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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 Ltd. (Nasdaq: PRFX) provided a business update for 2022, marking significant advancements in the clinical development of PRF-110, its lead drug candidate targeting post-operative pain relief. The initiation of a Phase 3 clinical trial for bunionectomy has commenced, focusing on a safety pharmacokinetic study with 15 patients in Texas, with results expected in May 2023. Following this, a larger trial involving 400 patients will evaluate pain reduction over 72 hours. Financially, the company recorded a net loss of approximately $8.8 million and has approximately $10.2 million in cash as of December 31, 2022.
PainReform Ltd. (Nasdaq: PRFX) has initiated a Phase 3 clinical trial for its lead drug candidate, PRF-110, targeting post-operative pain relief following bunionectomy. The trial comprises two parts: an open-label safety study with 15 patients, followed by a double-blind study with around 400 patients across multiple sites. PRF-110 aims to provide localized, extended analgesia without the need for repeated dosing, addressing the opioid crisis. Initial pharmacokinetic data is expected in May 2023, with potential to capture a share in the $12 billion post-operative pain market if successful.
PainReform Ltd. (Nasdaq: PRFX) announced on February 7, 2023, that it has received a 180-day extension from Nasdaq to regain compliance with the minimum $1 bid price per share requirement, giving it until August 7, 2023. The company previously failed to maintain this bid price for 30 consecutive trading days, first notified on August 10, 2022. To regain compliance, PRFX must achieve a closing bid price of $1 or higher for 10 consecutive trading days before the deadline. PainReform focuses on reformulating established therapeutics, with its lead product, PRF-110, targeting post-operative pain relief.
PainReform Ltd. (Nasdaq: PRFX) provided a business update for Q3 2022, focusing on PRF-110, a product for post-operative pain relief following bunionectomy surgery. The company made enhancements to its manufacturing process, leading to delays in starting the Phase 3 clinical trial but aims to rectify the issue. As of September 30, 2022, it reported $12.9 million in cash, supporting upcoming milestones. R&D expenses increased to $2.5 million, while net loss rose slightly to $5.6 million. PainReform plans to initiate another Phase 3 trial for pain treatment in hernia repair surgery.
PainReform Ltd. (Nasdaq: PRFX) announced a delay in the Phase 3 trial for PRF-110 due to manufacturing issues, which are expected to enhance efficiency and scalability. CEO Ilan Hadar highlighted optimism based on prior Phase 2 results and the potential of PRF-110 in the $12 billion post-operative pain market as a safer alternative to opioids. The company remains committed to providing updates on the trial's start date as they progress.
PainReform Ltd. (Nasdaq: PRFX) has announced successful improvements in the manufacturing process of its lead product PRF-110, enhancing efficiency and scalability. These advancements include the implementation of terminal filtration, aimed at ensuring high-quality production. The company confirms it is on track to initiate a Phase 3 clinical trial for bunionectomy in November 2022. PainReform focuses on reformulating established therapeutics to provide localized post-operative pain relief, reducing reliance on opiates.
PainReform Ltd. (Nasdaq: PRFX) announced that CEO Ilan Hadar will present at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, in New York City. The presentation will be available on-demand starting September 12 at 7:00 AM ET. One-on-one meetings with investors are scheduled for September 12-16. PainReform focuses on reformulating established therapeutics, with its lead product, PRF-110, designed to provide localized and extended post-operative pain relief using ropivacaine.
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.
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