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RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) has released a Letter to Stockholders detailing recent financing developments, updates on the FDA regulatory process for RGN-259, and a strategic 12-month operational plan. The company focuses on tissue protection and regenerative medicine, currently conducting clinical trials for several drug candidates aimed at various medical conditions. RegeneRx has secured multiple licensing agreements across several regions globally, further expanding its reach in the biopharmaceutical market.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) provided an update on its joint venture, ReGenTree LLC, regarding progress towards a pre-BLA meeting with the FDA for RGN-259, targeting dry eye syndrome. The company is collaborating with a 3rd party FDA consulting firm to complete regulatory analysis and plans to submit a meeting request by Q3 2021. ReGenTree is optimistic about the meeting's approval based on clinical data and a regulatory package. If granted, a briefing document will be provided to the FDA 30 days before the meeting.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced the closing of a private placement offering, raising $1,980,000 in gross proceeds. The offering includes Series A Warrants for approximately 7.5 million shares at an exercise price of $0.24 and Series B Warrants for around 7.5 million shares at $0.28, with varying terms. After fees, net proceeds are expected to be approximately $1,800,000. The company plans to file a resale registration statement with the SEC within 45 days to register these shares.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced a private placement agreement with investors to raise up to $2,000,000 through the sale of common stock and warrants priced at $0.20 per share. Each purchaser will receive Series A and B Warrants, enabling the purchase of approximately 15 million additional shares at specified exercise prices. The offering is expected to close by June 30, 2021, with net proceeds of $1.8 million to support ongoing operations. Roth Capital Partners is the sole placement agent for this offering.
On May 14, 2021, RegeneRx Biopharmaceuticals (RGRX) announced positive results from the Phase 3 clinical trial (ARISE-3) of RGN-259 for treating dry eye syndrome. The trial's data analysis revealed significant improvements in signs and symptoms, confirming the drug's consistent safety and tolerance profile. The company aims to prepare a regulatory package for a pre-BLA meeting with the FDA this summer. The analysis also includes pooled data from all three Phase 3 trials involving around 1,500 patients, indicating a strong efficacy trend in treating dry eye.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced updates on its ARISE-3 phase 3 dry eye clinical trial via its website. This information was provided by GtreeBNT during their shareholder meeting held on March 19, 2021. RegeneRx focuses on developing therapeutic peptides for tissue protection and regeneration, with three drug candidates in clinical trials and multiple strategic licensing agreements worldwide. The company holds several patents and patent applications related to its products, indicating a robust pipeline for future growth.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced that the ARISE-3 Phase 3 clinical trial for RGN-259 eyedrops in treating dry eye syndrome did not meet its primary outcome. However, secondary endpoint showed statistically significant improvement in ocular grittiness. RGN-259 maintained a safety profile consistent with prior trials, showing only mild to moderate adverse events. Ongoing analyses may lead to a pre-BLA meeting with the FDA. The company emphasizes potential in its clinical programs and looks forward to sharing comprehensive results post-analysis.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced the locking of the ARISE-3 Phase 3 clinical trial database for RGN-259 eyedrops, aimed at treating dry eye syndrome. This milestone comes after data collection from 20 U.S. clinical sites. The U.S. joint venture, ReGenTree, will now conduct statistical analyses of the trial's data. RGN-259 has been reclassified as a biologic by the FDA, necessitating a Biologics License Application (BLA) for marketing approval, potentially providing 12 years of market exclusivity. The dry eye market is projected to reach $11.1 billion by 2028, presenting significant growth opportunities.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced that its ARISE-3 phase 3 clinical trial for dry eye syndrome is close to completion, with enrollment expected to finish by November 2020 and data collection by December 2020. This trial is vital for the development of RGN-259, a treatment for dry eye. CEO J.J. Finkelstein expressed optimism despite COVID-19 challenges. RegeneRx is also considering a program for RGN-352, targeting COVID-19, pending funding. The company has previously completed two successful phase 3 studies for dry eye.
RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) announced a verbal agreement for a short-term financing transaction with major stockholders and executives, aimed at securing working capital through Q1 2021. This move comes as the company awaits results from the delayed phase 3 ARISE-3 clinical trial for dry eye syndrome. Due to reduced cash use, RegeneRx has enough funds to operate until October 2020. The company expresses optimism about finalizing the financing soon, yet no guarantees are provided about completion by October 31.