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November 6, 2012
10:02 EDTTDC, SREV, SKM, ESRX, AT, KBW, ENR, ASEI, HME, BMRNOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Science & Engineering (ASEI) downgraded to Hold from Buy at Benchmark Co.... Atlantic Power (AT) downgraded to Hold from Buy at Desjardins... BioMarin (BMRN) downgraded to Hold from Buy at Brean Capital... Energizer (ENR) downgraded to Market Perform from Outperform at Bernstein... Express Scripts (ESRX) downgraded to Hold from Buy at Jefferies... Home Properties (HME) downgraded to Underperform from Sector Perform at RBC Capital... KBW, Inc. (KBW) downgraded to Market Perform from Outperform at JMP Securities... SK Telecom (SKM) downgraded to Neutral from Outperform at Credit Suisse... ServiceSource (SREV) downgraded to Equal Weight from Overweight at Morgan Stanley... Teradata (TDC) downgraded to Sector Perform from Outperform at FBN Securities.
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November 20, 2015
08:21 EDTBMRNBioMarin says FDA posts briefing materials about Kyndrisa review
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08:08 EDTBMRNFDA staff say biomarker studies for BioMarin DMD drug 'greatly concerning'
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, which is being studied as a potential treatment for boys with Duchenne muscular dystrophy, or DMD, amenable to exon 51 skipping. In advance of that meeting, the FDA has just posted ot its website briefing documents prepared by the agency's staff. In the documents, the FDA staff states, "It is greatly concerning that a number of biomarker studies suggest that, contrary to initial published reports, drisapersen has little effect on increasing dystrophin levels, the putative mechanism of action." Further, the documents state: "This review concludes that, while there may be some evidence suggestive of efficacy of drisapersen, the evidence is inconsistent and in some cases contradictory, and does not reach the level of substantial evidence." Following the posting of the breifing documents, BioMarin shares are down about 11% to $92.50 in pre-market trading.
08:05 EDTBMRNBioMarin 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 EDTBMRNBefore 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.
08:28 EDTBMRNBaird sees 60% chance BioMarin, Sarepta DMD drugs both get rejected
Baird analyst Brian Skorney said he increasingly thinks that the FDA is more likely to reject the NDA's for the two Duchenne muscular dystrophy drugs it will soon review, BioMarin's (BMRN) drisapersen and Sarepta's (SRPT) eteplirsen, though he notes that his confidence in any of the various approval/rejection scenarios is low. 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. Skorney, who sees 20% upside potential and 10% downside potential for Biomarin based on this event, keeps a Neutral rating on its shares. The analyst thinks the risk-reward for Sarepta, however, is "massively" skewed to the upside, with 250% upside potential compared to 50% downside, and keeps an Outperform rating on its shares.
07:23 EDTBMRNBuy-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.
November 18, 2015
15:40 EDTESRXCongressman says U.S. may need look at pharmacy competition, dealReporter says
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10:02 EDTTDCHigh option volume stocks: CIT TDC MAR JNK EIX TIF NBG DSX FCS ARG
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09:33 EDTTDCTeradata resembles a company prepping for a sale, says Longbow
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08:32 EDTBMRNGoldman sees bluebird shares doubling on 'one-shot' gene therapy
Following a three and a half year rally for biotech stocks, and a more recent sector pullback from July's record high levels, Goldman Sachs analyst Salveen Richter said in a new note to investors that he has a Neutral view of the small- to mid-cap biotech space. Richter believes select small- to mid-cap biotech stocks should continue to outperform the broader market, but thinks stock picking is essential and laid out for investors who he thinks the winning and losing stocks in the space are likely to be. BUY BLUEBIRD: bluebird bio's (BLUE) innovative platform, which is designed to cure genetic diseases by introducing functional gene copies into a patient, makes it the "leading gene therapy play," contends Richter. bluebird's key value driver is LentiGlobin, a gene therapy for rare blood disorders, beta-thalassemia major and sickle cell disease, the analyst points out. Richter, who notes that bluebird has a major upcoming catalyst in the form of clinical updates from three Phase I/II studies of LentiGlobin in beta-thalassemia and sickle cell disease, set a 12-month price target of $165 on the stock, giving it 107% upside from current levels if his target is achieved. OTHERS TO BUY: Richter also recommends that investors own leading names in three areas of innovation, namely orphan diseases, gene therapy/editing, and immuno-oncology. In those areas, he identifies BioMarin (BMRN) as an orphan drug stock to buy, Incyte (INCY) as the best-positioned biotech immuno-oncology play for 2016 and Kite Pharma as a stock to own for the company's engineered T-cell platform focused on cancer. He set Buy rating on each of the three aforementioned names. SELL SEATTLE GENETICS: The only stock in the small- to mid-cap biotech space that Richter initiated coverage of with a Sell rating is Seattle Genetics (SGEN). The analyst acknowledges that the company is currently a leader in the antibody drug conjugate field, but thinks the consensus view of future competition for its Adcetris drug is "optimistic" and that the outlook for the rest of its pipeline is unclear. Richter set a 12-month price target of $33 on the stock, giving it 27% downside from current levels if his target is achieved. The analyst also began coverage of Atara Biotherapeutics (ATRA), Isis Pharmaceuticals (ISIS) and Juno Therapeutics (JUNO) with Neutral ratings, as he sees them all as having interesting drug platforms, but also believes their prospects are appropriately reflected in current valuations of their stocks. PRICE ACTION: Over the last six month, bluebird bio shares have fallen nearly 50%, but the stock has still more than doubled from where it was one year ago. In the last six months Seattle Genetics has risen 13%, bringing its gains over a one year timeframe to 28%.
06:30 EDTBMRNBioMarin assumed with a Buy at Goldman
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November 17, 2015
16:10 EDTBMRNBioMarin initiated with a Perform at Oppenheimer
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10:17 EDTESRXHouse Judiciary Committee to hold a hearing
The Subcommittee on Regulatory Reform, Commercial and Antitrust Law holds a hearing entitled, "The State of Competition in the Pharmacy Benefit Manager and Pharmacy Marketplaces" with Vice President Bricker of Express Scripts and Senior Vice President Pons of CVS Health on November 17 at 3 pm. Webcast Link
November 16, 2015
09:06 EDTESRXDiplomat seen as compelling amid specialty pharmacy fallout
Shares of specialty pharmacy operator Diplomat Pharmacy (DPLO) and pharmacy benefit manager Express Scripts (ESRX) have each been knocked down by the negative news surrounding the sector amid the troubles faced by Valeant (VRX) and others, but an analyst at Leerink contends in a note to investors that the pullbacks in both stocks provide buying opportunities. BACKGROUND: Drugmaker Valeant and its prior specialty pharmacy partner, Philidor Rx Services, have been at the center of the firestorm engulfing the sector. Following claims that Philidor urged its employees to modify prescriptions to ensure more orders of Valeant-branded drugs rather than generics, as well as other allegations of wrongdoing, Express Scripts (ESRX) and peer CVS Health (CVS) terminated Philidor from their networks. The day after those termination announcements, Valeant said that it was severing all ties with Philidor and that the pharmacy planned to shut down operations as soon as possible, consistent with applicable laws. Valeant has subsequently said that Philidor has committed to cease operations by January 30, 2016, at the latest. More recently, Express Scripts, the nation's largest pharmacy benefit manager, announced that it stopped doing business with Linden Care, accusing it of being a "captive" pharmacy that dispenses mostly products made by Horizon Pharma (HZNP). In turn, Horizon called the idea that Linden Care is a captive pharmacy "entirely false," stating that "at best Express Scripts is being reckless in its allegations and at worse it is intentionally attempting to mislead investors." Express Scripts' move also impacted shares of Insys Therapeutics (INSY), which reportedly also used Linden Care to fulfill prescription for its drugs. DIPLOMAT LIKELY TO STAY IN-NETWORK: Leerink analyst David Larsen acknowledged that recent events indicate that Express Scripts appears to be evaluating certain retail pharmacies and their relationships with manufacturers, but he believes Diplomat's mix of drugs for diseases like multiple sclerosis, HIV, hepatitis C and cancer differentiate it as a "true" specialty pharmacy. Larsen does not think Diplomat is at risk of being excluded from the pharmacy networks of Express Scripts, CVS or UnitedHealth's (UNH) Optum, he tells investors. Larsen expects limited distribution agreements to stay an important channel strategy for drugmakers and believes these agreements are appropriate for high cost specialty drugs that require special handling and additional services to manage patient adherence. The analyst, who thinks Diplomat remains well positioned to deliver annual growth of over 30% in the next several years, keeps an Outperform rating on its shares. EXPRESS BUYING OPPORTUNITY: Larsen also thinks concerns around manufacturer and pharmacy relationships have put unwarranted pressure on shares of Express Scripts. He does not expect Express Scripts to disclose new lawsuits around rebate dollars owed over other manufacturer disputes and keeps an Outperform rating on the stock, which he views as having an "attractive" valuation. WHAT'S NOTABLE: Larsen also thinks that the specialty channel remains an opportunity for Walgreens Boots Alliance (WBA) and believes its proposed acquisition of Rite Aid (RAD) can strengthen its specialty offering. The analyst keeps an Outperform rating on Walgreens shares as well. PRICE ACTION: Over the last three months, Diplomat Pharmacy shares have declined 28%, Express Scripts has fallen 6% and Walgreens has dropped 14%.
08:06 EDTENREnergizer should be bought on weakness, says RBC Capital
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07:16 EDTBMRNHayman Capital gives quarterly update on stakes
NEW STAKES: Impax (IPXL), CF Industries (CF), GW Pharmaceuticals (GWPH), ProNAi Therapeutics (DNAI). INCREASED STAKES: BioMarin (BMRN), NMI Holdings (NMIH), Vertex (VRTX), Endo (ENDP). DECREASED STAKES: Mylan (MYL). LIQUIDATED STAKES: Perrigo (PRGO), Oasis Petroleum (OAS), Whiting Petroleum (WLL), Newfield Exploration (NFX), SM Energy (SM).
07:16 EDTBMRNFDA likely feels compelled to approve at least one DMD drug, says Leerink
Leerink analyst Joseph Schwartz says the FDA likely feels compelled to approve at least one of the exon skipping drugs to treat Duchenne muscular dystrophy in this review cycle. There is so much public attention and vocal demand in the DMD community, Schwartz tells investors in a research note. The FDA advisory panel on BioMarin's (BMRN) drisapersen is on November 24 while the panel on Sarepta's (SRPT) eteplirsen is tentatively scheduled for January 22, 2016. The greatest likelihood is that both drugs are approved, Schwartz contends. Shares of BioMarin have "significant" upside potential on a positive panel vote as many investors still doubt that drisapersen is approvable based on existing data, and approval would "greatly aid" the company's goal to reach profitability, the analyst argues. He reiterates an Outperform rating on BioMarin and a Market Perform rating on Sarepta. Jefferies analyst Eun Yang said on Friday that regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin.
06:18 EDTESRXDiplomat Pharmacy selloff brings 'compelling' entry point, says Leerink
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November 13, 2015
15:32 EDTBMRNSarepta CEO says having BioMarin go first with AdCom is an advantage
Sarepta (SRPT) interim CEO Edward Kaye said BioMarin (BMRN) having to go first with its advisory committee meeting for its own DMD drug will allow Sarepta time to assess the committee's comments and questions on their drug and formulate responses. Kaye is speaking on CNBC.
07:57 EDTBMRNExperts see positive FDA panel for BioMarin, says Jefferies
Jefferies analyst Eun Yang says regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin's (BMRN) Kyndrisa, a treatment for Duchenne Muscular Dystrophy. The panel meeting is November 24 and the FDA action date for the drug is December 27. The experts point to a favorable risk/benefit profile for Kyndrisa as well as no current treatment option for DMD as supporting their confidence of FDA approval, Yang tells investors in a research note. The experts see a post-marketing study for Kyndrisa as likely necessary, she adds. On competitor Sarepta's (SRPT) DMD treatment eteplirsen, experts' views are "somewhat mixed," Yang adds. She has a Buy rating on BioMarin with a $166 price target. A positive panel vote could boost shares by 20% and bring increased confidence in BioMarin's three additional candidates targeting additional DMD patients, she contends. The orphan drug developer closed yesterday down $4.35 to $106.80.
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