TEV-53408

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

Teva again turns to Royalty for funding assistIn an effort to speed development of its anti-IL-15 antibody TEV-’408, Teva has sold certain rights to Royalty Pharma for up to $500 million, including an initial $75 million to support a Phase IIb study in vitiligo. Royalty Pharma also has an option to commit a further $425 million to co-fund a Phase III programme."This agreement…enables us to advance our science more efficiently and accelerate our pipeline," said Richard Francis, Teva's CEO. The Israeli drugmaker is increasingly investing in innovative medicines as part of its strategy to transition away from its pure-play generics past into a biopharmaceutical company.Teva said that emerging data from ongoing Phase Ib work provides preliminary support for IL-15 as a potential therapeutic target to treat a broad variety of autoimmune conditions, with results set to be shared this year. TEV-'408 is also in Phase IIa development for coeliac disease.If TEV-'408 is approved and launched, Teva will pay a milestone to Royalty Pharma and a royalty on worldwide net sales of the drug. The agreement mirrors one signed between the parties in 2023 focused on a once-monthly subcutaneous version of Eli Lilly's atypical antipsychotic Zyprexa (olanzapine), known as TEV-'749, which was recently submitted to the FDA.Kinaset raises $103M to advance inhaled JAK inhibitorKinaset Therapeutics closed an oversubscribed $103-million series B round to advance frevecitinib (KN-002), a novel inhaled pan-JAK inhibitor for patients with severe asthma inadequately controlled by standard maintenance therapies. The latest fundraise was led by RA Capital Management and Forge Life Science Partners, with contributions from new financers EQT Life Sciences, Vivo Capital, Schroders Capital, Willett Advisors, Pictet Alternative Advisors, Sixty Degree Capital and existing backers Atlas Venture, 5AM Ventures and Gimv.The biotech noted that the proceeds will fund a Phase II study of frevecitinib, which targets both eosinophilic and non-eosinophilic asthma phenotypes. "Frevecitinib has the potential to benefit all patients with severe asthma, including those with a non-eosinophilic phenotype," said Robert Clarke, chief executive of Kinaset.Kinaset debuted in 2020 backed by a $40-million series A commitment, alongside securing a global exclusive licence from Vectura to develop and commercialise frevecitinib.Lynk secures Phase III win for oral antirheumatic drugLynk Pharmaceuticals on Monday said its oral JAK1 inhibitor zemprocitinib (LNK01001) — commercially partnered with Simcere in Greater China — met the primary and key secondary goals in a Phase III trial involving patients with moderate-to-severe rheumatoid arthritis who have had an inadequate response to biologic disease-modifying drugs.The study enrolled 430 patients, who were randomised to receive zemprocitinib 12 mg or placebo twice daily, with the primary endpoint being ACR20 — a composite measure of disease improvement. At week 24, the ACR20 response rate with zemprocitinib was 79.1%, which was significantly greater than the 39.7% for placebo. Moreover, key secondary goals were also met, with the respective rates of ACR50 and DAS28 (CRP) ≤3.2 at week 24 for the zemprocitinib arm reaching 55.8% and 67.0%, respectively, compared with 22.0% and 23.4% for placebo.The company noted the experimental drug's safety profile was favourable, with most treatment-emergent adverse events being mild-to-moderate and no new safety signals were identified.Lyra suspends all drug development work Lyra Therapeutics will suspend further development of LYR-210 — a bioabsorbable implant designed to deliver six months of continuous mometasone furoate — for the treatment of chronic rhinosinusitis (CRS) in order to weigh strategic alternatives. The company cut 75% of its staff in mid-2024 following a Phase III failure for LYR-210.On Monday, Lyra said it will undertake another round of job reductions, which will impact its remaining 28 employees, as well as other cost-saving actions in order to buy more time. "The board has concluded that it is in the best interests of shareholders to cease Lyra's product development operations," remarked CEO Maria Palasis. The decision comes despite a second Phase III study of LYR-210 reading out positively this past June for the treatment of CRS without nasal polyps. Further, the company recently said that following a meeting with the FDA, it established a clinical development plan, which includes an additional late-stage trial to support the submission of a new drug application for LYR-210 in CRS without nasal polyps.As of September 30 last year, Lyra had approximately $22.1 million in cash, which is expected to last into the third quarter of 2026.BMS's Camzyos hits Phase III mark in teensBristol Myers Squibb reported positive topline results from a Phase III trial evaluating Camzyos (mavacamten) in 44 adolescents aged 12–17 with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The SCOUT-HCM study met its primary endpoint, showing a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at week 28 versus placebo, and achieved significance across multiple secondary endpoints as well. Safety findings were consistent with Camzyos' established adult profile, with no new safety signals.Camzyos, first approved by the FDA in 2022 for adults with symptomatic oHCM, has been prescribed to over 20,000 patients in the US alone. Monday's readout raises the possibility that Camzyos could become the first cardiac myosin inhibitor approved for adolescents, a population currently limited to medical symptom management or invasive surgery.BMS plans to present full results at an upcoming medical congress and engage with health authorities on potential regulatory submissions for adolescents.Last month, Cytokinetics' Myqorzo (aficamten) received FDA approval for adults with symptomatic oHCM.Matthew Dennis and Anna Bratulic contributed to this report.