Eli Lilly & Co. said Tuesday a phase 3 trial of galcanezumab for the treatment of episodic cluster headaches met its primary endpoint, and also achieved its secondary endpoint. Safety and tolerability was consistent with previous studies that had evaluated galcanezumab for preventing migraines. Lilly said it is now working with regulatory agencies to determine the best path forward for galcanezumab. "Cluster headache can be difficult to evaluate in clinical studies, which has contributed to few available treatment options for cluster headache, often considered the most severe pain one can experience," said Christi Shaw, president of Lilly Bio-Medicines. "The positive results in episodic cluster headache are truly a landmark moment-both for people living with cluster headache and for our researchers at Lilly, many of whom have spent more than two decades researching and developing innovative, non-opioid treatment options for diseases like migraine and cluster headache." The stock, which slipped 0.1% in premarket trade, has rallied 6.5% over the past three months while the S&P 500 has lost less than 0.1%.