PTC THERAPEUTICS, INC. (NASDAQ:PTCT) Files An 8-K Regulation FD DisclosureItem 7.01.Regulation FD Disclosure.
On January 27, 2018, PTC Therapeutics, Inc. (the “Company”) issued a press release (the “press release”) announcing the presentation of preliminary data from Part 1 of the FIREFISH trial in Type 1 SMA infants at the International Scientific Congress on Spinal Muscular Atrophy in Krakow, Poland. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”). A copy of the presentation is also attached to this Report as Exhibit 99.2 and is incorporated by reference into this Item 7.01. Additionally, copies of three posters that were presented at the conference, 1) Mercuri et al. (L. Servais as presenting author), "Updated pharmacodynamic and safety data from SUNFISH Part 1, a study evaluating the oral SMN2 splicing modifier RG7916 in patients with Type 2 or 3 spinal muscular atrophy" (the “SUNFISH poster”), 2) Chiriboga et al. (D. Kraus as presenting author) "Preliminary Evidence for Pharmacodynamics Effects of RG7916 in JEWELFISH, a Study in Patients with Spinal Muscular Atrophy who Previously Participated in a Study with Another SMN2-Splicing Targeting Therapy" (the “JEWELFISH poster”), and 3) Poirier et al. (L. Mueller as presenting author), "Relationship Between Central and Peripheral SMN Protein Increase Upon Treatment with RO7034067 (RG7916)"(the “SMN protein poster”), are attached to this Report as Exhibits 99.3, 99.4 and 99.5, respectively, and are incorporated by reference into this Item 7.01.
The presentationwas authored and givenbyDr.GiovanniBaranellofrom the Fondazione Istituto Neurologico Carlo Besta in Milan,Italy, who is a third-party investigator in the trial, and was neither prepared nor presented by or on behalf of the Company. The SUNFISH poster was authored by Dr. Eugenio Mercuri from the Paediatric Neurology and Nemo Center at Catholic University and Policlinico Gemelli in Rome, Italy, who is a third-party investigator in the trial. The JEWELFISH poster was authored by Dr. Claudia A. Chiriboga from the Department of Neurology at Columbia University Medical Center in New York, NY, who is a third-party investigator in the trial. The SMN protein poster was authored by Dr. Agnes Poirier from the Roche Innovation Center in Basel, Switzerland. The SUNFISH poster and the JEWELFISH poster were neither prepared nor presented by or on behalf of the Company. The Company is providing the presentation and the posters as a convenience for investors for informational purposes.
The information in this Current Report on Form 8-K, including Exhibits 99.1, 99.2, 99.3, 99.4 and 99.5 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward Looking Statements:All statements, other than those of historical fact, contained in this Current Report on Form 8-K, including those contained in Exhibits 99.1, 99.2, 99.3, 99.4 and 99.5, are forward-looking statements, including regarding any advancement of the joint development program in SMA with PTC, Roche, and SMAF, in particular as related to the timing of enrollment, completion and evaluation of the Phase 2 clinical studies of RG7916 in SMA patients and the period during which the results of the studies will become available; the clinical utility and potential advantages of RG7916, including its potential to impact every aspect of the disease. The Company's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to the initiation, enrollment, conduct and availability of data from either the SUNFISH or FIREFISH studies and the outcome of such studies; and the factors discussed in the “Risk Factors” section of the Company's most recent Quarterly Report on Form 10-Q as well as any updates to these risk factors filed from time to time in the Company's other filings with theSEC. You are urged to carefully consider all such factors. The forward-looking statements contained herein represent the Company's views only as of the date of this Current Report on Form 8-K and the Company does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this Current Report on Form 8-K except as required by law.
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Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
PTC THERAPEUTICS, INC. ExhibitEX-99.1 2 ex991ptcpressrelease12718.htm EXHIBIT 99.1 Exhibit Preliminary Data from FIREFISH trial in Type 1 SMA Infants Presented at the International Scientific Congress on Spinal Muscular AtrophySOUTH 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.