RBC Bioscience Corp.

Alzheimers disease remains one of the worlds most indomitable illnesses, and on Tuesday it defeated yet another potential treatment in an experimental drug from Sage Therapeutics.A mid-stage clinical trial has been evaluating the drug, known as dalzanemdor or SAGE-718, in patients with mild cognitive impairment or mild dementia due to Alzheimers. The study enrolled 174 participants and evaluated them over a 12-week treatment period. According to Sage, the drug didnt have a significantly greater effect on cognition than a placebo.Sage didnt disclose any data, but said it wont further develop the drug for Alzheimers based on the results. Data from a different mid-stage trial testing dalzanemdor in people with cognitive impairment associated with Huntingtons disease should come later this year, according to the company.Alzheimers is an incredibly complex and devastating condition, and people with related mild cognitive impairment and mild dementia need more treatment options, said Barry Greene, Sages CEO, in a statement. While we are disappointed by the results ... [w]e hope our work and these findings help to inform future research.Sages stock price was down more than 10% at markets open Tuesday, but later rebounded. Shares of the Massachusetts-based biotechnology company have lost much of their value this year, and hovered just under $7 apiece Tuesday morning.Dalzanemdor doesnt work like the three Alzheimers medicines that have received approval from the Food and Drug Administration. Those therapies, along with many in development, target a misfolded protein called amyloid beta, which many researchers believe to be a root cause of the memory-robbing disease.Instead, Sages drug targets the proteins on the outside of nerve cells that bind to glutamate. An essential chemical in the brain, glutamate is involved in cognition, mood regulation and memory formation. Given those functions, Sage has tested dalzanemdor across a variety of neurodegenerative diseases.So far, though, the drug hasnt worked. It recently failed a Parkinsons disease study, wherein its effects on brain function were not much different than a placebo. And the now-flunked Alzheimers trial removes yet another potential upside driver, according to Paul Matteis, an analyst at the investment firm Stifel.In a note to clients Tuesday, Matteis wrote that his team had always viewed this study to be high-risk, especially after the prior setbacks. Looking ahead to the Huntingtons study, expectations remain low. Brian Abrahams of RBC Capital Markets echoed those concerns in a note published late last week, in which he downgraded his rating on Sages stock to Underperform.The RBC team sees a low likelihood that dalzanemdor will show clear, clinically meaningful effects in Huntington's or Alzheimer's, Abrahams wrote. Without success for that program, we believe profitability will be difficult to achieve until the very long term and would require significant changes to the company's cost structure, he added.Sage had $647 million in cash, cash equivalents and marketable securities as of June 30. Over the first six months of this year, the company recorded a net loss from operations of $211 million.The past year and a half has been challenging for Sage. Last summer, an approval decision by the FDA sharply cut the sales potential for the companys closely watched depression drug Zurzuvae. In the wake of that decision, Sage laid off 40% of its workforce, deprioritized some of its research programs, and bid farewell to its longtime chief development and scientific officers.Then, a few months ago, another one of the companys experimental drugs lost out in a trial focused on the most common type of tremor. '

Thryv Therapeutics to participate in a fireside chat on Tuesday, October 1st, 2024, from 10:30 a.m. to 11:00 a.m. ET. MONTREAL, Sept. 23, 2024 /PRNewswire/ - Thryv Therapeutics announced today its participation in the upcoming 2024 RBC Capital Markets Private Company Virtual Conference. Thryv will attend on Tuesday, October 1st, 2024, and will sit for a fireside chat from 10:30 a.m. to 11:00 a.m. ET. Company management will also host and participate in one-on-one investor meetings at the conference. To schedule one-on-one meetings with the team, please contact [email protected]. About Thryv Therapeutics Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv Therapeutics is pioneering a precision medicine approach to treat indications including Congenital Long QT Syndrome (LQTS), atrial fibrillation and heart failure, with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase (SGK1). For more information, please visit . SOURCE Thryv Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Dive Brief:An experimental medicine from AstraZeneca and Daiichi Sankyo failed to help people with a common form of breast cancer live longer than those who received standard chemotherapy in a Phase 3 trial, the companies said Monday, raising more questions about the therapys approval prospects.AstraZeneca and Daiichi previously said that the treatment, a so-called antibody-drug conjugate called datopotamab deruxtecan, met one of its study goals by meaningfully delaying tumor progression in certain people with advanced, HER2-negative breast cancer. The partners filed for approval based on that finding, and the Food and Drug Administration is expected to issue a decision by early 2025. That result hasnt translated to a survival benefit, though, which is a stronger measure of a cancer drugs worth. In a statement, AstraZeneca said subsequent treatments study participants received after their disease progressed were likely to have affected survival results. But the finding likely complicates regulatory discussions, wrote Jefferies analyst Peter Welford in a Monday note to investors.Dive Insight:Wall Street analysts have high expectations for datopotomab deruxtecan, which is part of a lucrative alliance between AstraZeneca and Daiichi and is in clinical testing for several cancer types. Jefferies analysts have forecasted that, if approved, the drug could generate $9.4 billion in yearly sales at its peak, with $1.2 billion coming in breast cancer alone.But the future of datopotomab deruxtecan, or dato-dxd for short,is now unclear.In lung cancer,it similarly delayed disease progression in a Phase 3 trial,but didnt extend survival, even among those who had been expected to benefit the most from treatment. That result, which was disclosed earlier this month, led analysts at the investment bank Stifel to speculate that the FDA might delay an approval decision and convene a panel of outside advisers.Dato-dxd could now face a more complex path to market in breast cancer too.Overall survival was one of the two main goals of its breast cancer trial and is the FDAs gold standard for the approval of a cancer drug. Though comparing drugs across trials can be difficult, Jefferies analyst Welford noted that dato-dxds benefit on tumor progression was also broadly in-line with what was observed in testing of Gileads similar rival drug Trodelvy.The results, then, could give Gilead a leg up against a potential competitor, according to RBC Capital Markets analyst Brian Abrahams. The FDA could conceivably reject dato-dxd altogether.But even if it doesnt, the companies wouldnt be able to claim a survival benefit compared to chemotherapy, which Trodelvy was able to achieve in testing, he wrote.Furthermore, doctors sometimes retest patients HER2 status after disease progression. If theyre found to have low, but still detectable levels of the protein, clinicians could steer them towards AstraZeneca and Daiichis Enhertu, which is already marketed for breast cancer.After a slow start, Trodelvy sales grew to $1.1 billion in 2023. Its now Gileads fastest-growing drug, with year-over-year sales growing 30% through the first six months of 2024. '