Stockwinners Market Radar for July 10, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
TWTR... | Hot Stocks20:05 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. Twitter (TWTR) has hired U.S. law firm Wachtell, Lipton, Rosen & Katz LLP as it prepares to sue Elon Musk and force him to complete the $44 billion acquisition of the social media company, according to Reuters, citing people familiar with the matter. Musk, the chief executive officer of Tesla (TSLA), on Friday terminated his deal, saying Twitter had failed to provide information about fake accounts on the platform, after which Twitter's chairman, Bret Taylor, vowed a legal fight. 2. A leaked trove of confidential files has revealed the inside story of how Uber (UBER) flouted laws, duped police, exploited violence against drivers and secretly lobbied governments during its aggressive global expansion, The Guardian's Harry Davies, Simon Goodley, Felicity Lawrence, Paul Lewis and Lisa O'Carroll reported. The leak to the Guardian of more than 124,000 documents - known as the Uber files - spans a five-year period when Uber was run by its co-founder Travis Kalanick, who tried to force the cab-hailing service into cities around the world, even if that meant breaching laws and taxi regulations, the authors noted. During the fierce global backlash, the data shows how Uber tried to shore up support by discreetly courting prime ministers, presidents, billionaires, oligarchs and media barons. Leaked messages suggest Uber executives were at the same time under no illusions about the company's law-breaking, with one executive joking they had become "pirates" and another conceding: "We're just fucking illegal." 3. The temperature is rising, but shares of air-conditioning distributor Watsco (WSO) have cooled off, creating an opportunity for investors to buy the stock, Al Root wrote in this week's edition of Barron's. The HVAC distributor operates about 670 stores across the country, from which it sells tens of thousands of products to hundreds of thousands of contractors. Its wares include new AC units, replacement parts, refrigerants, and even Nest thermostats. It's a stable business, one that leads to consistent earnings and sales, and it should be attractive to investors looking to play defense while benefiting from the heat, the author noted. 4. Marvel and Disney's (DIS) "Thor: Love and Thunder" won this weekend's domestic box office with a $143M opening, the best showing of the standalone franchise with Chris Hemsworth as Thor. Overseas, the movie earned $159M for a global total of $302M. Audiences gave "Thor: Love and Thunder" a B+ CinemaScore. 5. Lowe's (LOW), Ford (F), Nordstrom (JWN), Eli Lilly's (LLY), and Altria (MO) saw positive mentions in this week's edition of Barron's.
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PLRX | Hot Stocks18:16 EDT Pliant announces safety, efficacy data from Phase 2a INTEGRIS-IPF trial - Pliant Therapeutics announced data from INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis. The trial met its primary and secondary endpoints demonstrating that PLN-74809 was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile. The trial's exploratory efficacy endpoints assessing changes in forced vital capacity and Quantitative Lung Fibrosis imaging, demonstrated a dose-dependent treatment effect on FVC and QLF versus placebo over 12 weeks in PLN-74809 treated patients. INTEGRIS-IPF is a randomized, double-blind, placebo-controlled Phase 2a multinational study evaluating PLN-74809 at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 90 patients with IPF. 67 patients were enrolled in the active arms and 23 patients were enrolled in the placebo arm. Approximately 80% of enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone. The primary endpoint of the INTEGRIS-IPF trial is the evaluation of the safety and tolerability of PLN-74809. The secondary endpoint is an assessment of its pharmacokinetics. PLN-74809 was well tolerated at all three doses tested. Of the 67 patients treated with PLN-74809, 65 completed 12 weeks of treatment with no discontinuations due to adverse events. No deaths or drug-related serious adverse events were reported. Most treatment emergent adverse events were mild or moderate in severity. PLN-74809 exhibited dose-proportional increases in plasma concentrations, consistent with prior studies.
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FRLN | Hot Stocks15:13 EDT Freeline presents data from first cohort of Phase 1/2 dose-confirmation B-LIEVE - Freeline Therapeutics announced the presentation of safety and initial efficacy data from the first cohort of the Phase 1/2 dose-confirmation B-LIEVE trial for FLT180a, the company's AAVS3-based gene therapy candidate for people with hemophilia B, at the International Society on Thrombosis and Haemostasis Congress being held in London, July 9-13, 2022. As of the data cut-off of May 23, 2022, a one-time FLT180a dose of 7.7e11 vg/kg generated a rapid increase of coagulation factor IX, reaching levels in the normal range for the three patients in cohort 1 through days 77, 56 and 36, respectively. Patients stopped FIX prophylaxis and did not require FIX replacement or experience bleeding following treatment with FLT180a. The treatment and the prophylactic immune management regimen were well tolerated. No serious adverse events or infusion reactions were observed, and there has been no evidence of FIX inhibitors. All adverse events were mild, and most were transient. AEs related to immune management were consistent with the known profiles of corticosteroids and tacrolimus. Dosing of cohort two was completed in June, with early results showing a similar initial response to FLT180a. Based on the data from cohort one and consistent with the advice of the independent Data Monitoring Committee of the B-LIEVE trial, patients in cohort two received the same dose of FLT180a and prophylactic immune management regimen that were used in the first cohort. As the data continue to evolve since the data cut-off for cohort one, two patients have experienced a decrease in FIX expression together with a mild and transient increase in liver enzymes. All patients continue to have expression levels above baseline, and no patient has experienced a bleed or required FIX supplementation.
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SNY | Hot Stocks15:04 EDT Sanofi, SOBI present data from XTEND-1 pivotal Phase 3 study - Sanofi and Swedish Orphan Biovitrum AB presented for the first time, in a late-breaking session at the 30th International Society on Thrombosis and Haemostasis Congress, results from the XTEND-1 pivotal Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa, an investigational factor VIII replacement therapy, in previously treated adults and adolescents greater than or equal to12 years with severe hemophilia A. The study met the primary efficacy endpoint, with once-weekly efanesoctocog alfa prophylaxis providing clinically meaningful bleed protection for people with severe hemophilia A. The median and mean annualized bleeding rates were 0.00 and 0.71 respectively. The study also met the key secondary endpoint, demonstrating superior bleed protection over prior factor VIII prophylaxis with an estimated ABR reduction of 77% and a mean ABR of 0.69 compared to 2.96 on prior prophylaxis, based on an intra-patient comparison. In a subset of participants studied at baseline and week 26, mean factor VIII levels remained in the normal to near-normal range for the majority of the week, and at 15 IU/dL at Day seven post-dose, providing increased factor activity level protection for patients with once-weekly prophylaxis. Data show adults and adolescents treated with once-weekly efanesoctocog alfa experienced statistically significant and clinically meaningful improvements in physical health, pain intensity, and joint health when comparing week 52 and baseline measurements.i Moreover, efanesoctocog alfa was effective at treating bleeds, including in target joints; 96.7% of bleeds were resolved with a single 50 IU/kg dose. Efanesoctocog alfa was well tolerated and inhibitor development to factor VIII was not detected. The most common treatment-emergent adverse events were headache, arthralgia, fall, and back pain.
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SNY | Hot Stocks15:00 EDT Data from Phase 3 ATLAS-PPX study presented at ISTH 2022 Congress - Positive data from the Phase 3 ATLAS-PPX study evaluating the efficacy and safety of once-monthly fitusiran in adults and adolescents with severe hemophilia A or B who were previously treated with prior factor or bypassing agent prophylaxis were presented in a late-breaking session at the International Society on Thrombosis and Haemostasis 2022 Congress. The study met the primary endpoint and demonstrated fitusiran prophylaxis significantly reduced bleeding episodes compared to prior factor or BPA prophylaxis. Of the 67 participants exposed to a least one dose of fitusiran, the most common adverse events were increased alanine aminotransferase, nasopharyngitis, and upper respiratory tract infection. Consistent with the previously identified risk of fitusiran, suspected or confirmed thromboembolic events were reported in 2 participants. Sanofi is currently investigating the efficacy and safety of fitusiran under an amended protocol which includes lower doses and a less frequent dosing regimen maintaining an antithrombin target range of 15-35% in all ongoing studies. Fitusiran has the potential to provide prophylactic treatment for all people with hemophilia A or B, with or without inhibitors, with as few as six subcutaneous injections per year.
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NVO | Hot Stocks14:54 EDT Novo Nordisk announces Phase 3 results of explorer7 study - Novo Nordisk announced the Phase 3 results of the explorer7 study, assessing the efficacy and safety of prophylactic treatment with concizumab in people living with haemophilia A or B with inhibitors. The results from the primary analysis were presented at the International Society of Thrombosis and Haemostasis Annual Congress in London, U.K. Concizumab is an anti-tissue factor pathway inhibitor antibody in development for once-daily prophylactic treatment by administration under-the-skin for all types of haemophilia. The use of concizumab is investigational and not approved by regulatory authorities. The results showed an 86% reduction in treated spontaneous and traumatic bleeds when on concizumab prophylaxis, with an estimated mean ABR of 1.7 compared to 11.8 with no prophylaxis, fulfilling the primary objective. The overall median ABR of concizumab was zero, compared to 9.8 for no prophylaxis. Twenty-one people on concizumab experienced no treated bleeds, compared to two on no prophylaxis. The safety and tolerability profile of concizumab in this study was within the expected range, with no thromboembolic events reported after treatment restart. Novo Nordisk expects to submit concizumab for regulatory approval for the prophylactic treatment of haemophilia A or B with inhibitors in the second half of 2022 in the U.S. and Japan, and in 2023 in the EU and the U.K.
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