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Gamida: Catalysts Ahead, Looks Interesting

Mar. 07, 2021 9:07 AM ETGamida Cell Ltd. (GMDA)2 Comments


  • GMDA addressed its cash issues, but its approval got a little delayed.
  • That was because the FDA raised manufacturing concerns.
  • The company seems confident in its ability to address those.
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Gamida Cell (NASDAQ:GMDA) is an Israeli company developing an enhanced version of commonly used cord blood HSCT. I covered it in March 2019, when I said that while the low cash position and somewhat obscure nature of the therapy fails to convince us, this is interesting enough to bear watching.

Since I wrote that, Gamida has fallen, and kept on falling; until now. I wrote that on March 12, 2019, when the stock was trading near $12. Right after that, for the entire two years since now, the stock stayed below $12 - indeed, it went down to near penny stock level a few times. However, recently, the stock has seen some movement. It went up to over $11 recently, then fell back to current levels of $8. So we need to see - what changed?

The core value proposition of GMDA is that hematopoietic stem cell transfer or HSCT is curative for a number of cancers, but it has certain limitations. These are basically four - lack of rapid availability due to type mismatch, inefficient engraftment, delayed onset of immune activation leading to infections, and host rejection leading to graft versus host disease or GvHD. GMDA’s nicotinamide-based technology resolves all of these limitations some of the time. Its pipeline looks like this:


The company recently published data from the phase 3 AML trial of lead candidate Omidubicel. The trial compared the time to neutrophil engraftment as the primary endpoint between nicotinamide enhanced ex vivo expanded umbilical cord blood grafts, i.e. Omidubicel, versus standard cord blood, in AML patients. The trial met its primary endpoint successfully and with statistically significant p-value.


In terms of safety, there were fewer viral infections in the drug arm, showing the benefit of Omidubicel. Although Omidubicel did not differentiate itself statistically significantly from standard UBC for

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Comments (2)

biogenius profile picture
Beyond the manufacturing issue, there is the marketing issue even if approved. How good is a small Israel company going to sell the product?
ofirm profile picture
@biogenius there are a small number of centers doing 80% of the
volume in the u.s market.
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