TLDR
- Polyrizon stock jumped 108.86% after announcing a manufacturing milestone for its PL-14 nasal spray formulation
- The company transitioned from small laboratory batches to large-scale controlled manufacturing with its production partner
- This batch will support clinical trial material needed for testing expected to begin in 2026
- Trading volume spiked to 42 million shares compared to the typical 42,000 daily average
- The stock has fallen 99.9% year-to-date despite today’s rally
Polyrizon stock exploded higher on Tuesday after the biotech company revealed it completed a key manufacturing milestone for its nasal spray technology. The shares rocketed 108.86% as investors responded to news about the PL-14 formulation production scale-up.
The company announced it successfully moved from batch laboratory production to large-scale controlled manufacturing. This marks a turning point for Polyrizon as it prepares for clinical trials scheduled to start in 2026.
The manufacturing run validated the reliability of producing PL-14 in large batches. Polyrizon worked with its contract manufacturing partner to hit this target.
PL-14 is a non-pharmacological intranasal spray designed to protect against airborne allergens. The product creates a barrier inside the nasal cavity that traps and neutralizes allergens before they reach the mucosa.
The technology uses a thin hydrogel-based shield. It’s intended for allergy sufferers in high-allergen environments.
Clinical Trial Preparation Moves Forward
CEO Tomer Izraeli commented on the achievement. “The process validated our manufacturing strategy,” he said. “With this batch in hand, we are energized and prepared to advance into next batches toward clinical trial material manufacturing.”
The production process aims to meet both U.S. and European regulatory standards. This positions the company for its planned clinical trial next year.
Polyrizon submitted a pre-submission package to the FDA for PL-14. The package includes detailed manufacturing plans and clinical development strategies.
The company’s Capture & Contain platform forms the basis for its intranasal product development. Polyrizon is also exploring the technology for intranasal delivery of active pharmaceutical ingredients.
Trading Activity Explodes on News
Trading volume told the story of investor interest. About 42 million shares changed hands on Tuesday morning. This compares to the three-month daily average of roughly 42,000 shares.
Pre-market trading saw shares up 114.87% before settling at a 108.86% gain. The stock had dropped 1.56% in the previous session.
The rally comes after a tough year for shareholders. Shares have fallen 99.9% year-to-date and 99.82% over the past 12 months.
Polyrizon maintains a market capitalization of just $6.24 million. The company operates as a development-stage biotech focused on intranasal protective products.
Laboratory testing previously showed the PL-16 Viral Blocker nasal gel protected against H1N1 influenza virus. The company also reported preclinical results for PL-14 that limited allergen diffusion in tests against house dust mite allergens.
A study with the University of Parma demonstrated PL-14 achieved over 60% deposition in the nasal vestibule. This is the initial contact point for airborne allergens.
The manufacturing batch will support clinical and regulatory activities while preparing the company for potential future commercial launch.
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