XENON Pharmaceuticals €2.63 am 9.2.2018 - 500 Beiträge pro Seite

[Cyberhexe]

bin via Ohad auf die Aktie aufmerksam geworden und hab mir nun eine kleine Anfangsposition (2000 Stück) ins Depot gelegt:

[Popeye82]

für Ihre Kompetenzen ist Diese "Vor"stellung aber doch mager.

[Cyberhexe]

Antwort auf Beitrag Nr.: 56.993.657 von Popeye82 am 10.02.18 16:11:46

sorry, habe momentan wenig Zeit - eine detaillierte Analyse hinsichtlich Gründe der Kaufentscheidung folgt selbstverständlich.

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.000.174 von Cyberhexe am 11.02.18 23:58:39

auf die Schnelle ein paar Info:

XEN1101 aus dem Epilepsie-Programm von Xenon wurde 2017 von 1stPharmaceuticals einlizenziert.
Dessen Wirkmechansismus (Öffnung des Kv7-Ionen-Kanal) wurde von Human Genetics validiert.

Das Vorgängermolekül "Ezogabine" wurde 2011 zugelassen, jedoch wegen unerwünschter Nebenwirkungen vom Markt zurückgezogen. Nebenwirkungen --> Pigmentierung von Haut und Auge, weshalb ein Sehverlust und Hauttox zu befürchten war. Diese Befürchtung hat sich in einer BlackBox-Warnung wiedergefunden.

Die Entwicklungsprodukte in der Indikation Schmerz, die gemeinsam mit Genentech und Teva in der Klinik getestet werden, kann man vergessen. Kaufentscheidung ist ausschliesslich im Epilepsie-Programm begründet. Marktkapitalisierung trotz Kursgewinn von heute (10%) immer noch niedrig (<70mUSD).
CASH-Probleme sind zu erwarten - reicht noch bis ca. Ende 2018. Bewertung dennoch günstig.

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.005.604 von Cyberhexe am 12.02.18 17:57:00

BURNABY, British Columbia, March 13, 2018 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (XENE), a clinical stage biopharmaceutical company, today announced that Dr. Ernesto Aycardi will join the company as its Chief Medical Officer (CMO) providing leadership and execution of Xenon’s clinical development programs, including its two clinical stage epilepsy product candidates, XEN1101 and XEN901, and recently announced orphan hemiplegic migraine product candidate, XEN007. Dr. Aycardi will join Xenon effective March 19, 2018.



Ernesto Aycardi
VP, Head Clinical Operations, Data Sciences and Biometrics & Clinical Pharmacology at Teva Pharmaceuticals

Aktuell
Teva Pharmaceuticals
Früher
EMD Serono, Inc., Biogen Idec, Biogen
Ausbildung
Universidad Nacional de Colombia

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.269.305 von Cyberhexe am 13.03.18 21:45:11

der neue CMO hat 50'000 Optionen zu einem Ausübungspreis von $4.65 mit Laufzeit 10y erhalten:

http://insideri.com/1734218_000117184318002118_0001171843-18…

Nur wenn der Kurs der Aktie nachhaltig steigt, ist dies für den Mitarbeiter ein Geschäft - dies ist im Sinne aller Aktionäre!

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.347.192 von Cyberhexe am 21.03.18 20:44:00

gibt es Neuigkeiten, die den heutigen Kursanstieg (aktuell 11%) rechtfertigen? Ich hab bisher nichts gefunden!

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.518.807 von Cyberhexe am 11.04.18 16:16:04

Xenon Pharmaceuticals to Present at the 2018 Bloom Burton & Co. Healthcare Investor Conference
BURNABY, British Columbia, April 25, 2018 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's Chief Executive Officer, will present a corporate update at the Bloom Burton & Co. Healthcare Investor Conference in Toronto, Canada on Wednesday, May 2, 2018 at 9:30 am ET.

A live audio webcast of the presentation will be available on the investors section of Xenon's website at www.xenon-pharma.com and will be available for replay following the event.

http://investor.xenon-pharma.com/phoenix.zhtml?c=253202&p=ir…

[kmastra]

Wow! Erste Ergebnisse von XEN1101 kommen schon demnächst auf der EILAT (13-16 Mai). Hatte ich gar nicht auf dem Schirm. Aber wohl eher mit Schwerpunkt auf der Sicherheit...

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.649.662 von kmastra am 27.04.18 20:25:56

BURNABY, British Columbia, May 01, 2018 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (XENE), a clinical-stage biopharmaceutical company, today announced that it will report its first quarter 2018 financial and operating results after the close of U.S. financial markets on Tuesday, May 8, 2018. Xenon management will host a conference call and live audio webcast at 4:30 pm Eastern Time (1:30 pm Pacific Time) to discuss the results and to provide a corporate update.

[kmastra]

Antwort auf Beitrag Nr.: 57.649.662 von kmastra am 27.04.18 20:25:56

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.682.239 von Cyberhexe am 03.05.18 05:50:58

14. EILAT-Konferenz in Madrid Spanien am 15.5.2018 --> Zwischenergebnis zu XEN1101:

https://www.ilae.org/congresses/14th-eilat-conference-on-new…

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.688.242 von kmastra am 03.05.18 17:49:50

hoppla....fast zeitgleich den selben Inhalt ins Forum übermittelt, aber du warst gut 1 1/2 min schneller - sorry für die Wdh. Hab das erst später registriert.

[kmastra]

Antwort auf Beitrag Nr.: 57.688.362 von Cyberhexe am 03.05.18 17:59:36

Kenn ich - kein Problem!
Die Präsentation von gestern war übrigens auch hörenswert...
Neulich zudem optimistische Kommentare von Alfredo Fontanini.

https://twitter.com/AF_biotech/status/990959369633304576

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.689.115 von kmastra am 03.05.18 19:16:32

Zitat von kmastra: Kenn ich - kein Problem!
Die Präsentation von gestern war übrigens auch hörenswert...
Neulich zudem optimistische Kommentare von Alfredo Fontanini.

https://twitter.com/AF_biotech/status/990959369633304576

guter Fund...dieser Fontanini scheint ein Experte in Neuroscience zu sein. Anbei seine bisherigen Publikationen:

https://www.researchgate.net/scientific-contributions/392710…

Fontanini bestätigt:
"Ezogabine was approved for partial seizures, but than withdrawn by the market for safety concerns. XEN1101, which is more potent than ezogabine according to in vitro studies, was designed by the same team to overcome the safety issues of the first gen compound."

Die Wirkung von XEN1101 sollte analog dem Vorgängermolekül Ezogabine ausser Frage stehen. Falls die Nebenwirkungen mit dem neuen "Design" verschwinden, hat XEN1101 riesiges Potenzial!

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.688.272 von Cyberhexe am 03.05.18 17:51:29

Zitat von Cyberhexe: 14. EILAT-Konferenz in Madrid Spanien am 15.5.2018 --> Zwischenergebnis zu XEN1101:

https://www.ilae.org/congresses/14th-eilat-conference-on-new…

Am Montag wird das Zwischenergebnis von XEN1101 in Madrid auf EILAT in Madrid veröffentlicht:

14th EILAT Conference on New Antiepileptic Drugs and Devices
EILAT XIV

Mechanismus durch Öffnen der Kv7-Ionenkanäle analog Ezogabine, dessen Wirkung bereits nachgewiesen wurde --> Zulassung 2011. Diese wurde jedoch aufgrund von Nebenwirkungen (Pigmentierun von Haut und Auge --> Sehverlust wurde befürchtet --> "Black Box-Warnung") 2017 von der FDA zurückgezogen.

Bei XEN-1101 sollte die Wirkung ähnlich sein ohne die unerwünschten Nebenwirkungen.

[kmastra]

[kmastra]

Ohad Hammer mit seinem angekündigten Update zu XENE:

http://www.orf-blog.com/xenon-p1-data-provide-more-de-riskin…

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.851.403 von kmastra am 28.05.18 22:41:50

Zitat von kmastra: Ohad Hammer mit seinem angekündigten Update zu XENE:

http://www.orf-blog.com/xenon-p1-data-provide-more-de-riskin…

die Pigmentierungen von Haut und Auge unter Ezogabine werden bei XEN1101 nicht beobachtet! Der Mechanismus ist jedoch der gleiche, so dass von einer ähnlichen bzw. sogar besseren Wirkung auszugehen ist.

Ohad schreibt:

XEN1101 was designed based on clinical experience with ezogabine (Potiga), an FDA approved Kv7 opener with proven clinical efficacy that was withdrawn from the market due to safety concerns. XEN1101 is more potent and does not seem to dimerize or bind melanin (seen as the primary liability with ezogabine as it leads skin and eye pigmentation). It also has a better PK profile that should support daily dosing vs. thrice daily with ezogabine.

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.851.682 von Cyberhexe am 28.05.18 23:32:16

Ohads Zusammenfassung zu Xenon vom 28.5.2018:

Upside potential

As a small cap biotech, Xenon comes with all the usual risks (no clinical proof of concept, long timelines, high rate of cash burn etc.) but at a valuation of $100M these are risks I am happy to take. Commercial potential for a new anti-epileptic drug with a favorable safety profile is in the $400M-$500M range, not including the orphan indications that could add additional ~$150M per indication. If safety data for XEN1101 and XEN901 continue to look clean (long term safety data is expected by YE18), it is hard for me to envision Xenon staying independent at these levels.

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.005.604 von Cyberhexe am 12.02.18 17:57:00

Zitat von Cyberhexe: XEN1101 aus dem Epilepsie-Programm von Xenon wurde 2017 von 1stPharmaceuticals einlizenziert.
Dessen Wirkmechansismus (Öffnung des Kv7-Ionen-Kanal) wurde von Human Genetics validiert.

Das Vorgängermolekül "Ezogabine" wurde 2011 zugelassen, jedoch wegen unerwünschter Nebenwirkungen vom Markt zurückgezogen. Nebenwirkungen --> Pigmentierung von Haut und Auge, weshalb ein Sehverlust und Hauttox zu befürchten war. Diese Befürchtung hat sich in einer BlackBox-Warnung wiedergefunden.

Die Entwicklungsprodukte in der Indikation Schmerz, die gemeinsam mit Genentech und Teva in der Klinik getestet werden, kann man vergessen. Kaufentscheidung ist ausschliesslich im Epilepsie-Programm begründet. Marktkapitalisierung trotz Kursgewinn von heute (10%) immer noch niedrig (<70mUSD).
CASH-Probleme sind zu erwarten - reicht noch bis ca. Ende 2018. Bewertung dennoch günstig.

aufgrund der relativ knappen Ressourcen (ca. 36m$ Cash+Short Term Investments) ist auch bei Xenon bald mit einer KE zu rechnen.

[Cyberhexe]

...und läuft und läuft und...aktuell $7.00

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.960.429 von Cyberhexe am 11.06.18 18:56:34

...und läuft und läuft und...

[Cyberhexe]

Antwort auf Beitrag Nr.: 57.968.811 von Cyberhexe am 12.06.18 17:56:31

XEN901 ist hinsichtlich pharmakologischer Kennzahlen sehr viel versprechend:

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.034.665 von Cyberhexe am 21.06.18 13:33:18

die FDA hat Ezogabine "Orphan Drug Designations and Approvals" zuerfkanntg:

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detai…

[kmastra]

https://www.chimeraresearchgroup.com/2018/08/xene-epilepsy-a…

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.392.843 von kmastra am 07.08.18 17:29:54

Xenon läuft richtig gut: über 200% in 6 Monaten!



http://investor.xenon-pharma.com/phoenix.zhtml?c=253202&p=ir…

Xenon Pharmaceuticals Reports Second Quarter 2018 Financial Results and Provides Corporate Update
Novel Epilepsy Product Candidates – XEN1101 and XEN901 – Continue to Advance in the Clinic

New XEN1101 Phase 1b TMS Pharmacodynamic Data to be Presented at upcoming European Congress on Epileptology

BURNABY, British Columbia, Aug. 07, 2018 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today reported its financial results for the quarter ended June 30, 2018 and provided a corporate update.

Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “As I reflect upon the first half of this year, we achieved a number of important milestones and continue to see exciting advancements in Xenon’s clinical-stage epilepsy programs. Over the last quarter, we presented encouraging preliminary clinical data from both of our ongoing XEN1101 and XEN901 Phase 1 clinical trials. We expect to announce results from the XEN1101 Phase 1b randomized TMS pharmacodynamic study at a scientific symposium at the end of this month.”

Dr. Pimstone continued, “Our strengthened balance sheet supports our strategic goals and the continued development of our innovative therapies to address epilepsy and other indications, and allows us to evaluate and potentially add new programs into our pipeline. Looking to the second half of the year, we anticipate a number of important catalysts, including: the XEN1101 Phase 1b clinical data; the complete results from the Phase 1 clinical trials for XEN1101 and XEN901; the initiation of an XEN1101 Phase 2 clinical trial in adult patients with focal seizures; and continued progress to advance XEN901 into a Phase 2 clinical trial.”

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.404.879 von Cyberhexe am 08.08.18 22:17:31

neues Kursziel:

Xenon Pharmaceuticals (XENE) PT Raised to $15 at Stifel
August 9, 2018 6:29 AM EDT Send to a Friend
Stifel raised its price ...

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.412.934 von Cyberhexe am 09.08.18 18:28:58

aus der Pressekonferenz vom 21.8.2018:

"We continue to examine various development strategies for XEN007 with key opinion leaders and leading clinicians within our strong network in the hemiplegic migraine, or HM, community. In addition to HM, we believe there may be other neurological disorders, where CNS-acting calcium channel inhibitor may be beneficial, and we are considering these future development ideas in both adults as well as pediatric populations. We look forward to updating you on 007 as our plans are finalized."

[agahnin85]

News

http://globenewswire.com/news-release/2018/08/29/1558101/0/e…

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.559.324 von agahnin85 am 29.08.18 12:28:13

...es würde mich nicht wundern, wenn Übernahmephantasie den Kurs noch weiter nach oben treibt:

Xenon Announces Positive XEN1101 Pharmacodynamic Data from Phase 1b TMS Study
XEN1101 Demonstrates Statistically Significant Reduction in Corticospinal and Cortical Excitability as Measured by TMS-EMG and TMS-EEG

XEN1101 Demonstrates Greater Effect on TMS-EMG Resting Motor Threshold at Significantly Lower Dose When Compared to Historical Ezogabine Data

XEN1101 Phase 2 Clinical Trial in Adult Focal Seizures Expected to be Initiated in Fourth Quarter of 2018

Conference Call Today at 8:30 am ET

http://investor.xenon-pharma.com/phoenix.zhtml?c=253202&p=ir…

[kmastra]

Ein ganz wichtiger Punkt wird hier angesprochen:



Es wäre natürlich toll, wenn XENE das Go! von der FDA bekäme. Die P2 bei Erwachsenen soll ja noch im Q4 starten. Da wird dann aber noch die P3 folgen müssen. Schnellster Weg auf den Markt wäre also die Subgroup bei Kindern.
So wie ich es verstehe ist die Chance durchaus vorhanden, wenngleich das ein sehr innovativer Weg ist. Bisher gab es die Zulassung bei Kindern erst nach einer Zulassung bei Erwachsenen.

Ein guter Follow bei Twitter ist auch:

https://twitter.com/GantosJ

[agahnin85]

Antwort auf Beitrag Nr.: 58.562.021 von kmastra am 29.08.18 16:29:17

News

Hierzu gibt es jetzt gute Neuigkeiten:

Based on feedback from the U.S. Food and Drug Administration (FDA), Xenon anticipates initiating a single, pivotal Phase 3 clinical trial in approximately mid-2019 examining XEN496’s efficacy as a precision medicine treatment of KCNQ2 epileptic encephalopathy (KCNQ2-EE) or EIEE7, which is a rare, severe, pediatric epilepsy caused by loss-of-function missense mutations in the KCNQ2 gene that encodes for the Kv7.2 channel.

http://globenewswire.com/news-release/2018/09/06/1566234/0/e…

[kmastra]

Antwort auf Beitrag Nr.: 58.631.367 von agahnin85 am 06.09.18 13:37:50

Sehr schön!
Auf den ersten Blick gefällt mir, dass man nur 1 P3 Studie mit 20 Patienten machen muss. Das sollte finanziell zu stemmen sein und auch nicht lange dauern.
Man wählt jetzt aber tatsächlich ezogabine und nicht 1101. Also den Wirkstoff, den GSK im Grunde vom Markt genommen hat und der jetzt generisch ist. Im CC werden sie bestimmt genauer erläutern, warum!
Eventuell geht das jetzt einfach schneller (ist ja schon bei Erwachsenen zugelassen, die FDA hat eine Menge Daten) und man hat 1101 dann als Nachfolgeprodukt.

http://globenewswire.com/news-release/2018/09/06/1566234/0/e…

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.631.595 von kmastra am 06.09.18 14:05:55

Xenon hat die Kapitalerhöhung erfolgreich abgeschlossen:

Xenon Pharmaceuticals Announces Closing of its $63.0 Million Public Offering of Common Shares
BURNABY, British Columbia, Sept. 17, 2018 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage, neurology-focused biopharmaceutical company, today announced the closing of its previously announced public offering of 4,500,000 common shares pursuant to its existing shelf registration statement at a public offering price of $14.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were $63.0 million.


by the way...die Daten zu XEN1101 sind positiv die Nebenwirkungen akzeptabel - schaut gut aus!

XEN1101 was well tolerated with all adverse events (AEs) reported as mild or moderate and reversible. The most common AEs were dizziness and drowsiness, similar to marketed antiepileptic drugs. There were no withdrawals, serious AEs, or deaths.

[pickuru]

Experte: "Biotech-Aktien aus Kanada" Das sind meine Favoriten!
u.a. Xenon Pharmaceuticals

https://aktien-boersen.blogspot.com/2018/09/experte-biotech-…

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.722.658 von Cyberhexe am 17.09.18 22:30:09

Unverändert: "Analyst consensus PT is currently $15!"

[kmastra]

Das kommt nicht wirklich überraschend:
Roche lässt jetzt auch das 2. Nav 1.7 Program (RG6029/GDC0310) fallen.
Das ist natürlich schade aber war zu erwarten, nachdem Roche die Weiterentwicklung immer mehr herausgezögert hat und es in den Präsentationen von XENE eigentlich kaum noch vorkam. Grundsätzlich sind die Epilepsie Kandidaten aber das was den Kurs hier bewegen sollte. Sollte der Kurs signifikant fallen kaufe ich zu...

[Cyberhexe]

Antwort auf Beitrag Nr.: 58.980.063 von kmastra am 17.10.18 11:26:21

Orphan Drug Designations für Flunarizine:

[kmastra]

http://encodelp.com/site/wp-content/uploads/2019/10/EI-Xenon…

[Cyberhexe]

melde mich zurück von einer Andenüberquerung und 2 internetfreien Wochen - die Spannung ob der Entwicklung "meiner Babies" war natürlich gross. Die Entwicklung war fast ausschliesslich positiv, insbesondere XENON und ICPT sind sehr gut gelaufen!

[pako21]

Antwort auf Beitrag Nr.: 62.108.345 von Cyberhexe am 08.12.19 19:30:44

Hallo Cyberhexe,

willkommen zurück!
Tolles Timing bei ICPT.

Viele Grüße

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.108.705 von pako21 am 08.12.19 20:51:31

Zitat von pako21: Hallo Cyberhexe,

willkommen zurück!
Tolles Timing bei ICPT.

Viele Grüße

Vielen Dank für den Willkommensgruss!

XENON hat XEN901 and NBIX auslizenziert. Die Bedingungen können sich durchaus sehen lassen:

"Xenon Receives $50 Million Upfront and Up to $1.7 Billion in Potential Development, Regulatory and Commercial Milestone Payments Across All Licensed Products, as well as Option to Co-Fund XEN901"

- 50m$ Vorabzahlung
- bis 1.7b$ Meilensteinzahlungen
- Möglichkeit der Kovermarktung von XEN901

Not too bad!

investor.xenon-pharma.com/news-releases/news-release-details…

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.112.422 von Cyberhexe am 09.12.19 12:51:34

In den knapp 2 Jahren seit Empfehlung ist Xenon bereits prächtig gelaufen, und dennoch dürfte das Ende der "Kurs-Fahnenstange" noch lange nicht erreicht sein. In 2020 werden für die 2 Epilepsieprogramme ph2-Ergebnisse erwartet, denen von verschiedenen Experten eine gute Erfolgswahrscheinlichkeit in Aussicht gestellt wird, zumal bisher keine besonderen Risiken bekannt sind. Beide Wirkstoffe (XEN901 bzw. 1101) sind hochwirksam bei vertretbarem Risiko. Der Deal mit Neurocrine Biosciences zu XEN901 ist zudem ein gutes Zeichen dafür, dass BigPharma von dessen Marktreife überzeugt ist, auch wenn dadurch etwas Phantasie verloren geht.

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.228.108 von Cyberhexe am 25.12.19 09:12:41

neues 52w-Hoch!

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.308.004 von Cyberhexe am 07.01.20 21:31:22

Zitat von Cyberhexe: neues 52w-Hoch!

...gute Aussichten für 2020:

Xenon’s Proprietary Programs Continue to Advance with Multiple Mid to Late Stage Clinical Trials Anticipated to be Underway in 2020

Xenon Eligible for Milestone Payments Based on the Advancement of Partnered Programs

Experienced Biotech Executive, Dr. Clarissa Desjardins, Joins Xenon’s Board of Directors

BURNABY, British Columbia, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (XENE), a clinical stage biopharmaceutical company, today provided a corporate update and outlined its key milestone opportunities for 2020.

Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “Xenon is entering 2020 in a very strong position with an exciting portfolio of proprietary neurology-focused candidates in clinical development, a healthy balance sheet, and valued collaborators advancing partnered programs. We expect to have multiple mid to late stage clinical trials underway in 2020 putting us in a position to generate important clinical data in 2020.”

Dr. Pimstone continued, “We anticipate a number of important milestone events in 2020, including the initiation of a Phase 3 clinical trial with XEN496 in patients with KCNQ2-DEE, a severe and rare form of pediatric epilepsy. In addition to the ongoing XEN1101 Phase 2b clinical trial in adult focal epilepsy, where we anticipate top-line data later this year, we are also seeking to expand the clinical development of XEN1101 in 2020 as we evaluate additional potential clinical indications for this novel Kv7 potassium channel modulator. Additionally, we look forward to the results from a physician-led Phase 2 study examining XEN007 in treatment-resistant childhood absence epilepsy.”

Dr. Pimstone added, “We are also fortunate to work with great collaborators who continue to advance our partnered programs. Neurocrine has guided that it expects to file an IND in mid-2020 in order to start a Phase 2 clinical trial for XEN901 (now known as NBI-921352) in SCN8A-DEE pediatric patients. Flexion continues to develop its pre-clinical FX301 program focused on peripheral nerve block for control of post-operative pain, and anticipates initiating FX301 clinical trials in 2021.”

Anticipated Milestones

Proprietary Programs

XEN1101 is a differentiated Kv7 potassium channel modulator being developed for the treatment of epilepsy and potentially other neurological disorders. A Phase 2b double-blind, placebo-controlled, multicenter clinical trial (called the X-TOLE study) is underway to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in approximately 300 adult patients with focal epilepsy. The primary endpoint is the median percent change in monthly focal seizure frequency from baseline compared to treatment period of active versus placebo. Patient enrollment for this XEN1101 Phase 2b clinical trial is ongoing in the United States, Canada and Europe. Long term six-and nine-month toxicology studies have now been completed, providing support for the 12-month open label extension for patients enrolled in the Phase 2b clinical trial. Depending upon the rate of enrollment, top-line results are anticipated in the second half of 2020. Xenon continues to explore the development of XEN1101 in other neurological indications.

XEN496 (active ingredient ezogabine) is a Kv7 potassium channel modulator being developed by Xenon. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for XEN496 as a treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). A pharmacokinetic (PK) study testing Xenon’s proprietary pediatric formulation of ezogabine (XEN496) in healthy adult volunteers is expected to complete in the first quarter of 2020. The FDA previously indicated that it is acceptable to study XEN496 in infants and children up to four years old, and that a single, small pivotal trial may be considered adequate in order to demonstrate XEN496’s efficacy in KCNQ2-DEE, provided the study shows evidence of a clinically meaningful benefit in patients with the intended indication. After completion of the XEN496 PK study and discussions with the FDA on a Phase 3 clinical trial design in the first quarter of 2020, Xenon expects to initiate a Phase 3 clinical trial in KCNQ2-DEE.

XEN007 (active ingredient flunarizine) is a CNS-acting calcium channel modulator that modulates Cav2.1 and T-type calcium channels. Other reported mechanisms include dopamine, histamine and serotonin inhibition. A physician-led, Phase 2 proof-of-concept study has recently been initiated to examine the potential clinical efficacy, safety, and tolerability of XEN007 as an adjunctive treatment in pediatric patients diagnosed with treatment-resistant childhood absence epilepsy. Results from this Phase 2 investigator-led proof-of-concept study are expected in 2020. Depending on the results from the study, CAE may represent a potential orphan indication for future development of XEN007.
Partnered Programs

In December 2019, Xenon entered into a license and collaboration agreement with Neurocrine Biosciences, Inc. (NBIX) to develop first-in-class treatments for epilepsy. Neurocrine Biosciences has an exclusive license to XEN901, now known as NBI-921352, a clinical stage selective Nav1.6 sodium channel inhibitor for epilepsy. In addition, Neurocrine Biosciences gained an exclusive license to pre-clinical compounds for development, including selective Nav1.6 inhibitors and dual Nav1.2/1.6 inhibitors. The agreement also included a multi-year research collaboration to discover, identify and develop additional novel Nav1.6 and Nav1.2/1.6 inhibitors. Neurocrine Biosciences anticipates filing an IND application with the FDA in mid-2020 in order to start a Phase 2 clinical trial in SCN8A developmental and epileptic encephalopathy patients in the second half of 2020. Xenon is eligible to receive up to $25 million upon the FDA acceptance of an IND for NBI-921352, with 55% of the amount in the form of an equity investment in Xenon at a 15% premium to Xenon's 30-day trailing volume weighted average price at that time.

In September 2019, Xenon entered into an agreement with Flexion Therapeutics, Inc. (FLXN) that provides Flexion with the global rights to develop and commercialize XEN402, a Nav1.7 inhibitor. Flexion’s pre-clinical program, known as FX301, consists of XEN402 formulated for extended release from a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion has indicated that it anticipates initiating FX301 clinical trials in 2021.
Corporate Updates

Effective immediately, Dr. Clarissa Desjardins has been appointed to Xenon’s Board of Directors and will also serve on the Compensation Committee. An award-winning entrepreneur with over 25 years of biotechnology experience, Dr. Desjardins has a doctorate in neurology and neurosurgery from McGill University’s Faculty of Medicine. In 2011, Dr. Desjardins founded Clementia Pharmaceuticals, a publicly traded biotechnology company focused on rare bone disorders that was acquired by Ipsen S.A. in 2019 for up to $1.3 billion. Dr. Richard Scheller will resign from Xenon’s Board effective January 14, 2020 after serving as an independent director since 2015.
Dr. Pimstone stated, “I am pleased to welcome Clarissa Desjardins to our Board of Directors. With her extensive biotechnology, entrepreneurial, and neuroscience background, Clarissa is a superb addition to Xenon’s Board. I expect her contributions will be invaluable as we continue to advance our clinical programs and strive to develop new therapeutics for patients in need. I also wish to thank Richard for his esteemed counsel and service on our Board of Directors. The Xenon team wishes him well in all of his future endeavors.”

[haowenshan]

Antwort auf Beitrag Nr.: 62.396.183 von Cyberhexe am 16.01.20 17:38:26

zuerst kommt mal eine kapitalerhöhung zu 16$ im umfang von geplanten 60 mio $.

[Cyberhexe]

Kapitalerhöhung erfolgreich durchgeführt:

Xenon Pharmaceuticals Announces Closing of its $60.0 Million Public Offering of Common Shares
January 27, 2020
BURNABY, British Columbia, Jan. 27, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today announced the closing of its previously announced public offering of 3,750,000 common shares pursuant to its existing shelf registration statement at a public offering price of $16.00 per share. The gross proceeds to Xenon from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon, were $60.0 million. In addition, Xenon has granted to the underwriters of the offering an option for a period of 30 days from January 22, 2020 to purchase up to an additional 562,500 common shares at the public offering price, less the underwriting discounts and commissions.

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.509.967 von Cyberhexe am 28.01.20 16:10:27

8-K

http://investor.xenon-pharma.com/static-files/01c840fa-0c0a-…

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.630.050 von Cyberhexe am 10.02.20 07:51:41

Zitat von Cyberhexe: 8-K

http://investor.xenon-pharma.com/static-files/01c840fa-0c0a-…

Thread wurde vor 2 Jahren eröffnet - mit der Performance darf man sehr zufrieden sein!

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.630.083 von Cyberhexe am 10.02.20 07:55:12

Zitat von Cyberhexe:

Zitat von Cyberhexe: 8-K

http://investor.xenon-pharma.com/static-files/01c840fa-0c0a-…

Thread wurde vor 2 Jahren eröffnet - mit der Performance darf man sehr zufrieden sein!

...und läuft und läuft und...

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.664.196 von Cyberhexe am 13.02.20 01:35:19

Xenon Pharmaceuticals Announces Full Exercise and Closing of Underwriters’ Option to Purchase Additional Shares
February 14, 2020
BURNABY, British Columbia, Feb. 14, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today announced that the underwriters of its previously announced public offering of 3,750,000 common shares, which initially closed on January 27, 2020, have exercised in full their option to purchase an additional 562,500 common shares at the public offering price of $16.00 per share, raising additional gross proceeds of $9.0 million and increasing the total gross proceeds of the public offering to $69.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Xenon.

Quelle: http://investor.xenon-pharma.com/news-releases/news-release-…

[Cyberhexe]

Antwort auf Beitrag Nr.: 62.785.886 von Cyberhexe am 25.02.20 20:22:49

endlich wieder mal ein positiver Tag, und was für einer: +24.5%

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.070.744 von Cyberhexe am 19.03.20 21:38:12

Zitat von Cyberhexe: endlich wieder mal ein positiver Tag, und was für einer: +24.5%

neue Optionen für das Management mit Strike $11.25:

March 26, 2020
BURNABY, British Columbia, March 26, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today announced equity inducement grants to eight new non-officer employees consisting of an aggregate of 63,200 share options. All of the foregoing share options were approved by the Compensation Committee of the Company’s Board of Directors with an effective date of March 25, 2020 and were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

The share options have an exercise price of $11.25 per common share, which is equal to the closing price per share of Xenon’s common shares on the grant date of March 25, 2020. The shares underlying the options vest over four years, with 25% vesting on the one-year anniversary of the date of grant and 1/36th of the remaining shares vesting monthly thereafter on the last day of each month, subject to such option recipient’s continued service relationship with the Company. Each option has a 10-year term and is subject to the terms and conditions of the share option agreement and the terms of the Company’s 2019 Inducement Equity Incentive Plan.

[Cyberhexe]

http://investor.xenon-pharma.com/news-releases/news-release-…

Xenon Pharmaceuticals Provides Corporate Update in the Context of COVID-19
March 31, 2020
BURNABY, British Columbia, March 31, 2020 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical stage biopharmaceutical company, today provided a corporate update in the context of the developing situation with the COVID-19 pandemic.

Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “The safety of Xenon’s employees and their families, as well as the healthcare professionals and patients involved in our clinical studies, is of the utmost importance to us. As we face an unprecedented health system crisis globally, we are focused on doing all we can at Xenon internally, in collaboration with our partners, and in our community to support the collective global public health initiatives to address the COVID-19 pandemic. Earlier this month, we implemented ‘work-from-home’ measures, suspended all non-critical lab work, and ceased non-essential business travel. Within the community in British Columbia, Xenon is in active discussions to assist in building COVID-19 screening capacity and has spearheaded a local initiative to collect Personal Protective Equipment from non-hospital-based research laboratories and collate an inventory of lab equipment useful in COVID-19 testing. Xenon will continue to live by our mission, to put people first, and will continue to do whatever we can, to protect the health and well-being of our staff, their families, and our community.”

Dr. Pimstone stated, “Given the rapidly changing environment, we are providing a corporate update on our proprietary and partnered programs. At a high level, it’s important to state that Xenon is in a very sound financial position. We have the benefit of a strong balance sheet and the resources to continue our work during this global public health crisis. Our cash, cash equivalents and marketable securities were approximately $235 million at the end of February 2020, which we anticipate provides us with sufficient cash to fund operations into 2022. We continue to make prudent business and spending decisions, with the flexibility to extend cash runway further if required, and are confident we have the necessary resources to manage through these unprecedented times.”

Dr. Pimstone continued, “Within our XEN1101 ‘X-TOLE’ Phase 2b clinical trial, as with other trials ongoing in our industry, we are seeing a significant reduction in new patient enrollment for numerous reasons related to the COVID-19 pandemic; therefore, we have adjusted guidance with topline data now anticipated in the first half of 2021, which is, of course, dependent upon the rate of patient enrollment throughout the remainder of this year. Despite this shift in guidance, we are pleased with our progress in the X-TOLE study to date. We are particularly encouraged by our review of safety data on a blinded basis, which suggests that XEN1101 is currently being well tolerated. The rate of discontinuations to date in the study is lower than modeled. Of note, to date, more than 90% of subjects from the double-blind portion of the trial have entered the open-label extension phase. Based on this review of blinded safety data to date, we believe tolerability is well within the modeled parameters, and, therefore, we do not believe an interim analysis is required. Our goal is to complete the study, as planned, in the shortest possible time frame.

Dr. Pimstone added, “We are also pleased to report that we recently completed a pharmacokinetic, or PK, study testing XEN496, our proprietary pediatric formulation of ezogabine, in healthy adult volunteers. The PK profile observed for XEN496 appears to be comparable to historical PK data for immediate-release ezogabine tablets, with XEN496 showing similar absorption and elimination curves, and we are excited that these data support Xenon’s planned Phase 3 clinical trial of XEN496 in patients with KCNQ2-DEE. We recently received Fast Track designation for XEN496 from the FDA, and we look forward to receiving FDA feedback on our Phase 3 protocol, which we anticipate receiving in the second quarter. In addition, our partnered programs remain on track with no changes to our previous guidance.”

[Cyberhexe]

interessant - es gibt Verbindungen zu Genentech über ein Patent von Anfang des Jahres:




und natürlich wie immer mit Quelle:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H…

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.261.811 von Cyberhexe am 07.04.20 11:07:45

Zitat von Cyberhexe: interessant - es gibt Verbindungen zu Genentech über ein Patent von Anfang des Jahres:




und natürlich wie immer mit Quelle:
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H…

Xenon nimmt wieder Fahrt auf:
13.37+0.91 (+7.27%)
As of 9:35AM EDT. Market open.

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.323.602 von Cyberhexe am 14.04.20 15:57:47

Our cash, cash equivalents and marketable securities were approximately $235 million at the end of February 2020, which we anticipate provides us with sufficient cash to fund operations into 2022.

bei einer aktuellen Marktkapitalisierung um 480m$ (ex yahoo 14.4.2020)


http://investor.xenon-pharma.com/news-releases/news-release-…

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.323.602 von Cyberhexe am 14.04.20 15:57:47

das Unternehmen sichert sehr sorgfältig und vorbildlich das geistige Eigentum über verschiedene Patente:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=H…

[opportoni]

Also dieses Jahr hoffentlich noch P2 Daten zu XEN007 und Start P3 für XEN496. Ausserdem kurzfristig Aussicht auf 25 Mio für XEN901

Bei XEN1101 muss man abwarten, ob es nicht doch zu Verzögerungen über H1 2021 hinaus wegen COVID kommt. Würde mich nicht überraschen.

Cash Situation sieht gut aus.

Ich bin optimistisch!

[opportoni]

Antwort auf Beitrag Nr.: 63.766.444 von opportoni am 21.05.20 23:46:34

Läuft. Gute Zeit für Biotech.

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.772.531 von opportoni am 22.05.20 16:07:42

alles im grünen Bereich:

http://investor.xenon-pharma.com/news-releases/news-release-…


Kursziele auf Ende 2020:
XENE > 20$
CHMA > 10$
TRVN > 2$
CYDY < 0.2$

[Cyberhexe]

Antwort auf Beitrag Nr.: 63.832.913 von Cyberhexe am 28.05.20 16:01:45

Xenon Pharmaceuticals (NASDAQ:XENE) Raised to Buy at BidaskClub



Xenon Pharmaceuticals Inc logoBidaskClub upgraded shares of Xenon Pharmaceuticals (NASDAQ:XENE) from a hold rating to a buy rating in a research report sent to investors on Friday, BidAskClub reports.

Several other analysts have also recently commented on XENE. Zacks Investment Research cut shares of Xenon Pharmaceuticals from a buy rating to a hold rating in a research note on Saturday, June 27th. Jefferies Financial Group initiated coverage on shares of Xenon Pharmaceuticals in a research note on Sunday, May 31st. They set a buy rating and a $23.00 price objective for the company. Wedbush started coverage on shares of Xenon Pharmaceuticals in a research note on Tuesday, March 24th. They set an outperform rating and a $23.00 price objective for the company. Finally, William Blair reiterated a buy rating on shares of Xenon Pharmaceuticals in a research note on Friday, May 22nd. One analyst has rated the stock with a hold rating and six have issued a buy rating to the stock. Xenon Pharmaceuticals has an average rating of Buy and a consensus price target of $21.25.



https://zolmax.com/investing/xenon-pharmaceuticals-nasdaqxen…

[opportoni]

Antwort auf Beitrag Nr.: 64.387.970 von Cyberhexe am 13.07.20 14:27:11

https://www.globenewswire.com/news-release/2020/08/04/207280…

Der CEO zeigt sich in den nöchsten Tagen auf zwei Konferenzen. Mal schauen, ob er dem Kurs wieder etwas Leben einhauchen kann.

[Cyberhexe]

derzeit hält sich die Aufregung in Grenzen - in 2021 dürfte sich dies jedoch ändern:

We also continue to advance our XEN1101 Phase 2b “X-TOLE” clinical trial currently underway in adult focal epilepsy with topline data expected in the first half of 2021 as previously guided, and we are exploring other potential indications for the novel Kv7 potassium channel modulator.

Quelle: https://investor.xenon-pharma.com/news-releases/news-release…

[opportoni]

Neue Analystenstimme mit Kursziel 22$ und Hinweis auf die Epilepsie-Pipeline:

https://thefly.com/landingPageNews.php?id=3169215&headline=X…

[opportoni]

P3 zu XEN496 ist jetzt auf clinicaltrials. Start soll noch dieses Jahr erfolgen mit Fertigstellung Ende 2022:

https://www.clinicaltrials.gov/ct2/show/NCT04639310?term=xen…

[Iltis57]

Mein bester Wert im Portfolio Dankeschön für die sehr gut Information
Alles Gute für 2021

[Malecon]

Heute war (die) spitze:





🎵

[Iltis57]

Antwort auf Beitrag Nr.: 67.185.336 von Malecon am 24.02.21 20:34:21

gibt es news?

[Malecon]

Antwort auf Beitrag Nr.: 67.272.639 von Iltis57 am 02.03.21 19:48:22

Zitat von Iltis57: gibt es news?

Ja, hier:

Xenon Pharmaceuticals Reports 2020 Financial Results and Provides Corporate Update

• XEN1101 Phase 2b “X-TOLE” Clinical Trial in Adult Focal Epilepsy on Track for Topline Data in Third Quarter of 2021
• Conference Call at 4:30 pm ET Today

https://www.globenewswire.com/news-release/2021/03/01/218466…

[Malecon]

Der Kurs randaliert mit + 83 %:






Das Unternehmen gab bekannt, dass seine Phase-2-Studie zu XEN1101 zur Behandlung von Epilepsie alle primären und sekundären Endpunkte erreicht hat.

XEN1101 zeigte eine statistisch signifikante und dosisabhängige Reduktion der monatlichen fokalen Anfallshäufigkeit im Vergleich zu Placebo.

🎵

[Malecon]

Xenon Pharmaceuticals: Möglicher Geheimtipp unter den Biotech-Aktien

Die Volumina in der Aktie haben sich in den letzten Monaten deutlich erhöht und es scheint, dass hier zahlreiche Fonds mit auf den Zug aufgesprungen sind.

Quelle: https://www.lynxbroker.de/boerse/boerse-kurse/aktien/xenon-p…


Mit Chartanalyse. 💡