Key Takeaways BIIB teams up with Dayra to discover and develop oral macrocyclic peptides for immunological targets.The collaboration leverages Dayra's platform to identify and optimize candidates that BIIB may advance.BIIB will pay $50M upfront and may make milestone payments as it builds its immunology pipeline.Biogen (BIIB) announced the signing of a research collaboration agreement with privately held Dayra Therapeutics to discover and develop oral macrocyclic peptides for priority targets in immunologic ...

Key Takeaways The EU approved Dupixent for moderate-to-severe chronic spontaneous urticaria in patients 12 and older.Study A and C showed Dupixent reduced itch and hives and improved disease control versus placebo at 24 weeks.Safety findings from all LIBERTY-CUPID studies aligned with the known safety profile of Dupixent.Sanofi (SNY) and partner Regeneron (REGN) announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (“CS ...

On Monday, the U.S. Food and Drug Administration (FDA) approved Novartis AG’s (NYSE:NVS) Itvisma (onasemnogene abeparvovec-brve) for children two years and older, teens, and adults with spinal muscular atrophy (SMA). The approval makes the gene replacement therapy the first and only one available for this broad population.Itvisma addresses the genetic root cause of SMA. The one-time fixed dose does not need adjustment for age or body weight.The patients with SMA have a confirmed mutation in the survival mot ...

Novo Nordisk A/S (NYSE:NVO) on Tuesday released headline results from a phase 2 trial with amycretin for type 2 diabetes.The update marks the first evaluation of amycretin in people with type 2 diabetes.Novo Nordisk is planning to initiate a phase 3 development program with amycretin for adults with type 2 diabetes in 2026. In June, the company said it planned to initiate a phase 3 development for amycretin for adults with overweight or obesity in the first quarter of 2026.The trial evaluated once-weekly su ...

CHONGQING, CHINA - SEPTEMBER 10: In this photo illustration, the logo of Novo Nordisk is displayed on a smartphone screen on September 10, 2025 in Chongqing, China. The maker of Wegovy and Ozempic, Novo Nordisk, has announced it will cut 9,000 jobs weeks after warning that profits will fall as more "knock-off" weight-loss drugs emerge. (Photo by Li Hongbo/VCG via Getty Images)VCG via Getty ImagesNovo Nordisk’s stock has faced pressure following its Ozempic pill’s failure in Alzheimer’s disease trials, intro ...

Financial Data and Key Metrics Changes - The cash position as of September 30 was $102.6 million, with no debt reported [15] - Cash utilized in operating activities during the quarter was $8.6 million, with a current cash balance of over $120 million, indicating a cash runway of more than three years at the current utilization rate [16] - Research and development expenses for the quarter were $7.3 million, down from $11.6 million in the same quarter last year, while general and administrative expenses increased to $3.5 million from $2.7 million [16][17] - The net loss for the quarter was $9.8 million, equating to $0.11 per share [17] Business Line Data and Key Metrics Changes - The company is focused on advancing its precision medicine compounds, particularly Blarcamesine and ANAVEX®3-71, with ongoing clinical trials and regulatory actions [3][11] - Blarcamesine has shown significant clinical efficacy in slowing cognitive decline in early Alzheimer's disease patients, with a reported decline of less than 2.68 points on the ADAS-Cog13 scale compared to control groups [9][10] Market Data and Key Metrics Changes - The company is exploring regulatory opportunities beyond the European Union and the United States for Blarcamesine [25] - Initial contacts have been made with U.S. authorities regarding the Alzheimer's disease program, with further updates expected [6] Company Strategy and Development Direction - The company aims to expand collaborative initiatives and strategic partnerships while progressing clinical trials and regulatory actions [3] - There is a focus on addressing unmet medical needs in Alzheimer's disease and exploring the potential of ANAVEX®3-71 in treating schizophrenia and depression associated with Alzheimer's [11][14] Management's Comments on Operating Environment and Future Outlook - Management highlighted the complexity of Alzheimer's disease and the unmet medical need following recent setbacks in the industry, emphasizing the unique mechanism of action of Blarcamesine [23] - The company remains committed to working with regulatory bodies to advance its investigational therapies and is optimistic about the re-examination of Blarcamesine by the CHMP [4][66] Other Important Information - The company has published several scientific studies supporting the efficacy of Blarcamesine, including findings on its mechanism of action and long-term benefits in clinical trials [7][10] - The company plans to present additional data at upcoming conferences, reinforcing its commitment to advancing its therapeutic pipeline [10][73] Q&A Session Summary Question: What is the likely commercial impact of the failure of semaglutide on the outlook for Blarcamesine in Alzheimer's disease? - Management noted that the recent setbacks in the industry highlight the unmet medical need and complexity of Alzheimer's disease, positioning Blarcamesine favorably due to its unique mechanism of action [23][24] Question: When is the next formal discussion of Blarcamesine scheduled to take place with the FDA? - Management indicated that updates will follow initial discussions with U.S. regulators and expressed excitement about these discussions [24] Question: What initiatives does Anavex plan near-term to pursue Blarcamesine approval in regions beyond the European Union and the United States? - The company is exploring other regulatory geographies and moving forward to address open questions [25] Question: Can you elaborate on the additional information needed by the CHMP? - Management stated that the focus is on demonstrating that the benefits of Blarcamesine outweigh the risks, including providing objective biomarker data [27][28] Question: Can the AbClear data be included for consideration on re-examination? - Management confirmed that the AbClear data showing significant cognitive benefits will be emphasized in discussions with regulators [31][32] Question: If approval ultimately came from the EMA, how long would a conditional trial take? - Management noted that it is difficult to speculate on timelines but emphasized the significant unmet need for effective treatments [34] Question: How is the company exploring options for marketing Blarcamesine if approved? - Management highlighted the focus on expanding corporate development partnership activities and participation in key industry conferences [38] Question: Does Anavex have support from the community for its re-evaluation? - Management stated that the community is aware of the drug, and the company is committed to the process of gaining regulatory confidence [68]

Accessibility StatementSkip Navigation NEW YORK, Nov. 25, 2025 /PRNewswire/ --Â Levi &Â Korsinsky, LLP notifies investors in Telix Pharmaceuticals Ltd. ("Telix Pharmaceuticals Ltd." or the "Company") (NASDAQ: TLX) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Telix Pharmaceuticals Ltd. investors who were adversely affected by alleged securities fraud between February 21, 2025 and August 28, 2025. Follow the link below to get more information and be ...

We recently published Top 10 Non-AI Stocks Redditors are Buying Ahead of Potential Bubble Burst. Novo Nordisk A/S (NYSE:NVO) is one of the top non-AI stocks Redditors are buying. Novo Nordisk A/S (NYSE:NVO) has long been a favorite stock of Redditors, and its popularity recently increased on the social media platform as investors recommended it as a non-AI play. However, many investors are now questioning the company’s fundamentals. Recently, the company cut its full-year guidance, citing lower-than-expe ...

We recently published Top 10 Non-AI Stocks Redditors are Buying Ahead of Potential Bubble Burst. Eli Lilly And Co (NYSE:LLY) is one of the top non-AI stocks redditors are buying. Eli Lilly And Co (NYSE:LLY) recently posted strong quarterly results amid robust growth from its diabetes and weight-loss products. With a diverse portfolio spanning oncology, immunology and neuroscience, Redditors believe the company can offset any potential weakness in GLP-1 drugs amid the US government’s push to lower prices. ...

Achieve Life Sciences Inc. (NASDAQ:ACHV) is one of the Canadian penny stocks to buy right now. Lake Street’s Thomas Flaten maintained a Buy rating on Achieve Life Sciences Inc. (NASDAQ:ACHV) at $11.00 on November 7. FDA Accepts Achieve Life Sciences, Inc. (ACHV) NDA Application for Cytisinicline in Smoking Cessation A day earlier, on November 6, the company confirmed that the US Food and Drug Administration has accepted its New Drug Application for cytisinicline in smoking cessation. The FDA has also gra ...