|August 7, 2014|
|06:48 EDT||PTCT||PTC Therapeutics files automatic mixed securities shelf|
News For PTCT From The Last 14 Days
|November 25, 2015|
|16:49 EDT||PTCT||On The Fly: Top stock stories for Wednesday|
Stocks began Wednesday in positive territory and remained higher for much of the day before dipping slightly near close. The averages moved in a narrow range as investors digested a host of economic data, including reports on consumer confidence, jobless claims and housing, none of which moved the market in any discernible way ahead of the Thanksgiving holiday. ECONOMIC EVENTS: In the U.S., several days of economic reports were compressed into a single, busy morning. Jobless claims for the week ended November 21 fell to 260,000 against expectations for 270,000 first-time claims. Personal income rose 0.4% in October, matching expectations, while spending rose 0.1% versus estimates for a 0.3% increase. Meanwhile, durable goods orders were up 3% last month versus expectations for up 1.7%. Removing transportation items showed a core reading of up 0.5% against estimates for 0.3%. The FHFA home price index rose 0.8% in September to 226.5, while Markit's services index improved to 56.5 in the flash reading for November, topping the 55.1 forecast. New home sales rose 10.7% to a 495,000 rate in October. Consumer sentiment rose to 91.3 in the final November print of the University of Michigan survey, up from October's 90.0 reading but down from the preliminary November reading of 93.1. COMPANY NEWS: Shares of HP Inc. (HPQ) and HP Enterprise (HPE) headed in opposite directions following the final combined earnings report of the recently-split companies. HP Inc., which was downgraded to Hold at research firm Needham following last night's report, ended the session down 13.63% to $12.65. Meanwhile, HP Enterprise, which also announced a cloud partnership with Microsoft (MSFT), gained 3.14% to $14.12... Deere (DE), which reported better than expected earnings and issued a 2016 sales outlook matching estimates, gained 4.79% to $80 following its quarterly report. MAJOR MOVERS: Among the notable gainers was Tesla (TSLA), which advanced $11.39, or 5.22%, to $229.64 after research firm Credit Suisse reiterated its Outperform rating and $325 price target on the shares, saying the carmaker's January volume report should positively address investor fears over its fourth-quarter performance and Model X production ramp. Also higher was American Capital (ACAS), which gained $1.32, or 9.50%, to $15.22 after expanding its stock buyback program and announcing a strategic review of the company, including a possible sale. Additionally, Veeva (VEEV) jumped 5.01% to $28.73 following its quarterly numbers, which prompted analysts at both JPMorgan and Canaccord to raise their price targets on the stock. Among the noteworthy losers was PTC Therapeutics (PTCT), which declined $2.23, or 7.02%, to $29.52 after Jefferies analyst Gena Wang downgraded the stock to Underperform, saying yesterday's FDA panel for BioMarin's (BMRN) competing muscular dystrophy drug is a negative for PTC. BioMarin, meanwhile, slipped 1.78% to $96.06 for the day, while Sarepta (SRPT), also competing in the same therapeutic space, was up fractionally to $37.49. Also lower were SunEdison (SUNE) and TerraForm Power (TERP), which crashed a respective 21.6% and 17.67% after research firm UBS downgraded both stocks on "considerable" risks suggested by recent management changes at Terraform. TerraForm Global (GLBL), meanwhile, plunged 21.26% to $4.11. Separately, Dow Chemical (DOW) slipped 2.72% to $51.93 after the EPA withdrew approval for the company's Enlist Duo herbicide. INDEXES: The Dow rose 1.20, or 0.01%, to 17,813.39, the Nasdaq gained 13.33, or 0.26%, to 5,116.14, and the S&P 500 slipped 0.27, or 0.01%, to 2,088.87.
|12:14 EDT||PTCT||On The Fly: Top stock stories at midday|
Stocks began the session in positive territory and have remained there throughout the morning, moving in a narrow range on fairly light volume as expected on a get-away day for many investors ahead of Thanksgiving. The tepid trading comes amid a packed economic calendar, with a number of reports that are usually scheduled for release on other days of the week being accelerated due to the holiday. ECONOMIC EVENTS: In the U.S., there was a very busy slate of economic data as several days of reports were crammed into a single morning. Jobless claims fell to 260,000 in the week ended November 21, versus expectations for 270,000 first-time claims. Personal income rose 0.4% in October, matching expectations, while spending rose 0.1%, versus expectations for spending to rise 0.3%. Durable goods orders were up 3.0% last month, versus expectations of up 1.7%. When transportation items are removed, the core reading was up 0.5%, versus expectations for it to be up 0.3%. The FHFA home price index rose 0.8% in September to a reading of 226.5. Markit's services index improved to 56.5 in the flash reading for November, topping the 55.1 forecast. New home sales rose 10.7% to a 495,000 rate in October. Consumer sentiment rose to 91.3 in the final November print of the University of Michigan survey, up from October's 90.0 reading but down from the preliminary 93.1 November reading. COMPANY NEWS: Shares of HP Inc. (HPQ) and HP Enterprise (HPE) moved in opposite directions following their last combined earnings report. HP Inc., which was downgraded by Needham analyst David Rold to Hold following last night report, fell 13% near midday. Meanwhile, HP Enterprise, which announced an Azure cloud partnership with Microsoft (MSFT) in addition to its results, gained about 3%... Deere (DE), which reported better than expected earnings and issued a 2016 sales outlook that met expectations, gained nearly 4% following its quarterly report. MAJOR MOVERS: Among the notable gainers was Pandora (P), which rallied almost 5% after it said that the Register of Copyrights ruled that it couldn't offer an opinion to counter the current "non-differentiated rate structure of licensors." Also higher was Guess (GES), which gained 8% after it reported quarterly earnings and provided guidance. Among the noteworthy losers were SunEdison (SUNE) and TerraForm Power (TERP), which fell 14% and 15%, respectively, after an analyst from UBS downgraded both companies' stocks, saying they are facing considerable risk after personnel changes at TerraForm. Also lower was PTC Therapeutics (PTCT), which lost 5% after Jefferies analyst Gena Wang downgraded its shares to Underperform, saying yesterday's FDA panel for BioMarin's (BMRN) competing muscular dystrophy drug is a negative for PTC. Following yesterday's FDA meeting, BioMarin slipped fractionally and Sarepta (SRPT), which is also competing in the same therapeutic area, was flat. INDEXES: Near midday, the Dow was up 23.48, or 0.13%, to 17,835.67, the Nasdaq was up 19.14, or 0.38%, to 5,121.94, and the S&P 500 was up 2.27, or 0.11%, to 2,091.41.
|10:22 EDT||PTCT||Options with decreasing implied volatility|
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|10:04 EDT||PTCT||On The Fly: Analyst Downgrade Summary|
Today's noteworthy downgrades include: 21Vianet (VNET) downgraded to Neutral from Overweight at JPMorgan... Anglo American (AAUKY) downgraded to Reduce from Hold at HSBC... Boulder Brands (BDBD) downgraded to Market Perform from Outperform at William Blair... Cracker Barrel (CBRL) downgraded to Hold from Buy at Argus... HP Inc. (HPQ) downgraded to Hold from Buy at Needham... PTC Therapeutics (PTCT) downgraded to Underperform from Hold at Jefferies... SunEdison (SUNE) downgraded to Sell from Neutral at UBS... TerraForm Power (TERP) downgraded to Sell from Neutral at UBS... Tiffany (TIF) downgraded to Neutral from Buy at Monness Crespi... Valspar (VAL) downgraded on negative catalysts at RBC Capital... eBay (EBAY) downgraded to Buy from Conviction Buy at Goldman.
|09:51 EDT||PTCT||Predictions all over map on BioMarin approval after FDA meeting|
Reactions from Wall Street analysts and influential biotech reporters to an FDA advisory panel on BioMarin's (BMRN) Duchenne muscular dystrophy treatment Kyndrisa have varied wildly, with one analyst saying he believes the likelihood of approval of the drug is 65% and a biotech columnist giving the drug a 5% chance of winning approval, which he adds "might be too generous." 65% CHANCE OF APPROVAL: After an advisory committee of the FDA met to discuss the data submitted to support the New Drug Application for BioMarin's Kyndrisa for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, Piper Jaffray analyst Joshua Schimmer believes the drisapersen approval likelihood is "65%," given the lack of a voting question and the compelling patient testimony, adding that he thinks the FDA will not find "an obvious reason to NOT approve." Schimmer, who called BioMarin a "solid investment" ahead of the December 27 PDUFA date, said meaningful upside potential outweighs the possible downside and maintained an Overweight rating and $168 price target on shares. REJECTION MORE LIKELY THAN APPROVAL: More cautious on Kyndrisa's prospects is JPMorgan analyst Cory Kasimov, who thinks it's more likely than not that BioMarin's drisapersen does not get approved. Yesterday's discussion didn't really answer any questions or add much to the conversation, Kasimov told investors in a research note. Nevertheless, at around $98 per share, and with the potential for a selloff today following the panel, Kasimov views the stock's risk/reward as compelling without or without approval of drisapersen. He keeps an Overweight rating on BioMarin. Meanwhile, William Blair analyst Tim Lugo cut his price target for BioMarin to $126 from $155, saying yesterday's AdCom was largely negative on Kyndrisa efficacy. Lugo stripped Kyndrisa value from his net present value of BioMarin shares, but still keeps an Outperform rating on the name. 5% CHANCE OF APPROVAL MAY BE GENEROUS: More bearish than virtually all Wall Street analysts is TheStreet's biotech columnist Adam Feuerstein, who now gives Kyndrisa a "5% chance of winning approval," which he adds "might be too generous." In his post-panel recap, Feuerstein noted that Baird's Brian Skorney has previously contended that BioMarin has "no chance" with drisapersen. "Going into Tuesday's panel, I predicted drisapersen would be approved for Duchenne. I was wrong. Skorney was right. I believe him now," Feuerstein stated. IMPACT ON SAREPTA: Generally, analysts were more favorable on the chances of Sarepta's(SRPT) competing DMD treatment, eteplirsen, winning approval from the FDA. Piper analyst Edward Tenthoff believes that despite the drisapersen AdCom foreshadowing a "harsh" FDA review in January, the company's eteplirsen drug should ultimately receive accelerated approval due to its "clean safety profile, mechanistic link of increased dystrophin expression, long-term clinical benefit and huge unmet medical need." Jefferies analyst Gena Wang raised her price target for Sarepta to $38 from $28 this morning, saying the negative FDA panel meeting for drisapersen is positive for the rival company. Sarepta has strong biomarker data, consistent clinical data and solid safety profile for its eteplirsen, said Wang, who now sees 70% probability of approval for Sarepta's drug. BAD NEWS FOR PTC: Also this morning, Wang downgraded PTC Therapeutics (PTCT) to Underperform from Hold, saying yesterday's FDA panel for drisapersen is a negative for the company. The FDA's analysis raised questions on PTC's ataluren's drug effect in pre-specified subgroup, Wang told investors. She lowered her probability of success for PTC's Duchenne muscular dystrophy drug to 20% from 55% and cut her price target for the stock to $18 from $26. PRICE ACTION: In early morning trading, BioMarin shares sunk 3% to $94.83, PTC fell nearly 10% to $28.67 and Sarepta slid 1% to $37 per share.
|07:43 EDT||PTCT||PTC Therapeutics downgraded to Underperform from Hold at Jefferies|
Jefferies analyst Gena Wang downgraded PTC Therapeutics (PTCT) to Underperform saying yesterday's FDA panel for BioMarin's (BMRN) drisapersen is a negative for the company. The FDA's analysis raised questions on PTC's ataluren's drug effect in pre-specified subgroup, Wang tells investors in a research note. She lowered her probability of success for the company's Duchenne muscular dystrophy drug to 20% from 55% and cut her price target for the stock to $18 from $26. PTC shares are trading down $2.86 to $28.89 in the pre-market.
|05:50 EDT||PTCT||UBS says FDA panel skews against BioMarin approval|
UBS analyst Andrew Peters believes the voting questions and discussion at yesterday's FDA advisory panel skew against approval of BioMarin's Duchenne muscular dystrophy drug Kyndrisa. Many of the underlying issues identified by FDA in the briefing documents were discussed at length and not resolved, Peters tells investors in a research note. He cut his price target for BioMarin shares to $140 from $150 to reflect approval risk, but keeps a Buy rating on the name. The analyst stays bullish longer term on BioMarin given the "breadth of the pipeline." Piper Jaffray analyst Joshua Schimmer last night put the prospects of Kyndrisa approval at 65%-plus. Shares of BioMarin were halted all day yesterday and closed Monday at $97.80. Other companies developing treatments for Duchenne muscular dystrophy include Sarepta (SRPT) and PTC Therapeutics (PTCT).
|November 23, 2015|
|07:44 EDT||PTCT||PTC Therapeutics should be owned ahead of BioMarin panel, says Oppenheimer|
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|November 20, 2015|
|13:26 EDT||PTCT||On 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 EDT||PTCT||BioMarin 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 EDT||PTCT||Before 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 EDT||PTCT||Options with increasing implied volatility|
Options with increasing implied volatility: TERP PTCT CHK CSC GNC RH ULTA QCOM VIMC
|08:07 EDT||PTCT||PTC 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 EDT||PTCT||Buy-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.