Stockwinners Market Radar for January 08, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:12 EST Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Goldman Sachs (GS) is embarking on one of its biggest round of job cuts ever as it locks in on a plan to eliminate about 3,200 positions this week, with the bank's leadership going deeper than rivals to shed jobs, Bloomberg's Sridhar Natarajan reports. The company is expected to start the process mid-week and the total number of people affected will not exceed 3,200, according to a person familiar with the matter. 2. Seattle's public school district filed a lawsuit against Big Tech claiming that the companies were responsible for a worsening mental health crisis among students and directly affected the schools' ability to carry out their educational mission, according to Reuters. The complaint, filed on Friday against Alphabet (GOOGL), Meta Platforms (META), Snap (SNAP), and TikTok-owner ByteDance with the U.S. District Court, claimed they purposefully designed their products to hook young people to their platforms and were creating a mental health crisis, the publication says. 3. Times are tough for Tesla (TSLA), with demand slowing, costs rising and Elon Musk both distracted and a distraction, Al Root writes in this week's edition of Barron's. It's time to buy the stock, the author adds, noting that Tesla is the leading EV manufacturer in the world and one that has a decade-plus head start on other auto makers, as well. Tesla stock is a risky bet, to be sure, but with shares off 72% from their all-time high, to $113.06, and near 21 times 12-month forward earnings, down from 201 times two years ago, the opportunity is too good to pass up, Root argues. 4. Disney's (DIS) "Avatar: The Way of Water" won this New Year's weekend with an estimated $86.3M for the four days for a domestic total of $444.4M as it crossed $1.4B in worldwide ticket sales on Monday. Overseas, the movie grossed an estimated $186.7M for the three-day weekend for a foreign cume of $956.9M. 5. Charles Schwab (SCHW) and Philip Morris' (PM) saw positive mentions in this week's edition of Barron's, while Bed Bath & Beyond (BBBY) was mentioned cautiously.

17:26 EST Day One announces top line data from pivotal Phase 2 FIREFLY-1 trial - Day One Biopharmaceuticals announced positive top line results from the ongoing, open-label, pivotal Phase 2 FIREFLY-1 trial evaluating the investigational agent, tovorafenib, as a monotherapy in recurrent or progressive pediatric low-grade glioma. Pediatric low-grade glioma is the most common brain tumor diagnosed in children and for which there is no standard of care, and for which there are no approved therapies for the majority of patients. Additional data will be submitted for presentation at an upcoming medical meeting in the second quarter of 2023. The primary endpoint of the FIREFLY-1 trial is overall response rate by Response Assessment for Neuro-Oncology criteria as assessed by blinded independent central review. Top line results as of September 28, 2022 include: among 69 RANO-evaluable patients -- 64% ORR and 91% clinical benefit rate; 4% confirmed complete responses; 59% partial responses; 28% patients with stable disease; 86% of patients had a BRAF fusion alteration, for which there are no approved systemic therapies, while the remaining 14% had a BRAF mutation. Safety data, based on 77 treated patients, indicated monotherapy tovorafenib to be generally well-tolerated. Among a total of 77 treated patients: Participants were heavily pretreated, with a median of three prior lines of systemic therapy; The median duration of tovorafenib treatment was 8.4 months, with 77% of patients on treatment at the time of the data cutoff; Nearly 60% of patients had already received at least one prior MAPK inhibitor prior to study participation. In addition to FIREFLY-1, Day One is expanding the development of tovorafenib as a front-line therapy for patients newly diagnosed with pLGG. The global, Phase 3, registrational FIREFLY-2/LOGGIC clinical trial is evaluating once-weekly monotherapy tovorafenib in newly-diagnosed patients with pLGG harboring a known activating RAF alteration.

16:49 EST Viracta announces first clinical response in EBV+ solid tumor setting - Viracta Therapeutics announced new clinical data from the Phase 1b/2 trial of Nana-val in patients with EBV+ R/M NPC and other EBV+ solid tumors and outlined its key 2023 clinical objectives. New Phase 1b data on Nana-val in patients with EBV+ R/M NPC, include: One PR and one disease progression were reported in evaluable patients in the third dose level; Preliminary safety data from the first three dose levels was previously presented at the European Society for Medical Oncology Immuno-Oncology Congress in December 2022, showing Nana-val was well-tolerated with no dose limiting toxicities; Enrollment in the fourth dose level is ongoing. Key 2023 clinical objectives include: Nana-val in patients with EBV+ R/R lymphoma; Pivotal NAVAL-1 study open for enrollment at more than 60 sites globally; the study footprint is expected to expand further in 2023; Anticipate providing an update on NAVAL-1's first lymphoma subtype that may advance from Stage 1 to Stage 2 in the first half of 2023; Expect to provide additional updates from other lymphoma subtype(s) throughout 2023. Regarding Nana-val in patients with advanced EBV+ solid tumors, the company anticipates completion of the Phase 1b dose escalation portion of the trial and selection of the recommended Phase 2 dose in 2023; anticipates initiating the Phase 2 randomized expansion portion of the trial, designed to evaluate Nana-val at the RP2D with or without pembrolizumab in patients with EBV+ R/M NPC, in the second half of 2023; anticipates initiating the exploratory Phase 1b cohort designed to evaluate Nana-val at the RP2D in other EBV+ solid tumors in the second half of 2023. Viracta strengthened its balance sheet by exercising its option to draw the $20 million tranche from its non-dilutive $50 million credit facility with Silicon Valley Bank and Oxford Finance. Viracta intends to use this additional capital to support Nana-val's development in EBV+ R/M NPC and to explore its potential in other advanced EBV+ solid tumor indications. As a result, Viracta ended 2022 with over $90 million in cash, cash equivalents, and investments, and has an anticipated cash runway into late 2024.

16:28 EST BioMarin announces data from follow up from Phase 3 GENEr8-1 study of ROCTAVIAN - BioMarin Pharmaceutical announced positive results from more than three years of follow up from its ongoing global Phase 3 GENEr8-1 study of ROCTAVIAN, an investigational one-time gene therapy for the treatment of adults with severe hemophilia A. This is the largest and longest global Phase 3 study to date for any gene therapy in hemophilia with 134 participants. In response to the U.S. Food and Drug Administration's request, and consistent with the FDA's guidance for other gene therapy trials for hemophilia, BioMarin has also analyzed annualized bleeding rate for all bleeds, regardless of whether those bleeds were treated with exogenous Factor VIII replacement. Results from that analysis were similar to those reflected in the table above. In Year 3, the mean/median ABR for all bleeds was 1.4/0.0, and in Year 4 the mean/median ABR for all bleeds was 1.6/1.0. At the end of Year 3, 92% of patients remained off prophylaxis. Those patients who returned to Factor VIII or emicizumab prophylaxis did so safely. BioMarin plans to present additional data from this study at upcoming medical meetings. As the company has previously indicated, BioMarin is targeting outcomes-based agreements with the three largest health insurance groups that represent about 80% of German lives. The company has executed an OBA with one of the three. The company expects to sign additional agreements in the coming weeks in Germany and continues to progress the European launch of ROCTAVIAN on a country-by-country basis, including meetings with authorities in France and the submission of the reimbursement dossier in Italy. For covered patients, the agreements provide for companion diagnostic testing and reimbursement of ROCTAVIAN, allowing physicians to prescribe and patients to be treated with therapy. The OBAs in Germany are multiyear agreements that cover payer risk of patients potentially returning to prophylaxis through direct BioMarin financial commitment in return for substantial and full upfront payment. Overall, to date, a single 6e13 vg/kg dose of valoctocogene roxaparvovec has been well tolerated with no delayed-onset treatment related adverse events. In Year 3, no new treatment-related serious adverse events or Grade 3 events attributed to valoctocogene roxaparvovec or corticosteroid use emerged. No participants have developed inhibitors to Factor VIII, thromboembolic events or malignancy associated with valoctocogene roxaparvovec. These data will be shared with the FDA as part of the agency's ongoing review of the Biologics License Application of ROCTAVIAN. The PDUFA date is March 31, 2023, subject to possible agency extension. Additionally, the FDA completed a Pre-License Inspection of the manufacturing facility in early December. BioMarin has provided responses to the comments and observations received at the close of the inspection, and the company believes all are addressable.