Stockwinners Market Radar for March 05, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

18:40 EST Eisai, Biogen say FDA accepted sBLA for LEQEMBI, granted Priority Review - Eisai and Biogen announced that the U.S. Food and Drug Administration has accepted Eisai's supplemental Biologics License Application, or sBLA, for LEQEMBI 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting. LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta, approved under the Accelerated Approval Pathway for the treatment of Alzheimer's Disease on January 6, 2023. Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Abeta pathology. On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway. The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. I LEQEMBI was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Abeta plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI's clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

16:55 EST Lumos Pharma announces additional data from OraGrowtH212 trial - Lumos Pharma announced that additional data from its OraGrowtH212 trial was included in an oral presentation of interim results at the 2023 International Meeting of Pediatric Endocrinology, held in Buenos Aires, Argentina, March 4-7, 2023. Data from the interim analysis of its OraGrowtH210 trial were also being presented as a poster during the conference. The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic and pharmacodynamic effects of oral LUM-201 in 22 treatment-naive PGHD subjects at two dose levels, 1.6 and 3.2 mg/kg/day. Subjects enrolled in the OraGrowtH212 Trial are PEM-positive and, therefore, enriched for responsiveness to LUM-201. In this presentation, results of analysis of 15 subjects were presented. The updated analysis included data on five additional subjects since interim results of the OraGrowtH212 Trial were announced in November 2022. Results showed that across the dose range of 1.6 to 3.2 mg/kg/day for 6 months, LUM-201 is well-tolerated and produces dose-dependent and substantial increases in GH AUC0-12h. Results also showed that increased GH pulse amplitude was associated with improved height velocity compared to baseline, and that effects on annualized height velocity were durable through 12 months. The OraGrowtH210 Trial is a multi-site, global Phase 2 trial evaluating orally administered LUM-201 at three dose levels against a standard dose of injectable rhGH in 82 subjects diagnosed with idiopathic PGHD. The poster presentation highlighted the results of the interim analysis of data for 41 subjects from the OraGrowtH210 Trial. These data showed mean annualized height velocity of 8.6 cm/year at the 1.6 mg/kg/day LUM-201 dose, in line with expectations of growth observed in multiple large historical datasets of this moderate idiopathic PGHD population treated with rhGH. An imbalance in baseline demographic characteristics between the LUM-201 and rhGH arms predicted the disparate growth responses observed across these cohorts. These imbalances, due primarily to two growth outliers in the rhGH cohort, are expected to diminish at full enrollment with a complete dataset of 82 subjects.

16:50 EST Abbott announces late-breaking data from landmark COAPT trial - Abbott announced late-breaking data for MitraClip, the leading therapy to treat leaky valves in people with mitral regurgitation, that demonstrate long-term benefits of the device in patients battling heart failure. The five-year results from the landmark COAPT trial show MitraClip is safe and effective and can cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary MR, a condition which has historically been extremely challenging to treat. In the COAPT trial, symptomatic heart failure patients with severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone. The primary results of the COAPT trial through two years found MitraClip to be superior to guideline-directed medical therapy in patients with significant secondary MR. Now, after five years of patient follow-up, data from the COAPT trial demonstrated even more substantial benefits for patients, including that MitraClip: Significantly reduced the risk of annualized hospitalizations by nearly half; Reduced the risk of death by almost 30%; Achieved durable MR reduction, with 95% of patients experiencing reduced MR from moderate-to-severe or severe to mild or moderate. While primary MR is due to problems with the mitral valve itself, people with heart failure may develop secondary MR when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing and allowing blood to flow backwards through the heart. Significant secondary MR can lead to reduced quality of life, recurrent hospitalizations and decreased survival. Prior to MitraClip, most heart failure patients with clinically significant secondary MR were treated with medication only. However, based on the strength of the primary results of the COAPT trial, in 2019 the FDA approved an expanded indication for MitraClip to treat secondary MR. Patients in the COAPT trial received the first-generation MitraClip, the world's first transcatheter edge-to-edge repair device. Since the introduction of MitraClip, there have been advances in the device, with the fourth generation of the technology currently on the market, which can reduce MR further. More than 150,000 patients have been treated with MitraClip globally.

16:43 EST 89bio presents new analysis of data from Phase 2 ENTRIGUE trial of pegozafermin - 89bio announced the presentation of additional data from the Phase 2 ENTRIGUE trial of pegozafermin in patients with severe hypertriglyceridemia at the American College of Cardiology's 72nd Annual Scientific Session & Expo Together with World Congress of Cardiology. The presentation featured results of a post hoc analysis exploring the effect of pegozafermin treatment on lipids among study participants based on their background lipid-modifying therapy status. The company previously announced that the randomized, double-blind ENTRIGUE trial met the primary endpoint of statistically significant reductions in median TGs from baseline in patients treated with 27mg of pegozafermin given weekly compared to placebo after 8 weeks. Significant reductions in TGs were observed consistently across all prespecified patient subgroups. The trial also met numerous secondary endpoints, including improvements in atherogenic lipoproteins, metabolic measures and liver fat. Approximately 50% of patients in ENTRIGUE were on concomitant lipid-modifying therapy, which is representative of the real-world setting. Pegozafermin was generally safe and well-tolerated. Of the 85 ENTRIGUE study participants randomized and treated with pegozafermin or placebo, 55% were on background lipid-modifying therapy. Results of the post hoc analysis of lipid effects of pegozafermin among study participants based on their lipid-modifying background therapy status demonstrated that pegozafermin significantly reduced TG and other atherogenic lipids after eight weeks of therapy. Pegozafermin also led to reductions in TGs among patients on background high-intensity statins compared with placebo. As previously reported, pegozafermin-treated patients reached their initial treatment goal irrespective of background therapy. In the overall study population, 80% of those treated with pegozafermin reached their initial treatment goal compared with 29% of those on placebo. Among those on lipid-modifying background therapy, the comparable figures were 85% and 46%, respectively; among those not on background therapy, the comparable figures were 73% and 0%, respectively. Treatment with pegozafermin also led to improvements in non-HDL cholesterol irrespective of background therapy; however, among study participants on background therapy those decreases were more robust. Improvements in apolipoprotein B, a key marker of cardiovascular risk and a direct measure of the number of atherogenic particles, were observed irrespective of background therapy, and there were no significant changes in levels of LDL-cholesterol across the participants.

16:37 EST Abbott announces data from TRILUMINATE pivotal study - Abbott announced late-breaking data for the TriClip transcatheter edge-to-edge repair, or TEER, system, a first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair. The TRILUMINATE Pivotal study evaluates the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation who are at intermediate or greater risk for open-heart surgery. The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group, primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include: Significant reduction in TR grade; Significant improvement in quality of life; A strong safety profile. There were no occurrences of device embolization or device thrombus.

15:56 EST Cytokinetics presents results from Cohort 4 of REDWOOD-HCM - Cytokinetics announced that positive results from Cohort 4 of REDWOOD-HCM, a Phase 2 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy, were presented at the American College of Cardiology 72nd Annual Scientific Session. Additionally, 48-week data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) were also presented at the meeting. Cohort 4 enrolled 41 patients with nHCM, who were New York Heart Association Class II/III with left ventricular ejection fraction greater than or equal to60% without a resting or provoked left ventricle outflow tract gradient. Eligible patients had a NT-proBNP greater than or equal to 300 pg/mL and no history of LVEF less than 45%. All patients received up to three escalating doses of aficamten, beginning with 5 mg once daily and increasing to 10 and 15 mg once daily guided by echocardiographic assessment of LVEF. Overall treatment duration was 10 weeks with a 2-week washout period. At 10 weeks, patients in Cohort 4 experienced significant improvements in NT-proBNP, with an average decrease of 66%. High-sensitivity troponin I levels also improved significantly proportional to baseline at each study visit (pless than0.05). An improvement of greater than or equal to1 NYHA Functional Class was observed in 22 of 41 patients. After the 2-week washout period, NT-proBNP and high-sensitivity troponin I levels returned to baseline levels. Aficamten was generally well-tolerated. By Week 6, 35 of patients achieved the highest dose of 15 mg of aficamten, and 6 achieved 10 mg. There were no drug discontinuations due to adverse events. One dose reduction to 10 mg occurred due to fatigue, and one temporary dose interruption occurred due to palpitation. Three patients had serious adverse events, but none were attributed to aficamten. In 27 patients, at least one treatment emergent adverse event was reported. Three patients had LVEF less than50% at Week 10; all three patients returned to baseline LVEF after the 2-week washout period. No adverse events of heart failure were reported. Meanwhile, previously presented data from FOREST-HCM showed that treatment with aficamten was associated with significant and sustained reductions in LVOT-G, improvements in New York Heart Association Functional Class, improvements in cardiac biomarkers, and improvement in self-reported health status using the Kansas City Cardiomyopathy Questionnaire through 24 weeks. New data through 48 weeks of treatment showed that aficamten was associated with significant reductions in the average resting LVOT-G. Treatment with aficamten also resulted in significant improvements in NYHA class, with 88% of patients experiencing a greater than or equal to 1 NYHA Functional Class improvement, and significant improvements in NT-proBNP, with an average decrease of 70% from baseline to Week 48. At baseline, 19 patients met eligibility criteria for septal reduction therapy, defined as NYHA Class III and peak LVOT-G greater than or equal to50 mmHg, but treatment with aficamten eliminated SRT eligibility in all 19 patients at 48 weeks. Aficamten was safe and well-tolerated, with no treatment-related serious adverse events. There were no instances of LVEF less than50% attributed to aficamten. One dose reduction and one temporary dose interruption occurred, neither of which were attributed to treatment with aficamten.