Xynomic Pharmaceuticals Holdings, Inc. (NASDAQ: XYN) announced it recently held a “pre-IND” meeting with the U.S. Food and Drug Administration for its pan-PAF inhibitor XP-102 for the treatment of cancers.
Xynomic said it's on track to file this Investigational New Drug application in the second half of 2019. The FDA has addressed Xynomic's questions and provided advice on the overall clinical development plan to advance the drugs.
"Our meeting with the FDA was a major step forward and the feedback provided by the agency was valuable in our development of clinical and regulatory strategies that will support our goal of advancing XP-102 through clinical development," said Mark Xu, Xynomic CEO. "We believe that XP-102 holds potential as an innovative therapy against B-RAF V600 mutated solid tumors including CRC and non-small cell lung cancer and hairy cell leukemia."
Shares traded as high as $3.83 on extremely heavy volume. The stock normally trades about 27,000 shares over the course of an entire day and there were about 160,000 shares traded less than two hours into Wednesday's session.
Xynomic shares traded up 2.5% at $3.47 at time of publication after gaining 11.6% Tuesday.
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