AstraZeneca raises guidance on stellar cancer drugs growth

 AstraZeneca has reported a strong set of fourth-quarter results and predicted a similarly strong performance for 2026, as it rides a growth wave driven by its cancer therapies.

Total revenues grew 8% to $58.7 billion, with oncology products rising 14%, which the company said keeps it on track to meet its lofty projection of making $80 billion a year by 2030. It is forecasting that revenues will increase by a mid to high single-digit percentage this year.

Chief executive Pascal Soriot said the strong commercial performance means it now boasts 16 brands with annual sales above $1 billion, and was accompanied by "excellent pipeline delivery," with 16 phase 3 readouts last year and another 20 or more cued up before the end of 2026.

Soriot added that AZ is pushing to have more than 25 blockbuster brands in the market in 2030 and is also building for further growth beyond that year, highlighting new drugs for cancer and weight loss, as well as gene therapies.

In 2025, highlights of AZ's commercial execution in cancer included 40% growth for Daiichi Sankyo-partnered anti-HER2 therapy Enhertu (trastuzumab deruxtecan) to $2.78 billion, a strong performance for PD-L1 inhibitor Imfinzi (durvalumab), climbing 28% to top $6 billion, and a 68% rise for prostate and breast cancer drug Truqap (capivasertib) to $728 million.

In other categories, asthma therapy Tezspire (tezepelumab), Sanofi-partnered respiratory syncytial virus (RSV) prophylactic Beyfortus (nirsevimab), and Saphnelo (anifrolumab) for lupus also made strong double-digit gains.

Oral GLP-1 hits the mark in phase 2

In its update, AZ said that phase 3 trials are starting for elecoglipron (formerly AZD5004), an oral GLP-1 agonist that could compete with Novo Nordisk's recently launched Wegovy (semaglutide) pill and Eli Lilly's late-stage rival orforglipron in the fiercely-contested weight-loss category.

AZ also revealed positive top-line results for elecoglipron in the phase 2b VISTA and SOLSTICE trials, achieving weight-loss of 5% or more at 26 weeks and improving blood glucose control in patients with type 2 diabetes.

Other new pipeline disclosures for AZ in its annual update include that it is discontinuing the TROPION-Lung12 study of PD-1/TIGIT bispecific antibody rilvegostomig, as a monotherapy and in combination with TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan) in high-risk non-small cell lung cancer (NSCLC). The company said the decision was due to "operational feasibility."

It has also abandoned plans to file PARP inhibitor Lynparza (olaparib) for newly-diagnosed, advanced ovarian cancer, after discussions with international regulators about data from the supporting DUO-O trial.

There was more good news for AZ's aldosterone synthase inhibitor (ASI) baxdrostat, already filed in the US for hard-to-treat hypertension and billed as a possible $5 billion-a-year product. The drug has also shown efficacy in the BaxAsia trial, setting up regulatory filings in Asian markets.

https://pharmaphorum.com/news/astrazeneca-raises-guidance-stellar-cancer-drugs-growth

AstraZeneca Teases ‘Very Competitive’ Weight-Loss Pill—But Stays Mum on Details

 

AstraZeneca will push the pill, elecoglipron, into a comprehensive late-stage program that will test the drug as a monotherapy, as part of a combination regimen and for several indications.

AstraZeneca CEO Pascal Soriot expects the company’s late-stage oral weight loss asset elecoglipron to go toe-to-toe with current leading therapies—at least enough to warrant an expansive late-stage program.

“We have a very competitive profile,” Soriot told reporters during a media call Tuesday morning for the company’s full-year 2025 earnings report. “We would not move into Phase 3 and unleash all this investment for monotherapy, combination, cardiovascular outcome trials, which you can imagine is not inexpensive . . . if we didn’t believe in the product.”

But the U.K. pharma was fairly mum on the details, announcing that elecoglipron, an oral GLP-1 drug, met the primary endpoints in the Phase 2 VISTA study of patients with overweight and obesity with at least one comorbidity, and in the Phase 2 SOLSTICE trial in type 2 diabetes. With these mid-stage results, the company is putting elecoglipron through a comprehensive Phase 3 program slated to start this year.

On the earnings call, Soriot declined to provide specific data for elecoglipron, instead saying that findings will be presented at the upcoming American Diabetes Association congress in June.

Outside of elecoglipron, AstraZeneca’s obesity push received a $1.2-billion boost just over a week ago when the pharma partnered with Hong Kong’s CSPC Pharmaceutical, gaining global rights to a long-acting dual-agonist of GLP-1 and GIP receptors. AstraZeneca will also be able to work with CSPC on up to seven other programs, leveraging the biotech’s sustained-release technology and AI-driven engine.

All told, the pharma will be on the hook for up to $18.5 billion, including R&D and sales milestones across all programs.

AstraZeneca’s revenues hit $58.74 billion in 2025, an 8% year-on-year increase at constant exchange rates. Cancer remained its top unit, accounting for 44% of total earnings and surging 17% to hit $25.62 billion. Tagrisso, an oral kinase blocker indicated for lung cancer, made $7.254 billion while the PD-L1 inhibitor Imfinzi brought in $6.063 billion.

Growth was driven strongly by the breast cancer antibody-drug conjugate Enhertu, which saw a 40% year-on-year uptick to bring in $2.78 billion. Meanwhile, sales of the oral breast cancer drug Truqap surged 68% to hit $728 million.

The diabetes drug Farxiga, an oral SGLT2 inhibitor, was AstraZeneca’s best-selling product in 2025, making $8.41 billion.

The pharma expects total revenue to continue growing in 2026, hitting a mid-to-high single-digit percentage increase.

https://www.biospace.com/business/astrazeneca-teases-very-competitive-weight-loss-pill-but-stays-mum-on-details

REGENXBIO’s Hunter Syndrome Gene Therapy Fails To Win FDA Nod

 

The FDA recommended that REGENXBIO run a new study, treat more patients and include a placebo arm to support a resubmission for the gene therapy RGX-121.

After waiting through a three-month delay, REGENXBIO’s investigational gene therapy RGX-121 has been rejected by the FDA for the treatment of Hunter syndrome, an ultra-rare neurodegenerative condition.

In a complete response letter (CRL), the regulator cited “uncertainty” over the eligibility criteria that REGENXBIO used for the study included in RGX-121’s data package. The agency also questioned the applicability of using natural history external controls and the validity of the surrogate endpoint—cerebrospinal fluid levels of the biomarker DS26—as basis for approval.

For a resubmission, the FDA recommended running a new study, adding more patients, following them for longer periods and using an untreated comparator group. REGENXBIO, however, called these options “challenging” in a Monday release, given the ultra-rare nature of Hunter syndrome. RGX-121 had been accepted into the FDA’s accelerated approval program in May 2025.

“The CRL indicates the FDA is clearly being cautious on granting accelerated approvals without placebo-controlled data,” William Blair told investors in a Monday note. In turn, this could pose a regulatory risk for Denali Therapeutics, which is also awaiting the agency’s verdict on the Hunter syndrome therapy tividenofusp alfa, for which a target action date has been set for April 5. While Denali did not rely on natural history comparators to establish the efficacy of its therapy, the study also did not have a placebo arm.

Regenxbio is trading at $9.05 before the opening bell on Tuesday, down 12% from its previous closing price of $10.31.

The FDA had previously agreed to REGENXBIO’s protocol, the biotech said on Monday, adding that throughout the application process, the biotech had “addressed the points raised in the CRL” by submitting additional data and complying with the regulator’s information requests.

CEO Curran Simpson called the rejection “devastating for the families of boys living with” Hunter syndrome. The biotech will seek a Type A meeting with the FDA to discuss not just the path forward for RGX-121 but also to “provide additional evidence” from experts to support the effectiveness of the gene therapy.

To support the approval application for RGX-121, REGENXBIO filed data from the Phase 1/2/3 CAMPSIITE study, which in February 2024 demonstrated that at 16 weeks, the gene therapy elicited 86% decrease in DS26, a key disease biomarker, in the cerebrospinal fluid of treated patients. CAMPSIITE enrolled 48 boys aged 4 months to 5 years of age with Hunter syndrome.

At the time of the readout, 80% of patients treated with the pivotal dose of RGX-121 were able to discontinue or stay naïve of enzyme replacement therapy.

Hunter syndrome affects around 500 boys in the U.S. The disease is caused by mutations to the iduronate-2-sulfatase (IDS) gene, rendering its corresponding enzyme defective and leading to a toxic buildup of waste inside cells across the body. REGENXBIO’s RGX-121 counters this mechanism by delivering a functioning copy of the IDS gene.

https://www.biospace.com/fda/regenxbios-hunter-syndrome-gene-therapy-fails-to-win-fda-nod

Intel down by 5% after TSMC's sales report

 Intel Corporation's shares declined by 5% on Tuesday as investors seemingly reacted to Taiwan Semiconductor Manufacturing Company Limited's (TSMC) latest earnings report. The Taiwanese chipmaker reported an annual rise of 38% in its sales in January, which totaled $12.7 billion.

https://breakingthenews.net/Article/Intel-down-by-5-after-TSMC's-sales-report/65641626

'Zelensky: Work underway to strengthen military'

 Ukrainian President Volodymyr Zelensky announced on Tuesday that the Defense Ministry is preparing new measures to strengthen the country's military capacity, including restructuring the air forces' strategies.

Speaking during his daily evening address, Zelensky noted that "many changes are currently underway in the air defense's work. In some regions, the way teams work is actually being completely restructured – interceptors, mobile fire groups, the entire component of small-scale air defense." However, he did not elaborate further on the modifications, saying it is too early to make the details public.

Zelensky's address came as a decree was published on his website, allowing men over the age of 60 to serve in the army under a contract if they want to.

https://breakingthenews.net/Article/Zelensky:-Work-underway-to-strengthen-military/65642185

'NYT: US may allow Hamas to keep some arms initially'

 The United States is requiring Hamas to hand over all weapons capable of striking Israel, although it would allow the Palestinian group to keep some small weapons initially, The New York Times reported on Tuesday, citing a draft plan and officials familiar with the matter.

The sources said that the US-led team, which includes US Special Envoy to the Middle East Steve Witkoff and US President Donald Trump's son-in-law Jared Kushner, plans to share the document with Hamas within weeks.

However, the sources did not reveal details on who would take possession of the heavy weapons that Hamas would have to surrender, or how the disarmament process would be carried out.

https://breakingthenews.net/Article/US-may-allow-Hamas-to-keep-some-arms-initially/65642316

EIA: OPEC+ not expected to grow production

 The United States Energy Information Administration (EIA) predicted in its short-term energy outlook released on Tuesday that the Organization of the Petroleum Exporting Countries and its partners (OPEC+) will not raise their production of liquid fuels soon, possibly only slightly in 2027.

The EIA also projected that OPEC+ targets for 2027 will remain at the levels it set for 2026. It revealed that global liquid fuels production increased by approximately 3 million barrels per day (bpd) in 2025; further, it forecast the growth to decline to an average of 1.6 million bpd in 2026 and 900,000 bpd in 2027.

The EIA foreshadowed that oil prices will decrease in 2026 and remain under $60 per barrel in 2027. The agency predicted that global liquid fuel consumption will rise by 1.2 million bpd in 2026, and 1.3 million in 2027.

https://breakingthenews.net/Article/EIA:-OPEC+-not-expected-to-grow-production/65641807