TG Therapeutics TGTX (Seite 47)
eröffnet am 13.07.20 10:32:08 von
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ISIN: US88322Q1085 · WKN: A1JXW7 · Symbol: NKB2
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Antwort auf Beitrag Nr.: 64.712.665 von StellaVella am 10.08.20 22:45:04Das "Risiko" eines RTF letters ist schonmal vom Tisch 
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
Aug 13, 2020
PDF Version
NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased with the FDA’s acceptance of our first NDA submission and look forward to working with the FDA during the review process. This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases.” Mr. Weiss continued, “If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end.”
The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Company’s target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.
ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.
The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).
The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Company’s prespecified response target of 40-50% ORR.
On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to the FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.
On August 12, 2020, the Company received notification from the FDA of its acceptance of the Company’s NDA for umbralisib as a treatment for patients with previously treated MZL and FL.
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
Aug 13, 2020
PDF Version
NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.
Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased with the FDA’s acceptance of our first NDA submission and look forward to working with the FDA during the review process. This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases.” Mr. Weiss continued, “If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end.”
The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Company’s target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.
ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.
The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the Company’s target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).
The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Company’s prespecified response target of 40-50% ORR.
On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to the FDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.
On August 12, 2020, the Company received notification from the FDA of its acceptance of the Company’s NDA for umbralisib as a treatment for patients with previously treated MZL and FL.
Wichtige Ereignisse in den nächsten 6 Monaten:
Key Objectives for Remainder of 2020 and Early 2021
- Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis.
- Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at a major medical meeting.
-Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
-Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.
Key Objectives for Remainder of 2020 and Early 2021
- Report topline results from the Phase 3 ULTIMATE I & II trials in Multiple Sclerosis.
- Present full data from the UNITY-CLL Phase 3 trial and present full data from the FL and MZL single agent umbralisib cohorts of the UNITY-NHL trial at a major medical meeting.
-Target an NDA/Biologics Licensing Application (BLA) submission of U2 for the treatment of patients with CLL (including both previously untreated and relapsed/refractory patients)
-Continue to advance our early pipeline candidates including our anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), our Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, and our anti-CD47/CD19 bispecific antibody, TG-1801.
Antwort auf Beitrag Nr.: 64.699.420 von lorbas95 am 09.08.20 19:16:57
Chance/Risiko erscheint mir sehr günstig, trotz des Risikos eines RTFs, den man nie ausschließen kann. Die aktuelle Finanzierung sollte solide genug sein, um auch einen RTF im schlimmsten Fall wegstecken zu können.
Bin heute mit einer ersten Position eingestiegen.
danke für den Tipp!
Zitat von lorbas95: Sieht sehr gut aus. Klasse Ergebnisse, super Pipeline.
Idealer Übernahmekandidat, eher früher als später...
Sehe - positive MS Ergebnisse - eine Übernahme im Bereich von 5b-6b als gut möglich an.
Chance/Risiko erscheint mir sehr günstig, trotz des Risikos eines RTFs, den man nie ausschließen kann. Die aktuelle Finanzierung sollte solide genug sein, um auch einen RTF im schlimmsten Fall wegstecken zu können.
Bin heute mit einer ersten Position eingestiegen.
danke für den Tipp!
Antwort auf Beitrag Nr.: 64.707.673 von opportoni am 10.08.20 16:28:35Ah, ok , klingt logisch - dankeschön
Antwort auf Beitrag Nr.: 64.707.415 von spassky1 am 10.08.20 16:13:17Milliarden nehme ich an. Von b wie billion im Englischen.
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Antwort auf Beitrag Nr.: 64.699.420 von lorbas95 am 09.08.20 19:16:57Was soll das "b" bedeuten?
Sieht sehr gut aus. Klasse Ergebnisse, super Pipeline.
Idealer Übernahmekandidat, eher früher als später...
Sehe - positive MS Ergebnisse - eine Übernahme im Bereich von 5b-6b als gut möglich an.
Idealer Übernahmekandidat, eher früher als später...
Sehe - positive MS Ergebnisse - eine Übernahme im Bereich von 5b-6b als gut möglich an.
https://www.nasdaq.com/market-activity/stocks/tgtx/short-int…
Bedenklich ist die hohe Zahl leerverkaufter Aktien.
Ende kommender Woche läuft die 60-Tage Frist für die NDA ab. Dann sollten wir hören, ob es einen RTF Brief gibt oder ein PFUFA Datum. Vielleicht ändert sich dann auch der short interest.
Bedenklich ist die hohe Zahl leerverkaufter Aktien.
Ende kommender Woche läuft die 60-Tage Frist für die NDA ab. Dann sollten wir hören, ob es einen RTF Brief gibt oder ein PFUFA Datum. Vielleicht ändert sich dann auch der short interest.
Der Anteil institutioneller Anleger legt ebenfalls zu ind liegt jetzt bei >50%:
https://www.nasdaq.com/market-activity/stocks/tgtx/instituti…
Im H2 werden auch Daten zum MS Trial erwartet. Das Enrollment ging schneller als gedacht.
https://www.nasdaq.com/market-activity/stocks/tgtx/instituti…
Im H2 werden auch Daten zum MS Trial erwartet. Das Enrollment ging schneller als gedacht.
Antwort auf Beitrag Nr.: 64.384.445 von opportoni am 13.07.20 10:32:08Und hier eine Meldung zur genannten Unity Studie (U2):
https://ir.tgtherapeutics.com/news-releases/news-release-det…
Die Studie, die unter Special Protocol Assessment durchgeführt wurde, wurde wegen der guten Wirksamkeit auf Anraten des DSMB nach der Interim Analyse beendet. Die finale Auswertung ist bis Jahresende angekündigt und dann soll es auch schon zur Behörde gehen.
https://ir.tgtherapeutics.com/news-releases/news-release-det…
Die Studie, die unter Special Protocol Assessment durchgeführt wurde, wurde wegen der guten Wirksamkeit auf Anraten des DSMB nach der Interim Analyse beendet. Die finale Auswertung ist bis Jahresende angekündigt und dann soll es auch schon zur Behörde gehen.
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