Brensocatib

Plus, news about Summit, Pfizer, Insmed, Bristol Myers Squibb, Lynk Pharmaceuticals, Stoke Therapeutics, UniQure, Teva, Royalty Pharma, Vibrant Therapeutics and Recludix Pharma: 💊 Nuvation Bio licenses lung cancer pill to Eisai : The Japanese company has obtained exclusive development, registration and sales rights to Nuvation’s Ibtrozi in Europe and Canada, as well as certain countries in the Middle East, Africa, Asia and Australasia. Eisai will pay €50 million ($58 million) upfront and up to €145 million in biobucks, plus double-digit tiered royalties. Nuvation will keep US rights to the pill, which is approved in the US, China and Japan for ROS1-positive non-small cell lung cancer. — Elizabeth Cairns 📉 Alnylam reveals preliminary Q4 sales, stock falls: The company said over the weekend that its TTR revenues, comprising Amvuttra and Onpattro, were $827 million and $32 million, respectively. In 2026, Alnylam is guiding toward combined sales of $4.4 billion and $4.7 billion for the two drugs. Alnylam’s stock $ALNY fell about 10% in Monday midmorning trading. — Max Gelman 🗂️ Summit asks FDA for lung cancer approval: The biotech submitted an FDA application for ivonescimab, its PD-1xVEGF bispecific antibody, in second-line patients with a specific form of lung cancer. Summit is expecting a decision in this year’s fourth quarter, if the FDA decides to review the application. An approval would mark the first for this new class of drugs, though analysts say the market opportunity in this population (EGFR-mutated non-small cell lung cancer) is relatively small. Separately, Summit also said it will test ivonescimab with a B7-H3 antibody-drug conjugate called risvutatug rezetecan, which is being developed by GSK. — Max Gelman 🌊 Pfizer’s Braftovi beats standard care in colorectal cancer : A new cut of data from Cohort 3 of the ongoing pivotal BREAKWATER trial showed an objective response rate of 64.4% for the BRAF inhibitor, used in combination with Erbitux and the chemo regimen known as FOLFIRI. Patients in the control arm, who received standard-of-care FOLFIRI with or without Avastin, had an ORR of 39.2%. Pfizer said the difference was clinically meaningful and statistically significant. Patients in the trial had not been treated before. The data were presented Monday at the 2026 ASCO GI confab. — Elizabeth Cairns Error: Survey not found. 🏷️ Insmed announces first full quarter sales for Brinsupri: The company’s preliminary figures show Brinsupri pulled in $144.6 million in 2025’s fourth quarter. Insmed secured FDA approval for the drug in August last year. Brinsupri is an oral, once-a-day treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. — Anna Brown 🫀 Bristol Myers Squibb gets a late-stage heart disease win in teens : Camzyos succeeded in a Phase 3 trial in 44 patients aged 12-17 with the heart muscle disorder obstructive hypertrophic cardiomyopathy. The cardiac myosin inhibitor showed a statistically significant improvement over placebo on a measure of obstructed blood flow at about six months, BMS said Monday. There were no new safety signals, and BMS intends to take the data to regulators, though it did not say when. — Elizabeth Cairns 🇨🇳 Lynk Pharmaceuticals’ arthritis pill hits in China-based trial : The Phase 3 trial of zemprocitinib in moderate to severe active rheumatoid arthritis met its primary and key secondary efficacy endpoints, the Hangzhou, China-based biotech said Monday. Of the patients given 12 mg of the JAK1 inhibitor twice daily, 79.1% had a 20% improvement in disease activity at about six months, versus 39.7% of those given placebo, a statistically significant difference. More patients given Lynk’s drug had a 50% improvement on the same measure. Rates of serious adverse events were similar in both arms. — Elizabeth Cairns ⏳ Stoke Therapeutics pulls forward Dravet development timeline: The biotech said a Phase 3 trial of its Biogen-partnered drug, called zorevunersen, is now expected to complete enrollment in the second quarter. The company is on track to start a rolling NDA submission in 2027, ahead of an expected readout in the middle of that year. In the meantime, the FDA has requested more information from Stoke, which is hoping to secure a faster pathway to approval in Dravet syndrome. — Ayisha Sharma 💼 UniQure secures FDA meeting for Huntington’s gene therapy: The Type A meeting will be spent discussing what sort of data package uniQure needs to support accelerated approval of AMT-130. The update seems to mark a step forward from November, when the biotech said the FDA no longer deemed its Phase 1/2 data compared to an external control sufficient for approval. — Ayisha Sharma 🖋️ Teva signs funding deal with Royalty Pharma: The Israeli biotech will receive $75 million in R&D funding to conduct a Phase 2b trial of its anti-IL-15 antibody, called TEV-‘408, in vitiligo. Royalty could also provide up to $425 million for Phase 3 development, depending on the results of that Phase 2b study. Royalty is eligible for milestone payments and a royalty on global sales. — Ayisha Sharma 💵 Pfizer Ventures joins $61M fundraise for Vibrant Therapeutics: The US-China biotech will use the proceeds to advance its pipeline, including its lead candidate for solid tumors, called VIB305. The candidate is currently in Phase 1 development in China and Australia, with US studies on the horizon. Pfizer Ventures chipped in as a new investor alongside several other backers. — Ayisha Sharma 💰 Recludix Pharma clinches $20M milestone from Sanofi: The payment was triggered because Recludix started dosing healthy volunteers in a Phase 1 trial of its STAT6 inhibitor, called REX-8756. Sanofi and Recludix’s deal , which dates back to 2023, features more than $1.2 billion in milestones. — Ayisha Sharma

The “blowout sales performance” has increased the confidence of William Blair analysts in Brinsupri’s “multi-blockbuster sales potential longer term,” according to a Jan. 9 note. Early launch numbers of Brinsupri are so strong that Insmed couldn’t wait for the J.P. Morgan Healthcare Conference to share them. The first-in-class inflammatory drug shattered Wall Street estimates in its first full quarter on the market, fueling fresh confidence in its blockbuster potential.Friday, Insmed announced preliminary Brinsupri total revenues of about $144.6 million in the fourth quarter of 2025. That sum beat Wall Street’s consensus projections by more than 150% in what Mizuho analysts called “a ginormous result.”Insmed’s share price jumped about 10% in premarket trading Jan. 9, although the stock has not fully recovered from the damage dealt by Brinsupri’s phase 2 trial flop in chronic rhinosinusitis without nasal polyps (CRwNP) in December.Approved by the FDA in August—and by the European Commission in November—to treat the chronic lung disease bronchiectasis, Brinsupri is the first DPP-1 inhibitor to reach the market and the first drug specifically cleared for the condition. The drug’s fourth quarter sales marked a significant acceleration from the $28.1 million it collected in the third quarter following its U.S. launch.Insmed plans to debut the drug in the European Union in the first half of 2026, with additional approvals anticipated in the U.K. and Japan this year.The “blowout sales performance,” meanwhile, has increased the confidence of William Blair analysts in Brinsupri’s “multi-blockbuster sales potential longer term,” according to a Jan. 9 note. The team expects the drug to reach blockbuster status in 2027 and has put its 2029 sales at nearly $3.3 billion. The Brinsupri sales beat was aided by a roughly 9% benefit from inventory build, according to an Insmed presentation. But this level was in line with the company’s expectations and was meaningfully lower than the 40% reported for the third quarter, the William Blair team noted.“[T]his is undoubtedly a clean beat,” Evercore ISI analysts wrote in a separate note Friday. The drug’s haul topped even the highest estimates of around $120 million to $125 million previously floated by investors, which accounted for inventory benefits, the analysts pointed out.Brinsupri added about 9,000 new patients in the fourth quarter, bringing its cumulative total to 11,550 as of the end of last year, according to Insmed. The number of prescribers also reached about 4,000, up from 1,700 in September. Despite the upbeat performance, Insmed, in a Jan. 9 presentation, tried to rein in expectations for 2026 with a few reasons for caution. These include routine patient out-of-pocket cost resets at the beginning of a year, as well as potential higher rebates and access criteria as payer contracts are finalized. While the CRwNP failure last year dented Insmed’s share price, analysts mostly remained bullish on Brinsupri’s potential. Even after the setback, TD Cowen analysts maintained modeled peak sales of $4.3 billion for the drug, according to a Dec. 17 note.Insmed expects a topline readout from another phase 2b study, called Cedar, of Brinsupri in hidradenitis suppurativa in the second quarter of 2026. DPP-1 has drawn increased interest from biopharma companies as a novel target for inflammatory diseases. Right before Brinsupri’s anticipated FDA go-ahead, inflammatory disease-focused startup Expedition Therapeutics licensed a DPP-1 candidate from Fosun Pharma in a potential $645 million deal. Back in 2023, Chiesi obtained a license to a DPP-1 inhibitor from China’s Haisco Pharmaceutical.Boehringer Ingelheim, too, has a potential rival DPP-1/CatC inhibitor, verducatib (BI 1291583), which was pushed into phase 3 testing in bronchiectasis last year.For its part, Insmed is also developing a next-generation DPP-1 drug, INS1033, and is moving toward the clinic in two large immunology indications—rheumatoid arthritis and inflammatory bowel disease—as the company expects to file an investigational new drug application with the FDA in 2026.