Based on very favorable study results we last detailed on September 11, Merck is now on a fast track to FDA approval for the first candidate out of the gate, via its $11.5 billion Acceleron acquisition, of late 2021.
By rule, then FDA should announce its approval/non-approval decision — on or before March 26, 2024 (though in such cases, it is nearly a 95 per cent probability — for approval).
Once again, this show-cases Rahway’s savvy as a deal doing pharma concern. Well played — and here is the latest, from Reuters:
…Merck’s application is based on data from a late-stage study in which sotatercept, combined with a background therapy, helped patients with pulmonary arterial hypertension (PAH) to walk about 40.8 meters more in six minutes….
Sotatercept could also be the first treatment of its class, which targets a type of protein called activins that lead to higher levels of follicle-stimulating hormone associated with the disease.
J.P. Morgan analyst Chris Schott had estimated the therapy to reach peak sales of $3 billion to $4 billion.
Merck had said it expects PAH to be a roughly $7.5 billion market by 2026 when it announced the Acceleron deal….
Now you know — but no order from the Supremes yet — on the Doughty mess out of Monroe, Louisiana to the Fifth Circuit. For its part, the Fifth entered an order staying all of Doughty’s July 4 ruling until further order. So, maybe the Supremes will rely on that, and not enter a formal extension of their own stay. We shall see. Onward.
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