Stockwinners Market Radar for July 18, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
FB... | Hot Stocks20:13 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. Johnson & Johnson (JNJ) is exploring a plan to offload liabilities from widespread Baby Powder litigation into a newly created business that would then seek bankruptcy protection, Reuters' Mike Spector, Jessica DiNapoli, and Dan Levine reported, citing seven people familiar with the matter. J&J has not yet decided whether to pursue the bankruptcy plan and could ultimately abandon the idea, some of the people said. 2. Facebook (FB) fired back after President Biden earlier said that social media platforms are "killing people" by allowing COVID-19 vaccine misinformation on their sites, Axios' Gigi Sukin reported. "We will not be distracted by accusations which aren't supported by the facts," a spokesperson for the tech giant said in a statement. 3. The latest cloud looming over U.S.-listed Chinese companies is uncertainty around how U.S. regulators will enforce last year's Holding Foreign Companies Accountable Act, which requires foreign companies to adhere to U.S. auditing standards in order to trade on U.S. exchanges, Reshma Kapadia wrote in this week's edition of Barron's. The Chinese government has long prevented Chinese companies from providing the necessary information to comply with U.S. auditing requirements, the author noted. Many large Chinese companies, including Alibaba Group (BABA), JD.com (JD), and Yum China (YUMC) have sought secondary listings closer to home, and many U.S. fund managers have shifted into those listings, the publication added. 4. AT&T (T) subsidiary Warner Bros.' "Space Jam: A New Legacy" won this weekend's domestic box office with a better-than-expected debut of $31.7M from 3,956 locations. Overseas, the movie opened to $23M from 64 territories for a global start of $54.7M as numerous markets are still impacted by the pandemic. The live-action/animated film is also available on HBO Max. 5. Amyris (AMRS), Zymergen (ZY), Ginkgo Bioworks - which is merging with Eagle Acquisition (SRNG) -, Academy Sports and Outdoors (ASO), and SAP (SAP) saw positive mentions in this week's edition of Barron's.
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DCRB HYZN | Hot Stocks16:01 EDT Hyzon Motors signs Memorandum of Understanding with Superior Pak - Hyzon Motors, through its wholly owned subsidiary Hyzon Motors Australia, is cleaning up garbage collection through a partnership with Superior Pak, an Australian manufacturer of waste handling equipment. This announcement comes ahead of Hyzon Motors' first day of trading under the symbols "HYZN" and "HYZNW" on the Nasdaq Marketplace, scheduled for Monday, July 19. Hyzon, a global supplier of zero-emission, hydrogen fuel-cell vehicles, announced a Memorandum of Understanding to develop and supply 20 refuse collection vehicles together with Superior Pak. The first 5 vehicles are expected to be delivered and operational in Q2 2022. Three of the first 5 vehicles are expected to be available from Hyzon under minimum 1 month demonstration loan arrangements in the Brisbane, Sydney and Melbourne areas associated with available hydrogen refueling facilities. Orders are currently being accepted for the balance of 15 vehicles with expected demand from local governments as well as waste collection operators across Australia.
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GSK PFE | Hot Stocks15:58 EDT ViiV Healthcare presents data from second Dovato switch study - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK), with Pfizer (PFE) and Shionogi Limited as shareholders, presented 48-week data from the SALSA study at the International AIDS Society Conference 2021, being held virtually 18-21 July. The 2-drug regimen Dovato demonstrated non-inferior efficacy compared to continuation of a current antiretroviral regimen of at least three drugs, with zero cases of virologic failure and no development of resistance, in a diverse population of virologically suppressed adults with HIV-1 who have not experienced prior virologic failure. The SALSA study population provides a broad representation of people living with HIV on a variety of different regimens of at least three drugs. It included more than 120 study sites across North America, Europe, Asia Pacific, South America and Africa, and a significant proportion of female participants, participants aged 50 or over, and participants of different racial backgrounds. The primary endpoint was met at Week 48, demonstrating that switching to Dovato was non-inferior to continuing a CAR in the Intention to Treat-Exposed analysis, based on the proportion of participants with plasma HIV-1 RNA greater than or equal to50 copies per millilitre at Week 48. Dovato also demonstrated a non-inferior rate of virologic suppression at Week 48, with 94.3% of participants achieving HIV-1 RNA less than50 c/mL versus 92.7% of participants on a CAR. The study findings showed that no participants in either arm met protocol-defined confirmed virologic withdrawal criteria, and as such no resistance mutation development was reported. Overall adverse event rates were similar between the Dovato and CAR arms. Rates of AEs leading to study withdrawal were low in both the Dovato and CAR arms and there were no serious drug-related AEs in either group. All drug-related AEs in the Dovato arm were grade 1-2. At Week 48, changes in fasting lipids were small and comparable between the study arms. From baseline to Week 48, changes in bone and proximal tubular renal biomarkers generally favored Dovato, suggesting improved or maintained bone and renal function when switching to the dolutegravir-based 2DR. Small changes in inflammatory biomarkers in both directions were observed across both arms, with no evidence of immune activation or inflammation differing between treatment arms.
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GSK PFE | Hot Stocks15:54 EDT ViiV Healthcare presents findings from CUSTOMIZE trial - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK), with Pfizer (PFE) and Shionogi Limited as shareholders, presented findings from the CUSTOMIZE trial. The study, which included people living with HIV and healthcare teams and overlapped with the COVID-19 pandemic, demonstrated that Cabenuva can be successfully implemented across a range of healthcare settings in the US. The 12-month findings were presented at the International AIDS Society Conference 2021 being held virtually 18-21 July. CUSTOMIZE was initiated in 2019 to identify successful methods of integrating the long-acting regimen of cabotegravir and rilpivirine for the treatment of HIV-1 after product availability into clinical practices in the US, in a variety of clinic types. This study included a variety of clinic types from private practices, university clinics and federally qualified health centres, to integrated health care systems. Regardless of clinic types, the majority of healthcare staff either agreed, or completely agreed, that the long-acting regimen was feasible to implement in their clinic, and most felt that optimal implementation was achieved within 1-3 months, with only minor adjustments to clinic logistics required. The people living with HIV who participated in the trial agreed that the long-acting regimen was acceptable and appropriate to implement, with the majority expressing interest in continuing to receive the long-acting regimen over daily oral therapy after the study ended at Month 12. In addition to assessing the implementation of cabotegravir and rilpivirine long acting into U.S. healthcare practices, the CUSTOMIZE trial also assessed the safety and efficacy of the regimen. Over the course of the study, findings showed that 100% of participants with available viral load results maintained viral suppression and there were no virologic failures. Injection site reactions were the most common overall adverse event, reported in 72% of participants who received greater than or equal to 1 injection through Month 12.
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GILD | Hot Stocks15:50 EDT Gilead announces pooled analysis of open-label extension of Phase 3 studies - Gilead Sciences announced a pooled analysis of a 48-week open-label extension of two Phase 3 studies shows 99% of participants who initiated treatment with Biktarvy maintained an undetectable viral load through four years of follow-up. In the 48-week open-label extension, there were zero cases of treatment-emergent resistance to any components of Biktarvy in participants treated with Biktarvy. These findings, along with long-term data from Phase 3 studies in virologically suppressed Black Americans and virologically suppressed people living with HIV aged 65 and older, demonstrated Biktarvy sustains efficacy with a high barrier to resistance across a range of people living with HIV, inclusive of their treatment history, gender, race or age. These data were presented at the 11th International AIDS Society Conference on HIV Science. Gilead presented additional Biktarvy data at IAS 2021, including findings from the BRAAVE 2020 Study, a Phase 3 clinical trial designed with community input to evaluate the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomly allocated and treated in a 2:1 ratio to either switch to open-label Biktarvy for up to 72 weeks or to stay on a standard regimen of two nucleoside reverse transcriptase inhibitors plus a third agent for 24 weeks with a delayed switch to Biktarvy for up to 48 weeks. At 72 weeks, 99% of participants who switched to Biktarvy at the start of the study maintained an undetectable viral load regardless of age or sex at birth. These results provide further evidence that Biktarvy is an effective and durable treatment option for Black adults who are virologically suppressed, including those with a history of treatment failure or pre-existing resistance. Gilead also presented long-term data from a Phase 3b open-label trial enrolling people living with HIV aged 65 and older who switched to Biktarvy from either Genvoya or a tenofovir disoproxil fumarate-based regimen. The analysis showed that 100% of participants and 74% of participants in the snapshot analysis of the Intention to Treat-Exposed population having HIV-1 RNA less than50 copies/mL maintained high rates of virologic suppression at Week 96 with no virologic failures or emergent resistance through 96 weeks. The COVID-19 pandemic impacted in-person visits during the study, with 11 participants unable to be assessed after 84 weeks due to restrictions. There were two participants with Grade 3-4 study drug-related AEs, 11 participants with Grade 3-4 laboratory abnormalities and three participants with drug-related adverse events leading to study drug discontinuation. These results reinforce Biktarvy as an effective and generally well-tolerated treatment option with a high barrier to resistance in the growing population of older people living with HIV. Results from a Phase 3 study demonstrated the safety and non-inferior efficacy of switching to Biktarvy in those replacing their existing treatment regimen. In Study 1844, participants who were virologically suppressed on a regimen containing abacavir, dolutegravir, and lamivudine were randomly allocated and treated in a 1:1 ratio to stay on their existing regimen of ABC/DTG/3TC or switch to Biktarvy in a blinded manner. The primary endpoint was the proportion of patients with HIV RNA greater than or equal to50 copies/mL at Week 48. Study participants were randomly allocated through 48 weeks, after which point participants electing to continue in the study enter an open-label extension receiving Biktarvy. At the point of the last study visit, 98% of those who switched to Biktarvy maintained virologic suppression for a median duration of two years, including those with pre-existing resistance or who experienced viral "blips." In participants treated with Biktarvy, there were no cases of treatment failure with resistance to any component of Biktarvy.
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GILD | Hot Stocks15:36 EDT Gilead announces results from ongoing Phase 2/3 CAPELLA trial - Gilead Sciences has announced new results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company's investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. In this patient population of high unmet medical need, 81% of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load at Week 26. The data were presented at the 11th International AIDS Society Conference on HIV Science. These data support the ongoing evaluation of lenacapavir for the treatment of HIV-1 infection and form the basis of the New Drug Application that the company recently submitted seeking U.S. Food & Drug Administration approval for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection in combination with other antiretrovirals. If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered every six months. In addition to 81% of CAPELLA participants achieving an undetectable viral load at Week 26, participants achieved a mean increase in CD4 count of 81 cells/microL. In the data presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections, the CAPELLA trial achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo during the 14-day functional monotherapy period. Those who received lenacapavir achieved a statistically significantly greater mean decrease in viral load than those who received placebo during the functional monotherapy period. Lenacapavir was generally well tolerated, with no adverse events leading to study drug discontinuation and no serious adverse events related to lenacapavir. Gilead presented additional lenacapavir clinical development program data at the conference. Phase 2 data from CALIBRATE, an ongoing, open-label, active-controlled trial in treatment-naive people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide led to high rates of viral suppression by Week 28. Specifically, in the pooled subcutaneous lenacapavir + F/TAF arms, 93% achieved an undetectable viral load. In the oral lenacapavir + F/TAF arm, 94% achieved an undetectable viral load. These results support the ongoing evaluation and further development of lenacapavir in combination with other long-acting partner agents for the treatment of HIV-1 infection and will support Gilead's long-acting oral and injectable development program. Lenacapavir was generally well tolerated. The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were generally mild in severity. The most common injection site reactions were injection site swelling and erythema. Importantly, there were no serious AEs related to study drug. Two participants discontinued due to AEs. One participant had treatment-emergent resistance to study drugs.
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MNR | Hot Stocks15:32 EDT Monmouth Real Estate receives amendment to unsolicited acquisition proposal - Monmouth Real Estate Investment announced that it received an amendment to the unsolicited acquisition proposal it previously received on July 8, 2021 from a certain large private investment company. The amendment to the proposal reflects an increase of 18c per share in the consideration that would be paid for each share of Monmouth Common Stock, resulting in a net cash consideration of $18.88 per share, reflecting a stated purchase price of $19.51 per share reduced by the termination fee of approximately $62.2 million, or 63c per share, if Monmouth terminates the merger agreement it previously entered into with Equity Commonwealth in accordance with its terms to accept the amended proposal. The increase results from the investment company's decision that the purchase price would no longer be reduced by the 18c per share dividend on Monmouth's common stock previously declared by Monmouth's Board on July 1, 2021 and payable on or about September 15, 2021. On July 16, 2021, Monmouth's common shares closed at $19.23 per share. As previously announced, on May 4, 2021, Monmouth entered into a definitive merger agreement with EQC pursuant to which EQC agreed to acquire Monmouth in an all-stock transaction valued at approximately $3.4 billion, including the assumption of debt. The combined company is expected to have a pro forma equity market capitalization of approximately $5.5 billion. Consistent with its statutory duties and in consultation with its financial and legal advisors, Monmouth's Board is now evaluating the amended proposal and has not made any determination as to what action to take in response to the proposal. The company's Board intends to respond to the proposal in due course and remains committed to acting in the best interests of the company and its shareholders.
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MNR | Hot Stocks15:31 EDT Monmouth Real Estate receives amendment to unsolicited acquisition proposal - Monmouth Real Estate Investment announced that it received an amendment to the unsolicited acquisition proposal it previously received on July 8, 2021 from a certain large private investment company. The amendment to the proposal reflects an increase of 18c per share in the consideration that would be paid for each share of Monmouth Common Stock, resulting in a net cash consideration of $18.88 per share, reflecting a stated purchase price of $19.51 per share reduced by the termination fee of approximately $62.2 million, or 63c per share, if Monmouth terminates the merger agreement it previously entered into with Equity Commonwealth in accordance with its terms to accept the amended proposal. The increase results from the investment company's decision that the purchase price would no longer be reduced by the 18c per share dividend on Monmouth's common stock previously declared by Monmouth's Board on July 1, 2021 and payable on or about September 15, 2021. On July 16, 2021, Monmouth's common shares closed at $19.23 per share. As previously announced, on May 4, 2021, Monmouth entered into a definitive merger agreement with EQC pursuant to which EQC agreed to acquire Monmouth in an all-stock transaction valued at approximately $3.4 billion, including the assumption of debt. The combined company is expected to have a pro forma equity market capitalization of approximately $5.5 billion. Consistent with its statutory duties and in consultation with its financial and legal advisors, Monmouth's Board is now evaluating the amended proposal and has not made any determination as to what action to take in response to the proposal. The company's Board intends to respond to the proposal in due course and remains committed to acting in the best interests of the company and its shareholders.
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