Oryzon Genomics

Oryzon has issued 4,444,445 new ordinary shares at €2.70 each, raising €12 million without subscription rights. The issue price is around 12–14% below recent reference prices. The proceeds are intended to strengthen the balance sheet and primarily to finance the clinical development of Iadademstat for acute myeloid leukemia as well as ongoing programs in hematology and psychiatry. In addition, there is a subscription commitment from the Social Impact Fund (managed by COFIDES) for up to €25 million for future capital increases, subject to certain conditions. » Więcej na de.investing.com

Oryzon Genomics has received written feedback from the FDA on the Phase‑III study protocol for Vafidemstat in borderline personality disorder. The comments concern study design, selection of endpoints and non‑clinical aspects; Oryzon plans to incorporate the recommendations and resubmit a revised protocol. The company is working with international clinical advisers and regulatory specialists on the revision and says it will provide further information after follow‑up discussions with the FDA. Other CNS studies are continuing on schedule in parallel, including the Phase‑IIb EVOLUTION study in schizophrenia. » Więcej na de.investing.com