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Analisten over UniQure

243 Posts
Pagina: «« 1 ... 8 9 10 11 12 13 »» | Laatste | Omlaag ↓
  1. Vitavita 21 augustus 2017 18:35
    August 21, 2017 Healthcare, Top Market News 0 Comments
    uniQure NV Receives a Buy from Oppenheimer
    By Austin Angelo

    [uniQure NV (NASDAQ: QURE)] In a report released today, Hartaj Singh from Oppenheimer reiterated a Buy rating on uniQure NV (NASDAQ: QURE), with a price target of $17. The company’s shares closed on Friday at $8.41.

    Singh wrote:

    “uniQure (QURE) reported a sales/earnings update to investors on August 8, 2017. While the company did not provide a concurrent business update call to investors, its activities over the last six months have been productive and focused on quickly moving along the Phase 3 ready AMT-060 program for hemophilia B and the preclinical AMT-130 program in Huntington’s disease. QURE’s partnership with BMY passed a preclinical milestone. QURE has also rounded out its management team following its strategic review in late 2016. With important regulatory, manufacturing, and preclinical milestones nearing completion in 2H17, we believe QURE sets up well for 2018.”

    www.analystratings.com/articles/uniqu...
  2. Fartknock 24 augustus 2017 13:24
    tools.eurolandir.com/tools/Pressrelea...

    uniQure Announces Company Participation at Citi Healthcare Conference

    Live webcast of gene therapy panel discussion on Thursday, September 7 at 11:00 am EDT

    LEXINGTON, Mass and AMSTERDAM, the Netherlands, Aug. 24, 2017 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ:QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it will participate in a gene therapy panel discussion and host investor meetings during the Citi Healthcare Conference held in Boston from September 5-7, 2017.

    Matt Kapusta, chief executive officer of uniQure, will participate on the analyst-moderated panel entitled, "Gene-Therapy Manufacturing and Regulatory - Challenges and Opportunities" on Thursday, September 7, 2017 at 11:00 am EDT. A live webcast of the panel discussion can be accessed through the link displayed in the Investor Section of the uniQure website at uniqure.com/investors-newsroom/events... A replay of the webcast will be available within 24 hours following the event, and will remain available for at least two weeks.
  3. Fartknock 20 oktober 2017 05:57
    www.smarteranalyst.com/2017/10/19/cow...

    Cowen Shines Light on Uniqure NV (QURE) as the Latter Advances Padua Variant AMT-061 into Phase 3

    Uniqure NV is back in the race for a hemophilia B gene therapy.

    Corey Williams-October 19, 2017, 3:28 PM EDT

    Uniqure NV (NASDAQ:QURE) investors are overwhelmingly excited today after the drug maker announced advancement of AMT-061, a Padua variant FIX AAV5 gene therapy, in hemophilia B, into a pivotal phase 3 trial in 3Q18.

    Cowen analyst Ritu Baral commented, “Surprisingly to us, this payload change (Padua FIX variant has a 2 nucleotide change leading to a single amino acid substitution) will be allowed to start clinical trials under the same IND and maintain FDA Breakthrough Designation and EMA PRIME Designation granted to AMT-060. While this is entirely logical and rational, we are still surprised by the relative flexibility demonstrated by both agencies particularly given historical conservatism and nascent experience with gene therapy both agencies have had.”

    “We do note other than the 2 nucleotide substitution, AMT-060 and AMT-061 are otherwise structurally identical, which we find encouraging given the predictability and duration of response seen with AMT-060 as well as excellent safety and low population seropositivity to date. QURE indicated the allowance, a remarkably positive development in our view, was not the result of any particular aggressive or extended regulatory negotiation on their part, and that the agencies main remaining focus in defining the potency of the new construct versus the old ‘060,” the analyst continued.

    As such, Baral reiterates an Outperform rating on QURE stock without suggesting a price target.
  5. Fartknock 20 oktober 2017 18:56
    Leerink Swann

    sportsperspectives.com/2017/10/20/uni...

    uniQure N.V. (QURE) Price Target Raised to $19.00 at Leerink Swann
    Posted by Brent Sawyer on Oct 20th, 2017

    uniQure N.V. (NASDAQ:QURE) had its target price increased by analysts at Leerink Swann from $17.00 to $19.00 in a report released on Friday. The firm presently has an “outperform” rating on the biotechnology company’s stock. Leerink Swann’s target price would suggest a potential upside of 25.33% from the company’s previous close.
  6. Fartknock 20 oktober 2017 19:00
    Oppenheimer (Hartaj Singh)

    www.smarteranalyst.com/2017/10/20/uni...

    Uniqure NV (QURE) Is Getting the Street All Fired Up on Its Gene Therapy Candidate in Hemophilia B; Oppenheimer Spotlights Efficacy/Safety Strength

    Hartaj Singh believes QURE trots out an upper hand advantage with AMT-061.

    Julie Lamb, Senior Editor Julie Lamb, Senior Editor-October 20, 2017, 10:07 AM EDT

    Uniqure NV (NASDAQ:QURE) shares vaulted 60% yesterday and continue to zoom almost 10% today on back of a clinical trial update on the biotech firm’s hemophilia B- targeting gene therapy Phase III designs for AMT-061. Investors can now look for a pivotal trial to kick-start in 2018 evaluating an asset that has already garnered a Breakthrough Therapy Designation from the FDA and PRIME designation from the EMA.

    Oppenheimer analyst Hartaj Singh takes the news under bullish wing, making a point to note that such positive sentiment from the FDA and EMA alike “possibly speaks to the strength of the efficacy/safety data for AMT-061.”

    In reaction to the share-popping news, the analyst reiterates an Outperform rating on QURE stock with a $17 price target, which represents a 2% increase from where the stock is currently trading. (To watch Singh’s track record, click here)

    The biotech firm is stepping forward with “two competitive advantages” with its gene therapy candidate in hemophilia B candidate, writes Singh, noting that the treatment “has not demonstrated any immune-mediated responses in AMT-060 trials with little loss of FIX activity and has the lowest prevalence of preexisting neutralizing antibodies (NAb) compared to other AAV vectors,” while the firm likewise boasts ” a commercial grade facility already operating to scale up manufacturing of AMT-061 as clinical trials progress.”

    Singh highlights: “While we have been waiting for an update to the clinical trial plan for the first hemophilia B product candidate AMT-060, QURE has astutely—and stealthily—brought another product candidate (AMT-061) into the clinic. This product has potentially 6x to 7x the well-known FIX expression levels of AMT-060 and may lead to mean FIX activity of approximately 30% to 50% of normal; a potentially significant benefit to moderate to severe hemophilia B patients. While we await further visibility on the pivotal Phase 3 design, we reiterate our bullish stance.”

    Additionally, according to TipRanks, cautious optimism is circling the biotech firm when looking at Wall Street sentiment, considering that based on 6 analysts polled in the 12 months, half rate a Buy on Uniqure stock while half maintain a Hold. The 12-month average price target stands at $10.25.
  8. Fartknock 5 januari 2018 14:27
    seekingalpha.com/article/4132245-uniq...

    uniQure: Continued Upside In 2018

    Dec.15.17 | About: uniQure N.V. (QURE)

    Jonathan Faison - Long only, biotech, event-driven

    Summary

    •Shares have risen by over 150% since my July article.

    •I provide a recap of the bull thesis and highlight recent data at ASH.

    •The company has an extended operational runway and AMT-061 should enter a pivotal study not too far in the future.

    •One game-changing development was the acquisition of the patent family which covers the use of Padua in gene therapy for hemophilia B.

    •A positive turn of events occurred when regulatory agencies ruled that for AMT-061 existing PRIME and Breakthrough designations (originally granted to AMT-060) would still apply.

    Shares of uniQure (QURE) have risen by over 150% since my July article in which I noted that even at six-month highs the stock was still significantly undervalued.
    Chart QURE data by YCharts
    I started by giving the back story on how the stock lost three quarters of its value as the gene therapy bubble temporarily deflated, management decided not to renew European marketing authorization for Glybera due to lack of demand and they were forced to size down their workforce as they refocused their clinical efforts.

    I then shifted the spotlight to their hemophilia B program AMT-060, which is a gene therapy candidate consisting of a codon-optimized wild type FIX gene cassette, the LP1 liver promoter and an AAV5 viral vector which utilizes the firm's own proprietary technology platform.

    The drug candidate had received PRIME status from the European Medicines Agency and long-term follow up data from an early stage trial was quite promising. Delving deeper, it was interesting that of 10 patients enrolled nine had severe hemophilia (FIX activity of less than 1%) while one had moderate disease (FIX activity of 1.5%). Nine of the 10 patients needed chronic infusions of prophylactic FIX therapy when they were enrolled, while one used FIX therapy on demand.

    Early data was promising, with all patients showing improvements as seen in reduced FIX replacement therapy and bleeding frequency, while no spontaneous bleeds were reported in the last six months of follow-up in the high dose cohort (total bleeds reduced by 64%). Eight of nine patients who previously required chronic FIX infusions discontinued prophylaxis after treatment and remained prophylaxis-free at the last follow up. The drug had a benign safety profile with no severe adverse events reported.

    Lastly, I was encouraged by the appointment of Steven Zelenkofske as Chief Medical Officer (former VP Head of Cardiovascular/Metabolism at AstraZeneca) and strengthening of the executive bench. While not a near-term catalyst, I reminded readers they had other promising assets even if only in the preclinical stage (AMT-130 for Huntington's Disease and their gene therapy collaboration with Bristol-Myers Squibb (BMY) for chronic heart failure and received $140 million to date from collaboration and stood to receive up to $2.3 billion in milestone payments).

    On December 11th in an oral presentation at ASH the company announced updated results from the dose-ranging phase 1/2 study of AMT-060 in severe hemophilia B (two years of follow-up in the low-dose cohort and up to 18 months in the higher-dose cohort). Of significant importance, the safety profile remained relatively unchanged with no new serious adverse events.

    For the high dose cohort, all five patients continued to demonstrate stable FIX activity with significant improvement in disease as seen through all patients discontinuing routine prophylactic FIX infusions. The annualized spontaneous bleeding rate fell 89% to a mean of 0.3 bleeds (in last year of follow-up there were no spontaneous bleeds reported).

    CEO Matthew Kapusta had the following to add:

    “
    These data give us continued confidence that our AAV5-based gene therapies offer multi-year durability, superior safety and broad applicability as a result of a favorable immunogenicity profile compared to other AAV vectors. We believe AMT-061 has the potential to provide curative benefits to nearly all hemophilia B patients, without the complications associated with capsid-related immune responses.

    For the third quarter the company reported cash and equivalents of $88.9 million, a figure which does not include the more than $90 million received from their October secondary offering. Net loss for the period was $10.2 million while research and development expenses totaled $20.1 million.

    A significant win for the company was the acquisition of the patent family which covers the use of Padua from Professor Paolo Simioni in gene therapy for hemophilia B in the US with pending patent applications in Europe. Surprisingly, regulatory agencies ruled that for their AAV5-Padua FIX gene therapy AMT-061 existing PRIME and Breakthrough designations (originally granted to AMT-060) would still apply. This ruling could be setting a new precedent for improved versions of existing drugs that could have far-reaching consequences for other fields of medicine as well.

    A presentation of data in non-human primates for AMT-061 at ASH revealed that animals receiving the same dose of AMT-060 and AMT-061 demonstrated comparable levels of hFIX protein. However, animals given AMT-061 had 6.5 times higher FIX activity, which would imply that the newer drug candidate could "achieve mean FIX activity in humans of approximately 30 to 50 percent of normal," according to Chief Scientific Officer Sander van Deventer, M.D.,Ph.D.

    As for catalysts, a pivotal study involving AMT-061 should get underway next year. An IND will be submitted for AMT-130 in Huntington's disease and preclinical heart study initiated for S100A1 gene therapy candidate AMT-126 targeting congestive heart failure.

    uniQure is a Buy.

    For readers who have done their due diligence and are interested in the stock I suggest initiating a pilot position in the near term. This appears to be an appropriate candidate to employ a "buy the dip" strategy. Considering that the hemophilia B market presents a blockbuster opportunity to be exploited and AMT-060 appears to be quite competitive to other clinical candidates being developed by competitors, this revaluation idea will likely move higher next year.

    I will be adding the stock to the ROTY Contenders List to keep a closer eye on this revaluation story in 2018.

    Dilution does not appear to be a risk in the near term due to their October offering. With an absence of near-term material catalysts, it is possible that the stock price stagnates or pulls back a bit. Setbacks in the initiation of a pivotal study for AMT-061 (and enrollment of patients), not to mention advancement of the early stage pipeline, would also weigh on the stock. Readers should keep a close eye on competition in the hemophilia B space as well (Spark Therapeutics, Sangamo, etc).
  9. Tex Mex 15 mei 2018 09:43
    www.thestreet.com/amp/investing/three...

    uniQure NV

    Dutch biotech company uniQure (QURE) appears to be rising from the ashes. Its previous therapy Glybera for an ultra-rare disease fizzled out. The world's first gene editing therapy missed U.S. approval and was withdrawn from Europe last year. Now, the company is focusing on the much bigger market of hemophilia, and interest in the company is spiking again. In fact, uniQure is increasingly looking like a prime takeout target for larger biotechs looking to enter the potentially very lucrative gene therapy space.
    UniQure expects to begin a late-stage study of its hemophilia therapy, called AMT-061, early in the third quarter, aiming to be first to market with such a treatment as early as 2020. It better hurry, Spark and Pfizer (PFE) are also collaborating on a hemophilia treatment.
    For now, HC Wainwright analyst Debjit Chattopadhyay isn't feeling too concerned. She writes that based on each company's projected timelines, "Pfizer might be in a position to initiate patient screening during 1Q19, which puts uniQure at least six months ahead and armed with the patent family covering mPADUA (R338L variant, patent # 9,249,405 issued on February 2, 2016), which gives uniQure significant commercial leverage, in our view."
    Plus, in a very bullish move top Leerink Swann analyst Joseph Schwartz ramped up his uniQure price target by an eyebrow raising $37 from $26 to $63. This new price target indicates 107% upside potential from current levels. According to Schwartz, this new projection is based on (1) pricing estimates for AMT-061 in hemophilia B of $1.5 million per patient in the U.S. and $1 million per patient in the EU; (2) increasing his probability of success for AMT-130 in Huntington's disease/HD to 15%; and (3) incorporating uniQure's first quarter financial results.
  11. Vitavita 27 juli 2018 13:52

    uniQure NV Initiated with a Buy at Cantor Fitzgerald

    Catie Powers-July 26, 2018, 4:14 PM EDT

    [uniQure NV Initiated with a Buy at Cantor Fitzgerald]
    In a report released today, Elemer Piros from Cantor Fitzgerald initiated coverage with a Buy rating on uniQure NV (NASDAQ: QURE) and a price target of $58. The company’s shares opened today at $32.56.

    Piros observed:

    “We are initiating coverage on uniQure with an Overweight rating and 12- month price target of $58. uniQure is developing AAV-vector-based gene therapies for the treatment of severe genetic disorders (hemophilia A and B, Huntington’s disease, and cardiovascular disease). The company recently initiated the first gene therapy Phase 3 “HOPE-B” study of AMT-061 in hemophilia B. Given the previous success we’ve seen in hemophilia gene therapy trials, along with the FDA stance, we believe uniQure has the potential to be the leader in hemophilia B treatment.”

    According to TipRanks.com, Piros ‘ ranking currently consits of no stars on a 0-5 ranking scale, with an average return of -6.1% and a 41.0% success rate. Piros covers the Healthcare sector, focusing on stocks such as Spring Bank Pharmaceuticals Inc, Strongbridge Biopharma Plc, and Global Blood Therapeutics.

    The word on The Street in general, suggests a Strong Buy analyst consensus rating for uniQure NV with a $50 average price target, representing a 53.6% upside. In a report issued on July 16, H.C. Wainwright also maintained a Buy rating on the stock with a $42 price target.

    Based on uniQure NV’s latest earnings release for the quarter ending March 31, the company reported a quarterly GAAP net loss of $18.79 million. In comparison, last year the company had a GAAP net loss of $21.27 million.

    Based on the recent corporate insider activity of 33 insiders, corporate insider sentiment is negative on the stock.

    TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

    uniQure NV engages in the research, development, and commercialization of gene therapies. Its discoveries intend to treat hemophilia, Huntington’s disease, glybera, and cardiovascular problems. The company was founded on January 9, 2012 and is headquartered in Amsterdam, the Netherlands.

    www.smarteranalyst.com/brief/uniqure-...
  12. Tex Mex 7 november 2018 19:00
    quote:

    Tex Mex schreef op 15 mei 2018 10:33:

    Catalysts per Chardan analyst.

    twitter.com/desertdweller93/status/99...
    www.watchlistnews.com/uniqure-qure-pr...

    Chardan verhoogt price target van $50 naar $70 ‘on better visibility of hemiphilia B gene therapy market leadership’.

    thefly.com/landingPageNews.php?id=281...

    twitter.com/_b_i_o_t_e_c_h_/status/10...
  14. Tex Mex 21 november 2018 21:56
    www.investors.com/news/technology/bio...

    G[u]ene Therapy And Hemophilia[/u]
    Gene therapy is likely to be in vogue in 2019, analysts say. Biotech companies use gene therapy to override a disease-causing mutation. It differs from gene editing, which changes the native genome and is more likely to be permanent.

    Brad Loncar, who manages a portfolio of immunotherapy-focused biotech companies, says gene therapy is "one of two technologies everyone has been talking about for awhile." The other one is, of course, gene editing.

    Gene therapy got a lot of attention this summer on news from Sarepta Therapeutics (SRPT) in treating Duchenne muscular dystrophy, a potentially fatal muscle-wasting disease.

    Biopharmas Solid Biosciences (SLDB) and Pfizer (PFE) also are working in this area.

    Finding A Cure For Hemophilia
    Meanwhile, an alphabet soup of biotech companies are looking at hemophilia gene therapy. Spark and BioMarin Pharmaceuticals (BMRN) are working in hemophilia A, with UniQure (QURE) in hemophilia B. Spark also has a partnership with Pfizer in hemophilia B.

    "The hemophilia pivotal trials might be finishing up and those might be in front of the FDA," Loncar said in an interview with IBD. "I think in gene therapy, one thing we have to see is how it's looking from a commercial standpoint."

    Raymond James analyst Reni Benjamin told IBD hemophilia is "an intense focus because we know the biology of the disease." In hemophilia, the blood doesn't clot normally because patients lack sufficient blood-clotting proteins.

    "This is a multibillion-dollar market which has solutions for it," he said. "It's not a totally unmet need. But it's clearly one of those poster children as a monogenic disease (caused by a single genetic mutation) where gene therapy can hit the mainstream."
  15. Vitavita 21 november 2018 22:23
    ....en dan te bedenken dat uniQure inmiddels een reuzensprong op gebied van Hemophilia A heeft gezet.
    Naast de andere nieuw aan te boren ziektegebieden als Fabry en Spinocerebellar Ataxia Type 3 (SCA3).

    De aandelenkoers wordt geforceerd ingedrukt gehouden om de (grotere) aandelenposities verder uit te breiden.
  16. Vitavita 21 november 2018 23:54
    quote:

    Vitavita schreef op 21 november 2018 22:23:

    ....en dan te bedenken dat uniQure inmiddels een reuzensprong op gebied van Hemophilia A heeft gezet.
    Naast de andere nieuw aan te boren ziektegebieden als Fabry en Spinocerebellar Ataxia Type 3 (SCA3).

    De aandelenkoers wordt geforceerd ingedrukt gehouden om de (grotere) aandelenposities verder uit te breiden.
    + HTT (Huntington)
  17. flosz 26 november 2018 20:29
    H.C. Wainwright: PT Raised to $60
    twitter.com/gupta_calling/status/1067...

    While the Street may shrug off the HemA program as potentially lagging peer efforts, we believe this approach: (1) could be compelling compared to peer programs, as it leverages an activated factor IX (FIXa); (2) benefits from the established safety uniQure’s AAV5 vectors;
    (3) potentially circumvents durability issues because hepatocytes are a natural substrate for FIX, whereas FVIII is typically synthesized in the liver sinusoid endothelial cells (LSEC); (4) could benefit patients with inhibitors to FVIII, who represent at least 15% of the HemA population; and (5) is likely to avoid thrombosis and antibody-related complications that plague Hemlibra."
  20. Tex Mex 21 januari 2019 16:34
    twitter.com/semodough/status/10873615...

    twitter.com/semodough/status/10873615...

    HCW $QURE PT 60 (1) Phase 3 HOPE-B study expected to dose its first patient over next few weeks; (2) Phase 1/2 program in Huntington’s disease now in IRB approval&site selection process; (3) potential for a Hemophilia A-related IND filing during late 2019; (4) a novel Fabry gene therapy IND during 2021; and (5) supported by an in house, commercial scale SF9 manufacturing process, uniQure is no longer leveraged to the outcome of a single program and is unlikely to remain an under-the-radar company for too long.
243 Posts
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