Voyager Therapeutics, Inc. - VYGR STOCK NEWS

Voyager Therapeutics (Nasdaq: VYGR) announced that the FDA has placed a clinical hold on the RESTORE-1 clinical trial for NBIb-1817 (VY-AADC), an investigational gene therapy for Parkinson's disease. This hold is due to MRI abnormalities observed in some trial participants, and additional patient data is required for review by the Data Safety Monitoring Board (DSMB) in early 2021. The trial had already been inactive due to COVID-19. Voyager and partner Neurocrine Biosciences are working with the FDA to address these concerns and determine the future course of the trial.

Voyager Therapeutics (NASDAQ: VYGR) reported strong third-quarter 2020 results, highlighting significant collaboration revenues of $117.8 million, up from $20.4 million in Q3 2019. The company achieved a net income of $85.6 million, a turnaround from a $15.0 million loss last year. Research and development expenses decreased to $25.0 million from $29.8 million. Despite challenges, including clinical holds and a pause in trial enrollments, Voyager anticipates ending the year with $150-$170 million in cash and equivalents, sufficient for operations into mid-2022.

Voyager Therapeutics (NASDAQ: VYGR) announced on October 12, 2020, that its IND submission for VY-HTT01, aimed at treating Huntington's disease, is on clinical hold due to unresolved chemistry, manufacturing, and controls (CMC) issues. The FDA notified Voyager of this status, and the company expects specific feedback within 30 days. Huntington's disease affects over 40,000 individuals in the U.S. with no approved treatments targeting its underlying cause. Voyager is committed to addressing the CMC matters and advancing the clinical evaluation of VY-HTT01.

Voyager Therapeutics (NASDAQ: VYGR) announced a new employment agreement that includes inducement awards for a newly hired employee. The agreement includes a non-qualified stock option for 36,000 shares and restricted stock units for 6,000 shares, both effective on September 30 and October 1, 2020, respectively. The option has a ten-year term with an exercise price of $10.67, and it vests over four years. The restricted stock units vest over three years. These awards aim to attract talent to support the company’s focus on developing gene therapies for severe neurological diseases.

Voyager Therapeutics (NASDAQ: VYGR) has appointed Nancy Vitale as an independent director to its Board of Directors, effective September 15, 2020. Vitale has over 25 years of human resources experience, including a role as Chief Human Resource Officer at Genentech. Her expertise is expected to enhance Voyager's focus on patient-centric culture and employee wellbeing. Vitale also co-founded a human resources consulting firm and will serve on the Board's Compensation Committee. This appointment aims to bolster the company's mission to develop treatments for severe neurological diseases.

Voyager Therapeutics (NASDAQ: VYGR) announced the appointment of Michelle Quinn Smith as Chief Human Resources Officer, bringing over 30 years of HR experience. Previously at Flagship Pioneering and Takeda Pharmaceuticals, Smith aims to enhance organizational strategies. Voyager approved inducement grants for her, including 100,500 stock options and 17,000 restricted stock units. The options have a ten-year term with an exercise price of $10.40 per share, and vest over four years. Voyager focuses on gene therapies for severe neurological diseases.

NBIb-1817 (VY-AADC), an investigational gene therapy for Parkinson's disease, demonstrated sustained improvements in motor function over three years. Data from the Phase Ib PD-1101 trial revealed that 14 of 15 patients reported enhanced disease staging, with reduced "Off" time by up to 1.91 hours and increased "On" time without dyskinesia by up to 2.23 hours. Additionally, medication requirements were lowered significantly, with reductions in daily dosages. The company plans to re-initiate enrollment in the registrational RESTORE-1 clinical trial later this year.

Voyager Therapeutics (NASDAQ: VYGR) has announced significant updates on their investigational gene therapy, VY-AADC, for advanced Parkinson's disease, with presentations at the International Parkinson and Movement Disorder Virtual Congress from September 12-16, 2020. Key findings include three-year safety and clinical outcomes from the PD-1101 trial and 24-month results from the PD-1102 trial. Moreover, Voyager will participate in upcoming investor conferences, including the Wells Fargo Healthcare Conference on September 9, 2020. More details can be found on their website.

Voyager Therapeutics (NASDAQ: VYGR) will release its Q2 2020 financial results and corporate updates on August 10, 2020, before U.S. markets open. The company is focused on gene therapy for severe neurological diseases and will participate in three virtual investor conferences from August 10 to August 12. These events highlight Voyager's commitment to advancing AAV gene therapy and its pipeline targeting therapies for diseases like Parkinson's and Huntington's.