TLDR
- Exicure shares climbed 140% after-hours Monday on positive Phase 2 data for burixafor in multiple myeloma patients
- 89.5% of trial participants collected enough stem cells for transplant within two sessions
- Drug showed 87.5% success rate in patients previously treated with daratumumab, a therapy that typically reduces collection success
- Burixafor demonstrated one-hour peak stem cell levels, enabling potential same-day dosing and collection
- No drug-related adverse events above Grade 2 were reported in the trial
Exicure shares exploded 140% in after-hours trading Monday after the company released encouraging Phase 2 trial results for burixafor. The drug helps multiple myeloma patients collect stem cells needed for transplants.
The trial met its primary goal. Nearly 90% of participants successfully collected the required number of CD34+ stem cells within two collection sessions. For a clinical-stage biotech, this type of data can be a game-changer.
Results were presented at the American Society of Hematology Annual Meeting. Of 19 study participants, 17 reached the target in two sessions. The remaining two patients needed one additional session but ultimately succeeded.
Strong Performance in Difficult Cases
The real story is how burixafor performed in challenging patient groups. Some participants had received daratumumab previously, a treatment known to make stem cell collection more difficult.
Even in these tougher cases, 87.5% still achieved the primary endpoint. That’s 14 out of 16 patients with prior daratumumab exposure. These results suggest burixafor could work where other options struggle.
Dr. Jack Khouri from Cleveland Clinic presented the findings. He emphasized how the drug could reduce the burden on patients who’ve received therapies that lower stem cell yields.
The safety profile looked solid. No burixafor-related side effects higher than Grade 2 were observed. Clean safety data is critical for any drug hoping to reach commercialization.
One-Hour Results Change the Game
Burixafor showed peak stem cell levels within one hour of administration. That speed sets it apart from other CXCR4 inhibitors currently available.
The rapid action opens the door for same-day dosing and collection. Patients currently face multiple hospital visits over several days. Condensing that timeline would benefit both patients and healthcare facilities.
The drug works by blocking CXCL12 binding to CXCR4 receptors on stem cells. This pushes the cells from bone marrow into the bloodstream where they can be collected.
Financial Picture Remains Tight
The stock surge is great news for shareholders. But Exicure still faces funding challenges typical of early-stage biotechs.
The company reported a $9.7 million net loss in 2024, improved from $16.9 million in 2023. Cash stood at $12.5 million at year-end, up from $4.5 million the prior year.
Operating expenses dropped 72% to $4.8 million. Revenue reached $2.6 million for 2024. These figures show a company stretching its resources while advancing clinical programs.
More capital will be needed for Phase 3 trials. The positive data should help attract investment through equity raises, partnerships, or licensing agreements.
The stock had been building momentum before Monday’s announcement. Shares gained for roughly six consecutive days, adding about $19 million in market value. The Phase 2 results amplified existing investor interest.
A Phase 3 trial represents the next major milestone. That’s where burixafor would be tested in a larger patient population to confirm these early findings. Regulatory approval requires consistent results across expanded studies.
The trial demonstrated burixafor’s effectiveness in a meaningful patient group with favorable safety data and faster stem cell mobilization than existing alternatives.
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