Company

Product

Description

Indication

Status

American Cryostem Corp., of Eatontown, N.J.

Atcell

Autologous adipose-derived mesenchymal stem cells

Post concussion syndrome

Submitted IND to FDA for phase I trial

CLS Therapeutics Inc., of New York

CLS-014

Gene therapy

Pancreatic cancer

FDA granted orphan designation

Genentech, of South San Francisco, part of the Roche Group

Gazyva (obinutuzumab)

Engineered monoclonal antibody targeting CD20

Lupus nephritis

FDA granted breakthrough therapy designation

Janssen Pharmaceutical Cos., of Horsham, Pa., part of Johnson & Johnson

Erleada (apalutamide)

Androgen receptor inhibitor

Metastatic castration-sensitive prostate cancer

Supplemental NDA approved by FDA under priority review

Ocugen Inc., of Malvern, Pa.

OCU-400

Gene therapy

CEP290 mutation-associated retinal disease

FDA granted orphan designation; mutations in CEP290 have been associated with diseases such as Leber congenital amaurosis, Bardet-Biedl syndrome, Joubert syndrome, Senior-Loken syndrome and Meckel-Grüber syndrome

Sound Pharmaceuticals Inc., of Seattle

SPI-1005

Contains ebselen, which mimics and induces glutathione peroxidase activity

Meniere's disease

FDA granted fast track designation

Notes

For more information about individual companies and/or products, see Cortellis.

 

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