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06:51 EDT Celldex Therapeutics presents data from Barzolvolimab chronic urticaria program - Celldex Therapeutics announced that updated data from the company's Phase 1b multi-dose clinical trial in chronic spontaneous urticaria and new data from the Phase 1b single-dose cholinergic cohort included in the chronic inducible urticaria trial were presented at the European Academy of Allergy and Clinical Immunology Annual Congress 2023. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of mast cells. Data continue to support that mast cell depletion by barzolvolimab, as demonstrated by tryptase suppression, parallels symptom improvement. Celldex's Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial designed to assess the safety of multiple ascending doses of barzolvolimab in patients with moderate to severe CSU who remain symptomatic despite treatment with antihistamines. Celldex previously presented interim Phase 1b CSU data at the American Academy of Allergy, Asthma & Immunology Annual Meeting 2023. The 0.5 mg/kg, 1.5 mg/kg and 3.0 mg/kg cohorts had completed study participation through 24 weeks; 6 of 9 patients in the 4.5 mg/kg cohort had completed through the week 20 visit. The study is now complete. At EAACI 2023, Celldex presented data on the complete 24 week experience for the 4.5 mg/kg cohort and data on angioedema impact across all study cohorts. 45 patients with moderate to severe CSU refractory to antihistamines were enrolled and treated. Data for the 0.5 mg/kg and placebo group are only outlined below through week 12 because, as expected, most patients from these groups had significant symptoms ahead of week 24 and discontinued follow up. Two patients did not receive all doses of study treatment. These data show that multiple doses of barzolvolimab resulted in rapid dose-dependent decreases in itch and hives with durable and prolonged symptom control in patients with moderate to severe CSU refractory to antihistamines, including patients with prior omalizumab treatment. During post-treatment follow up, 71% of patients who had been treated with doses greater than or equal to 1.5 mg/kg and had a complete response at week 12, remained urticaria free at week 24. Profound and durable improvement in angioedema symptoms as measured through the angioedema activity score over 7 days was achieved across all dose levels evaluated with sustained activity observed with the 1.5 mg/kg and greater dose levels. Barzolvolimab was well tolerated with a favorable safety profile; effects of multiple dose administration were consistent with observations in single dose studies. Most AEs were mild or moderate in severity and resolved while on study. Meanwhile, the company said that in an open-label, Phase 1 trial, a cohort of patients with antihistamine refractory cholinergic urticaria received a single intravenous 3.0 mg/kg barzolvolimab dose with a 12-week follow-up. Assessments included provocation testing using pulse-controlled ergometry, quality of life assessments, and measurement of circulating tryptase and stem cell factor and skin mast cell numbers. Safety assessments included adverse events and clinical laboratory monitoring. Data reported at EAACI 2023 include treatment and safety data through 12 weeks. 56% patients achieved a complete response with PCE provocation testing with just one dose of barzolvolimab and most responses remained durable through to week 12. PCE testing included controlled exercise on a stationary bicycle with monitoring for development of itch and wheals. 63% patients reported well controlled disease at week 8 and 50% at week 12, respectively. 100% patients who reported on quality of life measurements at week 8 had clinically significant improvements in QoL. These improvements in QoL were sustained through week 12 for the majority of patients. Barzolvolimab was generally well tolerated in patients with CholU, with a similar safety profile to that reported previously.

06:42 EDT FDA AdComm votes to confirm clinical benefit of LEQEMBI in Alzheimer's disease - BioArctic AB's (BIOA) partner Eisai announced that the U.S. Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai's Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI 100 mg/mL intravenous injection for the treatment of Alzheimer's disease. LEQEMBI received Accelerated approval from the FDA for the treatment of early Alzheimer's disease on January 6, 2023. The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review. Additionally, the committee members confirmed the overall risk-benefit profile of LEQEMBI, the clinical meaningfulness of the data and discussed its use in specific subgroups. The unanimous decision by the panel of independent experts was based on the supplementary Biologics License Application which includes data from Eisai's large global confirmatory Phase 3 clinical Clarity AD trial. The Clarity AD trial met its prespecified primary endpoint, demonstrating a highly statistically significant slowing of cognitive and functional decline compared to placebo over 18 months. Highly statistically significant treatment effects were also observed for all multiplicity-controlled secondary endpoints that examined cognition and functional changes using other validated scales. The most common adverse events in the LEQEMBI group were infusion reactions, ARIA-H, ARIA-E, headache, and fall. Infusion reactions were largely mild-to-moderate and occurred on the first dose. The results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen (BIIB) co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region. LEQEMBI has been approved under the FDA Accelerated Approval Pathway.