Biotech News

Enlivex Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Allocetra™ in Age-Related Knee Osteoarthritis

Enlivex Therapeutics (ENLV)Enlivex TherapeuticsFDA / regulatory

FDA grant of RMAT designation to Allocetra™ reinforces the potential of this program to deliver a meaningful, disease-modifying impact in age-related primary knee osteoarthritis, where patients face declined quality-of-life and limited treatment options.

RMAT designation provides the benefit of intensive, early FDA engagement and guidance for...

Related news

ENLVEnlivex Therapeutics2026-07-29 13:00 EST

Enlivex Management to Host Webinar to Discuss Capital Strategy, Rain Protocol Treasury Strategy, and Recent Clinical Milestones

ACIUAC Immune2026-08-11 11:00 EST

AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)

BMYBMYBristol-Myers Squibb Company2026-08-13 21:12 EST

U.S. FDA Grants Accelerated Approval to Bristol Myers Squibb's First CELMoD Therapy ZENBEXUS™, in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone (ZDd) for Patients with Multiple Myeloma, as Early as First Relapse

REPLReplimune Group2026-07-30 22:15 EST

Replimune Announces Favorable Outcome of FDA's Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

RHHBYRoche Holdings AG2026-07-24 10:15 EST

CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD)

RHHBYRoche Holdings AG2026-09-10 05:00 EST

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments

REPLReplimune Group2026-08-06 20:00 EST

Replimune Announces FDA Accelerated Approval of TUDRIQEVTM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen

BNTXBioNTech2026-08-27 20:30 EST

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

PHARPharming Group2026-09-11 18:00 EST

FDA approves Pharming’s Joenja® as first treatment for children with APDS in the U.S.

CMPXCompass Therapeutics2026-09-22 12:30 EST

Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA Feedback

Enlivex Therapeutics

Enlivex Therapeutics is an immunotherapy company focused on macrophage reprogramming and inflammation-related disease. Its story is centered on harnessing innate immunity to address hard-to-treat conditions.

Recent company news

Stock data

Close
0.42 USD
Market cap
204.87M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States