Stockwinners Market Radar for September 19, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:20 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. U.S. auto safety investigators have opened a new probe into 30 million vehicles built by nearly two dozen automakers with potentially defective Takata air bag inflators, Reuters' David Shepardson reported, citing a government document seen by the publication. The National Highway Traffic Safety Administration on Friday opened an engineering analysis into an estimated 30 million U.S. vehicles from the 2001 through 2019 model years, the author noted, adding that automakers were alerted to the investigation, which is not yet public. The new investigation includes vehicles assembled by Honda Motor (HMC), Ford Motor (F), Toyota Motor (TM), General Motors (GM), Nissan (NSANY), Subaru (FUJHY), Tesla (TSLA), Ferrari NV (RACE), Mazda (MZDAY), Daimler AG (DDAIF), BMW (BMWYY), Chrysler (STLA), Porsche Cars (POAHY), Jaguar Land Rover (TTM) and others. 2. Investment firms Tiedemann Group and Alvarium Investments are close to a deal to merge and go public through a special-purpose acquisition company, The Wall Street Journal's Amrith Ramkumar reported, citing people familiar with the matter. The combined investment firm would be called Alvarium Tiedemann Holdings and be valued at roughly $1.4 billion in the deal with the SPAC Cartesian Growth Corp. (GLBL), the people said. The merger could be announced as soon as this week, the author noted. 3. In the earliest days of COVID-19 pandemic, investor and drug developers looked to antivirals to blunt the impact of the disease but didn't have much luck, with the only antiviral authorized by the Food and Drug Administration to date being Gilead's (GILD) Veklury, also known as remdesivir, Josh Nathan-Kazis wrote in this week's edition of Barron's. But the next generation of COVID-19 antivirals are now on the way, and a pill to treat - or even prevent - COVID-19 could be available by the end of the year. Merck (MRK), Pfizer (PFE), and the biotech Atea Pharmaceuticals (AVIR) each expect late-stage data on an oral COVID-19 antiviral in the coming months. If the data are positive, the drugs provide a major opportunity for the companies-one that investors should not ignore, the author noted. 4. Disney's (DIS) "Shang-Chi and the Legend of the Ten Rings" remained atop the box office charts in its third weekend, earning an estimated $21.7M from 4,070 theaters for a total North American ticket sales of $176.9M. The superhero movie sports an A Cinemascore and unlike fellow Marvel Studios pic "Black Widow," "Shang-Chi" has an exclusive 45-day theatrical release. 5. Apple (AAPL), Sanofi (SNY), BHP Group (BHP), Rio Tinto (RIO), Anglo American (NGLOY), Glencore (GLNCY), Vale (VALE), Wynn Resorts (WYNN) and Las Vegas Sands (LVS) saw positive mentions in this week's edition of Barron's, while Nike (NKE) was mentioned cautiously.

15:31 EDT Seagen, Genmab present interim results from innovaTV 205 study - Seagen (SGEN) and Genmab (GMAB) presented interim data from two cohorts of the phase 1b/2 innovaTV 205 multi-cohort, open-label trial of tisotumab vedotin in recurrent or metastatic cervical cancer at the European Society for Medical Oncology Virtual Congress 2021 as part of a featured mini oral presentation. Initial results from these two dose expansion cohorts of the study showed "encouraging" and durable anti-tumor activity with tisotumab vedotin in combination with carboplatin as first-line therapy for patients with advanced cervical cancer who had not received prior systemic therapy, with a 55% objective response rate and with tisotumab vedotin in combination with pembrolizumab for patients with advanced cervical cancer who experienced disease progression after 1-2 lines of prior systemic therapy, with a 38% ORR, the companies said. Both combinations demonstrated a manageable and acceptable safety profile, with no new safety signals identified.

15:04 EDT Mirati Therapeutics announces results from cohort of Phase 1/2 KRYSTAL-1 study - Mirati Therapeutics announced results from a cohort of the Phase 1/2 KRYSTAL-1 study evaluating adagrasib at the 600mg BID dose as both monotherapy and in combination with cetuximab in patients with heavily pretreated colorectal cancer harboring a KRASG12C mutation. Results showed that adagrasib alone and with cetuximab demonstrated significant clinical activity and broad disease control in these patients. As of May 25, 2021, 80% of patients enrolled in the adagrasib monotherapy arm received at least two prior lines of systemic anticancer therapies, and had a median follow up of 8.9 months. Of the evaluable patients, results showed an investigator assessed response rate of 22%, including one unconfirmed partial response, and a disease control rate of 87%; the median duration of response was 4.2 months. In all enrolled patients, the median progression free survival was 5.6 months. As of July 9, 2021, 90% patients enrolled in the adagrasib plus cetuximab arm received at least two prior lines of systemic anticancer therapies, and had a median follow up of 7 months. Of the evaluable patients, results showed an investigator assessed RR of 43%, including two unconfirmed PRs and a DCR rate of 100%. After the data cutoff date, of the two unconfirmed PRs, follow up scans showed one patient had a confirmed PR, and the second patient progressed. At the time of the analysis, 63% of enrolled patients remained on treatment. Adagrasib monotherapy and in combination with cetuximab was well-tolerated in this study, with a manageable safety profile. Grade 3/4 treatment related adverse events were observed in 30% of patients treated with adagrasib alone, and in 16% of patients treated with the combination. Treatment related adverse events led to treatment discontinuation in 6% of patients who received combination therapy and in none of those who received adagrasib monotherapy. No Grade 5 TRAEs were observed in either treatment arm.

14:54 EDT Merck presents full results from pivotal Phase 3 KEYNOTE-826 trial - Merck announced the presentation of the full results from the pivotal Phase 3 KEYNOTE-826 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer at the European Society for Medical Oncology Congress 2021 (Abstract. These data were also simultaneously published in the New England Journal of Medicine. This is the first combination regimen with an anti-PD-1/PD-L1 therapy to improve overall survival (OS), progression-free survival and objective response rate compared to chemotherapy with or without bevacizumab as a first-line treatment of persistent, recurrent or metastatic cervical cancer. KEYTRUDA plus chemotherapy with or without bevacizumab reduced the risk of death by one-third, or 33%, versus chemotherapy with or without bevacizumab. Median OS for KEYTRUDA plus chemo +/- bev was 24.4 months compared to 16.5 months for chemo +/- bev. For the dual primary endpoint of PFS, median PFS was 10.4 months in those treated with KEYTRUDA plus chemo +/- bev and 8.2 months among those treated with chemo +/- bev. In the trial, KEYTRUDA plus chemo +/- bev showed an ORR of 65.9%, and chemo +/- bev showed an ORR of 50.8%. Median duration of response was 18.0 months in the KEYTRUDA plus chemo +/- bev arm and 10.4 months in the chemo +/- bev arm. The results were consistent with or without bevacizumab use. Treatment-related adverse events Grade greater than or equal to 3 occurred in 68.4% of patients in the KEYTRUDA plus chemo +/- bev arm and 64.1% of patients in the chemo +/- bev arm. Patients in the KEYTRUDA plus chemo +/- bev arm had a longer duration of treatment than those in the chemo +/- bev arm. In the KEYTRUDA plus chemo +/- bev arm, TRAEs led to discontinuation of any treatment in 31.3% of patients and of all treatment in 3.3% of patients. In the chemo +/- bev arm, TRAEs led to discontinuation of any treatment in 22.3% of patients and of all treatment in 1.9% of patients.

14:42 EDT Exelixis announces detailed Phase 1b results from cohort 6 of COSMIC-021 trial - Exelixis announced detailed results from the expanded cohort 6 of the phase 1b COSMIC-021 trial of cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer. Cohort 6 included patients with metastatic CRPC who had been previously treated with the novel hormone therapies enzalutamide and/or abiraterone acetate used along with prednisone. Eligible patients in the trial had measurable disease per Response Evaluation Criteria in Solid Tumors per investigator assessment, had progressed on prior NHT, and could have received prior docetaxel for metastatic hormone-sensitive disease. The analysis included 132 patients with metastatic CRPC, 101 of whom were high-risk, which was defined as having measurable visceral metastases and/or extrapelvic lymphadenopathy. The median follow-up for all patients was 15.2 months, and the primary endpoint was objective response rate by investigator per RECIST 1.1. As previously announced, in the high-risk patient population, investigator-assessed ORR was 27%, including 2% complete responses. The Blinded Independent Radiology Committee-assessed ORR was 18%, all partial responses. The disease control rate was 88% by investigator assessment and 84% by BIRC assessment. New detailed results being presented at the 2021 ESMO Congress demonstrate that median progression-free survival per RECIST 1.1 for the high-risk population was 5.6 months as assessed by investigators and 6.8 months as assessed by BIRC. The exploratory endpoint of overall survival for the high-risk patient population was 18.4 months. Tumor PD-L1 status, which was known for 75 patients, was not associated with response. The safety profile was consistent with that previously observed for each single agent. No new safety signals were observed. Discontinuation of both agents due to treatment-related adverse events occurred in 10% of patients. Frequent treatment-related AEs were diarrhea, fatigue, nausea and decreased appetite. Grade 3 or 4 treatment-related AEs occurred in 55% of patients, and one grade 5 treatment-related AE was reported. Following discussions with the U.S. Food and Drug Administration, Exelixis will not pursue a regulatory submission for the combination regimen based on cohort 6 of the COSMIC-021 trial. The CONTACT-02 study, a global phase 3 pivotal trial, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with atezolizumab versus a second NHT in patients with metastatic CRPC who have been previously treated with one NHT. Pending results, CONTACT-02 may serve as a basis for future regulatory applications in this setting.

10:20 EDT FDA VRBPAC votes in favor of COMIRNATY booster for EUA in people 65 and up - Pfizer (PFE) and BioNTech (BNTX) announced that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend the FDA grant Emergency Use Authorization for a booster dose of COMIRNATY - COVID-19 Vaccine, mRNA - in individuals 65 years of age and older and individuals at high risk of severe COVID-19. The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA. VRBPAC is made up of independent experts who advise the FDA on scientific and regulatory matters, including the evaluation of vaccine safety and efficacy. At this time, VRBPAC did not vote in favor of approval of a booster dose for the full population for which Pfizer and BioNTech submitted their supplemental Biologics License Application, which was individuals 16 and older. The same data have recently been submitted to the European Medicines Agency and will be filed with other regulatory authorities in the coming weeks. The companies remain vigilant and continue to generate relevant COMIRNATY booster dose data for evaluation for future licensure in further groups as well as to address emerging variants of concern. The FDA is expected to make its decision in the coming days. This decision could allow COMIRNATY to be the first COVID-19 vaccine with a booster authorized in the U.S.

08:43 EDT AstraZeneca presents results from head-to-head DESTINY-Breast03 Phase III trial - Detailed positive results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu, or trastuzumab deruxtecan,, the AstraZeneca and Daiichi Sankyo HER2-directed antibody drug conjugate, demonstrated superior progression-free survival versus trastuzumab emtansine, a HER2-directed ADC currently approved to treat patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. Results were presented in a Presidential Symposium at the European Society for Medical Oncology Congress 2021. At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1. After 15.5 and 13.9 months of follow-up in the Enhertu and T-DM1 arms respectively, the median PFS for patients treated with Enhertu was not reached compared to 6.8 months for T-DM1 as assessed by blinded independent central review. In the key secondary endpoint of PFS assessed by investigators, patients treated with Enhertu experienced a three-fold improvement in PFS of 25.1 months versus 7.2 months for T-DM1. A consistent PFS benefit was observed in key subgroups of patients treated with Enhertu, including those with a history of stable brain metastases. There was a strong trend towards improved overall survival with Enhertu, however this analysis is not yet mature and is not statistically significant. Nearly all patients treated with Enhertu were alive at one year compared to 85.9% of patients treated with T-DM1. Confirmed objective response rate more than doubled in the Enhertu arm versus the T-DM1 arm. Forty-two complete responses, and 166 partial responses were observed in patients treated with Enhertu compared to 23 CRs and 67 PRs in patients treated with T-DM1. The safety profile of the most common adverse events with Enhertu in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. There were 27 cases of treatment-related interstitial lung disease or pneumonitis reported, as determined by an independent adjudication committee. The majority were low Grade, with two Grade 3 events reported. No Grade 4 or Grade 5 ILD or pneumonitis events occurred.