also increase Invion’s appeal to strategic partners, especially as the pharmaceutical industry faces a major patent cliff.

More about Invion

Invion is a life-science company focused on the global research and development of Photosoft™ technology for treating various cancers, atherosclerosis, and infectious diseases. The company holds exclusive licensing and distribution rights for this technology in Australia, New Zealand, and parts of Asia Pacific, excluding China, Macau, Taiwan, and Japan.

Average Trading Volume: 112,144

Technical Sentiment Signal: Sell

Current Market Cap: A$7.79M

Find detailed analytics on IVX stock on TipRanks’ Stock Analysis page.

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