Humanigen Forum: Community User: Rothschild123

Noch nicht 😉 sie muss wieder zweistellig sein

@oxanabanana, das wärs! 👍

passiert was gutes oder schlechtes?:D

HC Wainwright Analyst Joseph Pantginis gab Buy Rating für Humanigen heute. price Target 28 Dollar

Aber ja, grundsätzlich in nächsten zwei drei Wochen muss was passieren

Amis reden von dieser Woche ggf

Bzw. Die nächsten zwei Wochen

Also nächste woche FOMO ?😉

MHRA muss eine Entscheidung vor Ende November rausgeben. Letzte Module wurden Ende September eingereicht. Dann haben die 60 T Zeit zu antworten. “MHRA rolling review mandates a 60 day response window after submission of the final module, which occurred at the end of September.”

BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, today announced it plans to support a Phase 2/3 study to evaluate lenzilumab for the early treatment of acute graft versus host disease (aGvHD) following allogeneic hematopoietic stem cell transplantation (HSCT) in collaboration with IMPACT, a world class accelerated trial network delivering innovative research for stem cell transplant patients in the UK. IMPACT delivers innovative research in partnership with the British Society of Blood and Marrow Transplantation and the University of Birmingham’s Cancer Research UK Clinical Trials Unit. The safety run-in component of the RATinG study is anticipated to be completed in 2022. The study is partially funded by IMPACT with Humanigen providing lenzilumab and the remaining funding for the study. “The IMPACT partnership is committed to improving the outcomes of stem cell transplant patients. Management of aGvHD disease is an area of significant unmet need in stem cell transplantation and I am really excited to collaborate with Humanigen and IMPACT to deliver on the promise of this therapeutic approach for patients with high risk aGvHD,” said Professor Adrian Bloor MA, MB BChir, PhD, FRCP, FRCPath, Director of Stem Cell Transplantation, The Christie NHS Foundation Trust. Lenzilumab neutralizes the immune signalling protein granulocyte-macrophage colony-stimulating factor (GM-CSF), which has been shown to initiate the inflammatory cascade that drives aGvHD, a serious condition with significant unmet needs that affects 30%-50% of all patients who undergo HSCT.1, 2 “We are pleased to be supporting the RATinG study in collaboration with IMPACT, the UK’s stem cell transplant clinical trials partnership, to evaluate lenzilumab, which represents a potential way to spare patients from the devastating effects of steroid refractory aGvHD after undergoing allogeneic HSCT,” said Cameron Durrant, Chairman and CEO, Humanigen.

Zus. data für FDA wird von Activ-5/Bet-B Studie vorgelegt. Studie begonnen am 19.Okt. Geplant zu beenden am 31.Dez. Evtl. Früher

Im Juli wurde Antrag gestellt. Ende September wurden alle Module/ Daren eingereicht

Die MHRA sollte sich mal langsam zu Wort melden. Die Daten wurden doch schon im Juli an die MHRA übermittelt oder?

Ja, MHRA . Für die Zulassung in UK. Die FDA hatte zus. Daten angefordert, daher auch Absturz

MHRA?

Leider nichts neues in der Präsentation 🤷‍♀️ MHRA Meldung wird jeder Zeit erwartet