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Heatwurx (PCSA) FDA Events

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FDA Events for Heatwurx (PCSA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Heatwurx (PCSA). Over the past two years, Heatwurx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NGC-Cap, NGC-Iri, and PCS6422. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Heatwurx's Drugs in FDA Review

NGC-Cap - FDA Regulatory Timeline and Events

NGC-Cap is a drug developed by Heatwurx for the following indication: In patients with advanced or metastatic breast cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NGC-Iri - FDA Regulatory Timeline and Events

NGC-Iri is a drug developed by Heatwurx for the following indication: For cancer treatments. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PCS6422 - FDA Regulatory Timeline and Events

PCS6422 is a drug developed by Heatwurx for the following indication: Advanced, Refractory Gastrointestinal Tract Tumors. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Heatwurx FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Heatwurx (PCSA) has reported FDA regulatory activity for the following drugs: NGC-Cap, PCS6422 and NGC-Iri.

The most recent FDA-related event for Heatwurx occurred on May 30, 2025, involving PCS6422. The update was categorized as "Abstract," with the company reporting: "Processa Pharmaceuticals, announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois."

Current therapies from Heatwurx in review with the FDA target conditions such as:

  • In patients with advanced or metastatic breast cancer - NGC-Cap
  • Advanced, Refractory Gastrointestinal Tract Tumors - PCS6422
  • For cancer treatments - NGC-Iri

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:PCSA) was last updated on 7/10/2025 by MarketBeat.com Staff
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