 | Your browser does not display parts of our website correctly. We use the latest technology available to provide you with a high quality experience; please upgrade your browser to its latest version to view the contents properly: |
Stockwinners Market Radar for July 30, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
| CTXR | Hot Stocks07:15 EDT Citius Pharmaceuticals receives Complete Response Letter from FDA for LYMPHIR - Citius Pharmaceuticals announced that the U.S. Food and Drug Administration, or FDA, has issued a Complete Response Letter regarding the company's Biologics License Application seeking approval for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma after at least one prior systemic therapy. The FDA has required Citius to incorporate enhanced product testing, and additional controls agreed to with the FDA during the market application review. Importantly, there were no concerns relating to the safety and efficacy clinical data package submitted with the BLA, or the proposed prescribing information.
|
| APLS | Hot Stocks07:13 EDT Apellis provides update on review of rare safety events with SYFOVRE - Apellis Pharmaceuticals provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with SYFOVRE for geographic atrophy secondary to age-related macular degeneration. Apellis has been conducting a thorough evaluation following these reported events, including a review of the SYFOVRE manufacturing process and drug product and of the safety data from the company's Phase 3 clinical trials of SYFOVRE. There were no changes in the formulation of the product between Phase 3 clinical trials and commercial supply. Based on this review, there is no indication that drug product or manufacturing issues contributed to these events, and there were no new safety findings in the clinical trials upon secondary review. Specifically: No manufacturing related issues impacting product quality were identified; No quality issues and no contaminants were discovered; No single manufacturing lot was implicated; No indication of drug related immunogenicity was observed in the clinical trial data; Zero events of retinal vasculitis were reported by investigators or identified by an independent reading center in the Phase 3 clinical trials. In addition Apellis re-reviewed all intraocular inflammation cases and confirmed no vasculitis events; External retina/uveitis specialists re-reviewed all severe IOI cases and further confirmed no vasculitis events; Apellis is working closely with the retina community as it continues to investigate potential contributing factors and plans to continue to provide updates. Since launch, Apellis has in total seven confirmed events of retinal vasculitis as determined by Apellis' internal safety committee and external retina/uveitis specialists. Two of these events followed injections in April, two in May, and three in June. Apellis is also evaluating one reported event of retinal vasculitis, which the company has not confirmed. Apellis can only review and confirm cases that have been reported directly to the company and will continue to submit all reported adverse events to the U.S. Food and Drug Administration consistent with reporting guidelines for drug manufacturers.
|
| REGN | Hot Stocks07:10 EDT Regeneron presents aflibercept 8 mg two-year results from pivotal PHOTON trial - Regeneron Pharmaceuticals announced the first presentation of positive two-year results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA Injection, in patients with diabetic macular edema. The results were presented at the American Society of Retina Specialists annual meeting. PHOTON is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg extended dosing intervals compared to EYLEA. Patients receiving aflibercept 8 mg were initially randomized to either 12- or 16-week dosing intervals compared to an 8-week dosing regimen for EYLEA after five initial monthly doses. During the trial, patients receiving aflibercept 8 mg could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Patients were only able to extend their dosing intervals in the second year by 4-week increments up to 24-weeks, if pre-specified criteria were met. The PHOTON trial met its primary endpoint last year with aflibercept 8 mg patients achieving clinically equivalent vision gains to EYLEA, with approximately 90% maintaining 12- and 16-week dosing regimens through the first year. Through two years, the mean number of injections administered were 9.5 for the 12-week aflibercept 8 mg group, 7.8 for the 16-week aflibercept 8 mg group, and 13.8 for the EYLEA group, with the vast majority of aflibercept 8 mg patients maintaining extended dosing intervals as first shared in June 2023. The safety of aflibercept 8 mg continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME. The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter of 2023.
|
| FDMT | Hot Stocks06:58 EDT 4D Molecular presents interim data from intravitreal 4D-150 Phase 1/2 trial - 4D Molecular Therapeutics announced additional interim clinical data from the Phase 1 Dose Exploration stage of the 4D-150 Phase 1/2 PRISM clinical trial for patients with wet age-related macular degeneration, or wet AMD. The data were presented at the 2023 American Society of Retinal Specialists Annual Meeting in Seattle, Washington. 4D-150 is a potentially transformative genetic medicine that utilizes 4DMT's evolved and customized retinotropic R100 vector, while targeting four VEGF family members. 4D-150 is being developed as a single dose, routine outpatient intravitreal therapy with the goal of reducing treatment burden and maintaining efficacy in patients with wet AMD and diabetic macular edema. 15 patients received a single intravitreal dose of 4D-150 across three dose cohorts. Enrolled participants had a high need for anti-VEGF therapy, with mean annualized injection rates ranging from 8 to 11 across cohorts prior to 4D-150 treatment As of the data cutoff date of July 3, 2023, all patients had completed follow-up through at least 36 weeks. 4D-150 was well tolerated, with no reported Grade greater than or equal to1 inflammatory cells and no hypotony, dose-limiting toxicities, or treatment-related serious adverse events. All three doses demonstrated clinical activity in the study, with evidence of a dose response favoring the 3E10 vg/eye dose. Initial interim efficacy data from Phase 2 Dose Expansion is expected to be presented at a medical conference in the first half of 2024. The company expects to provide update regarding Phase 3 pivotal trial plans in Q1 2024 after initial discussion with FDA, which is anticipated in Q4 2023. Expects to enroll first patient in Phase 2 SPECTRA clinical trial for DME in Q3 2023. Program update for 4D-175 in geographic atrophy expected in Q4 2023.
|
