Great find. Keep in mind Pharma companies always insert a pre-specified early look at the data to enable potential stoppage, whether for futility/safety or if warranted for efficacy. Usually they do this when a minimum number of patients have reached an event, and if memory serves the primary endpoint of that resq trial is ORR, so the biostats folks will try to predict how many patients need to be enrolled to hit that event, and that would be the accelerated pathway if positive and warranting an early halt. From that presentation it seems sometime in H2'26 could be the first look at the data, once all patients fully enroll, but potentially sooner depending on how quickly they enroll. That would imply filing H1'27 and potential for fast track if the data is good, so potential H2'27 approval if I had a guess, shaving 1yr off that timeline. Faster enrollment could yield H1'27 approval. Point being enrollment numbers will be a key metric to look for in that trial.
Okay I just wrote all that and am seeing two press releases today, holy shit!
They will be filing in papillary NMIBC, submitting BLA for new BCG alternative and submitting BLA for NSCLC all in 2025. That is some big time news! That means accelerated approval filing with the ReSq trial being the ongoing Ph3!
Can someone confirm that Opdivo is the only PD1 to be used in the ResQ trial? If so, BMS is for sure the #1 target for M&A by PSS, which makes sense given previous ties to Celgene.
So everything I wrote above shifts forward, let's assume they submit in Q4'25 as the worst case scenario, by then enrollment will be nearly fully complete and for sure past the midway. Let's assume they do not get fast-track, so worst case Q4'26 approval and best case Q2'26 approval if they do get fast track. That is potential massive expanded market in the next 12-18 months. not to mention possible EU/UK NMIBC.
This was the news I was looking for, needle moving update. Good things folks, now that 30$ analyst call is starting to make sense. |
