A busy end to 2026 for new drug approvals

Bepirovirsen (brand name: TBD) – new drug

Expected FDA decision: October 26, 2026

Therapeutic use

Bepirovirsen will be used in combination with standard of care, for treatment of adults with chronic hepatitis B (CHB) infection in patients without cirrhosis.

Hepatitis B is a liver infection caused by hepatitis B virus (HBV). Hepatitis B is a vaccine-preventable infection and vaccination is recommended in all infants. Hepatitis B can range from a mild, acute infection to a more serious, chronic infection. CHB can lead to liver damage, cirrhosis and liver cancer.

The CDC estimates that about 640,000 adults in the U.S. have CHB. An estimated 120,000 patients currently receiving chronic antiviral therapy represent the intended target population of patients eligible for add-on treatment with bepirovirsen alongside existing standard-of-care therapy, with the goal of achieving a functional cure.

Competitive environment

Approximately 15% to 25% of people with CHB develop chronic liver disease, including cirrhosis, liver failure or liver cancer. The primary goal of CHB treatment is to control the virus to a point where it is no longer actively producing key viral proteins. One of the main indicators of this success is the disappearance of hepatitis B surface antigen (HBsAg) from the blood.

HBsAg loss is associated with better long-term clinical outcomes than HBV DNA suppression alone. While current standards of care (e.g., tenofovir, entecavir) effectively suppress viral replication, HBsAg loss is rarely achieved. As a result, many patients require long-term or indefinite antiviral therapy.

Bepirovirsen is a first-in-class therapy that may offer a functional cure and 24-week regimen for a subset of patients with CHB when added to standard antiviral therapy. In pivotal trials, approximately 20% of virally suppressed patients receiving background antiviral therapy achieved a functional cure with bepirovirsen. For patients who respond, bepirovirsen could potentially allow discontinuation of chronic HBV antiviral therapy.

Despite the promising results, bepirovirsen is not expected to replace the current standard of care for CHB, but rather serve as an add-on therapy. While comparisons to the introduction of curative therapies for hepatitis C are likely, bepirovirsen represents a more incremental advance. Its ~20% functional cure rate is unprecedented in chronic hepatitis B, yet remains well below the >90% cure rates routinely achieved with hepatitis C therapies.  

Additionally, hepatitis C treatments are oral, finite-duration regimens used as standalone therapy, whereas bepirovirsen is a weekly injection administered in combination with existing antivirals and is intended only for a subset of virally suppressed patients. Bepirovirsen should not be used in patients with acute infection or untreated CHB.

Although the overall prevalence of CHB is only about 0.5% in the U.S., the burden is concentrated geographically, with more than half of all infections occurring in California, New York, Texas, Florida and New Jersey. As a result, bepirovirsen utilization and budget impact will vary by state or region.

GSK has not announced pricing, and there is no direct analog for bepirovirsen. Hepatitis C antivirals, which were initially priced at approximately $50,000 to $100,000 per treatment course, offer the closest precedent; however, those therapies achieved cure rates exceeding 90% with oral, standalone treatment regimens. 

While bepirovirsen’s ~20% functional cure would represent a meaningful breakthrough in chronic hepatitis B, it is a weekly injectable used in combination with existing antiviral therapy and only in a subset of virally suppressed patients. These differences limit the ability to justify hepatitis C-like pricing at the upper end of the range. By comparison, currently available generic HBV antivirals have wholesale acquisition costs of less than $1,000 annually.

Asundexian (brand name: TBD) – new drug

Expected FDA decision:  November 9, 2026

Therapeutic use

Asundexian will be used in combination with antiplatelet therapy, for secondary ischemic stroke prevention in patients with a history of acute non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA).

Approximately 795,000 people in the U.S. experience a stroke annually and of these, approximately 87% are ischemic. An ischemic stroke occurs when blood clots or other particles block the blood vessels to the brain.

Competitive environment

The current standard of care for secondary stroke prevention after non-cardioembolic ischemic stroke or high-risk TIA is antiplatelet therapy, either as monotherapy or dual therapy with agents such as aspirin and clopidogrel. 

Despite the use of antiplatelet therapy, recurrent stroke risk remains substantial, with approximately 5% of patients with an ischemic stroke or TIA experiencing another stroke within 1 year.  Currently available anticoagulants are generally not used for these patients because they have not shown enough added benefit to outweigh the increased risk of bleeding.

If approved, asundexian could represent the first major advance in secondary stroke prevention in years. It would be the first anticoagulant positioned as add-on therapy to antiplatelets for secondary stroke prevention in patients with non-cardioembolic ischemic stroke or high-risk TIA. 

In the pivotal trial, asundexian reduced the incidence of ischemic stroke by 26% when added to antiplatelet therapy without increasing the risk of major bleeding, suggesting that selective inhibition of Factor XIa may offer a more favorable efficacy-safety profile than traditional anticoagulants. 

Several factors may influence real-world uptake. A key limitation is that the pivotal trial enrolled patients within 72 hours of symptom onset. The magnitude of benefit beyond this timeframe remains unknown. In practice, asundexian is likely to be used more commonly in patients with a new or recent stroke. 

In addition, asundexian is not expected to compete directly with established anticoagulants across their current indications. In the separate OCEANIC-AF study, asundexian did not meet its primary endpoint for prevention of stroke or systemic embolism when compared head-to-head with Eliquis® (apixaban) for stroke prevention in patients with atrial fibrillation. 

Therefore, asundexian would more likely establish a new anticoagulant treatment niche in secondary stroke prevention, rather than displace anticoagulants used for atrial fibrillation or other established indications.

From a pricing perspective, Entresto® (sacubitril/valsartan), a branded cardiovascular therapy used in a broad patient population, has a wholesale acquisition cost of approximately $8,800 annually and may provide a relevant benchmark for asundexian potential pricing expectations.

Cagrilintide/semaglutide (brand name: CagriSema®) – new drug

Expected FDA decision:  December 18, 2026

Therapeutic use

CagriSema would be used to reduce excess body weight and maintain weight reduction long term in adults with obesity or overweight in the presence of at least one weight-related comorbid condition.

Overweight or obesity is very common in the U.S. with an estimated 40% of the adult population living with obesity and 74% overweight (including obesity).

Competitive environment

CagriSema would be the first GLP-1–containing combination product for chronic weight management. It combines semaglutide, the same GLP-1 receptor agonist used in Wegovy (semaglutide) that reduces appetite and food intake, with cagrilintide, a long-acting amylin analogue that promotes satiety and may further reduce hunger and caloric consumption. 

Compared with Novo Nordisk’s single-agent Wegovy products, it appears to offer incremental weight loss benefit, which may support use in treatment-naïve patients with higher baseline body mass index (BMI) or in patients who have tolerated semaglutide but require additional weight reduction. 

Despite the novel dual mechanism of action, CagriSema does not represent a significant improvement in weight loss relative to single-ingredient GLP-1 drugs. In the placebo-controlled studies, CagriSema reached a body weight reduction of 20.4% which is a modest improvement when compared indirectly to the 18.8% observed with Wegovy HD. 

In the head-to-head REDEFINE 4 study, CagriSema failed to demonstrate non-inferiority to Eli Lilly’s Zepbound® (tirzepatide), with mean percent change in body weight of -20.2% and -23.6%, respectively. The safety profiles were generally similar, with both treatments primarily associated with gastrointestinal adverse events. Without a clear efficacy or tolerability advantage over Zepbound, CagriSema may face challenges differentiating itself in an increasingly competitive obesity market.

Additionally, Eli Lilly’s next-generation “triple G” (GLP-1/GIP/glucagon) therapy, retatrutide, has demonstrated upwards of 25% body weight reduction in Phase 3 trials and could become available as early as late 2027 or early 2028, potentially raising the efficacy bar further and challenging CagriSema’s near-term market positioning while limiting the commercial opportunity for future higher-dose formulations. 

For reference, Novo has announced that Wegovy injection will have an annual WAC of approximately $8,200 beginning January 1, 2027, representing roughly a 50% reduction from its current list price. In contrast, Zepbound currently carries an annual WAC of approximately $14,100. Given that CagriSema demonstrated only modestly greater weight loss than Wegovy and failed to achieve non-inferiority versus Zepbound in head-to-head testing, we anticipate Novo will price CagriSema similarly to, or only modestly above Wegovy.