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Yahoo
4 days ago
- Business
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AbbVie to pay $700M for trispecific drug from Ichnos Glenmark
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that has shown promise in multiple myeloma. Under the terms of the deal announced Thursday, AbbVie will gain rights to ISB 2001 in North America, Europe, Japan and China. Ichnos Glenmark will be eligible for as much as $1.23 billion more in payments if the medicine reaches certain development, regulatory and commercial milestones and will also receive royalties on sales if the drug reaches the market. Glenmark Pharmaceuticals, which joined with Ichnos Sciences to create Ichnos Glenmark in 2024, will be responsible for development, manufacturing and lead commercialization of the drug in emerging markets. That includes the rest of Asia, Latin America and the Middle East. AbbVie is betting on a treatment that promises to knock out cancer cells by engaging three different targets, building on the success of bispecific drugs in oncology. ISB 2001 binds CD3 on T cells, while also hunting for two proteins, BCMA and CD38, that are expressed on cancerous cells. The company says the triple action can eliminate more myeloma cells more effectively, offering the potential of a cure for the disease. AbbVie also aims to test the approach on autoimmune diseases, a therapeutic area where multifaceted antibody drugs have recently attracted interest. The promise of ISB 2001 led the Food and Drug Administration to award Orphan Drug and Fast Track Designations to the drug, smoothing the path for faster development. So far, the experimental treatment has only reached Phase 1 testing. Preliminary results showed an overall response rate of 79% among patients with relapsed or refractory multiple myeloma, according to data presented at the recent American Society of Clinical Oncology's annual meeting. The drug was generally well tolerated, the company said. Sign in to access your portfolio
Yahoo
01-07-2025
- Business
- Yahoo
Atai and Beckley, set to merge, reveal study success for psychedelic drug
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant depression in a Phase 2b study. Shares of Atai jumped 20% after the companies' announcement Tuesday. Atai also announced a $50 million private placement in a financing round led by Ferring Ventures and Apeiron Investment, the family office of Atai founder and Chairman Christian Angermayer. With the successful study in hand and a new infusion of cash, the companies are proceeding with plans to merge in the second half of this year. The combination, announced in June, was contingent on positive results from the Phase 2b trial. Atai had previously scooped up a 36% stake in privately held Beckley in 2024. Atai and Beckley are looking to benefit from a new openness to psychedelic drugs for the treatment of mental health conditions. Both Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration Commissioner Martin Makary have touted the potential benefits of the medicines for patients, while Johnson & Johnson's Spravato, a derivative of ketamine, has generated blockbuster sales. Investors so far have shown a willingness to support the research but are looking for strong results. Compass Pathways recently failed to meet that mark with a medicine that succeeded in a Phase 3 trial but nevertheless disappointed shareholders by only reducing scores on a scale used to gauge depressive symptoms by a mean difference of 3.6 points compared with placebo. Beckley's mebufotenin showed a difference of 5.3 points and 6.3 points for the two therapeutic doses it tested as compared with a low-dose group used as a control when measured at Day 29 after treatment. Wall Street was looking for a difference of at least 5 points, Jefferies analyst Andrew Tsai wrote in a note to clients. Like Spravato, mebufotenin is administered through the nose. Atai and Beckley said participants in its study generally were able to leave the clinic within 90 minutes, which would put the drug in the conventional treatment window established by Spravato. The study also found no serious side effects and no evidence of suicidal intent or behavior in patients given mebufotenin. Researchers tested an 8 milligram dose and a 12 milligram dose against an 0.3 milligram control. The larger difference in depression symptom measurement was in the 8 mg dose, though the companies said they consider efficacy equivalent between the 8 mg and 12 mg doses. They plan to advance the 8 mg dose into Phase 3 testing after consulting with regulators. The companies said improvements were seen as early as one day after treatment and generally lasted at least eight weeks. While the results need to be confirmed in a continuing open-label study of a second dose and the eventual Phase 3 trial, the data suggests Atai and Beckley may be able to offer a longer window between treatments, possibly giving their drug an advantage over rivals such as Spravato, Tsai said. Recommended Reading Compass' big psychedelic study doesn't impress investors
Yahoo
01-07-2025
- Business
- Yahoo
Sage to lay off most staff amid Supernus buyout
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of being acquired by Supernus Pharmaceuticals, according to a Massachusetts regulatory filing. The move comes less than two weeks after Supernus announced it would buy the developer of the postpartum depression drug Zurzuvae for $561 million, a move that one analyst described as an 'unremarkable' outcome for a company that was once worth billions of dollars. The layoffs will be effective Aug. 22, according to the filing. It is unclear how the layoffs will impact ongoing R&D programs Supernus will acquire as part of its deal to buy Sage. Sage has seen its share of ups and downs in the 15 years since its launch. The biotech sought to develop medicines for a variety of brain disorders, including epilepsy, Huntington's disease and major depressive disorder. At its peak, Sage commanded a share price of nearly $200 apiece. It managed to develop and market an intravenous treatment for postpartum depression, Zulresso, but failed to generate notable sales. An oral drug Sage developed next, Zurzuvae, was approved by the Food and Drug Administration in 2023. However, the agency rejected the company's application to permit wider use among people with MDD. Other hurdles included a string of clinical trial busts with its neurology programs. Last fall, Sage cut one-third of its workforce and, earlier this year, said it would pursue strategic alternatives after rebuffing an offer from Biogen to buy out the struggling company. Sage employed 353 full-time employees as of the beginning of February, according to an annual filing. Of those, nearly one-third, or 122 employees, were involved in research and development. Neither Sage nor Supernus responded to BioPharma Dive's request for comment. Recommended Reading Amarin, Fibrogen lay off staff as biotech cost cutting continues Sign in to access your portfolio
Yahoo
18-06-2025
- Business
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A startup banks $66M to pursue ‘inclusive precision medicine'
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to support drug research it's initially aiming at rare genetic diseases, but sees having broader potential, too. Actio's most advanced program is in early-stage testing for the degenerative nerve disorder Charcot-Marie-Tooth disease, but may also be useful in treating overactive bladder, the company said. A second program focused on a genetic form of epilepsy is expected to enter the clinic by the end of the year. The startup's Series B round was co-led by new investor Regeneron Ventures and existing backer Deerfield Management. Canaan, Droia Ventures and Euclidean Capital also participated. Actio emerged from stealth in late 2023 with $55 million in Series A funding and, since then, has brought two small molecule drugs either into or near clinical testing. One of the medicines it's developing, ABS-1230, is for epilepsies caused by mutations in a gene called KCNT1. These KCNT1-related epilepsies can strike early and come with severe health complications, such as an impact on brain function or even death. They're also the target of programs Praxis Precision Medicines, Servier and Atalanta Therapeutics, among others, are pursuing through different drugmaking methods. David Goldstein, Actio's CEO and formerly co-founder of Praxis, claimed that small molecules still hold the most promise for targeting epilepsies related to KCNT1, mutations which cause the overactivation of a kind of ion channel expressed in the brain. Some researchers turned to biologics, believing that they may have a better chance dealing with the disease's myriad mutations, he said. However, Actio believes its drug ABS-1230, which blocks this malfunctioning ion channel, should inhibit all repeatedly observed, disease-causing mutations, making it useful to many patients with the condition. "This kind of inclusive precision medicine is a key priority for the company," Goldstein said. Actio's other drug, ABS-0871, blocks a different ion channel protein called TRPV4 and is currently in a Phase 1 trial with healthy volunteers. By the end of the year, though, Actio intends to start a Phase 1b study in people with the Type 2C form of Charcot-Marie-Tooth, which is characterized by severe muscle weakness and respiratory complications. ABS-0871 is hoping it will show promise in overactive bladder, too, as part of the company's strategy to use insights from its rare disease research in more common disorders. Actio began raising its Series B round at the beginning of the year, and was able to complete it despite an accelerating, sector-wide pullback that's making it harder for companies to close funding rounds. Goldstein attributed its success to picking programs that have 'very high biological plausibility.' 'I'm sure that the climate will return back to funding those ideas that might be huge payoffs later, but it's just a little bit hard to predict,' Goldstein said. 'You really need to have programs that have a pretty predictable path.' 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
13-06-2025
- Business
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BioNTech buys mRNA, courtroom rival CureVac in all-stock deal
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property on messenger RNA drugs. Per deal terms, each CureVac share will be exchanged for about $5.46 worth of BioNTech's U.S.-listed shares, valuing the company at $1.25 billion. Upon the deal's close, CureVac shareholders will own between 4% and 6% of BioNTech. In the early days of the COVID-19 pandemic, BioNTech and CureVac were among the companies racing to develop the first coronavirus vaccines. BioNTech, however, partnered with Pfizer and won approval of the first COVID-19 shot, while CureVac's program never made it to market. The two companies have since been embroiled in patent litigation. CureVac was a leading candidate to develop the first COVID-19 vaccine, launching rumors, later denied, that the U.S. government might even buy the company or its research. But while BioNTech and fellow mRNA drugmaker Moderna succeeded in making vaccines that saved millions of lives and earned billions of dollars in revenue, CureVac fell short. Its initial project wasn't effective enough at preventing sickness, prompting it to scrap development. A year later, CureVac sued BioNTech, claiming it infringed four patents. CureVac has since changed course, selling off most rights to influenza and COVID-19 vaccines to partner GSK and focusing on cancer instead. But its legal spat with BioNTech has lingered. The European Patent Office had upheld two CureVac patents, and a trial in a Dusseldorf regional court was set on July 1 to determine if BioNTech had infringed on them. A separate trial in the U.S. was scheduled to begin Sept. 8 in Virginia. Some Wall Street analysts, as a result, speculated that BioNTech's primary purpose is buying CureVac is to sidestep the risk of a loss in court. A single-digit percentage royalty awarded to CureVac could've cost BioNTech as much as $3 billion, Evercore ISI analyst Umer Raffat wrote in a note to clients. 'It seems to us that [BioNTech] assessed the cost of a cash settlement as substantially greater than the cost of buying [CureVac] outright,' Raffat wrote. The deal could also help BioNTech further its oncology ambitions. Like CureVac, BioNTech has made cancer research a top priority. It's invested in a variety of programs, from cell therapies to mRNA vaccines and a coveted type of bispecific antibody. Some are in advanced testing. CureVac's cancer vaccines are in earlier phases of development. A brain cancer shot has delivered early clinical data, while a lung cancer immunotherapy was cleared in April for human testing. The deal should help CureVac because of 'the early stage of the oncology pipeline and the need for a development partner to effectively compete in personalized cancer vaccines – which [BioNTech] is well positioned to execute,' wrote Leerink Partners analyst Mani Foroohar. Raffat, of Evercore ISI, however, wrote that the deal ascribes 'very little value' to CureVac's pipeline. Recommended Reading Recursion to acquire two Canadian drug discovery startups Sign in to access your portfolio
