Editor’s Briefing: November 6, 2026

In Short. Novartis confirmed nine reports of tumors in patients treated with its gene therapy Zolgensma, two showing signs that the therapy's DNA had entered patients' own DNA. Biodesix updated its sales outlook, and Eton and Natera expected more revenue.

Novartis confirms tumor reports after its spinal muscular atrophy gene therapy

SPINAL MUSCULAR ATROPHY (SMA) is an inherited disease in which a faulty SMN1 gene leaves the nerve cells that control muscles without a protein they need. Zolgensma, sold by Novartis since 2019 for children under two, uses a modified virus called an adeno-associated virus (AAV) to deliver a working copy of that gene. On Thursday Novartis told BioSpace that nine tumors had been reported in patients treated with it (BioSpace). In two cases there was "evidence of vector integration into the DNA of the patients", meaning the delivered genetic material had inserted itself into the patients' own DNA. Both patients were treated and are being monitored. The other seven reports have not been causally linked to the therapy. More than 6,000 patients have received Zolgensma, and its label already warns of a possible tumor risk from AAV integration. SMA Europe, a patient group, said regulators were assessing the evidence.

Biodesix updates its sales outlook after slower growth in lung testing

Biodesix, of Louisville, Colorado, sells blood tests that help doctors judge whether a spot found on a lung scan, called a nodule, is likely to be cancer. On Thursday afternoon it reported results for the quarter ended September 30 (Biodesix release). Total revenue was $24.0m, up 10% from a year earlier, and revenue from diagnostic testing grew 16% as test volumes rose 24%. The company now expects 2026 revenue of $101m to $103m. Scott Hutton, the chief executive, said growth "was below our expectations". He gave three reasons: fewer sales representatives than planned, a larger seasonal dip in ordering from primary-care doctors, and delays by outside customers that pushed back the start of paid development projects. He said the causes were "largely execution and timing related rather than a change in demand".

Eton expects more revenue from its rare-disease medicines

Eton Pharmaceuticals, of Deer Park, Illinois, sells medicines for rare diseases, including HEMANGEOL, which is part of its franchise for infantile hemangioma, a benign blood-vessel growth that appears in some infants. On Thursday afternoon it reported results for the quarter ended September 30 (Eton release). Product sales were $57.9m, up 158% from $22.5m a year earlier. The company said the increase came from adding HEMANGEOL and from higher sales of INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, DESMODA and carglumic acid. It now expects 2026 revenue of more than $175m, compared with its earlier guidance of more than $145m. Earnings before interest, taxes, depreciation and amortization, adjusted for some items, were 49% of revenue, up from 13% a year earlier. Sean Brynjelsen, the chief executive, said the company had reached a yearly sales rate of $200m five quarters ahead of its own schedule.

Natera expects more revenue as cancer testing grows

Natera, of Austin, Texas, analyzes fragments of DNA that circulate in the blood, known as cell-free DNA, for women's health and to look for traces of cancer left after treatment, called molecular residual disease (MRD). On Thursday afternoon it reported results for the quarter ended September 30 (Natera release). Total revenue was $794.0m, up 34.1% from $592.2m a year earlier. Natera processed about 1,093,100 tests, up 22.3%, and about 339,500 cancer tests, up 60.9%. Clinical MRD cancer tests grew by 32,700 from the second quarter. Gross margin was 64.7%, compared with 64.9% a year earlier. The company now expects 2026 revenue of $3.005bn to $3.035bn, compared with its earlier range of $2.850bn to $2.910bn.

Precision BioSciences sells $125m of stock to fund gene-editing work

Precision BioSciences, of Durham, North Carolina, develops treatments that edit genes inside the body using ARCUS, an enzyme system it designed to cut DNA at chosen sites. On Thursday it priced an offering of 10,235,077 shares at $7.75 each, along with pre-funded warrants, which let some investors buy shares later for a nominal sum, for up to 5,893,964 more (Precision release). The company expects gross proceeds of about $125m before fees and expenses, with the sale due to close on or about November 6. Precision said it intends to use the money for continued research on two programs, PBGENE-HBV and PBGENE-DMD, and for general corporate purposes. New and existing investors took part, and TD Cowen and Guggenheim Securities are managing the offering.