Stockwinners Market Radar for January 12, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:04 EST Guardant Health, NGR Oncology initiate NRG-GI005 study - Guardant Health and NRG Oncology, a National Cancer Institute funded National Clinical Trials Network group conducting clinical and translational research, have initiated the NRG-GI005 study to validate the clinical utility of Guardant Health's molecular residual disease assay as a diagnostic biomarker for selecting which patients with stage II colon cancer need adjuvant chemotherapy. The NRG-GI005 COBRA study, or Circulating TumOr DNA as a Predictive BiomarkeR in Adjuvant Chemotherapy in Stage II Colon Cancer, is a prospective multi-center randomized controlled trial that will enroll 1,408 patients with resected stage II colon cancer who meet their physician's criteria for active surveillance. Patients will be randomized to either receive ctDNA-directed therapy or standard of care active surveillance. The study's primary endpoint is to evaluate recurrence-free survival in patients who are ctDNA-positive post-operatively and treated with chemotherapy as compared to the current standard-of-care active surveillance.

19:38 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. Teladoc Health (TDOC) announced it has entered into a definitive agreement to acquire InTouch Health. The transaction is expected to close by the end of the second quarter, subject to customary closing conditions. Under the terms of the agreement, the purchase price of $600M will consist of approximately $150M in cash and $450M of Teladoc Health common stock. Meanwhile, Woodward (WWD) and Hexcel (HXL) have announced a definitive agreement to combine in an all-stock merger of equals. Under the terms of the agreement approved by the Boards of Directors of both companies, Hexcel shareholders will receive a fixed exchange ratio of 0.625 shares of Woodward common stock for each share of Hexcel common stock, and Woodward shareholders will continue to own the same number of shares of common stock in the combined company as they do immediately prior to the closing. Upon completion of the merger, existing Woodward shareholders will own approximately 55% and existing Hexcel shareholders will own approximately 45% of the combined company on a fully diluted basis. In connection with the transaction, Woodward is increasing its quarterly cash dividend to 28c a share. 2. Seattle is expected to approve on Monday legislation banning political contributions by companies with at least 5% foreign ownership, Reuters' Gregory Scruggs wrote. The bill is widely viewed as aimed at reining in political spending from companies like Amazon (AMZN), the author noted, adding that the e-commerce giant has donated a record $1.5M to back a slate of pro-business candidates in the November council elections. 3 Apple (APPL) was a blessing to investors in 2019, soaring 86% last year and adding $579B in new market value, but now it has become a trillion-dollar headache, Tae Kim wrote in this week's edition of Barron's. Investors can take profits on their Apple 2019 gains and still have a significant holding in the stock, all while hedging against the risks of pricey Apple shares, the author contended. For Apple investors that want exposure to faster-growing tech names, TSMC (TSM) is a good bet, Kim noted, while for investors looking for higher return potential-admittedly with higher risk-Barron's recently highlighted shares of Datadog (DDOG). 4. Comcast (CMCSA) subsidiary Universal's WWI movie "1917" won this weekend's domestic box office with $36.5M, in one of the best nationwide debuts ever for the month of January. Overseas, the film earned $19.9M from its first 30 markets for an early foreign cume of $21.1M and $60.4M globally. "1917" sports an A- CinemaScore and a 90% Rotten Tomatoes rating. 5. Bank of America (BAC) and Wingstop (WING) saw positive mentions in this week's edition of Barron's.

18:27 EST Adverum Biotechnologies provides 2020 outlook - Adverum Biotechnologies reviewed recent business and development progress and provided an outlook for 2020. "In 2019, we made significant progress advancing our lead gene therapy candidate ADVM-022 in the ongoing OPTIC phase 1 dose-ranging clinical trial in patients with wet age-related macular degeneration," said Leone Patterson, president and chief executive officer of Adverum Biotechnologies. "Patients with wet AMD typically require frequent ocular anti-VEGF injections to maintain their vision. Yesterday, additional data were presented from the first cohort of patients in OPTIC, which demonstrated zero anti-VEGF rescue injections required following a single intravitreal injection of ADVM-022 and with median follow up of 44 weeks, ADVM-022 treatment was safe and well-tolerated. This year, we look forward to presenting additional data from all four cohorts of patients in OPTIC. Additionally, we plan to submit an IND for ADVM-022 in a second indication, diabetic retinopathy, and begin enrolling patients in a new clinical trial. We believe ADVM-022 has the potential to be a paradigm-changing treatment for patients with wet AMD and for patients with diabetic retinopathy."

17:21 EST Agios Pharmaceuticals announces 'Agios 2025' strategic vision - Agios Pharmaceuticals announced its "Agios 2025" six-year strategic vision focused on creating and commercializing differentiated medicines to treat hematologic malignancies, solid tumors and rare genetic diseases. Under this plan, by the end of 2025, the company expects to have four marketed products across at least eight indications, at least six molecules in clinical development and be cash-flow positive. Agios also announced that it expects to achieve the following key milestones in 2020: Deliver full-year U.S. revenue for TIBSOVO of $105M-$115M; Receive European Medicines Agency CHMP opinion for TIBSOVO in relapsed or refractory acute myeloid leukemia with an IDH1 mutation by year-end; Complete enrollment of Phase 3 AGILE trial of TIBSOVO in combination with azacitidine in adult patients with previously untreated IDH1 mutant AML by year-end; Complete enrollment of the relapsed or refractory myelodysplastic syndrome arm of the TIBSOVO Phase 1 study of IDH1 mutant advanced hematologic malignancies by year-end; File supplemental new drug application for TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma by year-end; Announce topline data for ACTIVATE and ACTIVATE-T pivotal trials for mitapivat in adults with pyruvate kinase deficiency by year-end; Submit updated data from the Phase 2 study of mitapivat in thalassemia for presentation at the European Hematology Association Congress and finalize pivotal development strategy by year-end; Achieve proof of concept for mitapivat in sickle cell disease by mid-2020; Receive investigational new drug clearance for AG-946, a next generation PKR activator, and initiate first-in-human study in healthy volunteers in the first half of 2020; Achieve at least one new development candidate by year-end.

16:47 EST Exelixis outlines key priorities, anticipated milestones for 2020-2021 - Exelixis (EXEL) announced its key priorities and anticipated milestones for 2020-21, including generating top-line data from key clinical trials, completing enrollment of ongoing studies, initiating new pivotal trials, and progressing its mid-stage and early pipeline. The company intends to make appropriate investments to maximize the clinical development opportunities for CABOMETYX, which Exelixis believes could lead to as many as four additional approved indications by year-end 2021, while concurrently working to advance a pipeline of potential new Exelixis medicines through internal drug discovery and business development. Bristol-Myers Squibb (BMY) and Exelixis anticipate results from CheckMate 9ER, the phase 3 pivotal trial evaluating cabozantinib in combination with nivolumab in previously untreated advanced or metastatic renal cell carcinoma, in the first half of 2020. Bristol-Myers is sponsoring this trial, which completed enrollment in early 2019. If the data are positive, Exelixis, Bristol-Myers and their respective partners plan to expeditiously pursue regulatory filings. In the first half of 2020, Exelixis anticipates completing enrollment of the first 100 patients in this phase 3 pivotal trial evaluating cabozantinib versus placebo in patients with radioactive iodine-refractory differentiated thyroid cancer who have progressed after up to two VEGF receptor-targeted therapies. As planned, Exelixis expects to conduct an interim analysis in these first 100 patients for the co-primary endpoints of objective response rate and progression-free survival and reach total enrollment of 300 patients in the second half of 2020. Exelixis expects to complete enrollment in the first half of 2020 and conduct the analysis for the co-primary endpoint of PFS and an interim analysis for overall survival for this phase 3 pivotal trial evaluating cabozantinib in combination with atezolizumab, Genentech's (RHHBY) anti-PD-L1 immune checkpoint inhibitor, versus sorafenib in previously untreated advanced hepatocellular carcinoma. The analyses are event-driven and may occur as early as in the second half of 2020. COSMIC-021, the phase 1b trial evaluating cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic tumors, enrolled more than 550 patients across the 24 expansion cohorts by the end of 2019. Exelixis expects to present data from the metastatic castration-resistant prostate cancer cohort of the trial at the ASCO Genitourinary Cancers Symposium in February 2020, and from the non-small cell lung cancer cohort when data have matured and at the appropriate time in 2020. Based on regulatory feedback from the U.S. Food & Drug Administration and if supported by the data from the mCRPC expansion cohorts, Exelixis intends to file with the FDA for accelerated approval in an mCRPC indication as early as 2021. Bristol-Meyers and Exelixis expect that results of a cohort from the phase 1/2 CheckMate 040 trial investigating the safety and efficacy of nivolumab plus cabozantinib with or without ipilimumab in patients with advanced HCC will be presented at the ASCO Gastrointestinal Cancers Symposium in January 2020. In addition, the PFS results for the medullary thyroid cancer EXAMINER trial are expected in 2020. Finally, Calithera expects the analysis of CANTATA to take place in the second half of 2020. CANTATA completed enrollment in October 2019 and is sponsored by Calithera; Exelixis provides cabozantinib for the trial. In 2020, based on emerging data from the COSMIC-021 trial, Exelixis and its collaboration partner Roche expect to initiate three new pivotal trials of cabozantinib in combination with atezolizumab under the companies' expanded clinical development collaboration announced on December 19, 2019. The clinical program, which Roche and Exelixis will co-fund, is expected to include three phase 3 pivotal trials in advanced NSCLC, mCRPC and RCC. In late 2020, Exelixis anticipates completing enrollment in COSMIC-021. Since its initiation in 2017, data from COSMIC-021 have been instrumental in guiding Exelixis' clinical development strategy for cabozantinib plus ICIs, including supporting the initiation of COSMIC-312 and the additional future trials described above. Exelixis expects to complete enrollment for COSMIC-313, the phase 3 pivotal trial evaluating the triplet combination of cabozantinib, nivolumab and ipilimumab versus the combination of nivolumab and ipilimumab in patients with previously untreated advanced intermediate- or poor-risk RCC, in early 2021 and to report top-line results of the event-driven analyses from the study in the 2022 timeframe. The dose escalation phase 1 trial for this next generation MET, AXL and VEGFR targeting tyrosine kinase inhibitor is ongoing, and Exelixis anticipates that dose expansion cohorts and potential combination cohorts with ICIs will begin to enroll in 2020. Exelixis and its partners are currently advancing three compounds through preclinical development. If the data are supportive, Exelixis believes there is the potential for these compounds to reach Investigational New Drug filing status before the end of 2020. In addition, multiple development candidates from internal and collaborative efforts are expected to reach preclinical development in 2020, and Exelixis believes these candidates have the potential to move into clinical trials starting in 2021.

15:48 EST Moderna announces additional development candidates in new therapeutic area - Moderna announced that it has entered a new autoimmune therapeutic area. Building on the clinical validation of systemic delivery of mRNA provided by data from its antibody against the chikungunya virus program, the new therapeutic area will include autoimmune and inflammatory diseases. The company also announced that it will expand its pipeline of innovative vaccines in the near-term, following six positive Phase 1 clinical trial readouts from its infectious disease portfolio and the initiation of a Phase 2 study for its CMV vaccine. The announcement reflects the company's belief that recent positive Phase 1 data from its infectious disease vaccine portfolio, including its complex CMV vaccine, and chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics modalities. As a result, Moderna intends to bring new development candidates forward within these two areas. Moderna currently has 21 mRNA development candidates in its portfolio with 13 in clinical studies. Across Moderna's pipeline, more than 1,500 participants have been enrolled in clinical studies. Autoimmune diseases are characterized by immune activation in response to antigens normally present in the body, reflecting a loss of tolerance. Within this therapeutic area, the company is developing two potential medicines, mRNA-6231 and mRNA-6981, designed to engage peripheral tolerance pathways to dampen autoimmune activation and help restore immune homeostasis, thereby reducing autoimmune pathology. As an initial step to addressing a range of autoimmune indications, the company plans to conduct a Phase 1 study of mRNA-6231 in healthy adult volunteers and intends to pursue proof-of-concept with mRNA-6981 in a Phase 1 study in type 1 autoimmune hepatitis, a condition that involves liver inflammation and can lead to cirrhosis and liver failure. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Both of these new autoimmune development candidates share the same delivery technology as mRNA-1944, the antibody against chikungunya, reducing technology risk. The autoimmune therapeutic area is Moderna's fifth therapeutic area, in addition to infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases. The company expects cash, cash equivalents, and investments at December 31, 2019 to be approximately $1.26B unaudited, as compared to $1.69B as of December 31, 2018. Reiterating prior guidance, in 2020, the company expects net cash used in operating activities and purchases of property and equipment to be between $490M-$510M.

15:30 EST Intel announces collaboration with AREA15 - Intel announced a collaboration with AREA15, one of the first purpose-built experiential retail and entertainment complexes. The alliance will initially focus on immersive experiential retail design with the launch of the Intel Experience Incubation Hub, a multiuse venue for innovation and collaboration. It will allow retail ecosystem partners - from creatives to technologists - to test new design concepts and leading-edge technologies. Opening in April, the AREA15 property in Las Vegas aims to be the gravitational center for the new experience economy, building a flexible platform where Intel innovation will play an integral role. AREA15's technical and physical infrastructure will be modular, allowing for innovations coming out of the Experience Incubation Hub to be easily tested for proof of concept and scalability - within AREA15 and beyond - in a variety of forms, from pop-ups to short-term engagements to more permanent installations.

15:16 EST Syros Pharmaceuticals announces strategic priorities, expected milestones - Syros Pharmaceuticals outlined its strategic priorities and expected upcoming milestones. "2019 was marked by significant progress across our pipeline, as Syros redefines the power of small molecules to control the expression of genes, [...] We are excited to build on this progress in 2020, with multiple milestones expected across our clinical and discovery-stage pipeline," said Nancy Simonian, Syros' CEO. "We look forward to advancing SY-5609 into clinical development in the first quarter, and to reporting clinical data for both SY-1425 and SY-5609, including potential proof-of-concept data for SY-1425 in RARA-positive relapsed or refractory AML patients, in the fourth quarter. In parallel, we continue to advance our discovery pipeline in cancer and monogenic disease areas where we believe we have the potential to deliver transformative gene control medicines for diseases that have eluded other genomics-based approaches." Syros expects to nominate its next development candidate by the end of 2021. Syros also announced that the company's second monogenic disease program is in myotonic dystrophy type 1. Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities are sufficient to fund its anticipated operating expenses and capital expenditure requirements into the fourth quarter of 2021 through key clinical milestones for both SY-1425 and SY-5609.

15:05 EST Jumei receives preliminary non-binding acquisition proposal of $20 per ADS - Jumei International announced that its board of directors has received a preliminary non-binding proposal letter, dated January 11, 2020, from Leo Ou Chen, chairman of the Board, chief executive officer and acting chief financial officer of the company, to acquire all of the outstanding ordinary shares of the company, including Shares represented by American depositary shares, that are not already owned by Chen and his affiliates for a purchase price of $20 per ADS in cash. The Proposed Transaction, if completed, would result in the company becoming a privately-held company owned by the Buyer Group, and the company's ADSs would be delisted from the New York Stock Exchange. The company has formed a special committee of the Board, composed of Sean Shao and Adam J. Zhao, each an independent and disinterest director, to consider the Proposal and the Proposed Transaction. The special committee has retained Hogan Lovells as its U.S. legal counsel in connection with its review and evaluation of the Proposal and the Proposed Transaction.