Baxdrostat

A cost-effectiveness analysis out this week suggests that two aldosterone synthase inhibitors (ASIs) — AstraZeneca's newly approved Baxfendy (baxdrostat) and Mineralys Therapeutics' lorundrostat, which is still under review — do lower blood pressure effectively and may cause fewer side effects than older hypertension drugs. Their price, however, may be harder to justify."In cost-effectiveness analyses, treatment with baxdrostat and lorundrostat (at its placeholder price) generally provided small benefits in quality-adjusted life years (QALYs) and equal-value life-years (evLYs) compared to spironolactone, eplerenone, and amiloride, but at a much higher total cost," according to a draft evidence report Wednesday from the Institute for Clinical and Economic Review (ICER).Baxfendy is an oral drug that was approved by the FDA in May, in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled. The decision was based on "gamechanger" data from the Phase III BaxHTN study — the therapy lowered seated office systolic blood pressure (SBP) by a placebo-adjusted average of 9.8 mmHg — that made it the first drug in the ASI class authorised for this population.AstraZeneca also sees Baxfendy as a $5-billion asset, and possibly double that if other indications are eventually tacked on (see – Physician Views Results: Clinicians back Baxfendy's efficacy, but safety monitoring may define early uptake).Meanwhile, the FDA is currently reviewing Mineralys' application for lorundrostat, which is also taken orally. The filing includes data from the Phase III Launch-HTN trial showing it reduced automated office SBP by 11.7 mmHg compared to placebo. The US regulator is slated to render its verdict by Dec. 22.However, against older drugs, the ICER analysis found that the ASIs offered only small additional health benefits, at least based on currently available evidence.Pricy gainsThe cost per QALY gained with Baxfendy ranged from about $833,000 versus spironolactone and $851,000 versus amiloride, to more than $2 million versus eplerenone, far above the $100,000-$150,000 thresholds commonly used to judge cost-effectiveness. Using a placeholder price for lorundrostat that is equivalent to Baxfendy's price, ICER estimated costs of around $1.4 million to $1.5 million per QALY versus spironolactone and amiloride, while lorundrostat was "more costly and less effective" than eplerenone."Despite effective blood pressure lowering," the group said that "questions remain about the long-term effects of ASIs, as well as their impact on patient-important outcomes," such as cardiovascular events, kidney disease, dementia, quality of life, or mortality. "The other comparators in our review have demonstrated a positive impact on patient-important outcomes."ICER also highlighted the potential budget impact, estimating that at Baxfendy's net price of $10,950 per year, switching to the drug would add about $8300 per patient in healthcare costs in the first year, rising to $15,700 by year five. For lorundrostat, using the same annual placeholder price, the corresponding figures were $8500 and $16,300.

With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies results and how theyre being received by investors. Today, were offering insight into the latest numbers from Biogen, AstraZeneca and GSK.Biogens resilient quarterBiogen, with its latest earnings report out Wednesday, drummed up more confidence in its product portfolio on Wall Street.The Boston-area biotechnology company reported $2.7 billion in revenue between April and the end of June, a 3% increase from the same period a year prior. Diluted earnings per share were 66 cents under generally accepted accounting principles and $3.60 when adjusted. In a note to clients, Jefferies analyst Andrew Tsai wrote that analysts, on average, expected revenue to come in at $2.5 billion and non-GAAP EPS at $2.88.Several of Biogens flagship products contributed to the beat. Sales of Spinraza, a treatment for an uncommon muscular disorder, were up 7% from the first quarter, to $402 million. The $381 million Biogen got from royalties tied to Roches multiple sclerosis drug Ocrevus were about $21 million above analyst forecasts. And Biogens broader MS franchise, though pressured by competition from copycat drugs, still delivered $963 million on the quarter. The business continues to be more resilient than expectations, wrote RBC Capital Markets analyst Brian Abrahams.Newer additions to the portfolio impressed as well. Sales of Skyclarys, a rare disease medicine Biogen picked up through its $7.3 billion purchase of Reata Pharmaceuticals, rose to $168 million, topping consensus estimates of $157 million. Biogen also recorded $30 million and $97 million, respectively, from two drugs from the recent acquisition of Apellis Pharmaceuticals. Both of those figures exceeded analyst predictions, according to Tsai, who added that the earnings in full showcase resiliency in Biogens base business.Leqembi, the closely watched medicine for Alzheimers disease that Biogen co-developed with Japans Eisai, grew 15% year-over-year to $184 million in global sales.The Food and Drug Administration recently started allowing patients to begin treatment with Leqembi at home, using a form of the medicine given as an under-the-skin shot. The latest Leqembi figures could help instill confidence that this new launch will be coming off of a solid base and could catalyze a pickup in sales in the near to medium term, helping to reclaim market share, Abrahams wrote.In its report, Biogen updated its full-year guidance. It now expects revenue to increase by a mid-single-digit percentage, and non-GAAP EPS to settle somewhere between $12 and $13. Thats down from the previous range of $15.85 to $16.85, in good part because of dilution and research costs from the Apellis deal.Biogen shares were up almost 5%, to trade just over $215 apiece, by late Wednesday morning. Jacob BellAstraZenecas growth pitchUp until recently, AstraZeneca had been on the kind of extended tear that separated it from many large pharmaceutical peers. A series of successes in cancer and other areas of drug research has helped the company more than double its yearly earnings between 2015 and 2025. Executives think the company can reacheven higher and hit $80 billion in sales by 2030, nearly $21 billion more than AstraZeneca pulled in last year.We have the science, we have the pipeline, and we have the team to make that happen, CEO Pascal Soriot assured analysts and investors on a Monday conference call.Wall Street has reason to be nervous, though. Etcamah, a breast cancer drug important to AstraZenecas future, has been delayed in the U.S. The company also suffered a major setback earlier this month when eplontersen, a drug its been counting on, fell short in a big study in a deadly heart condition. That trial was widely expected to succeed and executives were accordingly optimistic. Its failure was therefore seen as a credibility loss given managements confidence level, one analyst wrote at the time. Company shares have fallen more than 10% since.Still, executives are confident AstraZeneca will hit its target. The $80 billion figure is risk-adjusted, Soriot said, adding that AstraZeneca would far surpass that total if “everything worked. Etcamah, the cancer drug Datroway and newly approved blood pressure medication Baxfendy could all peak at more than $5 billion in annual sales.AstraZeneca now believes a respiratory disease drug currently known as tozorakimab could hit that mark, too, following positive results that surprised analysts earlier this year. Its earnings presentation listed a smattering of weight loss and oncology programs as having $5 billion-plus sales potential, too. All should produce pivotal results before 2030.To Soriot, those coming readouts suggest the company doesnt need to do more deals to meet its mark. There may be other setbacks, but AstraZeneca is planning as if its success rate in Phase 3 will be at or below the industry average, even though the companys performance has consistently been higher, he said.The likelihood that there will be puts and takes is part of how we plan, Soriot added. We've taken this into account. Ben FidlerGSKs oncology pushBest known for its HIV drugs, respiratory disease medicines and vaccines, GSK has for years worked to build an oncology business, too. That effort is now the centerpiece of an accelerate growth plan, through which GSK aims to reach 40 billion in annual revenues by 2031 even as key patents fortifying its HIV products expire.Dealmaking has helped the British pharma acquire cancer drugs like Jemperli, Zejula and Blenrep. But that business only brought in 600 million in the second quarter and 2 billion in 2025, a small fraction of GSKs overall revenue and much lower than what the sectors major oncology players report.In an earnings presentation Tuesday, though, the company spotlighted its next wave of oncology drugs as critical revenue drivers in the years ahead. Its confidence is derived from their differentiation and potential benefit to patients, Chief Scientific Officer Tony Wood told analysts on a conference call.Chief among those prospects are two antibody-drug conjugates licensed from China-based biotech Hansoh Pharmaceutical. Known as riz-rez and mo-rez, respectively, both have rapidly advanced through clinical development, and riz-rez has now succeeded in two Phase 3 trials in China. Global studies for both are underway.GSK also has high hopes for a pair of lung cancer drugs it acquired through a nearly $11 billion acquisition of Nuvalent in June. One, named Jideytro, won approval from U.S. regulators earlier this month. Another, dubbed neladalkib, is currently under regulatory review, with a decision expected this November. Both are also in testing in first-line lung cancer, and have already shown best-in-class efficacy profiles, Hesham Abdullah, GSKs global head of oncology R&D, said on Tuesdays call.GSK claimed to have the capacity for additional dealmaking, too, with CSO Wood noting that the company wants to boost its mid-stage drug pipeline with medicines that address efficacy or tolerability gaps.But the key message to investors was that GSK increasingly views oncology as a major future growth pillar, supported by a rapidly expanding pipeline rather than reliance on a small number of products, wrote Jefferies analyst Michael Leuchten, in a client note. Delilah Alvarado '