Stockwinners Market Radar for December 11, 2021 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
BDR | Hot Stocks17:34 EST Blonder Tongue Laboratories receives delisting notice from NYSE American - Blonder Tongue Laboratories announced that it received notice today from NYSE American stating that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of the company from the Exchange because the company was unable to demonstrate that it had regained compliance with Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide, relating to maintaining a certain level of stockholder's equity if the company has a history of reported losses from continuing operations, by the end of the maximum 18-month compliance plan period, which expired on December 10. The company intends to exercise its right to appeal the staff's determination. The company has been advised that the shares of the company's common stock will continue to be listed and traded on NYSE American during the pendency of the company's appeal, subject to NYSE American's discretion to suspend trading if it believes suspension to be in the public interest. Following the appeal, the decision of the committee of the Board of Directors of the Exchange hearing the appeal will be announced by NYSE Regulation regarding either proceeding with suspension and delisting or continued trading in the company's common stock.
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WSBF | Hot Stocks17:06 EST Waterstone Financial announces 3.5M share repurchase program - Waterstone Financial announced that on December 10, its Board of Directors authorized a share repurchase program pursuant to which the company intends to repurchase up to 3.5M of its issued and outstanding shares, representing approximately 14.1% of its issued and outstanding shares of common stock. The repurchase program will commence on or about December 13. This share repurchase program follows the Board of Directors termination of the previous repurchase program during which the company repurchased a total of 1,453,554 shares of its common stock at a weighted average price of $17.16 per share.
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MYSZ | Hot Stocks17:01 EST My Size resolves litigation with Ault Parties - My Size announced that based on recent discussions with Todd Ault and his representatives, the company has entered into a settlement agreement with the Ault Parties, in which the company agreed to withdraw the lawsuit asserting a claim for violation of Section 16(b) of the Securities Exchange Act of 1934 it previously filed in the United States District Court for the Southern District of New York against the Ault Parties. The Ault Parties have agreed to withdraw the counterclaim that they asserted in that action against the company.
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JNJ | Hot Stocks17:01 EST Janssen EMEA announces conditional marketing authorization for Rybrevant - The Janssen Pharmaceutical Companies of Johnson & Johnson announced conditional marketing authorization of Rybrevant for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor exon 20 insertion mutations, after failure of platinum-based therapy. "Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC," the company stated. "This CMA follows other recent approvals for amivantamab, including the U.S. Food and Drug Administration, who approved the treatment in May 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Additional regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide," the company added.
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RRD | Hot Stocks16:40 EST R.R. Donnelley board determines Chatham's acquisition proposal 'superior' - R.R. Donnelley & Sons Company announced that its Board of Directors unanimously determined that an unsolicited proposal from Chatham Asset Management, LLC to acquire all of the common stock of the company not already owned by Chatham and its affiliates for $10.85 per share in cash constitutes a "Superior Proposal" as defined in the Company's previously announced definitive merger agreement with affiliates of Atlas Holdings LLC, dated as of November 3, 2021, subject to the condition that Chatham agree to extend the Revised Chatham Proposal until 9:05 a.m. CST on Friday, December 17, 2021. If Chatham refuses to agree to the Timing Condition, the Board will deem the Revised Chatham Proposal as withdrawn and incapable of being accepted by the company. Under the terms of the Amended Agreement, affiliates of Atlas have agreed to acquire the company for $10.35 per share in cash. RRD has notified Atlas of the Board's determination that the Revised Chatham Proposal constitutes a Superior Proposal and that RRD intends to terminate the Amended Agreement for the purpose of entering into a definitive merger agreement with affiliates of Chatham. Pursuant to the Amended Agreement, Atlas has the contractual opportunity through December 16, 2021 (the "Negotiation Period") to negotiate an amendment of the Amended Agreement such that the Revised Chatham Proposal would no longer constitute a Superior Proposal. RRD intends, and is required by the terms of the Amended Agreement, to negotiate in good faith any adjustments or revisions to the terms and conditions of the Amended Agreement proposed by Atlas. RRD is contractually prohibited from terminating the Amended Agreement or entering into a definitive merger agreement with affiliates of Chatham during the Negotiation Period, which is the reason the Company has conditioned the Revised Chatham Proposal on the Timing Condition. Subject to the foregoing, RRD has informed Atlas that RRD intends to terminate the Amended Agreement at 9:00 a.m. CST on Friday, December 17, 2021 for purposes of entering into the Revised Chatham Proposal. Under the Amended Agreement, the Company is required to pay a $20 million termination fee and $12 million expense reimbursement to Atlas if the Company terminates the Amended Agreement in order to enter into a definitive merger agreement with affiliates of Chatham as described herein. Chatham has agreed to pay the $20 million termination fee to Atlas on the Company's behalf in such event; the Company has agreed to pay the expense reimbursement of $12 million. Under the terms of the Revised Chatham Proposal, the Company would be required to repay Chatham for such termination fee paid by Chatham under certain circumstances in connection with a termination of the proposed definitive merger agreement with affiliates of Chatham.
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CDOR | Hot Stocks16:37 EST Condor reports $7.94 per share liquidation distribution, intent to delist shares - Condor Hospitality Trust announced that its board of directors has approved a special dividend liquidation distribution of $7.94 per share of the company's common stock to its stockholders of record as of the close of business on December 27. The special dividend liquidation distribution will be paid on December 30. This special dividend liquidation distribution is being made in accordance with the company's voluntary plan of liquidation previously approved by its stockholders, whereby the company is engaged in its winding-up process. Upon completion of the winding-up process and dissolution, if any funds remain, such funds will be distributed to stockholders. The company also announced that it notified the NYSE of its intent to delist its common stock from the NYSE. The company expects to file a Form 25 with the Securities and Exchange Commission and NYSE American relating to the delisting of the common stock on or about December 20 and that its common stock will be suspended from trading on the NYSE American on or about December 31. The company does not expect that a trading market will develop for its Common stock following suspension of trading on NYSE. The company expects that the official delisting of its common stock will be effective on or about December 31.
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TXMD | Hot Stocks16:32 EST TherapeuticsMD sNDA to revise Annovera manufacturing not approved by FDA - TherapeuticsMD announced that the FDA determined that it could not approve revisions to certain manufacturing testing limits for Annovera through the sNDA previously submitted by the company. In its complete response letter, the FDA provided recommendations and requested additional information that could support approval of revisions to certain manufacturing testing limits. The company will continue to manufacture and supply Annovera under the existing approved specifications. The sNDA requested minor revisions to the in vitro release testing specification for Annovera to allow for normal commercial manufacturing variation. The company submitted the proposed revisions to the manufacturing testing limits to allow it to efficiently and quickly increase supply to meet anticipated patient demand for Annovera. Annovera was approved by the FDA in August 2018 as the only long-lasting, reversible, procedure-free birth control.
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TRN | Hot Stocks16:31 EST Trinity Industries raises quarterly dividend to 23c from 21c per share - The quarterly cash dividend, representing Trinity's 231st consecutively paid dividend, is payable January 31, 2022 to stockholders of record on January 14, 2022.
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DIT | Hot Stocks16:11 EST AMCON Distributing declares special cash dividend of $5.00 per share - This cash dividend is payable on December 30 to shareholders of record as of December 23.
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DIT | Hot Stocks16:11 EST AMCON Distributing announces $5.00 per share special dividend - AMCON Distributing Company announced that the board of AMCON declared a special cash dividend of $5.00 per common share. This cash dividend is payable on December 30 to shareholders of record as of December 23.
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UNP | Hot Stocks16:10 EST Union Pacific raises quarterly dividend 10% to $1.18 per share - Union Pacific Corporation announced that its board of directors voted to increase the quarterly dividend on the company's common shares by 10% to $1.18 per share. The dividend is payable December 30, 2021, to shareholders of record December 20, 2021. Union Pacific has paid dividends on its common stock for 122 consecutive years.
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TRMB | Hot Stocks16:09 EST Trimble senior VP Kirkland sells 6,899 common shares - In a regulatory filing, Trimble senior VP James Kirkland disclosed the sale of 6,899 common shares of the company on December 8 at a price of $88.47 per share.
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PRLB | Hot Stocks16:01 EST Proto Labs announces $50M increase to share repurchase program - Protolabs announced that on December 8, its Board of Directors approved a $50M increase in its authorized stock repurchase program currently in effect, with an expiration date of December 31, 2023. This authorization increases the stock repurchase program to $150M. As of December 7, Protolabs had repurchased an aggregate dollar value of $87M, resulting in $63M remaining available to purchase common stock under the expanded stock repurchase program.
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TSLA | Hot Stocks14:34 EST Tesla CEO says 'thinking of quitting' his jobs - Last night, Tesla CEO Elon Musk tweeted that he was "thinking of quitting" his jobs and "becoming an influencer full-time." Reference Link
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CHRW | Hot Stocks14:03 EST C.H. Robinson amends record date for upcoming dividend - C.H. Robinson Worldwide announced that it has amended the record date of its recently declared quarterly cash dividend of 55c per share. The record date has been changed to December 15 from the previously announced date of December 13, the company stated.
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ABT | Hot Stocks14:02 EST Abbott says White to retire as Executive Chair, names CEO Ford as Chairman - Abbott announced that its board of directors has elected Chief Executive Officer Robert Ford as Chairman of the Board, effective today. Miles White, executive chairman and former CEO, will step down from the Abbott board effective today and will retire "after a remarkable 38-year career with the company," Abbott stated.
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UNP | Hot Stocks13:32 EST Union Pacific appoints Michael Miller as treasurer to succeed Gary Grosz - Union Pacific has named Michael Miller vice president and treasurer effective Feb. 1, 2022, following the announced retirement of Gary Grosz. Miller, currently assistant vice president-Corporate Finance and assistant treasurer, has been with Union Pacific for 28 years. Miller will succeed Grosz, who is retiring March 1 after nearly 40 years at Union Pacific. Grosz served as assistant vice president-Corporate Finance and assistant treasurer for nearly 20 years before being promoted to vice president and treasurer in April 2019.
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JNJ... | Hot Stocks13:13 EST CDC says in 43 U.S. COVID-19 omicron cases studied, 79% were fully vaccinated - In its Morbidity and Mortality Weekly Report, the CDC stated in part: "During December 1-8, 2021, 22 U.S. states reported at least one COVID-19 case attributed to the Omicron variant. Among 43 cases with initial follow-up, one hospitalization and no deaths were reported... Details are available for 43 cases of COVID-19 attributed to the Omicron variant; 25, or 58%, were in persons aged 18-39 years. The earliest date of symptom onset was November 15 in a person with a history of international travel. Fourteen, or 33%, persons reported international travel during the 14 days preceding symptom onset or receipt of a positive test result. Among these cases of COVID-19 attributed to the Omicron variant, 34, or 79%, occurred in persons who completed the primary series of an FDA-authorized or approved COVID-19 vaccine greater than or equal to14 days before symptom onset or receipt of a positive SARS-CoV-2 test result, including 14 who had received an additional or booster dose; five of the 14 persons had received the additional dose less than14 days before symptom onset. Six, or 14%, persons had a documented previous SARS-CoV-2 infection. The most commonly reported symptoms were cough, fatigue, and congestion or runny nose." Reference Link
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BKR | Hot Stocks13:02 EST Baker Hughes reports U.S. rig count up 7 to 576 rigs - Baker Hughes reports that the U.S. rig count is up 7 from last week to 576 with oil rigs up 4 to 471, gas up 3 to 105, and miscellaneous rigs unchanged at 0. The U.S. Rig Count is up 238 rigs from last year's count of 338, with oil rigs up 213 gas rigs up 26 and miscellaneous rigs down 1. The U.S. Offshore Rig Count is up 1 to 14, up 1 year-over-year. The Canada Rig Count is down 3 from last week to 177, with oil rigs down 3 to 110, gas rigs unchanged at 67. The Canada Rig Count is up 66 rigs from last year's count of 111, with oil rigs up 58, gas rigs up 8.
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BKR | Hot Stocks13:02 EST Baker Hughes reports U.S. rig count up 7 to 576 rigs
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ABT | Hot Stocks13:02 EST Abbott board authorizes $5B share buyback - Abbott's board has authorized the repurchase of up to $5B of the corporation's common shares. This new authorization is in addition to the unused portion of the previous program authorized by Abbott's board in October 2019. The purchases may be made from time to time as market conditions warrant and subject to regulatory considerations.
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SONY | Hot Stocks13:02 EST Sony Interactive Entertainment to acquire Valkyrie Entertainment - Sony Interactive Entertainment announced that it has entered into an agreement to acquire Seattle-based videogame developer, Valkyrie Entertainment. Valkyrie Entertainment will join PlayStation Studios as the 17th studio and will aid in the development of key PlayStation Studios franchises, the company said in a statement. "Valkyrie Entertainment is a highly adaptable and respected studio which has produced high-quality work on a range of platforms from console to PC; and a variety of styles from action to games-as-a-service titles," said Hermen Hulst, Head of PlayStation Studios. "Valkyrie's diverse capabilities will be welcomed by every team at PlayStation Studios as we continue to focus on delivering extraordinary gaming experiences." The day-to-day operations post-acquisition will continue to be run by Valkyrie Entertainment's current management team. Terms of this transaction including the acquisition cost are not disclosed due to contractual commitments.
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ABT | Hot Stocks13:01 EST Abbott raises quarterly dividend 4.4% to 47c per share - Abbott announced that its board of directors has increased the company's quarterly common dividend, marking the company's 50th consecutive year of dividend growth. Abbott's quarterly common dividend has been increased to 47c per share, a 4.4% increase that follows a 25% increase to the company's quarterly dividend in 2021. It will be the 392nd consecutive quarterly dividend to be paid by Abbott since 1924. The cash dividend is payable Feb. 15, 2022, to shareholders of record at the close of business on Jan. 14, 2022.
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PIK | Hot Stocks12:52 EST PIK Stock trading resumes
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PIK | Hot Stocks12:47 EST PIK Stock trading halted, volatility trading pause
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XOM | Hot Stocks12:43 EST Exxon Mobil VP Wojnar sells 12,512 common shares - In a regulatory filing, Exxon Mobil VP Theodore Wojnar, Jr. disclosed the sale of 12,512 common shares of the company on December 8 at a price of $62.5101 per share.
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AMZN CIDM | Hot Stocks12:32 EST Cinedigm renews agreement with Prime Video Channels - Cinedigm (CIDM) announced that the Company has renewed its agreement with Prime Video Channels (AMZN) for five of its streaming channels. This include indie platform Fandor, horror service Screambox, the family-friendly destination Dove Channel, fanboy-centric CONtv and the documentary-focused Docurama.
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FB MVRS | Hot Stocks12:29 EST Meta offers new controls to help creators moderate comments - Facebook (FB), also known as Meta (MVRS), said it is rolling out a few updates for creators, including new controls to help creators more easily moderate comments, live chat support tests to troubleshoot account issues, and a webinar series on how to stay safe on Facebook. "We're adding more controls to help you manage the conversation around your content like blocking a user and new accounts they create, and improving how you hide unwanted comments on your posts," the company said. "With the hide action now available next to each comment, you can quickly hide comments with one click and easily view all hidden comments in a single place by changing the comment filter view on your posts. For keyword blocking, you can now automatically hide comments with variations of words that use numbers, symbols, or different spellings. We're also testing Moderation Assist, which - similar to Admin Assist for Groups - makes it easy to set criteria to automatically moderate comments on your posts, reducing how much time is spent on comment moderation. You can select from a list of rules to automatically hide certain types of comments on your posts such as comments with links, images, and more." Reference Link
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ESRT | Hot Stocks12:22 EST Empire State Realty announces new $500M share repurchase authorization - The company announced that its Board of Directors has approved a new repurchase authorization of up to $500M of the Company's Class A common stock and Empire State Realty OP, L.P.'s Series ES, Series 250 and Series 60 operating partnership units during the period from January 1, 2022 through December 31, 2023. This will replace an earlier $500M repurchase authorization that runs from January 1, 2021 through December 31, 2021.
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PBYI | Hot Stocks12:11 EST Puma Biotechnology presents updates from Phase II SUMMIT trial - Puma Biotechnology presented an update from its Phase II SUMMIT trial at the ongoing 2021 San Antonio Breast Cancer Symposium Annual Meeting. The data presented was from the cohort of patients with hormone receptor-positive, HER2-mutant metastatic breast cancer, exposed to CDK4/6 inhibitors, and treated with a combination of neratinib with fulvestrant and trastuzumab and a separate cohort of patients with metastatic triple negative breast cancer with a HER2 mutation treated with the combination of neratinib plus trastuzumab. The presentation, entitled "Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease: Latest updates from the SUMMIT trial," is being presented at an oral session by Komal Jhaveri, MD, FACP, Medical Oncologist at Memorial Sloan Kettering Cancer Center, on December 10 at 11:00 a.m. CST. The Phase II SUMMIT trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 mutations or lung cancers with EGFR exon 18 mutations. In the HER2-mutant, hormone receptor-positive, metastatic breast cancer cohort, patients who have previously received CDK4/6 inhibitors were previously enrolled in a non-randomized cohort and received 240 mg of neratinib per day, 500 mg fulvestrant on day 1 and 15 of Cycle 1 and then 8mg/kg trastuzumab every 4 weeks initially and then 6mg/kg trastuzumab every 3 weeks thereafter. In the HER2-mutant, triple negative metastatic breast cancer cohort, patients received 240 mg of neratinib per day and 8mg/kg body weight trastuzumab initially and then 6mg/kg trastuzumab every 3 weeks. All patients received anti-diarrheal prophylaxis with loperamide alone for the first two treatment cycles. The SUMMIT trial was later amended to randomize hormone receptor-positive, HER2-mutant metastatic breast cancer patients to receive either: the combination of neratinib, trastuzumab and fulvestrant, the combination of fulvestrant and trastuzumab, or fulvestrant alone. Once randomized, patients received either neratinib plus fulvestrant plus trastuzumab, fulvestrant plus trastuzumab, or fulvestrant in 1:1:1 ratio. All patients received anti-diarrheal prophylaxis with loperamide alone for the first two treatment cycles. In the non-randomized cohort, for the 26 patients with HR+, HER2-mutated MBC who had previously received CDK4/6 inhibitors, the efficacy results showed that for the patients who received neratinib plus fulvestrant plus trastuzumab, 12 patients experienced a confirmed objective response, all of which were partial responses, and 15 patients experienced clinical benefit. The median duration of response was 14.4 months and the median progression-free survival was 8.2 months. For the randomized portion of the trial, for the patients with HR+, HER2-mutated MBC who had previously received CDK4/6 inhibitors, no patient in either the fulvestrant plus trastuzumab or fulvestrant alone arm experienced a confirmed objective response. In the 7 randomized patients who received the combination of neratinib, trastuzumab and fulvestrant, 2 patients experienced a confirmed objective response, including one complete response and one partial response, and 2 patients experienced clinical benefit. The median duration of response was not reached and the median progression-free survival was 6.2 months. For all 33 patients with HR+, HER2-mutated MBC, who had previously received CDK4/6 inhibitors, who received the combination of neratinib plus trastuzumab plus fulvestrant, the efficacy results showed that 14 patients experienced a confirmed objective response, including one complete response and 13 partial responses, and 17 patients experienced clinical benefit. The median duration of response was 14.4 months and the median progression-free survival was 7.0 months. Based on the results from the randomized portion of the trial, for patients with hormone receptor-positive, HER2-mutant metastatic breast cancer, the Independent Data Monitoring Committee recommended closing enrollment to the fulvestrant plus trastuzumab and fulvestrant alone arms of the trial and recommended continuing enrollment in the neratinib plus trastuzumab plus fulvestrant arm of the trial. To date, the Company has enrolled 19 additional patients in this triplet arm of the trial. For the 18 patients with HER2-mutant triple negative breast cancer who received fulvestrant plus trastuzumab, 6 patients experienced a confirmed objective response, including one complete response and 5 partial responses, and 7 patients experienced clinical benefit. The median duration of response has not been reached and the median progression-free survival was 6.2 months. The safety profile observed in patients treated with neratinib in the SUMMIT study was consistent with that observed previously in metastatic patients with HER2 amplified tumors. The interim safety results of the study showed that the most frequently observed adverse event was diarrhea. For the 33 safety-evaluable HR-positive breast cancer patients who received the combination of neratinib plus trastuzumab plus fulvestrant, 15 patients reported grade 3 diarrhea. One patient permanently discontinued neratinib due to diarrhea. For the 18 safety-evaluable triple negative breast cancer patients who received the combination of neratinib plus trastuzumab, 3 patients reported grade 3 diarrhea. No patient permanently discontinued neratinib due to diarrhea.
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PSX PSXP | Hot Stocks12:08 EST Phillips 66 projects total 2022 capital program at $3B including JV spending - Phillips 66's (PSX) announced that its proportionate share of capital spending by joint ventures Chevron Phillips Chemical Company LLC, or "CPChem," WRB Refining LP, or "WRB," and DCP Midstream is expected to total $1.1B and to be self-funded. "CPChem's growth capital will fund expansion of its normal alpha olefins production, optimization and debottleneck opportunities in the olefins and polyolefins chains, as well as continuing development of world-scale petrochemicals projects in the U.S. Gulf Coast and Qatar. WRB's capital spending will be directed to sustaining projects, crude flexibility and enhancing clean product yield. Including Phillips 66's proportionate share of capital spending for these large ventures, the company's total 2022 capital program is projected to be $3.0B," stated Phillips 66 in announcing its 2022 capital program of $1.9B.
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PSX PSXP | Hot Stocks12:05 EST Phillips 66 announces 2022 capital program of $1.9B - Phillips 66 (PSX) announced its 2022 capital program of $1.9B, which includes $992M for sustaining capital and $916M for growth capital. Approximately 45% of growth capital supports lower-carbon opportunities, the company noted. The Midstream capital plan of $703M, which includes Phillips 66 Partners (PSXP), comprises $426M for growth projects and $277M for sustaining projects. Growth capital will be directed toward completing construction of Sweeny Frac 4 and repayment of its 25% share of the Bakken Pipeline joint venture's debt due in 2022. Midstream growth capital also includes Emerging Energy opportunities to advance the company's lower-carbon efforts. In Refining, Phillips 66 plans to invest $896M, with $488M for reliability, safety and environmental projects. Refining growth capital of $408M is primarily for the reconfiguration of the San Francisco Refinery in Rodeo, California, as part of the Rodeo Renewed project. Upon expected completion in early 2024, the facility will initially have over 50,000 barrels per day, or 800 million gallons per year, of renewable fuel production capacity, "making it one of the world's largest facilities of its kind," the company said. Refining growth capital will also support opportunities for high-return, low-capital projects. "The 2022 capital program demonstrates our commitment to disciplined capital allocation. Our plan for sustaining capital reflects our ongoing focus on operating excellence to ensure the safety and reliability of our operations. We are also investing in returns-focused growth opportunities, including projects that will help us advance a lower-carbon future. In addition to a disciplined capital program, we will continue to prioritize debt reduction and returns to shareholders," said Greg Garland, Chairman and CEO of Phillips 66.
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PFE | Hot Stocks12:02 EST Pfizer increases quarterly cash dividend to 40c per share - Pfizer announced that its board of directors declared an increase in the quarterly cash dividend on the company's common stock to 40c for the first-quarter 2022 dividend, payable March 4, 2022, to holders of the common stock of record at the close of business on January 28, 2022. "The increase in dividend is a direct reflection of our strong financial performance and continued confidence in our current product portfolio and R&D pipeline," said Dr. Albert Bourla, Pfizer Chairman and CEO.
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APRN | Hot Stocks12:00 EST Blue Apron falls -10.9% - Blue Apron is down -10.9%, or -$1.16 to $9.52.
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RFL | Hot Stocks12:00 EST Rafael Holdings falls -14.3% - Rafael Holdings is down -14.3%, or -85c to $5.10.
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FIGS | Hot Stocks12:00 EST Figs falls -16.6% - Figs is down -16.6%, or -$5.18 to $26.04.
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NTP | Hot Stocks12:00 EST Nam Tai Property rises 13.3% - Nam Tai Property is up 13.3%, or $1.38 to $11.73.
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CXM | Hot Stocks12:00 EST Sprinklr rises 15.4% - Sprinklr is up 15.4%, or $2.08 to $15.60.
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ORCL | Hot Stocks12:00 EST Oracle rises 15.9% - Oracle is up 15.9%, or $14.14 to $102.91.
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YAC | Hot Stocks11:18 EST Yucaipa expects to close SIGNA Sports United combination on December 14 - Yucaipa Acquisition Corporation announced that, subject to shareholder approval, it expects all conditions to be met or waived to complete its previously announced business combination with SIGNA Sports United. The transaction is expected to raise at least $484M from YAC trust proceeds and a fully committed, upsized private placement of common stock from institutional and high-tech investors, sovereign wealth funds and high net-worth individuals. The company said, "As previously disclosed, the Company believes its short-term revenue growth targets for the current fiscal year will be adversely affected by the on-going COVID-19 related supply chain disruptions and will likely land in the range of EUR 1.4B to EUR 1.55B on a full-year pro forma basis. However, the Company reiterates that it is very confident demand remains strong, the strategic consolidation opportunities are huge and the mid and long-term mega-trends behind the business are accelerating. The Company expects to continue on its strong growth track once the COVID-19 related supply chain situation normalizes."
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VLVLY | Hot Stocks10:45 EST Volvo discloses cyber security breach by third party - Volvo said it has become aware that one of its file repositories has been illegally accessed by a third party. Investigations so far confirm that a limited amount of the company's R&D property has been stolen during the intrusion. Volvo Cars has concluded, based on information available, that there may be an impact on the company's operation. After detecting the unauthorised access, the company immediately implemented security countermeasures including steps to prevent further access to its property and notified relevant authorities. Volvo Cars is conducting its own investigation and working with third-party specialist to investigate the property theft. The company does not see, with currently available information, that this has an impact on the safety or security of its customers' cars or their personal data. Reference Link
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KSU CP | Hot Stocks10:39 EST Kansas City Southern stockholders approve merger with Canadian Pacific - Kansas City Southern (KSU) announced that the company's stockholders have voted to approve the previously announced combination with Canadian Pacific Railway (CP) at today's virtual special meeting of stockholders. Of the 64.5M shares voting at the special meeting, approximately 99.6% were cast in favor of the adoption of the proposed merger agreement, the company noted. On December 8, CP's stockholders voted to approve the issuance of the CP common shares to KCS stockholders in connection with the proposed merger. The transaction is expected to close on Tuesday, December 14. KCS stockholders will receive $90 in cash and 2.884 CP shares for each KCS common share held and $37.50 in cash for each KCS preferred share held. Immediately upon close, ownership of KCS will be held in a voting trust pending the Surface Transportation Board's review and approval of CP's proposed control of KCS, which is expected to occur in the fourth quarter of 2022.
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NVEI | Hot Stocks10:31 EST Nuvei expands acquiring capabilities to UAE, North Africa - Nuvei Corporation announced its expansion of local acquiring services to support merchants in the United Arab Emirates and North Africa. Nuvei is certified by the Dubai Multi Commodities Centre and licensed to operate in the free trade zone. This new development positions the Company well to support its existing merchant base, as well as local merchants and international businesses looking to expand their footprint into this booming market.
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AHPI | Hot Stocks10:19 EST Allied Healthcare trading resumes
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AHPI | Hot Stocks10:14 EST Allied Healthcare trading halted, volatility trading pause
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FIGS | Hot Stocks10:00 EST Figs falls -10.6% - Figs is down -10.6%, or -$3.31 to $27.91.
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VNCE | Hot Stocks10:00 EST Vince Holding falls -11.9% - Vince Holding is down -11.9%, or -$1.35 to $9.96.
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BOXD | Hot Stocks10:00 EST Boxed falls -12.7% - Boxed is down -12.7%, or -$1.52 to $10.41.
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YMM | Hot Stocks10:00 EST Full Truck Alliance rises 11.0% - Full Truck Alliance is up 11.0%, or $1.13 to $11.37.
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CXM | Hot Stocks10:00 EST Sprinklr rises 13.3% - Sprinklr is up 13.3%, or $1.80 to $15.31.
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ORCL | Hot Stocks10:00 EST Oracle rises 16.0% - Oracle is up 16.0%, or $14.23 to $103.00.
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CHWY | Hot Stocks09:47 EST Chewy falls -6.2% - Chewy is down -6.2%, or -$3.48 to $52.82.
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VNCE | Hot Stocks09:47 EST Vince Holding falls -7.4% - Vince Holding is down -7.4%, or -84c to $10.47.
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BOXD | Hot Stocks09:47 EST Boxed falls -9.8% - Boxed is down -9.8%, or -$1.17 to $10.76.
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AI | Hot Stocks09:47 EST C3.ai rises 11.0% - C3.ai is up 11.0%, or $3.52 to $35.61.
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CXM | Hot Stocks09:47 EST Sprinklr rises 11.5% - Sprinklr is up 11.5%, or $1.55 to $15.06.
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ORCL | Hot Stocks09:47 EST Oracle rises 17.6% - Oracle is up 17.6%, or $15.62 to $104.39.
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EVBG | Hot Stocks09:37 EST Everbridge trading resumes
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GMBL | Hot Stocks09:36 EST Esports Entertainment partners with Hard Rock Hotel for esports wagering event - Esports Entertainment announced a new partnership with the Hard Rock Hotel & Casino Atlantic City that will be kicked-off by hosting the first sanctioned esports skill-based wagering event in the United States. EEG and Hard Rock Atlantic City have teamed up to create a tournament on January 22 and 23, 2022 that will launch LANDuel and be the springboard for more esports betting events and permanent installations in the future at the casino and hotel venue. The launch will include a two-day 256-player in-person tournament, the first skill-based gaming event approved by the New Jersey Division of Gaming Enforcement where participants will be permitted to wager on themselves in each round of the event.
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CELC | Hot Stocks09:35 EST Celcuity presents results of Phase 1b study of gedatolisib with palbociclib - Celcuity presented a poster at the 2021 San Antonio Breast Cancer Symposium with updated results from a four-arm Phase 1b expansion study. This study evaluated gedatolisib, a first-in-class pan-PI3K/mTOR inhibitor, in combination with palbociclib, a CDK4/6 inhibitor and endocrine therapy in women with ER+/HER2- advanced breast cancer. The poster presented data as of a May 10, 2021 data cutoff. Preliminary data from this Phase 1b study was presented earlier this year with results as of a January 11, 2021 data cut-off. Consistent with the previously released results, the addition of gedatolisib to palbociclib and endocrine therapy demonstrated promising antitumor activity in both first and later line settings for ER+/HER2- ABC that compared favorably to historical controls. A significant objective response rate was also observed in patients refractory to their last treatment or who had received two or more lines of prior treatment for advanced breast cancer. Gedatolisib was well tolerated with manageable toxicity and a low number of patients discontinued treatment due to an adverse event. Phase 1B Study Design and Results: Patients with ER+/HER2- advanced breast cancer were treated in one of four arms. Palbociclib, letrozole, and fulvestrant were administered at standard doses. Gedatolisib 180 mg was intravenously administered weekly in Arms A, B, and C and three weeks on/one week off in Arm D. The primary endpoint was ORR and secondary endpoints were safety, duration of response, and progression free survival. Patient assessment was conducted by the investigator. A summary of key results follows below: Arm A: Patients who were treatment naive in the ABC setting: ORR: 85%; PFS: 31.1 months. Arm B: Patients who received prior endocrine therapy without a CDK4/6 inhibitor: ORR: 77%; PFS: 11.9 months. Arm C: Patients who received prior treatment with a CDK4/6 inhibitor; greater than2 prior therapies for ABC: 66% of patients; ORR: 32%; PFS: 5.1 months. Arm D - Patients who received prior treatment with a CDK4/6 inhibitor; greater than 2 prior therapies for ABC: 33% of patients; ORR: 63%; PFS: 12.9 months. Results from an exploratory comparative and a longitudinal intrapatient analysis were also presented for two sub-groups of Arm C and Arm D patients: patients who had the same number of prior lines of treatment; and patients who had similar durations of treatment with their immediate prior therapy. The two analyses were performed to isolate the effect of the different gedatolisib schedules used in Arm C and Arm D on patient response. Key findings from the analyses are presented below: The ORR in Arm D relative to Arm C was superior irrespective of the number of prior therapies for ABC. Patients who had received one prior line of therapy were 1.7 times more likely to report an objective response in Arm D than Arm C. Patients who had received 2 or more prior lines of therapy were 2.4 times more likely to report an objective response in Arm D than Arm C. The median duration of treatment with gedatolisib was significantly longer in Arm D relative to Arm C, irrespective of the treatment period of their immediate prior therapy. For patients who had progressed on their prior treatment in less than six months, the median duration of treatment for Arm D patients was 3.33 times longer than patients in Arm C. The ORR for this sub-group of Arm D and C patients was 71% and 0% respectively. For patients who had progressed on their prior treatment in less than 12 months, Arm D patients remained on treatment 2.10 times longer than patients in Arm C. The ORR for this sub-group of Arm D and C patients was 73% and 15% respectively. Because duration of treatment tends to decline in subsequent lines of therapy, a longitudinal intrapatient analysis was performed to compare the efficacy of the gedatolisib regimen to the immediate prior regimen for the sub-group of Arm C and D patients who remained on their prior therapy less than six and 12 months. The analysis was performed using duration of treatment because progression free survival data was not available for patients' immediate prior therapy. For Arm D patients who progressed on their prior therapy in less than six months, the median duration of gedatolisib treatment was 2.6 times longer than their immediate prior treatment period. For Arm C patients, the ratio between the time on gedatolisib versus immediate prior therapy was 0.8. For Arm D patients who had progressed on prior therapy in less than 12 months, the median duration of gedatolisib treatment was 1.8 times longer than their immediate prior treatment period. For Arm C patients, the ratio between time on gedatolisib versus immediate prior therapy duration was 0.9. Overall, this exploratory analysis of ORR and duration of treatment found significantly higher ORR and longer duration of treatment in Arm D vs. Arm C patients who progressed within six months and within 12 months on their prior therapy. In addition, ORR was superior in Arm D relative to Arm C in patients irrespective of the number of prior therapies for ABC. This suggests that Arm D's gedatolisib/palbociclib synchronized dosing schedule may have played a significant role in the different outcomes between the Arms. The study of gedatolisib in combination with palbociclib and endocrine therapy also demonstrated that the treatment was well tolerated with side effects managed by available standards of care. No Grade 5 event occurred; the most common Grade 3-4 adverse events were stomatitis and neutropenia. Less than 10% of all patients, and only one patient in Arm D, discontinued treatment due to an adverse event. Fewer patients experienced Grade 3-4 adverse events associated with PI3K/mTOR inhibition compared to data reported for other products in this class. Across all study arms, Grade 3-4 hyperglycemia was observed in less than or equal to7% of patients, AST and ALT elevation in less than or equal to10% of patients, diarrhea and colitis in less than or equal to7% of patients, pneumonitis in less than or equal to4% of patients. These results reflect gedatolisib's differentiated pharmacokinetic properties and indicate that gedatolisib can be safely combined with other targeted agents.
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EVBG | Hot Stocks09:33 EST Everbridge trading halted, volatility trading pause
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PFE | Hot Stocks09:31 EST Pfizer receives EC approval for 100 mg, 200 mg doses of Cibinqo - Pfizer announced that the European Commission, or EC, has approved the 100 mg and 200 mg doses of Cibinqo, an oral, once-daily, Janus kinase 1, or JAK1, inhibitor, for the treatment of moderate-to-severe atopic dermatitis, or AD, in adults who are candidates for systemic therapy. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate and severe renal impairment or certain patients receiving treatment with inhibitors of cytochrome P450 2C19. The approval of Cibinqo was based on the results of five clinical studies of more than 2,800 patients including four Phase 3 studies and an ongoing long-term open label extension study. Cibinqo demonstrated meaningful improvements across measures of symptom relief and disease control versus placebo. In one trial including an active control arm with dupilumab, which evaluated patients on background topical medicated therapy, Cibinqo 200 mg was associated with a greater improvement in itch relief after two weeks than dupilumab. Cibinqo also demonstrated a consistent safety profile across trials, including in a long-term extension study, showing a favorable benefit-risk profile. The most common adverse events reported with Cibinqo in 5% of patients were nausea and headache. The most frequent serious adverse reactions were infections.
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FST | Hot Stocks09:31 EST Fast Acquisition, Fertitta Entertainment mutually terminate merger pact - FAST Acquisition Corp. and Fertitta Entertainment announced that they have agreed to mutually terminate their merger agreement, originally entered into on February 1 and amended on June 30. The parties have simultaneously terminated their Merger Agreement after a settlement was reached regarding the parties' disagreement over the termination date in the Merger Agreement. The settlement provides FAST and its shareholders up to $33M through a combination of upfront and deferred payments, part of which is contingent on whether FAST ultimately effectuates a business combination transaction. The settlement includes a payment to the SPAC which will be used to cover expenses associated with the terminated transaction as well as a replenishment of the SPAC's working capital account. FAST intends to continue to seek a business combination with another operating company.
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CVS | Hot Stocks09:28 EST CVS Health raises quarterly dividend 10% to 55c per share - The dividend is payable on February 1, 2022, to holders of record on January 21, 2022.
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XXII | Hot Stocks09:25 EST 22nd Century 'ready to provide' commercial support to New Zealand Smokefree Plan - 2nd Century Group announced that it is fully engaged and ready to provide commercial support to the New Zealand Ministry of Health's Smokefree Aotearoa 2025 Action Plan, including supplying reduced nicotine content combustible cigarettes able to meet New Zealand's proposed standards. The final version of the Plan introduced on December 9th details comprehensive measures to reduce smoking, including legislation to implement a reduced nicotine mandate. 22nd Century has been an active supporter of New Zealand's smoke-free efforts throughout the plan's development process. 22nd Century's VLN cigarettes would enable New Zealand to authorize a reduced nicotine content cigarette for sale immediately. With just 0.5 mg of nicotine per gram of tobacco, 22nd Century's VLN reduced nicotine content cigarettes contain 95% less nicotine than conventional cigarettes, but they taste, smell and smoke the same. An extensive body of independent, clinical science shows that this innovative alternative to addictive, conventional cigarettes will help adult smokers reduce their exposure to nicotine, smoke fewer cigarettes and support their efforts to quit smoking. 22nd Century is already advancing to international VLN sales commencing in the first quarter of 2022 in select international markets in Asia and Europe and has established a branch in New Zealand. The Company is fully prepared to produce VLN reduced nicotine content cigarettes for export to New Zealand.
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IMAC WMT | Hot Stocks09:17 EST IMAC's The Back Space announces Nashville location reaches 100 active members - IMAC Holdings (IMAC) announced that its first location of The Back Space has reached 100 active members. The Back Space, located within Walmart (WMT) stores, are retail healthcare centers specializing in chiropractic adjustments, nerve and muscle stimulation, and percussion tool therapies for soft tissue recovery, muscle relaxation, and spinal wellness. Services are offered on a walk-in and appointment basis, priced at $25 per treatment, with memberships available for $65 per month that are valid at any The Back Space location.
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MRNA | Hot Stocks09:13 EST Moderna drops 13% to $237.90 after reporting flu vaccine data
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BTC... | Hot Stocks09:11 EST Crypto stocks track higher as bitcoin trades up from overnight lows - The price of bitcoin is up about 5% from yesterday evening's lows, testing the upside of $50,000 level. Stocks levered to bitcoin prices are also tracking higher in the pre-market session, with Bit Digital (BTBT) up 3.3%, Riot Blockchain (RIOT) up 3.8%, Marathon Digital (MARA) up 5.4%, and Coinbase Global (COIN) up 3.1%.
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BRDS | Hot Stocks09:06 EST Bird Global awarded three-year contract by Reno - Bird Global announced that it was awarded a conditional exclusive three-year contract to operate e-scooters in Reno after a unanimous vote by the Reno City Council. Committed to expanding transportation access to its 250,000 residents, "the Biggest Little City in the World" is set to welcome Bird's micro-electric vehicles in 2022. The program will feature up to 1,000 Bird scooters and is part of Reno's commitment to eliminating transit deserts throughout the community. Prior to final launch approval, Bird will continue hosting community outreach and engagement events aimed at increasing access to its eco-friendly services.
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LEFUF | Hot Stocks09:04 EST The Brick opens first new Calgary store in 12 years - The Brick is celebrating the grand opening of its new store in Calgary, the retailer's first in the city since 2009. Strategically placed in the busy south end off Macleod Trail, the Shawnessy location officially opens to the public today and is ideally located to serve customers in Calgary as well as outlying communities such as High River, Okotoks, Black Diamond and Turner Valley.
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MRNA | Hot Stocks09:04 EST Moderna announces additional 20M doses of COVID-19 vaccine to COVAX - Moderna announced an amendment to its existing contract with Gavi, the Vaccine Alliance, to accelerate supply of 20M doses to COVAX by December 31 for a total of 54M doses made available to COVAX in 2021. Deliveries to COVAX Advance Market Commitment, or AMC, countries have already begun. These doses are included in Moderna's previously announced agreement with Gavi and were originally scheduled for delivery in the first quarter of 2022. Given the acceleration into 2021, Moderna expects to supply up to 96.5M doses in Q1 of 2022 and an additional 116.5M doses in Q2. Gavi retains the option to procure 233M additional doses in 2022 under the original agreement. Moderna is also announcing a new supply agreement with Gavi for an additional 20M doses for delivery in the second quarter of 2022 for a total of up to 136.5M doses in the second quarter of 2022. Gavi retains options to purchase an additional 30M doses in the second quarter of 2022 and an additional 100M doses in the third quarter of 2022. Together, these two agreements allow Gavi to purchase up to 650M doses of the Moderna COVID-19 vaccine for delivery through 2022.
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RRR | Hot Stocks09:04 EST Red Rock Resorts reports preliminary results of modified Dutch auction - Red Rock Resorts announced preliminary results of its "modified Dutch auction" tender offer which expired at 12:00 midnight, New York City time, at the end of the day on December 9. Based on the preliminary count by American Stock Transfer & Trust Company, a total of 6,921,149 shares of RRR's Class A Common Stock, par value $0.01 per share, were properly tendered and not properly withdrawn at or below a purchase price of $51.50 per Share, including 1,992,710 Shares that were tendered by notice of guaranteed delivery. In accordance with the terms and conditions of the tender offer and based on the preliminary count by the Depositary, RRR expects to purchase all 6,921,149 shares through the tender offer at a price of $51.50 per Share, for an aggregate cost of approximately $356.4M, excluding fees and expenses relating to the tender offer. Included in the 6,921,149 Shares that RRR expects to purchase are 125,033 Shares that RRR has elected to purchase pursuant to its right to purchase up to an additional 2% of its outstanding Shares. The total of 6,921,149 Shares that RRR expects to purchase represents approximately 10.13% of the total number of Shares outstanding, or 6.12% of the total number of Shares outstanding assuming exchange of all shares of the company's Class B Common Stock and limited liability interests in Station Holdco LLC, as of December 9.
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UEPS | Hot Stocks09:03 EST Net 1 UEPS appoints Naeem Kola as Group Chief Financial Officer - Net 1 UEPS Technologies announced that it has appointed Naeem Kola as Group Chief Financial Officer. Kola will take up his role with effect from March 1, 2022, and joins Net1 soon after the announcement of the acquisition of the Connect Group. Alex Smith will remain in the role of Chief Financial Officer until Kola joins, and will then transition into newly created role of Group Chief Accounting Officer from March 1, 2022. Kola has progressively held senior finance roles across Middle East and Africa, based out of Dubai, most notably as Group Chief Financial Officer of the Emerging Markets Payments Group.
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IAIC | Hot Stocks09:02 EST Information Analysis Incorporated announces $10M equity financing - Information Analysis announced it has obtained subscriptions for the sale of 3,289,525 Units at a price of $3.04 per Unit in a private investment in public equity financing. Each Unit consists of a share of $0.01 par value common stock of the Company and the right to receive a warrant exercisable for .20 shares of common stock which equates to one share for every five Units purchased. Each such warrant is exercisable commencing January 1, 2023 through December 31, 2026 at a price of $4.50 for each whole share. The price per Unit was determined using the 5-day Volume Weighted Average Price from November 26, 2021 to and including December 2, 2021. The Company estimates net proceeds from the PIPE will be approximately $9.9 million, after deducting attorneys fees and other expenses. No commissions were paid in connection with this financing. The financing was led by the Company's Chairman and CEO, Mr. Jamie Benoit, and newly-appointed board member Chip DiPaula, with participation from existing investors, Company executives, and members of the IAI Board of Directors. Several limited partners of Marlinspike Capital also made leading investments in the PIPE.
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AJG | Hot Stocks09:02 EST Arthur J. Gallagher acquires The Robbi Davis Agency, terms not disclosed - Arthur J. Gallagher & Co. announced the acquisition of Little Rock, Ark.-based The Robbi Davis Agency. Terms of the transaction were not disclosed. Founded in 1996, RDA is a full-service insurance agency specializing in employee benefits, Medicare supplement/drug plans and individual health insurance, with a focus on small group businesses.
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FAT | Hot Stocks09:01 EST Fat Brands continues Middle East expansion with 10-store Libya deal - FAT Brands, parent company of Fatburger, Johnny Rockets, and 13 other restaurant concepts, announces a new deal to enter Libya with 10 new franchised restaurants. The new stores will be made up of five co-branded Johnny Rockets and Hurricane Grill & Wings locations and five co-branded Fatburger and Buffalo's Express restaurants, which are slated to open over the next three years. Franchisee Al Majmoua Al Moutakamila is spearheading the 10-store deal which will also mark the first co-branded Johnny Rockets and Hurricane Grill & Wings location to date in the region. On the heels of recently announced expansion plans in United Arab Emirates, Kingdom of Saudi Arabia, Bahrain, Qatar, and Kuwait, the Libya development deal further reinforces FAT Brands' commitment to growing in the Middle East. "The Middle East is an important growth area for FAT Brands," said FAT Brands CEO Andy Wiederhorn. "With a growing appreciation for quick-service restaurants in the region, we look forward to bringing our beloved burger and wing brands to Libya. Similarly, we are excited to unveil the first co-branded Johnny Rockets and Hurricane Grill & Wings location in the region. We saw tremendous success when we co-branded Fatburger and Buffalo's Express and expect to see the same with this burger and wing pairing with locals."
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CERN | Hot Stocks09:01 EST Cerner raises quarterly dividend 23% to 27c per share - Cerner Corporatiom announced that its board of directors declared a cash dividend to stockholders of 27c per issued and outstanding share, up 23% from the prior quarterly dividend of 22c. The cash dividend will be payable January 11, 2022, to shareholders of record as of the close of business December 27, 2021.
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SNPS | Hot Stocks09:01 EST Synopsys announces $1B share repurchase program - Synopsys announced that its Board of Directors has approved a new stock repurchase program with authorization to purchase up to $1B of common stock. The program replaces Synopsys' prior stock repurchase program, which was originally approved by Synopsys' Board of Directors in 2002.
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SAWLF | Hot Stocks08:53 EST Shawcor closes C$150M unsecured note financing - Shawcor announced that it has successfully closed its previously announced private offering of C$150M aggregate principal amount of 9.00% senior unsecured notes due 2026. As previously stated, the Company will utilize net proceeds of the Offering to repay amounts outstanding under its existing syndicated credit facility. The Offering was underwritten by a syndicate of underwriters, led by National Bank Financial and TD Securities.
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DUAVF | Hot Stocks08:50 EST Dassault Aviation notes Finland chooses U.S. with F-35 - The company said, "Dassault Aviation takes note of the sovereign decision of the Finnish authorities to choose the American solution for the replacement of the F-18 Air Component. Once again, we notice and regret an American preference prevailing in Europe. For their part, Dassault Aviation and its industrial partners are continuing to develop the Rafale's operational capabilities, in the service of France and of countries that want to have a first-rate air force with full sovereignty, as Greece and Croatia have recently chosen in Europe, and others outside Europe."
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NAT | Hot Stocks08:40 EST Nordic American Tankers board members buy shares - The company said, "We are pleased to report to you that Board Members have recently increased the number of NAT shares they own. Board member Alexander Hansson has since November 26 bought 150,000 shares. His private holding is 1,135,000 shares. Board member Jim Kelly has 210,000 shares in NAT. Board member Doug Penick joined the Board July 19, 2021. He has 175,000 shares. The Hansson family is the largest private shareholder, holding marginally below 5 million shares."
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SON | Hot Stocks08:39 EST Sonoco Products provides update on sustainability strategy focus - Elizabeth Rhue, Staff Vice President of Sustainability, outlined Sonoco's global sustainability strategy, which is targeting significant reduction of the Company's carbon footprint while providing customers with more sustainable products. "We are focused on three areas," Rhue explained. "Products - As in what products we will be delivering to the marketplace, including thinking through material selection and how we leverage emerging technologies; Infrastructure - How does current and future infrastructure play into end-of-life treatment of our products; and Partnerships - How we leverage relationships across a number of different areas, from academia to customer to our supply chain to deliver on our goals." Earlier this year, Sonoco established Scope 1, 2 and 3 emission reduction goals validated by the Science-Based Targets initiative. By 2030, the Company has pledged to reduce Scope 1 and 2 greenhouse gas emissions by 25 percent, and in cooperation with suppliers and customers, the Company is committed to reducing Scope 3 emission by 13.5 percent. "Because we know it will not be easy to meet these commitments, we have put together a cross-functional team focused on ensuring we are incorporating sustainability and environmental metrics into our business strategy and incentives. This includes establishing business-level greenhouse gas emission targets, implementing shadow carbon pricing as part of our capital approval process and improving reporting and transparency of environmental data."
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MMMB | Hot Stocks08:36 EST MamaMancini's secures $2M in sales through TSV promotion on QVC - MamaMancini's announced that QVC selected the Company's 3-Cheese Beef and Turkey Meatballs in Italian Sauce as the network's Today's Special Valuem, TSV, promotion for December 8th, 2021. "The promotion was extremely successful with MamaMancini's sales over $800,000 for immediate delivery throughout the holidays," the company said. The airings, which launched at midnight, provided QVC customers the opportunity to purchase MamaMancini's product throughout the day at specia pricing. In addition, the product was sold in the auto-delivery program adding approximately $1.2M in scheduled 2022 sales. Over 30% of all customers enrolled in the recurring 60-day, 5-installment auto-delivery schedule. Carl Wolf, Chairman and Chief Executive Officer of MamaMancini's said "We place significant value on our mutually beneficial relationship with QVC, representing an exciting partnership for our business through the access to their unique direct-to-consumer platform - reaching millions of shoppers nationwide. I look forward to continued success on QVC in the months to come, creating value for both MamaMancini's cherished customers and shareholders," concluded Wolf.
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SON | Hot Stocks08:35 EST Sonoco Products targets annual EBITDA growing to $1B by 2026 - Sonoco provided an overview of its five-year strategic plan and 2022 financial guidance during a virtual meeting with investors. Featured presenters at the meeting included: Howard Coker, President and Chief Executive Officer; Rodger Fuller, Executive Vice President; Julie Albrecht, Vice President and Chief Financial Officer; and Elizabeth Rhue, Staff Vice President of Sustainability. The presentation from today's event is available on the Investor Relations section of Sonoco's website at www.sonoco.com. President and CEO Howard Coker discussed the Company's value-creation strategy that is focused on Sonoco being viewed as a benchmark yield and stability packaging company and targeting to grow organic annual earnings before interest, taxes, depreciation and amortization to $1 billion by 2026. Key elements of the strategy include: Further capital investment in the Company's core Consumer and Industrial businesses to augment growth and generate strong returns; Executing an operating strategy to implement a series of "self-help" actions that are expected to generate approximately $180 million in incremental annual EBITDA over the next five years; Simplifying Sonoco's structure to create a more effective and efficient organization and managing the Company's portfolio for "fit" around fewer, bigger businesses; Continuing to consider and pursue acquisitions that improve the portfolio and complement the strategy beyond the path to $1 billion in annual EBITDA.
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DRTT | Hot Stocks08:34 EST Dirtt announce independent directors reviewing requisition made by 22NW Fund - DIRTT Environmental Solutions announced that the committee of its independent directors tasked with reviewing and considering the requisition made by an activist investor, 22NW Fund, LP, has reiterated its commitment to being prepared to engage in discussions with the Activist to settle this proxy fight. Since August 5, 2021, representatives of the Company have been in negotiations with Aron English regarding him joining the board of directors of the Company, and without prior notice, on November 17, 2021, English issued his requisition. The December 9, 2021 "proposal" was made less than 24 hours after the Company filed a complaint against the Activist with the Alberta Securities Commission.
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IBIO | Hot Stocks08:33 EST iBio announces partial adjournment of annual meeting to December 22 - iBio announced that its annual meeting of stockholders scheduled for and convened yesterday has been partially adjourned to December 22, 2021 at 9:00 a.m. Eastern Time. A quorum was present at yesterday's Annual Meeting, and Proposals 1, 2 and 3 put forth in the definitive proxy statement received the requisite votes for approval. The Company's stockholders also approved Proposal 6 for the purpose of continuing to solicit votes in favor of Proposal 4 and Proposal 5. With over 60% of all shares voted, iBio stockholders are in favor of the reverse split and authorized share decrease by approximately a 2-to-1 margin. Results of votes cast "FOR" Proposals 4 and 5 to-date are 64% and 67%, respectively. Additionally, both of the leading proxy advisory firms have recommended that stockholders vote "FOR" the proposals. With a clear plurality of the vote in favor of the proposals and strong, independent third-party support for the reverse split and authorized share decrease, the Company is allowing additional time for stockholders holding approximately 40% of the shares that have yet to be voted the opportunity to express their views. Proposals 4 and 5 require a majority of all shares outstanding to vote "FOR" the measures, not just a plurality of the vote.
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FTK | Hot Stocks08:32 EST Flotek receives continued listing standard notice from NYSE - Flotek Industries announced it has received written notice from the New York Stock Exchange that the average closing price of the company's shares of common stock was below $1.00 per share over a period of 30 consecutive trading days, which is below the requirement for continued listing on the NYSE. In accordance with applicable NYSE procedures, the company plans to notify the NYSE that it intends to cure the $1.00 per share deficiency.
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IONM | Hot Stocks08:32 EST Assure Holdings announces results of annual general meeting - Assure Holdings announced that it held its virtual annual general meeting of shareholders yesterday and that all matters submitted to the shareholders of the Company for approval as set out in the Company's definitive proxy statement dated November 9, 2021, were approved by the requisite majority of votes cast at the Meeting, including: Electing all nominees to the board of directors of the Company, including Martin Burian, John Farlinger, Preston Parsons, Christopher Rumana, Steven Summer and John Flood. Re-appointing Baker Tilly US as auditors of the Company for the ensuing year. Approving the executive compensation for the Company's named executive officers. Approving the frequency of advisory votes on executive compensation, being every three years. Approving certain amendments to the Company's stock option plan. Approving certain amendments to the Company's equity incentive plan. Approving the Company's new stock incentive plan. Approving the Company's new employee stock purchase plan. Pursuant to the terms of the 2021 Stock Incentive Plan and 2021 Employee Stock Purchase Plan, the maximum aggregate number of shares that may be issued under all awards under such plans, plus any shares granted under the 2020 Option Plan and 2020 Equity Incentive Plan, is 2,367,260 shares. The amendments to the 2020 Option Plan, the amendments to the 2020 Equity Incentive Plan, the 2021 Stock Incentive Plan and the 2021 Employee Stock Purchase Plan each remain subject to the approval of the TSX Venture Exchange (the "TSXV").
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FOCS | Hot Stocks08:31 EST Focus Financial sees $4.0B in revenue by 2025, up from $3.5B prior view - In its Analyst Day presentation update yesterday, the company also raised its forecast for adjusted EBITDA to $1.1B from $840M and EBITDA margin to 28% from 24%. Reference Link
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TROW | Hot Stocks08:31 EST T. Rowe Price reports preliminary AUM $1.63T at November 30 - Client transfers from mutual funds to other portfolios, including trusts and separate accounts, were $1.1B in November, and $4.2B for the quarter-to-date period ended November 30.
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ABML | Hot Stocks08:25 EST American Battery receives permit approval for exploration drilling - American Battery Technology has received approval of its required Notice of Operation Permit from the Bureau of Land Management Tonopah Field Office, as well as its Reclamation Bonding from the BLM Nevada State Office in Reno, for its initial Phase One subsurface sampling of its recently secured 305 lode mining claims located on land in Little Smokey Valley near Tonopah, Nev. The company previously announced the initial results of its surface sampling from these claims, and after experiencing promising results, exploratory drilling on these claims, now referred to as ABTC's Tonopah Flats Lithium Exploration Project, is the next critical step in developing this high potential resource. The samples collected during these exploratory drilling operations will be characterized and analyzed in order to define and quantify the extent of the lithium-bearing deposit in footprint, depth, and grades of lithium. Preliminary evaluation of historical sampling and characterization efforts have indicated that the composition and structure of the resources on these claims could be representative of resources identified on nearby claims in the same region. In April 2020, American Lithium published a resource assessment of their 7,500-acre TLC project, which directly borders these ABTC secured claims, which stated a Measured and Indicated resource of 5.37 million tonnes of lithium carbonate equivalent, with an additional 1.76 million tonnes inferred. Over the past two years, ABTC has been designing and optimizing its internally developed processing train for the manufacturing of battery cathode grade lithium hydroxide from these Nevada-based sedimentary claystone resources. The majority of these development efforts to date have been performed with sedimentary claystone resource samples provided by partner companies in the Tonopah, Nev. region. While ABTC will continue to work with these partners to refine, test, and validate its internally developed technologies for potential commercialization at these resource sites, ABTC is also evaluating the performance of its lithium extraction and manufacturing technologies directly on its own lithium-bearing resource.
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LMT | Hot Stocks08:24 EST Finland selects Lockheed Martin's F-35 Lightning II as its next fighter - The Finnish Government has announced Lockheed Martin's 5th Generation F-35 Lightning II is the aircraft selected from its HX Fighter Program. By selecting the F-35, Finland gains a significant capability to ensure stability in the region. The Finnish Air Force will receive 64 F-35A multirole stealth fighters, a robust weapons package, a sustainment solution tailored to Finland's unique security of supply requirements, as well as a comprehensive training program.
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GENI | Hot Stocks08:20 EST Genius Sports enters partnership with Canadian Football League - Genius Sports announced a strategic partnership with the Canadian Football League, or CFL, the second largest football league globally with over 100 years of history. Genius Sports will provide a wide range of technology and services that will enable the CFL to accelerate its growth plans and engage new audiences around the world. As part of the agreement, Genius Sports will have the exclusive rights to commercialize the CFL's official data worldwide and video content with sportsbooks in international markets, replicating the global distribution and success of its official betting products for the EPL and NFL, among others. In connection with the partnership, in addition to the official data rights agreement, Genius Sports and the CFL have also agreed that Genius Sports will acquire a minority stake in CFL Ventures, the new commercial arm of the league, allowing the company to benefit strategically and financially from the CFL's growth. The transaction is expected to become effective in January 2022.
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NFYEF | Hot Stocks08:17 EST Xplore Dundee orders 12 NFI electric double-deck buses - NFI Group subsidiary Alexander Dennis Limited announced that the ADL and BYD electric vehicle partnership has supplied 12 British-built electric double deck buses to bus operator Xplore Dundee. These new vehicles will reduce greenhouse gas emissions and deliver cleaner, quieter, more sustainable mobility along one of Scotland's most polluted streets.
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ARVN PFE | Hot Stocks08:15 EST Arvinas, Pfizer announce update on Phase 1 dose escalation data of ARV-471 - Arvinas (ARVN) and Pfizer (PFE) announced an update on Phase 1 dose escalation data of ARV-471, a novel PROTAC estrogen receptor degrader, which is being co-developed for the treatment of patients with locally advanced or metastatic ER-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer. These data were presented as a virtual spotlight poster session at the 2021 San Antonio Breast Cancer Symposium and showed: ARV-471 demonstrated antitumor activity in CDK4/6 inhibitor-pretreated patients with a clinical benefit rate of 40% in 47 evaluable patients. This heavily pretreated patient group had a median of four prior therapies. Three patients exhibited confirmed partial responses among the 38 patients with response evaluation criteria in solid tumors measurable lesions and at least one on-treatment tumor assessment. ARV-471 continues to demonstrate a favorable tolerability profile. Robust ER degradation was observed at all dose levels, reaching 89% reduction of ER. Erika P. Hamilton, MD, Director of the Breast Cancer and Gynecologic Cancer Research Program and Principal Investigator, Sarah Cannon Research Institute, provided an overview of these data. These data support and further validate the evaluation of ARV-471 as a potential treatment for metastatic breast cancer that is ongoing in a Phase 1b combination study with IBRANCE and a Phase 2 monotherapy dose expansion study. As of the data cut-off date of September 30, 2021, 60 adult patients with locally advanced or metastatic ER+/HER2- breast cancer were treated in the Phase 1 dose escalation portion of the study with total daily ARV-471 doses ranging from 30 mg to 700 mg. This patient group is heavily pretreated, with a median of four prior therapies. All patients were previously treated with cyclin-dependent kinase 4/6 inhibitors; 80% of patients received prior fulvestrant; and 78% received prior chemotherapy. Of 47 patients who were evaluable for clinical benefit the CBR was 40%. As of the data cutoff date, 14 patients were continuing to receive study treatment, including two patients who had been on treatment for over 18 months. Three confirmed PRs were observed among the 38 patients with baseline RECIST measurable disease and at least one on-treatment tumor assessment. Patients were treated in the monotherapy escalation at total daily doses of 30 mg, 60 mg, 120 mg, 180/200 mg, 360 mg, 500 mg, and 700 mg. All patients in the 700 mg cohort received ARV-471 twice-daily, a subset of patients who received 500 mg as a total daily dose received ARV-471 twice-daily, and other all doses were administered once-daily. A maximum tolerated dose was not reached and no dose limiting toxicities or Grade greater than or equal to4 treatment-related adverse events were observed. Of the 60 patients, 37% had Grade 1 TRAEs and 57% had Grade less than or equal to2 TRAEs, and the most common TRAEs were nausea, fatigue, and vomiting. No Grade 1 or 2 TRAEs led to discontinuation or dose reduction of ARV-471. Four patients experienced six Grade 3 TRAEs that were potentially related to ARV-471, including: headache lasting 1-day, single occurrence of asymptomatic increased amylase and lipase, nausea and asymptomatic QTc prolongation, and post-biopsy venous embolism. The patient with the venous embolism was the only Grade 3 patient who discontinued ARV-471 due to a TRAE, and the patient with Grade 3 nausea was the only patient with a dose reduction due to a TRAE. In paired biopsies from 14 patients across all doses up to 500 mg daily, robust ER degradation of up to 89% was observed, regardless of ESR1 mutation status. Median and mean ER degradation across dose levels were 67% and 64%, respectively. ARV-471 demonstrated a dose-related increase in plasma exposure, with doses from 30 mg to 500 mg daily, resulting in steady-state Cmax and AUC24 that exceeded the exposure associated with tumor regression in preclinical breast cancer models. Mean exposure on day 15 exceeded the nonclinical efficacious range at doses greater than or equal to60 mg daily. ARV-471 currently is being evaluated as a treatment for metastatic breast cancer in a Phase 1 dose escalation study, a Phase 1b combination study with IBRANCE, and a Phase 2 monotherapy dose expansion study. In 2022, we expect to: Initiate Phase 3 studies across lines of therapy in metastatic breast cancer, as both monotherapy and in combination. Initiate two additional trials of ARV-471, including a Phase 1b combination trial with everolimus in 2L/3L metastatic breast cancer, potentially as part of a planned umbrella study to explore multiple combination agents, and a Phase 2 neoadjuvant trial in early breast cancer. Present data from the ongoing Phase 1b combination study with IBRANCE and from the ongoing Phase 2 monotherapy dose expansion study.
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SWM | Hot Stocks08:10 EST Schweitzer-Mauduit closes sale of Spotswood, New Jersey property for $35M - SWM International has finalized the sale of its former Spotswood, New Jersey facility to an undisclosed buyer, with net proceeds of approximately $35M. Net proceeds from the transaction will be used to reduce Company debt. As previously disclosed, the Company closed its Spotswood, NJ facility at the end of 2020 as the Company transitioned to a newly developed manufacturing technology to better support the site's customer.
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BBKCF | Hot Stocks08:09 EST Bigg Digital Assets' Netcoins launches Netcoins Pay - BIGG Digital Assets is pleased to announce the launch of Netcoins Pay, a prepaid card that enables users to draw from their Canadian dollar balance within Netcoins, and earn bitcoin back with every purchase they make on it. Netcoins Pay makes it easy for users to grow their bitcoin holdings through their everyday spending. Within the Netcoins platform, users will be able to keep track of their Netcoins Pay transactions and rewards. All rewards will be earned in CAD and automatically converted into bitcoin at set intervals by Netcoins. Netcoins Pay will have the following features: Earn 3% bitcoin back for the first 3 months; Earn 1% bitcoin back after that point; No monthly or annual account fees; Easy top up and funding via Interac e-Transfers or bank wires; Apple Pay and Google Pay support; A choice of a virtual and/or physical card. Netcoins Pay will be launched in waves, with it now available to a select group of testers.
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BYSI | Hot Stocks08:09 EST BeyondSpring announces analysis of data from Phase 3 PROTECTIVE-2 trial - BeyondSpring Pharmaceuticals announced the presentation of additional analyses from the Phase 3 portion of the PROTECTIVE-2 trial evaluating the combination of plinabulin and pegfilgrastim for the prevention of chemotherapy-induced neutropenia, CIN, in breast cancer patients at the 2021 San Antonio Breast Cancer Symposium, SABCS, held both live and virtually from December 7-10, 2021. Poster Title: Mechanistic evidence associated with the benefit of plinabulin significantly reducing bone pain in breast cancer patients treated with TAC and pegfilgrastim. Key Findings: Patients treated with pegfilgrastim and plinabulin experienced less bone pain than did patients treated with pegfilgrastim only; Treatment with plinabulin may mitigate the need for compensatory hematopoiesis and intracavitary pressure build-up, resulting in bone pain sensations; Patients treated with pegfilgrastim and plinabulin had a higher absolute neutrophil count at the nadir; The depth of ANC nadir was statistically significantly correlated with bone pain scores. Poster Title: Combination plinabulin+pegfilgrastim had better toxicity management and health related quality-of-life compared to Peg alone in early-stage breast cancer patients treated with taxotere, doxorubicin and cyclophosphamide. Key Findings: Adding plinabulin to pegfilgrastim decreases toxicity and improves HrQoL among patients with breast cancer receiving TAC; The adverse event profile among patients treated with plinabulin and pegfilgrastim was shifted towards lower grade AEs; Adding plinabulin to pegfilgrastim prevented a decline in HrQoL scores for mobility, self-care, daily activities, pain and anxiety.
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NVS | Hot Stocks08:09 EST Novartis presents new Piqray data from Phase II BYLieve study - Novartis announced new Piqray data indicating benefit across a broad range of patient and disease characteristics as seen in analyses from all three cohorts of BYLieve. BYLieve is an ongoing Phase II, open-label, 3-cohort non-comparative study evaluating Piqray with endocrine therapy including men and pre- and postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer who have progressed on or after prior therapies, including CDK4/6 inhibitor plus endocrine therapy. "The data from all three cohorts of the BYLieve study have value for the medical community and for the patients we care for with mBC, because these cohorts show a benefit from alpelisib in the post-CDK4/6i setting for patients with HR+/HER2- PIK3CA-mutated cancer," said Dr. Hope Rugo, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. "Beyond illustrating the efficacy and safety of alpelisib, regardless of the duration of prior CDK4/6i treatment, the data provide meaningful insights into how alpelisib may benefit different subgroups of patients."
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DOX | Hot Stocks08:08 EST Amdocs files fiscal 2021 Annual Report - Amdocs has filed its Annual Report on Form 20-F for the fiscal year ended September 30, 2021 with the U.S. Securities and Exchange Commission. The annual report is available through the Company's website. Upon the request of a shareholder of the Company, the Company will promptly provide to such shareholder a copy of the 2021 annual report, free of charge.
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MANT | Hot Stocks08:07 EST ManTech completes acquisition of Gryphon Technologies - ManTech International has completed the acquisition of Gryphon Technologies from AE Industrial Partners for $350 million in cash. Founded in 1998 and headquartered in Washington, D.C., Gryphon Technologies provides advanced capabilities including model-based systems engineering, predictive analytics, data/computational science and cloud engineering solutions that drive mission success for an array of Department of Defense agencies. This acquisition expands ManTech's capabilities in the Defense Sector with new customers and programs - and some 1,500 skilled professionals who will add momentum to ManTech's success at Bringing Digital to the Mission in innovative ways that support national and homeland security.
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AUB | Hot Stocks08:06 EST Atlantic Union Bankshares announces $100M share repurchase authorization - The Board of Directors of Atlantic Union Bankshares Corporation has authorized the repurchase of up to $100M worth of the Company's common stock through December 9, 2022. Shares of common stock may be purchased under the Repurchase Program periodically in open market transactions or privately negotiated transactions at prevailing market prices, including pursuant to a trading plan in accordance with Rule 10b5-1 and/or Rule 10b-18 under the Securities Exchange Act of 1934, as amended.
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CADL | Hot Stocks08:05 EST Candel Therapeutics, partnership for PACT to collaborate for trial on CAN-2409 - Candel Therapeutic announced a collaboration with Partnership for Accelerating Cancer Therapies, PACT, and the Cancer Immune Monitoring and Analysis Centers - Cancer Immunologic Data Commons, CIMAC-CIDC, to profile the biomarker response to a combination of CAN-2409 + valacyclovir in combination with anti-PD-1 and PD-L1 immune checkpoint inhibitors in patients with non-small cell lung cancer, NSCLC. Analysis of longitudinal biologic samples from a Candel phase 2 clinical trial will be performed by the CIMAC-CIDC research centers and sponsored by PACT. Candel's clinical trial in NSCLC is designed to assess the tumor response to CAN-2409 when added to anti-PD-1 or PD-L1 immune checkpoint inhibitor treatment after patients have inadequately responded to ICI with or without chemotherapy. The trial comprises three cohorts; 1) patients whose best response to ICI treatment has been stable disease; 2) patients who have initially responded to ICI treatment, but whose disease is now progressing; and 3) patients who have refractory disease, meaning they are progressing rapidly despite ICI treatment. In each of these settings, minimal to no response is expected from further ICI treatment. The collaboration will analyze samples from each of these cohorts with the aim to identify early biological indicators of response and further stratify potential responders to treatment.
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INFI | Hot Stocks08:03 EST Infinity Pharmaceuticals presents updated data from MARIO-3 study - Infinity Pharmaceuticals presented updated data from the ongoing MARIO-3 clinical study during the 2021 San Antonio Breast Cancer Symposium, or SABCS. MARIO-3 is the company's ongoing Phase 2 study evaluating eganelisib in combination with atezolizumab and nab-paclitaxel in frontline metastatic triple negative breast cancer, or TNBC. This data update includes 50 patients enrolled and 44 evaluable as of the October 2 data cutoff date, with a median duration of follow up of 9.9 months. Of evaluable patients, tumor reduction was observed in 92.8% of patients with PD-L1 positive tumors and 85.2% of patients with PD-L1 negative tumors. Overall, 92.8% DCR in patients with PD-L1 positive tumors and 81.4% DCR in patients with PD-L1 negative tumors. In patients with PD-L1+ tumors, median PFS in MARIO-3 was 11 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130. In patients with PD-L1- tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130 . In total, 72% of the 32 PD-L1 (+) and PD-L1(-) patients treated since the June 26 data cut remain on treatment and 67% of the PD-L1(-) patients who reached the median PFS of 7.3 months remain on treatment. MARIO-3 did not demonstrate any new safety signals compared to benchmark trials, and its safety profile was consistent with expectations for the three component drugs. The most common Grade 3 or higher treatment-related TEAEs were hepatic AEs; neutropenia AEs; skin AEs; fatigue, diarrhea and peripheral sensory neuropathy and vomiting and weight decreased. Seven patients discontinued treatment for treatment-related TEAEs and nine patients had treatment-related SAEs. Quantification across 11 paired tumor biopsies shows increased immune activation and decreased immune suppression including an increase in CD8+ T cells, activated T cells, and anti-tumor M1 macrophages and a decrease in tumor cells and pro-tumor M2 macrophages resulting in an increase in the M1:M2 ratio. Paired tumor biopsy data show 5 of 8 patients with PD-L1(-) tumors converting to PD-L1(+) two months after treatment utilizing the same 1% PD-L1 cutoff standard used in the benchmark IMpassion130 study. PD-L1 expression also increased in the three patients with PD-L1(+) tumors who started the study above the 1% cutoff. None of the patients converting to PD-L1(+) or patients with PD-L1(+) tumors who experienced increased PD-L1 expression had disease progression.
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MRUS | Hot Stocks08:03 EST Merus presents updated analyst on zenocutuzumab combination study - Merus presented clinical data on zenocutuzumab in combination with trastuzumab and vinorelbine in patients with HER2 positive/amplified metastatic breast cancer, MBC, who had progressed on anti-HER2 antibody drug conjugates (ADC), at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The reported data are from the completed phase 2 study, designed to explore the efficacy of a triplet combination of Zeno plus trastuzumab and vinorelbine in MBC patients. Preliminary results for patients treated with the triplet regimen were presented at the American Society of Clinical Oncology 2020 Annual Meeting. The combination was observed to be well-tolerated in the run-in cohort and the cohort was expanded. The primary endpoint of the study was clinical benefit rate at 24 weeks of 45%. Updated results from the cohort expansion are presented here: At the efficacy data cut-off, March 31, 2021, 39 patients, with a median age of 57 and with a median number of five prior therapies, had received the Zeno-based triplet combination. All patients had completed at least 6 months of treatment or discontinued 37 patients with locally confirmed HER2 overexpression (IHC 3+ or IHC 2+/FISH-positive) were evaluable for antitumor activity; The clinical benefit rate per investigator assessment was 49%; Confirmed responses were reported in 10 patients, including 2 patients with complete response; Median duration of response was 4.2 months, including 2 patients with CR lasting 4.2 and 7.2+ months, and 8 patients with partial responses lasting from 2.6 to 12.4 months; Median progression-free survival was 5.5 months; 7 patients were censored. Estimated overall survival rates at 12 and 24 months were 73% and 61%, respectively; and The combination was observed to be well tolerated, with AEs primarily related to chemotherapy
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MN | Hot Stocks08:01 EST Manning & Napier reports preliminary AUM $22B as of November 30 - Compared with $22.5B at October 31, and $22B at September 30.
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CYTK | Hot Stocks07:41 EST Cytokinetics announces data from its ALS program - Cytokinetics announced that new data were presented at the 32nd International Symposium on ALS/MND including an analysis of baseline characteristics from the initial patients enrolled in COURAGE-ALS, the ongoing Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis, ALS. In addition, supplemental analyses from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in ALS, were presented, as were results from the IMPACT ALS Europe survey, a patient and caregiver survey funded in part by Cytokinetics. COURAGE-ALS: Analysis of Baseline Characteristics for First 27 Patients Enrolled: COURAGE-ALS is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv. From this analysis it appears that adjusting the inclusion criteria in COURAGE-ALS is achieving the intended goal of increasing the proportion of patients with middle to fast disease progression rates, as compared to FORTITUDE-ALS. FORTITUDE-ALS: Grip Strength Correlated with Fine Motor Function and Arm Function: In FORTITUDE-ALS, secondary and exploratory endpoints included change from baseline in the ALSFRS-R, in which higher scores represent better physical function, change from baseline in the ALS Assessment Questionnaire, a patient reported measure of health status in which higher scores represent worse quality of life, and change from baseline in grip strength. For all seven time points collected, average grip strength was strongly correlated with the ALSFRS-R fine motor domain sub-score. Average grip strength was moderately inversely correlated with scores for Question 2 of the ALSAQ-5, which assesses the patients' perception of difficulty using their arms and hands, with an overall Spearman correlation coefficient of -0.634. FORTITUDE-ALS: Extremity Muscle Strength Correlated with Physical Function and Quality of Life: An additional analysis from FORTITUDE-ALS was presented exploring how muscle strength relates to functional status and quality of life. Muscle strength was measured using hand-held dynamometry in three upper extremity muscles and three lower extremity muscles. Upper extremity muscle strength was moderately to strongly correlated with the ALSFRS-R fine motor domain, and moderately inversely correlated with Question 2 of ALSAQ-5. Lower extremity muscle strength was moderately correlated with the ALSFRS-R gross motor domain, and moderately inversely correlated with Question 1 of the ALSAQ-5. IMPACT ALS Europe Survey Results Reveal ALS Patient and Caregiver Perspectives on Burden of Disease and Treatment: Presented new results from IMPACT ALS, a self-reported online survey of ALS patients and caregivers in Europe. Results showed that within the previous two weeks, nearly every person with ALS experienced at least one symptom. Among responders who indicated which symptoms they preferred a new treatment to address. Of the respondents, 73.6% indicated they had fears about the future, with the most common fears for patients being leaving their family too soon, being isolated from family and friends, and dying from respiratory failure.
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CNC | Hot Stocks07:40 EST Centene sees FY22 health benefits ratio of 87.6%-88.2% - Sees FY22: Selling, general and administrative expense ratio of 7.9%-8.4%, which excludes depreciation expense as it will be separately disclosed from SG&A expense in 2022. Adjusted SG&A expense ratio of 7.8%-8.3%, which excludes $132M-$147M of acquisition related expenses. Effective tax rate of 25.5%-26.5%. Adjusted effective tax rate of 25.0%-26.0%.
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GOL BA | Hot Stocks07:39 EST Gol Linhas announces preliminary 2022 outlook - Brazil's largest domestic airline provided its preliminary financial outlook for 2022. GOL's (GOL) guidance reflects expected passenger and loyalty program revenues, cash flow, interest expense, oil prices and exchange rates, and fleet and network plans. Highlights: To meet the expected domestic air travel demand for 2022 of approximately 100B RPKs, the company plans to operate an average of 108 aircraft in its network during the year. Through the acceleration of its fleet transformation, including the addition of 18 and 16 Boeing (BA) MAX aircraft in 2H21 and 2022, respectively, GOL expects to end 2022 with 44 Boeing MAX aircraft in its fleet. The company's revenue for 2022 is expected to increase around 100% compared to 2021. GOL estimates that its 2022 results will include R$1.2B of increased cash flow from important transactions entered into in 2021 including R$450M from the re-incorporation of Smiles and R$700M from the additional MAX aircraft in the fleet.
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ANPC | Hot Stocks07:34 EST AnPac Bio announces publication on CDA cancer detection technology - AnPac Bio-Medical Science announced its joint technical paper on novel Cancer Differentiation Analysis Technology for multi-cancer screening with multiple leading medical institutions was accepted and published online on November 30, 2021 by the Expert Review of Molecular Diagnostics, a peer-reviewed international medical journal that has an impact factor of 5.2. The title of the published paper is "Development and Evaluation of Cancer Differentiation Analysis Technology: A Novel Biophysics-Based Screening Method". The co-authors of the paper included several leading medical institutions in China, including the School of Medicine, Shanghai Jiao Tong University, and Department of Statistics and Data Management at Children's Hospital of Fudan University. The paper reported the mechanism of CDA technology, as well as an extensive, multi-year, multi-cancer screening validation work that included a two-stage study design. This cross-sectional study of CDA testing in the initial stage, included a routine health checkup involving 75,942 individuals which was followed by a prospective population-based cohort study involving 1,957 individuals. The studies concluded that the CDA test is useful for cancer screening with high specificity and moderate sensitivity among healthy individuals and continues to lay both the conceptual and practical foundation for AnPac Bio's novel biophysics-based test for cancer screening. Based on results from the study, the published technical paper also cited a number of advantages of CDA technology which include its potential suitability for health screening, estimated cost quite comparable or lower than that of other screening methods, and its multi-cancer screening ability for large population.
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GENE | Hot Stocks07:33 EST Genetic Technologies presents study on geneType Breast Cancer Test - Genetic Technologies confirms that the Company's Director of Clinical Affairs & Medical Education, Erika Spaeth, PhD will be presenting at 2021 San Antonio Breast Cancer Symposium. New geneType Breast Cancer Test showed improved discrimination and calibration over traditional clinical models; Study included over 200,000 participants to validate the risk model with an expanded panel of 313 SNPs; Poster Presentation highlights the ongoing development of geneType Breast Cancer Risk Test GeneType for Breast Cancer can identify risk in more than 85% of women. Note that only about 15% of women with breast cancer have a family member with history of this disease. GENE is pleased to announce the Company's Director of Clinical Affairs & Medical Education, Erika Spaeth, PhD will be presenting data from a new study the Company has undertaken with an expanded panel of 313 SNPs as part GENE's ongoing test development and improvement for its geneType Breast Cancer Test. This work has formed part of a development program to further improve the performance of the geneType Breast Cancer Test. It has been established that the ability to efficiently stratify women at high risk of developing breast cancer can lead to improved risk-reduction measures and patient outcomes. GENE's latest model demonstrated an improvement in calibration and discrimination in women at risk of developing sporadic, non-hereditary breast cancer from traditional models. The study used 200,009 active UK Biobank members aged 40 to 69 who were genetically Caucasian, with SNP data for 313 breast cancer associated variants.
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IRM | Hot Stocks07:32 EST Iron Mountain to acquire ITRenew for $725M in cash - Iron Mountain has entered into a definitive agreement to acquire ITRenew, a data center lifecycle management solutions company. Upon closing, Iron Mountain will acquire 80% of the outstanding shares of ITRenew on a cash- and debt-free basis for approximately $725M in cash, with the remaining 20% acquired within three years of close for a minimum enterprise value of $925M. Previous investor ZMC, a private equity firm, will exit its position as part of this transaction. Following the close of the transaction, ITRenew will form the platform for Iron Mountain's Global IT Asset Lifecycle Management business. Under the terms of the agreement, Iron Mountain will acquire at closing 80% of the shares of ITRenew for approximately $725M in cash. The remaining 20% will be acquired in cash within three years from close, with a minimum payment of $200M and the final amount subject to the performance of the business. The transaction implies a minimum enterprise value of $925M, which corresponds to a purchase multiple of approximately 12x based on trailing twelve month EBITDA as of September 30. The transaction is expected to close in Q1 of 2022, subject to regulatory approval and other customary closing conditions.
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RLAY | Hot Stocks07:32 EST Relay Therapeutics announces preclinical data on RLY-2608 - Relay Therapeutics shared additional preclinical data at the 2021 San Antonio Breast Cancer Symposium for RLY-2608, the first known allosteric, pan-mutant and isoform-selective PI3Kalpha inhibitor. The data presented in the poster help support the clinical development of RLY-2608 both in single agent and combination clinical trials for patients with PIK3CA mutant tumors, including PI3Kalpha-mutant, HR+/HER2- breast cancer. The data indicate RLY-2608 synergizes with fulvestrant and the CDK4/6 inhibitor abemaciclib in cell viability assays in PIK3CAmut/ER+/HER2- cell lines. Oral administration of RLY-2608 in combination with fulvestrant or abemaciclib led to improved efficacy compared to either agent alone in ER+/HER2- xenograft models representing the most commonly observed PIK3CA mutations in breast cancer. The triple combination of all three agents resulted in deep regressions across all models. Additionally, the combination arms had similar tolerability to monotherapy arms. "We continue to validate our novel allosteric approach for PI3Kalpha inhibition and believe that RLY-2608 has the potential to overcome many of the toxicity limitations seen with non-selective orthosteric inhibition of PI3K that lead to frequent discontinuations and challenges combining with standard of care inhibitors," said Don Bergstrom, M.D., Ph.D., executive vice president of R&D at Relay Therapeutics. "This preclinical profile supports the clinical development of RLY-2608 as what we believe is a truly differentiated molecule that can be safe and effective both as a single agent and in combination, and has the potential to address a major unmet medical need for patients with PI3Kalpha mutant tumors, PI3Kalpha-mutant, HR+/HER2- breast cancer." The data presented at the conference also include previously presented preclinical data, showing RLY-2608 preferentially binds to the mutant protein, and binding occurs in a novel allosteric pocket and thus is not abrogated by buparlisib, an orthosteric site inhibitor. These results support clinical investigation of RLY-2608 as a differentiated mechanism of mutant PI3Kalpha inhibition with the first-in-human study anticipated to start in the first half of 2022.
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BBIO | Hot Stocks07:31 EST BridgeBio reports inducement grants under Nasdaq listing rule - BridgeBio Pharma announced that on December 6, 2021, the compensation committee of BridgeBio's board of directors granted nine new employees restricted stock units for an aggregate of 12,073 shares of the Company's common stock. All of the above-described awards were made under BridgeBio's 2019 Inducement Equity Plan. The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4), and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio's board of directors in November 2019.
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NMMC | Hot Stocks07:30 EST North Mountain Merger Corporation (Class A Stock) trading resumes
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NMMC | Hot Stocks07:29 EST North Mountain Merger Corporation (Class A Stock) trading halted, news pending
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AVCT | Hot Stocks07:21 EST Kandy, Braidio announce expanded partnership - American Virtual Cloud Technologies' Kandy Communications business unit, and Braidio announced an expanded partnership that will power next-generation user experiences for an 80,000-user telehealth application and for a pet wellness application by a premier veterinary hospital system in the US servicing 25,000+ customers. Braidio WorkStreams threads information, knowledge, people, customers and business tools into a single point of revenue capture and productivity, and in partnership with Kandy, creates more engaging, edge-driven customer engagement experiences for its clients.
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CTRE | Hot Stocks07:07 EST CareTrust REIT appoints David Sedgwick to succeed CEO Greg Stapley - The Board of Directors of CareTrust REIT announced the appointment of David Sedgwick as CEO, to be effective as of January 1, 2022. Sedgwick will succeed founding Chairman and CEO Greg Stapley, who will continue to serve as CareTrust's Executive Chairman during an approximately six-month transition period, following which he and his wife Deborah will commence a three-year, full-time volunteer assignment for The Church of Jesus Christ of Latter-day Saints. The Board also announced that Diana Laing has been appointed as Lead Independent Director. Sedgwick, who has been with CareTrust since 2014, currently serves as CareTrust's President and COO and will retain his title as the Company's President.
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MRNA | Hot Stocks07:07 EST Moderna provides interim data for mRNA-1010, program update - Moderna announced the first interim data from the Phase 1 study of the company's quadrivalent seasonal flu vaccine candidate, mRNA-1010. In the study, mRNA-1010 successfully boosted hemagglutination inhibition, or HAI, assay geometric mean titers against all strains 29 days after vaccination at all doses tested in both younger and older adults. The company also announced that the Phase 2 study of mRNA-1010 is now fully enrolled and preparation for the Phase 3 study is underway. Moderna also provided an update on its seasonal flu vaccine program including the announcement of two beyond quadrivalent seasonal flu development candidates. Quadrivalent mRNA-1010 encodes for the hemagglutinin, or HA, protein from four seasonal influenza viruses based on the recommendations of the World Health Organization, or WHO, including seasonal influenza A/H1N1, A/H3N2 and influenza B/Yamagata- and B/Victoria-lineages. In the Phase 1 study, mRNA-1010 was evaluated at 50 microgram, 100 microgram and 200 microgram dose levels in younger adult and older adult cohorts. No significant safety findings were observed through day 29. Adverse reactions, or ARs, were generally reported more frequently in younger adults compared to older adults, and at higher dose levels. The most common solicited local ARs for both age groups included pain and axillary swelling/tenderness. The most common solicited systemic ARs for both age groups included fatigue, arthralgia, myalgia and headache. At the lowest dose level in younger adults, Day 29 geometric mean titers against influenza A strains were 538 and 530; GMT against influenza B strains were 467 and 261. Geometric mean fold-rises above baseline for influenza A strains were approximately 10-fold and 8-fold, and approximately three-fold for B/Yamagata and 2-fold for B/Victoria. Minimal dose response was observed between the 50 microgram, 100 microgram and 200 microgram dose levels, suggesting the potential to explore even lower doses. At the lowest dose level in older adults, Day 29 GMT against influenza A strains were 310 and 263; GMT against influenza B strains were 305 and 215. GMFR for influenza A strains were approximately 6-fold and 6-fold, and approximately 3-fold for B/Yamagata and 2-fold for B/Victoria. Minimal dose response was observed between the 50 microgram, 100 microgram and 200 microgram dose levels. Moderna announced two beyond quadrivalent development candidates which the company believes offer the opportunity to expand strain coverage and enhance tools available to public health authorities when selecting antigens. mRNA-1011 will have one additional hemagglutinin antigen and mRNA-1012 will have two additional HA antigens. Separately, the company previously announced that it is also developing two next-generation flu candidates that incorporate neuraminidase antigens to broaden immunity beyond hemagglutinin. One pillar of Moderna's product strategy is to develop a pan-respiratory annual booster vaccine, which the company plans to continuously customize. The company believes that it could be first to market with a COVID + Flu + RSV booster vaccine. Moderna's RSV vaccine candidate demonstrated positive Phase 1 results and the company's Phase 2/3 study is ongoing. A pan-respiratory annual single booster vaccine to cover multiple viruses could create value for the healthcare system through compliance, convenience to the customer and reduction in vaccine administration cost.
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XRTX | Hot Stocks07:06 EST Xortx announces publication of study of hospitalized COVID-19 patients - XORTX Therapeutics announces the online publication of the peer reviewed paper entitled "Prevalence and Outcomes Associated with Hyperuricemia in Hospitalized Patients with COVID-19" in the American Journal of Nephrology. This paper highlights the results of the study that was conducted by the Icahn School of Medicine at Mount Sinai in partnership with XORTX and focused on the clinical outcomes of 834 patients with COVID-19 infection who were hospitalized at Mount Sinai Hospital in New York City. As is typical for COVID-19 infection, the patients were very sick with approximately 60% developing acute kidney injury, AKI, and with 31.7% dying in hospital. The study investigated the potential predictive role of serum uric acid on clinical outcomes. Serum uric acid was elevated in nearly 38 percent of subjects when first measured. Dr. Allen Davidoff, CEO of XORTX added, "The results of this study support the Company's provisional patent filings in March 2020 and 2021 that contain claims to the use of any uric acid lowering agents to prevent and treat acute kidney, acute organ injury or sepsis associated with COVID-19 infection. Resulting from this study is a more fulsome understanding that measurement of uric acid at the time of hospitalization, rapid uric acid lowering in patients who show evidence of acute kidney injury plus hyperuricemia may improve outcomes in hospitalized patients." This study authored by the Mount Sinai team contains several key findings that will help in understanding the acute injury occurring in hospitalized patients with accompanying COVID-19 infection, including: 1/ A large proportion of individuals hospitalized with COVID-19 arrive at hospital, or soon after admission, develop acute kidney injury and concerningly high serum uric acid concentrations. 2/ High serum uric acid is associated with increased biomarker indicators of kidney and heart injury and increased propensity toward sepsis. 3/ Hyperuricemia has historically been associated with increased systemic and local inflammation and in the setting of COVID-19 may play a potential role for inflammation in kidney, heart and other organs. 4/ Patients with hyperuricemia and COVID-19 have worse outcomes.
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CASI | Hot Stocks07:06 EST Casi Pharmaceuticals says China NMPA approves CTA for BI-1206 - CASI Pharmaceuticals announces that the China National Medical Products Administration has approved the company's Clinical Trial Application for BI-1206, a First-in-class fully human monoclonal antibody that targets FcgammaRIIB. CASI is planning Phase 1 trials of BI-1206 as a single agent to evaluate the PK/safety profile and in combination with rituximab in NHL to assess safety and tolerability, select the Recommended Phase 2 Dose and assess early signs of clinical efficacy as part of its development program for BI-1206 in China. The studies are expected to start in 1H 2022.
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NMMC | Hot Stocks07:05 EST Corcentric to go public via combination with North Mountain Merger - Corcentric and North Mountain Merger Corp. announced that they have entered into a definitive agreement to consummate a business combination that would result in Corcentric becoming a publicly listed company. Upon the closing of the Transaction, the combined entity will be named Corcentric. The company is expected to have an implied pro forma enterprise value of approximately $1.2B at closing. Following the closing of the Transaction, the Corcentric executive management team will continue to be led by Founder and Chief Executive Officer Douglas Clark and President and Chief Operating Officer Matthew Clark. Thomas Sabol will serve as Chief Financial Officer and Mark Joyce will serve as the Company's Executive Vice President and Chief Accounting Officer. The Transaction implies a pro forma enterprise value of the combined company of approximately $1.2B, representing an 8.1x multiple to 2022 expected adjusted revenue of $149M. The Transaction is expected to deliver approximately $182M in gross proceeds, comprising NMMC's approximately $132M of cash held in trust and $50M of fully committed PIPE financing from anchor investors, including Wellington Management and Millais Limited, an affiliate of the Sponsor. Under the terms of the Transaction, Corcentric's existing shareholders will convert their ownership stakes into equity of the combined company and are expected to own approximately 81% of the post-combination company immediately following the closing of the transaction. Bregal Sagemount, a prominent growth equity firm, will continue as a shareholder of Corcentric. In addition, existing Corcentric equity holders have the potential to receive an earnout of additional shares of common stock of the Company, if certain stock price targets are met as set forth in the definitive merger agreement. The Transaction has been unanimously approved by the Boards of Directors of both Corcentric and North Mountain. The Transaction, which is expected to close in the second quarter of 2022, will require the approval of the stockholders of both Corcentric and North Mountain and is subject to other customary closing conditions, including the receipt of requisite regulatory approvals.
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CLNN | Hot Stocks07:04 EST Clene RESCUE-ALS Phase 2 study of CNM-Au8 did not meet primary endpoint - Clene along with its subsidiaries "Clene" and its wholly owned subsidiary Clene Nanomedicine presented data from the RESCUE-ALS Phase 2 study of CNM-Au8, a catalytically active gold nanocrystal suspension, for the treatment of amyotrophic lateral sclerosis, ALS, in a late-breaking oral presentation at the 32nd International Symposium on ALS/MND, Dec. 10, 2021 at 1:05 pm ET. RESCUE-ALS, a 36-week randomized, placebo-controlled, Phase 2 clinical trial enrolled 45 patients with early ALS, demonstrated: Significant reduction in risk of disease progression in CNM-Au8 treated patients; Significant reduction in risk of major functional decline in CNM-Au8 treated patients; Significant improvement in quality of life as measured by ALS specific quality of life short form; Trend for a slower rate of decline in the summated motor unit index score observed in in limb-onset ALS patients suggesting preservation of lower motor neurons. The primary endpoint, percent change in MUNIX score from Baseline to week 36, was not met; Trend in preservation of respiratory function, which was more prominent in limb-onset patients; and CNM-Au8 was well tolerated and safe with no drug related serious adverse events or drug discontinuations. Rob Etherington, Clene's Chief Executive Officer, added, "The statistically significant RESCUE-ALS results in reducing the number of patients experiencing a 6-point decline in ALSFRS-R and the data suggesting improved survival are highly relevant to the fully-enrolled, Phase 2-3 Healey ALS Platform Trial. Our lead asset CNM-Au8 was one of the first therapies chosen for the HEALEY ALS Platform Trial, led by the Sean M Healey & AMG Center for ALS at Massachusetts General Hospital. The Healey-ALS Platform Trial has a primary endpoint of ALSFRS-R change, and involves significantly more subjects with more than six times the number of participants than were enrolled in RESCUE-ALS. We are grateful to our advisors, Professors Steve Vucic and Matthew Kiernan, their clinical teams, the FIGHTMND Association for substantially funding the trial, and especially to the ALS patients who participated and their families. We look forward to the topline results from the HEALEY ALS platform trial in the second half of 2022."
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GOLD | Hot Stocks07:04 EST Barrick Gold publishes Human Rights report - Barrick Gold Corporation published its report on Human Rights outlining the company's revised policies and standards and their implementation since the merger with Randgold Resources. The publication of the report coincides with the United Nations' Human Rights Day, which commemorates the day, in 1948, when the UN General Assembly adopted the Universal Declaration of Human Rights. The theme for this year is Equality. During 2020, Barrick updated several standards including the Use of Force Standard and developed a new Voluntary Principles on Security and Human Rights Standard. It also revised, updated and restarted its human rights program, in which every operation conducts a human rights assessment on a two- to three-year cycle. To date, all high- and medium-risk sites have been assessed, with Kibali in the Democratic Republic of Congo and Loulo-Gounkoto in Mali completed during 2021. Barrick trained its employees and contractors in these updated standards and policies and worked with independent human rights experts, Avanzar, to develop online modules to ensure that human rights training was not hampered by Covid-19 related travel and social distancing restrictions. Barrick also developed 'train the trainer' programs to empower its site security leadership with the knowledge and skills to deliver long-term training to their teams and local public security forces. These programs were successfully implemented at the North Mara and Bulyanhulu operations in Tanzania during 2021. In the report, president and chief executive Mark Bristow said that recognizing and respecting human rights was a core value for Barrick, and its Human Rights Policy was one of the first the group updated following the merger with Randgold Resources. It is codified in Barrick's standalone Human Rights Policy and informed by the expectations of the UN Guiding Principles on Business and Human Rights, the Voluntary Principles on Security and Human Rights and the OECD Guidelines for Multinational Enterprises. The report also provides an insight into Barrick's salient human rights issues such as non-discrimination in the workplace, health and safety, working conditions, resettlement, security, water and the rights of indigenous people; and reflects on Barrick's legacy human rights challenges as well as the actions the company has taken to remedy these.
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IBIBF | Hot Stocks07:03 EST IBI Group completes acquisition of Telenium - IBI Group announced that it has completed the purchase of the assets of Telenium, including all intellectual property and technology assets. Specializing in telecommunications that integrate telephone, computer, and web technologies, Manitoba-based Telenium is most known in Canada for its integrated 511 advanced traveller information solution. The Acquisition bolsters IBI's Travel-IQ product through access to new markets, and increases the firm's SaaS portfolio and recurring revenue profile. Established in 2001, Telenium's software offering includes its 511 advanced traveller information solution and road condition reporting system. Its private- and public-sector client portfolio includes the Canadian provinces of Saskatchewan, Manitoba, New Brunswick, Nova Scotia, Newfoundland and PEI, as well as The Weather Network. As part of the Acquisition, IBI welcomes Telenium's software development team to the firm. IBI's traveller information technology has been a significant contributor to the firm's Intelligence-sector portfolio for more than 10 years. It is currently operational across North America in Alaska; Arizona; Kern County, California; Southern California; Connecticut; Florida; Georgia; Louisiana; Massachusetts; New York; Suffolk, Virginia; Wisconsin; Yukon; Alberta; and Ontario. IBI's Travel-IQ technology is also being deployed in the UK and South Africa.
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ONCY | Hot Stocks07:01 EST Oncolytics presents 'positive' safety data from Phase 2 IRENE trial - Oncolytics Biotech announced a positive interim safety update from the investigator-sponsored, phase 2 IRENE trial in a poster presentation at the 2021 San Antonio Breast Cancer Symposium. The IRENE trial is designed to evaluate the safety and efficacy of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer. Safety data from the trial show that the combination has been well-tolerated, as no safety concerns have been noted in any of the five patients enrolled in the trial at the time of reporting. The trial remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.
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TEL | Hot Stocks06:57 EST TE Connectivity to increase quarterly dividend to 56c per share - TE Connectivity announced that its board of directors approved a recommendation to increase the company's quarterly dividend from 50c to 56c per share, for the four fiscal quarters starting in April 2022, the beginning of the third fiscal quarter. The recommendation would raise the company's dividend from the annual rate of $2.00 per share to $2.24 per share, and will be presented for shareholder approval at the company's annual general meeting of shareholders on March 9, 2022.
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LAZ | Hot Stocks06:46 EST Lazard reports preliminary AUM approximately $267.4B as of November 30 - The month's AUM included market depreciation of $5.8B, foreign exchange depreciation of $3.4B and net outflows of $3.1B.
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LLY | Hot Stocks06:34 EST Eli Lilly, Regor enter deal to discover therapies for metabolic disorders - Eli Lilly and Regor Therapeutics have entered into a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders. Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except for People's Republic of China, Macau, Hong Kong and Taiwan, where Regor will maintain these rights and responsibilities. The agreement will allow each company the opportunity to fully leverage both parties' existing compounds and technologies globally to maximize patient treatment choice. Regor will receive an upfront payment of up to $50M, which partially includes an equity investment by Lilly in Regor, subject to the parties entering into standard equity agreements. The company is also eligible to receive up to $1.5B in potential payments based on the achievement of prespecified preclinical, clinical development and commercial milestones, as well as tiered royalties from low-single to low-double digits on sales resulting from the agreement. This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles. There will be no change to Lilly's 2021 non-GAAP earnings per share guidance as a result of this transaction.
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FIGS | Hot Stocks06:33 EST Figs CFO Jeffrey Lawrence to retire, Daniella Turenshine to succeed - FIGS announced that Jeffrey Lawrence, its CFO, has decided to retire, effective December 24. Jeff joined FIGS in December 2020, coming out of retirement to help lead FIGS' highly successful initial public offering earlier this year. FIGS is excited to announce that Daniella Turenshine, its Senior Vice President of Finance and Strategy, has been appointed FIGS' CFO, effective December 24. Daniella joined FIGS in 2018 and led FIGS' finance team for over two years before Jeff joined the company, and she has continued to serve on FIGS' senior executive team and as a leader on the finance team. Prior to FIGS, she served as Vice President at Garnett Station Partners, a growth-oriented investment firm where she helped to build out a high-growth consumer products company.
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SWTX ABBV | Hot Stocks06:32 EST SpringsWorks Therapeutics announces trial collaboration with AbbVie - SpringWorks Therapeutics (SWTX) announced that the company has entered into a clinical trial collaboration agreement with AbbVie (ABBV) to evaluate nirogacestat, SpringWorks' investigational gamma secretase inhibitor, in combination with ABBV-383, AbbVie's investigational CD3 bispecific antibody directed against B-cell maturation agent, in patients with relapsed or refractory multiple myeloma. Under the terms of the agreement, AbbVie will sponsor and conduct the Phase 1b study to evaluate the safety, tolerability, and preliminary efficacy of the combination in patients with relapsed or refractory multiple myeloma, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. AbbVie and SpringWorks will also form a joint steering committee to manage the clinical study, which is expected to commence in the first half of 2022.
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LL | Hot Stocks06:08 EST Lumber Liquidators to complete name change to LL Flooring Holdings on Jan. 1 - Lumber Liquidators Holdings announced that it expects to complete its corporate entity name change to LL Flooring Holdings effective January 1, 2022, upon satisfying all applicable legal and regulatory requirements. The company's stock will continue to be listed on the NYSE under the ticker symbol "LL" and the CUSIP identifier for the stock will not change. No action is needed from current stockholders.
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PRPB GETY | Hot Stocks06:06 EST Getty Images to go public via merger with CC Neuberger Principal Holdings II - Getty Images (GETY) announced it has entered into a business combination agreement with CC Neuberger Principal Holdings II (PRPB). Upon closing of the transaction, a newly formed parent company of Getty Images will become a publicly traded company, and its common stock is expected to be listed on the New York Stock Exchange under the symbol "GETY." Craig Peters, who joined the company in 2007 and has served as CEO since 2019, will continue to lead the business post-transaction. The business combination values Getty Images at an enterprise value of $4.8B, representing a multiple of approximately 15.2x of enterprise value to 2022E Adj. EBITDA of $315M. The total equity investment of approximately $1.2B raised in this transaction will be used to pay down existing debt and conservatively capitalize the company's balance sheet for the future. In the event the cash in CC Neuberger's trust account is reduced by redemptions, an affiliate of CC Neuberger's sponsor will backstop redemptions for up to $300M. With the $300M backstop, as well as a $200M forward purchase agreement provided by an affiliate of the CC Neuberger sponsor and $150M in PIPE financing, this transaction has been structured to provide for a high degree of capital certainty. Additionally, existing common equity shareholders will roll 100% of their equity in the transaction and together with existing preferred shareholders are expected to own approximately 64% of the combined company at closing. In connection with the closing of the transaction, which is expected in the first half of 2022, CC Neuberger will merge into a subsidiary of Getty Images Holdings, Inc, a newly formed Delaware corporation that will continue as the publicly traded company and parent of Getty Images.
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IMOS | Hot Stocks06:03 EST ChipMOS reports November revenue $80.8M, up 9% - ChipMOS reported its unaudited consolidated revenue for the month of November. Revenue for the month of November was $80.8M, an increase of 9% compared to November 2020 and a decrease of 2.3% compared to October. Revenue increased 21% in the first eleven months of 2021 compared to the first eleven months of 2020. The company noted the slight decline sequentially in November revenue compared to October reflects one less working day in November.
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RDY | Hot Stocks05:24 EST Dr. Reddy's announces launch of Venlafaxine ER tablets in U.S. - Dr. Reddy's announced the launch of Venlafaxine ER Tablets which is therapeutically equivalent to Venlafaxine Extended-Release Tablets, 150 mg and 225 mg approved by the FDA.
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RHHBY | Hot Stocks05:18 EST Genentech announces new follow-up data for CITYSCAPE trial - Genentech, a member of Roche, announced new follow-up efficacy, safety and patient-reported outcomes, or PROs, data from the Phase II CITYSCAPE trial, investigating the novel anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq compared with Tecentriq alone as an initial treatment for people with PD-L1-positive metastatic non-small cell lung cancer, or NSCLC. The full results are being featured as an oral presentation in the Proffered Paper session 2 at the European Society for Medical Oncology, or ESMO, Immuno-Oncology Congress. After 2.5 years median follow-up, tiragolumab plus Tecentriq continued to show an improvement in the intention-to-treat, or ITT, population, driven by the PD-L1-high population. In the ITT population, the combination reduced the risk of disease worsening or death by 38% and improved overall response rates, or ORR, compared with Tecentriq alone. A predefined exploratory analysis in the PD-L1-high population showed a 71% reduction in the risk of disease worsening or death and a clinically meaningful improvement in ORR with the combination compared with Tecentriq alone. The analysis also showed that tiragolumab plus Tecentriq improved overall survival, or OS, a secondary endpoint of the study, in the ITT population, which was driven by the PD-L1-high population. After 2.5 years median follow-up, median OS was 23.2 vs. 14.5 months in the ITT population. The exploratory data in the PD-L1-high population showed a clinically meaningful OS improvement. The median was not reached for the tiragolumab regimen and is projected to be greater than 30.3 months based on the lower confidence interval vs.12.8 months. Data suggest that the combination was generally well-tolerated, showing similar rates of Grade 3-4 treatment-related adverse events, or AEs, when adding tiragolumab to Tecentriq compared with Tecentriq alone. The most common all cause AEs seen with the combination were infusion-related reactions, stiffness, dry skin, fatigue and rash. After longer follow-up, no new safety signals were observed with the combination. Patients generally reported minimal-to-moderate symptoms and generally maintained their quality of life compared with the start of treatment. PRO data from this exploratory analysis showed that lung symptoms, such as dyspnea and pain, did not appear to deteriorate with the addition of tiragolumab to Tecentriq.
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BGNE | Hot Stocks05:14 EST BeiGene reports RATIONALE 309 trial meets primary endpoint - BeiGene announced results from the RATIONALE 309 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer, or RM-NPC, at the European Society for Medical Oncology Immuno-Oncology, or ESMO I-O. As of March 26, with a median follow-up time of 10 months, RATIONALE 309 achieved the primary endpoint at the interim analysis, with the combination of tislelizumab and chemotherapy demonstrating a statistically significant improvement in PFS, compared to the combination of placebo and chemotherapy, per IRC assessment. The median PFS was 9.2 months in Arm A, compared to 7.4 months in Arm B, with a stratified hazard ratio, or HR, of 0.52. The PFS rate at six, nine, and 12 months was 66.1%, 51% and 35.7% in Arm A, compared to 53%, 21.6%, and 12.2% in Arm B, as assessed by IRC; The median PFS was 9.8 months in Arm A, compared to 7.6 months in Arm B, with a stratified HR of 0.54 as assessed by investigators; Consistent PFS benefit was observed in most subgroups, including disease status, baseline liver metastases, and gender. The ORR and complete response rate were 69.5% and 16.0% in Arm A, compared to 55.3% and 6.8% in Arm B, as assessed by IRC and The median DoR was 8.5 months, compared to 6.1 months as assessed by IRC. All patients in Arm A experienced at least one treatment-emergent adverse event of any grade, with the most common being anemia, decreased white blood cell count, decreased neutrophil count, nausea, decreased platelet count, decreased appetite, vomiting, constipation, leukopenia, neutropenia, rash, hypothyroidism, increased alanine aminotransferase, hyponatremia, increased blood creatinine, increased aspartate aminotransferase, malaise, and pyrexia; In comparison, 131 patients in Arm B experienced at least one TEAE of any grade, with the most common being anemia, nausea, decreased white blood cell count, decreased platelet count, decreased neutrophil count, vomiting, decreased appetite, constipation, leukopenia, neutropenia, hyponatremia, malaise, hypokalemia, rash, increased AST, and hypoalbuminemia; Grade 3 TEAEs were reported in 106 patients in Arm A, compared to 108 patients in Arm B; Serious TEAEs were reported in 36 patients in Arm A, compared to 44 patients in Arm B; TEAEs leading to permanent treatment discontinuation and death occurred in two patients and five patients, respectively, in Arm A, compared to 3 patients and 2 patients, respectively, in Arm B; and In Arm A, 24 patients experienced at least one immune-mediated TEAE of any grade, including 3 patients reporting Grade 3 events.
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KHC | Hot Stocks05:05 EST Kraft Heinz to acquire 85% stake in Just Spices, terms undisclosed - Kraft Heinz announced that it has reached an agreement to acquire an 85% stake in Germany-based Just Spices. The remaining 15% ownership stake will be retained by Just Spices' three founders, who will continue on with the company and focus on driving the business and its international growth. Launched in 2014, Just Spices is an start-up with annual sales of approximately EUR 60M. The deal is subject to customary closing conditions, including merger control approval, and is expected to be completed in the first quarter of 2022.
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