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July 9, 2014
14:01 EDTPTCTPTC Therapeutics announces expanded access program for Translarna
PTC Therapeutics announced the initiation of a reimbursed expanded access program, or EAP. PTC's EAP program is intended to make Translarna available to patients before commercial availability in certain countries. Where mechanisms exist and in accordance with local regulations, PTC will make Translarna available to nonsense mutation Duchenne muscular dystrophy patients through funded EAP programs.
News For PTCT From The Last 14 Days
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November 23, 2015
07:44 EDTPTCTPTC Therapeutics should be owned ahead of BioMarin panel, says Oppenheimer
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November 20, 2015
13:26 EDTPTCTOn The Fly: Top stock stories at midday
Stocks began the session sharply higher and have remained there since the open. The move higher has come despite a barren economic calendar and amid headlines coming out of Mali regarding a new terrorist event that took place there. The equity market is working on its fourth higher close in the past five sessions, while oil prices continue struggling to stay above $40 per barrel. ECONOMIC EVENTS: In the U.S., no major economic data was released. COMPANY NEWS: Shares of Nike (NKE) advanced nearly 5% after the Dow member announced a two-for-one stock split, a $12B stock repurchase program and plans to boost its dividend... BioMarin (BMRN) shares were down 4% near noon, but that was well off their worst levels of the day, after the FDA posted briefing materials ahead of next weeks advisory committee meeting to review the New Drug Application for Kyndrisa for the potential treatment of Duchenne muscular dystrophy amendable to exon 51 skipping. Sarepta (SRPT), which is at work on a competing drug, eteplirsen, that has its own committee review scheduled for January, rose 31% and another player in the DMD space, PTC Therapeutics (PTCT), fell 7.5%. MAJOR MOVERS: Among the notable gainers was Abercrombie & Fitch (ANF), which rallied 21% after the company reported better than expected quarterly earnings. Also higher was Cabela's (CAB), which gained 10% after Bloomberg reported that the company was receiving takeover interest. In addition, Foot Locker (FL) was up 5% after reporting Q3 earnings and guiding for Q4. Among the noteworthy losers was Nimble Storage (NMBL), which fell 50% after its stock was downgraded by no fewer than 11 analysts following its quarterly report. Also lower was Mentor Graphics (MENT), which lost 32% after its shares were downgraded by no fewer than five analysts. INDEXES: In early afternoon trading, the Dow was up 101.65, or 0.57%, to 17,834.40, the Nasdaq was up 32.02, or 0.63%, to 5,105.66, and the S&P 500 was up 10.09, or 0.48%, to 2,091.33.
08:05 EDTPTCTBioMarin drops after FDA posts review of DMD drug drisapersen
Shares of BioMarin are down 7% to $96.01 after the FDA posted a review of the company's Duchenne muscular dystrophy treatment drisapersen ahead of Tuesday's panel vote. Sarepta Therapeutics (SRPT), which is developing its own treatment for DMD, is trading higher while PTC Therapeutics (PTCT) is moving lower. Reference Link
November 19, 2015
14:49 EDTPTCTBefore the Move: Watch BioMarin into FDA advisory committee
BioMarin Pharmaceutical (BMRN), which develops and commercializes pharmaceuticals for serious diseases and medical conditions including Duchenne muscular dystrophy, or DMD, is awaiting an FDA advisory committee for its DMD drug drisapersen, which is brand named Kyndrisa. WHAT'S NEW: The Peripheral and Central Nervous System Drugs Advisory Committee is meeting on Tuesday, November 24 to discuss the New Drug Application, or NDA, for Biomarin's drisapersen. It is expected that briefing documents related to that meeting will be posted on the FDA's website tomorrow, Friday, November 20. BULLISH TAKE: On November 15, Leerink analyst Joseph Schwartz said he believes the FDA will feel compelled to approve at least one DMD drug due to "public attention and vocal demand," and says that most likely both drisapersen and Sarepta Therapeutics' (SRPT) eteplirsen will be approved. However, he also makes a case where eteplirsen is not approved due to the "extremely limited" clinical data on the drug. Schwartz noted that drisapersen's advisory panel on November 24 happens first and will be important for both companies, adding that he sees "significant" upside potential for BioMarin. On November 18, Goldman Sachs said it views the risk/reward in BioMarin as favorable, with the advisory committee as a key catalyst on the company's path to non-GAAP profitability. Goldman has a Buy rating on BioMarin shares. On November 19, Jefferies analyst Gena Wang wrote that a buy-side survey the firm conducted suggests positive expectations for BioMarin's advisory committee. Wang, who said the survey of 58 investors suggests buy-side expectations of a positive panel for Kyndrisa are 62%, noted that a positive outcome could push BioMarin higher by almost 20%, and positively impact peers PTC Therapeutics (PTCT) and Sarepta by over 20% and 6%, respectively. BAIRD CAUTIOUS: On November 19, Baird analyst Brian Skorney wrote a note titled "A Skeptic's Guide to DMD Regulatory Reviews" where he says the firm has "increasingly come to believe that the FDA is more likely to reject the NDA's for drisapersen and eteplirsen," although he notes the risk reward for BioMarin is skewed to the upside -- with 20% upside potential on approval, but only 10% downside potential on rejection. Baird has a Neutral rating on BioMarin. Skorney sees a 30% probability both drugs get approved during this review period, a 5% chance BioMarin's drug gets approved and Sarepta's gets rejected, a 5% chance Sarepta's gets approved and BioMarin's gets rejected, and a 60% chance that both get rejected. PRICE ACTION: In afternoon trading on Thursday, shares of BioMarin were down about 4.5% to $102.88, while shares of peers Sarepta and PTC Therapeutics were down 8% and 9.5%, respectively.
10:46 EDTPTCTOptions with increasing implied volatility
Options with increasing implied volatility: TERP PTCT CHK CSC GNC RH ULTA QCOM VIMC
08:07 EDTPTCTPTC Therapeutics completes enrollment of Phase 3 clinical trial of Translarna
PTC Therapeutics has completed enrollment of ACT CF, the company's second Phase 3 clinical trial of Translarna for patients with nonsense mutation cystic fibrosis. Nonsense mutations in cystic fibrosis are categorized as Class I mutations, which are the most difficult to treat, as they result in little or no production of the cystic fibrosis transmembrane conductance regulator protein. Approximately 10% of cystic fibrosis patients have their disease as a result of a nonsense mutation. On September 30, 2015, the EMA validated the submission of a variation for a new indication for Translarna for the treatment of nmCF.
07:23 EDTPTCTBuy-side sees 62% chance of positive BioMarin panel, says Jefferies
Jefferies analyst Gena Wang says her firm's survey of 58 investors suggests buy-side expectations of a positive FDA panel on November 24 for BioMarin's (BMRN) Kyndrisa are 62%. Both positive and negative outcomes are expected to result in significant moves for all three stocks developing treatments for Duchenne muscular dystrophy, or BioMarin, Sarepta (SRPT) and PTC Therapeutics (PTCT), Wang tells investors in a research note. Investors expect a positive Kyndrisa outcome to push BioMarin shares 19% higher, PTC shares 23% higher and Sarepta shares 6% higher, the analyst points out. She notes that a negative panel vote is expected to drive all three stocks 20%-30% lower.

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