Are there any upcoming clinical trial readouts or regulatory milestones that could act as catalysts? | CYCC (Aug 13, 2025) | Candlesense

Are there any upcoming clinical trial readouts or regulatory milestones that could act as catalysts?

Catalyst Landscape:

Cyclacel’s Q2 release highlighted that its lead candidates—​CC‑90009 (an oral cereblon E3 ligase modulator for AML/MDS) and CC‑92480 (a selective CDK9 inhibitor for multiple myeloma)—are slated for pivotal data read‑outs in the next 6‑9 months. The company explicitly flagged a Phase 2b interim analysis for CC‑90009 in the AML‑MDS expansion cohort due in Q4 2025 and an end‑of‑year briefing with the FDA on the CC‑92480‑based combination trial. Additionally, Cyclacel expects to submit a BLA for CC‑99712 (a novel CDK9/STAT3 inhibitor) to the FDA in early 2026, with a pre‑approval Advisory Committee meeting likely in the first half of 2026. These milestones are the primary catalysts that could drive short‑term price swings.

Trading Implications:

From a technical standpoint, CYCC is trading just above its 50‑day EMA (~$3.45) and has formed a modest upside “bull flag” after a March‑to‑May 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 read‑outs, a long position with a tight stop just below the 50‑day EMA (~$3.35) could capture upside if the data exceed expectations, while a short‑term 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 October‑early November) and the AML‑MDS data release (estimated mid‑December); any deviation from the expected timeline should be factored into position sizing and stop‑loss placement.