Stockwinners Market Radar for September 07, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
BA... | Hot Stocks20:16 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. Production problems at a Boeing (BA) 787 Dreamliner factory have prompted air-safety regulators to review quality-control lapses potentially stretching back almost a decade, The Wall Street Journal's Andrew Tangel and Andy Pasztor reported, citing an internal government memo and people familiar with the matter. The plane maker has told U.S. aviation regulators that it produced certain parts at its South Carolina facilities that failed to meet its own design and manufacturing standards, according to an August 31 internal Federal Aviation Administration memo reviewed by The Wall Street Journal. As a result of "nonconforming" sections of the rear fuselage, or body of the plane, that fell short of engineering standards, according to the memo and these people, a high-level FAA review is considering mandating enhanced or accelerated inspections that could cover hundreds of jets. 2. Samsung (SSNLF) has inked a $6.6B contract to help Verizon (VZ) build its fifth-generation wireless network, New York Post's Noah Manskar reported. Samsung will provide Verizon with network equipment along with installation and maintenance, the publication notes, adding that the pact will run through the end of 2025. 3. Peloton (PTON) has been one of the great COVID-19-era success stories, with demand soaring and shareholders reaping the benefits, Eric Savitz wrote in this week's edition of Barron's. Just how big a benefit will become clear this week, with the company due to report earnings on Thursday, the author noted, adding that expectations are sky high. Peloton bulls sniff the potential for the kind huge outperformance that Zoom Video (ZM) reported last week, and they have bid up the stock accordingly, the publication pointed out. 4. Christopher Nolan's "Tenet" launched domestically with $20.2M over the long Labor Day weekend as theaters slowly reopen after being shut almost six months due to the COVID-19 pandemic. Last week only three states remained fully closed in terms of movie theaters, namely New York, North Carolina and New Mexico, as New Jersey and Maryland opened. States partially open include California. Overseas, AT&T (T) subsidiary Warner Bros.' movie earned $126M through its first two weekend for a global total of $146.2M. "Tenet" sports a B CinemaScore and an 74% Rotten Tomatoes. 5. JPMorgan (JPM), Citigroup (C) and Regions Financial (RF) saw positive mentions in this week's edition of Barron's.
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RHHBY BPMC | Hot Stocks19:52 EDT Blueprint Medicines announces FDA approval of Gavreto - Blueprint Medicines (BPMC) announced that the U.S. Food and Drug Administration has approved GAVRETO for the treatment of adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA approved test. The approval is based on data from the Phase 1/2 ARROW clinical trial, which showed efficacy for GAVRETO in patients with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement. Under Blueprint Medicines' collaboration with Roche (RHHBY), Blueprint Medicines and Genentech, a member of the Roche Group, will co-commercialize GAVRETO in the U.S. GAVRETO is a once-daily oral RET-targeted therapy developed by Blueprint Medicines. It is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately 1% to 2% of patients with NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy. GAVRETO was granted accelerated approval by the FDA, and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In 87 patients previously treated with platinum-based chemotherapy, the overall response rate was 57% with a 5.7% complete response rate, and the median duration of response was not estimable. In 27 treatment-naive patients who were ineligible for platinum-based chemotherapy per the study protocol, the ORR was 70% with an 11% CR rate, and the median DOR was 9.0 months. GAVRETO has warnings and precautions of interstitial lung disease/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, risk of impaired wound healing and risk of embryo-fetal toxicity. Blueprint Medicines and Genentech plan to make GAVRETO available in the U.S. within one week. GAVRETO will be available in a 100 mg dose strength, and the recommended starting dose is 400 mg once daily. Additionally, Blueprint Medicines announced the FDA has accepted the company's new drug application for pralsetinib for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. This NDA was accepted for 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. The FDA granted priority review and set an action date of February 28, 2021 under the Prescription Drug User Fee Act.
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INSM | Hot Stocks15:27 EDT Results from Insmed's Phase 2 WILLOW study of brensocatib published in NEJM - Insmed announced that final results from the Phase 2 WILLOW study of brensocatib in patients with non-cystic fibrosis bronchiectasis were published online in the New England Journal of Medicine. New data from subgroup analyses of the WILLOW study also were presented during a late-breaking clinical trials session at the virtual European Respiratory Society International Congress 2020. Brensocatib is a novel, first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases. The results published showed that brensocatib significantly prolonged time to first pulmonary exacerbation, the primary endpoint, over the 24-week treatment period for both treatment doses versus placebo. The risk of exacerbation at any time during the trial was reduced by 42% for the 10 mg group versus placebo and by 38% for the 25 mg group versus placebo. Treatment with brensocatib also reduced the rate of pulmonary exacerbations, a key secondary endpoint. Patients treated with brensocatib experienced a 36% reduction in the 10 mg arm and a 25% reduction in the 25 mg arm, compared with the placebo arm. In addition, mean concentrations of active neutrophil elastase in sputum showed dose-dependent reductions compared with placebo over the 24-week treatment period. Study results were consistent among subgroups based on age, baseline NE concentrations, prior exacerbation history, bronchiectasis severity index, and lung function. In addition to the results published in NEJM, new data from the WILLOW study were presented at the ERS International Congress. Subgroup analyses showed that brensocatib consistently prolonged time to first exacerbation and reduced rates of exacerbation among patient subgroups analyzed by baseline disease severity, P. aeruginosa infection, and sputum NE concentration. Further, brensocatib reduced the sputum concentrations of all three neutrophil serine proteases assessed. Brensocatib was generally well-tolerated in the WILLOW study. Rates of adverse events leading to drug discontinuation in patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg were 11%, 7%, and 7%, respectively. The most common AEs in patients treated with brensocatib were cough, headache, sputum increase, dyspnea, infective exacerbation of bronchiectasis, and diarrhea. Rates of adverse events of special interest in patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg, respectively, were as follows: rates of skin events were 12%, 15%, and 24%; rates of dental events were 4%, 16%, and 10%; and rates of infections considered AESIs were 18%, 14%, and 17%. Hyperkeratosis was reported in 1/85, 3/81, and 1/89 patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg, respectively. The study included extensive dental evaluations to closely monitor progression of periodontal disease. The results did not raise a signal about dental safety. No skin or dental adverse events were considered serious. Brensocatib received breakthrough therapy designation from the U.S. Food and Drug Administration in June 2020 for the treatment of adult patients with NCFBE for reducing exacerbations. Insmed plans to initiate a Phase 3 program for brensocatib in bronchiectasis by the end of 2020.
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RDY AZN | Hot Stocks15:22 EDT Dr. Reddy's announces launch of Fulvestrant injection in U.S. market - Dr. Reddy's (RDY) has announced the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe, a therapeutic equivalent generic version of Faslodex Injection, 250 mg/5 mL (50 mg/mL), approved by the U.S. Food and Drug Administration. The Faslodex brand and generic market had U.S. sales of approximately $407M MAT for the most recent twelve months ending in June 2020 according to IQVIA Health. Dr. Reddy's Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes. Faslodex is a trademark of the AstraZeneca (AZN) group of companies.
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CCL | Hot Stocks15:18 EDT Costa Crociere suspends 2020-2021 season in South America - Costa Crociere, a cruise line in Europe and a part of Carnival, has announced the cancellation of the arrival of its ships for the 2020-2021 season in South America. All cruises aboard the Costa Fascinosa, Costa Luminosa and Costa Pacifica ships in South America, with embarkations scheduled for the period from November 2020 to April 2021, are canceled. The cruise company is in contact with the travel agencies and the guests who purchased the impacted cruises, to inform their decision and communicate about the conversion of the amount paid for the canceled cruise, minus the travel agent commission, in credit to be used as payment, for reservations made up to December 31, 2021, of any other cruise departing until June 30, 2022, under the terms of Law No. 14,046 of August 24, 2020. When booking a new cruise by March 31, 2021, guests will also receive from Costa a bonus in the form of credit, to use it on their next trip exclusively to pay their expenses on board. In announcing this decision, Costa also announces the opening of sales for the 2021-2022 season in South America on Sept. 8. The company will have two ships operating between December 2021 and April 2022 in the region. With embarkations in Santos, the Costa Favolosa will have its first regular cruise departing on December 5, 2021, and will offer 17 itineraries from six to seven nights, dedicated to the northeast region of the country. Tourists from that region will be able to embark in Salvador to experience holidays onboard with the best Italian style product offered. Costa Favolosa will offer three mini-cruises, from three to four nights, and will have Christmas and New Year's Eve cruises on Copacabana beach and Carnival. Thematic cruises are confirmed with departure dates to be defined. Confirmed for another summer in South American waters, Costa Pacifica will have cruises of seven and eight nights through the Prata region, with embarkations from Rio de Janeiro, Buenos Aires and Montevideo. On December 31, 2021, the ship will dock at Copacabana beach for a New Year's Eve celebration. The 2021-2022 season will still be marked by cruises between Italy and Brazil and Brazil and Italy.
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WUBA | Hot Stocks14:52 EDT 58.com announces shareholders' approval of merger agreement - 58.com Inc. announced that at an extraordinary general meeting of shareholders, the company's shareholders voted in favor of, among other things, the proposal to authorize and approve the execution, delivery and performance of the previously announced agreement and plan of merger, dated as of June 15, 2020, among the company, Quantum Bloom Group, an exempted company with limited liability incorporated under the laws of the Cayman Islands, and Quantum Bloom, an exempted company with limited liability incorporated under the laws of the Cayman Islands and a wholly-owned subsidiary of Parent, and the plan of merger required to be filed with the Registrar of Companies of the Cayman Islands, pursuant to which Merger Sub will merge with and into the company, with the company continuing as the surviving company and becoming a wholly owned subsidiary of the Parent, and to authorize and approve the consummation of any and all transactions contemplated by the Merger Agreement and the Plan of Merger, including the Merger. Approximately 61% of the company's total outstanding Class A ordinary shares and Class B ordinary shares, par value $0.00001 per share, including Class A Shares represented by the company's American depositary shares, attended the extraordinary general meeting by proxy. Each shareholder has one vote for each Class A Share or 10 votes for each Class B Share. These shares represented approximately 65% of the total outstanding votes represented by the company's total ordinary shares outstanding at the close of business in the Cayman Islands on the record date of August 14, 2020. The Merger Agreement, the Plan of Merger and the transactions contemplated thereby, including the Merger, were approved by over 75% of the total votes cast at the extraordinary general meeting. Completion of the Merger is subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement. If and when completed, the Merger would result in the company becoming a private company and its ADS would no longer be listed or traded on any stock exchange, including the New York Stock Exchange, and the company's ADS program would be terminated.
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BORR | Hot Stocks14:44 EDT Borr Drilling receives notice from NYSE regarding continued listing standard - Borr Drilling announced the company has received written notice from the New York Stock Exchange that the company is not in compliance with the NYSE continued listing standard with respect to the minimum average share price required by the NYSE because the average closing price of its common shares had fallen below $1.00 per share over a period of 30 consecutive trading days. Under the NYSE rules, the company can regain compliance with this standard and cure this deficiency if, during the six-month period following receipt of the NYSE notice, on the last trading day of any calendar month or on the last trading day of this six-month cure period, the company's common shares have a closing share price of at least $1.00 and an average closing share price of at least $1.00 over the 30-trading day period ending on the last trading day of that month or the last trading day of the cure period, which for the company means February 25, 2021. The company has responded to the NYSE to confirm its intent to cure this non-compliance. During this period, the company's common shares will continue to be traded on the NYSE subject to the company's compliance with other applicable NYSE listing requirements.
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BORR | Hot Stocks14:42 EDT Borr Drilling announces change to Board of Directors - Borr Drilling has announced that, in connection with the assumption of his new role as CEO and in line with the company's corporate governance policies, Patrick Schorn will step down from the company's board of directors with effect from September 8, 2020.
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TSEM | Hot Stocks14:41 EDT Tower Semiconductor provides update on cyber event - Tower Semiconductor announced that the company's IT security systems identified a security incident on some of its systems as a result of a cyber event. As a preventive measure, the company halted certain of its servers and proactively held operations in some of its manufacturing facilities, and has done so in a gradual, organized manner. Tower has notified relevant authorities and said it is working closely with law enforcement organizations and with a leading team of worldwide experts, coordinated with its insurance providers, in order to recover the impacted systems as soon as possible. The company has implemented specific measures to prevent the expansion of this event. At this point there is no assessment as to the actual effect on the company.
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