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Home » Pipeline

Pipeline

October 19, 2020

Company

Drug/Device

Medical Condition

Status

COVID-19 Trials and Actions    

ARCA Biopharma

AB201 (rNAPc2)

patients hospitalized with COVID-19

IND approved by the FDA

ImmunityBio

 hAd5-COVID-19

COVID-19 vaccine

IND approved by the FDA

CytoAgents

GP1681

COVID-19 cytokine storm (hypercytokinemia)

initiation of phase 1 trial

Taiwan Liposome Company

TLC19 (liposomal suspension of hydroxychloroquine for inhalation)

prophylaxis of COVID-19

first patient enrolled in phase 1 trial

VaxArt

VXA-CoV2-1

oral tablet COVID-19 vaccine

first patient dosed in phase 1 trial

Enlivex

Allocetra

severe and critical COVID-19 patients

initiation of phase 2 trial

Rigel Pharmaceuticals

fostamatinib

hospitalized COVID-19 patients

first patients enrolled in phase 2 trial

National Institutes of Health

remdesivir (Vitrakvy) and hyperimmune intravenous immunoglobulin (hIVIG)

adults hospitalized for COVID-19 with symptoms for 12 days or fewer without life-threatening organ dysfunction or organ failure

initiation of phase 3 trial

The CoVIg-19 Plasma Alliance/National Institute of Allergy and Infectious Diseases

anticoronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine 

hospitalized adults at risk for serious complications of COVID-19 disease

first patients enrolled in phase 3 trial

Abbott

AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test 

diagnosis of COVID-19

Emergency Use Authorization granted by the FDA

Other Trials and Actions

 

 

Armata Therapeutics

AP-PA02

pseudomonas aeruginosa infections

IND approved by the FDA

Ascletis Pharma

ASC42

nonalcoholic steatohepatitis

IND approved by the FDA

Nanobiotix

NBTXR3 activated by radiation therapy

lung cancer and esophageal cancer

IND approved by the FDA

Nuvation Bio

NUV-422

patients with high-grade gliomas 

IND approved by the FDA

Seattle Gummy Company

allergy gummy medication

allergies

IND approved by the FDA

SoniVie

Therapeutic Intra-Vascular Ultrasound (TIVUS) System

pulmonary arterial hypertension

IDE approved by the FDA

Amolyt Pharma

AZP-3601

hypoparathyroidism

first patient dosed in phase 1 trial

NANOBIOTIX

NBTXR3 activated by radiation therapy

pancreatic cancer

first patient dosed in phase 1 trial

Sumitomo Dainippon Pharma Oncology

TP-1454 administered alone and in combination with ipilimumab and nivolumab

advanced metastatic or progressive solid tumors

first patient dosed in phase 1 trial

Bold Therapeutics

BOLD-100 in combination with FOLFOX 

advanced gastric, pancreatic, colorectal and bile duct cancers

phase 1b trial initiated 

Celldex Therapeutics

CDX-0159

chronic spontaneous urticaria

first patient dosed in phase 1b trial

Evelo Biosciences

EDP1815

mild to moderate atopic dermatitis

patient enrollment complete in phase 1b trial

Regulus Therapeutics

RGLS4326

autosomal dominant polycystic kidney disease

first patients dosed in phase 1b trial

Castle Creek Biosciences

FCX-013

moderate to severe localized scleroderma

first patient dosed in 

phase 1/2 trial

Linnaeus Therapeutics

LNS8801 in combination with Keytruda (pembrolizumab) 

advanced cancer

first patient dosed in 

phase 1/2 trial

Alessa Therapeutics

Biolen device

localized sustained delivery of bicalutamide into the prostate of men scheduled for prostate surgery for treatment of nonmetastatic prostate cancer

first patient enrolled in phase 2 trial

Evelo Biosciences

EDP1815

mild to moderate psoriasis

first patient dosed in phase 2 trial

CartiHeal

Agili-C implant

cartilage lesions in arthritic and nonarthritic joints

Breakthrough Device designation granted by the FDA

Inventiva

lanifibranor

nonalcoholic steatohepatitis

Breakthrough Therapy designation granted by the FDA

miR Scientific

miR Sentinel PCC4 Assay (miR Sentinelä Prostate Test)

prostate cancer liquid biopsy test

Breakthrough Device designation granted by the FDA

Axovant Gene Therapies 

AXO-AAV-GM2

GM2 gangliosidosis

Rare Pediatric Disease designation granted by the FDA

Curtana Pharma

CT-179

medulloblastoma

Rare Pediatric Disease designation granted by the FDA

Italfarmaco Group

givinostat

Duchenne Muscular Dystrophy

Rare Pediatric Disease designation granted by the FDA

Oxular

OXU-003

retinoblastoma

Rare Pediatric Disease and Orphan Drug designation granted by the FDA

Y-mAbs Therapeutics

nivatrotamab

neuroblastoma

Rare Pediatric Disease and Orphan Drug designation granted by the FDA

Orca Bio

Orca-T 

patients with blood cancers who are eligible for a hematopoietic stem-cell transplant

Regenerative Medicine Advanced Therapy designation granted by the FDA

Apexigen

APX005M

esophageal- and gastroesophageal-junction cancer and pancreatic cancer

Orphan Drug designation granted by the FDA

Ascentage Pharma

APG-115

acute myeloid leukemia

Orphan Drug designation granted by the FDA

Ascentage Pharma

APG-1252

small-cell lung cancer

Orphan Drug designation granted by the FDA

Immunomedics

Trodelvy (sacituzumab govitecan-hziy)

adult and pediatric patients with glioblastoma

Orphan Drug designation granted by the FDA

Orca Bio

Orca-T 

enhancing cell engraftment in patients who qualify for a hematopoietic stem-cell transplant

Orphan Drug designation granted by the FDA

Redhill Biopharma

RHB-204

nontuberculous mycobacteria disease

Orphan Drug designation granted by the FDA

Alexion Pharma

Ultomiris (ravulizumab-cwvz) 

adults with paroxysmal nocturnal hemoglobinuria and for atypical hemolytic uremic syndrome 

approved by the FDA for new formulation

BioMarin

Palynziq (pegvaliase-pqpz) Injection

adults with phenylketonuria

approved by the FDA for expanded dosing

CrossBay

CrossGlide ETS Plus, Endometrial Tissue Sampler

endometrial biopsy procedure

approved by the FDA

FH Ortho

Telegraph Evolution, humeral nailing system

proximal and/or mid-shaft humeral fractures

approved by the FDA

Harmony Biosciences

Wakix (pitolisant) 

cataplexy in adult patients with narcolepsy

approved by the FDA for expanded indication

Merck

Keytruda (pembrolizumab)

monotherapy for adults with relapsed or refractory classical Hodgkin lymphoma

approved by the FDA for expanded indication

Regeneron Pharmaceuticals

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)

Zaire ebolavirus 

approved by the FDA

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