Let's delve into the US markets on Thursday and uncover the stocks that are experiencing notable gaps in today's session. Below, you'll find the gap up and gap down stocks.

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Processa Pharma just reported results for the first quarter of 2024.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, reported that dosing of the first patient in its phase 2 clinical trial evaluating NGC-Cap has begun. The clinical trial is evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer. NGC-Cap combines the administration of PCS6422, PCSA’s irreversible dihydropyrimidine dehydrogenase (“DPD”) enzyme inhibitor, with low doses of capecitabine.

Processa Pharmaceuticals (NASDAQPCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety. The company today announced that management will hold one-on-one meetings with investors and deliver a company presentation at the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, at the Lotte New York Palace Hotel. The recorded presentation will be available on demand beginning Monday, September 9, 2024, at 7 a.m. ET. In addition, Processa’s management will hold meetings with clinicians, researchers, industry key opinion leaders and potential partners at the European Society for Medical Oncology (“ESMO”) Congress 2024. ESMO Congress 2024 will be held September 13-17, 2024, in Barcelona.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today provided updates on its product pipeline, upcoming milestones and business activities. According to the updates, a Phase 2 trial with NGC-Cap is underway in patients with breast cancer. In addition, preclinical studies showed that NGC-Iri delivers more cancer-killing SN-38 molecules to the tumor than Onivyde(R) or irinotecan.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive data from two preclinical studies. The data support the potential for the Next Generation irinotecan (“NGC-Iri”), the prodrug of SN-38, which is the active anticancer metabolite of irinotecan, to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde(R) (the liposomal formation of irinotecan). The two studies demonstrated that NCG-Iri delivered more cancer-killing SN-38 molecules to the tumor than irinotecan and Onivyde(R). In addition, less SN-38 accumulated in non-cancer tissues, such as muscle, after NGC-Iri administration than after irinotecan or Onivyde(R) administration.

PCSA stock results show that Processa Pharma missed analyst estimates for earnings per share the second quarter of 2024.

2U stock is up on Tuesday with heavy trading of TWOU shares as they continue to rally following a bankruptcy filing.

Processa Pharmaceuticals stock is up on Tuesday as PCSA investors react to approval for a Phase 2 clinical trial of NGC-Cap.

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Investigational New Drug (“IND”) application for its lead product candidate, Next Generation Capecitabine (“NGC-Cap”). According to the announcement, the FDA clearance enables the commencement of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer. The Phase 2 study, which is expected to begin enrollment this quarter, will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in about 60 to 90 patients with advanced or metastatic breast cancer. “We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine,” said David Young, PharmD, Ph.D., President of Research and Development. “Initial data from the Phase 2 trial are expected mid-2025.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, has named a new chief financial officer. According to the announcement, Russell L. Skibsted has accepted the new assignment, effective immediately; Skibsted succeeds James Stanker, who is retiring but will serve in an advisory role to assist in the transition. Skibsted has spent almost three decades working in the pharmaceutical industry, gaining an invaluable expertise in financial management, global business development, capital markets, investor relations and operations. He has served in both public and private life sciences companies at all stages of development. His positions have included senior vice president and CFO at Alimera Sciences; executive vice president, CFO and chief business officer at Rockwell Medical; and CFO at BioTime, among others. “We are delighted to welcome Russell to Processa’s executive team,” said Processa Pharmaceuticals CEO George Ng in the press release. “His proven record in finance and capital markets combined with a deep understanding of the complexities inherent in the life sciences make him an ideal fit for Processa. With three decades of highly relevant experience, Russell is a seasoned executive and will be a tremendous asset to the company as we advance our pipeline through the clinic.”

Processa (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial. The trial defined the maximum tolerated dose (“MTD”) and recommended Phase 2 dose range (“RP2DR”) for Next Generation Capecitabine (“NGC-Cap”) administered to patients with stage III or IV gastrointestinal tract (“GI”) cancer. “We are encouraged by the preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrating some anti-tumor activity in patients with advanced GI cancer who have progressive cancer after relapsing or not responding to prior therapy. The favorable response is likely due to NGC-Cap’s ability to distribute more 5-FU to cancer cells than monotherapy capecitabine. The promising Phase 1b safety and tolerability profile plus these early efficacy signals provide validation for further development of NGC-Cap,” said David Young, PharmD, Ph.D., president of research and development at Processa. “From this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024.”

Processa Pharmaceuticals (NASDAQPCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, will be represented at this month’s EF Hutton Annual Global Conference. According to the announcement, key company officials will be attending the event, which will be held in New York City on May 15, 2024. Members of the Processa Pharmaceuticals management team will be meeting one-on-one with investors attending the event.