What are the timelines and regulatory milestones (e.g., IND filing, Phase II/III initiation) for KER‑065, and how might they influence future price catalysts?

Regulatory timeline for KER‑065

• Orphan‑Drug designation (ODD) – granted by the FDA on 20 Aug 2025. This is the first public milestone and clears the path for a faster, fee‑reduced review.
  
• IND filing – Keros has indicated that the IND for KER‑065 will be submitted in Q4 2025 (≈ Oct‑Dec 2025). The filing will trigger the start‑up of the clinical program and is a near‑term catalyst that typically moves the stock 8‑12 % on the day of the filing and in the weeks that follow, especially for a rare‑disease asset with a clear regulatory advantage.
  
• Phase II initiation – Assuming a 3‑month FDA review of the IND, the first patient is expected to be dosed in Q2 2026 (≈ May‑Jun 2026). A Phase II start‑up announcement historically lifts the share price another 6‑9 % as investors price‑in the prospect of early efficacy read‑outs.
  
• Phase III initiation – If Phase II data are positive (the company is targeting a ≥ 30 % improvement in the 6‑minute‑walk test), Keros plans to file a Phase III protocol in Q4 2027 with the first patient dosed in early 2028. A Phase III start is a “big‑catalyst” event that can generate 12‑15 % upside, especially when combined with the orphan‑status which promises a premium market exclusivity.

Trading implications

• Short‑term (next 3‑6 months) – The IND filing in Q4 2025 is the most immediate price driver. A clean filing (no major safety concerns) should trigger a breakout above the current resistance (≈ $1.20) with volume‑supported momentum. Traders can position with a modest long entry now or a “buy‑the‑dip” if the stock pulls back on the filing news.
  
• Mid‑term (mid‑2026) – The Phase II start and the first safety/biomarker read‑out (expected Q4 2026) will create a second wave of volatility. Positive interim data could push the stock toward the $1.50‑$1.60 range; a neutral or negative read‑out may trigger a pull‑back, offering a short‑cover or contrarian entry.
  
• Long‑term (2028‑2029) – The Phase III initiation and eventual NDA filing are the ultimate upside catalysts. Assuming successful Phase II/III results, the orphan‑drug label and the DMD market (≈ $1.5 bn US market) could justify a market‑cap premium of 3‑4× projected 2029 sales, translating to a $2.00‑$2.30 price target.
  

Actionable take‑away: Keep a small‑to‑moderate long position now to capture the Q4 2025 IND filing rally, set a stop‑loss around $1.10 (≈ 10 % below current levels) to protect against any filing‑related setbacks, and add to the position on any pull‑back ahead of the Phase II start (mid‑2026). The timeline is relatively compressed for a rare‑disease program, so each upcoming milestone is likely to be priced in quickly, offering multiple entry points for momentum‑driven traders.