price target reduced from USD 91 to USD 62.
https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/
Friday, May 3, 2024
Amgen Inc.: Barclays upgrades to equalweight from underweight
price target raised from USD 230 to USD 300.
FTC seeks more information on Novo Nordisk parent-Catalent deal
The U.S. FTC has sought more information on Novo Nordisk parent's $16.5 billion bid for contract drug manufacturer Catalent, weeks after an application to the regulator was refiled for approval of the deal.
Catalent said on Friday the companies were in the process of gathering information to respond to the U.S. Federal Trade Commission's request received on May 2.
Novo Holdings in February agreed to buy Catalent to boost output of the popular weight-loss drug Wegovy. To that end, it would sell three of Catalent's fill-finish sites to Novo Nordisk for $11 billion.
Access to the three Catalent sites would be a win for Novo Nordisk, which is gradually increasing production of Wegovy to meet explosive demand.
David Ricks, CEO of Novo's main rival in the obesity market - Eli Lilly, has said that Novo's proposal to buy the plants was "unusual" and raises potential antitrust concerns.
Lilly manufactures weight-loss drug Zepbound and related diabetes treatment Mounjaro.
Catalent and Novo Holdings, Wegovy producer's parent, continue to expect to close the deal by the end of 2024, but a refiled application for its approval in April have raised doubts that the transaction may not complete within the target period.
Novo did not disclose details about why the application was refiled.
Novo is the investment arm of Novo Nordisk's controlling shareholder, the Novo Nordisk Foundation.
https://finance.yahoo.com/news/us-ftc-seeks-more-information-125812911.html
Tandem Diabetes strong start to 2024, ups sales guidance
Revenue: Q1 worldwide sales grew 12% year-over-year to $193 million.
U.S. Sales: First quarter sales of $131 million with approximately 15,000 pump shipments.
International Sales: Grew over 60% to $62 million with nearly 10,000 pump shipments.
Gross Margin: Reported at 50%, consistent with the prior year.
Adjusted EBITDA Margin: Improved nearly 5 percentage points year-over-year to negative 7%.
Operating Expenses: Increased by 5% on 12% sales growth.
2024 Sales Guidance: Increased to approximately $868 million, or 12% growth year-over-year.
Profitability Guidance: Maintaining full year guidance of 51% for gross margin and breakeven for adjusted EBITDA.
Q2 Sales Forecast: Worldwide sales anticipated to be $205 million.
Q2 Gross Margin: Expected to be approximately 50%.
Q2 Adjusted EBITDA: Expected to improve to negative 5%.
FDA’s Accelerated Approval of Sarepta DMD Gene Therapy Comes Under Fire
The FDA’s authorization of therapies that fail their efficacy endpoints casts doubt on the regulator’s accelerated approval pathway, according to an article from David Rind, chief medical officer of the drug pricing non-profit Institute for Clinical and Economic Review, published Wednesday in the Journal of the American Medical Association.
In his viewpoint piece, Rind specifically called out Sarepta Therapeutics’ gene therapy Elevidys (delandistrogene moxeparvovec-rokl), which won the FDA’s accelerated approval in June 2023—despite falling short of its primary efficacy endpoint in two studies.
To support its decision to grant Elevidys accelerated approval in Duchenne muscular dystrophy (DMD), the FDA pointed to expression levels of the protein micro-dystrophin, which the regulator said was “reasonably likely to predict clinical benefit in individuals 4 to 5 years of age,” for whom Elevidys is indicated.
In DMD, a rare neuromuscular disorder, mutations to the dystrophin gene lead to a dysfunctional protein, which manifests as developmental delays and muscle weakness. Elevidys works by delivering a functional copy of the dystrophin genes to the patients’ muscles.
“In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children, and the urgent unmet medical need,” the regulator noted in its announcement at the time.
Still, the accelerated approval came as a surprise to many, given that Elevidys had failed the primary outcome in a Phase I study, unable to significantly improve patients’ functional performance versus placebo.
Among those that raised concerns about this Phase I miss were the regulator’s own reviewers, who in briefing documents published ahead of an advisory committee meeting said that micro-dystrophin levels “only provides information about expression of the transgene product in cells transduced by SRP-9001, rather than insight into a pharmacologic effect on a biomarker in the pathway of the disease.”
Sarepta narrowly cleared the same advisory committee vote, earning support from eight out of 14 panelists.
To keep Elevidys on the market, Sarepta ran the confirmatory Phase III EMBARK study looking at the clinical benefit of its gene therapy. In October 2023, the biotech announced that EMBARK had failed its primary endpoint, unable to significantly improve functional mobility versus placebo, but Sarepta nevertheless called the findings “robust evidence” of clinically meaningful benefit.
The FDA accepted Sarepta’s supplemental Biologics License Application earlier this year, with a verdict due on June 21, 2024.
Rind in his viewpoint article on Wednesday also blasted the price tag of Elevidys, which Sarepta has set at $3.1 million per dose, making it one of the world’s most expensive therapies.
“This is an enormous price tag for a therapy that has failed to meet its primary end point in the 2 randomized trials in which it has been studied and that is clearly not curative," Rind wrote.
AstraZeneca Targets First-Line Mantle Cell Lymphoma Therapy with Phase III Data
AstraZeneca on Thursday revealed high-level results from the Phase III ECHO trial, demonstrating that BTK inhibitor Calquence (acalabrutinib)—when used with standard chemotherapy agents bendamustine and rituximab—yielded significant survival benefits as a first-line therapy in mantle cell lymphoma.
The pharma did not provide specific data in its announcement but said that the Calquence-based regimen resulted in a “statistically significant and clinically meaningful improvement” in progression-free survival, compared with standard of care. ECHO, a randomized, double-blinded and placebo-controlled trial, enrolled nearly 600 patients with previously untreated mantle cell lymphoma (MCL).
Data for overall survival (OS) was not yet mature at the time of the interim analysis, but AstraZeneca noted in its announcement that “a trend was observed in favor of Calquence plus chemoimmunotherapy.” ECHO will continue as planned to assess OS.
In terms of safety, ECHO found no new signals of concern. Calquence’s adverse event profile in the study was consistent with what has been established in prior trials.
Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in a statement called the results “impactful” and said that “bringing Calquence to the first-line setting significantly delays disease progress and, for the first time, shows potential to extend survival.”
AstraZeneca will present full data and analyses from ECHO at an upcoming medical congress and will share these with regulatory authorities.
Designed to be orally available, Calquence is a small-molecule BTK inhibitor that works by covalently bonding to the active site of the BTK protein, which deactivates its enzymatic activity. BTK is a signaling molecule involved in the pathways for B-cell proliferation and trafficking, and its inhibition could prevent the division and survival of malignant B-cells.
The FDA first approved Calquence in 2017 for previously treated MCL and the drug has since become one of AstraZeneca’s top-performing assets. In the first quarter of 2024, Calquence brought in $718 million for the pharma, up 6% from its sales during the same period in 2023.
AstraZeneca is also assessing Calquence as a monotherapy for several B-cell blood cancers, including chronic lymphocytic leukemia and diffuse large B-cell lymphoma. In addition, the pharma is studying various Calquence-based combination regimens.
Thursday’s late-stage readout comes a year after AbbVie and J&J voluntarily pulled the accelerated MCL approval for their BTK blocker Imbruvica (ibrutinib). While data from Phase III confirmatory trials showed that Imbruvica can significantly improve PFS versus placebo, the treatment yielded no significant benefit in terms of OS and complete response.
Arizona Senate Approves Repeal of Near-Total Abortion Ban
by Samantha Flom via The Epoch Times (emphasis ours),
Arizona’s near-total abortion ban will be repealed just weeks after the state’s Supreme Court ruled it enforceable.
The Arizona House narrowly passed the repeal on April 24 as three Republicans joined with Democrats to approve the measure.
On May 1, the state Senate followed suit in a 16–14 vote—but not before several disappointed senators had the opportunity to air their grievances.
“What we’re actually voting on is death,” state Sen. Anthony Kern said, chiding the members of his Republican party who voted with Democrats in support of the repeal.
“The Democrat Party stands and runs on death. The Republican Party stands and is supposed to run on life.”
State Sen. Sonny Borrelli, meanwhile, objected to the fact that the bill was never sent to a committee, nor was any time allotted for debate or amendments. And during one particularly emotional moment, state Sen. Justine Wadsack recounted her own tragic loss of a child by miscarriage.
“God chose when that heartbeat was going to stop,” Ms. Wadsack said, tears streaming down her face. “It is not my place as a senator to determine when a child’s heart stops beating.”
The abortion ban prohibits all abortions in Arizona except those performed to save the mother’s life. It was initially enacted in 1864, before Arizona was a state, though it was later recodified by the Legislature in the late 1970s.
Arizona Gov. Katie Hobbs, a Democrat, has promised to sign the repeal once it reaches her desk, though it will not be effective until 90 days after the Legislature adjourns. At that point, a 2022 law limiting abortions to 15 weeks of pregnancy will become the state’s prevailing law.
In the meantime, however, the abortion ban is slated to take effect on June 27.
Proponents of the repeal, pointing to the ban’s pre-statehood origins, had argued that it was outdated and inconsistent with the state’s more recent laws.
“I don’t want us honoring laws about women, written during a time when women were forbidden from voting because their voices were considered inferior to men,” state Sen. Eva Burch said May 1.
For decades, the law was blocked by a permanent injunction. But a two-year court battle, prompted by the reversal of Roe v. Wade, culminated in the Arizona Supreme Court’s bombshell ruling on April 9.
Although the court initially stayed the law’s enforcement for two weeks, an agreement in a related case pushed back its effective date.
The Arizona vote came on the same day that a six-week abortion limit in Florida took effect.
That law includes limited exceptions for situations involving rape, incest, human trafficking, or a serious threat to the mother’s physical health. But as with the Arizona ban, the law has been the subject of much controversy.
As the Florida law took effect, abortion advocates took to social media to decry what they perceived to be the erosion of women’s rights in the Sunshine State.
“Today, Florida is putting the health of millions of women at risk,” New York Gov. Kathy Hochul posted on social media. “It’s clear: Anti-choice extremists will stop at nothing to deny women their right to make their own health care decisions.”
Nikki Fried, chair of the Florida Democratic Party, likewise charged that the law had rolled back women’s rights “by 50 years,” and President Joe Biden called the situation a “nightmare.”
Florida and Arizona are expected to play a key role in deciding the next president, and abortion will be on the ballot in both states come November.
While President Biden has aligned himself with abortion advocates, former President Donald Trump, the presumptive Republican nominee, has shied away from what he’s deemed to be a losing issue for the GOP.
The former president, who claims to be pro-life, has said he believes abortion to be a states’ rights issue, as opposed to a federal issue. In taking that stance, he denounced both the Arizona and Florida laws as too restrictive.
“It’s the will of the people—this is what I’ve been saying. It’s a perfect system,” he said on April 10.
“For 52 years, people have wanted to end Roe v. Wade, to get it back to the states. We did that—it was an incredible thing, an incredible achievement. We did that, and now the states have it, and the states are putting out what they want. It’s the will of the people.”
https://www.zerohedge.com/political/arizona-senate-approves-repeal-near-total-abortion-ban
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