Stockwinners Market Radar for March 27, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:07 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. Tesla (TSLA) plans to suspend production at its Shanghai plant for at least one day as the local government intensifies COVID restrictions after a surge in cases in the city, according to Bloomberg, citing people familiar with the matter. Production will be halted Monday, the people said. Tesla hasn't yet informed employees whether it will extend the suspension beyond Monday, they added. 2. The U.S. National Highway Traffic Safety Administration has reinstated higher penalties for automakers failing to meet fuel efficiency requirements in recent years, a win for Tesla that could cost other automakers hundreds of millions of dollars or more, according to a document seen by Reuters. President Donald Trump's administration in its final days in January 2021 delayed a 2016 regulation that more than doubled penalties for automakers failing to meet Corporate Average Fuel Economy requirements starting in the 2019 model year. NHTSA's final rule, which was viewed by Reuters, reinstates the higher penalties and boosts them further for the 2022 model year. The hike is expected to cost Chrysler parent Stellantis (STLA), for instance, hundreds of millions of dollars, the publication noted. 3. GameStop (GME) expects to launch a marketplace for non-fungible tokens, or NFTs, by the end of July, pushing into the digital asset space as investors hope for a wider turnaround at the embattled videogame retailer, Jack Denton wrote in this week's edition of Barron's. The move into NFTs would be a significant departure from GameStop's core retail business. It's also a gamble that may not move the revenue needle much, and adds another element of uncertainty around the highly volatile stock, the author noted. 4. ViacomCBS (VIACA) subsidiary Paramount's "The Lost City" won this weekend's domestic box office with a better-than-expected $31M debut from 4,352 theaters. Overseas, Sandra Bullock and Channing Tatum's movie grossed $3.7M from its first 16 smaller-sized markets. 5. nVent (NVT) and Berkshire Hathaway (BRK.A, BRK.B) saw positive mentions in this week's edition of Barron's.

14:37 EDT Vertex announces reimbursement agreement in Australia for TRIKAFTA - Vertex Pharmaceuticals announced that as of 1 April 2022, TRIKAFTA will be reimbursed on the Australian Pharmaceutical Benefits Scheme for the treatment of cystic fibrosis in people ages 12 years and older who have at least one F508del mutation in the CFTR gene, the most common CF-causing mutation worldwide. TRIKAFTA was approved by the Australian Therapeutic Goods Administration in March 2021 based on the results of four global Phase 3 clinical trials, which included multiple Australian trial sites and patients. CF is a rare, life-shortening, genetic disease affecting approximately 3,500 people in Australia. It is caused by a defective and/or missing CFTR protein, resulting from mutations in the CFTR gene. Up to 90 percent of people living with CF have at least one F508del mutation. Australia now joins the list of 30 countries where the triple combination therapy is approved and reimbursed including Denmark, Finland, France, Germany, Italy, Ireland, Israel, Poland, Spain, Switzerland and the countries within the U.K.

14:27 EDT Eli Lilly, Incyte present OLUMIANT alopecia areata data - Adults with severe alopecia areata who took OLUMIANT achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to OLUMIANT 4-mg achieved 90% scalp coverage at 52 weeks, Eli Lilly (LLY) and Incyte (INCY) announced at the American Academy of Dermatology Annual Meeting. In February 2022, the U.S. Food and Drug Administration granted priority review for OLUMIANT in severe AA as a potential first-in-disease medicine. Lilly expects regulatory decisions in the U.S., European Union and Japan in 2022. In the pooled 52-week analysis, patients at baseline had a mean Severity of Alopecia Tool score of 85.5; severe AA is defined as having a SALT score greater than or equal to 50. At baseline, 69.4% and 57.9% had significant eyebrow and eyelash hair loss, respectively, as defined by Clinician-Reported Outcome scores greater than or equal to2. Patients' average age was 37.6 years, with hair loss starting around age 25 and a mean of 12.2 years since symptom onset. Among patients who took OLUMIANT 4-mg, two out of five achieved significant scalp hair regrowth, defined as a SALT score less than or equal to 20, or 80% or more scalp hair coverage, and nearly three out of four of those patients also achieved a SALT score less than or equal to 10, or 90% hair coverage, at 52 weeks. Separately, more than two out of five patients with ClinRO baseline scores greater than or equal to 2 saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair. Among patients who took OLUMIANT 2-mg, more than one out of five achieved significant scalp hair regrowth and two out of three of those patients achieved 90% or more hair coverage at 52 weeks. Separately, more than one in five and one in four patients, respectively, saw full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair. These 52-week pooled analyses demonstrate continued improvement in scalp, eyebrows and eyelash hair regrowth from 36-week results published in the New England Journal of Medicine and presented at the 2021 European Academy of Dermatology and Venereology Congress. In an evaluation of OLUMIANT 4-mg and 2-mg long-term safety, incidence rates of frequently reported adverse events up to 52 weeks (median 56 weeks exposure) were consistent with the 36-week, placebo-controlled period and included upper respiratory tract infection, headache, acne, urinary tract infection and increases in muscle-related blood markers. There were no new safety signals.

14:18 EDT Incyte announces 52-week data from Phase 3 TRuE-V program - Incyte announced new 52-week results from its pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream, a topical JAK1/JAK2 inhibitor, in adolescent and adult patients with nonsegmental vitiligo. These data were presented as an oral presentation in a late-breaking abstract session at the 2022 American Academy of Dermatology Annual Meeting, held from March 25-29 in Boston. The 52-week results build on the previously announced positive 24-week results and include data from the 24-week double-blind and 28-week treatment extension periods of the Phase 3 TRuE-V1 and TRuE-V2 studies. Findings from the Week 52 analysis showed that patients applying 1.5% ruxolitinib cream twice daily had clinically meaningful facial and total body repigmentation as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring endpoints at Week 52. Specifically, efficacy results of patients who applied ruxolitinib cream from Day 1 showed: At Week 52, approximately 50% of patients achieved greater than or equal to 75% improvement in the facial Vitiligo Area Scoring Index compared to the F-VASI75 improvement from baseline reported for these patients at Week 24 which was approximately 30%. At Week 52, approximately 75% of patients achieved greater than or equal to50% improvement in F-VASI, and nearly one-third achieved greater than or equal to 90% improvement in F-VASI compared to the Week 24 response rates for F-VASI50 and F-VASI90 which were approximately 51% and 15%, respectively. Additionally, a greater proportion of patients at Week 52 achieved greater than or equal to50% improvement in total body Vitiligo Area Scoring Index, and over one-third of patients achieved a Vitiligo Noticeability Scale response. Further improvement on percentage change from baseline in facial body surface area with application of ruxolitinib cream was also observed. Results at Week 52 in crossover patients were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1. The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data - there were no clinically significant application site reactions or serious treatment-related adverse events related to ruxolitinib cream. As previously announced, based on the 24-week results, Incyte submitted marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo to the U.S. Food and Drug Administration and the European Medicines Agency. The FDA Prescription Drug User Fee Act target action date is July 18, 2022.

14:10 EDT Lilly says majority of patients achieved skin clearance in Phase 3 AD studies - More than 50 percent of patients with moderate-to-severe atopic dermatitis experienced at least 75 percent reduction in disease severity at 16 weeks when receiving lebrikizumab monotherapy in the ADvocate program, Eli Lilly announced at the American Academy of Dermatology Annual Meeting. Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo. Lebrikizumab is a monoclonal antibody that binds to the interleukin 13 protein with high affinity to specifically prevent the formation of IL-13Ralpha1/IL-4Ralpha which blocks downstream signaling through the IL-13 pathway. 1-5 IL-13 plays the central role in Type 2 inflammation. In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin. In ADvocate 1, 43 percent of patients receiving lebrikizumab achieved clear or almost clear skin at 16 weeks compared to 13 percent of patients taking placebo. Among those receiving lebrikizumab, 59 percent achieved an EASI-75 response, compared to 16 percent with placebo. In ADvocate 2, 33 percent of patients taking lebrikizumab achieved clear or almost clear skin at 16 weeks, compared to 11 percent of patients on placebo. Among those receiving lebrikizumab, 51 percent achieved an EASI-75 response, compared to 18 percent taking placebo. Within four weeks, patients receiving lebrikizumab experienced statistically significant improvements in skin clearance and itching, as well as improvements in interference of itch on sleep, and quality of life, as measured by key secondary endpoints. The safety profile of the 16-week period was consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab, compared to placebo, reported a lower frequency of adverse events in ADvocate 1 and ADvocate 2. Most adverse events across the two studies were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. Detailed 52-week results from ADvocate 1 and 2, as well as 16-week data from ADhere, the Phase 3 AD study of lebrikizumab with topical steroids, will be disclosed in coming months. Lilly and Almirall S.A. plan to submit filings to regulatory authorities around the world by the end of 2022 following completion of the ADvocate studies. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

10:41 EDT AnPac Bio announces receipt of Staff delisting determination from Nasdaq - AnPac Bio announced that on March 24, 2022, it received a Staff determination letter from the Listing Qualifications Department of The Nasdaq Stock Market notifying the company of the Staff's determination to delist the company's securities from The Nasdaq Global Market due to its failure to regain compliance with the minimum $50,000,000 Market Value of Listed Securities required for continued listing as set forth in Listing Rule 5450(b)(2)(A), following the 180 calendar day compliance period. The Letter also indicates that the company has not met the Nasdaq's minimum standard requirements of $10,000,000 in stockholders' equity, $50,000,000 in total assets and $50,000,000 in total revenue. Pursuant to the Letter, unless the company requests an appeal of the Letter, trading of the company's American Depositary Shares will be suspended at the opening of business on April 4, 2022, and Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the company's securities from listing and registration on the Nasdaq Stock Market. The Company may also apply to list its securities on The Nasdaq Capital Market if it satisfies the requirements for continued listing on that market. The company is applying to transfer to The Nasdaq Capital Market and will appeal the Letter to seek additional time to meet the requirements to transfer. The company intends to request a hearing before a Hearings Panel. Such a request will allow the company to continue to be traded for a period of the time and the filing of the Form 25-NSE pending the Panel's decision; during the period before the hearing, the company's American Depositary Shares will continue to trade. At the hearing, the company intends to request a transfer to the Nasdaq Capital Market, present a plan to achieve compliance with continued listing requirements of The Nasdaq Capital Market and request that the Panel allow the Company additional time within which to regain such compliance.