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Processa Pharmaceuticals Inc (PCSA) is a clinical-stage biopharmaceutical company pioneering Next Generation Chemotherapy (NGC) treatments through advanced regulatory science. This dedicated news hub provides investors and industry professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives in oncology innovation.
Access comprehensive coverage of PCSA's progress in modifying FDA-approved cancer therapies, including trial results, partnership announcements, and scientific advancements. Our curated news collection features essential updates on pharmacokinetic optimization research, NGC pipeline developments, and regulatory submissions.
Key content includes analysis of treatment efficacy studies, executive leadership updates, and expert commentary on Processa's unique approach to enhancing existing oncology drugs. Stay informed about developments in chemotherapy modification techniques and their implications for cancer care standards.
Bookmark this page for verified updates on Processa's clinical programs and regulatory engagements. Check back regularly for objective reporting on biopharmaceutical innovations that balance scientific rigor with patient-focused therapeutic improvements.
Processa Pharmaceuticals (Nasdaq: PCSA) announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, was accepted for poster presentation at ASN Kidney Week 2025 in Houston, Nov 5–9, 2025.
The poster is scheduled in the session “Glomerular Clinical Trials: From Data to Impact” on Nov 7, 2025, 10:00–12:00 CT (board FR-PO0829). PCS499 is an analog of a pentoxifylline metabolite that has shown a favorable safety profile versus PTX, potentially allowing higher dosing for greater benefit in rare kidney diseases like FSGS. Processa will discuss an adaptive Phase 2/3 design with the FDA later in 2025 to optimize dosing and accelerate development.
Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage biopharmaceutical company focused on Next Generation Cancer therapies, has announced two strategic initiatives: securing an undisclosed strategic investment and exploring cryptocurrency treasury strategies.
The company is evaluating blockchain-based assets as a potential avenue to diversify its capital base and enhance financial flexibility while funding clinical development programs. This approach aims to reduce shareholder dilution and position Processa at the biotech-fintech intersection.
To implement its cryptocurrency treasury strategy, Processa has engaged LifeSci Capital, LLC as an advisor.
Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage pharmaceutical company, has provided significant updates on its product pipeline and business developments. The company has signed a binding term sheet with Intact Therapeutics for PCS12852, potentially worth up to $454 million in milestone payments plus 12% royalties and a 3.5% equity stake.
The company's lead oncology asset, PCS6422 (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer, with interim analysis expected in H2 2025. For PCS499, Processa is designing a new adaptive pivotal Phase III study for rare kidney diseases and establishing a dedicated subsidiary to enhance strategic flexibility.
In portfolio optimization moves, Processa has terminated the PCS3117 license agreement, while continuing to explore development strategies for PCS11T, their preclinical oncology asset. The company has also strengthened its balance sheet with a $7 million capital infusion.
Processa Pharmaceuticals (Nasdaq: PCSA) has announced that Dr. David Young, Founder and President of Research & Development, will present at the World Orphan Drug Congress USA 2025 in Boston. The presentation, scheduled for April 24, 2025, at 2:00 p.m. ET, will focus on 'Applying Principles of FDA's Project Optimus to Oncology and Non-Oncology Rare Diseases'.
Dr. Young will discuss how Project Optimus principles can be utilized to determine optimal dosing for improved efficacy and safety in rare disease treatments, both oncological and non-oncological. This approach aligns with Processa's Regulatory Science strategy, which aims to enhance therapeutic outcomes through improved regulatory science methodologies.
Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage pharmaceutical company specializing in next-generation cancer therapies, has announced its participation in the upcoming MedInvest Biotech and Pharma Investor Conference. The event will take place on March 27-28, 2025, at Cooley's law office in New York City.
The company's management team will deliver a corporate overview presentation on March 28th at 9:40 a.m. Eastern time. Additionally, they will engage in one-on-one meetings with registered investors and conference attendees throughout the event. The presentation materials will be made accessible on Processa's website.
Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing next-generation cancer therapies, has announced its participation in the 2025 BIO CEO & Investor Conference. The event will take place on February 10-11, 2025, at the New York Marriott Marquis.
The company's management will deliver a corporate overview presentation on Tuesday, February 11 at 10:00 a.m. Eastern time in the Plymouth Room. Throughout the conference, management will be available for one-on-one meetings with registered investors and attendees. Interested parties can schedule meetings through the BIO Partnering portal, while those unable to attend can contact Yvonne Briggs at Alliance Advisors to arrange meetings with management.