Diskussion zu SANTHERA PHARMACEUTICALS HOLDING AG (Seite 806)

[aaahhh]

Antwort auf Beitrag Nr.: 49.654.649 von question-mark am 27.04.15 19:25:39

Wenn ich die Wahrscheinlichkeit nicht als extrem hoch einschätzen würde, wäre ich hier nicht mit einer solchen Stückzahl/Summe investiert. Das gilt übrigens auch für DMD nächstes Jahr.
Gruß aaahhh

[question-mark]

Antwort auf Beitrag Nr.: 49.653.275 von aaahhh am 27.04.15 16:58:21

gibt es denn ernsthafte Bedenken? Natürlich weiss man nie, was die Behörden entscheiden, aber die Wahrscheinlichkeit der Zulassung ist doch hoch, zumindest habe ich nie anderes gehört.

[aaahhh]

Antwort auf Beitrag Nr.: 49.653.065 von liquidx am 27.04.15 16:33:12

Der Markt ist nervös, die einen glauben an die Zulassung durch die EMA, die anderen hoffen auf ein negatives Urteil.
Gruß aaahhh

[liquidx]

Ich versteh das nicht, jetzt sind wir schon bei 93€ trotz guter Meldungen in der letzten Zeit.

[PigRace]

Knackige Position mittlerweile:

.................Net..........Total....
Date...........Change....Shorted
-----------------------------------
2015/04/15....6,490.....46,129
2015/03/31....1,225.....39,639
2015/03/13....9,858.....38,414
2015/02/27...19,414.....28,556
2015/02/13....1,498.......9,142
2015/01/30....5,661.......7,644
2015/01/15.......123.......1,983
2014/12/31......-240.......1,860

Da schlagen wohl zwei Herzen in der Brust (des Marktes)...

Gruß

PigRace

[PigRace]

Anbei die Präsentation von SANN auf der ANN.

Beeindruckend die gepoolten Studienergebnisse auf S. 26.

Gruß

PigRace

[PigRace]

Erste Rückmeldung von RBC zu SANN's Präsentation auf der American Association of Neurolgy:

"DELOS Phase III DMD data presentation impresses neurologists at AAN

Positive reaction and first step in increased exposure to physicians and investors: We view today's presentation at AAN as a significant incremental positive for Santhera. While the main findings presented today had been revealed previously in smaller forums, we believe publication in The Lancet and presentation in front of this large audience at AAN are high impact events for the company. These two venues provide the opportunity to engage pediatric neurologists on the respiratory benefits provided to non-ambulatory DMD patients. Moreover, a greater number of investors will gain insight into the promising revenue-generating potential of idebenone and the attractiveness of Santhera as a possible takeout target. We spoke to a number of neurologists following the presentation of the data and received a uniformly positive reaction on the dataset, with mentions on the “uniformity” and “clarity” of the data and the “clear benefit” of the drug. Clinicians spoke of the severe unmet medical need in the space and said they would use idebenone, if approved, in the vast majority of their DMD patients."

Gruß

PigRace

[Oberlaendler]

Eigentlich bin ich ja kein Freund von AF, für mehr Aufmerksamkeit in den USA dürfte es aber allemal sorgen:

Santhera -- A Duchenne Drug With Positive Study Results That Few Know About
By Adam Feuerstein Follow | 04/23/15 - 10:01 AM EDT

NEW YORK (TheStreet) -- Santhera Pharmaceuticals (SANN.SW) doesn't get much attention from investors, which is surprising for two reasons.

The company is developing a drug to treat Duchenne muscular dystrophy, a rare, inherited muscle-wasting disease very much on Wall Street's radar screen. Santhera has also accomplished something that higher-profile DMD companies BioMarin (BMRN - Get Report), PTC Therapeutics (PTCT - Get Report) and Sarepta Therapeutics (SRPT - Get Report) have not done to date: complete a successful phase III study. ...

... Commenting on the Santhera phase III study in a Tuesday blog post, John Porter, CEO of Parent Project Muscular Dystrophy, said, "This is an important and certainly not a modest effect on respiratory function and may well have a substantial effort on quality of life for Duchenne ... We very much look forward to the approval of [idebenone] and to the potential use of the drug in a combination therapy approach to Duchenne."

Approval of idebenone in the U.S. is not without risk. Santhera's use of peak expiratory flow as the primary measure of lung function improvement in the phase III study could raise some concern at the FDA because regulators are more comfortable evaluating drugs based on forced vital capacity, a different measure of lung function.

Santhera included improvement in forced vital capacity (FVC) as a secondary endpoint in the study, but the difference between idebenone and placebo was not statistically significant at one year. There was a statistically significant FVC benefit favoring idebenone over placebo when measured at 13, 26 and 39 weeks.

If idebenone is approved in the U.S. and Europe for DMD, peak sales could exceed $500 million using conservative pricing, forecasts RBC Capital analyst Simos Simeonidis. He also believes Santhera is likely to put itself up for sale if idebenone is approved.

One commercial issue which Santhera will need to navigate around is CoenzymeQ, a chemically similar, gray-market version of idebenone available as a nutritional supplement. Some DMD patients are known to take CoenzymeQ today.

Santhera insists its prescription-grade idebenone is chemically unique and superior to CoenzymeQ. The company points to prior FDA statements that idebenone is an investigational medicine and therefore cannot be marketed as a nutritional supplement.
http://www.thestreet.com/story/13123457/1/santhera--a-duchen…

AF reißt hier noch interessante Aspekte an.

Gruß Oberländler

[DasTier666]

hier die Meldung vom 11.03.15 für die morgige Präsentation

March 11, 2015: Principal Investigator to Present Phase III Data on Idebenone in Duchenne Muscular Dystrophy (DMD) at the Annual Meeting of the American Academy of Neurology (AAN)

Liestal, Switzerland, March 11, 2015 - Santhera Pharmaceuticals (SIX: SANN) announces that Gunnar M. Buyse, PhD, MD, Professor of Child Neurology at the University Hospitals Leuven (Belgium), and principal investigator, will present outcome data of the Phase III trial with Raxone®/Catena® (idebenone) in Duchenne Muscular Dystrophy (DMD) at the upcoming annual meeting of the American Academy of Neurology (AAN).

The oral presentation titled, "Idebenone Reduces Loss of Respiratory Function in Duchenne Muscular Dystrophy-Outcome of a Phase III Double Blind, Randomised, Placebo controlled Trial (DELOS)," will be held during the Clinical Trials Plenary Session on Friday, April 24, 12:00 pm-1:30 pm. This session was designed by the AAN to address important clinical topics identified throughout the neurology community that affect patient care, and the Science Committee considered the DELOS outcome a critical advancement in the field of neuroscience.

"Progressive lung disease and irreversible loss of lung function are a main cause of morbidity and early mortality in DMD", stated Professor Gunnar M. Buyse, invited presenter at the AAN conference. "The statistically significant and clinically relevant outcomes of primary and secondary endpoints of this Phase III trial coherently demonstrate the therapeutic potential of idebenone in reducing the loss of respiratory function."

"I am excited that Professor Buyse was invited by the organizers of this year's AAN conference to present the outcome of this first successful phase III trial in DMD as a prominent lecture to a general audience of neurologists," commented Thomas Meier, PhD, CEO of Santhera. "This is as much a tribute to the positive outcome of the trial as it is tribute to the scientists and patients and families conducting it." ...

http://www.santhera.com/index.php?docid=212&vid=&lang=en&new…

[Oberlaendler]

Könnte heute noch ein SK über 100 Franken werden. Irgendwie auffällig, dass die Aktie zum Handelsschluss immer anzieht.

Gruß Oberländler

PS: Habe zufällig gesehen, dass am 11.05. auch die GV ist. Wäre lustig, wenn zu Beginn oder während der HV eine adhoc-Meldung mit der Zulassung bekannt gegeben werden müsste.