Oryzon up 3% After Progress in Trial of Its Drug for Personality Disorder

Oryzon Genomics rose almost 3% on the stock market minutes after the stock market opened on Tuesday, after reporting that it had received support from the US Food and Drug Administration (FDA) to begin a new trial of its drug for borderline personality disorder (BPD).

Specifically, the biopharmaceutical company’s shares rose 2.8% on the Continuous Market at around ten o’clock in the morning, to 1.8 euros. In this context, Oryzon has received the official minutes of its recent End-of-Phase II meeting with the FDA for the use of the molecule vafidemstat in borderline personality disorder, with positive comments from the American agency.

Based on these positive comments, Oryzon has announced that it will begin preparing a full protocol for the Phase III study, which will be submitted to the FDA for approval shortly.

Oryzon Genomics will enroll 350 patients for its Phase III study of the drug

The minutes of the meeting cover the US agency’s view on the adequacy of the vafidemstat programme to date in a number of areas including preclinical data, toxicology, clinical pharmacology and clinical studies.

The company and the FDA have reached an understanding regarding several key elements of the Phase III clinical study design for vafidemstat. The estimated total sample size for the Phase III study will be 350 patients , with a total study duration of 18 weeks.

“We are delighted with the positive outcome of our interactions with the FDA and the prospect of advancing vafidemstat into Phase III clinical studies for BPD, an area with significant unmet medical need as there are currently no approved drugs,” said Carlos Buesa, CEO of Oryzon.

The recent patent approvals for vafidemstat in the field of BPD further highlight its commercial potential. This marks a defining moment for Oryzon,” he concluded.

__

(Featured image by Simone van der Koelen via Unsplash)

DISCLAIMER: This article was written by a third party contributor and does not reflect the opinion of Born2Invest, its management, staff or its associates. Please review our disclaimer for more information.

This article may include forward-looking statements. These forward-looking statements generally are identified by the words “believe,” “project,” “estimate,” “become,” “plan,” “will,” and similar expressions. These forward-looking statements involve known and unknown risks as well as uncertainties, including those discussed in the following cautionary statements and elsewhere in this article and on this site. Although the Company may believe that its expectations are based on reasonable assumptions, the actual results that the Company may achieve may differ materially from any forward-looking statements, which reflect the opinions of the management of the Company only as of the date hereof. Additionally, please make sure to read these important disclosures.

First published in PlantaDoce. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us