News

August 20, 2025: BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression Sickness (DCS)

Fast Track status accelerates regulatory pathway for BioAegis’ recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases. Second Fast Track designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven conditions. NORTH BRUNSWICK, N.J., August 20, 2025 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech company at the forefront of […]

August 20, 2025: BioAegis Therapeutics Awarded Second FDA Fast Track Designation for Recombinant Human Gelsolin to Treat Inflammasome-Driven Decompression Sickness (DCS) Read More »

June 17, 2025: BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Fast Track status enables expedited regulatory review timelines and supports the development of recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases.  Global Phase 2b clinical trial underway evaluating rhu-pGSN for the treatment of moderate to severe ARDS.  NORTH BRUNSWICK, N.J., June 17, 2025 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech

June 17, 2025: BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Read More »

June 10, 2025: BioAegis Therapeutics Announces US Navy Contract to Support Phase 2 Study of Recombinant Human Gelsolin, for Inflammasome-Driven Decompression Sickness (DCS)

Phase 2 proof-of-concept study for rhu-pGSN, a promising intervention across a spectrum of  inflammatory diseases, to be studied as an intervention for the negative outcomes of decompression in SCUBA Divers. NORTH BRUNSWICK, N.J., June 10, 2025 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory

June 10, 2025: BioAegis Therapeutics Announces US Navy Contract to Support Phase 2 Study of Recombinant Human Gelsolin, for Inflammasome-Driven Decompression Sickness (DCS) Read More »

May 6, 2025: BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

600-patient study to assess efficacy of rhu-pGSN,  an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens.  Results from this landmark study expected to inform therapeutic strategies beyond ARDS, positioning rhu-pGSN as a promising intervention across a spectrum of acute and chronic inflammatory diseases.  NORTH BRUNSWICK, N.J., May 6, 2025

May 6, 2025: BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Read More »

March 18, 2025: BioAegis Therapeutics to Highlight Lead Product Gelsolin’s Critical Role in Immune Function at Upcoming Conferences

Phase 2 clinical trial will be presented at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) conference in Brussels, Belgium on March 19, 2025.  COO Valerie Ceva will present at MedInvest Biotech & Pharma Investor Conference in NYC on March 27, 2025.  NORTH BRUNSWICK, N.J., March 18, 2025 (GLOBE NEWSWIRE) — BioAegis Therapeutics,

March 18, 2025: BioAegis Therapeutics to Highlight Lead Product Gelsolin’s Critical Role in Immune Function at Upcoming Conferences Read More »

October 17, 2024: BioAegis Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)

Global 600 patient study will evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS.  Rhu-pGSN is an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens. Endogenous levels plummet in ARDS, correlating with disease severity.  NORTH BRUNSWICK, N.J., October 17, 2024 (GLOBE NEWSWIRE) — BioAegis Therapeutics,

October 17, 2024: BioAegis Therapeutics Enrolls First Patient in Phase 2 Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Read More »

September 12, 2024: BioAegis Therapeutics to Present at Upcoming MedInvest Biotech & Pharma Investor Conference in NYC

NORTH BRUNSWICK, N.J., September 12, 2024 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that its Co-founder, Steve Cordovano, will present at the upcoming MedInvest Biotech & Pharma Investor Conference in New York City on September 18 and 19. The presentation, “Conquering Diseases Driven

September 12, 2024: BioAegis Therapeutics to Present at Upcoming MedInvest Biotech & Pharma Investor Conference in NYC Read More »

February 27, 2024: BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Large phase 2 global study will evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS. NORTH BRUNSWICK, N.J., February 27, 2024 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce site recruitment for BTI-203, a Phase 2 study

February 27, 2024: BioAegis Therapeutics Unveils Upcoming Clinical Study of Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS) Read More »

October 16, 2023: BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Partnership supports execution of a large phase 2 global study to evaluate efficacy and safety of recombinant human plasma gelsolin (rhu-pGSN) for moderate-to-severe ARDS. NORTH BRUNSWICK, N.J., October 16, 2023 (GLOBE NEWSWIRE) — BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership

October 16, 2023: BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS) Read More »

May 2023: BioAegis Therapeutics to Sponsor a Webinar, Below the Eyes of the Hippopotamus: The Expanding Spectrum of Auto- and Hyper- Inflammatory Diseases

Webinar will take place Tuesday, May 23, 2023 at 2:00 PM Eastern Time NORTH BRUNSWICK, N.J., May 10, 2023 (GLOBE NEWSWIRE) — BioAegis Therapeutics, Inc., a clinical-stage company developing novel therapies for inflammatory diseases through a portfolio built around plasma gelsolin (pGSN), a highly conserved and abundant endogenous human immune regulatory protein, announces that it

May 2023: BioAegis Therapeutics to Sponsor a Webinar, Below the Eyes of the Hippopotamus: The Expanding Spectrum of Auto- and Hyper- Inflammatory Diseases Read More »

error: Content is protected !!