Diskussion zu Eleven Biotherapeutics (Seite 6)
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ISIN: US14216R1014 · WKN: A3DZG2 · Symbol: W2J
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FeedbackSell the news?
heute Ausverkauf, nach einem kurzen rasanten Anstieg? ODER
doch mal ein langfristiger Anstieg?
ich stelle mal in beide Richtungen meine Körbchen auf
Sesen Bio Announces Acceptance of Analytical Comparability Plan by the U.S. Food and Drug Administration to Support the BLA and Commercialization of Its Lead Asset, Vicinium® for Non-Muscle Invasive Bladder Cancer
Sesen Bio (SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration (FDA) on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time.
In its Phase 2 and 3 clinical trials, Sesen Bio manufactured Vicinium in its facility in Winnipeg, Manitoba. Based on the Company’s assessment of the global demand potential for Vicinium, Sesen Bio sought a commercial manufacturer with outstanding manufacturing quality, a proven track record with regulatory agencies, and the capacity to meet global demand forecasts.
In October 2018, Sesen Bio entered into an agreement for the manufacturing process and technology transfer of Vicinium production with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FUJIFILM). In April 2019, the first in a series of full-scale, commercial GMP runs was successfully completed at FUJIFILM. The final bulk drug substance produced in this first run met all release specifications.
“Because we are changing manufacturing sites, it was important to agree on an approach to establish product comparability, which will be part of the BLA submission for Vicinium,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Gaining FDA agreement with our proposed Analytical Comparability Plan was the primary objective for yesterday’s meeting with the FDA. This is a very positive outcome and brings us one step closer to regulatory approval of Vicinium, and our ability to help save and improve the lives of patients.”
On June 6, 2019, Sesen Bio will meet with the FDA for its second scheduled meeting, a Type B Pre-BLA meeting, to discuss the registration strategy for Vicinium. Due to the wide-range of topics to be discussed at the Pre-BLA meeting, the Company plans to provide an update on the outcome of that meeting upon receipt of the final meeting minutes, which is typically within 30 days.
About Vicinium®
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
https://seekingalpha.com/pr/17518729-sesen-bio-announces-acc…
Sesen Bio (SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration (FDA) on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time.
In its Phase 2 and 3 clinical trials, Sesen Bio manufactured Vicinium in its facility in Winnipeg, Manitoba. Based on the Company’s assessment of the global demand potential for Vicinium, Sesen Bio sought a commercial manufacturer with outstanding manufacturing quality, a proven track record with regulatory agencies, and the capacity to meet global demand forecasts.
In October 2018, Sesen Bio entered into an agreement for the manufacturing process and technology transfer of Vicinium production with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FUJIFILM). In April 2019, the first in a series of full-scale, commercial GMP runs was successfully completed at FUJIFILM. The final bulk drug substance produced in this first run met all release specifications.
“Because we are changing manufacturing sites, it was important to agree on an approach to establish product comparability, which will be part of the BLA submission for Vicinium,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “Gaining FDA agreement with our proposed Analytical Comparability Plan was the primary objective for yesterday’s meeting with the FDA. This is a very positive outcome and brings us one step closer to regulatory approval of Vicinium, and our ability to help save and improve the lives of patients.”
On June 6, 2019, Sesen Bio will meet with the FDA for its second scheduled meeting, a Type B Pre-BLA meeting, to discuss the registration strategy for Vicinium. Due to the wide-range of topics to be discussed at the Pre-BLA meeting, the Company plans to provide an update on the outcome of that meeting upon receipt of the final meeting minutes, which is typically within 30 days.
About Vicinium®
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.
https://seekingalpha.com/pr/17518729-sesen-bio-announces-acc…
Antwort auf Beitrag Nr.: 60.608.393 von MaxiKingKurt am 21.05.19 08:19:04Hallo Kurt, bin auch schon länger dabei. Da hießen die noch Eleven 
Mal schauen wie es nun weitergeht. Zum gestrigen Meeting habe ich noch nichts im Netz gefunden. Wir haben aber eine Reihe Optionen bei 2,50$. Sieht so aus als wollten sich da aktuell viele von den Puts mit KO 2,50 trennen.
https://www.nasdaq.com/symbol/sesn/option-chain/most-active
Mal schauen wie es nun weitergeht. Zum gestrigen Meeting habe ich noch nichts im Netz gefunden. Wir haben aber eine Reihe Optionen bei 2,50$. Sieht so aus als wollten sich da aktuell viele von den Puts mit KO 2,50 trennen.
https://www.nasdaq.com/symbol/sesn/option-chain/most-active
Antwort auf Beitrag Nr.: 60.607.967 von boersenkeks am 21.05.19 07:27:14Hi Börsenkeks,
"willkommen im Club!"
Ja, da geht es gerade mächtig voran. Letzter CC vor gut 1 Woche war mega stark und gestriges als auch in 2 Wochen nächstes Meeting mit FDA geben viel Zuversicht für die weitere Entwicklung = Approval, Produktion, Umsätze ... oder buyout? Wir werden sehen.
Bin seit Langem dabei, es waren schon schlechtere Zeiten&Aussichten
Viel Glück!
Maxi
"willkommen im Club!"
Ja, da geht es gerade mächtig voran. Letzter CC vor gut 1 Woche war mega stark und gestriges als auch in 2 Wochen nächstes Meeting mit FDA geben viel Zuversicht für die weitere Entwicklung = Approval, Produktion, Umsätze ... oder buyout? Wir werden sehen.
Bin seit Langem dabei, es waren schon schlechtere Zeiten&Aussichten
Viel Glück!
Maxi
Antwort auf Beitrag Nr.: 60.403.812 von Santana123 am 23.04.19 14:25:53Sieht sehr gut aus aktuell, nachbörslich 1,85$.
Artikel vom letzten Freitag: Gab da wohl gestern ein Date mit der FDA...
Sesen Bio Looks Better Than Ever - An Update
"The company meets with the FDA on May 20 to discuss manufacturing aspects.
A pre-BLA meeting is scheduled for June 6; products that get through BLA submission have approval probability of 82%.
The company continues to strategize for commercialization and globalization.
The continuing BCG shortage may be a boon for Sesen.
Additional time for tracking patients improves Phase 3 data."
https://seekingalpha.com/article/4264984-sesen-bio-looks-bet…
Artikel vom letzten Freitag: Gab da wohl gestern ein Date mit der FDA...
Sesen Bio Looks Better Than Ever - An Update
"The company meets with the FDA on May 20 to discuss manufacturing aspects.
A pre-BLA meeting is scheduled for June 6; products that get through BLA submission have approval probability of 82%.
The company continues to strategize for commercialization and globalization.
The continuing BCG shortage may be a boon for Sesen.
Additional time for tracking patients improves Phase 3 data."
https://seekingalpha.com/article/4264984-sesen-bio-looks-bet…
Trading Spotlight
Antwort auf Beitrag Nr.: 60.371.470 von Santana123 am 16.04.19 21:39:04
Mal ein kleines Körbchen aufstellen.
so
langsam könnte man wieder bei Sesen einsteigen, war ja eine nette Korrektur Mal ein kleines Körbchen aufstellen.
bin immer noch von SESN überzeugt, aber die Versuchung war zu gross, ausserdem brauche ich das Geld bei Sirona, da dürfte kurzfristig mehr Gewinn möglich sein.
Aber Sesn ist definitiv noch auf der Warteliste!
Aber Sesn ist definitiv noch auf der Warteliste!
Habe auch einige verkauft. Aber nicht alle. Hier könnten eines Tages bei positiven Ergebnissen ganz andere Kurse möglich sein.
Antwort auf Beitrag Nr.: 60.020.858 von MaxiKingKurt am 05.03.19 08:48:32
Habe mich mal wieder von meinen Aktien getrennt, hoffe es war kein Fehle, aber bei 50% Gewinn konnte ich nicht nein sagen.
Ausserdem brauche ich das Geld noch für eine meiner anderen Aktien
30% UP
heute 30% hoch, netter Run OHNE irgendwelche News, gibt wohl einige, die auf einen buyout spekulieren. Habe mich mal wieder von meinen Aktien getrennt, hoffe es war kein Fehle, aber bei 50% Gewinn konnte ich nicht nein sagen.
Ausserdem brauche ich das Geld noch für eine meiner anderen Aktien
Antwort auf Beitrag Nr.: 60.313.549 von Santana123 am 09.04.19 15:24:53
ups ein "freudscher" Verleser
CYTX habe ich keine Aktien, sieht aber definitiv besser aus als CYTRX.
Zitat von Santana123: jo, bin auch bei Stocktwits.
Gehöre aber mehr zur lesenden Generation, schreibe nicht viel dort.
Bei Sesen habe ich nochmal nachgelegt und sobald sich irgendeine meiner sonstigen Aktien mal bewegt, wollte ich noch etwas nachfassen bei Sesen.
Nabriva hoffe ich, dass es kurzfristig was werden könnte (Termin: 30.4 PDUFA für Contepo)
Cytrx.. Ohne Kommentar
Was Soon sich da abhält
ups ein "freudscher" Verleser
CYTX habe ich keine Aktien, sieht aber definitiv besser aus als CYTRX.
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