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Industry News
Industry events covered by at least two independent newsrooms, plus prominent-outlet exclusives. BioSpace and press releases do not count as independent coverage.
Ultragenyx said its experimental treatment for Angelman syndrome failed a phase 3 study, showing no benefit over a sham treatment. The result is a late-stage setback for an antisense approach to treating this rare neurodevelopmental disorder.
Source: STAT
More: Endpoints News
Teva said a single dose of its experimental antibody reduced intestinal damage in people with celiac disease who underwent a daily gluten challenge. The result supports further testing of a drug approach to limiting gluten-triggered injury, but it is still a company-reported, mid-stage finding rather than an approved treatment.
Source: Endpoints News
More: Fierce Biotech, MedCity News
Typewriter raised $56 million to develop jumping-gene technology and in vivo CAR-T therapies, Endpoints reported in an exclusive. Its approach could offer a way to deliver whole genes without viral carriers or bacterial-derived editing enzymes, but that potential is not evidence of clinical success.
Source: Endpoints News (exclusive)
Simcere Zaiming licensed global rights to a preclinical, B-cell-directed trispecific antibody to Roche for $75 million upfront. The deal adds another immune-disease approach to Roche's pipeline, but the preclinical stage means clinical benefit remains to be established.
Source: Endpoints News
More: Fierce Biotech
Alumis' TYK2 inhibitor envudeucitinib missed both primary and secondary goals in a phase 2b lupus trial. The company still plans phase 3 on the strength of a prespecified subgroup, so its next development bet rests on a narrower signal than a successful overall study.
Source: Endpoints News
More: BioPharma Dive, Fierce Biotech
ArsenalBio cut 99 jobs and stopped work on its ex vivo clinical assets as it pivots to in vivo CAR-T for solid tumors. This is a retreat from the existing clinical pipeline, not just a staffing cut, as the remaining effort shifts to a different cell-therapy strategy.
Source: Endpoints News
More: Fierce Biotech
Novartis said remibrutinib, marketed as Rhapsido, reduced relapse rates and met the main goals of two phase 3 multiple-sclerosis trials. No liver-safety signal was reported, a potentially important distinction from other BTK inhibitors that have encountered liver-related side effects.
Source: Endpoints News
More: BioPharma Dive, Fierce Pharma
GSK plans to start phase 3 testing of its mRNA flu vaccine after reporting stronger immune responses than licensed comparators in a 971-person phase 2 study. Its two-protein design offers a potential point of difference from Moderna's shot, but stronger immune responses are not yet proof of better protection.
Source: Endpoints News
More: Fierce Biotech, MedCity News
Novartis halted its autoimmune CAR-T program after three trial deaths, while Bristol Myers paused a similar program following immune-related side effects. The setbacks interrupt two attempts to expand cell therapy into autoimmune disease and make safety a central hurdle for those programs.
Source: Endpoints News
More: BioPharma Dive, Fierce Biotech
Nine more drugmakers reached voluntary pricing agreements with the White House, including participation in a Medicaid model tied to international prices. For the companies, the negotiations also concern tariffs and participation in federal pricing programs, putting the agreements in a broader policy context than the discount alone.
Source: Endpoints News
More: BioPharma Dive, STAT
Lilly agreed to buy Merida Biosciences for up to $2.875 billion, adding autoimmune and allergy programs led by the Graves' disease candidate MER511. Merida says its approach aims to remove disease-causing antibodies without broadly suppressing immunity, giving Lilly a distinct strategy for expanding its immune-disease pipeline.
Source: Endpoints News
More: BioPharma Dive, Fierce Biotech, GEN
AstraZeneca reported improvements in cardiac function with its oral relaxin agonist in a phase 2b heart-failure study, although the benefit did not extend to all patients. The mixed result offers a reason to keep investigating the approach while leaving uncertainty about which patients might benefit.
Source: Endpoints News
More: Fierce Biotech
Novartis plans a phase 3 trial of its anti-IL-6 antibody to test whether reducing inflammation can prevent cardiovascular events in higher-risk patients. Earlier reductions in inflammation are encouraging, but the decisive question is whether they translate into better heart outcomes rather than improved biomarkers alone.
Source: Endpoints News
More: STAT
Takeda and Protagonist won FDA approval for rusfertide, branded Mimrylo, to treat the rare blood cancer polycythemia vera. It adds a new treatment approach where options are limited and gives Takeda a launch as its leading product faces patent expirations.
Source: Endpoints News
More: BioPharma Dive, Fierce Pharma, MedCity News, STAT
BioNTech and Genentech ended a phase 2 colorectal-cancer vaccine study after an independent safety board found a numerical imbalance in deaths against the vaccine arm. The study's termination is a setback in colorectal cancer; its different setting limits comparisons with Merck and Moderna's vaccine result.
Source: Endpoints News
More: Fierce Biotech
Cytokinetics presented detailed Acacia results reporting benefits and tolerability for Myqorzo in non-obstructive hypertrophic cardiomyopathy. The data support a bid to expand the heart drug's use into another patient group, though that broader use still depends on regulatory approval.
Source: Endpoints News
More: Fierce Pharma, STAT
Detailed CARDIO-TTRansform results showed no cardiovascular benefit from adding AstraZeneca and Ionis' Wainua to background stabilizer treatment in ATTR-CM. The findings challenge the case for combining these approaches in TTR heart disease, without establishing that all RNA-silencing drugs lack benefit in every setting.
Source: STAT
Under a new antibody-drug conjugate pact, DualityBio will receive $45 million from Genentech at signing and could earn over $1 billion in milestones. The collaboration targets resistance to existing antibody-drug conjugates, while the headline billion-dollar value depends on future milestones rather than cash paid at signing.
Source: Endpoints News
More: Fierce Biotech
Electra Therapeutics filed for an IPO to support its immunology and cancer pipeline, including phase 2/3 development of its immunology drug. The filing is a step toward financing further clinical work, not evidence that the offering has closed or the drug has succeeded.
Source: Endpoints News
More: Fierce Biotech
The FDA approved Priovant's Lisraya, or brepocitinib, for dermatomyositis, a rare autoimmune disorder. The clearance gives the Pfizer-licensed asset its first approved use, while trials in three other rare immune disorders offer potential expansion rather than established new indications.
Source: Endpoints News
More: BioPharma Dive, MedCity News, STAT
Tezspire cleared its phase 3 study objectives in eosinophilic esophagitis, AstraZeneca and Amgen reported. An approval would give it a third indication and offer a biologic alternative to Dupixent in this disorder, but the trial result is not itself a regulatory clearance.
Source: BioPharma Dive
More: MedCity News
Akeso reported a phase 3 biliary-tract cancer win for ivonescimab, its antibody targeting PD-1 and VEGF. The result supports exploring the drug beyond lung cancer, although the company's interpretation continues to face scrutiny and is not a new approval.
Source: Fierce Biotech
More: Endpoints News
Cellares plans 68 job cuts in New Jersey after losing its Bristol Myers cell-therapy manufacturing contract. Bristol Myers questioned the readiness of Cellares' manufacturing technology and Cellares disputes that assessment, making this a technology-execution issue as well as a capacity reduction.
Source: Fierce Pharma
More: Endpoints News
Spyre is deprioritizing SPY072 as a standalone rheumatoid-arthritis treatment after disappointing phase 2 results for its anti-TL1A antibody. The readout erased more than $1 billion in market value and raises indication-specific questions about TL1A inhibition, rather than settling its prospects in other diseases.
Source: Fierce Biotech
More: BioPharma Dive
SK Biopharmaceuticals licensed Biohaven's epilepsy candidate opakalim in a deal with $350 million upfront and potential payments totaling $795 million, plus royalties. Biohaven gains funding without issuing shares as cash dwindles, while SK adds a pivotal-stage epilepsy asset to its potential commercial pipeline.
Source: MedCity News
More: PR Newswire, BioPharma Dive, Fierce Biotech
The FDA approved Revolution Medicines' Rasonque, or daraxonrasib, as the first RAS inhibitor for advanced pancreatic adenocarcinoma. Trial results showing nearly twice the median survival add weight to the approval in a disease with few treatment options.
Source: Fierce Biotech
More: BioPharma Dive, GEN, MedCity News, STAT