Latest news with #PADOVA
Yahoo
17-06-2025
- Business
- Yahoo
Roche's Phase 3 Move Boosts Outlook for Prothena Corporation plc (PRTA)
Prothena Corporation plc (NASDAQ:PRTA) is among the best NASDAQ stocks under $50 to buy. Roche, a partner of Prothena Corporation plc (NASDAQ:PRTA), has announced plans to initiate Phase 3 development of prasinezumab for early-stage Parkinson's disease. Although the company faced a setback with birtamimab, which failed to meet the desired result, the giant is keen on taking things forward with new developments. This decision comes after the company's favorable Phase 2b PADOVA results and sustained follow-up data highlighting clinical benefit when prasinezumab solution and symptomatic treatment are used together. This creates exciting opportunities for the company, which has a potential upside of over 300%, as the one-year price target of $24.29 by Yahoo Finance suggests. A doctor examining the results of a patient's medical scan displayed on a computer monitor. One thing that is most important for companies such as Prothena Corporation plc (NASDAQ:PRTA) is the determination to stand strong despite failures. The company's strong pipeline, including Alzheimer's, Parkinson's, and ATTR-CM candidates, makes us believe that achieving the upside potential isn't hard to achieve, particularly when the Alzheimer's Disease market is anticipated to reach $19.3 billion by 2033. Prothena Corporation plc (NASDAQ:PRTA) is an Ireland-based late-stage clinical biotechnology company that identifies and develops novel therapies for diseases caused by protein dysregulation. Incorporated in 2012, the company focuses on advancing therapies through clinical development, often in collaboration with other organizations. While we acknowledge the potential of PRTA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Business Wire
16-06-2025
- Health
- Business Wire
Genentech to Advance Prasinezumab Into Phase III Development for Early-Stage Parkinson's Disease
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today its decision to proceed with Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson's disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLEs) of PADOVA and Phase II PASADENA studies. "We are encouraged by the efficacy signals observed across the two Phase II trials and their open-label extensions, combined with the favorable safety and tolerability profile of prasinezumab," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We also recognize the substantial need for new treatment options, and the totality of data suggest that prasinezumab may have the potential to become the first disease-modifying treatment for people with Parkinson's disease." Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson's disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology. The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson's disease, are ongoing. About prasinezumab Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease. Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson's disease. PADOVA investigated prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance (p=0.0657). In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99], p=0.0431 (nominal). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The safety database for prasinezumab consists of data from more than 900 Parkinson's disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years. Roche/Genentech entered into a Licensing, Development, and Commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting aggregated alpha-synuclein, such as prasinezumab, for the treatment of Parkinson's disease. About Parkinson's disease Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells, and the development of motor and non-motor symptoms that may appear years before diagnosis. Today, Parkinson's disease affects over 10 million people worldwide. The prevalence of Parkinson's disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available today, having a significant impact on people's quality of life; however, no available symptomatic therapies slow down or stop the clinical progression of Parkinson's disease and the effects wear off over time as the disease progresses. Genentech and Roche are evaluating multiple approaches to slow down disease progression and potentially prevent Parkinson's disease that involve targeting underlying disease processes such as aggregated α-syn production, lysosomal dysfunction and neuroinflammation. About Genentech in Neuroscience Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer's disease, Huntington's disease, Parkinson's disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit
Business Wire
16-06-2025
- Business
- Business Wire
Prothena's Partner Roche to Advance Prasinezumab into Phase III Development for Early-Stage Parkinson's Disease
DUBLIN--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA) today announced partner Roche will advance prasinezumab, an investigational anti-alpha-synuclein antibody, into Phase III development in early-stage Parkinson's disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLE) from both PADOVA and the Phase II PASADENA study. 'As pioneers in developing the first anti-alpha-synuclein targeting antibody, we are excited to see Roche advancing prasinezumab into Phase III development, with the potential to deliver the first disease-modifying treatment option to the millions of individuals living with Parkinson's disease and their families,' stated Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. Multiple endpoints from the PADOVA and OLE studies suggest a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson's disease. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, although missed statistical significance. Positive trends towards reduced motor progression at 104 weeks (two years) were observed; these effects appear to be sustained over longer treatment periods based on additional OLE data. The PADOVA study also provided the first biomarker evidence of prasinezumab impacting the underlying disease biology. The PASADENA and PADOVA OLE studies, which are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson's disease, are ongoing. About Prasinezumab Prasinezumab is an investigational monoclonal antibody designed to bind aggregated alpha-synuclein and thereby reduce neuronal toxicity. By reducing the build-up of alpha-synuclein protein in the brain, prasinezumab can potentially prevent further accumulation and spreading between cells, which may slow progression of the disease. Data from the Phase IIb PADOVA study suggest the possible clinical benefit of prasinezumab on top of effective symptomatic treatment in early-stage Parkinson's disease. PADOVA investigated prasinezumab in 586 people with early-stage Parkinson's disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression with a HR=0.84 [0.69-1.01], although the study missed statistical significance (p=0.0657). In a pre-specified analysis, the effect of prasinezumab was more pronounced in the population treated with levodopa (75% of participants), HR=0.79 [0.63-0.99], p=0.0431 (nominal). Consistent positive trends across multiple secondary and exploratory endpoints were also observed. Trends towards reduced motor progression at 104 weeks (two years) were observed, showing 30-40% relative reduction versus placebo across the overall and levodopa-treated populations. Prasinezumab continues to be well tolerated and no new safety signals were observed in the study. The safety database for prasinezumab consists of data from more than 900 Parkinson's disease study participants that have been treated with the investigational medicine, of which more than 750 remain in open label treatment with over 500 treated for 1.5-5 years. In December 2013, Prothena and Roche entered into a worldwide collaboration to develop and commercialize antibodies that target alpha-synuclein, including prasinezumab. Roche has sole responsibility for developing and commercializing prasinezumab and has agreed to pay Prothena up to double-digit teen royalties on net sales. To date, Prothena has earned $135 million with up to $620 million in additional milestone payments that include regulatory and sales milestones. In addition, Prothena has an option to co-promote prasinezumab in the U.S. About Parkinson's disease Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disease characterized by the gradual loss of neurons that make dopamine and other nerve cells. Today, Parkinson's disease affects over 10 million people worldwide. The prevalence of Parkinson's disease is increasing, and it has become one of the fastest-growing neurological disorders. Currently, symptomatic treatments that effectively alleviate motor symptoms are available. However, no therapies slow down or stop the clinical progression of Parkinson's disease. About Prothena Prothena Corporation plc is a clinical-stage biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena's pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including ATTR amyloidosis with cardiomyopathy, Alzheimer's disease, Parkinson's disease and a number of other neurodegenerative diseases. For more information, please visit the Company's website at and follow the Company on X (formerly Twitter) @ProthenaCorp. Forward-Looking Statements This press release contains forward-looking statements. These statements relate to, among other things, the treatment potential, design, and proposed mechanism of action prasinezumab; plans for ongoing and future clinical trials of prasinezumab; and amounts we might receive under our collaboration with Roche. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to those described in the 'Risk Factors' sections of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2025, and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. We undertake no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events, or changes in our expectations.
