Welcome to our dedicated page for Painreform news (Ticker: PRFX), a resource for investors and traders seeking the latest updates and insights on Painreform stock.
Company Overview
PainReform Ltd is a clinical-stage specialty pharmaceutical company dedicated to the reformulation of established pain therapeutics. With a focus on innovation within the postoperative analgesia and extended-release drug-delivery space, the company is committed to transforming pain management for both physicians and patients. By leveraging the FDA 505(b)(2) regulatory pathway, PainReform aims to enhance the clinical efficacy of existing medications while reducing adverse effects and optimizing dosing convenience.
Core Technologies and Therapeutic Advances
PainReform’s portfolio is anchored by its lead product candidate, PRF-110, which is based on the local anesthetic ropivacaine. Utilizing a proprietary, oil-based, viscous solution, PRF-110 is deposited directly into the surgical wound bed prior to closure. This innovative approach ensures localized, extended postoperative analgesia by maintaining therapeutic drug concentrations at the site of tissue injury over an extended period. The formulation addresses common limitations of traditional pain management therapies by reducing the necessity for repeated dosing and potentially lowering reliance on opioids.
Operational Strategy and Market Position
The company operates within the niche of drug reformulation, addressing specific clinical needs within the pain management segment. Through its disciplined focus on reformulating proven therapeutics, PainReform differentiates itself by applying unique technologies that enhance drug performance and patient compliance. The company’s operational model blends ongoing clinical research with strategic process improvements designed to bolster future commercialization efforts, thereby ensuring a resilient market presence in a dynamic therapeutic landscape.
Competitive Landscape and Differentiating Factors
PainReform competes in a complex landscape where innovation in drug delivery systems is critical to success. Unlike companies that develop entirely new molecular entities, PainReform capitalizes on reformulating established therapies to improve their safety and efficacy profiles. This approach allows the company to navigate regulatory pathways more efficiently while providing significant clinical benefits. Its extended-release technology is a key differentiator, offering both a therapeutic and operational advantage in a competitive market characterized by high standards of care and rigorous regulatory oversight.
Product Focus and Clinical Advantages
At the heart of PainReform’s clinical efforts is PRF-110, a product designed to address the unmet need for sustained postoperative pain relief. The product's oil-based, clear solution enables a streamlined mode of application and controlled drug release, tailoring pain management to the procedural landscape. By depositing the medication directly into the surgical wound bed, the company’s strategy minimizes the potential for systemic side effects and improves the overall patient experience. This method supports a growing clinical consensus that targeted, extended-release formulations can substantially improve postoperative recovery trajectories.
Industry Insights and Technological Integration
Within the specialty pharmaceutical sector, the intersection of drug reformulation and advanced delivery platforms represents a significant area of innovation. PainReform’s approach reflects a broader industry trend that prioritizes patient-centric therapies designed to deliver tangible clinical improvements. The integration of advanced drug-delivery systems not only refines the pharmacokinetic profile of established agents but also reinforces the company’s commitment to clinical excellence and operational efficiency. By adhering to rigorous regulatory standards and leveraging industry expertise, PainReform continues to evolve its technology platform, setting benchmarks in extended-release formulations and targeted therapeutic interventions.
Commitment to Quality and Clinical Validation
PainReform’s development strategy is reinforced by a commitment to clinical validation and quality assurance. Robust compatibility studies and ongoing clinical trials underscore the safety and efficacy of its formulations, positioning the company as a trusted entity within the pharmaceutical research community. Each phase of development is guided by stringent quality controls and backed by scientific data, ensuring that the therapeutic benefits of its products are communicated clearly to healthcare professionals and regulatory bodies alike.
Summary
In summary, PainReform Ltd stands as a specialist in the reformulation of pain therapeutics, harnessing innovative extended-release drug-delivery systems to address postoperative pain. Its focused approach, centered around PRF-110 and similar candidates, positions the company favorably within a competitive and evolving market. With an emphasis on clinical benefits, operational efficiency, and regulatory compliance, PainReform continues to advance a portfolio that is both strategic and clinically transformative, ensuring that it meets the essential needs of modern pain management.
PainReform Ltd. (Nasdaq: PRFX) reported significant advancements towards launching Phase 3 clinical trials for PRF-110, targeting post-operative pain relief in bunionectomy surgery. With a strong cash position of $19.4 million as of March 31, 2021, the company is prepared for ongoing activities and future trials. Recent financial results show a net loss of $2.041 million for Q1 2021, reflecting a 57% increase from the previous year due to rising operational costs linked to clinical trial preparations. The firm remains optimistic about PRF-110's potential to reduce opioid reliance.
PainReform Ltd. (Nasdaq: PRFX) announced significant progress in its Phase 3 clinical trials for PRF-110. The company engaged Lotus Clinical Research for the bunionectomy surgery trial, set to begin mid-2021. Recent achievements include a $6 million private placement, enhancing its cash runway for key milestones. However, the company reported a net loss of $4.1 million for 2020, with substantial increases in R&D and administrative expenses. The cash position as of December 31, 2020, was $15.7 million, expected to fund operations into Q2 2022.
PainReform Ltd. (Nasdaq: PRFX) announced that CEO Ilan Hadar will present at the Inaugural Emerging Growth Virtual Conference from March 17-19, 2021. This presentation will be accessible to registered participants and later posted on PainReform’s website. The company specializes in reformulating established therapeutics, with its lead product, PRF-110, focusing on post-operative pain relief using a local anesthetic, ropivacaine. PRF-110 aims to provide extended analgesia through a unique delivery system, reducing the need for opiates.
PainReform Ltd. (Nasdaq: PRFX) announced a private placement to raise approximately $6.0 million by issuing 1,304,346 ordinary shares and warrants. The purchase price is set at $4.60 per share, with warrants allowing the purchase of an additional 652,173 shares. Closing is expected on March 10, 2021, pending customary conditions. Maxim Group LLC and Joseph Gunnar & Co., LLC are acting as placement agents. The securities will not be registered under the Securities Act and are offered only to accredited investors. This move highlights PainReform's strategy to secure funding for its pain relief product, PRF-110.
PainReform Ltd. (Nasdaq: PRFX), a clinical stage specialty pharmaceutical company, announced participation in the H.C. Wainwright BioConnect 2021 Conference, occurring virtually from January 11-14, 2021. A webcast of the presentation will be available on-demand starting January 11, 2021, at 6:00 a.m. ET, accessible for 90 days. PainReform's lead product, PRF-110, aims to enhance post-operative pain relief using a proprietary extended-release drug-delivery system, targeting the local anesthetic market with reduced opiate needs.
PainReform Ltd. (Nasdaq: PRFX) has appointed Rita Keynan as Vice President of Pharmaceutical Operations. With over 25 years in the pharmaceutical sector, Keynan has a solid background in drug development, overseeing all facets from early trials to NDA filings. Her prior role was with VYNE Therapeutics, managing a team focused on drug development. CEO Ilan Hadar expressed confidence in her capabilities as the company prepares for Phase 3 trials of their lead product, PRF-110, aimed at post-operative pain relief through an innovative drug-delivery system.
PainReform Ltd. (NasdaqCM:PRFX) announced the appointment of Lotus Clinical Research as its CRO for the upcoming Phase 3 trial of PRF-110. This trial will focus on patients undergoing bunionectomy and hernia repair operations. LCR is specialized in analgesic studies, with a history of approximately 350 trials resulting in over ten approvals. Previous Phase 2 results showed PRF-110 provided pain relief for up to 72 hours, outperforming ropivacaine's 2-6 hours. The CEO stated confidence in the trial's design, aiming to address the opioid crisis while demonstrating safer pain relief options.
PainReform Ltd. (NASDAQ:PRFX) has appointed Ilan Hadar as its new CEO, effective immediately. With over 20 years in the pharmaceutical sector, Hadar has led operations and developed products in the U.S. and Israel. His previous roles include serving as Country Manager and CFO at Foamix Pharmaceuticals and Finance Director at Pfizer. The appointment comes as PainReform prepares for pivotal Phase 3 trials for its lead product PRF-110, aimed at changing post-operative pain management by reducing reliance on opioids.
PainReform Ltd. (NASDAQ:PRFX) has appointed Dr. Ellen Baron to its Board of Directors, enhancing its leadership after a recent IPO. Dr. Baron brings over 20 years of experience in the healthcare and capital markets sectors, previously holding key positions at Outcome Capital LLC and Healthios Capital Markets. Her expertise in business development and clinical affairs will be pivotal as PainReform advances its PRF-110 drug through Phase 3 trials aimed at the post-operative pain relief market. The company is optimistic about its future growth potential, targeting a significant market opportunity.
PainReform Ltd. (NASDAQ:PRFX) has appointed Augustine Lawlor to its Board of Directors following its recent IPO. Lawlor, with extensive experience in the pharmaceutical sector, previously served as COO of Leap Therapeutics and held key positions at LeukoSite and Alpha-Beta Technologies. His expertise includes finance, business development, and mergers and acquisitions, making him a valuable addition as PainReform advances its lead product, PRF-110, through Phase 3 trials. This product aims to revolutionize post-operative pain management while potentially reducing reliance on opioids.
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