SpringWorks' Investigational Cancer Treatment Is Standard Care, Analyst Unfazed By FDA Update

In March, the FDA issued SpringWorks Therapeutics Inc SWTX with a Form 483 letter due to a failure to ensure that the analysis of an exploratory endpoint in the Phase 3 DeFi trial, which evaluated nirogacestat for the treatment of desmoid tumor (DT) patients that have experienced progressive disease.

Desmoid tumors are noncancerous growths that occur in the connective tissue. Desmoid tumors most often occur in the abdomen, arms, and legs.

In June, SpringWorks Therapeutics announced that the FDA updated the Prescription Drug User Fee Act action date for the New Drug Application for nirogacestat from the previous date of August 27, 2023, by three months.

HC Wainwright notes that new tumors were included in calculating the sum of target tumors for seven patients, which was not under the statistical analysis plan (SAP). 

However, there was no change to nirogacestat's efficacy profile after SpringWorks corrected the analysis. 

The analysts Robert Burns and Raghuram Selvaraju note that the FDA has completed all required inspections.

Accordingly, given the strength of the DeFi trial results, the analysts continue to view nirogacestat as the eventual standard-of-care regimen for treating DTs and write that it should ultimately receive FDA approval, including pain reduction in the label. 

The analyst reiterates the Buy rating for the stock with a price target of $66, noting that the FDA inspection report does not alter the analyst's conviction regarding nirogacestat's probability of approval.

Price Action: SWTX shares are down 2.42% at $27.78 on the last check Thursday.