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PTC Therapeutics Inc (PTCT.OQ)

PTCT.OQ on NASDAQ Stock Exchange Global Select Market

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27 Mar 2017
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Latest Key Developments (Source: Significant Developments)

PTC says they "plan to re-examine the price of Emflaza": Conf Call
Thursday, 16 Mar 2017 08:00am EDT 

PTC Therapeutics Inc : PTC says prior to FDA approval, access to Emflaza has been limited to small number of patients, "We aim to close this gap with the launch": Conf Call . PTC says deal will diversify its business, enabling revenue generation through 2 products, & expanding commercial geographic footprint to include us: Conf Call . PTC says they "plan to re-examine the price of Emflaza": Conf Call . PTC says Emflaza launch would enable it to establish a complete U.S medical sales and marketing footprint ahead of a potential Translarna launch : Conf Call . PTC says anticipate an increase in operating expenses in 2017 : Conf Call . PTC says Emflaza sales are expected to begin later this year : Conf Call . PTC says "we appreciate that pricing is receiving a lot of attention and we believe that a change needs to be made": Conf Call . PTC says "ensuring access to the drug (Emflaza) is a priority and until recently only a small fraction of patients had access": Conf Call . PTC says it's "premature" to comment on exactly what that price level (for Emflaza) is going to be at this time: Conf Call . PTC "we'll think about updating our guidance in terms of operating expenses probably on our Q1 call as we close the (Emflaza) launch & finalize plan: Conf Call . PTC says "really prior to this approval there is really less than 10 percent of patients that were able to get Emflaza": Conf Call.  Full Article

PTC Therapeutics reports Q4 loss per share of $0.78
Thursday, 16 Mar 2017 07:30am EDT 

Ptc Therapeutics Inc : Total revenues for Q4 of 2016 were $25.2 million versus $12.7 million in same period of 2015 . For 2017, ptc expects to achieve ex-U.S. Translarna net sales between $105 and $125 million . Net loss for Q4 of 2016 was $26.8 million compared to a net loss of $50.9 million for same period in 2015 . PTC is reviewing its guidance for 2017 operating expenses and ending cash in light of PTC's planned acquisition of Emflaza . Translarna net product sales were $25.1 million for Q4 of 2016, representing 98 pct growth versus $12.7 million in Q4 of 2015 . Two SMA clinical trials on track to advance into pivotal studies in 2017 . Qtrly loss per share $0.78 .Q4 earnings per share view $-1.07, revenue view $24.0 million -- Thomson Reuters I/B/E/S.  Full Article

PTC Therapeutics to buy Emflaza
Thursday, 16 Mar 2017 07:15am EDT 

PTC Therapeutics Inc : PTC Therapeutics announces agreement to acquire Emflaza™ for the treatment of duchenne muscular dystrophy in U.S. . PTC Therapeutics Inc- transaction is expected to be accretive to both earnings and cash flow beginning in 2018 . PTC Therapeutics Inc - deal comprised of approximately $75 million in cash and approximately $65 million in PTC common stock . PTC Therapeutics Inc- in addition, marathon has opportunity to receive a single $50 million sales-based milestone . PTC Therapeutics Inc - deal for $140 million upfront consideration . PTC Therapeutics Inc - Marathon is also entitled to receive payments from ptc based on annual net sales of emflaza beginning in 2018 .PTC Therapeutics Inc- has entered into an asset purchase agreement with Marathon Pharmaceuticals, Llc to acquire all rights to emflaza.  Full Article

PTC Therapeutics announces FDA acknowledgment of NDA filing for translarna
Monday, 6 Mar 2017 08:00am EST 

PTC Therapeutics Inc : PTC Therapeutics announces FDA acknowledgment of new drug application filing for translarna for the treatment of nonsense mutation duchenne muscular dystrophy .Fda has assigned a PDUFA date of October 24, 2017.  Full Article

PTC Therapeutics says EU ratifies positive CHMP opinion for renewal of Translarna
Monday, 9 Jan 2017 05:48pm EST 

Ptc Therapeutics Inc - :PTC therapeutics - European Commission adopted positive decision granting annual renewal of conditional marketing authorization for translarna.  Full Article

PTC Therapeutics provides corporate update
Monday, 9 Jan 2017 08:00am EST 

PTC Therapeutics Inc : Preliminary 2016 translarna unaudited net sales of approximately $81 million . Translarna 2017 net sales guidance of $105 to $125 million . Topline act cf data anticipated late Q1 2017 . Non-GAAP operating expenses for 2017 are expected to be between $190 and $200 million .PTC expects to finish 2017 with approximately $160 million of cash and cash equivalents.  Full Article

Camber Capital Management LLC reports 5.84 pct passive stake in PTC Therapeutics
Thursday, 29 Sep 2016 11:40am EDT 

Camber Capital Management LLC:Camber Capital Management LLC reports 5.84 pct passive stake in PTC Therapeutics Inc as of Sept. 19 - SEC filing.  Full Article

PTC Therapeutics qtrly Translarna net sales of $15.4 mln
Thursday, 4 Aug 2016 04:05pm EDT 

PTC Therapeutics Inc : Says full-year Translarna net sales on-track to meet guidance of $65m to $85m . Says ema review of european marketing authorization for translarna continues .Qtrly Translarna net sales of $15.4m.  Full Article

PTC Therapeutics provides regulatory update on Translarna
Monday, 25 Jul 2016 10:45am EDT 

: Says no longer anticipates that chmp will issue its opinion regarding ema approval of translarna in mid-2016 . Says confirmatory phase 3 act cf trial of translarna is currently ongoing . Says there is substantial risk that results from translarna trial, expected in early 2017, will be required for approval . Ptc therapeutics provides regulatory update on translarna™ (ataluren) . Ptc Therapeutics Inc Says Company Has Been Informed That Renewal Assessment Procedure Cannot Be Completed By Mid Year 2016 . Expects translarna's current marketing authorization status will remain valid until a decision is adopted by european commission .Chmp has agreed to proposal by ptc to submit a draft clinical trial protocol for translarna for further discussion.  Full Article

PTC Therapeutics and NHS England negotiate managed access agreement
Thursday, 7 Jul 2016 08:18am EDT 

PTC Therapeutics Inc : Co and NHS England negotiate managed access agreement translarna for patients with nonsense mutation duchenne muscular dystrophy .Decision provides reimbursed patient access to translarna in england via a five-year MAA.  Full Article

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