Bioline RX ISIN: US09071M2052 Forum: Aktien Thema: Hauptdiskussion

TEL AVIV, Israel, Jan. 18, 2022 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ-CM: BLRX) (TASE: BLRX) a late clinical-stage biopharmaceutical company focused on oncology, today announced that the Company has completed a successful pre-New Drug Application (NDA) meeting with the US Food and Drug Administration (FDA) regarding Motixafortide as a novel stem-cell mobilization agent for autologous bone marrow transplantation in multiple myeloma patients. The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA and, in particular, to confirm that the Company's single Phase 3 pivotal study, GENESIS, is sufficient to support an NDA submission. During the pre-NDA meeting, the FDA agreed that the proposed data package is sufficient to support an NDA submission, which the Company continues to anticipate will occur in H1 2022. "We are highly encouraged by the collaborative pre-NDA meeting that we held with the FDA, and having confirmed alignment with the agency, our NDA submission remains on track for the first half of this year," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This successful meeting continues the positive momentum generated from the compelling results of our GENESIS Phase 3 study, which demonstrate a highly significant improvement over the current standard of care, alongside the positive results of the pharmacoeconomic study that we reported more recently. As a result, Motixafortide, if approved, has the potential to become the standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation, especially in light of new and more intense induction treatment regimens given to these patients, which make stem-cell mobilization more difficult than ever before," concluded Mr. Serlin. In May 2021, BioLineRx announced positive top-line results from its GENESIS Phase 3 trial of Motixafortide in stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients. The study met all primary and secondary endpoints with a very high degree of statistical significance (p<0.0001). Importantly, ~90% of patients went directly to transplantation after mobilizing the optimal number of stem cells following only one administration of Motixafortide and in only one apheresis session.

https://www.conferencecalltranscripts.com/summary/?id=10327054

Endlich geht es Mal wieder in die richtige Richtung. Habe trotz des Anstiegs nachgelegt.

Der MA200 2,9514$ (Tagebasis/NASDAQ) wurde bereits nach oben gekreuzt... Sofern wir auch darüber schließen sieht es vorzüglich aus 😁

+16% Aktuell bei hohem Umsatz

An der NASDAQ startet sie gerade durch😁🥁💤

BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization https://www.blackhillsfox.com/prnewswire/2021/10/13/biolinerx-announces-positive-results-pharmacoeconomic-study-positioning-motixafortide-potential-standard-care-stem-cell-mobilization/ - Results demonstrate significant cost benefits of using Motixafortide in combination with G-CSF as standard-of-care mobilization therapy for all multiple myeloma patients undergoing autologous stem cell transplantation - ...

Ich habe mein Invest nun verdoppelt. Das satt positive Phase-3-Studienergebnis ( GENESIS)  könnte nun bis zum diesbezüglich geplanten Pre-NDA-Meetings mit der FDA in diesem Jahr den Kurs langsam nordwärts treiben. 😁🥁💤

https://finance.yahoo.com/news/11-best-stocks-long-term-083813941.html

Diese Aktie hat meiner Meinung nach viel Kurspotenzial. Bin natürlich investiert....

Bin auch schon seit 4 Monaten dabei. Mehrere Analysten geben das Ziel 15$ +. Nur Geduld. Erfolgreiche Phase 3 Studie und weitere Forschung an Krebsbehandlung in Phase 2.

Ich hab hier 100% plus rausgeholt und bin seit dem nicht mehr investiert

Über 700% Kurspotential und keiner ist mit ner kleinen Pos dabei? 🤔. SOS an Gleichgesinnte🙃✌️

verstehe nicht warum diese Aktie so unbekannt ist... die hat doch Zukunft 🙈

nice

🧐