Pipeline

May 11, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Organicell Regenerative Medicine	Organicell Flow	moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection	IND approved by the FDA
Global Institute of Stem Cell Therapy and Research (GIOSTAR)	mesenchymal stem cells	Covid-19	expanded access for compassionate use granted by the FDA
Eiger Biopharmaceuticals	peginterferon lambda	patients with mild COVID-19	first patient treated in phase 2 trial
Pulmotect	PUL-042	prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease	approval for two phase 2 trials granted by the FDA
Athersys	MultiStem cell therapy	COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS)	enrollment of first patients in phase 2/3 trial
Mesoblast	remestemcel-L	COVID-19-infected patients with moderate to severe ARDS on ventilator support	first patients dosed in phase 2/3 trial
Aridis Pharmaceuticals	AR-301	S. aureus induced pneumonia in COVID-19 patients on mechanical ventilators	enrollment of first patient in phase 3 trial
Gilead	remdesivir	COVID-19	Emergency Use Authorization (EUA) granted by the FDA
EUROIMMUN (a PerkinElmer company)	Anti-SARS-CoV-2 ELISA (IgG) serology test	detection of COVID-19 antibodies	EUA granted by the FDA
Rheonix	Rheonix COVID-19 MDx Assay	detection of SARS-CoV-2	EUA granted by the FDA
Roche	Elecsys Anti-SARS-CoV-2 antibody test	detection of COVID-19 antibodies	approved by the FDA
Other Trials and Actions
Bicycle Therapeutics	BT5528 in combination with nivolumab	advanced solid tumors in indications associated with EphA2 expression	first patient dosed in phase 1 trial
Scholar Rock	SRK-181	locally advanced or metastatic solid tumors	first patients dosed in phase 1 trial
Viriom	VM1500A	HIV-infected patients	initiation of phase 2a trial
Kubota Vision	emixustat hydrochloride	macular atrophy secondary to Stargardt disease	completion of patient enrollment in phase 3 trial
Spero Therapeutics	tebipenem HBr	complicated urinary tract infection and acute pyelonephritis	completion of patient enrollment in phase 3 trial
Alume Biosciences	ALM-488	peptide-dye conjugate for fluorescence highlighting of nerves during head and neck surgery	IND approved by the FDA
Green Valley Pharmaceutical	GV-971	Alzheimer’s disease	IND approved by the FDA
Lipocine	LPCN 1148	liver cirrhosis in adult male cirrhotic patients	IND approved by the FDA
Nanobiotix	NBTXR3	patients with locally advanced or borderline resectable cases of pancreatic ductal adenocarcinoma	IND approved by the FDA
GeneTx Biotherapeutics Ultragenyx Pharmaceuticals	GTX-102	Angelman syndrome	Fast Track designation granted by the FDA
Ascentage Pharma	HQP1351	chronic myeloid leukemia	Orphan Drug designation granted by the FDA
Seelos Therapeutics	SLS-005	Sanfilippo syndrome	Orphan Drug designation granted by the FDA
AstraZeneca	Farxiga (dapagliflozin)	adults with New York Heart Association's functional class II-IV heart failure with reduced ejection fraction	approved by the FDA for new indication
Galderma Research	Restylane Kysse	lip augmentation and the correction of wrinkles around upper lips in adults over the age of 21	approved by the FDA
Halozyme Therapeutics Janssen Biotech	DARZALEX FASPRO (daratumumab hyaluronidase human- fihj)	multiple myeloma	approved by the FDA
Novartis	Tabrecta (capmatinib)	NSCLC tumors that have an abnormal mesenchymal-epithelial transition gene that leads to MET exon 14 skipping	approved by the FDA
Tolmar Pharmaceuticals	FENSOLVI (leuprolide acetate)	pediatric patients two years of age and older with central precocious puberty	approved by the FDA