[U: Approved!] Ed Silverman's Pharmalot: Sotatercept Will Be FDA Approved At Close Of Business Today...

We had long ago (in September 2023) reported that the drug candidate had shown remarkable results, and had won priority review at FDA. Today is decision day, and it is a near certainty that it will be approved after tonight's NYSE closing bell. This development portends to add, and add materially, to Merck's revenue and profitability. This is likely so, because it is the only known approach to treating PAH, and as such, it is a treatment for a fairly rare blood vessel disorder -- one which primarily presents in middle aged women.

The candidate came into Merck's fold as part of the Acceleron deal in 2021. The company had said it expected PAH to be a roughly $7.5 billion market, by 2026 -- when it announced that ~$11 billion M&A deal.

So. . . Rahway essentially took title to all of Acceleron's R&D assets for about one and one half times the expected annual revenue of one of its drugs -- starting tomorrow. That's smart deal making. Here's Ed's very fine and long standing property, with the news of the day:

. . .The Food and Drug Administration is expected to approve Merck’s drug to treat a rare lung disorder called pulmonary arterial hypertension on Tuesday, making available a novel treatment for a deadly condition that’s long been challenging to treat.

In a large trial published last year, the drug, called sotatercept, exceeded expectations in significantly increasing the distance that patients could walk and cutting the risk that their condition would worsen, that they would die, and that they would need new treatments. . . .

Now you know -- onward, baffled at how a cargo ship flagged from Singapore -- just starting a 27 day long journey. . . finds itself striking the Francis Scott Key Bridge in the first hour of its journey, collapsing the bridge like an "Iron Man" movie scene, and leaving at least seven cars with people in them in the water, in need of rescue. It seems someone wasn't being. . . very careful.

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