Geron Path Forward
Posted: Sat Mar 01, 2025 12:52 am
I've been observing the board comments closely since Geron's abysmal conference call on 2024 Q4 results and I cannot agree more.
To me, Scarlett’s plan, after Rytelo FDA approval, was to get MDS approval in Europe and the UK, and with FDA IMpact MF approval or at least positive results and NDA filing, partner up ex-US for MDS and MF commercialization. Geron has a few personnel stationed in Europe/UK, but no serious commercialization buildout like the US. The monkey wrench in the works was and continues to be the slow enrollment in the IMpact CT, but more importantly, the continued push out of the timeline in interim and final trial results. This seems extremely positive as patients are living longer with Rytelo, and with BAT crossover patients also helping push out the timeline. All good things, other than also pushing out the timeline for Rytelo to reach the market for MF patients and begin creating sales/revenue - what the market expects for Geron to achieve its real potential.
Scarlett needs FDA approval for MF to achieve his ex-US deal. There may be some ways to bring the timeline forward:
FDA halting the trial due to compelling results, especially BAT crossover/unblinded patients;
Geron sharing the unblinded population results with the potential ex US partner (if that’s even possible); or
Scarlett going ahead with a MDS ex-US partner with a first right of refusal deal on MF upon approval.
Scarlett needs to get MDS commercialized as soon as possible upon EMA and UK approval.
JMO.
To me, Scarlett’s plan, after Rytelo FDA approval, was to get MDS approval in Europe and the UK, and with FDA IMpact MF approval or at least positive results and NDA filing, partner up ex-US for MDS and MF commercialization. Geron has a few personnel stationed in Europe/UK, but no serious commercialization buildout like the US. The monkey wrench in the works was and continues to be the slow enrollment in the IMpact CT, but more importantly, the continued push out of the timeline in interim and final trial results. This seems extremely positive as patients are living longer with Rytelo, and with BAT crossover patients also helping push out the timeline. All good things, other than also pushing out the timeline for Rytelo to reach the market for MF patients and begin creating sales/revenue - what the market expects for Geron to achieve its real potential.
Scarlett needs FDA approval for MF to achieve his ex-US deal. There may be some ways to bring the timeline forward:
FDA halting the trial due to compelling results, especially BAT crossover/unblinded patients;
Geron sharing the unblinded population results with the potential ex US partner (if that’s even possible); or
Scarlett going ahead with a MDS ex-US partner with a first right of refusal deal on MF upon approval.
Scarlett needs to get MDS commercialized as soon as possible upon EMA and UK approval.
JMO.