Merck Sees A Path Forward — Albeit Slightly Elongated At FDA, For Its Next Gen Cough Therapy Candidate, Gefapixant.

There is a race afoot, among three very-capables… to see who first clears the FDA regulatory process for a new generation, prescription cough treatment. Merck had the early lead, being first to file, but FDA sent a complete response letter seeking better (actual clinical) measurements, on whether the candidate was suppressing coughs in a statistically significant way (over the prior standard therapies).

So, Merck has proposed its clinical plan for collecting that data, and in the mean time a smaller but NYSE traded outfit, called Bellus Health (NYSE: BLU), will start enrolling on its much similar candidate’s clinical trials as soon as this Fall, with likely enough data for an FDA filing in early in 2023 (including clinical data on actual cough reduction levels). So it may yet beat Merck to market. We shall see. Here is the latest, from FierceBiotech, this morning:

…After receiving a complete response letter from the FDA in January, Merck has now promised to perform new analyses to fulfill a request for more efficacy information from the agency. The Kenilworth, New Jersey-based pharma was seeking an FDA nod for gefapixant to treat refractory chronic cough or unexplained cough in adults. . . .

Merck plans to conduct “additional analyses” and the application should be back before the FDA in the first half of 2023. Meanwhile, a review timeline for a similar application in Europe has been extended to wait for the same information….

Once approved both companies are likely to see solid sales figures, but since Bellus is so much smaller, getting out first would have a proportionately much larger positive impact on its NYSE stock price. It is up over 5.4% this morning, on heavy volume — likely due to this news, out of Kenilworth.

Now you know. Onward, grinning — ever grinning.

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