Obviously, the news that $BNTX and Roche are stopping their cancer "vaccine" study in adjuvant colorectal cancer is not good. It's also not that big a surprise. This is a reminder that this technology won't work in every cancer and may work best in the areas where medicines like Keytruda are already effective. Keytruda is only used in colorectal cancer when it is driven by defects in DNA repair (MSI-High or mismatch repair deficient cancer). So this was a longer-shot trial. The one to watch for the $BNTX is pancreatic cancer. The biggest market for such treatments -- and the one valuations will swing on -- is non-small cell lung cancer, which is also the big market for Keytruda. This is probably less of a big deal than it seems at first glance. $BNTX $ARCT $MRNA $MRK are all down.

$ALNY -5% this morning Sellside comments re: the 1.14 event rate ratio from the stabilizer (combo) arm of the CARDIO-TTRansform study: Paul Matteis, Stifel "While minimal benefit was largely expected for the eplontersen/tafamidis combo arm in CARDIO-TTRansform, it's an incremental surprise to see that the combination had a hazard ratio of 1.14--clearly worse than expected." Michael Leuchten, Jefferies: "The presentation showed a treatment effect of rate ratio (RR) 1.14 for the baseline stabiliser group vs overall RR of 0.89, with a strong enough interaction p-value (0.017) suggesting a potential differential treatment effect between patients without stabiliser at baseline. The primary endpoint curves in patients that were on stabilisers at baseline do not show an improvement over time, if anything there is a worsening rate in the combination group." Cory Kasimov, Evercore: "...the 1.14 RR in pts on baseline stabilizers was the key metric investors cared about most coming in and will likely not be viewed favorably as it relates to implications for ALNY. At first glance, the results appear less suggestive of a trial-design issue and more consistent with a potential limitation to the incremental benefit of dual therapy with silencers and stabilizers, further entrenching the competitive positioning of the stabilizer class."

FDA approves Roivant $ROIV therapy for rare autoimmune disease Matt Gline is steering Roivant in the direction of Insmed, BridgeBio, Argenx, and other companies that have figured out how to develop and sell drugs for “big orphan” diseases where relatively high prices are accepted. Lisraya is the first drug that will test Roivant’s ability to match the commercial success of those biotech peers.  “It’s exciting, in that it’s the first time we have this opportunity. It’s daunting in the sense that, now, the onus is on us to deliver,” Gline added. 

Alnylam’s $ALNY heart drug troubles take center stage at a cardiology conference #ESC26# kicks off tomorrow morning, where we will get full data from the failed CARDIO-TTRansform study of eplontersen. Important Alynylam read-thru...

Call it the mystery of Moderna’s magic algorithm. The company's therapeutic cancer vaccine, intismeran autogene, would be the first approved medicine whose genetic instructions — that is, the individual letters of its mRNA — is determined by a computer. "I have no idea” what’s in Moderna’s algorithm, one expert says. But we have some clues. Also: What the head of R&D at Merck says about the idea that perhaps the efficacy is not due to the algorithm at all -- but just to the effects of an mRNA lipid nanoparticle. By me, @Jasonmmast and @angRchen $MRNA $MRK

Our story: FDA approves new pancreatic cancer drug expected to usher in new era of treatment The therapy, Rasonque from Revolution Medicines $RVMD, nearly doubled overall survival in a key clinical trial

New treatments for common cardiovascular risk factor near the market, with billions at stake My colleague @DrewQJoseph takes a look at the race to develop drugs targeting Lp(a) — $NVS $AMGN and $LLY

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