Sanofi reports a phase 3 trial success 🔎 Promising year ahead?

Sanofi’s blood cancer treatment has achieved key co-primary endpoints in the phase 3 Iraklia study. The stock gained 1% today in Paris, continuing its newly found upward trend after a dismal slide in late 2024.

According to the press release, the new subcutaneous (SC) formulation of Sarclisa, combined with pomalidomide and dexamethasone, demonstrated a non-inferior objective response rate when delivered via an on-body delivery system (OBDS), compared to the traditional intravenous weight-based dose of Sarclisa. The treatment also met secondary endpoints, including a ‘very good’ partial response rate and reduced infusion reactions.

The SC formulation, administered through the hands-free, automated enFuse OBDS, offers patients a more convenient and time-efficient treatment option, reflecting Sanofi’s patient-centered strategy. The company plans to seek regulatory approval for the SC formulation of Sarclisa in both the US and EU in the first half of 2025.

2024 performence and 2025 outlook

Sanofi’s stock has been on a rather challenging ride in 2024. By beating EPS estimated over the first three quarters of the previous year, the company set itself on an upward ride, additionally supported by favorable analysts’ ratings. One of the key drivers of Sanofi’s success has been its blockbuster immunology drug Dupixent, with sales going up almost 24% in Q3 and confirmed full-year 2024 target of €13 bn.

The overall sentiment in the drug and biotech sector weakened in the final quarter of 2024, driven by guidance cuts, pipeline setbacks, and concerns over the political environment, including the appointment of R.F. Kennedy as Head of the Health and Human Services Department. Despite tight competition and an uncertain regulatory outlook under Trump’s administration, investors are far from pessimism. Sanofi's robust project portfolio (including 5 projects in registration and 27 in phase 3 trials, including 3 vaccines) positions the company well for a potential stock rebound, given that successive administrative approvals are secured.

Sanofi's US-quoted stock (SNY.US) has recently broken above the shorter-term 30-period Exponential Moving Average (light purple) and is now trading above the 23.6% Fibonacci retracement level. The rebound from the well-tested support near $46, combined with recent price action, indicates a potential trend reversal heading into 2025.