Brensocatib

Insmed guides for $1B in Brinsupri salesBiogen bins mid-stage MS studyModerna's mNEXSPIKE faces patent suitInsmed guides for $1B in Brinsupri salesHaving been approved in the US last August, and subsequently authorised in the EU, as the first treatment for non-cystic fibrosis bronchiectasis (NCFB), Insmed now expects Brinsupri (brensocatib) to generate revenue of at least $1 billion in 2026. "Our US commercial launch…continues to exceed our expectations," said CEO Will Lewis.The oral, once-daily DPP1 inhibitor — designed to block the activation of neutrophil serine proteases in neutrophils that are responsible for the underlying inflammation in NCFB — generated sales of $144.6 million in the fourth quarter of 2025 and $172.7 million for the full year.Insmed expects regulatory decisions for Brinsupri for the treatment of NCFB in the UK and Japan in 2026. However, the company cautioned that it "continues to evaluate the potential effect of evolving US policies," which could impact the timing of potential international commercial launches.-Matthew DennisBiogen bins mid-stage MS study Biogen this week terminated the Phase II FUSION study evaluating BIIB091 in patients with relapsing multiple sclerosis (MS), according to an update on ClinicalTrials.gov. The candidate, a reversible, non-covalent BTK inhibitor, was being studied alone or in combination with diroximel fumarate; the trial had enrolled 127 patients. The study discontinuation comes as at least one BTK inhibitor seems to have found its footing in MS. While the drug class has shown tantalising promise in treating the disease, none have yet reached the finish line — though Roche's fenebrutinib may be nearing approval (see – Physician Views Results: Neurologists share cautious optimism for Roche's fenebrutinib in PPMS).However, Sanofi was recently hit with a controversial FDA rejection for its BTK inhibitor, tolebrutinib, to treat non-relapsing secondary progressive MS. For more on how BTK inhibitors may shake up the MS treatment landscape, see KOL Views Q&A: What Sanofi’s PERSEUS, Roche’s FENtrepid divergence says about BTK inhibitors in MS.-Elizabeth EatonModerna's mNEXSPIKE faces patent suit BioNTech has filed a patent infringement lawsuit alleging that Moderna's next-generation COVID-19 vaccine unlawfully infringes on a patent related to the German company's own mRNA shot, Comirnaty. The complaint, filed Thursday in US District Court for the District of Delaware, claims Moderna's mNEXSPIKE infringes US Patent No. 12,133,899, which covers a streamlined mRNA vaccine design that allows for lower dosing. The case intensifies a long-running legal battle between the companies behind two of the world's most successful COVID-19 vaccines. BioNTech developed Comirnaty with Pfizer, while Moderna brought its own shot, Spikevax, to market in late 2020. In 2022, Moderna sued BioNTech and Pfizer, claiming they "unlawfully copied" its mRNA inventions to make Comirnaty; that case remains ongoing. Moderna recently highlighted mNEXSPIKE, which was approved by the FDA in 2025, as a significant growth driver with expected approvals this year in Europe and Japan. According to BioNTech's complaint, mNEXSPIKE accounted for 55% of COVID-19 vaccines sold by Moderna in the 2025-2026 respiratory virus season. A spokesperson for Moderna said Thursday it would defend itself against the new allegations.-Anna Bratulic

Insmed is projecting sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026 and join a small group of products that have achieved blockbuster sales in their second to fifth full quarters on the market. In a fourth-quarter conference call, Insmed CEO Will Lewis admitted that it was “audacious” that his company would project sales of newly approved respiratory drug Brinsupri to reach $1 billion in 2026. Then he laid out the case of why the forecast isn’t so cheeky at all. “We have a number of different data sources we examine,” Lewis said on Thursday morning. “Across all the metrics, we’re seeing [numbers] at or above our targets and that’s very much behind why we have a conviction that we’ll do at least $1 billion in revenue in Brinsupri this year.”Approved in August with much fanfare as a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, Brinsupri was pegged by analysts at Mizuho Securities for a peak sales potential of $6.6 billion, but even they were surprised by its dynamic launch. Last month at the J.P. Morgan Healthcare Conference, Insmed revealed sales of $145 million in the fourth quarter, prompting Mizuho to call it “a ginormous result.” On Thursday, Lewis added that the launch “surpassed even our most ambitious expectations,” which were based on “a basket of historically strong respiratory launches as our guide.”Of the 500,000 patients in the U.S. who have been diagnosed with non-cystic fibrosis bronchiectasis (NCFBE), Insmed initially figured that half would be candidates for the oral daily pill, as it was tested in the clinic on those who had suffered at least two exacerbations over the course of a year. Insmed based its initial peak sales estimate of $5 billion on that addressable patient population of 250,000.“In addition, we believe over time that more of the remaining 250,000 currently diagnosed patients with less than two exacerbations will start to move into the category of those who have had two or more exacerbations in a 12-month period,” Lewis said. “This is due to the progressive nature of the disease and better patient reporting and documentation of exacerbation events now that there’s an available treatment.” Additionally, Insmed believes that many with NCFBE have been inaccurately diagnosed as having COPD or asthma in the U.S. Lewis said that Insmed is reaching out to physicians to alert them to the possibility of this misdiagnosed group.“The potential additional patients from these populations, which would be on label for Brinsupri if they are confirmed to have bronchiectasis, dwarfs the total addressable market we have just been discussing,” Lewis added. “We are currently working on a number of different programs to advance the exploration and quantification of these patients.”As for potential launches of Brinsupri in Europe and Japan, the company is playing a waiting game to find out the impacts of President Donald Trump’s Most Favored Nation (MFN) drug pricing plan, the CEO explained. Brinsupri is priced at $88,000 per year in the U.S.   “We want clarity on the MFN policies that are coming forward now. I think we’re going to have that in the coming weeks and at the most, months,” Lewis said. “But until that’s clear, it seems to us that the prudent thing to do is to put things on hold until we know what that’s going to look like.” In May of last year, Trump signed an executive order that introduced the MFN plan, saying it would cut the price of drugs in the U.S. by up to 90%. The policy aims to tie drug prices paid by the U.S. government to the lowest prices paid by other economically advanced countries. So far, there have been indications that some companies are treading carefully with EU drug launches during the MFN era. Overall, last year, Insmed reported (PDF) 2025 sales of another of its respiratory drugs, Arikayce, at $434 million, and projects it to generate between $450 million and $470 million this year. It was approved in 2018 to treat a narrow group of patients with lung disease caused by the mycobacterium avium complex (MAC) family of bacteria.