Where does Amgen’s Sjögren’s drug show an advantage?
- In a phase III trial involving 648 patients with moderate to severe systemic disease activity, both monthly and quarterly dazodalibep met the primary endpoint: at week 48, disease activity scores fell by 1.8 and 1.4 points more than placebo, respectively. Monthly dosing also significantly improved patient-reported dryness symptoms, including dry mouth.
- Goldman Sachs sees modest differentiation relative to Novartis’s ianalumab: dazodalibep produced a numerically greater reduction in systemic disease activity scores, and improvement in dryness symptoms was statistically significant. However, neither drug’s improvement over placebo reached the widely cited 3-point threshold for a minimum clinically important improvement.
- Convenience of administration and indication scope also affect competition. Ianalumab can be injected subcutaneously at home; dazodalibep requires intravenous infusion at a clinic but can be given quarterly. In the trial, rates of adverse events, serious adverse events and discontinuations due to adverse events were similar to placebo for both dazodalibep regimens.
Why do the next phase III data affect commercial potential?
- The reported OASIZ-301 trial enrolled Sjögren’s patients with more severe systemic disease activity; another phase III trial, OASIZ-303, targets patients with more severe symptoms such as dryness, pain and fatigue but lower systemic organ activity. Its data are expected in the fourth quarter of 2026.
- Positive results from both trials could support a broader indication covering different patient types. Goldman Sachs forecasts peak dazodalibep sales of approximately 1.8 billion dollars, in line with the FactSet market consensus; the bank rates Amgen buy, with a 12-month price target of 481 dollars.
How did CRISPR Therapeutics’ allogeneic CAR-T perform?
- In a phase I trial in refractory systemic sclerosis, 6 people had received zugo-cel as of 27 April 2026, with a median follow-up of 2 months. At the last follow-up, the median skin thickening score fell from 36 to 25.5; among 4 patients followed for 28 days, 4 met the rCRISS-25 composite response criterion.
- Both patients followed for 3 months met the more stringent rCRISS-50 criterion. Goldman Sachs considers the results broadly comparable to rival CAR-T therapies using patients’ own cells, but the samples and follow-up periods differ, and longer-term data are needed to determine how long the effects last.
- On safety, the trial recorded no immune effector cell-associated neurotoxicity syndrome or grade three or higher cytokine release syndrome; one patient did, however, experience a serious pulmonary embolism considered possibly treatment-related. Goldman Sachs rates CRISPR Therapeutics neutral, with a 12-month price target of 55 dollars.
What distinguishes Allogene’s dual-target approach?
- Allogene’s ALLO-329 targets both CD19 and CD70, aiming to eliminate B cells and some T cells. Goldman Sachs believes this design may reduce or eliminate the need for chemotherapy-like lymphodepletion before infusion, potentially expanding the treatable population.
- The first two dose groups in the phase I trial included 9 patients in total, with a median follow-up of 65 days; some patients did not receive lymphodepletion. B-cell suppression was observed after infusion regardless of whether a lymphodepletion regimen was used, and no dose-limiting toxicity occurred.
- In one systemic sclerosis patient treated at the second dose level, the skin thickening score fell from 19 on the day of treatment to 6 at month 3. Goldman Sachs is watching data from additional dose groups and patients who did not receive lymphodepletion, because higher doses may be necessary to achieve efficacy.