Stockwinners Market Radar for July 28, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
AAPL... | Hot Stocks20:06 EDT Fly Intel: Top five weekend stock stories - Catch up on the weekend's top five stories with this list compiled by The Fly: 1. Apple's (AAPL) upcoming artificial intelligence features will arrive later than anticipated, missing the initial launch of its upcoming iPhone and iPad software overhauls but giving the company more time to fix bugs, Bloomberg's Mark Gurman reports. The company is planning to begin rolling out Apple Intelligence to customers as part of software updates coming by October, according to people with knowledge of the matter. That means the AI features will arrive a few weeks after the initial iOS 18 and iPadOS 18 releases planned for September, said the people. 2. A jury ordered Abbott Laboratories (ABT) to pay $495M in compensation and damages after determining that the company failed to warn that its formula for premature infants increased the risk for a bowel disease, The Wall Street Journal's Victor Stefanescu reports. "We strongly disagree with the verdict," an Abbott spokesman said. "We will pursue all avenues to have the erroneous decision overturned." The verdict included $400M in punitive damages. 3. Alphabet (GOOGL) stock dropped after what looked like a strong earnings report -and it may have created a buying opportunity, Jacob Sonenshine writes in this week's edition of Barron's. There wasn't much wrong with the numbers from Alphabet, home to Google and YouTube. Expectations were likely high heading into earnings, given the stock's 30% gain this year heading into the print, but there were other worries too, the author says. First and foremost was the amount of money Alphabet is spending on artificial intelligence, particularly after capital expenditures rose 91% in the second quarter and are likely to keep on rising at a fast rate. The drop, though, seems too extreme, Sonenshine adds. 4. Disney (DIS) and Marvel's "Deadpool & Wolverine" opened to an impressive $205M at the domestic box office, making it the 8th biggest debut recorded and by far the most for an R-rated movie. Overseas, "Deadpool and Wolverine" opened to $233.3M for a worldwide total of $438.3M. The threequel has a 97% audience score on Rotten Tomatoes, the second-best score ever for a Marvel title behind Sony (SONY) and Marvel's "Spider-Man: No Way Home." 5. Albany International (AIN), Barnes Group (B), AMN Healthcare (AMN), Owens & Minor (OMI), Topgolf Callaway Brands (MODG), Boot Barn (BOOT), and Cohu (COHU) saw positive mentions in this week's edition of Barron's.
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NOG VTLE | Hot Stocks18:06 EDT Vital Energy to expand Delaware Basin position through bolt-on acquisition - Vital Energy (VTLE) announced the signing of a definitive joint purchase and sale agreement to acquire the assets of Point Energy Partners, a Vortus Investments portfolio company. The transaction will significantly increase the company's operational scale and footprint in the Delaware Basin and add high-value development inventory. The agreement was signed in partnership with Northern Oil and Gas (NOG). Under the terms of the agreement, the two companies will acquire Point Energy's assets in an all-cash transaction for total consideration of $1.1B. Vital Energy agreed to acquire 80% of Point's assets, with NOG acquiring the remaining 20%. The transaction is expected to close by the end of the third quarter of 2024 with an effective date of April 1, 2024, subject to customary closing conditions. Closing price adjustments are expected to total approximately $75M, reducing total consideration to approximately $1.025B. Vital Energy expects to fund its $820M portion, net of expected purchase price adjustments, through the use of its credit facility, which was recently expanded to $1.5B.
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VTLE NOG | Hot Stocks18:02 EDT NOG announces second joint acquisition with Vital Energy in the Delaware Basin - Northern Oil and Gas (NOG) announced that it has entered into a definitive agreement to acquire a 20% undivided stake in the Point Assets in the Delaware Basin, in partnership with Vital Energy (VTLE), for a purchase price net to NOG of $220.0M in cash, subject to typical closing adjustments. The acquired Assets are primarily located in Ward County, Texas and include approximately 4,000 net leasehold and mineral acres, 26.4 net producing wells, 1.6 net wells-in-process and about 12.1 low-breakeven net undeveloped locations. Upon closing, the operator of the assets will be Vital, with NOG participating in development pursuant to cooperation and joint operating agreements entered into with Vital in connection with the acquisition. Recent production on the Acquired Assets was greater than4,500 Boe per day. For the fourth quarter of 2024, NOG expects average production of greater than3,250 Boe per day and approximately $11.3M of capital expenditures. The effective date for the transaction is April 1, 2024, and NOG expects to close the transaction in the late third quarter of 2024.
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AVXL | Hot Stocks17:16 EDT Anavex presents results from Phase IIb/III trial of Blarcamesine - Anavex Life Sciences presented comprehensive results from the Phase IIb/III study showing that blarcamesine, once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease. The data were presented at the 2024 Alzheimer's Association International Conference. Blarcamesine significantly slowed clinical progression by 38.5% and 34.6% at 48 weeks in 50 mg and 30 mg groups vs. placebo, respectively, on the prespecified primary cognitive endpoint ADAS-Cog13. As specified in the March 2024 FDA Guidance for Early AD, a sole cognitive measure can serve as the primary endpoint for early Alzheimer's trials.1 The protocol was designed with ADAS-Cog13 and ADCS-ADL as co-primary endpoints. The functional co-primary endpoint, ADCS-ADL, was trending positive but did not reach significance at Week 48. A possible explanation is that the ADCS-ADL scale is designed for AD with overt dementia and is less sensitive for early AD.2 The prespecified key secondary composite endpoint CDR-SB, also recommended as an alternative primary endpoint for early AD in the new FDA guidance, is significant at both 30 mg and 50 mg at Week 48. The findings are supported by biomarkers from the A/T/N spectrum, including plasma Abeta42/40-ratio and reduction of brain atrophy. Blarcamesine significantly slowed brain atrophy in key regions of interest, including the whole brain by 37.6%, total grey matter by 63.5%, and lateral ventricles by 25.1%. Blarcamesine, a small molecule administered orally once daily, demonstrated numerically superior clinical efficacy to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine's safety profile indicates not requiring routine MRI monitoring, and given its differentiated mechanism of action, could represent a novel treatment that could be complementary to the currently approved anti-beta amyloid monoclonal antibody drugs. For the primary endpoint ADAS-Cog13, blarcamesine is significantly better than placebo for both 50 mg at 48 weeks and for 30 mg blarcamesine dosage groups at 48 weeks. The key secondary endpoint CDR-SB was significantly improved vs. placebo in both 50 mg and 30 mg assigned dose groups. CGI-I was significantly improved in both 50 mg and 30 mg groups.
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LGVN | Hot Stocks17:13 EDT Longeveron presents study results from CLEAR MIND Phase 2a trial - Longeveron announced that its positive Phase 2a clinical trial data and biomarker results were featured in two presentations, including a Featured Research Session oral presentation, at the Alzheimer's Association International Conference, taking place July 28 - August 1, 2024, in Philadelphia and online. The randomized, placebo-controlled Phase 2a CLEAR MIND trial evaluated a total of 48 patients who were 60-85 years old and had a diagnosis of mild Alzheimer's Disease in accordance with National Institutes of Health - Alzheimer's Association criteria, a Mini-Mental State Examination score of 18-24, and a brain MRI and positron emission tomography scan consistent with Alzheimer's Disease. The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results presented at AAIC 2024 support the therapeutic potential of Lomecel-B. Key findings include: The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities. Patients treated with Lomecel-B showed an overall slowing of disease worsening compared to placebo. Positive efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer's Disease Score - a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains. Administration of Lomecel-B was associated with slowing cognitive and functional decline as demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical trending improvements compared to placebo in CDR-SB and MMSE. There was a statistically significant improvement relative to placebo observed in the Alzheimer's Disease Cooperative Study Activities of Daily Living. Lomecel-B minimized the loss in brain volume in areas associated with Alzheimer's Disease, statistically significant for left hippocampal volume relative to placebo. Along with positive changes in brain volumes, there was 20%-30% reduction in left and right ventricular enlargement, respectively. Diffusion tensor imaging MRI supports the concept that Lomecel-B has the potential to reduce neuroinflammation compared to placebo. Lomecel-B treated patients demonstrated a numerical improvement relative to placebo in quality of life observed by caregivers and measured by the Alzheimer's Disease Related Quality of Life and Quality of life AD scales. The FDA has granted Lomecel-B both Regenerative Medicine Advanced Therapy designation and Fast Track designation for the treatment of mild Alzheimer's Disease, which allow greater access to the FDA during Lomecel-BTM's development for Alzheimer's Disease.
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ALEC | Hot Stocks08:07 EDT Alector presents baseline characteristics for INVOKE-2 Phase 2 trial of AL002 - Alector announced the presentation of a poster on baseline characteristics for the global INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer's disease at the Alzheimer's Association International Conference 2024. The conference is being held online and in Philadelphia, Pennsylvania from July 28 - August 1, 2024. INVOKE-2 is the first global Phase 2 trial exploring a novel TREM2 agonist, AL002, in early AD. AL002 is an investigational humanized monoclonal antibody that binds to triggering receptor expressed on myeloid cells 2, and it is the most advanced TREM2 agonist product candidate in clinical trials. The candidate is being developed in collaboration with AbbVie. Baseline characteristics are important in Phase 2 trials because they ensure the reliability and interpretability of trial results, help manage patient safety, and facilitate appropriate statistical analyses. A total of 381 participants were randomized in INVOKE-2. Treatment-emergent brain MRI changes resembling amyloid-related imaging abnormalities have been observed in the trial. These changes were of greater incidence and severity in homozygous APOE e4 carriers, and the company chose to discontinue homozygous APOE e4 carriers early in the trial. Of the 381 enrolled participants, 59% were heterozygous APOE e4 carriers. Amyloid positivity was confirmed in all participants prior to enrollment by analysis of cerebrospinal fluid or amyloid PET. For those participants with amyloid PET assessed at baseline, the mean standard deviation in centiloids was 100.1. Results of the INVOKE-2 trial are expected in the fourth quarter of 2024, and the long-term extension study is ongoing for those who completed the planned treatment period.
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ABOS | Hot Stocks08:05 EDT Acumen presents patient experience, biomarker Data from Phase 1 INTERCEPT-AD - Acumen Pharmaceuticals, a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers for the treatment of Alzheimer's disease, announced new findings from its Phase 1 INTERCEPT-AD study of sabirnetug. The research highlights the experiences of patients in the clinical trial to inform development of future trials, biomarker data to support sabirnetug's mechanism of action, and an ultra-sensitive method of measuring small amounts of sabirnetug in cerebrospinal fluid. The posters will be presented at the Alzheimer's Association International Conference 2024 taking place in Philadelphia and online from July 28-Aug. 1, 2024. The study revealed that three administrations of sabirnetug significantly lowered CSF levels of both pre- and post-synaptic proteins, consistent with its proposed mechanism of action to inhibit synaptic binding of AbetaOs. VAMP2, a biomarker associated with synaptic injury, was significantly lowered in all multiple ascending dose cohorts and appeared to be the biomarker most sensitive to sabirnetug in this study. Acumen is planning to evaluate longer-term changes in biomarkers and their relationship to clinical outcomes in the ongoing 18-month Phase 2 clinical trial ALTITUDE-AD to further support sabirnetug's mechanism of action. Acumen developed an ultra-sensitive assay to detect total levels of sabirnetug, both bound and unbound, in CSF. The assay demonstrated sensitivity, accuracy and precision, selectivity, specificity, dilutional linearity, and stability of the method. This development will aid in the accurate quantification of total drug exposure of sabirnetug in clinical trials since only a small fraction of peripherally-administered monoclonal antibodies typically move from blood to the brain. The Phase 2 clinical trial ALTITUDE-AD is designed to evaluate the clinical efficacy and safety of sabirnetug in patients with early AD. The global study is currently enrolling at multiple investigative sites located in the United States and Canada with plans for additional sites in Europe and the U.K.
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