Clinical Trial News

Recent breakthroughs in Alzheimer's treatment, notably lecanemab's FDA approval and donanemab's Phase 3 trial success, offer new hope for patients and investment opportunities. Despite challenges in access and infrastructure, these developments mark a significant step forward in combating Alzheimer's, promising better outcomes and reducing healthcare burdens.

Acelyrin's IL-17A inhibitor, izokibep, did not meet the primary endpoint in a phase 2b/3 trial for hidradenitis suppurativa treatment, with 39% of patients on once-weekly 160 mg achieving HiSCR75 at 16 weeks vs. 29% on placebo. Despite high discontinuation rates and unexpected placebo response, izokibep showed potential in HiSCR100 and has an ongoing phase 3 trial.

Risankizumab showed non-inferiority for clinical remission at week 24 and superiority for endoscopic remission at week 48 compared to ustekinumab in treating Crohn's disease. All secondary endpoints were statistically significant, with a consistent safety profile for risankizumab.

Acelyrin's stock dropped after disappointing Phase 2b trial results for izokibep in treating Hidradenitis Suppurativa. Despite not meeting the primary endpoint, early HiSCR100 responses and dose-effect data support further evaluation. Analysts maintain a Strong Buy rating for SLRN.

Acelyrin Inc's stock (NASDAQ:SLRN) drops 62% to $10.60 after its skin disease drug fails in a trial. Jefferies cuts price target to $15 from $31, calling the data 'painfully disappointing.' Despite a 'strong buy' rating from analysts, SLRN faces volatility and lands on the short sell restricted list.

FDA approved updated Pfizer and Moderna Covid vaccines targeting XBB.1.5 for ages 12+, with emergency use for younger children. Availability pending CDC approval. Novavax's vaccine under review. Vaccines aim to protect against current strains as cases and hospitalizations rise.

Vir Biotechnology Inc's shares dropped 54% YTD due to disappointing influenza A and HBV trial results, leading BofA to downgrade the stock to Neutral and lower its price target to $14. Despite a negative enterprise value offering downside protection, near-term HBV trial readouts are unlikely to improve investor sentiment. Key HBV trial results expected in 4Q23 and 2Q24 could impact future share trajectory.

Retail pharmacies are partnering with pharmaceutical companies to enroll patients in decentralized clinical trials, aiming to increase diversity and convenience. This shift, accelerated by the COVID-19 pandemic, may impact clinical laboratories' revenue but promises broader participation and faster drug development.

Spectral Medical Inc. closed a private placement of 9.0% convertible notes, raising US$4,553,000 for its Tigris Study on PMX treatment for septic shock. Patient enrollment reached 72, aiming for 90 by end of 2023. Baxter International Inc. supported the funding, aligning with Spectral's strategy for FDA approval.

The EMA is reviewing givinostat for Duchenne muscular dystrophy (DMD) treatment, following a similar FDA priority review. Givinostat blocks HDACs to potentially improve muscle repair and strength, based on Phase 3 trial results showing slowed motor function decline and delayed muscle fat build-up in DMD patients.