Stockwinners Market Radar for June 20, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

MDLZ

Hot Stocks

16:28 EDT Mondelez to acquire energy bar maker Clif Bar & Company for $2.9B - Mondelez International announced an agreement to acquire Clif Bar & Company, maker of energy bars with organic ingredients, for $2.9 billion with additional contingent earnout consideration. The acquisition of leading on-trend brands CLIF, LUNA and CLIF Kid expands Mondelez International's global snack bar business to more than $1 billion, including its complementary and leading refrigerated snacking business Perfect Snacks in the U.S. and leading performance nutrition business Grenade in the U.K. This acquisition also advances the company's strategy to reshape its portfolio to sustain higher long-term growth. The transaction is expected to be top-line accretive in year two and create cost synergies by using Mondelez International's global and North American scale to expand Clif's sales distribution and gain further penetration in existing and new customers and channels in the U.S. The acquisition is subject to customary closing conditions and a pre-closing F reorganization and conversion to a limited liability company by Clif Bar & Company, and the transaction is expected to close in Q3 following customary regulatory review.
MA

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15:02 EDT MasterCard Board of Directors announces quarterly dividend of 49c per share - MasterCard announced that its Board of Directors has declared a quarterly cash dividend of 49c per share. The cash dividend will be paid on August 9, 2022 to holders of record of its Class A common stock and Class B common stock as of July 8, 2022.
M

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15:01 EDT Macy's launches Discord Channel, new NFT series - Macy's said it will launch a new series of free NFTs, or Non-Fungible Tokens, celebrating the brand's 4th of July Fireworks. In preparation for the new NFT drop, Macy's will launch its Discord channel, adding to the company's roster of social platforms where the brand engages with fans and customers. Available on a first come, first serve basis, to collect the NFTs fans must first register via the newly launched Macy's Discord channel available at Discord: Macy's Server. This set of 10,000 Macy's Fireworks NFTs will be available in Classic, Rare and Ultra Rare designs and will showcase graphic elements from this year's Macy's 4th of July Fireworks celebration. The NFTs will come with added utility including the ability to access Augmented Reality wearables that can be used on a selection of social media and video communications platforms.
WTI

Hot Stocks

12:00 EDT W&T Offshore falls -14.4% - W&T Offshore is down -14.4%, or -95c to $5.67.
NOG

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12:00 EDT Northern Oil and Gas falls -14.4% - Northern Oil and Gas is down -14.4%, or -$4.63 to $27.52.
LABD

Hot Stocks

12:00 EDT Daily S&P Biotech Bear 3x Shares falls -17.3% - Daily S&P Biotech Bear 3x Shares is down -17.3%, or -$11.19 to $53.66.
STRY

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12:00 EDT Starry rises 26.0% - Starry is up 26.0%, or $1.07 to $5.18.
GROV

Hot Stocks

12:00 EDT Grove rises 68.1% - Grove is up 68.1%, or $4.05 to $10.00.
REV

Hot Stocks

12:00 EDT Revlon rises 91.3% - Revlon is up 91.3%, or $1.78 to $3.73.
XBIT

Hot Stocks

10:15 EDT XBiotech announces completion of Phase I portion of pancreatic cancer study - XBiotech announced it successfully completed the Phase I portion of its 1-BETTER study, a Phase I/II randomized, double-blind, placebo-controlled clinical study to evaluate its anti-cancer drug Natrunix in combination with chemotherapy for treating pancreatic cancer. Enrollment in the Phase II portion is commencing immediately. The Phase I study enrolled patients in three groups, using escalating dose levels of Natrunix. Subjects received the maximum dosing of Natrunix without a single report of "possibly, probably, or definitely related dose limiting toxicity" associated with the investigational agent. Subjects received two 14-day cycles of Natrunix in combination with the chemotherapy drugs Onivyde, 5-fluorouracil and leucovorin. At the discretion of the treating oncologist, after completing the two 14-day cycles, patients were allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent. All patients in the highest dose group have continued to receive Natrunix; at this time a total of 14 additional cycles of therapy have been administered to the Phase I subjects. The Phase II portion of the study is commencing immediately. Key endpoints in the Phase II portion will be progression-free survival, overall survival and time-to-treatment-failure. The Phase II portion is enrolling 60 subjects that will be randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU, or placebo plus the chemotherapy combination. Subjects will receive the treatment for up to 12 cycles and will be allowed to continue to receive Natrunix if they were deemed to be potentially benefiting from the investigational agent.
SNDL

Hot Stocks

10:12 EDT Sundial Growers enters into bid agreement for Zenabis Global's assets - Sundial Growers announced that, in the context of the initial order pursuant to the companies' Creditors Arrangement Act pertaining to the Zenabis Group rendered on June 17, 2022, it entered into a purchase agreement, in the form of a "stalking horse bid," pursuant to which the shares of Zenabis Global and the business and assets of its direct and indirectly wholly-owned subsidiaries would be acquired by Sundial. The Bid Agreement is subject to the approval by the Quebec Superior Court supervising the CCAA Proceedings, and to potential alternative bids pursuant to bidding procedures that will follow. All amounts are denominated in Canadian dollars unless otherwise noted. Subject to the Court's approval of the Bid Agreement and of bidding procedures that will be sought on July 5, 2022, the Bid Agreement will set the floor, or minimum acceptable bid, in a sale and investment solicitation process, which is designed to achieve the highest and best offer for the Zenabis Group's business and assets and is under the supervision of Ernst & Young, acting as CCAA Monitor. The assets covered by the Bid Agreement include the 380,000 square foot indoor growing facility located in Atholville, New Brunswick with an annual production capacity of approximately 46,000 kgs of dried cannabis and 15,000 kgs of extraction capacity. The facility received EU GMP certification, providing a license to the facility to export internationally to Israel, Malta, the United Kingdom, and the EU. Zenabis Group also has a joint venture agreement with ZenPharm Limited, based in Malta, allowing for commercial bulk imports into Malta from the facility in Atholville and subsequent exports of finished medicinal cannabis products to countries of the EU and United Kingdom. The Bid Agreement also provides for the acquisition of a decommissioned 255,000 sq. ft. indoor facility in Stellarton, Nova Scotia, that was used as a packaging, processing, and value-added cannabis product manufacturing facility.
WTI

Hot Stocks

10:00 EDT W&T Offshore falls -14.4% - W&T Offshore is down -14.4%, or -95c to $5.67.
NOG

Hot Stocks

10:00 EDT Northern Oil and Gas falls -14.4% - Northern Oil and Gas is down -14.4%, or -$4.63 to $27.52.
LABD

Hot Stocks

10:00 EDT Daily S&P Biotech Bear 3x Shares falls -17.3% - Daily S&P Biotech Bear 3x Shares is down -17.3%, or -$11.19 to $53.66.
STRY

Hot Stocks

10:00 EDT Starry rises 26.0% - Starry is up 26.0%, or $1.07 to $5.18.
GROV

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10:00 EDT Grove rises 68.1% - Grove is up 68.1%, or $4.05 to $10.00.
REV

Hot Stocks

10:00 EDT Revlon rises 91.3% - Revlon is up 91.3%, or $1.78 to $3.73.
VSAT

Hot Stocks

09:59 EDT FAA approves Viasat's Ka-band IFC system for Dassault Falcon 7X and 8X aircraft - Viasat announced the Federal Aviation Administration approved the installation and use of Viasat's Ka-band in-flight connectivity business aviation system on Dassault Falcon 7X and 8X aircraft, marking the first time this equipment has been certified for these specific airframes. Viasat's connectivity solution is available at Dassault Owned Service Centers globally. "With Viasat's Ka-band service, Dassault Falcon 7X and 8X operators can benefit from similar connectivity in-flight as they do on the ground, typically with speeds greater than 20 Mbps. In fact, some operators with Viasat Ka-band IFC have reported speeds greater than 80 Mbps. That level of connectivity, made possible by Viasat's satellite network capacity, will allow all connected passengers to enjoy in-flight applications such as video conferencing, streaming video, corporate VPN access, and more during all phases of flight, including taxi, takeoff and landing," the company said.
VLGEA

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09:56 EDT Village Super Market declares quarterly dividend of 25c per Class A share - The Board of Directors of Village Super Market declared quarterly cash dividends of 25c per Class A common share and $0.1625 per Class B common share. The dividends will be payable on July 28, 2022 to shareholders of record at the close of business on July 7, 2022.
HEPA

Hot Stocks

09:54 EDT Hepion receives FDA Orphan Drug status designation for Rencofilstat - Hepion Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of HCC. HCC is the most common form of liver cancer, accounting for 85%-90% of all cases. NASH, viral hepatitis infection, and alcohol consumption all are major causes of HCC. The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States. Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.
WTI

Hot Stocks

09:47 EDT W&T Offshore falls -14.4% - W&T Offshore is down -14.4%, or -95c to $5.67.
NOG

Hot Stocks

09:47 EDT Northern Oil and Gas falls -14.4% - Northern Oil and Gas is down -14.4%, or -$4.63 to $27.52.
LABD

Hot Stocks

09:47 EDT Daily S&P Biotech Bear 3x Shares falls -17.3% - Daily S&P Biotech Bear 3x Shares is down -17.3%, or -$11.19 to $53.66.
STRY

Hot Stocks

09:47 EDT Starry rises 26.0% - Starry is up 26.0%, or $1.07 to $5.18.
GROV

Hot Stocks

09:47 EDT Grove rises 68.1% - Grove is up 68.1%, or $4.05 to $10.00.
REV

Hot Stocks

09:47 EDT Revlon rises 91.3% - Revlon is up 91.3%, or $1.78 to $3.73.
EWTX

Hot Stocks

09:46 EDT Edgewise announces 2-month interim results from ARCH open label study - Edgewise Therapeutics announced 2-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics of EDG-5506 in adults with BMD. EDG-5506 is an orally administered small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as Duchenne muscular dystrophy and BMD. The twelve adults with BMD enrolled in the ARCH study, including all seven participants from the Phase 1b study, were administered daily 10 mg oral doses of EDG-5506 at night. EDG-5506 was well-tolerated with no discontinuations or dose reductions. The most common adverse events observed at the 10 mg dose were dizziness and somnolence. These were generally transient and typically observed in the first few days of dosing. All patients have subsequently been dose escalated to 15 mg daily as per protocol. The 2-month plasma PK data for the 10 mg once-daily dose of EDG-5506 showed exposure levels that were approximately 61% of what was observed in the Phase 1b study where BMD participants were dosed with 20 mg EDG-5506 once-daily for two weeks. The reduced exposure for BMD participants in the ARCH study is consistent with the lower dose of 10 mg and a shorter half-life of EDG-5506 in BMD patients, likely associated with a decreased overall muscle mass. Treatment with EDG-5506 led to a significant decrease in key biomarkers of muscle damage when assessed by laboratory assays. Importantly, creatine kinase and fast skeletal muscle troponin I were reduced by an average of 30% and 68%, respectively, after 2 months. BMD participants in the ARCH study were fitted with a pedometer to measure daily activity during waking hours. Activity levels at 2 months of dosing with EDG-5506 increased over both activity levels at 1 month and activity levels observed in participants in the Phase 1b study, even with lower overall exposure to EDG-5506. The observation that both CK and TNNI2 were significantly decreased in the context of typical everyday activity levels is encouraging. The company believes the 2-month ARCH study data provide further support for the hypothesis that EDG-5506 meaningfully reduces damage from the excessive stress present in dystrophic muscle, thus potentially preserving muscle function and preventing disease progression in dystrophinopathies.
RXRX

Hot Stocks

09:43 EDT Recursion announces initiation of Phase 2/3 trial for NF2-Mutated Meningiomas - Recursion announced the initiation of its Phase 2/3 POPLAR-NF2 clinical trial during the Children's Tumor Foundation NF Conference. The trial will evaluate REC-2282: a potentially first-in-disease, orally bioavailable, central nervous system penetrant small molecule histone deacetylase inhibitor, for the treatment of progressive neurofibromatosis type 2-mutated meningiomas. There are currently no FDA-approved drugs for the treatment of patients with NF2, an inherited genetic syndrome that can cause a variety of benign tumors in the central nervous system, including meningiomas. Recursion discovered REC-2282 as a potential candidate for treatment of disease resulting from mutation in the NF2 gene by leveraging its proprietary AI-powered drug discovery platform, the Recursion OS. The Phase 2/3 trial is designed as a randomized, multi-center, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of REC-2282. The study is expected to enroll approximately 90 participants.
SHYF

Hot Stocks

09:39 EDT Shyft Group appoints Randy Wilson as Vice President - Shyft Group named Randy Wilson as Vice President, Investor Relations and Group Treasurer, effective June 20, 2022. In his new role, Wilson will be responsible for all aspects of the investor relations and treasury functions at Shyft Group.
BMY

Hot Stocks

09:23 EDT EMA validates Bristol-Myers application for CAR T cell therapy Breyanzi - Bristol-Myers announced that the European Medicines Agency has validated its type II variation application for extension of the indication for Breyanzi to treat adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who are refractory or have relapsed within 12 months of initial therapy and are candidates for haematopoietic stem cell transplant. Validation of the application confirms the submission is complete and begins the EMA's centralized review procedure. The type II variation is supported by data from the pivotal Phase 3 TRANSFORM study evaluating Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL compared to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus HSCT. In the study, Breyanzi significantly improved event-free survival compared to standard of care, the study's primary endpoint, and demonstrated clinically meaningful and statistically significant improvements in complete response rates and progression-free survival compared to standard of care. Breyanzi exhibited a well-established safety profile with very low rates of severe cytokine release syndrome and neurologic events, and no new safety signals were observed in this second-line setting, consistent with the safety profile observed with Breyanzi in the third-line plus setting. LBCL is an aggressive blood cancer and the most common type of non-Hodgkin lymphoma. A supplemental Biologics License Application for Breyanzi for the treatment of relapsed or refractory LBCL after failure of first-line therapy is currently under Priority Review with the U.S. Food and Drug Administration, with an assigned Prescription Drug User Fee Act goal date of June 24, 2022. A New Drug Application for Breyanzi for the second-line treatment of patients with relapsed or refractory LBCL is also under review with Japan's Ministry of Health, Labour and Welfare. Breyanzi, a differentiated CD-19 directed CAR T cell therapy, is currently approved in the European Union for the treatment of adult patients with relapsed or refractory diffuse DLBCL, primary mediastinal large B-cell lymphoma PMBCL, and FL3B after two or more lines of systemic therapy. Breyanzi is not approved in any region for the second-line treatment of LBCL.
SMR

Hot Stocks

09:16 EDT NuScale announces strategic shift to product services and delivery organization - NuScale Power announced that the company will make a strategic shift from product development to product delivery by establishing the new VOYGR Services and Delivery business unit. Comprised of services, supply chain, and client management functions, this new organization will be dedicated to working with customers and tasked with the delivery of services and equipment associated with the sale, development, delivery, and commercial operation of NuScale VOYGR power plants. After receiving the first ever small modular reactor design approval from the U.S. Nuclear Regulatory Commission in August 2020, NuScale has been focused on completion of its deployment readiness program, including finalization of the standard plant design and supply chain readiness like extensive manufacturing trials. In May 2022, NuScale became the first publicly traded company focused on the design and deployment of SMR technology; this growth, in combination with this announced strategic shift, will bolster and accelerate the commercialization of NuScale's SMR technology. The organization will be led by Thomas Mundy, who will transition from his role as NuScale's Chief Commercial Officer to President, VOYGR Services and Delivery, reporting to Hopkins, and will have full Profit and Loss accountability for the new business unit. In February 2022, the company expanded its leadership team to include Clayton Scott, who joined NuScale as Executive Vice President of Business Development in support of NuScale's transition to a product and service delivery organization and was reporting to Mundy. Scott will continue to lead the sales and marketing and communications teams, and report directly to Hopkins.
KBR

Hot Stocks

09:14 EDT KBR JV awarded contract by BP Exploration for SDA platform - KBR announced that its SOCAR-KBR joint venture has been awarded a front-end engineering design, turnaround engineering, and procurement support services contract by BP Exploration for the Shah Deniz Alpha platform in Azerbaijan. This project will significantly reduce SDA's overall carbon footprint and increase operational efficiency, providing a robust, long-term, high-availability power supply. SOCAR-KBR will be responsible for the FEED services for decommissioning the existing five main power generators on the SDA platform. They will then create a power supply from the KBR-designed Shah Deniz Bravo platform through subsea cables and a back-up power generator. This project will be delivered from SOCAR-KBR's Baku office to maximize local execution, with specialist subject matter expert support provided from KBR's London operations.
VALN PFE

Hot Stocks

09:01 EDT Pfizer takes 8.1% stake in Valneva for $95M into Lyme disease study - Valneva (VALN) and Pfizer (PFE) announced that they have entered into an equity subscription agreement and have updated the terms of their collaboration and license agreement for Lyme disease vaccine candidate VLA15. As previously announced on April 26, Pfizer plans to initiate the Phase 3 study of VLA15 in Q3. As part of the equity subscription agreement, Pfizer will invest $95M in Valneva, representing 8.1% of Valneva's share capital at a price of EUR 9.49 per share, through a reserved capital increase to "further support the strategic Lyme partnership between the two companies." The per share purchase price was determined based on the average closing price of the company's shares during the 10 trading days preceding the date of the equity subscription agreement. Valneva is planning to use the proceeds from Pfizer's equity investment to support its Phase 3 development contribution to the Lyme disease program. In addition, Valneva and Pfizer updated the terms of their collaboration and license agreement which they announced on April 30, 2020. Valneva will now fund 40% of the remaining shared development costs compared to 30% in the initial agreement. Pfizer will pay Valneva tiered royalties ranging from 14% to 22%, compared to royalties starting at 19% in the initial agreement. In addition, the royalties will be complemented by up to $100M in milestones payable to Valneva based on cumulative sales. Other development and early commercialization milestones are unchanged, of which $168M remain, including a $25M payment to Valneva upon Pfizer's initiation of the Phase 3 study. Pending successful initiation and completion of the planned Phase 3 study for VLA15, Pfizer said it could potentially submit a Biologics License Application to the Food and Drug Administration as early as 2025.