At Overweight
https://seekingalpha.com/news/4010331-atossa-stock-jumps-in-wake-of-cantor-overweight-rating
Friday, September 8, 2023
Kroger to pay up to $1.4 billion to resolve US opioid lawsuits
Kroger on Friday said it would pay as much as $1.4 billion to resolve thousands of lawsuits by U.S. states, local governments and Native American tribes claiming the supermarket chain's pharmacies helped fuel the nation's opioid epidemic.
Kroger agreed to pay up to $1.2 billion to U.S. states, counties and municipalities and $36 million to Native American tribes to resolve the majority of opioid cases it faced. It will also pay $177 million to cover attorneys' fees and expenses.
Kroger took a $1.4 billion charge related to the tentative settlement, which is dependent on participation by 33 eligible states and the District of Columbia. The $1.2 billion would be paid out over 11 years.
The Cincinnati, Ohio-based supermarket chain, which is merging with smaller rival Albertsons, will not admit wrongdoing as part of the deal, and said it will defend against any other claims the tentative settlement does not resolve.
Thousands of lawsuits have been filed by states, local governments and Native American tribes accusing drug companies of downplaying the risks of opioid painkillers, and distributors and pharmacies of ignoring red flags that they were being trafficked illegally.
The litigation has resulted in more than $51 billion in settlements, according to lawyers for the plaintiffs, with deals already struck with major drugmakers and the nation's largest distributors.
Kroger itself faced more than 2,000 such lawsuits. In May, it agreed to pay $62 million to West Virginia to resolve opioid cases stemming from that state, which was hit hard by the deadly drug addition epidemic.
Friday's settlement by Kroger followed a collective $13.8-billion in settlements reached last year with three larger pharmacy chain operators, CVS Health Corp, Walgreens Boots Alliance and Walmart.
In a statement on Friday, the lead lawyers representing cities and counties in the litigation -- Jayne Conroy, Paul Farrell and Joe Rice -- called Kroger's deal the first by one of the smaller, regional supermarket pharmacies that had played a role in the drug crisis.
"This $1.2 billion agreement-in-principle is another step forward in holding each company that played a role in the opioid epidemic accountable and ensuring hard-hit communities are provided with much-needed resources," the lawyers said.
https://finance.yahoo.com/news/1-kroger-pay-1-4-141204068.html
Newsom 'NOT Running In 2024', Dubs Kamala 'Natural Successor' To Biden
California Governor Gavin Newsom, long thought to be the Democrats' secret weapon against Donald Trump in 2024, announced on Friday that he's not running for president in 2024, and that Vice President Kamala Harris is the "natural successor" to Biden.
"We need to move past this notion that he's not going to run," Newsom told NBC News' Chuck Todd, adding "President Biden is going to run, and looking forward to getting him reelected. I think there's been so much wallowing in the last few months, and handwringing in this respect. But we're gearing up for the campaign. We're looking forward to it."
"'I think the vice president is naturally the one lined up' to run after Biden, he said, noting 'maybe I'm a little old-fashioned about, you know, presidents and vice presidents. I was a lieutenant governor, so I'm a little subjective," he continued.
Asked if he could imagine running against her, Newsom responded: "Of course not. By definition. Won't happen. But we've – I've said that 1,000 times. We privately continue to maintain a very good relationship, interpersonal. Just, 'How are you doing? Checking in.' It's been a challenging few years with Covid. And we've had the opportunity to sit down, have lunch together in the White House, spend time talking about important things."
Watch:
AbbVie’s Humira to Take Hit from Biosimilars, Next-Gen Therapies: Report
With the U.S. launch of the first Humira (adalimumab) biosimilars in July, the Crohn’s disease market is poised for a “transformative” shift as AbbVie loses its iron grip on the patient population, according to a new report released Thursday from data and analytics company GlobalData.
Over the next few years, GlobalData predicts another company will displace the pharma giant in the Crohn’s disease (CD) market, driven by advancements in biologics and oral small molecules.
Second-quarter 2023 sales already revealed hastily slipping revenues for Humira—a 25% drop compared to the same period last year, bringing in $4 billion. Erosion for the year is projected at 35%. AbbVie is leaning heavily on Skyrizi, its anti-IL-23 drug, and Rinvoq, its oral JAK inhibitor for patients after anti-Tumor Necrosis Factor (TNF) treatment failure, to bolster sales amidst the decline.
AbbVie has enjoyed its standing as market leader for Crohn’s with sales of $2.7 billion last year for the indication in the eight major markets, according to GlobalData. But that dominance is quickly eroding.
“The recent launch of adalimumab biosimilars not only will cause an overall reduction in the cost of treatment, but also provide the opportunity for another company to knock AbbVie from its standing as the market leader within CD,” Adeleke Badejo, senior analyst of immunology at GlobalData, said in a statement.
Humira’s competition had already been heating up with the approval of Janssen’s Stelara—an IL-23 and IL-12 blocker—with $2.1 billion in 2022 sales in the market. Takeda’s Entyvio binds to the α4β7 integrin to keep white blood cells from entering the gastrointestinal tract to reduce inflammation. It took $1.7 billion of Crohn’s sales in the major markets last year.
However, as GlobalData points out, Stelara and Entyvio are viewed and prescribed as second- or third-line therapies following failure with Humira or other anti-TNF biologics. All three therapies now face decline with the approval and commercialization of biosimilars, some already entering the market and others coming soon.
Badejo points out the strategy for most companies hoping to knock AbbVie off its pedestal appears to be targeting the market already exposed to biologic treatment for their disease, instead of attempting to create a next-generation replacement of Humira.
In clinical trials, 36% of patients on Humira achieved and maintained remission after 56 weeks, a 4% drop from the number that had achieved and maintained remission at 26 weeks, leaving a large percentage of the Crohn’s population who don’t find long-lasting relief of symptoms on the biologic.
“This strategy of developing therapies for the TNF-refractory patient group is a viable approach,” Badejo said, anticipating that competition within that population will heat up five to 10 years from now.
Janssens’ Tremfya, currently approved for psoriasis and psoriatic arthritis, is hoping to push into the Crohn’s space. A Phase II trial showed that 73% of adults with severe Crohn’s disease achieved clinical remission when treated with the drug at its highest dose. Approval and launch of the treatment for this indication is anticipated in the next two to three years.
Eli Lilly’s human monoclonal antibody Mirikizumab entered the Japanese market as the first IL-23p19 inhibitor for ulcerative colitis earlier this year. It’s currently in Phase III testing for Crohn’s.
“With a focus on biologic-exposed CD patients, novel therapies for TNF-refractory individuals are gaining prominence,” GlobalData concluded.
AstraZeneca Signs AI-Powered Drug Discovery Pact with Verge
AstraZeneca, through its rare disease division Alexion, has entered into a multi-target agreement with Verge Genomics to discover and develop drugs against novel targets in rare neurodegenerative and neuromuscular diseases, the companies announced Friday.
Under the agreement, Alexion will make a $42 million payment in upfront fees, as well as equity and near-term investments. Counting milestones, the four-year collaboration can yield up to $840 million for Verge, plus potential royalties down the line. Alongside the drug discovery pact, AstraZeneca will also take an equity position in Verge.
In return, Alexion will gain access to the California biotech’s proprietary full-stack CONVERGE platform, which applies machine learning to human tissue data in order to identify novel disease targets that have a high probability of yielding clinical success.
Friday’s partnership will apply the AI-driven approach to several yet-undisclosed rare neurodegenerative and neuromuscular conditions. Alexion will have the option to select “high-potential targets” for each of these indications, as well as license and advance successful targets through clinical development, according to the announcement.
Alexion will also take charge of commercialization of products that result from the collaboration.
“By leveraging Verge’s AI-enabled platform in combination with data from patient tissue samples, we see potential in helping researchers more efficiently identify and validate therapeutic targets for rare diseases,” Seng Cheng, Alexion’s head of research and product development, said in a statement.
Unlike the typical drug discovery process, which usually begins with animal or cell models, CONVERGE starts off with genomic data obtained directly from human tissue. This is bolstered by a human-centered biology platform, yielding new insights into candidates.
Verge validated this approach with Phase I data in June 2023 demonstrating that its investigational PIKfyve inhibitor VRG50635 had promising safety, tolerability and pharmacokinetic profiles in healthy volunteers. The company is planning to launch a proof-of-concept study of the candidate in amyotrophic lateral sclerosis in the fourth quarter.
VRG50635 was discovered using CONVERGE and has best-in-class potential.
Friday’s agreement is AstraZeneca’s second rare disease deal recently. In late July, the company paid $1 billion to fellow powerhouse Pfizer to acquire “a dozen” of the latter’s portfolio of preclinical gene therapies and technologies, Alexion CEO Marc Dunoyer said during AstraZeneca’s second-quarter earnings call.
The deal brings several novel AAV capsids into the AstraZeneca fold, along with some Pfizer employees.
The Verge partnership will also help AstraZeneca build a more robust neurology pipeline, which already includes the early-stage Alzheimer’s disease hopeful MEDI1814 and the mid-stage MEDI1341 for multiple system atrophy and Parkinson’s disease. Its rare disease pipeline is more robust in comparison, with the late-stage molecules acoramidis for transthyretin amyloidosis cardiomyopathy and danicopanfor paroxysmal nocturnal hemoglobinuria.
https://www.biospace.com/article/astrazeneca-signs-ai-powered-drug-discovery-pact-with-verge/
Plus Therapeutics Licenses Diagnostic Assay To Detect Central Nervous System Cancers
Plus Therapeutics Inc (NASDAQ: PSTV) has expanded its supply agreement with Biocept Inc (NASDAQ: BIOC) by acquiring an option to exclusively license Biocept's CNSide, a cerebrospinal fluid (CSF)-based tumor cell capture and enumeration platform, for patients receiving CNS radiotherapy.
Under the terms of the agreement, CNSide developer Biocept has granted Plus Therapeutics a non-exclusive license to its CNSide cell enumeration assay for Plus' investigational therapy for leptomeningeal metastases (LM), rhenium (186Re) obisbemeda and an option for an exclusive license to the assay.
In exchange, Plus Therapeutics will provide $150,000 in stock to Biocept.
Before January 1, 2024, Plus Therapeutics will have the option for exclusivity for the field of radiotherapy in exchange for a $1.0 million payment, to be exercised at Plus Therapeutics' discretion.
"Thus far, in our ReSPECT-LM trial, we have had a very positive experience with the CNSide assay and think it has significant potential," said Marc Hedrick, President & CEO of Plus Therapeutics.
CNSide is an assay based on a proprietary quantitative tumor cell capture method paired with digital imaging and molecular markers used to detect, characterize, and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer and melanoma which are leading causes of LM.
In March 2023, Biocept initiated enrollment in the FORESEE trial with CNSide to evaluate the performance of CNSide in monitoring LM's response to treatment and to assess the impact of CNSide on treatment decisions.
The feasibility phase of the study is expected to be completed in 1H of 2024, followed by a validation phase estimated to include between 40 and 100 subjects.
https://finance.yahoo.com/news/exclusive-cancer-firm-plus-therapeutics-123032762.html
Why Is Cancer Diagnostic Focused Biocept Stock Trading Higher
Biocept Inc (NASDAQ: BIOC) shares are trading higher after the company signed a non-exclusive licensing agreement for CNSide with Plus Therapeutics Inc (NASDAQ: PSTV), which expands the comprehensive laboratory services agreement between the two companies that was announced in June 2022.
Plus Therapeutics is using CNSide in a clinical trial with their targeted radiotherapeutic to treat patients with carcinomas and/or melanomas with suspected leptomeningeal metastases (LM), cancer in the membranes surrounding the brain and spinal cord.
CNSide is Biocept's proprietary cerebrospinal fluid (CSF)-based tumor cell capture and enumeration platform used in detecting, quantifying, and monitoring tumor status in LM.
Plus will pay Biocept an upfront fee of $150,000 in stock, plus $6,000 per CSF tumor cell enumeration analysis performed in Biocept's laboratory before the completion of the technology transfer.
Once the technology transfer is complete, Plus will pay Biocept $300,000 plus fees on a sliding scale starting at $2,800 for each CNSide test they perform.
The license agreement also gives Plus the option to negotiate for third-party exclusivity with a $1,000,000 payment to Biocept.
https://finance.yahoo.com/news/why-cancer-diagnostic-focused-biocept-151829323.html
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