Welcome to our dedicated page for PainReform Ltd. news (Ticker: PRFX), a resource for investors and traders seeking the latest updates and insights on PainReform Ltd. stock.
PainReform Ltd. (symbol: PRFX) is a clinical-stage specialty pharmaceutical company dedicated to the development of innovative pain management solutions. The company focuses on the reformulation of established pain therapeutics, leveraging the US FDA 505(b)(2) regulatory pathway to bring enhanced products to market more efficiently.
The company’s flagship product, PRF-110, is designed to address the significant need for localized and extended post-operative pain relief. PRF-110 is a unique, oil-based, viscous solution containing the local anesthetic ropivacaine. This solution is applied directly into the surgical wound bed before closure, providing sustained pain relief and reducing the need for additional analgesics post-surgery.
PainReform applies proprietary technologies to improve the efficacy, reduce the adverse effects, and increase the convenience of pain medications. Their mission is to deliver pain therapeutics that offer clinically meaningful benefits to both physicians and patients.
Recent Achievements: PRF-110 has demonstrated superior formulation properties, particularly in terms of surface-tissue spreading, which is crucial for effective localized pain management. The company remains on track to announce top-line data from their clinical trials by mid-2024, indicating significant progress in their development timeline.
PainReform Ltd. continues to build strategic partnerships and collaborations to advance its product pipeline and bring new pain management solutions to market. By focusing on the reformulation of established drugs, the company aims to enhance patient outcomes and contribute positively to the field of pain management.
PainReform (Nasdaq: PRFX) has filed a patent for a new, highly scalable manufacturing process for PRF-110, its flagship post-operative pain control product. This development follows successful completion and testing of the process, marking a significant step towards potential market launch. The improved process includes:
- Continuous Process Manufacturing for increased productivity
- Single Reactor Manufacturing for reduced costs and contamination risk
- Enhanced Batch Size capabilities while maintaining quality
These improvements are expected to reduce production costs and COGS for PRF-110. The company has completed its bunionectomy Phase 3 trial and believes PRF-110 could set a new standard in non-opioid post-operative pain relief.
PainReform has successfully completed patient enrollment for the second part of its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate aimed at treating post-operative pain. The double-blind, placebo-controlled study enrolled 428 patients across eight U.S. sites. The trial's primary endpoint is to determine the drug's efficacy in reducing post-operative pain intensity over 72 hours compared to a placebo. Secondary endpoints include comparisons with Naropin and assessments of safety and rescue analgesic use. The company anticipates reporting top-line data in the second half of 2024, a critical step towards regulatory submission and potential commercialization.
PainReform, a clinical-stage specialty pharmaceutical company, announced it received a notification from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share set forth in Listing Rule 5550(a)(2). The company has 180 days, from May 28, 2024, to November 25, 2024, to regain compliance by maintaining a closing bid price of at least $1 for a minimum of ten consecutive business days. Failure to do so may result in delisting, although the company may be eligible for an additional compliance period if it meets other listing standards. The notification does not immediately affect PainReform’s Nasdaq listing or trading under the symbol 'PRFX'.
PainReform provided a business update for Q1 2024, noting significant progress in the clinical development of its lead drug candidate, PRF-110.
The company reached 50% enrollment in the second part of its Phase 3 clinical trial for PRF-110 in bunionectomy, with over 200 patients enrolled across eight U.S. sites. No serious adverse events have been reported.
PainReform expects to announce top-line data in Q3 2024. New studies showed PRF-110's superior in-vitro release rates compared to industry leaders, and the company is optimistic about its potential to reduce opioid use.
Financially, R&D expenses rose to $4.7 million, mainly due to the Phase 3 trial, while general and administrative expenses decreased to $823,000. The company incurred a net loss of $5.5 million. As of March 31, 2024, PainReform held $4.3 million in cash and raised $4 million through a public offering in April 2024.
PainReform CEO, Ilan Hadar, discussed the benefits of PRF-110 in addressing the opioid epidemic during an interview with Proactiveinvestors.com. PRF-110 offers extended post-operative pain relief without opioids, with positive updates on the Phase 3 trial and market potential.
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