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Today, a brief rundown of news from GSK and Amgen, as well as updates from Roche, AbbVie, and Marinus Pharmaceuticals that you may have missed.Amgen set a list price of $1,665 per shot for its biosimilar version of Regenerons Eylea, a 10% discount from the eye drugs current wholesale cost, RBC analyst Brian Abrahams wrote in an Oct. 25 note to clients. On Tuesday, Amgen said it would launch its biosimilar, branded Pavblu, without a legal settlement with Regeneron following a court decision that lifted a temporary injunction on its launch. Such at risk launches are uncommon, and could result in steep penalties for Amgen if subsequent legal judgments side with Regeneron. The small discount means the market impact of Pavblu may be more muted than Amgen investors feared, Abrahams wrote. Further price erosion could occur when additional biosimilars launch. The FDA has approved four others. Jonathan GardnerGSK is making its largest investment in U.S. manufacturing, committing $800 million to expand a site in Marietta, Pennsylvania with new drugmaking facilities. One will handle production of sterile liquid vaccines and medicines, and should be ready by the end of 2028. Another will include a drug substance facility set to start operations by the end of 2027 as well as a pilot plant for making clinical trial medicines. Ned PagliaruloRoche has inked a second research collaboration with gene therapy specialist Dyno Therapeutics. The companies originally linked up in 2020 and, similar to that deal, the one announced Thursday revolves around neurological diseases. Roche and Dyno think the latter's technology can be used to create better “viral vectors“ the microscopic tools that shuttle genetic medicines to a desired target. The new deal tasks Dyno with designing these improved vectors, which will then be applied to potential gene therapies for nervous system disorders. Roche will be responsible for testing the therapies and, if they make it to the market, selling them. Dyno is getting $50 million upfront, plus research payments. It's also eligible for royalties on resulting products, and could nab north of $1 billion more by hitting certain milestones. Jacob BellLongtime partners AbbVie and Gideon Richter are working together on another brain-focused project. Through a sparsely detailed agreement announced Thursday, the companies hope to discover new targets that could be used to treat neuropsychiatric conditions. They plan to share the costs of the necessary research and development. Richter will receive $25 million upfront, and could take home more through milestone and royalty payments. AbbVie, meanwhile, will get worldwide rights to programs that advance to commercialization, except in traditional markets of Richter, such as Europe and Russia. Jacob BellMarinus Pharmaceuticals will lay off staff, cut costs and consider strategic alternatives, after results from a Phase 3 study showed the companys seizure drug ganaxolone did not meet the trials goal. On Thursday, Marinus said the data, while finding nominal reductions in seizure frequency that favored ganaxolone, were likely not enough to support an approval application. The study tested ganaxolone in people with epilepsy related to tuberous sclerosis complex; the drug is already cleared for use treating seizures in people with a condition called CDKL5 deficiency disorder. Ned Pagliarulo '

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. '

Dive Brief:Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded.Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and depressive episodes associated with bipolar disorder. Intra-Cellular now wants to add major depressive disorder to the list.The latest study followed 480 patients already medicated to treat depression. Patients who randomly received Caplyta as an add-on to existing therapy showed a significantly better response on scales that measure depression symptoms compared with participants who received a placebo, Intra-Cellular said Tuesday.Dive Insight:The results could open up a huge potential market for Intra-Cellular. Major depressive disorder affects about 21 million people in the U.S. each year, and first-line treatments fail to completely address the condition for about two-thirds of patients, according to the company.If approved for major depressive disorder, Caplytas sales could top $3 billion a year, analysts said. RBC Capital Markets estimates the indication could add as much as $1.7 billion. Caplytas launch for schizophrenia and bipolar depression has already been impressive, with sales on track to reach an annual peak of $2 billion, Jefferies analyst Andrew Tsai said in a note to clients.Efficacy results from the latest study, 502, look very similar to the outstanding data from the first trial, known as 501, RBC analyst Brian Abrahams wrote in a note to clients. Safety and tolerability were also consistent with previous research. Given all that, the second study clears a straightforward path for approval of Caplyta in depression, Abrahams said.Intra-Cellular said it intends to submit an application to the Food and Drug Administration in the second half of this year to include adjunctive treatment of major depressive disorder in Caplytas label. That would set up a potential approval for the new use in 2025.Intra-Cellulars success comes at a time when the pharmaceutical industry is paying more attention to psychiatry drugs after years of neglect. Late last year, Bristol Myers Squibb agreed to buy Karuna Therapeutics for $14 billion to gain an experimental schizophrenia drug with blockbuster potential. AbbVie acquired Cerevel Therapeuticsin a multibillion-dollar deal as well. '