Cosmo Pharmaceuticals (CMOPF) announced it submitted a New Drug Applicaton (“NDA”) for Rifamycin to the FDA for approval to treat traveler’s diarrhea under an expedited review process. Market chatter suggests Rifamycin could compete with Valeant’s (VRX) Xifaxan, assuming the drug is approved:

Cosmo Pharmaceuticals earlier today announced that its New Drug Application for Rifamycin has been submitted to the FDA seeking market authorization for the treatment of traveler’s diarrhea under an expedited review process in the U.S. Rifamycin, if approved, would compete with Valeant Pharmaceuticals’ largest product, Xifaxan, which is indicated to treat both traveler’s diarrhea and irritable bowel syndrome with diarrhea and generated $979M of sales in 2017, Wells Fargo analyst David Maris tells investors in a research note.

Wells Fargo’s (WFC) Maris implies Rifamycin could garner FDA approval in the second half of this year and launch in early 2019.



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