Athena Gold Corp

Alzheon to Present Phase 3 Data for ALZ-801, Aiming to Slow Alzheimer's Progression

4 months ago

• Alzheon is set to present Phase 3 trial data for ALZ-801 in April 2025, a drug designed to prevent the formation of toxic beta-amyloid plaques in early Alzheimer's patients with the ApoE4 gene. • Anavex Life Sciences has submitted blarcamesine for approval in Europe after completing Phase 2/3 trials, though its efficacy has faced criticism and legal challenges. • Athira Pharma discontinued fosgonimeton development after failing to demonstrate clinical benefit and settled with the DOJ over data manipulation allegations. • Eisai and Biogen's Leqembi may become more accessible with an injectable version under FDA review, potentially allowing for at-home administration.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Tyra Biosciences' TYRA-300 Shows Promise in Bladder Cancer and Achondroplasia

5 months ago

• Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients. • The FDA cleared the IND for TYRA-300's Phase 2 study in pediatric achondroplasia (BEACH301), with the first patient expected to be dosed in Q1 2025. • TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development. • The company appointed Doug Warner, MD, as Chief Medical Officer and reported a cash position of $360.1 million, expected to last through at least 2026.

Alzheimer's Clinical Trial Update: New Data on Tau-Targeting Drugs and More

7 months ago

• Eisai presented Phase 1/2 data on E2814, an anti-tau drug, showing reduced levels of disease biomarkers in participants with mild to moderate genetic Alzheimer’s. • Roche terminated its agreement with UCB for beprenemab, an experimental tau-targeting antibody, after Phase 2 trial results showed it did not slow cognitive decline. • A Phase 2 trial of intranasal insulin and empagliflozin showed that insulin alone was associated with a small improvement in cognitive test performance in early Alzheimer’s patients.

Athira Pharma Presents LIFT-AD Trial Results for Fosgonimeton at CTAD 2024

7 months ago

• Athira Pharma presented Phase 2/3 LIFT-AD trial results of fosgonimeton for Alzheimer's at CTAD, Madrid, from October 29 to November 1, 2024. • The LIFT-AD trial did not meet statistical significance for its primary endpoint, the Global Statistical Test, at 26 weeks compared to placebo. • Subgroup analysis showed cognitive and functional improvements in patients with moderate Alzheimer's and APOE4 carriers treated with fosgonimeton. • ATH-1105, a next-generation small molecule HGF modulator, is being advanced for ALS and Alzheimer's, with Phase 1 trial data expected by year-end 2024.

Alzheimer's Disease: Late-Stage Pipeline Explores Novel Therapeutic Targets Beyond Amyloid and Tau

8 months ago

• The Alzheimer's disease therapeutic pipeline is expanding beyond amyloid and tau targets, with 32 therapeutics in 48 Phase III trials exploring neuroprotection, neurotransmitters, and inflammation. • Recent approvals of anti-amyloid antibodies like Leqembi and Kisunla have shown modest clinical benefits but also carry risks, prompting the development of alternative approaches. • Several Phase III candidates, such as Athira's fosgonimeton, Anavex's ANAVEX 2-73, and Novo Nordisk's semaglutide, target different mechanisms like neurotrophic factors, neuronal homeostasis, and neuroinflammation. • Experts suggest that combination therapies and brain-healthy lifestyles may be essential for effectively managing the heterogeneous nature of Alzheimer's disease.

Athira Pharma's Fosgonimeton Fails to Meet Primary Endpoint in Phase II/III Alzheimer's Trial

9 months ago

• Athira Pharma's fosgonimeton did not meet the primary endpoint in the Phase II/III LIFT-AD trial for mild-to-moderate Alzheimer's disease. • The trial failed to show statistically significant improvement in cognition and function compared to placebo after 26 weeks of treatment. • Subgroup analyses showed some improvements in cognition and function in patients with moderate Alzheimer's and APOE4 carriers. • Despite the setback, Athira Pharma believes the data suggest potential benefits of HGF pathway modulation on neuronal health.