Latest news with #MylesMinter
Business Insider
07-05-2025
- Business
- Business Insider
William Blair Keeps Their Buy Rating on Denali Therapeutics (DNLI)
In a report released today, Myles Minter from William Blair reiterated a Buy rating on Denali Therapeutics (DNLI – Research Report). The company's shares closed yesterday at $13.97. Protect Your Portfolio Against Market Uncertainty Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. According to TipRanks, Minter is a 4-star analyst with an average return of 5.0% and a 48.62% success rate. Minter covers the Healthcare sector, focusing on stocks such as Axsome Therapeutics, Alnylam Pharma, and Arcturus Therapeutics. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Denali Therapeutics with a $39.00 average price target.
Reuters
16-04-2025
- Health
- Reuters
EU authorizes Eisai-Biogen's drug for early Alzheimer's treatment
April 15 (Reuters) - The European Commission on Tuesday authorized the use of Eisai (4523.T), opens new tab and Biogen's (BIIB.O), opens new tab drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than two-year-long review process. This makes Leqembi the first approved drug in the European Union that targets an underlying cause of the fatal mind-wasting disease. It had been under regulatory review since January 2023. here. Biogen's head of development, Priya Singhal, said the company and its partner Eisai were "moving with urgency" to make the therapy available to patients in Europe. Rival Eli Lilly's (LLY.N), opens new tab Alzheimer's drug was rejected last month as its benefits were not significant enough to outweigh serious safety risks. The authorization allows the use of Leqembi to treat people with only one or no copy of the ApoE4 gene and who exhibit sticky clumps of a protein called amyloid beta in the brain, which is believed to be a hallmark of Alzheimer's. The decision to exclude those with two copies of the gene is the regulator leaning on the side of safety, said William Blair analyst Myles Minter. He estimates over $900 million peak sales for the drug in the 2030s. The EC's decision is in line with that of the European Medicines Agency, which recently reiterated that Leqembi would be approved for a narrower set of patients than those in which it was tested. The regulator had backed Leqembi for patients with only one copy of the ApoE4 gene, but the EC had requested another safety review. Initially, the European medicines regulator had refused to back the drug's approval due to serious safety risks. Leqembi is approved in the United States for patients with two copies of the gene, but patients must undergo regular brain scans to monitor for any brain swelling. Leqembi is also approved in Japan, China, Great Britain and several other markets.
Yahoo
11-02-2025
- Business
- Yahoo
Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As 'Top Pick For 2025'
On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) signed a settlement agreement with Teva Pharmaceuticals Inc (NYSE:TEVA). The settlement resolves all patent litigation related to Axsome's Auvelity (dextromethorphan HBr – bupropion HCl) product. Auvelity is approved in the U.S. for major depressive disorder. The litigation resulted from Teva submitting an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Auvelity in the U.S. before the expiration of applicable Axsome patents. Also Read: Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of Auvelity beginning on or after March 31, 2039, if pediatric exclusivity is granted for Auvelity, or on or after September 30, 2038, if no pediatric exclusivity is granted. The parties will terminate all ongoing litigation between Axsome and Teva regarding Auvelity patents pending in the U.S. District Court for the District of New Jersey. In January, Axsome Therapeutics reported preliminary Auvelity net product sales are expected to be approximately $92.6 million and $291.4 million for the fourth quarter and full year of 2024, respectively. Recently, the FDA approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults. 'Axsome is our top pick for 2025,' William Blair writes. Analyst Myles Minter reiterates the Outperform rating based on favorable litigation settlement and clarity on Auvelity's generic launch timing. 'We also remain impressed with the Auvelity launch, which showed 15% growth in revenue over the prior quarter and is annualizing about $370 million after two years of launch,' William Blair adds. Axsome now has three commercial products with the approval of Symbravo for migraines. While investors are mainly watching Auvelity's rollout for depression and its potential use in Alzheimer's-related agitation, analyst Minter writes Symbravo's potential in treating acute migraines is being overlooked. William Blair also views Axsome as a takeout candidate with Johnson & Johnson buying Intra-Cellular Therapies Inc. for $14.6 billion. Needham analyst Ami Fadia reiterates Axsome Therapeutics with a Buy and maintains a $133 price target. Price Action: AXSM stock is up 24.6% at $131.77 at last check Monday. Read Next:Photo: Courtesy of Ulf Wittrock via Shutterstock. Date Firm Action From To Mar 2022 SVB Leerink Maintains Outperform Nov 2021 SVB Leerink Maintains Outperform Aug 2021 HC Wainwright & Co. Maintains Buy View More Analyst Ratings for AXSM View the Latest Analyst Ratings UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? AXSOME THERAPEUTICS (AXSM): Free Stock Analysis Report This article Axsome Therapeutics Resolves Generic Patent Litigation With Teva Over Depression Drug, Analyst Maintains Axsome As 'Top Pick For 2025' originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
