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Pluristem Therapeutics (NASDAQ:PSTI) announced the full enrollment of its Phase III study involving 240 patients to evaluate PLX-PAD cells for muscle injury treatment post-hip fracture surgery. The topline results are expected in Q3 2022. The company will also hold an online event on November 22 to discuss muscle regeneration. CEO Yaky Yanay emphasized the potential of PLX-PAD to address rising healthcare needs due to aging populations. The annual treatment costs for hip fractures in the U.S. range from $10.3 to $15.2 billion, highlighting the demand for innovative therapies.
Pluristem Therapeutics (Nasdaq:PSTI) has received approval for an additional budget from the Israel Innovation Authority (IIA) to advance its work with the CRISPR-IL consortium. Following the successful completion of the first 18-month period, the new budget of approximately 1,800,000 NIS (around $583,000) will support the development of PLX cells using CRISPR technology. The consortium aims to enhance genome editing capabilities across various fields, including pharmaceuticals and agriculture, positioning Pluristem at the forefront of regenerative medicine.
Pluristem Therapeutics (PSTI) provided an update on its clinical pipeline and strategic plan. The company anticipates significant milestones in the coming months, including topline results from Phase I and II studies for PLX-R18 and PLX-PAD cells, respectively. Enrollment for a Phase III study on muscle regeneration post-hip fracture surgery is also nearing completion. Additionally, Pluristem is advancing its manufacturing platform for placental cells and exploring CRISPR technology for new therapeutic candidates. The management emphasizes its competitive edge in efficient manufacturing and innovation.
Pluristem (Nasdaq: PSTI) has appointed two new board members: Prof. Varda Shalev and Mr. Doron Birger, enhancing its leadership team. Prof. Shalev brings over 30 years of experience in healthcare and technology, having established Israel's largest biobank and led significant innovations in medical informatics. Mr. Birger, with extensive high-tech and life sciences industry expertise, has successfully led numerous companies through significant product developments and mergers. This strategic addition aims to advance Pluristem's mission of developing regenerative cell therapies.
Pluristem Therapeutics announced a clinical readout for its Phase II studies targeting COVID-19 related Acute Respiratory Distress Syndrome (ARDS). Over 100 patients across the U.S., Europe, and Israel were enrolled, with key results expected in Q4 2021. The company has opted not to expand its COVID-19 program to Mexico due to a decline in severe cases. Pluristem is also advancing its product candidates, with promising developments in muscle regeneration and hematology deficiencies. The company highlights a proprietary process for producing PLX cells effectively.
Pluristem Therapeutics has announced the receipt of a €20 million (about $24 million) disbursement from the European Investment Bank as part of a €50 million agreement, reflecting a key milestone in its funding strategy. The company expects to receive the funds in June 2021, which will bolster its R&D efforts for regenerative cell therapies. Following this tranche, Pluristem's cash balance will exceed $90 million. This funding is seen as a non-dilutive financing option, supporting Pluristem’s commitment to developing innovative treatments to address Europe’s aging population.
Pluristem Therapeutics (Nasdaq:PSTI) reported positive topline results from a Phase I study exploring the safety and efficacy of PLX-R18 for patients recovering from Hematopoietic Cell Transplantation. The study involved 21 patients, revealing that PLX-R18 could improve blood counts across all three cell lineages. At six months, patients demonstrated significant hemoglobin and platelet count improvements. Notably, approximately 60% of participants showed recovery in all blood cell types. The company plans a call on May 3, 2021, to discuss these findings further.
Pluristem Therapeutics (Nasdaq:PSTI) has received safety committee clearance to proceed with patient enrollment for cohort II of its Phase I/II study evaluating PLX-PAD cells in treating steroid-refractory chronic graft-vs-host disease (cGvHD). Interim results from cohort I of 6 patients revealed no treatment-related side effects, with 4 patients showing symptom improvement and reduced steroid use. This next phase will treat 14 patients with 4 injections. cGvHD is a serious complication post-bone marrow transplants, with a significant unmet treatment need.
Pluristem Therapeutics (Nasdaq:PSTI) has received approval from the Israeli Ministry of Health to enroll patients for its Phase II COVID-19 clinical trial, aimed at treating severe cases complicated by Acute Respiratory Distress Syndrome (ARDS). The trial will enroll 40 patients across Israel and Germany. The primary efficacy endpoint is the number of ventilator-free days within 28 days. This trial complements Pluristem's ongoing clinical initiatives in the U.S. and aims to advance treatment options during the ongoing pandemic.
Pluristem Therapeutics (Nasdaq: PSTI) provided a shareholder update from CEO Yaky Yanay, emphasizing collaboration efforts during the COVID-19 pandemic. The company is advancing its late-stage regenerative medicine pipeline, with four clinical readouts expected, including interim results from a Phase III study in Critical Limb Ischemia (CLI). Financially, Pluristem reported $59 million in cash as of June 30, 2020. The company highlights its strong workforce and culture, focusing on resilience amid challenges while preparing for future clinical developments and potential regulatory discussions.