Susan Serrao

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 »

March 27-28, 2025: MedInvest Biotech & Pharma Investor Conference

BioAegis COO and Co-founder, Valerie Ceva, was invited to present at the upcoming MedInvest Biotech & Pharma Investor Conference in New York City. The presentation, “Conquering Disease Driven by Excess Inflammation” will highlight BioAegis’ novel, host-directed immune regulator protein. The presentation will also discuss BioAegis’ lead indication, Acute Respiratory Distress Syndrome (ARDS), and its phase

March 27-28, 2025: MedInvest Biotech & Pharma Investor Conference Read More »

March 18-21, 2025: 44th Annual International Symposium on Intensive Care and Emergency Medicine (ISICEM)

BioAegis is a sponsor of the upcoming International Symposium on Intensive Care and Emergency Medicine (ISICEM) conference in Brussels, Belgium from March 18-21, 2025. Current information on our ongoing ARDS trial will be presented at this key critical care conference.

March 18-21, 2025: 44th Annual International Symposium on Intensive Care and Emergency Medicine (ISICEM) 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 »

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