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January 24, 2014
07:23 EDTPTCTPTC Therapeutics: EMA adopted negative opinion on MAA for Atuluren approval
PTC Therapeutics announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the company's marketing authorization application for conditional approval of ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy. The response from the CHMP is consistent with the company's previous guidance concerning the substantial risks regarding conditional EMA approval and underscores the importance of PTC's work in completing the ongoing confirmatory Phase 3 clinical trial. In April 2013, PTC initiated a 48-week, 220-patient confirmatory Phase 3 clinical trial of ataluren for the treatment of nmDMD. The trial is on track to complete enrollment in mid-2014 with top-line data expected in mid-2015. PTC intends to request a re-examination of the CHMP opinion with a final outcome expected in the second quarter of 2014, when the confirmatory study is expected to be more fully enrolled.
News For PTCT From The Last 14 Days
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April 23, 2015
09:18 EDTPTCTOn The Fly: Pre-market Movers
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07:51 EDTPTCTPTC Therapeutics price target raised to $155 from $135 at Oppenheimer
Oppenheimer increased its price target on PTC after the company, along with Roche (RHHBY), presented data on its RG7800 drug that the firm believes showed proof-of-mechanism in health subjects. The firm recommends owning PTC ahead of two events: the scheduled October 2015 P3 read-out of Translarna in DMD, and an update on the MOONFISH trial of RG7800 slated to occur in early 2016. The firm keeps an Outperform rating on the shares.
April 20, 2015
08:19 EDTPTCTPTC Therapeutics to present Phase 1 clinical data from SMA program
PTC Therapeutics announced that Phase 1 clinical data from the company's joint development program with Roche and the SMA Foundation in spinal muscular atrophy, or SMA, will be presented at the 2015 American Academy of Neurology 67th Annual Meeting. As previously disclosed, findings from the Phase 1 study indicated that RG7800, an investigational oral therapy for SMA, showed a favorable safety profile and was well tolerated at all dose levels studied. In addition, proof of mechanism was demonstrated by a dose-dependent effect on Survival Motor Neuron 2, or SMN2, splicing towards the production of full length SMN2 mRNA. The Phase 1 study was a single ascending dose, placebo-controlled, double-blind study in 48 healthy volunteers testing single oral doses from 0.5 to 90 mg.
07:59 EDTPTCTJPMorgan sees range-bound as best case for PTC shares
JPMorgan believes the many triple-digit price targets for shares of PTC Therapeutics factor in unrealistic expectations for the company's pipeline in the absence of positive phase 3 data. The firm expects shares to be range bound in a best case with volatility likely amid continued takeover speculation. JPMorgan thinks a potential buyer is unlikely to pay "significantly" higher than current shares levels, particularly with the Phase 3 trial of ataluren in Duchenne muscular dystrophy in Q4. The firm raised its price target for PTC shares to $77 from $65 to reflect the MPS 1 opportunity for Translarna. It reiterates a Neutral rating on the stock.
April 16, 2015
10:00 EDTPTCTOn The Fly: Analyst Upgrade Summary
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07:58 EDTPTCTPTC Therapeutics upgraded to Outperform at Cowen
As previously reported, Cowen upgraded PTC Therapeutics to Outperform from Market Perform ahead of its upcoming ACT-DMD data in the fourth quarter. The firm expects positive Phase 3 data after Phase 2 data established proof of concept. Cowen raised its price target to $120 from $70 on PTC Therapeutics to reflect the chance of success of Translarna in DMD.
07:55 EDTPTCTPTC Therapeutics upgraded to Outperform from Market Perform at Cowen
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