Collaboration builds on Alloy’s existing and highly productive engagement with Pfizer and will apply Alloy’s innovation expertise to address Pfizer’s specific antibody discovery objectives
Alloy Therapeutics Inc. ("Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies, announced today its latest strategic collaboration with Pfizer Inc., to develop a new platform that could enhance Pfizer’s ability to discover potent, specific, and effective antibodies against targets that are difficult to address with existing antibody discovery technologies. Under the terms of the collaboration, Alloy will receive an upfront payment from Pfizer and will be eligible for pre-specified preclinical to commercial milestones on products originating from the newly developed platform.
"Pfizer has leveraged our industry-leading ATX-GxTM platform for several years, and we collaborated closely with them to develop the common light chain ATX-CLC strains. This collaboration exemplifies how pharma can leverage Alloy’s technology and expertise broadly in antibody discovery and technological innovation by participating in the creation of pre-competitive tools," said Heather Schwoebel, Chief Business Officer, Antibodies and Head of Strategic Collaborations at Alloy. "We will now apply this expertise to jointly create a new platform that enhances Pfizer’s ability to develop antibodies against challenging high-value targets. We are proud to expand our collaboration with Pfizer in the fight against disease."
Alloy’s ATX-Gx platform has rapidly become the industry standard for fully humanized transgenic mice, being used by over 170 partners and in turn enabling many therapeutic discovery programs. Alloy is dedicated to reinvesting its revenue into innovation and has continuously expanded its murine platforms, adding new strains such as ATX-GLTM with the full human lambda repertoire, as well as ATX-GKHTM hyperimmune strain for increased generation of antigen-specific B-cells and enhanced IgG class switching.
CVS Health investors will closely examine this week turnaround initiatives spearheaded by new CEO David Joyner and their impact on cost pressures in its health insurance business.
The healthcare conglomerate, which reports its fourth-quarter results on Wednesday, has missed earnings targets for the last three quarters and withdrawn its annual forecast, causing its shares to slump more than 40% in 2024.
"Unfortunately for CVS, we believe that every line of business has become incrementally more challenging," said Deutsche Bank analyst George Hill.
CVS owns a pharmacy benefit manager, a large insurance unit, and one of the largest U.S. retail pharmacy chains.
The challenges with higher costs will probably continue, and accelerate, said Leerink Partners analyst Michael Cherny.
CVS, like its peers, has faced elevated costs across its Medicare plans for people who are aged 65 and older, but the hit was more pronounced as the company enrolled the highest number of new members under the plans.
It reported a medical loss ratio - a percentage of premiums spent on medical care - at a record high of 95.2% in October, as Medicaid eligibility redetermination by states after the end of a pandemic-era policy added to insurers' costs.
But investors are now hoping for a change.
CVS, which underwent a top management reshuffle since Joyner's appointment in October, laid out major plans for cost cutting in November.
MANAGEMENT CREDIBILITY
Investors are keenly awaiting 2025 forecast and looking out for comments on healthcare demand trends, Medicaid rate adjustments as well as annual enrollment and pharmacy business performance.
In the past few years, CVS cut its annual forecasts a few times after issuing over-optimistic targets, which damaged its management's credibility and hurt its stock, said James Harlow, senior vice president at Novare Capital Management.
Analysts on average expect a 2025 profit of $5.96 per share, according to data compiled by LSEG.
Peers UnitedHealth and Elevance have warned of elevated costs to persist in 2025.
"I don't think the bar is that high, but people just want to see that it's not worse than what they had initially expected," said Jefferies analyst Brian Tanquilut.
Several bombshell claims were made on Tucker Carlson's show while he interviewed Lt. Col. Daniel Davis, a retired United States Army officer who was awarded a Bronze Star for valor in Afghanistan.
Carlson stated that billions of dollars' worth of US arms are being siphoned off and sold to America's enemies. While the black market arms trade in Ukraine during the war has long been documented, including in mainstream media sources, Carlson and his guest Col. Davis agreed that many weapons have made it into the hands of Mexican drug cartels, among other criminal organizations.
Ukraine receives American weapons, they are skimmed by Ukrainian military officials, who then sell them to the cartels, the show asserted.
"They sell weapons to drug cartels... the fact is that the Ukrainian military sells a huge percentage, up to half of the weapons we send them. And this is not my guess. This is a fact. Not speculation. They sell it, and a lot of it ends up with drug cartels on our border. So this is a crime," Carlson said, quoted by RIA Novosti.
"They're selling it, and a lot of it winds up with the drug cartels on our border," he also said.
Tucker Carlson EXPOSES a major scandal:
Up to 50% of U.S. weapons sent to Ukraine are being resold on the black market—some ending up with Mexican drug cartels.
Not only is this wasting billions in U.S. tax dollars, but it’s also arming criminals at our border. pic.twitter.com/RBL4jeyCzw
However, the claim has come under fire and much scrutiny online, particularly the statement that "half" of all US-provided arms end up with the cartels, given no particular evidence for this was presented in the show.
Given many tens of billions worth of US and Western arms have been sent over the nearly 3-year course of the Ukraine war, this would be an immense amount of weaponry requiring large military transport planes or else steady streams of trucks going back across Ukraine's border to foreign destinations. This level of illicit arms trade would require immense logistics and would be incredibly difficult to conceal. Carlson suggested CIA assistance or profiting from the scheme, however.
But certainly it's easy enough to believe that at least some quantities of black market US-provided arms or ammo have gone from Ukraine into an array of criminal networks worldwide, including possibly to the Mexican cartels just south of the US border.
The Blaze has meanwhile reviewed of the Ukraine to Mexico arms pipeline reporting as follows:
However, multiple reports have denied that this was evidence of any nefarious use of the money. Outlet Voice of America painted the claim as Russian propaganda, while PolitiFact claimed any accusations were based on a misunderstanding of how the aid has been distributed.
At the same time, a June 2024 study by Harvard said it was "highly likely that some weapons will go missing over the course of the conflict" but admitted it would be hard to prove the extent of which illicit weapons were being sold.
Harvard, too, stated that sales of arms to sources like "Finnish gangsters, French rioters, Nigerian fighters, and Mexican cartels" were debunked as "Russian propaganda" and cited a report from the Global Initiatives Against Transnational Organized Crime as evidence.
Watch the full interview here:
The Ukrainian military is selling American weapons systems on the black market, including to drug cartels. This war is killing the United States. Col. Daniel Davis on how Donald Trump can end it.
(0:00) Why Crimea Is So Pivotal (13:17) Ukraine Is Powerless Without the US (31:16)… pic.twitter.com/PgL3og9lTE
In 2023, the Pentagon's Office of Defense Cooperation-Kyiv admitted after conducting an investigation that it "was unable to conduct required [end-use monitoring] of military equipment that the United States provided to Ukraine in FY 2022."
"The inability of DoD personnel to visit areas where equipment provided to Ukraine was being used or stored significantly hampered ODC-Kyiv’s ability to execute" the monitoring, the report stated. Reports have since shown that the lack of monitoring and tracking situation has grown even worse since then.
Boehringer Ingelheim has a second positive trial under its belt for nerandomilast in pulmonary fibrosis, setting up regulatory filings.
The new data from the 1,178-patient FIBRONEER-ILD study showed that the oral PDE 4B inhibitor was able to improve lung function in patients with progressive pulmonary fibrosis (PPF), a form of interstitial lung disease (ILD).
Last September, the FIBRONEER-IPF trial also showed an improvement in lung function with the drug in patients with idiopathic pulmonary fibrosis (IPF), another ILD subtype that tends to be less prone to swift progression than PPF.
The two positive studies mean that Boehringer can now seek approval for nerandomilast with a broad label claim in pulmonary fibrosis, making the drug a potential successor to its $3.6 billion-a-year blockbuster IPF therapy Ofev (nintedanib).
Topline data from FIBRONEER-ILD showed that nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) – how much air a patient can exhale after taking in a full breath – compared to placebo after a year's treatment.
The FIBRONEER-IPF trial used the same endpoint and had a similar outcome, and both studies suggest that nerandomilast is well tolerated with a side-effect profile that is comparable to placebo, according to Boehringer, which said it will now press ahead with submitting marketing applications for nerandomilast to the US FDA and other health authorities worldwide.
"The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges," said Shashank Deshpande, head of the privately-held German pharma group's human pharma division.
In IPF and PPF, the lungs become increasingly damaged by scar tissue, resulting in breathing getting progressively more difficult, and it is generally considered a terminal illness despite the availability of drug treatments. It has an average survival time of only three to five years from diagnosis.
Currently approved treatments are Ofev and Roche's kinase inhibitor Esbriet (pirfenidone) – the latter now available in generic form – which have also been shown to slow down the decline in lung function, but have sometimes resulted in troublesome side effects.
Ofev, for example, causes gastrointestinal symptoms like diarrhoea, nausea, and stomach pain in around two-thirds of patients, and discontinuation rates for both drugs are high.
Boehringer's drug is due to start losing patent protection in 2029, and the company is hoping to bring nerandomilast to market before then to defend its IPF franchise.
The future of another experimental oral pulmonary fibrosis treatment – Pliant Therapeutics' αvβ6 and αvβ1 integrin inhibitor bexotegrast – is being debated after the company announced a pause in its phase 2b/3 trial of the drug due to a safety signal.
It's been a decade since Roche bought InterMune for $8.3 billion on the promise of its idiopathic pulmonary fibrosis (IPF) therapy Esbriet. Now, it's sold the business.
The buyer is Legacy Pharma, a business registered in the Cayman Islands that sells a portfolio of branded generic medicines through a US business unit of the same name and two other companies, Allegis Pharma and Marnel Pharma.
It is taking control of the InterMune unit and US rights to Esbriet (pirfenidone), which has been FDA-approved for IPF since October 2014. The price being paid for the assets has not been disclosed.
Esbriet was able to achieve blockbuster status, with sales of around $1 billion in 2021 although it never reached the heights of its rival and only other FDA-approved therapy for IPF – Boehringer Ingelheim's Ofev (nintedanib) – which outsold it almost three times over in the same year and has since grown into a $3.6 billion-a-year product.
Sales of Esbriet plunged after it lost patent protection in 2022, with generic competition swiftly taking its toll, and the brand declined to just over $200 million in 2023. Sales figures were not broken out in Roche's 2024 financial reporting but have been estimated to be around $100 million.
It's worth noting that Roche isn't giving up on IPF as an indication, despite the decision to ell Esbriet, and has switched its attention to an anti-OSMRβ antibody – licensed by its Genentech subsidiary from Kiniksa Pharmaceuticals in 2022 – which is in mid-stage clinical testing for IPF and other forms of interstitial lung disease (ILD), as well as inflammatory bowel disease (IBD).
Legacy Pharma said the acquisition "underscores [the company's] commitment to expanding its portfolio of high-quality pharmaceutical products and enhancing patient access to innovative treatments."
Taking over the brand will ensure the continued availability and distribution of Esbriet to patients across the US, it added. Roche is retaining rights to the product in other parts of the world.
Roche's sale of InterMune and Esbriet in the US comes as Boehringer revealed its own follow-up play in the IPF, category, oral PDE 4B inhibitor nerandomilast, which is heading for regulatory filings in the US and elsewhere this year after generating positive results in two phase 3 trials.
Vertex expects to make the newly approved non-opioid pain medicine Journavx available by the end of February.
Vertex Pharmaceuticals is working toward making its recently approved non-opioid pain medicine Journavx not only broadly available—through private and public payer coverage—but also easy for doctors to deploy in the clinic.
That’s according to chief operating officer Stuart Arbuckle, who in an investor call on Monday said that the company is currently in talks with insurance providers to secure favorable coverage arrangements for Journavx.
Part of these discussions, he emphasized, is establishing minimal “utilization management controls,” which “can get in the way of physicians wanting to prescribe and patients getting access to a new medicine.”
“Broad access on its own is insufficient,” Arbuckle said, noting that “if you’re putting lots of hurdles in the way of prescribers to actually use your medicine,” then usage rates and uptake will remain low. “Our goal is not just broad access, but broad access in both commercial and government channels, but with minimal utilization management controls.”
Vertex’s negotiations with payers have reflected these goals, Arbuckle continued, adding that aside from minimizing use controls, the company is also “certainly not considering things like step edits through generic opioids, which I think would be medically and ethically inappropriate.” Insurers sometimes require patients to “fail” less costly treatments before they can receive the physician’s first-choice therapy.
In an investor note on Monday, analysts at Leerink Partners called Arbuckle’s statement about Journavx access “encouraging,” given how promising the pain drug is for Vertex. “We believe the market underappreciates Journavx’s sales potential; although its efficacy is similar to generic drugs with different mechanisms, Journavx appears to have a better benefit-risk ratio.”
In its fourth-quarter and full-year business report on Monday, Vertex announced that the launch of Journavx is underway and that the company is in the process of minting “broad stocking arrangements” for the drug with several national retail pharmacies. Vertex expects Journavx to start shipping out by the end of February and will be available on shelves shortly thereafter.
The FDA approved Journavx in late January 2025, marking the first new non-opioid pain management option in more than 20 years. Initially, analysts raised doubts about how easily Journavx would penetrate clinical practice, with William Blair analysts writing in a note at the time of the approval that the drug could suffer from “initial inertia” from doctors.
Still, Vertex remains confident. In its news release on Monday, it pointed to legislative efforts that it says could “build momentum” in providing equitable access to Journavx. In particularl, the Non-Opioids Prevent Addiction In the Nation (NOPAIN) Act, which came into effect on Jan. 1, will provide separate payments for non-opioid pain medications given to patients under Medicare. Vertex expects Journavx to be covered under the NOPAIN Act.
In the fourth quarter, Vertex brought in $2.91 billion, representing 16% year-on-year growth—and a 5% beat of the consensus estimate. In the full year, the biotech’s revenue jumped 12% to $11.02 billion. Cystic fibrosis continued to be Vertex’s main money-maker, with a net product revenue for Trikafta of $2.91 billion in the fourth quarter. Its gene therapy Casgevy made $8 million in the same period.
Looking ahead to the year, Vertex expects total revenue to be between $11.75 billion and $12.0 billion, a forecast that is broadly in line with consensus estimates at the mid-point, according to Leerink.
Gov. Kathy Hochul put the brakes on Democrats’ plan to rewrite rules for an upstate special election to leave a House seat vacant and hobble Trump’s agenda, sources familiar with negotiations said Monday.
Democrats’ move would have left a safely Republican House seat empty through November as the GOP clings to a razor-thin majority, but Hochul stepped in as she continues high-powered talks with Trump over congestion pricing in Manhattan.
Republican Rep. Elise Stefanik, Trump’s pick to be US Ambassador to the United Nations, would vacate her congressional seat when she is confirmed – leaving the GOP with a two-seat majority until a replacement can take office in the red upstate district.
Stefanik is expected to be confirmed, though the White House has not forwarded her for confirmation yet.
Gov. Kathy Hochul put the brakes on Democrats’ plan to rewrite rules for an upstate special election to leave a House seat vacant and hobble Trump’s agenda, sources familiar with negotiations said Monday.Hans Pennink
Democrats in the state Senate and Assembly introduced legislation on Friday that would delay holding a special election to fill the House District seat until the Nov. 4 general election — keeping the seat vacant for months.
Republicans slammed the Democrats for being hypocritical, engaging in an undemocratic partisan-power play in a bid to try to stymie Trump’s agenda.
“It deprives 800,000 people of representation. This is about thwarting President Trump’s agenda in Congress,” Senate Republican Minority Leader Robert Ortt said during a press conference Monday.
Albany insiders confirmed that Hochul requested the legislature to postpone any action on the bill for the time being while she continues talks with Trump over the controversial $9 toll to enter Manhattan south of 60th Street, which went into effect last month.
Republican Rep. Elise Stefanik, Trump’s pick to be US Ambassador to the United Nations, would vacate her congressional seat when she is confirmed – leaving the GOP with a two-seat majority until a replacement can take office in the red upstate district.ZUMAPRESS.com
One source close to the negotiations said Hochul considers the bill as leverage in her talks with Trump, who is considering killing congestion pricing.
“The bill is definitely on hold while these other conversations on congestion pricing are happening,” a source said.
Hochul’s office declined comment.
Trump told Post columnist Miranda Devine he could rescind the toll approved by the prior Biden Administration through the US Department of Transportation he now controls. But he also noted he’s in conversations with Hochul about the issue.
“I think it’s really horrible, but I want to discuss it with her at this point,” Trump said. “If I decide to do it, I will be able to kill it off in Washington through the Department of Transportation.
GOP sources confirmed that Trump’s confirmation of Stefanik has been slow-walked over concern that her vote may be needed to get his agenda through the razor-thin majority of the House. Party members are concerned if she officially resigns, her seat could be vacant for the months leading up to a special election.
But Republicans also said Hochul is on thin ice and a well-financed lawsuit is already in the works if she and Democratic-run legislature try to keep the seat vacant by waiting until Nov. 4 to hold the special election.
Hochul and the Democratic lawmakers are even getting pilloried by liberal media outlets for even attempting the partisan power play, one GOP House operative noted..
“Hochul is weak politically,” the GOP insider said.
Rep. Mike Lawler and other state Republicans last week sent a formal letter to Trump’s Department of Justice asking for a racketeering probe into Hochul and state legislative leaders over the just shelved legislation to delay the special election for House District 21.
Ortt, the Senate Republican minority leader, said public exposure and pressure forced Hochul and Democrats to abandon their “disgraceful scheme.”
“While this bill appears to be defeated for now, we will remain vigilant against any effort to bring it back,” Ortt said.
“The fact that Democrats even attempted this sham is proof of how corrupt and desperate the Albany swamp has become,” he said. “Senate Republicans will continue to stand up for the people of New York, fight back against these disgraceful attacks, and put the needs of the people, not power-hungry politicians, first.”
