Latest news with #ASCENT
Yahoo
27-05-2025
- Business
- Yahoo
Why Is Prothena Stock Trading Lower On Tuesday?
Prothena Corporation plc (NASDAQ:PRTA) released data from the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis on Friday. AL (amyloid light-chain) amyloidosis is a systemic disease where abnormal proteins, called amyloid fibrils, accumulate in various organs. It's the most common type of systemic amyloidosis. The Phase 3 AFFIRM-AL trial enrolled 207 newly diagnosed patients. Birtamimab was given to the active arm every 28 days at a dose level of 24 mg/kg (maximum dose not to exceed 2500 mg). Patients in both the active and control arms received a bortezomib-containing chemotherapy regimen as the standard of care, and the use of daratumumab was trial did not meet its primary endpoint (HR=0.915, p-value=0.7680). Based on these results, the company will discontinue the development of birtamimab, including stopping the open-label extension of the AFFIRM-AL clinical trial. 'This is not the outcome that we expected, and we are surprised and disappointed by these results...,' said Gene Kinney, President and Chief Executive Officer, Prothena. 'With these results, we believe that the most appropriate action is to discontinue all development of birtamimab.' In the Phase 3 AFFIRM-AL clinical trial, the primary endpoint of time to all-cause mortality was not met for patients treated with birtamimab. In addition, neither of the secondary endpoints: 6-minute walk test distance (nominal p-value=0.5288) and Short Form-36 version 2 Physical Component Score (nominal p-value=0.9597). Birtamimab was generally safe and well-tolerated, consistent with its established safety profile. 'While we are all disappointed with today's results, Prothena has meaningful data readouts and pipeline updates over the next 18 months,' said Daniel G. Welch, Chair of Prothena's Board of Directors. 'We look forward to initial data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease expected in August, and program updates from our partners at Roche expected mid-year, Novo Nordisk expected in 2H25, and Bristol Myers Squibb expected in 2026. The company and board have begun the work to thoughtfully and expeditiously decrease spend, including but not limited to an expected substantial workforce reduction, and evaluate with its financial advisors business options in the best interest of its shareholders.' In June, the company expects to provide details of plans to reduce ongoing operating expenses. Once the analysis and plans are finalized, the company will communicate the results of reviewing its business options as appropriate. Price Action: At the last check on Tuesday, PRTA stock was down 26.80% at $4.82 during the premarket session. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Why Is Prothena Stock Trading Lower On Tuesday? originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
Prothena Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary Endpoint
Birtamimab did not meet the primary endpoint of time to all-cause mortality or the secondary endpoints Birtamimab development will be discontinued, including stopping the open label extension of the AFFIRM-AL clinical trial Company will decrease ongoing operating expenses, including an expected substantial reduction in organizational size, and plans to provide a further update in June DUBLIN, May 23, 2025--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA) today announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680). Based on these results, the Company will discontinue the development of birtamimab, including stopping the open label extension of the AFFIRM-AL clinical trial. "This is not the outcome that we expected, and we are surprised and disappointed by these results for patients, their families and caregivers, and for the entire AL amyloidosis community," said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. "With these results, we believe that the most appropriate action is to discontinue all development of birtamimab. Prothena would like to thank all of the patients, their families and caregivers, and the investigators, site staff and Prothenians that made this clinical trial possible." In the Phase 3 AFFIRM-AL clinical trial, the primary endpoint of time to all-cause mortality was not met for patients treated with birtamimab. In addition, neither of the secondary endpoints were met: 6-minute walk test distance (nominal p-value=0.5288) and Short Form-36 version 2 Physical Component Score (nominal p-value=0.9597). Birtamimab was generally safe and well-tolerated, consistent with its established safety profile. "While we are all disappointed with today's results, Prothena has meaningful data readouts and pipeline updates over the next 18 months," said Daniel G. Welch, Chair of Prothena's Board of Directors. "We look forward to initial data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease expected in August, and program updates from our partners at Roche expected mid-year, Novo Nordisk expected in 2H25, and Bristol Myers Squibb expected in 2026. The Company and board have begun the work to thoughtfully and expeditiously decrease spend, including but not limited to an expected substantial workforce reduction, and evaluate with its financial advisors business options in the best interest of its shareholders." In June, the Company expects to provide details of plans to reduce ongoing operating expenses. The results of the Company's review of its business options will be communicated as appropriate once the analysis and plans are finalized. About the Phase 3 AFFIRM-AL Clinical Trial The Phase 3 AFFIRM-AL clinical trial was a global, double-blind, placebo-controlled, time-to-event clinical trial that enrolled 207 newly diagnosed, treatment naïve patients with Mayo Stage IV AL amyloidosis. Birtamimab was given to the active arm every 28 days at a dose level of 24 mg/kg (maximum dose not to exceed 2500 mg). Patients in both the active and control arms received a bortezomib-containing chemotherapy regimen as standard of care, and use of daratumumab was allowed. 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 sufficiency of our cash position to fund advancement of a broad pipeline and completion of our ongoing clinical trials; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2025, 2026, and beyond, including upcoming initial data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease expected in August 2025, and program updates from our partners at Roche expected mid-year, Novo Nordisk expected in 2H25, and Bristol Myers Squibb expected in 2026; our efforts to reduce ongoing operating expenses, including the timing and scope of any such activities, and a potential workforce reduction; and our evaluation of business options. 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 uncertainties related to the completion of operational and financial closing procedures, audit adjustments and other developments that may arise that would require adjustments to the preliminary financial results included in this press release, as well as 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. View source version on Contacts InvestorsMark Johnson, CFA, Vice President, Investor Relations650-417-1974, MediaMichael Bachner, Senior Director, Corporate Communications609-664-7308, Sign in to access your portfolio
Business Wire
23-05-2025
- Business
- Business Wire
Prothena Announces Phase 3 AFFIRM-AL Clinical Trial for Birtamimab in Patients with AL Amyloidosis Did Not Meet Primary Endpoint
DUBLIN--(BUSINESS WIRE)--Prothena Corporation plc (NASDAQ:PRTA) today announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680). Based on these results, the Company will discontinue the development of birtamimab, including stopping the open label extension of the AFFIRM-AL clinical trial. 'This is not the outcome that we expected, and we are surprised and disappointed by these results for patients, their families and caregivers, and for the entire AL amyloidosis community,' said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. 'With these results, we believe that the most appropriate action is to discontinue all development of birtamimab. Prothena would like to thank all of the patients, their families and caregivers, and the investigators, site staff and Prothenians that made this clinical trial possible.' In the Phase 3 AFFIRM-AL clinical trial, the primary endpoint of time to all-cause mortality was not met for patients treated with birtamimab. In addition, neither of the secondary endpoints were met: 6-minute walk test distance (nominal p-value=0.5288) and Short Form-36 version 2 Physical Component Score (nominal p-value=0.9597). Birtamimab was generally safe and well-tolerated, consistent with its established safety profile. 'While we are all disappointed with today's results, Prothena has meaningful data readouts and pipeline updates over the next 18 months,' said Daniel G. Welch, Chair of Prothena's Board of Directors. 'We look forward to initial data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease expected in August, and program updates from our partners at Roche expected mid-year, Novo Nordisk expected in 2H25, and Bristol Myers Squibb expected in 2026. The Company and board have begun the work to thoughtfully and expeditiously decrease spend, including but not limited to an expected substantial workforce reduction, and evaluate with its financial advisors business options in the best interest of its shareholders.' In June, the Company expects to provide details of plans to reduce ongoing operating expenses. The results of the Company's review of its business options will be communicated as appropriate once the analysis and plans are finalized. About the Phase 3 AFFIRM-AL Clinical Trial The Phase 3 AFFIRM-AL clinical trial was a global, double-blind, placebo-controlled, time-to-event clinical trial that enrolled 207 newly diagnosed, treatment naïve patients with Mayo Stage IV AL amyloidosis. Birtamimab was given to the active arm every 28 days at a dose level of 24 mg/kg (maximum dose not to exceed 2500 mg). Patients in both the active and control arms received a bortezomib-containing chemotherapy regimen as standard of care, and use of daratumumab was allowed. 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 sufficiency of our cash position to fund advancement of a broad pipeline and completion of our ongoing clinical trials; the continued advancement of our discovery, preclinical, and clinical pipeline, and expected milestones in 2025, 2026, and beyond, including upcoming initial data from the Phase 1 ASCENT clinical trials on PRX012 in Alzheimer's disease expected in August 2025, and program updates from our partners at Roche expected mid-year, Novo Nordisk expected in 2H25, and Bristol Myers Squibb expected in 2026; our efforts to reduce ongoing operating expenses, including the timing and scope of any such activities, and a potential workforce reduction; and our evaluation of business options. 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 uncertainties related to the completion of operational and financial closing procedures, audit adjustments and other developments that may arise that would require adjustments to the preliminary financial results included in this press release, as well as 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.
Yahoo
27-04-2025
- Science
- Yahoo
ASCENT's Technology Expo aims to inspire careers in STEM fields
BAY COUNTY, Fla. (WMBB) – Gadgets and gizmos galore, the ASCENT program hosted its third annual Technology Expo at Florida State University, Panama City, on Saturday. ASCENT stands for Advancing Science and Career Education in New Technologies. It's a $23 million program, partially funded by Triumph Gulf Coast and Florida State University, Panama City. The program is designed to build up the IT and cybersecurity workforce. Ascent built a K-12 program for students, serving eight coastal counties on the Gulf Coast that were impacted by the BP oil spill. The tech expo provides a variety of STEM activities to get kids interested in technology. They can launch a bottle rocket, play Minecraft, visit the mobile planetarium, and operate sphere bots. The activities help prepare kids for the future of artificial intelligence. Car crash turns into shooting investigation in Okaloosa County 'We all are going to rely on these kids to keep our information secure and work for the companies that we use every day. And so getting them started and getting them excited, you know, helping them to learn how to utilize A.I. appropriately,' FSU Panama City Ascent K-12 Program Manager Brianne Biddle said. 'A.I. is going to take over the world. But at the same time, you have to have somebody that knows how to speak to it because it can't do it alone. And that's one of the things that this tech expo is supposed to do. It teaches people how to utilize things like A.I., how to utilize systems engineering, how to where electrical engineering, mechanical engineering, where that fits in your day-to-day life,' FSU Panama City Ascent Program Director Duriel Crittenden said. The tech expo also showcases local integrated technology clubs. Students can show off the projects they've been working on throughout the school year, such as their self-made robots. While on campus, students can learn more about the engineering programs offered at FSU Panama City. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
27-04-2025
- Automotive
- Yahoo
Free fun for kids at the 28th annual 'Kidfest'
BAY COUNTY, Fla. (WMBB) – Something big was brewing at the Central Panhandle Fairgrounds on Saturday. The Early Education and Care Head Start program is hosting its biggest event of the year to celebrate the little ones. They held their 28th annual 'Kidfest'. Early education and care is an educational program for children that also provides comprehensive services for families. It is a day about the kiddos, with 40 different agencies providing all sorts of fun activities for the children. Program Director Janice Flowers says the event offers free fun for children. ASCENT's Technology Expo aims to inspire careers in STEM fields 'It is truly rewarding to see the smiles on our children's faces, but also the smiles on the parents' faces. Too, to see because it's not a lot of things that are being provided today for children. That's not expensive. You can walk into these gates today for free and have fun,' Early Education & Care Head Start Program Director Janice Flowers said. They were joined by law enforcement agencies, like the Panama City Fire Department, the Bay County Sheriff's Office, and the Florida Highway Patrol. The Florida Highway Patrol brought a car crash simulator machine to teach children about car safety. PanCare and the health department were also there to provide physicals and dental exams for children. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
