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. (PRFX) has made significant progress in developing its lead product, PRF-110, designed for post-surgical pain relief. The company has successfully completed tech transfer for manufacturing clinical batches and is on track to start Phase 3 clinical trials in bunionectomy by Q4 2022. Financially, PainReform reported a net loss of $3.5 million for the first half of 2022, an improvement from a $3.7 million loss in 2021. The company maintains a strong balance sheet with $13.8 million cash on hand, sufficient to support ongoing activities and trials.
PainReform (Nasdaq: PRFX) has received a Nasdaq Listing Qualifications notice indicating non-compliance with the minimum bid price requirement of $1.00 per share. The company has a 180-day grace period until February 6, 2023, to regain compliance by maintaining a closing bid price of at least $1 for ten consecutive business days. If compliance is not achieved, PainReform may be subject to delisting. Despite this, the current trading of its shares will continue on the Nasdaq Capital Market during the grace period.
PainReform (Nasdaq: PRFX) announced successful batch manufacturing of PRF-110 and progress towards Phase 3 clinical trials expected in H2 2022. CEO Ilan Hadar confirmed that FDA approval for the 505(b)(2) pathway sets the stage for efficient trial execution. The company has $15.4 million in cash and no debt, ensuring capital availability for key milestones. Q1 2022 reported R&D expenses decreased to $680,000, and net loss decreased to $1.694 million, reflecting cost management. PainReform focuses on reformulating established therapeutics for enhanced surgical pain relief.
PainReform Ltd. (Nasdaq: PRFX), a clinical-stage specialty pharmaceutical company, announced that CEO Ilan Hadar will present at the Noble Capital Markets’ Eighteenth Annual Investor Conference on April 20-21, 2022, in Hollywood, Florida. Hadar's presentation is scheduled for April 20 at 12:00 pm ET in Seminole Ballroom C, with a breakout session at 4:00 pm ET at Table 9. A video webcast of the presentation will be available the following day on the Company's website and other platforms, archived for 90 days.
PainReform Ltd. (Nasdaq: PRFX) announced its participation in the 2022 Virtual Growth Conference hosted by Maxim Group LLC and M-Vest, scheduled for March 28-30, 2022, from 9:00 a.m. to 5:00 p.m. EDT. The conference will include various discussions and presentations, featuring a corporate update by CEO Ilan Hadar. To attend, individuals must register as M-Vest members. PainReform focuses on reformulating established therapeutics, with its lead product PRF-110 aimed at providing extended post-operative pain relief through a unique drug-delivery system.
PainReform Ltd. (Nasdaq: PRFX) provided a business update for 2021, revealing plans to start a Phase 3 trial of PRF-110 for bunionectomy in H2 2022. The company has $16.6 million in cash, a positive working capital of $18.3 million, and no debt. R&D expenses surged to $2.9 million from $0.4 million in 2020, while the net loss increased to $7.2 million. PainReform's lead product, PRF-110, aims to meet the $35 billion post-operative pain management market, potentially reducing opioid use. Key developments are anticipated in 2022 to enhance shareholder value.
TEL AVIV, Israel, Dec. 14, 2021 – PainReform Ltd. (Nasdaq: PRFX) announced that CEO Ilan Hadar will participate in the Benzinga All Access event on December 16, 2021, at 10:00 A.M. ET. The event features a live interview with Spencer Israel, Executive Producer of Benzinga TV. Investors can watch the event here. PainReform, focused on reformulating established therapeutics, aims to provide extended post-operative pain relief with its product PRF-110.
PainReform (Nasdaq: PRFX) has reported progress towards commencing Phase 3 clinical trials for PRF-110, its lead product aimed at post-operative pain relief, using ropivacaine. The company has selected Pharmaceutics International, Inc. as its U.S. manufacturer for clinical batches. They expect to start the first trial in bunionectomy by late 2022. Despite a net loss of $5.5 million for the first nine months of 2021, PainReform maintains a healthy cash balance of $18.4 million, providing a runway for important milestones ahead.
PainReform Ltd. (Nasdaq: PRFX) announced that CEO Ilan Hadar will present at the Dawson James Securities Small Cap Growth Conference on October 21, 2021, at 3:15 PM ET in Jupiter, Florida. This conference will feature one-on-one meetings with qualified investors. The live webcast and recorded presentation will be accessible on PainReform's investor relations website. PainReform specializes in reformulating therapeutics, focusing on PRF-110, which targets post-operative pain relief through an innovative drug-delivery system.
PainReform Ltd. (NASDAQ: PRFX) announced a shift of manufacturing operations for its lead product, PRF-110, to a U.S.-based Contract Development and Manufacturing Organization to enhance quality and efficiency. This decision aims to resolve previous manufacturing delays, with plans to initiate Phase 3 clinical trials by Q1 2022. As of June 30, 2021, PainReform reported $17.8 million in cash, which increased to over $19 million following recent warrant exercises. The company also reported a net loss of $3.7 million for the first half of 2021, up from $2.0 million a year earlier.
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