Stockwinners Market Radar for September 10, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

10:07 EDT Crinetics' Paltusotine achieves primary, secondary endpoints in Phase 3 study - Crinetics Pharmaceuticals announced that paltusotine, an oral, once-daily investigational compound, achieved "positive results" by meeting the primary endpoint and all secondary endpoints of the Phase 3 PATHFNDR-1 study. PATHFNDR-1 was a randomized, double-blind, placebo-controlled 36-week treatment period followed by an optional open-label extension study evaluating paltusotine in participants with acromegaly switching from standard-of-care injected depot somatostatin analogs. The study enrolled participants with acromegaly who were biochemically controlled on octreotide or lanreotide depot monotherapy. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies of once-daily, oral paltusotine. The study met statistical significance on the primary endpoint, based on the proportion of participants taking paltusotine who maintained an insulin-like growth factor 1 level less than or equal to 1.0 times the upper limit of normal compared to those taking placebo. All secondary endpoints also met statistical significance. In PATHFNDR-1, paltusotine was well tolerated and no serious or severe adverse events were reported in participants treated with paltusotine. The frequency of participants with at least one treatment emergent adverse event was comparable in the paltusotine treatment arm vs placebo arm. The frequency of adverse events considered related to acromegaly was notably lower in paltusotine treated participants compared to placebo treated participants. A full analysis of the PATHFNDR-1 results is underway, which the company expects to present at upcoming scientific conferences.

07:47 EDT Mineralys Therapeutics presents Target-HTN Phase 2 trial results - Mineralys Therapeutics presented final results from the Target-HTN Phase 2 trial of lorundrostat, a highly selective aldosterone synthase inhibitor, in individuals with uncontrolled hypertension and resistant hypertension. The data were presented during a late-breaking science session at the 2023 American Heart Association Hypertension Scientific Sessions, which is being held in Boston from September 7-10, and simultaneously published in the Journal of the American Medical Association. Target-HTN trial results demonstrate treatment with lorundrostat at doses of 50mg and 100mg once daily led to a statistically and clinically significant reduction of systolic blood pressure in inadequately controlled hypertensive individuals on at least two background antihypertensive medications. The reduction in BP was particularly evident among participants with hypertension and concomitant obesity. Key clinical data from Target-HTN suggest robust BP reductions in the treatment of patients with uHTN and rHTN. There was a modest, dose-dependent increase in mean serum potassium and low incidence of elevated serum potassium. Three serious adverse events occurred, only one was deemed treatment-related. Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for inadequately controlled hypertension. The company's ongoing pivotal development program for lorundrostat to treat uHTN and rHTN is currently enrolling subjects in the Advance-HTN trial, and the Phase 3 Launch-HTN trial is expected to be initiated in the second half of the year, with topline data expected in the first half of 2024 and mid-2025, respectively.

07:42 EDT Daiichi Sankyo, AstraZeneca present initial results from TROPION-Lung04 phase 1b - Initial results from the TROPION-Lung04 phase 1b trial showed that datopotamab deruxtecan in combination with durvalumab, an anti-PD-L1 therapy, with or without carboplatin demonstrated encouraging responses and no new safety signals in patients with previously untreated advanced or metastatic non-small cell lung cancer without actionable genomic alterations. These data were presented during a late-breaking oral presentation at the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate being jointly developed by Daiichi Sankyo and AstraZeneca. In previously untreated patients, datopotamab deruxtecan plus durvalumab demonstrated an objective response rate of 50.0%, including seven partial responses and a disease control rate of 92.9%. Response rates were higher in patients receiving datopotamab deruxtecan plus durvalumab and carboplatin which demonstrated an ORR of 76.9%, including 10 PRs and a DCR of 92.3%. Responses were observed across PD-L1 expression levels. In both previously treated and untreated patients, the safety profiles of datopotamab deruxtecan and durvalumab with and without carboplatin were consistent with other clinical trials and with the known safety profile of each agent. Grade 3 or greater treatment-emergent adverse events occurred in 42.1% of patients receiving doublet therapy and 71.4% of patients receiving triplet therapy. In patients receiving triplet therapy, the most common grade 3 or greater TEAEs were anemia and thrombocytopenia. No grade 3 or higher TEAE occurred in more than 15% of patients receiving doublet therapy. Across treatment cohorts, there were four interstitial lung disease events adjudicated as drug-related by an independent committee including one grade 1 event, two grade 2 events and one grade 4 event. No grade 5 ILD events were observed. In the doublet cohort, 73.7% of patients were previously untreated. In the triplet cohort, 92.9% of patients were previously untreated. Both the doublet and triplet cohorts included patients with PD-L1 expression levels ranging from less than 1%, 1% to 49% and 50% or greater, respectively. As of the March 6, 2023 data cut-off, median study duration was six months for both cohorts and treatment was ongoing in 31.6% and 50.0% of patients in the doublet and triplet cohorts, respectively.

07:33 EDT Supernus announces new Qelbree data showing improvement in ADHD symptoms - Supernus Pharmaceuticals announced the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree. When added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile as well as a significant improvement in ADHD symptoms in pediatric patients, regardless of timing of dosing. In an eight-week, Phase IV, open-label study, children and adolescents took psychostimulants at least five days a week in the morning throughout the duration of the study, and received Qelbree once-daily in the morning through week four and then switched to evening dosing through week eight; children received 100mg per day of Qelbree at week one and were optimized to 100-400mg per day, and adolescents received 200mg per day of Qelbree at week one and were optimized to 200-600mg per day. Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant. At baseline, mean ADHD-RS-5 and CGI-S scores were 37.2 and 4.4, respectively, and improved at week four by -13.5 and -0.9, respectively, and at week eight by -18.2 and -1.4, respectively. Reported adverse events of the combination therapy included headache, decreased appetite, and upper respiratory tract infection, and 3.6% of patients discontinued the combination treatment due to an AE. Conclusive outcomes from a long-term, open-label extension trial of the double-blind pivotal Phase III study that led to the U.S. Food and Administration-approval of Qelbree in adults with ADHD, found that adult patients saw an improvement in ADHD symptoms and executive function with safety and tolerability similar to the initial trial. Adults received 200mg of Qelbree every day for one week, increased to 400mg, and then optimized over twelve weeks up to 600mg per day. Patients in this open-label trial received Qelbree for 265 days. Patients ADHD symptoms improved from 37.9 to 19.7 on the Adult ADHD Investigator Symptom Rating Scale, representing average symptom reduction of -18.2. Patients executive function improved from 70.4 to 58.3 on the BRIEF-A Global Executive Composite scale, representing improvement in executive function of -12.9. The treatment related adverse events seen in this long-term trial were consistent with those seen in the short-term pivotal adult trial.