Description

Summary 

SpringWorks Therapeutics (SWTX) is finally reporting their P3 data for their lead compound nirogacestat after a year of delays.  Nirogacestat has never been studied in a placebo controlled setting before this, and efficacy is very hard to tease out in this slow progressing disease.  The delays have rendered their statistical powering assumptions meaningless and make failure highly likely.  We believe the stock can fall by 50% on failure. 

DeFi Study Has Been Repeatedly Delay Rendering the SAP Meaningless

SWTX’s DeFi study is finally about to read out.  Trial enrollment started in mid 2019.  Enrollment was completed July 22, 2020.  

This is a 140 patient study.  Their powering assumptions were for 8 months PFS in the placebo group and 20 months in the drug group and a total of 51 events.  Primary endpoint of the study is progression free survival (PFS).  Originally it was designed to only include clinical progression as assessed by the investigator.  However in April 2021 they [stealthily] changed it to include radiographic progression as well.  

Timeline for the study has been consistently pushed out.  

In August 2020 they had guided to data readout in 2Q/3Q 2021.

By February 2021 they had pushed it out to 2H 2021.

In Nov 2021 they pushed it out against to 4Q21/early 2022.