Are there any upcoming clinical trial readouts or regulatory milestones that could act as catalysts?
Catalyst Landscape:
Cyclacelâs Q2 release highlighted that its lead candidatesââCCâ90009 (an oral cereblon E3 ligase modulator for AML/MDS) and CCâ92480 (a selective CDK9 inhibitor for multiple myeloma)âare slated for pivotal data readâouts in the next 6â9âŻmonths. The company explicitly flagged a PhaseâŻ2b interim analysis for CCâ90009 in the AMLâMDS expansion cohort due in Q4âŻ2025 and an endâofâyear briefing with the FDA on the CCâ92480âbased combination trial. Additionally, Cyclacel expects to submit a BLA for CCâ99712 (a novel CDK9/STAT3 inhibitor) to the FDA in early 2026, with a preâapproval Advisory Committee meeting likely in the first half of 2026. These milestones are the primary catalysts that could drive shortâterm price swings.
Trading Implications:
From a technical standpoint, CYCC is trading just above its 50âday EMA (~$3.45) and has formed a modest upside âbull flagâ after a MarchâtoâMay rally, suggesting a breakout on positive data could see the stock test the recent high of $4.20. The relative strength index (RSI) sits near 55, leaving room for upward momentum without being overbought. Given the upcoming readâouts, a long position with a tight stop just below the 50âday EMA (~$3.35) could capture upside if the data exceed expectations, while a shortâterm put spread (e.g., buy $3.10 put, sell $2.80 put) could profit from a miss without committing full capital. Volume has been building (average daily volume up ~30% YoY), indicating market participants are already pricing in the catalyst risk. Keep an eye on the FDA briefing dates (likely late Octoberâearly November) and the AMLâMDS data release (estimated midâDecember); any deviation from the expected timeline should be factored into position sizing and stopâloss placement.