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RaphaLX™

Amyotrophic Lateral Sclerosis (ALS)

Pre-clinical/PilotActive

Key Facts

Indication

Amyotrophic Lateral Sclerosis (ALS)

Phase

Pre-clinical/Pilot

Status

Active

Company

New Biotic

About New Biotic

New Biotic is a private, clinical-stage biotech founded in 1962, leveraging microbiome-derived therapeutics to address ALS, a disease with significant unmet need. Its flagship candidate, RaphaLX™, has received Orphan Drug Designation from both the FDA and EMA and has shown promise in early human studies to slow progression and potentially reverse symptoms. The company collaborates with the Avera Institute for Human Genetics and is developing diagnostic biomarkers while exploring a novel hypothesis linking muscle atrophy to ALS onset.

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Therapeutic Areas

Amyotrophic Lateral Sclerosis (ALS)Neurodegenerative Diseases

Other Amyotrophic Lateral Sclerosis (ALS) Drugs

Drug	Company	Phase	Status
NPT520-34	Neuropore Therapies	Pre-clinical/Phase 1	Partnered (Biogen), Active
NUZ-001	Neurizon Therapeutics	Phase 2/3 (Platform Trial)	Active
CNM-Au8	Clene	Phase 2/3	Active
Masitinib	AB Science	Phase 3	Active
Undisclosed Program	Zhimeng Biopharma	Clinical	Active
SLS-005	Seelos Therapeutics	Platform Trial	Active (HEALEY ALS Platform Trial – Regimen E)
PMN442	ProMIS Neurosciences	Preclinical	Active
nAV-101	nVector	Pre-clinical	Active
ALTA-808	Alteron Therapeutics	Preclinical	IND-enabling studies launching
GM6	Genervon Biopharmaceuticals	Phase 2	Active
Lou Gehrig’s disease	Genclis	Discovery	Active
Treg-directed therapy for ALS	Iltoo Pharma	Pre-clinical	Active