Stockwinners Market Radar for April 16, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:55 EDT SNBL to acquire Satsuma Pharmaceuticals for 91c in cash per share - Satsuma Pharmaceuticals announced that it has entered into a definitive agreement to be acquired by Shin Nippon Biomedical Laboratories for 91c in cash per share at the closing of the transaction plus one non-tradeable contingent value right of up to $5.77 per share. The CVR is payable pursuant to the future sale, license, or any other monetization events related to STS101, a novel investigational therapeutic product candidate for the acute treatment of migraine,. Satsuma submitted a New Drug Application to the U.S. Food and Drug Administration in March 2023 for STS101, which incorporates nasal powder formulation and delivery device technologies developed by SNBL and exclusively licensed by Satsuma. Consummation of the transaction is subject to customary closing conditions, including the tender of a majority of Satsuma's outstanding shares of common stock. The Tender Offer period is expected to commence in the next few weeks and to expire 20 business days after its commencement, unless otherwise extended. If the Tender Offer conditions are not satisfied, SNBL may be required to extend the Tender Offer under certain circumstances.

18:17 EDT MSG Networks to launch sports streaming service with Harmonic - Harmonic (HLIT) announced that MSG Networks will use Harmonic's VOS360 SaaS for its new MSG+ sports streaming service, due to launch this summer. With VOS360 SaaS, MSG Networks (MSGE) "can deliver outstanding video quality and individually addressable advertising, including dynamic brand insertion, with unparalleled scalability and geo-redundancy," the companies said. In related news on Sunday, Harmonic also announced that these same server-side ad insertion capabilities are available as a new stand-alone SaaS solution, VOS360 Ad SaaS. The company will showcase its latest innovations in streaming and broadcast delivery at the 2023 NAB Show in Las Vegas.

16:37 EDT Affimed presents final results from Phase 2 REDIRECT study - Affimed N.V. provided the final results from its phase 2 REDIRECT study investigating its innate cell engager AFM13 monotherapy in patients with heavily pretreated advanced-stage r/r PTCL. AFM13 monotherapy showed efficacy in the treatment of relapsed/refractory peripheral T cell lymphoma patients with a differentiated safety profile. Primary efficacy measures include an ORR of 32.4% and a CR rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, progression free survival and overall survival. Median DoR was 2.3 months, median PFS was 3.5 months and median OS was 13.8 months. PFS and OS were comparable with currently approved therapies for r/r PTCL. Of all PTCL subsets, patients with AITL exhibited the highest ORR and CR with DoR not meaningfully different across the various subsets. The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13. Most common TEAEs were IRR, neutropenia and pyrexia. No AFM13-related fatal toxicities were observed.

16:30 EDT Merck announces results from Phase 3 KEYNOTE-966 trial - Merck announced results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with standard of care chemotherapy for the first-line treatment of patients with advanced or unresectable biliary tract cancer. Results from the trial showed the KEYTRUDA regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy alone for these patients. After a median follow-up of 25.6 months, KEYTRUDA plus chemotherapy reduced the risk of death by 17% compared to chemotherapy alone for these patients. Median OS was 12.7 months for the KEYTRUDA regimen versus 10.9 months for chemotherapy alone. The one-year OS rate was 52% for the KEYTRUDA regimen versus 44% for chemotherapy alone; the two-year OS rates were 24.9% versus 18.1%, respectively. The OS results were generally consistent across subgroups. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Grade 3-4 treatment-related adverse events occurred in 70% of patients receiving the KEYTRUDA regimen and 69% of patients receiving chemotherapy alone; TRAEs led to death in eight versus three patients, respectively. No new safety signals were identified. Grade 3-4 immune-mediated adverse events occurred in 7% of patients receiving the KEYTRUDA regimen and 4% of patients receiving chemotherapy alone; immune-mediated AEs led to death in one patient receiving the KEYTRUDA regimen.

16:06 EDT Merck, Moderna announce results from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial - Moderna (MRNA) and Merck (MRK) announced the first presentation of detailed results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157, an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma. In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival, and reduced the risk of recurrence or death by 44% compared with KEYTRUDA alone. Based on data from KEYNOTE-942/mRNA-4157-P201, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the PRIME scheme, respectively, for mRNA-4157 in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma following complete resection. Additional data from KEYNOTE-942/mRNA-4157-P201 will be shared at an upcoming medical meeting and published in a peer-reviewed publication. The companies previously announced positive data from this study in December 2022. Adverse events reported with mRNA-4157 in KEYNOTE-942 were consistent with those previously observed in a Phase 1 clinical trial. The safety profile of KEYTRUDA was consistent with findings from previous studies.

08:56 EDT Gilead announces results from several COVID-19 clinical, real-world studies - Gilead Sciences announced results from several COVID-19 clinical and real-world evidence studies being presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases. A Phase 3 clinical study demonstrated that Veklury, or remdesivir, was generally well tolerated in people with moderate to severe renal impairment. Additional data includes a retrospective real-world study which demonstrated that Veklury treatment is associated with a lower risk of death from COVID-19 for people living with cancer. A separate real-world analysis demonstrated that use of Veklury is also associated with reduced hospital readmission risk in immunocompromised patients hospitalized with COVID-19. Results from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics of obeldesivir, previously known as GS-5245, a novel investigational oral compound being developed by Gilead for the treatment of SARS-CoV-2 infection, showed obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19. Results from a Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the safety of Veklury in patients with moderately and severely reduced kidney function who were hospitalized for COVID-19, a population with increased COVID-19-related mortality. The trial included 243 hospitalized adult participants with confirmed COVID-19 and renal impairment, including 90 participants with acute kidney injury, 64 participants with chronic kidney disease and 89 participants with end stage kidney disease requiring hemodialysis. Patients were randomized 2:1 to receive Veklury or placebo, in addition to standard of care. No new safety signals were observed in the study and no additional adverse reactions to Veklury were identified in 163 hospitalized patients with AKI, CKD or ESKD on hemodialysis receiving Veklury for up to 5 days. Two real-world studies of clinical practice presented at ECCMID examined Veklury's effectiveness in reducing COVID-19-associated mortality for those living with cancer, as well as the role Veklury plays in reducing hospital readmission for immunocompromised patients infected with dominant variants of concern: pre-Delta, Delta and Omicron. In the first analysis, 7,482 people with cancer and hospitalized for COVID-19 who were treated with Veklury in the first two days of admission were evaluated. Results at Day 28 showed that people with cancer treated with Veklury had a significantly lower risk for mortality compared to people with cancer that were not treated with Veklury. This finding was seen across all VOC at Day 28: pre-Delta, 25%; Delta, 32%; and Omicron, 40%. In the second analysis, 4,664 immunocompromised patients were evaluated and those who received treatment with Veklury had lower risk for hospital readmission at both 30- and 60-day time periods. Results demonstrated that 60-day readmission rates were 16% lower for patients treated with Veklury during the Delta wave and 13% lower during the Omicron wave compared to matched controls. These data further confirm RWE presented at CROI earlier this year which demonstrated that use of Veklury was associated with a reduced risk of 30-day all-cause readmission. Gilead also announced positive data at ECCMID from its Phase 1 randomized, double-blind, placebo-controlled, dose escalation study of obeldesivir in healthy adult participants. Results demonstrated that obeldesivir reaches expected therapeutic plasma concentrations for the treatment of COVID-19. Obeldesivir is an investigational novel oral antiviral being developed for the treatment of COVID-19, which once metabolized, works in the same way as Veklury by targeting SARS-CoV-2 virus replication through inhibition of the viral RNA polymerase. Gilead has advanced obeldesivir into two Phase 3 studies - BIRCH and OAKTREE - in broad populations and geographies to assess the efficacy and safety of obeldesivir for the treatment of non-hospitalized participants with COVID-19.