Welcome to our dedicated page for Processa Pharmaceuticals news (Ticker: PCSA), a resource for investors and traders seeking the latest updates and insights on Processa Pharmaceuticals stock.
Processa Pharmaceuticals, Inc. (PCSA) generates a steady flow of news as a clinical-stage pharmaceutical company developing Next Generation Cancer (NGC) therapies and advancing select non-oncology programs. News coverage for PCSA commonly centers on its lead asset NGC-Cap (PCS6422 plus capecitabine) in advanced or metastatic breast cancer, where the company reports on Phase 2 trial enrollment milestones, interim analyses, and emerging safety and pharmacokinetic data.
Investors following PCSA news can expect detailed updates on clinical trial progress, including randomized Phase 2 study design features, preliminary findings on cancer-killing metabolite exposure, and comparative safety versus standard capecitabine monotherapy. Releases have highlighted how NGC-Cap may increase exposure to active metabolites while reducing toxic catabolites such as FBAL, along with observations on side-effect profiles like hand-foot syndrome.
Beyond oncology, Processa news also covers its rare disease and gastrointestinal programs, such as PCS499 in focal segmental glomerulosclerosis (FSGS) and PCS12852 for gastroparesis and related gastrointestinal motility disorders. Announcements have included acceptance of abstracts for major meetings like ASN Kidney Week and the signing of a binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852, with associated milestone, royalty, and equity terms.
PCSA news items frequently address capital markets and corporate strategy, including public offerings, private placements, reverse stock split approvals and implementation, and Nasdaq listing compliance updates. The company has also disclosed its evaluation of corporate cryptocurrency treasury strategies as part of its financial planning. In addition, Processa regularly announces participation in high-profile industry events such as the BIO International Convention, the American Society of Clinical Oncology (ASCO) Annual Meeting, and the J.P. Morgan Healthcare Conference, where management meets with investors and potential partners.
By monitoring this news feed, readers can track how Processa’s NGC platform, pipeline decisions, partnership activities, and financing events evolve over time, all based on the company’s own press releases and regulatory disclosures.
Processa Pharmaceuticals (Nasdaq: PCSA) will attend the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on January 12-15, 2026. CEO George Ng and Chief Business & Strategy Officer Patrick Lin will be available for one-on-one investor and partner meetings to discuss the company’s clinical pipeline, including the ongoing Phase 2 study of NGC-Cap in advanced or metastatic breast cancer.
Preliminary Phase 2 data reportedly show increased exposure to capecitabine metabolites with a safety profile comparable to capecitabine monotherapy. A formal interim analysis of the first 20 patients is expected in early 2026. Meeting requests can be directed to Wendy Guy at wguy@processapharmaceuticals.com.
Processa Pharmaceuticals (Nasdaq: PCSA) completed enrollment and dosing of the 20 patients required for the planned formal interim analysis in its randomized Phase 2 study of NGC-Cap (PCS6422 + capecitabine) in advanced or metastatic breast cancer.
The formal interim analysis will compare safety and preliminary efficacy versus capecitabine monotherapy and is expected to be completed in Q1 2026. Key interim objectives include evaluating comparative safety/efficacy, deciding whether to add a higher or lower NGC-Cap dose as a third arm, and assessing whether to adjust overall sample size.
Enrolled patients had a median of 2–3 prior treatment regimens. NGC-Cap dosing: single PCS6422 dose one day before capecitabine; capecitabine schedule: 150 mg twice daily, seven days on/seven days off. Mono-Cap dosing: 1,000 mg/m² twice daily, 14 days on/7 days off.
Processa Pharmaceuticals (Nasdaq: PCSA) provided a Phase 2 clinical update for NGC-Cap (PCS6422 + capecitabine) on Dec 17, 2025. Preliminary analysis of the first 16 of 19 randomized patients indicates NGC-Cap increases exposure to capecitabine's active, cancer-killing metabolites while maintaining comparable severity of side effects versus standard capecitabine monotherapy.
Key measured facts: NGC-Cap dosing was 150 mg BID vs Mono-Cap 1,000 mg/m² BID, and exposure to the catabolite FBAL was reduced by up to 10-fold. A formal interim analysis of the first 20 patients is expected in early 2026 with final enrollment targeted by end of Q1 2026.
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.