Amgen reports Phase 3 win for dazodalibep in Sjögren's disease
The injectable fusion protein dazodalibep met its primary endpoint in the first of two pivotal Phase 3 trials in patients with Sjögren's disease.
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Thursday, October 15, 2026Thu, Oct 15
Updated 10:01 PM PT
Clinical readouts, approvals, and setbacks, financing, dealmaking, platform progress, and reported research across biotech and biopharma, including the companies building AI into biology.
The injectable fusion protein dazodalibep met its primary endpoint in the first of two pivotal Phase 3 trials in patients with Sjögren's disease.
Researchers at MIT, Massachusetts General Hospital, and Harvard Medical School have developed RamanOmics, a noninvasive technique pairing Raman vibrational microscopy with single-cell gene expression to profile senescent cells.
Novartis has licensed a preclinical radioligand cancer therapy from Chinese biotech BoomRay Therapeutics, agreeing to an upfront payment and milestones that could reach $900 million alongside future sales royalties.
Viking Therapeutics reported that patients who received its dual GLP-1 and GIP receptor agonist VK2735 maintained 85% of their weight loss after switching to once-monthly dosing.
Vertex Pharmaceuticals reported that inaxaplin, an oral small molecule designed to inhibit APOL1, improved measures on a urine test across two different patient populations with kidney disease.
Contract research and manufacturing provider Syngene International has extended its 25-year partnership with Bristol Myers Squibb through 2035, broadening work across discovery, translational medicine, clinical trials, and manufacturing.
Anthropic has launched its newest frontier model, Opus 5.5, which cuts output token pricing to $20 per million tokens compared to $25 for its predecessor.
San Diego-based Iambic Therapeutics filed for an initial public offering with the US Securities and Exchange Commission to advance its pipeline of AI-designed small molecules.
Otsuka and Ionis Pharmaceuticals reported that their Phase 3 Fusion trial of ulefnersen met its primary endpoint in 73 patients with amyotrophic lateral sclerosis caused by FUS gene mutations.
Weekly injections of enicepatide, an injectable dual GLP-1/GIP receptor agonist acquired through Roche's $2.7 billion purchase of Carmot Therapeutics, reduced HbA1c by 2.65% and body weight by 15.5% at week 48 in adults with Type 2 diabetes.
The National Institutes of Health released a pilot tool called Linked Discoveries to help scientists track citations, topic connections, and reproducibility across PubMed papers.
Beacon reported that its RPGR gene therapy, laru-zova, met its primary endpoint in an 85-patient pivotal study for X-linked retinitis pigmentosa, an inherited condition that causes progressive blindness.
Boehringer Ingelheim will use Envisagenics' SpliceCore machine-learning platform to identify and validate tumor-specific targets originating from aberrant RNA splicing, with total potential deal payments reaching $1 billion.
Regulatory T cell specialist TRex Bio and blood pressure drugmaker Retension Pharmaceuticals filed initial public offering paperwork with the Securities and Exchange Commission, joined by existing backer Eli Lilly indicating interest in buying more shares in TRex.
The FDA has approved IntraBio's Aqneursa, an orally administered modified amino acid known as levacetylleucine, to treat neurological symptoms in patients with ataxia-telangiectasia.
Australian radiopharmaceutical company Telix will acquire Germany-based ITM for $1.65 billion upfront, with up to $700 million in additional regulatory and commercial milestone payments.
Cue Biopharma reported that its injected allergy drug CUE-221 met its primary endpoint in a 145-patient Phase 2 trial for chronic spontaneous urticaria, a severe hives condition.
The FDA cleared Eli Lilly to market a combination of its oral selective estrogen receptor degrader Inluriyo (imlunestrant) and its CDK4/6 inhibitor Verzenio (abemaciclib).
Alkermes reported that its oral orexin agonist ALKS 7290 reduced symptom scores in a 50-patient Phase 1b trial in adults with attention deficit hyperactivity disorder.
Anthropic has set up a physical biology laboratory to run wet-lab experiments that validate predictions made by its artificial intelligence models, life sciences head Eric Kauderer-Abrams told Reuters.
Novo has acquired three early-stage obesity programs from New York biotech Kallyope, expanding its metabolic pipeline beyond the GLP-1 hormone class.
Hansoh Pharma's risvutatug rezetecan, partnered with GSK, and MediLink Therapeutics' tambotatug pelitecan, partnered with Roche, both cut the risk of death by 54% compared to standard topotecan chemotherapy in late-stage relapsed small-cell lung cancer trials.
Researchers at Stanford, Caltech, and UCSF found that the human brain develops from two separate progenitor cell lineages rather than a single unified origin.
Draft US regulations on outbound pharmaceutical investment in China would preserve Western companies' ability to license Chinese drug candidates, according to reporting by Reuters.
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Zealand Pharma's Zeydovio (glepaglutide), a long-acting GLP-2 analog for short bowel syndrome.
Xenon Pharmaceuticals voluntarily stopped new patient enrollment in its Phase 3 trials of azetukalner, an oral Kv7 potassium channel opener, following reports of confusion, ataxia, and rare cases of psychosis.
Bristol Myers Squibb has terminated development of ORM-6151, an antibody designed to deliver a protein degrader to CD33-expressing leukemia cells, which it bought from Orum Therapeutics for $100 million in 2023.
The confirmatory Phase 3 trial evaluated Lunsumio (mosunetuzumab), a bispecific antibody that redirects T cells to kill cancerous B cells by targeting CD20 and CD3, in earlier-line patients with follicular lymphoma.
Roche will pay Dualitas Therapeutics $36.5 million upfront to test more than 300,000 bispecific antibody pairings across immunology and inflammation targets.
The US Advanced Research Projects Agency for Health has unveiled the SPECTRA program, an effort combining computational tools and biological data to personalize autism care.