Stockwinners Market Radar for September 20, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:37 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. President Trump has announced that ByteDance has received tentative approval for an agreement with the U.S. Government to resolve the outstanding issues, which will now include Oracle (ORCL) and Walmart (WMT) together investing to acquire 20% of the newly formed TikTok Global business. As a part of the deal, TikTok is creating a new company called TikTok Global that will be responsible for providing all TikTok services to users in United States and most of the users in the rest of the world. The administration has conditionally approved a landmark deal where Oracle becomes TikTok's secure cloud provider. TikTok Global will be majority owned by American investors, including Oracle and Walmart. TikTok Global will be an independent American company, headquartered in the U.S., with four Americans out of the five member Board of Directors. All the TikTok technology will be in possession of TikTok Global, and comply with U.S. laws and privacy regulations. Data privacy for 100M American TikTok users will be quickly established by moving all American data to Oracle's Generation 2 Cloud data centers. TikTok Global will create more than 25,000 new jobs in the Unites States and TikTok Global will pay more than 5B in new tax dollars to the U.S. Treasury. TikTok Global will have an Initial Public Offering in less than 12 months and be listed on a U.S. Exchange. 2. KPS Capital Partners, through a newly formed affiliate, has entered into a stock and asset purchase agreement with Garrett Motion (GTX), under which KPS will acquire substantially all of the assets of Garrett for approximately $2.1B. Garrett will file a motion with the United States Bankruptcy Court for the Southern District of New York seeking the designation of KPS as the "stalking horse bidder" in a bidding procedures motion in connection with the company's filing of voluntary petitions under Chapter 11 of the Bankruptcy Code. To facilitate the sale process, Garrett has begun a process in the United States to financially restructure through a voluntary Chapter 11 proceeding. The completion of the sale is subject to court approval, among other customary conditions. 3. Nvidia (NVDA) became the largest U.S. chip maker by market value in July, passing industry titan Intel (INTC), but by most measures, Nvidia remains a niche player, Max Cherney wrote in this week's edition of Barron's. For Nvidia to grow into its value, the company has to do something big, and CEO Jensen Huang may have found the answer with his $40B deal for Arm Holdings, the author noted. If there ever was a way to challenge Intel's dominance, Huang may have cracked the code, with a combination of Nvidia's leading graphics processors, Arm's central-processing-unit chips, and its longstanding partnership with TSMC (TSM), which fabricates many of the world's most advanced chips, the report added. 4. Christopher Nolan's "Tenet" earned an estimated $4.7M domestically in its third weekend for a North America total of $36.1M. Internationally, the AT&T (T) subsidiary Warner Bros.' movie grossed another $25M for a foreign tally of $214M and a worldwide total of $250.1M. "Tenet" sports a B CinemaScore and an 74% Rotten Tomatoes. 5. PayPal (PYPL), Square (SQ) and Albertsons (ACI) saw positive mentions in this week's edition of Barron's.

20:23 EDT Innovent, Eli Lilly release results of ORIENT-12 study - Innovent Biologics announced with Eli Lilly that the results of the ORIENT-12 study were released in a mini oral presentation at the European Society of Medical Oncology Virtual Congress 2020. ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT or placebo in combination with GEMZAR and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer. A total of 357 subjects were enrolled. In the interim analysis, TYVYT in combination with GEMZAR and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival compared with placebo in combination with GEMZAR and platinum chemotherapy, meeting the prespecified primary endpoint. The updated analysis demonstrated that the median PFS assessed by IRRC was 5.5 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm while the median PFS assessed by the investigators was 6.7 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm. The interim analysis suggested that the median overall survival data was not yet mature, but the sintilimab combination arm potentially showes an OS benefit over the placebo combination arm. The safety profile was consistent with that in previously reported studies with sintilimab, and no new safety signals were identified.

20:17 EDT Eli Lilly says Verzenio 'significantly' reduced risk of cancer recurrence by 25% - Eli Lilly announced Verzenio in combination with standard adjuvant endocrine therapy "significantly" decreased the risk of breast cancer recurrence by 25% compared to standard adjuvant ET alone for people with hormone receptor-positive, human epidermal growth factor receptor 2-negative high risk early breast cancer. This statistically significant benefit was consistent across all pre-specified subgroups and corresponds to a 3.5% difference between arms at two years. These results are from a preplanned interim analysis with 323 IDFS events observed in the intent-to-treat population across both arms, including 136 in the Verzenio arm and 187 in the control arm. Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed. At the time of analysis, approximately 70% of patients in each arm were still on the two-year treatment period. The median follow up was approximately 15.5 months in both arms. The median duration on Verzenio was 14 months. The addition of Verzenio to endocrine therapy also resulted in an improvement in distant relapse-free survival, or the time to developing cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 28%, with the largest reductions occurring in rates of metastases to the liver and bone. This treatment benefit was consistent across all prespecified subgroups. Two-year distant relapse-free survival rates were 93.6% in the Verzenio arm and 90.3% in the control arm. Overall survival results were immature and monarchE will continue through the completion date, estimated for June 2027. At the time of the interim analysis, the IDFS results are considered definitive. All patients on monarchE will be followed until primary analysis and beyond to assess overall survival and other endpoints. Lilly will submit the monarchE data to regulatory authorities before the end of 2020.

20:11 EDT Pieris presents data from monotherapy, atezolizumab combo studies of PRS-343 - Pieris Pharmaceuticals presented a clinical data update from the phase 1 monotherapy and atezolizumab combination studies of PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in an oral presentation at the European Society for Medical Oncology Virtual Congress 2020. PRS-343 continues to demonstrate durable clinical benefit in the active dose cohorts, including a confirmed complete response, in heavily pre-treated patients across multiple HER2-positive tumor types. Additionally, a significant expansion of CD8+ T cells in the tumor microenvironment of responders and a substantial increase of soluble 4-1BB were observed in the active dose cohorts, suggesting 4-1BB-mediated target engagement driving clinical benefit. PRS-343 also shows an acceptable safety profile at all doses and schedules tested in each clinical study. The company reaffirmed its commitment to moving PRS-343 into a phase 2 trial in second-line gastric cancer in combination with paclitaxel and ramucirumab. The phase 1 first-in-human, open-label multicenter monotherapy trial has enrolled 74 patients, including 21 additional patients enrolled in higher dose cohorts since the data presented at the Society for Immunotherapy of Cancer 2019 Annual Meeting. Thirteen dose levels have been evaluated, 11 of which have been evaluated at a Q3W dosing schedule. The 11th dose level has also been evaluated at a Q2W dosing schedule, including a Q2W dosing schedule in combination with obinutuzumab, and at a Q1W dosing schedule. The 12th and 13th dose levels have been evaluated exclusively at a Q2W dosing schedule. The phase 1 first-in-human, open-label multicenter atezolizumab combination trial has enrolled 41 patients. Seven dose cohorts have been evaluated at a Q3W dosing schedule ranging from 0.05 mg/kg to 8 mg/kg in combination with a fixed 1200 mg dose of atezolizumab. Primary objectives of both trials include characterizing the safety profile of PRS-343 in monotherapy or in combination with atezolizumab and identifying the maximum tolerated dose and/or the recommended phase 2 dose of PRS-343 alone and in combination with atezolizumab. Secondary objectives include assessing potential immunogenicity and pharmacodynamic effects, characterizing the pharmacokinetic profile, investigating a dosing schedule, and investigating efficacy. As of the cut-off date of July 27, 2020, 33 patients in the monotherapy trial and 29 patients in the atezolizumab combination trial were evaluable for a response at active dose levels in the trials, which began at cohort 9 in the monotherapy trial and cohort 4 in the atezolizumab combination trial. In the monotherapy study, one patient with stage 4 rectal adenocarcinoma achieved a confirmed complete response at the 18 mg/kg Q2W dose level and three patients achieved a partial response at the 8 mg/kg Q2W dose level. In the atezolizumab combination trial, four patients achieved a confirmed partial response at active dose levels. Across the active dose levels and schedules, 13 patients in the monotherapy trial and 8 patients in the atezolizumab combination trial experienced stable disease. As of the cutoff date, treatment duration across active dose levels is over 66 weeks in the monotherapy trial and over 78 weeks in the atezolizumab combination trial for at least one patient. Post-treatment increases in CD8+ Tumor Infiltrating Lymphocytes and blood-based s4-1BB suggest clinical benefit is linked to 4-1BB activity Treatment-related adverse events in both trials were primarily grade 1 and 2.

20:05 EDT MacroGenics presents MGD019 Phase 1 data at ESMO - MacroGenics has announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019. MGD019, a bispecific PD-1 CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells. Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 - 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types of solid tumors. There were no dose-limiting toxicities. A total of 28 patients were treated at doses greater than or equal to 3.0 mg/kg administered every three weeks initially. MGD019 was well-tolerated in patients who received less than 10 mg/kg. In this study, sustained peripheral PD-1 blockade was evident at doses greater than or equal to 1.0 mg/kg. In addition, dose-dependent upregulation of the inducible costimulator molecule was evident in treated patients, including those who responded to MGD019 therapy. This is consistent with the previously reported observation that anti-CTLA-4 therapy increases the frequency of CD4 T cells expressing the ICOS molecule. Of the 18 evaluable patients who received doses greater than or equal to 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer, confirmed partial responses in microsatellite stable colorectal cancer and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.

19:59 EDT Blueprint Medicines reports ARROW trial data at ESMO - Blueprint Medicines (BPMC) has announced results from the ongoing ARROW clinical trial showing durable responses and a well-tolerated safety profile for GAVRETO in patients with advanced RET-mutant medullary thyroid cancer. In these registrational data, GAVRETO demonstrated consistent clinical activity in patients across lines of therapy and regardless of RET mutation genotypes, including a high response rate in patients with gatekeeper mutations resistant to multi-kinase inhibitors. The results were presented in a proffered paper session during the European Society for Medical Oncology Virtual Congress 2020. As previously announced, the U.S. Food and Drug Administration has accepted a new drug application for GAVRETO for the treatment of patients with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer. This NDA was accepted for priority review under the FDA's Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. In addition, Blueprint Medicines has announced that the National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer to include GAVRETO as a preferred treatment option for patients with RET fusion-positive NSCLC as a first-line or subsequent therapy. This rating indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Guidelines are the recognized clinical standard for cancer care by U.S. healthcare providers and payers, and are maintained by a committee of expert physicians from leading U.S. cancer centers. GAVRETO is being jointly commercialized by Genentech, a wholly owned member of the Roche Group (RHHBY), and Blueprint Medicines in the U.S. and will be commercialized by Roche outside of the U.S., excluding Greater China.

19:53 EDT Merck, Eisai present data from two studies evaluating KEYTRUDA plus LENVIMA - Merck, known as MSD outside the United States and Canada, and Eisai have announced new investigational data from two trials under the LEAP clinical program evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the Phase 2 LEAP-004 trial, KEYTRUDA plus LENVIMA showed an objective response rate of 21.4% in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. In the Phase 2 LEAP-005 trial, KEYTRUDA plus LENVIMA demonstrated an ORR that ranged from 9.7-32.3% in previously treated patients with triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, glioblastoma multiforme and biliary tract cancer. Results from LEAP-004 and LEAP-005 were accepted as late-breaking abstracts and are being presented in proffered paper presentations at the European Society for Medical Oncology Virtual Congress 2020.

19:47 EDT Oracle chosen as TikTok's secure cloud provider - Oracle (ORCL) announced that it was chosen to become TikTok's secure cloud technology provider. This technical decision by TikTok was heavily influenced by Zoom's (ZM) recent success in moving a large portion of its video conferencing capacity to the Oracle Public Cloud. "As a part of this agreement, TikTok will run on the Oracle Cloud and Oracle will become a minority investor in TikTok Global," said Oracle CEO Safra Catz. "Oracle will quickly deploy, rapidly scale, and operate TikTok systems in the Oracle Cloud. We are a hundred percent confident in our ability to deliver a highly secure environment to TikTok and ensure data privacy to TikTok's American users, and users throughout the world. This greatly improved security and guaranteed privacy will enable the continued rapid growth of the TikTok user community to benefit all stakeholders."

14:52 EDT Analysis shows AstraZeneca Tagrisso demonstrated improvement in CNS DFS - Results from a prespecified exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca's TAGRISSO demonstrated a clinically "meaningful" improvement in central nervous system disease-free survival in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer, after complete tumor resection. While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease.1-3 CNS recurrence, when cancer spreads to the brain, is a frequent complication of EGFRm NSCLC and these patients have an especially poor prognosis. This analysis showed that fewer patients treated with TAGRISSO in the adjuvant setting had recurrence events or deaths compared to placebo. Among patients whose cancer recurred, 38% of those treated with TAGRISSO had a metastatic recurrence compared to 61% of patients on placebo. TAGRISSO showed an 82% reduction in the risk of CNS recurrence or death. Median CNS DFS was not yet reached in either arm. In a post-hoc analysis, the estimated probability of observing disease recurrence in the brain at 18 months for patients treated with TAGRISSO was less than 1% versus 9% for placebo among patients who had not experienced another type of recurrence. On the primary endpoint of DFS in patients with Stage II and IIIA disease, TAGRISSOin the adjuvant setting reduced the risk of disease recurrence or death by 83%.

14:45 EDT Ipsen announces results from Phase III CheckMate -9ER trial - Ipsen (IPSEY) announced the first presentation of results from the pivotal Phase III CheckMate -9ER trial, in which Cabometyx in combination with Bristol Myers Squibb's (BMY) Opdivo demonstrated "significant improvements" across all efficacy endpoints, including overall survival, in previously untreated advanced renal cell carcinoma. Cabometyx in combination with Opdivo reduced the risk of death by 40% versus sunitinib. In patients receiving Cabometyx in combination with Opdivo, median progression-free survival, the trial's primary endpoint, was doubled compared to those receiving sunitinib alone: 16.6 months versus 8.3 months respectively. In addition, Cabometyx in combination with Opdivo demonstrated a superior objective response rate, with twice as many patients responding compared to sunitinib, and 8% versus 5% achieved a complete response. Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months. Additionally, patients treated with the combination had a much lower rate of treatment discontinuation versus sunitinib, and a significantly lower rate of treatment discontinuation due to disease progression versus sunitinib. All key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium risk and PD-L1 subgroups. Cabometyx in combination with Opdivo was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in previously untreated advanced RCC. The incidence of treatment-related adverse events, including any-grade and high- grade TRAEs, was slightly higher for Cabometyx in combination with Opdivo versus sunitinib, with a low rate of treatment- related discontinuations. Patients treated with Cabometyx in combination with Opdivo reported significantly better health-related quality of life than those treated with sunitinib at most time points, according to National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 scores. Based on these efficacy and safety results from CheckMate -9ER, Ipsen and Bristol Myers Squibb have each submitted type II variation applications for Cabometyx in combination with Opdivo to the European Medicines Agency. On September 12, the EMA validated the type II variations, confirming the submissions are complete and beginning the EMA's centralized review process. In addition, Bristol Myers Squibb and Exelixis (EXEL), which has exclusive rights to commercialize and develop Cabometyx in the U.S., recently completed their respective U.S. FDA submissions for Cabometyx in combination with Opdivo and for Opdivo in combination with Cabometyx, and along with their partners, they plan to discuss the CheckMate -9ER data with regulatory authorities across the world.

14:13 EDT Merck announces findings from Phase 3 EORTC1325/KEYNOTE-054 trial - Merck, known as MSD outside the United States and Canada, and the European Organisation for Research and Treatment of Cancer announced new and updated findings from the Phase 3 EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Late-breaking, first-time study results showed that with 3.5 years of follow-up, adjuvant KEYTRUDA met the key secondary endpoint of distant metastasis-free survival, reducing the risk of distant metastasis or death by 40% versus placebo, with 3.5-year DMFS rates of 65.3% and 49.4%, respectively. In addition, KEYTRUDA demonstrated a sustained recurrence-free survival benefit versus placebo across stage IIIA, IIIB and IIIC melanoma, with 3.5-year RFS rates of 59.8% for KEYTRUDA versus 41.4% for placebo. The RFS and DMFS benefits were observed across key subgroups, including disease stages, BRAF mutation status and PD-L1 expression. These late-breaking data were presented as a proffered paper at the European Society for Medical Oncology Virtual Congress 2020.