Mesoblast

"Mesoblast is an Australia-based biotechnology company developing adult stem-cell therapies based on its proprietary MPC and MSC platforms. Its lead programs are in pediatric aGvHD, heart failure, ARDS and lower back pain, all of which are in Phase III or later."

"Mesoblast announced that Novartis has signed a partnership with the company to develop remestemcel-L for acute respiratory distress syndrome (ARDS), whether or not the ARDS was caused by COVID-19. This is an important validation of both the platform as well as its application in the treatment of respiratory disease. Novartis will make a US$25m upfront payment and an additional US$25m equity investment. Mesoblast may receive a total of US$505m in development milestones, an additional US$750m in sales milestones and tiered double-digit royalties. Additionally, Novartis will fully fund global clinical development for all-cause ARDS and potentially other respiratory indications."  

 

gestern die Order an der Nasdaq hat mich beeindruckt......

Sind Organe nachhaltig geschädigt, zB Herz, Lunge, Niere , besteht die Möglichkeit des Organersatzes ( Dialyse, Beatmung) oder Transplantation von einem Organspender.

Stammzellen hingegen:

"Stammzellen sind Zellen, die in der Lage sind, eine Kopie von sich selbst hervorzubringen, indem sie sich teilen. Doch durch die Teilung entstehen nicht zwei neue Stammzellen, sondern es handelt sich um eine asymmetrische Zellteilung, bei der zwei verschiedene Zellen entstehen. Die eine der neu entstandenen Zellen ist ein Duplikat der Mutterzelle und hat die gleichen Eigenschaften, es entsteht also eine neue Stammzelle. Die andere Zelle, die durch die asymmetrische Zellteilung entstanden ist, entwickelt sich zu einem spezialisierten Zelltyp, d.h. sie differenziert sich. Die aus den Stammzellen hervorgegangen Zellen sind dann in der Lage, durch Differenzierung in weitere Zelltypen zu reifen und stellen eine essentielle Grundlage für die Entwicklung von komplexen Geweben und Organen, wie z.B. Herz und Niere, dar. "

 

"Key Highlights:
• Sales of TEMCELL® HS Inj.13 in Japan for the treatment of aGVHD have recovered rapidly from the effects of the temporary shutdown in production during mid-2020 which was undertaken in order to increase capacity to meet growing demand for the product
• Revenues from royalties on TEMCELL® HS Inj. sales for the quarter ended December 31, 2020 were US$2.1 million compared to US$2.0 million in the quarter ended December 31, 2019
• Mesoblast has amended its existing agreement with Hercules to extend the interest-only period of the loan up to March 2022, subject to achieving certain milestones
• Cash on hand at December 31, 2020 was US$77.5 million. Over the next 12 months, Mesoblast may receive up to an additional US$92.5 million through existing financing facilities and strategic partnerships
• During Q4 2020, Phase 3 trial results of rexlemestrocel-L (REVASCOR®) in patients with chronic heart failure with reduced left ventricular ejection fraction (HFrEF) showed that a single dose of rexlemestrocel-L resulted in substantial and durable reductions in heart attacks, strokes, and cardiac deaths. Mesoblast plans to meet with the FDA to discuss how the results may support a pathway to approval
• When the 60-day results of the COVID-19 ARDS trial become available during Q1 2021, they will be analysed by Mesoblast and Novartis to identify meaningful clinical outcomes that may guide decisions on the development program for remestemcel-L in non-COVID ARDS
• Mesoblast intends to meet with the FDA during Q1 2021 through a well-established process to have further discussions on the potential for accelerated approval of remestemcel-L in the treatment of children with steroid-refractory acute graft-versus-host disease (SR-aGVHD)
• Results from the Phase 3, 404-patient, randomized placebo-controlled trial evaluating MPC-06-ID (rexlemestrocel-L) in patients with chronic low back pain due to degenerative disc disease are expected shortly
• Mesoblast is actively exploring additional strategic initiatives with a number of global pharma companies across its advanced-stage pipeline of product candidates"  

halbiert aus dem Top
Momentum positiv  

110 Mio. $ Privatplatzierung
https://stockhead.com.au/health/...nfusion-for-cash-guzzling-biotech/  

https://seekingalpha.com/news/...l-l-in-development-for-low-back-pain  

Novartis beendet Deal

https://www.afr.com/companies/...rtis-terminates-deal-20211214-p59he5

 

CRL für Mesoblast´s GVHD Zelltherapie

"Die FDA benötigt mehr Daten, um die Marktzulassung zu unterstützen. Co. wird eine gezielte, kontrollierte Studie bei Erwachsenen mit dem höchsten Risiko und der höchsten Sterblichkeit durchführen."

https://www.xm.com/research/markets/allNews/...-for-children-53608177