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Biogen strikes RNAi deal with City; Aurion withdraws IPO
Biogen strikes RNAi deal with City; Aurion withdraws IPO

Yahoo

time28-05-2025

  • Business
  • Yahoo

Biogen strikes RNAi deal with City; Aurion withdraws IPO

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving City Therapeutics and Grin Therapeutics, as well as updates from Savara Pharma, Aurion Biotech and Prothena that you may have missed. Biogen is partnering with RNA drug developer City Therapeutics to develop a better way of reaching a unspecified target that 'mediates key central nervous system diseases.' Biogen will pay City, a startup that launched publicly late last year, $16 million in upfront fees and invest another $30 million in convertible notes that could later become a minority stake. 'With this effort, we are further expanding the modalities in our R&D toolbox to potentially reach our targets of interest more precisely by adding an RNAi-based approach," Biogen research head Jane Grogan said in a statement. — Ned Pagliarulo Biotechnology startup Grin Therapeutics will get $50 million in a deal that hands Angelini Pharma rights outside of North America to an experimental drug Grin has developed for genetic epilepsies and other neurological conditions. On Tuesday, Grin also announced the closing of a $140 million Series D round that involved Angelini and Blackstone Life Sciences. Grin's drug, radiprodil, targets a receptor that is thought to contribute to epilepsy when overactivated. The company plans to start a Phase 3 trial in the third quarter that will test radiprodil in a neurodevelopmental condition that causes seizures. — Gwendolyn Wu The Food and Drug Administration declined to review a drug Savara is developing for a rare lung condition called pulmonary alveolar proteinosis. According to Savara, the agency deemed the company's application incomplete and asked for more information about how the treatment, Molbreevi, is made. The FDA didn't identify any safety issues or request more efficacy data, Savara said. The company will request a meeting with the FDA within the next month. Its share price fell by more than 20% Tuesday.— Ben Fidler Aurion Biotech has withdrawn plans to go public, according to a regulatory filing. The cell therapy developer filed for an initial public offering in January, but did so despite opposition from shareholder Alcon, leading to a legal spat between the firm and another equity holder, Deerfield Management, over Aurion's future. Alcon bought a majority stake in Aurion in late March, however, and replaced the biotech's CEO. Aurion said in a Friday filing that an IPO is no longer "in the best interests of the company." — Ben Fidler Shares in Prothena fell by more than 30% to open Tuesday trading following the company's disclosure Friday that a late-stage trial of a drug called birtamimab failed to reach its main goal. As a result, Prothena has decided to shelve further development of birtamimab, which it had been studying as a treatment for the disease AL amyloidosis. 'This is not the outcome that we expected, and we are surprised and disappointed by these results,' said Prothena CEO Gene Kinney, in a statement. The company is now considering ways to reduce expenses, among them an expected substantial workforce reduction.' — Ned Pagliarulo Recommended Reading Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff 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

Why Is Prothena Stock Trading Lower On Tuesday?
Why Is Prothena Stock Trading Lower On Tuesday?

Yahoo

time27-05-2025

  • 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

Prothena announces AFFIRM-AL trial did not meet primary endpoint
Prothena announces AFFIRM-AL trial did not meet primary endpoint

Business Insider

time24-05-2025

  • Business
  • Business Insider

Prothena announces AFFIRM-AL trial did not meet primary endpoint

Prothena (PRTA) announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint. Based on these results, the company will discontinue the development of birtamimab, including stopping the open label extension of the AFFIRM-AL clinical trial. 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 and Short Form-36 version 2 Physical Component Score. Birtamimab was generally safe and well-tolerated, consistent with its established safety profile. 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. Confident Investing Starts Here:

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