NeuroOne Medical Secures FDA 510(k) Approval for OneRF Device
FDA Clearance: NeuroOne Medical Technologies has received FDA clearance for its OneRF Trigeminal Nerve Ablation System, designed for creating radiofrequency lesions to treat pain and perform functional neurosurgical procedures.
Commercial Launch Timeline: The company aims for a limited commercial launch of the system in the fourth quarter of 2025, having completed the FDA submission earlier than expected.
Target Condition: The device targets trigeminal neuralgia, a chronic pain condition that affects approximately 150,000 people annually in the United States.
Technology Overview: The OneRF Ablation System utilizes a proprietary RF generator platform specifically for treating the trigeminal nerve, which is responsible for facial sensation and can trigger severe pain.
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TELO, PCSA, RVPH, NMTC, BRTX Experience After-Hours Trading Surge Amid Limited News and Specific Updates
Biotech Stock Gains: Small-cap biotech stocks TELO, PCSA, RVPH, NMTC, and BRTX experienced significant after-hours gains driven by speculative trading and company updates, despite the absence of new disclosures.
Telomir Pharmaceuticals (TELO): TELO shares surged 43% after-hours, attributed to renewed interest in its in vitro data showcasing Telomir-1's unique targeting capabilities in cancer therapies.
Processa Pharmaceuticals (PCSA): PCSA shares rose 32.6% in after-hours trading, continuing a rally from the regular session, with no recent official news or updates from the company.
NeuroOne Medical Technologies (NMTC): NMTC shares increased 9.5% after announcing a 163% rise in preliminary product revenue for fiscal year 2025, alongside an upcoming virtual webinar, which sparked investor interest.
Biotech Stocks Recover in After-Hours Trading Driven by Positive Sector Trends
Biotech Stocks Performance: Biotech stocks experienced strong after-hours gains, with notable rebounds from small-cap companies like Ovid Therapeutics, NeuroOne Medical, and PepGen, driven by positive sentiment following Pfizer's drug price cuts and investment in domestic manufacturing.
Ovid Therapeutics Update: Ovid Therapeutics saw a 7.69% increase in after-hours trading, supported by a recent Buy rating from Lucid Capital and a narrower quarterly loss, alongside a $7 million royalty sale agreement related to future revenues.
PepGen's Recent Surge: PepGen's stock rose 3.03% after-hours, continuing a volatile week with over 120% growth, attributed to positive Phase 2 trial results for its myotonic dystrophy treatment and a successful $100 million public offering.
Reviva Pharmaceuticals and Anika Therapeutics: Reviva Pharmaceuticals gained 5.81% after-hours following a significant intraday surge, while Anika Therapeutics rose 5.53% ahead of its upcoming earnings report, despite a quiet news cycle for both companies.
