PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Regulation FD Disclosure
On March 2, 2017, PTC Therapeutics, Inc. (“PTC” or the “Company”) issued a press release announcing the results from ACT CF, its Phase 3, double-blind, placebo-controlled, 48-week clinical trial to evaluate the efficacy and safety of ataluren (brand name: TranslarnaTM) in patients with cystic fibrosis caused by nonsense mutations, or nmCF. PTC will host a conference call Thursday, March 2, 2017, at 9:00 a.m. ET to discuss the results of ACT CF.
The full text of the press release announcing the results of ACT CF as well as information on how to access the conference call is attached as Exhibit 99.1 hereto and is incorporated by reference into this Item 7.01.
The information set forth in or incorporated by reference into this Item 7.01 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 8.01. Other Events.
On March 2, 2017, the Company announced that the primary and secondary endpoints were not achieved in ACT CF.
In the intent-to-treat population, the primary endpoint of lung function as measured by absolute change in percent-predicted FEV1 (forced expiratory volume in one second), over 48 weeks from baseline, there was a 0.6% difference in favor of ataluren versus placebo (-1.4% change on ataluren versus -2.0% change on placebo; p=0.534). For the secondary endpoint of rate of pulmonary exacerbations, there was a trend in favor of ataluren, with the rate in the ataluren group being 14% lower than the placebo group (p=0.401). The results were not statistically significant.
Item 9.01. Financial Statements and Exhibits.
(d)> Exhibits:
99.1 Press Release dated March 2, 2017
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. PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Recent Trading Information
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) closed its last trading session 00.00 at 13.18 with 1,258,278 shares trading hands.
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. PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Recent Trading Information
PTC THERAPEUTICS, INC. (NASDAQ:PTCT) closed its last trading session 00.00 at 13.18 with 1,258,278 shares trading hands.