MorphoSys: A Buying Opportunity Following Mixed Phase 3 Results In Myelofibrosis

Summary

  • MorphoSys announced positive topline results from its phase 3 trial of pelabresib in frontline myelofibrosis, nearly doubling spleen volume reduction (the primary endpoint) compared to placebo.
  • However, key secondary endpoints assessing symptomatic improvement did not reach statistical significance in the total population. Nevertherless, significant improvement was shown in the pre-specified intermediate-risk subgroup (majority of enrolled patients).
  • Totality of the evidence supports the approval of pelabresib, which could have a significant multi-billion dollar market potential. MorphoSys plans regulatory submissions in the US and Europe in mid 2024.
  • Considering a projected cash runway into 2025, regulatory delays could have a significant negative impact. Beyond pelabresib, no other major catalyst is expected within the projected cash runway.
Bone marrow biopsy from myelodysplastic condition under the microscope view. Histology tissue of bone marrow biopsy.

tonaquatic

Thesis overview

MorphoSys AG (MOR) recently announced positive topline results from its phase 3 trial of pelabresib in myelofibrosis (MF). The study easily met the primary endpoint. However, despite the strong positive trend, statistical significance was not achieved at key secondary endpoints assessing

This article was written by

Background: Physician involved in clinical research. Investment style: Clinical-stage biotech stocks, long only, both long-term ideas and event-driven trading. My academic/medical background helps me evaluate the scientific fundamentals of biotech stocks.

Analyst’s Disclosure:I/we have a beneficial long position in the shares of MOR either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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