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20:58 EDT New York Community's Flagstar to assume Signature Bank deposits, FDIC says - The Federal Deposit Insurance Corporation entered into a purchase and assumption agreement for substantially all deposits and certain loan portfolios of Signature Bridge Bank (SBNY) by Flagstar Bank, a wholly owned subsidiary of New York Community Bancorp (NYCB). The 40 former branches of Signature Bank will operate under New York Community Bancorp's Flagstar Bank on Monday, March 20. The branches will open during their normal business hours. Customers of Signature Bridge Bank should continue to use their current branch until they receive notice from the assuming institution that full-service banking is available at branches of Flagstar Bank, the FDIC said in a statement. Depositors of Signature Bridge Bank, other than depositors related to the digital banking business, will automatically become depositors of the assuming institution. All deposits assumed by Flagstar Bank will continue to be insured by the FDIC up to the insurance limit. Flagstar Bank's bid did not include approximately $4B of deposits related to the former Signature Bank's digital banking business. The FDIC will provide these deposits directly to customers whose accounts are associated with the digital banking business.

15:46 EDT Incyte announces data from Phase 2b study evaluating Povorcitinib - Incyte announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib, an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. These data were presented in a late-breaking oral presentation at the 2023 American Academy of Dermatology Annual Meeting, held from March 17-21 in New Orleans. Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index scores. Specifically, the study met its primary endpoint and patients receiving povorcitinib experienced statistically superior improvements in T-VASI at Week 24 compared to placebo. Additionally, more patients who received povorcitinib achieved the key secondary endpoint of T-VASI50 at Week 24 and continued to improve during an open-label extension period through Week 36 of treatment, following dose adjustment.

15:42 EDT Incyte announces long-term extension data from Phase 3 TRuE-V program - Incyte announced new 104-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin. These data were presented in two late-breaking oral presentations at the 2023 American Academy of Dermatology Annual Meeting, held from March 17-21 in New Orleans. The 104-week long-term extension data build on the 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine. The LTE evaluated TRuE-V1 and TRuE-V2 study participants from Weeks 52 to 104 in two separate cohorts based on patients who achieved a complete or almost complete response by Week 52. In the cohort of patients who achieved complete or almost complete facial repigmentation, patients were randomized in a double-blind fashion to receive Opzelura twice daily or vehicle through Week 104 to evaluate time to relapse and time to maintain greater than or equal toF-VASI90 response; time to regain F-VASI75 and F-VASI90 response after relapse was also evaluated. In the cohort of patients who did not achieve complete or almost complete facial repigmentation, all patients were continued on Opzelura BID to evaluate long-term efficacy and safety. Key findings from Cohort A: Many patients who achieved a high level of facial repigmentation in TRuE-V1/TRuE-V2 were able to maintain durable response for one year after discontinuing Opzelura treatment. Approximately 29% of patients randomized to the withdrawal arm relapsed during the extension period . Among patients who relapsed in the withdrawal arm, 75% of patients regained greater than or equal toF-VASI75 once treatment with Opzelura was reinitiated and 69% of patients regained greater than or equal toF-VASI90. For those continuing Opzelura treatment, approximately 62% of patients who achieved greater than or equal toF-VASI90 at Week 52 maintained response for one year with ongoing Opzelura treatment. Opzelura was well tolerated with no serious treatment-related adverse events through Week 104. Mild or moderate treatment-related adverse events among patients in the Opzelura arm included application site dermatitis, application site rash and hyperlipidemia. Key findings from Cohort B: In patients who did not achieve near complete facial repigmentation at Week 52 and continued treatment with Opzelura, improvements in facial and total body repigmentation, as shown by greater proportions of patients reaching F-VASI75 and T-VASI50, were observed through Week 104. For patients treated with Opzelura from Day 1 in the parent studies, the percentage who achieved F-VASI75 at Week 104 more than doubled compared to Week 52, and approximately 34% attained F-VASI90 at Week 104. Additionally, T-VASI50 was achieved at Week 104 by 64% of TRuE-V1 and TRuE-V2 patients applying Opzelura since Day 1, increasing from 43% at Week 52. Opzelura was well tolerated with no serious treatment-related adverse events through Week 104. All treatment-related adverse events in the Opzelura arm were mild or moderate, the most common being application site pruritus.

15:36 EDT Regeneron, Sanofi present results from Dupixent clinical trial - Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) presented positive results from the clinical trial assessing Dupixent in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. The trial, the first evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. The results were featured in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology 2023 Annual Meeting. In the trial, patients received Dupixent every two weeks or placebo. At 16 weeks, patients treated with Dupixent experienced the following: 40% achieved clear or almost clear skin on hands and feet compared to 17% with placebo, the primary endpoint. 52% saw a clinically meaningful reduction in itch on hands and feet compared to 14% with placebo, the key secondary endpoint. 69% average reduction in signs of hand and foot lesions from baseline compared to 31% with placebo. 75% average improvement in hand eczema disease severity from baseline compared to 40% with placebo. There were significant improvements in measures of hand and foot skin pain, sleep, and hand eczema-related quality of life. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Overall rates of adverse events were 66% for Dupixent and 74% for placebo. AEs more commonly observed with Dupixent compared to placebo included nasopharyngitis, upper respiratory tract infection, conjunctivitis, herpes viral infections and increased blood creatine phosphokinase. Additionally, 3% of patients taking Dupixent used at least one rescue medication compared to 21% of patients on placebo. The potential use of Dupixent in chronic spontaneous urticaria is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

15:30 EDT Castle Biosciences announces performance data for DecisionDx-SCC test - Castle Biosciences shared new performance data from a novel, multi-center, independent cohort demonstrating how the independent risk-stratification of DecisionDx-SCC can significantly improve metastatic risk predictions by complementing current staging systems. Additionally, consistent with previous studies,3,4 DecisionDx-SCC independently and significantly stratified a novel cohort according to patients' biologic metastatic risk. This study analyzed the performance of the DecisionDx-SCC test in a novel, independent performance cohort of 534 patients with primary cSCC and one or more risk factors from 45 contributing centers. The data from the study consistently demonstrated the performance of DecisionDx-SCC to classify risk for metastasis in cSCC patients with one or more risk factors. Multivariate models showed that the metastatic risk prediction of AJCC8 and BWH staging systems were significantly improved when DecisionDx-SCC test results were included. Overall, the study data further support that DecisionDx-SCC independently predicts metastatic risk for patients with cSCC and can complement clinicopathologic staging systems and improve risk predictions based on staging alone to support risk-aligned patient management decisions.

15:12 EDT Credit Suisse says UBS confident staff employment will be continued - Credit Suisse (CS) said it and UBS (UBS) have entered into a merger agreement on Sunday following the intervention of the Swiss Federal Department of Finance, the Swiss National Bank and the Swiss Financial Market Supervisory Authority FINMA. UBS will be the surviving entity upon closing of the merger transaction. Under the terms of the merger agreement all shareholders of Credit Suisse will receive 1 share in UBS for 22.48 shares in Credit Suisse. Until consummation of the merger, Credit Suisse will continue to conduct its business in the ordinary course and implement its restructuring measures in collaboration with UBS. The Swiss National Bank will grant Credit Suisse access to facilities that provide substantial additional liquidity. On March 19, Swiss Federal Department of Finance, the Swiss National Bank and FINMA have asked Credit Suisse and UBS to enter into the merger agreement. Pursuant to the emergency ordinance which is being issued by the Swiss Federal Council, the merger can be implemented without approval of the shareholders. The consummation of the merger remains subject to customary closing conditions. On Sunday, Credit Suisse has been informed by FINMA that FINMA has determined that Credit Suisse's Additional Tier 1 Capital in the aggregate nominal amount of approximately CHF 16B will be written off to zero. UBS has expressed its confidence that the employment of the staff of Credit Suisse will be continued, the bank said in a statement.

14:59 EDT Swiss National Bank grants Credit Suisse liquidity loan up to CHF 100B - UBS (UBS) today announced the takeover of Credit Suisse (CS), the Swiss National Bank said in a statement. "This takeover was made possible with the support of the Swiss federal government, the Swiss Financial Market Supervisory Authority FINMA and the Swiss National Bank," it said. Both banks have unrestricted access to the SNB's existing facilities, and in addition, Credit Suisse and UBS can obtain a liquidity assistance loan with privileged creditor status in bankruptcy for a total amount of up to CHF 100B. Furthermore, and based on the Federal Council's Emergency Ordinance, the SNB can grant Credit Suisse a liquidity assistance loan of up to CHF 100B backed by a federal default guarantee. The structure of the loan is based on the Public Liquidity Backstop, the key parameters of which were already decided by the Federal Council in 2022. "The substantial provision of liquidity will ensure that both banks have access to the necessary liquidity. By providing substantial liquidity assistance, the SNB is fulfilling its mandate to contribute to the stability of the financial system, and it continues to work closely with the federal government and FINMA to this end," said the agency. Reference Link

14:50 EDT Swiss government announces support for Credit Suisse takeover by UBS - The Federal Council of the Swiss government said it welcomes the planned takeover of Credit Suisse (CS) by UBS (UBS). "To strengthen financial market stability until the takeover is complete, the federal government is providing a guarantee for additional liquidity assistance from the Swiss National Bank to Credit Suisse. This support is intended to secure the liquidity of Credit Suisse and thus also ensure the successful implementation of the takeover. The Federal Council is taking this measure in order to protect financial stability and the Swiss economy," the agency said in a statement. The Federal Council has created the necessary legal basis for the Swiss National Bank to be able to provide Credit Suisse with additional liquidity assistance. Specifically, the Federal Council has established bankruptcy privilege rights for this additional liquidity assistance. Second, to ensure that Credit Suisse is provided with sufficient liquidity at all times, the Federal Council has decided to give the SNB a default guarantee for liquidity assistance. In order to reduce any risks for UBS, the federal government is also granting UBS a guarantee in the amount of CHF 9B to assume potential losses arising from certain assets that UBS takes over as part of the transaction, should any future losses exceed a certain threshold. Reference Link