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  2. flosz 10 april 2015 22:14

    • flosz

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    jefferies $Qure QURE notes unfavorable preliminary EU regulatory opinion for Glybera in LPLD
    on 6-yr FU data; similar to previous review prior to approval under exceptional
    circumstances in 10/12. CHMP decision is expected in ~2-3 months. With much
    slower-than-guided EU launch timeline, expectations for Glybera have been low
    and such negative regulatory review, while not new, does not help. We now
    assume 50% probability-adjusted EU Glybera potential.
    On 6-year follow-up data, CAT-designated rapporteur reports lack of efficacy
    and negative benefit risk balance for Glybera in LPLD; QURE said not surprised
    given the similar position taken previously. Based on final clinical study report
    including the six-year follow-up data, the assessment report states that the rapporteur
    considers that Glybera lacks efficacy and therefore that the benefit-risk balance of Glybera is
    negative. Glybera was approved under exceptional circumstances in EU on 10/31/12. QURE
    notes that with approval under exceptional circumstances, review of efficacy/safety upon
    additional data availability is a normal process.
    QURE expects resolution in next ~2-3 months; still likely that EMA could await
    Ph4 results (study to begin early-2016) before potential reversal of marketing
    authorization per QURE. This report will be reviewed at upcoming CAT (4/16-4/17/15)
    and CHMP meetings (4/21-4/23/15). Though not ruling out possibility for EU marketing
    authorization removal, QURE notes that it is still very likely that EU regulatory bodies wait to
    see Ph4 results for Glybera (initiation expected in early-2016) before reversing its position.
    Glybera accounts for <10% of our QURE valuation; its EU launch has been very
    slow & partner Chiesi is yet to generate sales revenue (vs. EU launch in ~1H14
    originally). Even with continued EU marketing authorization, it is highly likely that sales
    would be very slow; our current cumulative sales of ~$480M could be aggressive.
    Resetting PT to $40 (from $42) on decreased EU Glybera probability of success
    to 50% (from 100% prior). Our $40 PT now includes $3/sh for Glybera (vs. $5/sh
    previously).

    twitter.com/biorunup
  3. [verwijderd] 10 april 2015 22:42

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    Super Flosz!
    Iedereen lees bovenstaande tweet aandachtig als je een afgewogen risicoanalyse wil hebben over Glybera, en maak op grond daarvan een belsuit over hoe je denkt dat het verder gaat. Veel beter info krijg je niet. Ik denk dat iemand van Jefferies met Reg Affairs bij QURE heeft gesproken en dat dit de gebalanceerde weergave is van het gesprek.

    Grootste kans is dat Glybera niet wordt teruggetrokken en dat de koers daarna weer als een dolle opveert. Kleinste kans is het omgekeerde en dan gaat de koers flink onderuit totdat de markt zich bewust wordt dat de waarde van QURE elders zit. In dat geval kan je bijkopen op het dieptepunt. Ben je kotsmisselijk van deze achtbaan: pak nu je winst.

    NOGMAALS DEZE TWEET IS M.I. EEN HEEL
  4. flosz 10 april 2015 23:19

    • flosz

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    Na AMT kunnen we hier toch wel wat hebben....haha. Heb er vertrouwen in, alles sal reg kom, al was het alleen al vanwege de patiënten zoals Prof. Dollar op twitter reeds aan gaf.
  5. flosz 13 april 2015 14:00

    • flosz

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    Leerink $QURE ( $CLDN ) Risk/Reward Compelling Ahead of Potential Catalysts, in Our View
    • Bottom Line: On 4/9 QURE disclosed in a filing that it received an
    assessment report as part of its ongoing EU regulatory procedure to
    update the Glybera label to include additional six-year follow-up data.
    In the report the rapporteur concludes that the benefit-risk balance of
    Glybera is negative. Although surprising to us, the report reflects only
    a part in a complex regulatory process, the outcome of which depends
    on QURE's negotiation with regulators over the next 3-4 months. We
    note that Glybera is only a small value driver for the stock, given its
    limited commercial potential, and we believe with the recently announced
    BMY (OP) partnership, QURE is well positioned to capitalize on its gene
    therapy platform ahead of news flow including CLDN CUPID2 data in
    April, and QURE hemophilia B and Sanfilippo B Phase I data in 2H15.
    Reiterating Outperform rating.
    • QURE announced in a filing on 4/9 that it received an assessment
    report from EU regulators questioning the risk-benefit profile of
    Glybera. The report by the CAT (Committee for Advanced Therapy
    Medicinal Products) rapporteur is part of QURE's ongoing EU regulatory
    process to update the Glybera EU label to include additional six-year
    follow-up data. The report states the rapporteur considers that Glybera
    lacks efficacy and therefore that the benefit-risk balance of Glybera is
    negative. Recall QURE reported the six-year follow-up data last June
    and showed a 40-50% lower post-treatment pancreatitis rate. The CAT
    advises the EMA’s CHMP on gene therapies; however the views of the
    rapporteur are not binding.
    • The CAT report reflects the first step in a complex regulatory
    process over the next 3-4 months, involving repeated requests for
    additional information after a CHMP meeting. Mgmt expects to have
    additional requests after April 23rd and will then have an additional 30-60
    days to respond. This will then initiate another 30-60 day review by the
    CAT/CHMP before reaching a conclusion. Based on mgmt comments,
    we believe the rapporteur opinion reflects an ongoing discussion about
    the robustness and meaningfulness of the clinical benefit of Glybera
    and the rapporteur has been critical since the beginning of the program.
    Regardless of the outcome of the process which could include the
    request for additional supportive clinical data, we note that Glybera is only
    a small value driver for the stock. We currently model 2015E, '16E, and
    '17E EU Glybera royalties of EUR 2, 3, and 8M. respectively, and Glybera
    EU royalties reflect only 10% of our $50 price target.
    • Potential positive read through from CLDN CUPID2 data this
    month. Whereas positive CUPID2 data could derisk the congestive
    heart failure (CHF) opportunity for gene therapy in general and hence
    BMY/QURE's program, we believe potentially disappointing CUPID2
    data position QURE well to move forward with a strong partner and
    a potentially differentiated lead CHF asset. We believe BMY has
    recognized the opportunity in QURE's platform and has hence licensed
    QURE's CHF program before CLDN data have been publicly released.
    We note that QURE/BMY's lead CV program could also be differentiated
    from CLDN's in terms of: (1) cardiac delivery, (2) vector design, and (3)
    the gene payload. QURE has employed retrograde coronary venous
    delivery in animal models while CLDN is utilizing antegrade coronary
    artery infusion. Our checks with MEDACorp KOLs suggest that the
    retrograde approach could be more efficient given the ability to infuse
    vector at a greater pressure gradient, which would lead to greater transfer
    to the heart muscle tissue. While QURE has not yet committed to a
    specific AAV vector, it is utilizing a cardiomyocyte-specific promoter vs.
    CLDN's CMV promoter. One KOL we spoke with noted that the key rate
    limiter to high transduction efficiency is getting the virus delivered to the
    heart across the endothelial barrier. Hence, vector choice and dose are
    important factors influencing success chances. KOLs we spoke with were
    in agreement that both the SERCA2a gene (used by CLDN) and the
    S100A1 gene (used by QURE) hold significant promise. However, one
    KOL noted that S100A1 could be more potent than SERCA2a given its
    involvement in several aspects of the heart function.
    • Key value drivers in 2H15 include hemophilia B and Sanfilippo
    B data. We believe durable and consistent Factor IX expression in
    hemophilia B patients would be a key de-risking data point for QURE's
    liver-targeted pipeline. Positive Sanfilippo B data in 2H15 could validate
    the potential opportunity in CNS/lysosomal storage diseases (LSDs),
    representing another near-term source of upside, which is not yet
    accounted for in our valuation.
    mobile.twitter.com/captainfuture__
  6. flosz 13 april 2015 14:05

    • flosz

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    Piper: $QURE note 4/13 Last week, unfortunately timed with its secondary offering, QURE was notified by the CHMP that a negative assessment on Glybera is being submitted to the CAT
    (Committee for advanced Therapy Medicinal Products) which theoretically places the
    drug's EU approval at risk. The CHMP held the same negative view the first time Glybera
    was approved, so we are skeptical it will have any impact this time. Even if it does, QURE
    has become far less reliant on EU Glybera prospects as the hemophilia B gene therapy
    program has advanced to the clinic and it recently signed a transformative partnership
    with BMY. We reiterate our $40 PT.
    • More of the same? After review of the 6-year follow-up data for Glybera, the CHMP
    rapporteur has concluded the drug has not demonstrated robust efficacy and as such
    the benefit-risk balance is negative. This is the same conclusion the CHMP had prior
    to Glybera approval, which required 4 CAT committee meetings to assess. After an
    initial CAT negative vote, the subsequent ones were all positive because it was decided
    that the drug's effect on post-prandial chylomicrons was much more relevant for
    predicting pancreatitis risk than the drug's overall effect on triglycerides; a perspective
    we share.
    • What's next: The rapporteur's report will be submitted to the CAT for further
    assessment. The analysis is likely to be considered during an April 21-23 meeting;
    following this meeting there may be additional correspondence with the company to
    clarify any outstanding questions. A final decision may take up to a few months. We'd
    be surprised if the 6 year update led to any different decision by the CAT this time
    around.
    • Worst case: If the CAT reversed its prior views and decided to pull Glybera from the
    market, it would have a modest impact on our valuation (<25% impact) since we
    assume only modest contribution given a slow launch and royalty partially offset by
    payments owed. At this year's Phacilitate conference we had an opportunity to speak
    with one of the CHMP members who had been opposed to Glybera's approval- she
    was quite clear that this was not because it was a gene therapy product but because
    she didn't believe the drug had clear efficacy. She fully expected other gene therapy
    products will be approved on the basis of a larger demonstrated effect size. As such,
    we do not believe there should be any negative readthroughs even in the unlikely
    circumstance that Glybera is withdrawn.

    Ook via link vorige post.
  8. flosz 14 april 2015 14:02

    • flosz

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    Roth.
    We initiate coverage of uniQure N.V. (QURE) with a Buy rating and a $38/share price target.ROTH nice report on $QURE t.co/eOMauACLpn

    Glybera $1.50/share
    Bijlage:
  9. flosz 14 april 2015 14:32

    • flosz

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    Ratings Breakdown:5 Buy Rating(s)
    Consensus Rating:Buy (Score: 3.00)
    Consensus Price Target:$41.80 (43.99% upside)
    Bijlage:
  11. [verwijderd] 23 april 2015 01:12

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    quote:

    flosz schreef op 23 april 2015 00:35:

    BMO Capital Initiates Coverage on uniQure at Outperform, Announces $49.00 PT

    Afb. via:
    twitter.com/ymscapital
    misschien is dit de trigger voor de hogere koers in de after market? (weet niet wanneer het bericht verscheen?)

    Hemofilie A partnering zou overigens ook een top-bericht kunnen zijn.
  16. [verwijderd] 24 april 2015 20:48

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    finance.yahoo.com/news/hottest-niche-...

    The Hottest Niche in Biotech Still Has Ample Upside
    StreetAuthority Network
    4 minutes ago

    Over the past half decade, large biotechnology stocks have delivered robust gains across the board. These companies sell a range of very popular drugs and have been generating massive profits.

    At the other end of the spectrum, small biotechs, most of which are still in their developmental stage, have been a hit-or-miss proposition, with a lot more hits and misses.

    Yet one group of small biotechs has been on fire, and gains look set to continue. Investors are only now coming to realize that the young, recently-public companies working on gene therapy aren't a flash in the pan, but a vanguard in the fight against many maladies.

    Since I profiled these stocks a year ago, they have exploded higher. On average, they have risen 191% over the past 12 months. (For more background, please read the April 2014 article.)

    View photo
    .

    The catalysts for these stocks are quite clear: either they have announced impressive clinical advances, or secured the endorsement (and financial backing) of the big drug makers. For example:

    In December 2014, bluebird bio, Inc. (Nasdaq: BLUE) announced that patients in early stage trial were given the company's LentiGlobin355 drug, and their need for chronic blood transfusions simply ceased. Shares surged when the news was announced, and they keep rising.
    [More from StreetAuthority.com: ]

    UniQure NV (Nasdaq: QURE) had been making a series of promising announcements regarding its drug development path throughout 2014. Yet shares really caught investors' attention earlier this month when Bristol-Myers Squibb Co. (NYSE: BMY) announced a deal to license UniQure's gene therapy platform, replete with a series of upfront and milestone payments.

    Shares of Celladon Corp. (Nasdaq: CLDN) had also been up more than 100% (since April 2014), but have recently sold off on concerns that the company's Mydicar drug may not have sufficient efficacy to merit FDA approval.

    Applied Genetic Technologies Corp. (Nasdaq: AGTC) has yet to garner much buzz with its drug development efforts.

    But what about Bluebird Bio and Uniqure? After delivering such great returns, do they still possess further robust upside? Yes, they do, for risk-tolerant investors with multi-year time horizons.

    Regarding UniQure, I noted a year ago that the company "appears to offer the most appealing broad-based approach to gene therapy, and its sub-$150 million market value also makes it a relative bargain." Well, that market value is now approaching $500 million, so we need to stop thinking of this stock as a bargain. Instead, it needs to be viewed in terms of its total addressable market opportunity.

    Simply put, the company's total addressable market opportunity is very large. In the second half of this year, UniQure will deliver a clinical trial update regarding patients that have Hemophilia B. Although it afflicts only one in every 25,000 people, current treatments are extremely costly. Patients require a $2,500 injection three times a week. Analysts at Leerink Swan, an investment firm solely-focused on healthcare, think that the Phase I/II data will prove to be the next catalyst for this stock, and they see nearly 100% upside to their $50 target price.
    [More from StreetAuthority.com: ]

    Investors shouldn't just focus on the Hemophilia progress. UniQure is working a wide range of gene therapy treatments. The company and Bristol-Myers Squibb have identified 10 in particular that are worthy of collaboration. And as UniQure announces clinical trial progress with each indication, BMY will issue milestone payments. That likely eliminates the need for dilutive secondary offerings, a key consideration with any young biotech firm.

    Analysts at BMO Capital are also bullish. They just initiated coverage of UniQure with a $49 price target, noting that the company's work in the area of congestive heart failure could prove to eventually develop very robust revenue streams.

    Here's where the important biotech caveat comes in: UniQure and other gene therapy firms are showing great progress early in their clinical development work, but investors won't fully believe in this medical approach until large-scale Phase III trials are well underway. That means such stocks require a multi-year time horizon.

    Bluebird bio faces similar opportunities and threats. The company's gene therapy technologies appear to hold great promise for sickle cell disease, ALD (the "Lorenzo's Oil" drug discussed in last year's article) and several other "monogenic" (or single gene disease) disorders. The key distinction between these gene therapy firms and other biotechs is that the gene therapy approach would yield a one-time permanent cure, rather than years of costly treatments,

    The actual number of sufferers of such disorders that the gene therapy firms are targeting is relatively small. Yet "single-treatment, gene therapy-based cures could be priced at $500,000-plus per patient in the developed markets, and still offer a compelling cost-benefit profile for payors and patients," note analysts at Roth Capital Partners.
  17. [verwijderd] 28 april 2015 16:08

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    al die mooie aanbevelingen, hoge koersdoelen etc....het kan toch geen toeval zijn?
    Beleggers worden massaal op het verkeerde been gezet.

    Gisteren bleef het aandeel stevig staan op een turbulente dag in de biotech met bijna 800k...en nu met geen nieuws en iets meer dan 50k in elkaar gerost (6% lager!)
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