PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Other EventsItem 8.01.Other Events
On February 20, 2018, PTC Therapeutics,Inc. issued a press release announcing that it received a decision to its appeal of the Complete Response Letter from the U.S. Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) for Translarna (ataluren).
The press release is attached hereto as Exhibit99.1 and is incorporated herein by reference.
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Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit No. |
Description |
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Press Release, dated February 20, 2018 |
PTC THERAPEUTICS, INC. ExhibitEX-99.1 2 ex991pressrelease022018.htm EXHIBIT 99.1 Exhibit PTC Therapeutics Receives Formal Dispute Resolution Request Decision from the FDA’s Office of New DrugsSOUTH PLAINFIELD,…To view the full exhibit click here
About PTC THERAPEUTICS, INC. (NASDAQ:PTCT)
PTC Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of orally administered, small molecule therapeutics that focus on post-transcriptional control processes. The Company’s lead product, Translarna (ataluren), is used for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients with age of over five years and older. Its programs include Translarna for nonsense mutation cystic fibrosis (nmCF), Translarna for mucopolysaccharidosis type I caused by nonsense mutation (nmMPS I), Translarna for nonsense mutation aniridia, Translarna for nonsense mutation Dravet syndrome/CDKL5, Spinal muscular atrophy (SMA) in collaboration with Spinal Muscular Atrophy Foundation (SMA Foundation) and F. Hoffman-La Roche Ltd and Hoffman- La Roche Inc. (collectively Roche), and Cancer stem cell program (PTC596). It has two compounds in clinical development within the SMA program: RG7800 and RG7916.