Stockwinners Market Radar for April 23, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

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BBBY...		Hot Stocks 20:11 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Bed Bath & Beyond (BBBY) announced that it and certain of its subsidiaries filed voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of New Jersey to implement an orderly wind down of its businesses while conducting a limited marketing process to solicit interest in one or more sales of some or all of its assets. 2. Comcast (CMCSA) announced that the company and Jeff Shell, Chief Executive Officer of NBCUniversal, have mutually agreed that Shell will depart effective immediately following the company's investigation led by outside counsel into a complaint of inappropriate conduct. 3. Netflix (NFLX) kicked off tech earnings season and things didn't look so good, Eric J. Savitz writes in this week's edition of Barron's. Even still, the Netflix story is in transition and should reward patient investors. The company has launched two initiatives intended to boost growth-an advertising-supported subscription tier and a crackdown on password sharing. The early signs are promising, but it might take a few quarters for the impact of the programs to show up in financial results, leading to some uncomfortable year-over-year comparisons in the short term, the author notes. 4. Illumination and Universal's Nintendo (NTDOY) video game adaptation "The Super Mario Bros. Movie" wins the weekend at the domestic box office with another $58.2M in its fourth weekend as the movie crossed the $400M mark domestically and $800M globally. The pic also surpassed "Jurassic World" and now ranks as Universal's biggest third weekend in history. 5. TJX (TJX), Expedia (EXPE), Nvidia (NVDA), Caterpillar (CAT), Micron (MU), Philip Morris (PM), Estee Lauder (EL), and Tesla (TSLA) saw positive mentions in this week's edition of Barron's.
SNY		Hot Stocks 19:24 EDT Sanofi announces launch of AVAXIM Junior in U.K. - Sanofi has announced the launch of AVAXIM Junior in the U.K., an inactive hepatitis A vaccine indicated for use in children aged 12 months to 15 years inclusive to prevent infection caused by the hepatitis A virus. The vaccination schedule consists of two vaccine doses injected by the intramuscular route 6 months to 36 months apart but can be given up to 7 years apart. This launch was based on data from 20 clinical studies in 14 countries across Europe, the Middle East, Asia and the Americas, involving more than 6,200 children aged 12 months to 15 years who have received at least one dose of the vaccine in the context of a clinical trial. The data show that AVAXIM Junior is effective in inducing a protective antibody response within two weeks in over 95% of individuals, and in nearly 100% before the booster dose administered six months after the first dose.
APLS		Hot Stocks 18:21 EDT Apellis presents Phase 3 functional analyses of SYFOVRE for geographic atrophy - Apellis Pharmaceuticals announced post hoc analyses from the 24-month, Phase 3 OAKS and DERBY studies evaluating SYFOVRE for the treatment of geographic atrophy secondary to age-related macular degeneration. The analyses were reported during oral presentations at the Association for Research in Vision and Ophthalmology Annual Meeting taking place April 23-27 in New Orleans. SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions. Additionally, SYFOVRE showed a meaningful reduction in the loss of photoreceptor and retinal pigmented epithelial cells, which are both required for vision. These analyses utilized data from patients with SPECTRALIS optical coherence tomography images, which allowed for artificial intelligence-based automated segmentation of the photoreceptor and RPE layers as well as determination of the amount of the central foveal region covered by the GA lesion. SYFOVRE showed visual function and quality-of-life benefits in patients with extrafoveal lesions. Due to sample size considerations, every-other-month and monthly data from OAKS and DERBY were combined for the SYFOVRE and sham groups. These data are in addition to the functional benefit outcomes previously reported in the post hoc junctional zone microperimetry analysis. SYFOVRE slowed photoreceptor and RPE cell loss compared to sham. Marketing applications are currently under review with five regulatory agencies worldwide. A decision in the EU is expected in early 2024, and decisions in Canada, Australia, Switzerland, and the United Kingdom are expected in the first half of 2024.
ISEE		Hot Stocks 18:19 EDT Iveric bio announces findings from exploratory analyses of data for ACP - Iveric bio announced new findings from exploratory analyses of data for avacincaptad pegol, or ACP, which were presented today at the 2023 annual meeting of the Association for Research in Vision and Ophthalmology, in New Orleans. A post-hoc analysis from the GATHER1 and GATHER2 pivotal Phase 3 clinical trials showed, for the first time in an interventional study in GA, a relationship between GA growth and worsening vision loss. In this combined analysis, greater vision loss was correlated with increased GA growth. See accompanying graph. As previously announced, the post-hoc analysis of GATHER1 and GATHER2 combined data signaled a 56% risk reduction in the rate of persistent vision loss in GA patients receiving ACP 2 mg compared to sham over the first 12 months of treatment. Persistent vision loss was defined as a loss of greater than or equal to15 letters in Best Corrected Visual Acuity from baseline measured at any two consecutive visits up to month 12. Multiple sensitivity analyses were conducted to evaluate this finding, including 10- and 20-letter loss at two consecutive visits up to month 12, and results were consistent.
CMCSK CMCSA		Hot Stocks 16:22 EDT Comcast says NBCUniversal CEO Jeff Shell leaving company - Comcast announced that the company and Jeff Shell, Chief Executive Officer of NBCUniversal, have mutually agreed that Shell will depart effective immediately following the company's investigation led by outside counsel into a complaint of inappropriate conduct. Shell said, "Today is my last day as CEO of NBCUniversal. I had an inappropriate relationship with a woman in the company, which I deeply regret. I'm truly sorry I let my Comcast and NBCUniversal colleagues down, they are the most talented people in the business and the opportunity to work with them the last 19 years has been a privilege."
ADVM		Hot Stocks 16:17 EDT Adverum Biotechnologies presents nonclinical data at 2023 ARVO meeting - Adverum Biotechnologies announced nonclinical data supporting the two doses of ixoberogene soroparvovec being evaluated in the Phase 2 LUNA trial and the potential for staggered, bilateral administration in the treatment of wet AMD. The data were featured in an oral presentation at the Association for Research in Vision and Ophthalmology 2023 Annual Meeting in New Orleans, Louisiana. Staggered, bilateral administration of Ixo-vec in NHPs was well tolerated with encouraging therapeutic activity and no signals of increased inflammation. A no-observed-adverse-effect level was identified in NHPs at the human equivalent dose of 2E11 supporting the human 2E11 and 6E10 doses in the ongoing Phase 2 LUNA study in wet AMD. Both 2E11 and 6E10 human equivalent doses resulted in therapeutic aflibercept levels with mean peak levels comparable with those observed in previous NHP and in human studies utilizing higher doses of Ixo-vec. Administration of a single intravitreal dose of Ixo-vec in the second eye resulted in peak aflibercept levels that are within the targeted therapeutic range. Despite elevated systemic humoral response after first eye injection, second eye total antibodies were undetectable prior to injection of Ixo-vec dose in the second eye.
CNI		Hot Stocks 16:13 EDT Canadian National, TCRC reach tentative agreement - Canadian National announced that a tentative agreement has been reached with the Teamsters Canada Rail Conference, or TCRC. The union represents approximately 6,000 CN Locomotive Engineers, Conductors, Yard Conductors, and Yard Coordinators working on CN's mainline, shortlines and yards, in Canada. "We are pleased to have reached an agreement with the TCRC. We would like to thank their leadership for engaging with CN in proactive and productive discussions, ensuring uninterrupted service for our customers. We look forward to working with them in the future," said Tracy Robinson, President and Chief Executive Officer, CN.
IDYA		Hot Stocks 09:11 EDT Ideaya announces interim Phase 2 data for darovasertib, crizotinib combination - Ideaya Biosciences announced further interim results from its Phase 2 clinical trial evaluating darovasertib and crizotinib combination in metastatic uveal melanoma, or MUM, patients. "The observed efficacy in first-line metastatic uveal melanoma patients - including confirmed ORR of 45% and median PFS of ~ 7 months - is clinically significant and represents a potential paradigm shift for treating MUM patients. The interim data for the darovasertib and crizotinib combination treatment in MUM suggests a compelling clinical efficacy and tolerability profile," said Meredith McKean, Director, Melanoma and Skin Cancer Research at Sarah Cannon Research Institute. "These clinical data, considered with the FDA's guidance from our recent Type C meeting, provides Ideaya with a registrational trial design in first-line HLA-A2 negative MUM patients which includes a path to potential accelerated approval based on median PFS as the primary endpoint," said Darrin Beaupre, Chief Medical Officer, Ideaya Biosciences. Ideaya is targeting to initiate a potential registration-enabling Phase 2/3 clinical trial in Q2 2023 in first-line HLA-A2 negative MUM patients. The Phase 2/3 clinical trial design incorporates guidance and feedback from the FDA following a recent Type C meeting.
GEHI		Hot Stocks 06:53 EDT Gravitas Education appoints new Chief Financial Officer - Gravitas Education announced that it has appointed Siyuan Wang as its chief financial officer, effective April 23. Wang will succeed Hao Gu, who has decided to resign from this position for personal reasons. Gu's resignation does not involve any disagreement with the company with regard to its business, finance, accounting or any other affairs.
BBBY		Hot Stocks 06:50 EDT Bed Bath & Beyond files voluntary Chapter 11 petitions - Bed Bath & Beyond announced that it and certain of its subsidiaries filed voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of New Jersey to implement an orderly wind down of its businesses while conducting a limited marketing process to solicit interest in one or more sales of some or all of its assets. To facilitate this process, the Company has received a commitment of approximately $240 million in debtor-in-possession financing from Sixth Street Specialty Lending. Following court approval, the company expects this financing to provide the necessary liquidity to support operations during the Chapter 11 process. The company's 360 Bed Bath & Beyond and 120 buybuy BABY stores and websites will remain open and continue serving customers as the company begins its efforts to effectuate the closure of its retail locations. Through the filing of customary motions with the Court, the company intends to uphold its commitments to customers, employees, and partners, including continued payment of employee wages and benefits, maintaining customer programs, and honoring obligations to critical vendors. While the company has commenced a liquidation sale, Bed Bath & Beyond intends to use the Chapter 11 proceedings to conduct a limited sale and marketing process for some or all of its assets. The company has filed motions with the Court seeking authority to market Bed Bath & Beyond and buybuy BABY as part of an auction pursuant to section 363 of the Bankruptcy Code. Alongside these efforts, the company is also strategically managing inventory to preserve value. In the event of a successful sale, the company will pivot away from any store closings needed to implement a transaction. The company believes this dual-path process will best maximize value.