Company Product Description Indication Status
CSL Behring, unit of CSL Ltd., of Melbourne, Australia CSL-889 Hemopexin modulator Sickle cell disease EU and FDA granted orphan drug designation
DBV Technologies SA, of Montrouge, France Viaskin Peanut (DBV-712) Peanut allergy desensitization vaccine Peanut hypersensitivity EMA validated MAA to treat children 4 to 11 years old
Imugene Ltd., of Sydney PD1-Vaxx PD-1 inhibitor Non-small-cell lung cancer  FDA cleared IND for phase I trial
Innocare Pharma Ltd., of Beijing Orelabrutinib BTK inhibitor Multiple sclerosis FDA cleared IND for phase II trial in 160 people with relapsing-remitting disease
Innovation Pharmaceuticals Inc., of Wakefield, Mass. Brilacidin Dual PDE3/PDE4 inhibitor COVID-19 infection FDA provided written feedback on development plan for phase II trial in people hospitalized with infection, completing pre-IND process
Janssen Pharmaceutical Cos. of Johnson & Johnson, of New Brunswick, N.J. Paliperidone palmitate 6-month  5-HT receptor antagonist; dopamine D2 receptor antagonist Schizophrenia Supplemental NDA submitted to FDA for twice-yearly dosing in adults
Neuraly Inc., of Gaithersburg, Md. NLY-01 (exenatide pegylated, subcutaneous) GLP-1R agonist Alzheimer's disease FDA cleared IND for phase IIb trial in 500+ participants with mild cognitive impairment due to AD
Pharmaxis Ltd., of Sydney, and Chiesi USA Inc., affiliate of Chiesi Farmaceutici SpA, of Parma, Italy Bronchitol (mannitol inhalation powder) Mucolytic agent Cystic fibrosis FDA approved for maintenance therapy to improve pulmonary function in people 18 and older
Polarityte Inc., of Salt Lake City Skinte Autologous cell and tissue-based therapy Diabetic foot ulcers FDA provided written response following type B pre-IND meeting, including feedback and recommendations on manufacturing, preclinical studies, data submitted in briefing package and additional studies to support IND submission, expected in second half of 2021
Poseida Therapeutics Inc., of San Diego P-PSMA-101 PSMA-targeted autologous CAR T-cell therapy Prostate cancer FDA lifted clinical hold on phase I study, expected to resume immediately, in people with metastatic castration-resistant disease
Provention Bio Inc., of Red Bank, N.J. Teplizumab CD3 antagonist Type 1 diabetes Completed submission of rolling BLA to FDA to delay or prevent T1D in at-risk individuals 
Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) PD-L1 inhibitor Hepatocellular carcinoma European Commission approved, in combination with Avastin (bevacizumab, Roche), to treat adults with advanced or unresectable disease who did not receive prior systemic therapy
Senhwa Biosciences Inc., of Taipei, Taiwan Silmitasertib Casein kinase II inhibitor COVID-19 infection IND submitted to FDA for phase II trial in individuals with severe infection
Taigen Biotechnology Co. Ltd., of Taipei, Taiwan TG-1000 Pan-influenza antiviral Influenza A and B infection FDA approved IND for phase I trial

Notes

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