NEO100 Hits Primary Endpoint in Phase 2a Glioma Trial, Paving Way for FDA Talks
NTHI sits 62% above its 52-week low of $3.005 on elevated volume (11× avg).
Summary
NeOnc's intranasal NEO100 met its Phase 2a primary endpoint in recurrent IDH1-mutant high-grade glioma, with six-month progression-free survival of 48.9% versus a 20% benchmark (p=0.0047). Median overall survival reached 26.09 months, and 86.7% of patients were alive at six months. The drug was well tolerated with no major toxicities. The company plans to request a Type B meeting with the FDA to discuss a registrational path. This follows the August 10th 8-K confirming pivotal data would be released, and the positive results strengthen the case for NEO100 in a setting with no approved targeted therapy. With only $2M in cash and a going concern warning, the data could be critical for securing financing or partnership interest. The investor call this morning may provide additional color on the regulatory strategy.
At the time of this announcement, NTHI was trading at $4.88 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $112.8M. The 52-week trading range was $3.01 to $12.99. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.