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Stockwinners Market Radar for April 07, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
| PEAR | Hot Stocks13:10 EDT Pear Therapeutics files Chapter 11, intends to pursue sale - Pear Therapeutics announced that the company filed for protection under chapter 11 of the U.S. Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware and intends to pursue a sale of the business or assets under section 363 of the Bankruptcy Code. "Prior to the filing of the Chapter 11 cases, the Debtors evaluated a wide range of strategic alternatives to maximize value for all stakeholders. The Debtors also significantly reduced operating expenses. With the protections afforded by the Bankruptcy Code, the Debtors intend to continue their marketing efforts to potential purchasers interested in specific assets as well as continuing to seek a sale of the whole business. Any of those sales would be subject to review and approval by the Bankruptcy Court and compliance with bidding procedures to be approved by the Bankruptcy Court," the company said in a statement. Pear intends to continue scaled-down operations during the Chapter 11 as it seeks to "execute an expedited sale process." Having reached a settlement prior to the filing with its lender, Pear intends to use available cash to fund post-petition operations and costs in the ordinary course of its business.
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| ABT | Hot Stocks11:22 EDT Abbott says no FreeStyle Libre readers being physically recalled - After the FDA yesterday posted a notice regarding FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems' reader devices, Abbott issued the following statement to The Fly: "No readers are being physically recalled and customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers. The steps outlined at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter. Similar to mobile phones and many other handheld electronic devices, most continuous glucose monitoring system readers or receivers use rechargeable lithium-ion batteries. While rechargeable lithium-ion batteries are generally safe when used properly, they may present a fire hazard if they are damaged or used improperly. We've been communicating with people who use our FreeStyle Libre family of readers since February to ensure they know how to safely store, charge and use our readers and have set up a website www.FreeStyleBattery.com where they can learn more. This notice does not impact people who do not own a reader or only use FreeStyle Libre portfolio sensors with our mobile apps." The FDA recall notice, dated April 6, which states that the FDA has identified this as a Class I recall, "the most serious type of recall," can be found [here.]:[https://www.fda.gov/medical-devices/medical-device-recalls/abbott-recalls-readers-used-freestyle-libre-freestyle-libre-14-day-and-freestyle-libre-2-flash]
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| OCX | Hot Stocks08:28 EDT OncoCyte announces peer-reviewed publication of DetermaIO study - Oncocyte announces the peer-reviewed publication of the results of a study applying DetermaIO to samples collected from the randomized Phase II AtezoTRIBE clinical trial in metastatic colorectal cancer. The results were published in Clinical Cancer Research and "showed the utility of DetermaIO in potentially identifying more responders to ICI therapy than current standard of care biomarkers," the company said in a statement. In the overall population of 122, DetermaIO positive patients achieved better outcomes in terms of progression-free survival from the addition of atezolizumab among mCRC patients than DetermaIO negative patients, regardless of MMR status, according to OncoCyte. A similar trend was observed in the pMMR population that does not currently qualify for ICI therapy in mCRC, it added.
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| KERN POSAF | Hot Stocks07:34 EDT Akerna announces superior offer for software business - Akerna (KERN) announces that it has received an unsolicited acquisition proposal that its board has determined is a superior offer, from an undisclosed company, for Akerna's software business. The board approved the termination of the agreement for the sale of its software business to POSaBIT (POSAF). Akerna's board believes the "confidential, unsolicited acquisition proposal will provide enhanced value to shareholders." Gryphon Digital Mining supports Akerna pursuing the new acquisition proposal "as a superior offer that will ultimately benefit the stockholders of the combined company and, once the new transaction is finalized, the transaction with Gryphon will be amended to reflect the new party's acquisition of Akerna's software business," the company said in a statement. The termination fee due to POSaBIT under the terms of the agreement "will be borne by the undisclosed party," it added. Further details regarding the unsolicited acquisition proposal will be disclosed as the negotiation process advances and all necessary regulatory approvals are obtained.
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| MRK ESALY | Hot Stocks07:05 EDT Merck, Eisai colorectal cancer study did not meet statistical significance - Merck (MRK) and Eisai (ESALY) provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating Keytruda plus Lenvima. The Phase 3 LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of overall survival for the treatment of patients with unresectable and metastatic colorectal cancer that is mismatch repair proficient or not microsatellite instability-high who experienced disease progression on, or became intolerant to, prior therapy. In the final pre-specified analysis of overall survival, a trend toward improvement was observed with Keytruda plus Lenvima versus regorafenib or TAS-102. However, the results did not meet statistical significance per the pre-specified statistical analysis plan. A trend toward improvement was also observed in key secondary endpoints of progression-free survival, objective response rate and duration of response with Keytruda plus Lenvima versus regorafenib or TAS-102; however, per the pre-specified statistical analysis plan the results were not tested for statistical significance, the companies said in a statement.
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| MRK ESALY | Hot Stocks07:01 EDT Merck, Eisai discontinuing Phase 3 melanoma combination study - Merck (MRK) and Eisai (ESALY) provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating Keytruda plus Lenvima. Merck and Eisai are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for the first-line treatment of adults with unresectable or metastatic melanoma. The decision is based on the recommendation of an independent Data Monitoring Committee, which reviewed data from a planned interim analysis and determined Keytruda plus Lenvima did not demonstrate an improvement in overall survival, one of the study's dual primary endpoints, versus Keytruda alone.
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