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Sio Gene Therapies Inc. (NASDAQ: SIOX) reported significant advancements in its gene therapy programs during its fiscal second quarter ending September 30, 2021. The company highlighted positive Phase 1/2 clinical data for AXO-AAV-GM1 in GM1 gangliosidosis, including normalization of key biomarkers and safety results. Both AXO-AAV-GM1 and AXO-AAV-GM2 received Fast Track Designation from the FDA. Financially, Sio ended the quarter with $101.7 million in cash, providing runway into Q4 2022. However, it reported a net loss of $21.2 million, higher than the previous year's loss.
Sio Gene Therapies Inc. (NASDAQ: SIOX) announced a significant update regarding its gene therapy AXO-Lenti-PD for Parkinson's disease. Three GMP batches have successfully completed fill and finish, meeting target titers. The certification for at least one batch by a Qualified Person is expected by Q4 2021. Furthermore, the company received scientific guidance from the MHRA to advance the clinical development. An update on the program is anticipated in Q1 2022, marking a possible inflection point for the AXO-Lenti-PD initiative.
Sio Gene Therapies Inc. (NASDAQ: SIOX) announced that the FDA granted Fast Track Designation for AXO-AAV-GM2, a gene therapy targeting Tay-Sachs and Sandhoff diseases. This milestone accelerates the development of a treatment for these severe pediatric conditions, which currently lack approved therapies. The designations complement existing Rare Pediatric Disease and Orphan Drug designations. Ongoing clinical trials aim to evaluate the safety and efficacy of the therapy. Sio emphasizes its commitment to bringing AXO-AAV-GM2 to patients and families.
Sio Gene Therapies (NASDAQ: SIOX) announced the departure of Chief Research and Development Officer, Gavin Corcoran, effective November 12, 2021, to pursue other opportunities. Pavan Cheruvu, the company's CEO, will take over Dr. Corcoran's responsibilities. The company is realigning its R&D organization by creating two new executive positions: Chief Medical Officer and Senior VP of Early Development and Scientific Affairs. Positive clinical progress in GM1 gangliosidosis was also highlighted, indicating Sio's commitment to developing gene therapies for neurodegenerative diseases.
Sio Gene Therapies (NASDAQ: SIOX) announced that the FDA has granted Fast Track Designation to its gene therapy candidate, AXO-AAV-GM1, for treating Type I and II GM1 gangliosidosis, a severe pediatric condition. This designation is aimed at expediting development and review for serious conditions lacking approved treatments. AXO-AAV-GM1 has also received Orphan Drug and Rare Pediatric Disease Designations. Recent clinical data highlighted significant normalization of disease biomarkers with no serious adverse events, marking a pivotal step in the therapy's advancement.
Sio Gene Therapies Inc. (SIOX) presented positive interim data from its Phase 1/2 study of AXO-AAV-GM1 for GM1 gangliosidosis at the ESGCT Virtual Congress 2021. Results showed dose-dependent improvements in key biomarkers, with normalization of serum β-galactosidase and GM1 ganglioside levels in the high-dose cohort. No serious adverse events were reported among ten treated patients, with six showing no disease progression. Management plans to engage the FDA for further development.
Sio Gene Therapies (NASDAQ: SIOX) announced it will present new data on the Phase 1/2 trial of AXO-AAV-GM1 for GM1 gangliosidosis at the ESGCT Virtual Congress 2021 from October 19-22. The oral presentations will focus on new findings from high- and low-dose cohorts. Notably, the presentation titled Phase 1/2 Trial of AXO-AAV-GM1 by Erica De Boever is scheduled for October 21. Additionally, Sio will present a poster on AXO-Lenti-PD for Parkinson's disease, reviewing data up to 24 months, highlighting the company's commitment to advancing gene therapies.
Sio Gene Therapies (NASDAQ: SIOX) has announced its participation in the European Society of Gene & Cell Therapy (ESGCT) Virtual Congress 2021, showcasing clinical advancements in AXO-AAV-GM1, a gene therapy for GM1 gangliosidosis. On October 21, 2021, two oral presentations will feature updates from the ongoing Phase 1/2 trial, including data from high- and low-dose cohorts, and a poster on AXO-Lenti-PD for Parkinson’s disease. AXO-AAV-GM1 has received Orphan Drug and Rare Pediatric Disease designations, highlighting its significance in treating rare genetic disorders.
Sio Gene Therapies Inc. (NASDAQ: SIOX) announced its participation in several upcoming investor and scientific conferences. CEO Pavan Cheruvu will present at the Cantor Fitzgerald Global Healthcare Conference on September 27 at 10:00 AM ET and at the Chardan Genetic Medicines Conference on October 5 at 9:00 AM ET. The company will also be represented by Parag V. Meswani at the Alliance for Regenerative Medicine: Cell & Gene Meeting on the Mesa on October 12, with an on-demand presentation available. Sio focuses on developing gene therapies for neurodegenerative diseases.
Sio Gene Therapies Inc. (NASDAQ: SIOX) has made significant progress in its Phase 1/2 study of AXO-AAV-GM1 for GM1 gangliosidosis, enrolling nine patients in total. The first Type I patient has been dosed in the low-dose cohort, marking a crucial milestone. Preliminary results show no serious adverse events linked to the therapy. Sio plans to release 12-month topline data on safety and efficacy in October 2021, with a focus on improving treatment options for patients suffering from this terminal condition, which currently lacks FDA-approved therapies.
