Pipeline

August 10, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
BioAegis Therapeutics	recombinant human plasma gelsolin (rhu-pGSN)	hospitalized patients with severe COVID-19 pneumonia	first patient enrolled in phase 2 trial
Eli Lilly AbCellera	LY-CoV555	prevention of SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities	initiation of phase 3 trial
Revive Therapeutics	Bucillamine	patients with mild-moderate COVID-19	clearance to proceed with a phase 3 trial granted by the FDA
ANA Therapeutics	ANA001 (niclosamide capsules)	hospitalized patients with COVID-19 who are not on ventilators	IND approved by the FDA
Calidi Biotherapeutics Personalized Stem Cells	allogeneic mesenchymal stem cells	COVID-19 and pneumonia	IND approved by the FDA
NeuroRx	RLF-100 (aviptadil) for inhaled use	patients with moderate and severe COVID-19 in order to prevent progression to respiratory failure	IND approved by the FDA
Abiomed	left-sided Impella heart pumps	left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis	Emergency Use Authorization (EUA) granted by the FDA
Co-Diagnostics Clinical Reference Laboratory	CRL Rapid Response self-administered COVID-19 test	SARS-Cov 2 detection	EUA granted by the FDA
Seegene	Allplex 2019-nCoV Assay, a real-time RT-PCR test	SARS-Cov 2 detection	EUA granted by the FDA
Siemens	ADVIA Centaur COV2G and Attelica COV2G	semi-quantitative tests to estimate the quantity of a patient's antibodies produced against COVID-19 viral infection	EUA granted by the FDA
Vela Diagnostics	ViroKey SARS-CoV-2 RT-PCR Test	SARS-Cov 2 detection	EUA granted by the FDA
Other Trials and Actions
Gan and Lee Pharmaceuticals	GLR2007	advanced solid tumors	initiation of phase 1 trial
Innovent Biologics	IBI322	advanced malignancies	first patient dosed in phase 1 trial
Keros Therapeutics	KER-047	anemia and fibrodysplasia ossificans progressiva	patient dosing complete in planned dosing cohorts
MODAG	anle138b	multiple system atrophy	completion of phase 1 trial
Personalized Stem Cells	autologous stem cells	knee osteoarthritis	patient enrollment complete in phase 1 trial
SAB Biotherapeutics	SAB-176	seasonal influenza	first patient dosed in phase 1 trial
TFF Pharmaceuticals	voriconazole inhalation powder	invasive pulmonary aspergillosis	patient dosing complete in phase 1 trial
Algernon Pharmaceuticals	NP-120 (Ifenprodil)	idiopathic pulmonary fibrosis and chronic cough	first patient dosed in phase 2 trial
Clovis Oncology	Lucitanib in combination with Opdivo (nivolumab)	advanced gynecological solid tumors	first patient enrolled in phase 2 portion of phase 1/2 trial
Hepion Pharmaceuticals	CRV431	non-alcoholic steatohepatitis	first patient dosed in phase 2 trial
KBP Biosciences	KBP-5074	patients with advanced (stage 3b/4) chronic kidney disease and uncontrolled hypertension	patient dosing complete in phase 2b trial
Lexicon Pharmaceuticals	LX9211	diabetic peripheral neuropathic pain	initiation of phase 2 trial
Oncopeptides	melflufen in combination with dexamethasone	patients with relapsed refractory multiple myeloma	first patient enrolled in phase 2 trial
Palatin Technologies	PL9643	dry eye disease	patient enrollment complete in phase 2 trial
MyoKardia	mavacamten	patients with obstructive hypertrophic cardiomyopathy who have been referred for septal reduction therapy and are refractory to current therapeutic options, including those who have severe symptoms (NYHA Class IV)	first patient dosed in phase 3 trial
Redhill Biopharma	RHB-204	adults with pulmonary nontuberculous mycobacteria disease caused by mycobacterium avium complex (MAC) infection	IND for phase 3 trial approved by the FDA
Synthetic Biologics	SYN-020	multiple indications, including radiation enteropathy secondary to pelvic cancer therapy	IND approved by the FDA
BioCryst Pharmaceuticals	BCX9930	paroxysmal nocturnal hemoglobinuria	Fast Track designation granted by the FDA
Biosight	BST-236 (aspacytarabine)	acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy	Fast Track designation granted by the FDA
PolyPid	D-PLEX100	prevention of postabdominal surgery incisional infections	Fast Track designation granted by the FDA
ReViral	sisunatovir	serious RSV infection	Fast Track designation granted by the FDA
Cerecor	CERC-006	lymphatic malformations	Orphan Drug designation granted by the FDA
Eloxx Pharma	ELX-02	cystic fibrosis	Orphan Drug designation granted by the FDA
Tyme	SM-88 (racemetyrosine)	pancreatic cancer	Orphan Drug designation granted by the FDA
Sonoran Biosciences	SBG003 (tobramycin and vancomycin hydrogel)	postabdominal surgical site infection	Qualified Infectious Disease Product (QIDP) designation granted by the FDA
Axsome Therapeutics	AXS-12	cataplexy in patients with narcolepsy	Breakthrough Therapy designation granted by the FDA
Ethicon	transbronchial microwave ablation technology	soft tissue lesions	Breakthrough Device designation granted by the FDA
Eyenuk	EyeArt autonomous AI System	diabetic retinopathy	approved by the FDA
Genentech	Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib)	BRAF V600 mutation-positive advanced melanoma	approved by the FDA
GlaxoSmithKline	BLENREP (belantamab mafodotin-blmf)	patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent	approved by the FDA
Greenwich Biosciences	Epidiolex (cannabidiol) [CBD] oral solution	seizures associated with tuberous sclerosis complex in patients one year of age and older	approved by the FDA
Janssen Pharmaceuticals	Spravato (esketamine) CIII nasal spray, taken with an oral antidepressant	depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior	approved by the FDA for expanded indication
Life Spine	PLATEAU-A Ti Anterior Lumbar Spacer System	anterior column reconstruction	approved by the FDA
Morphosys Incyte	Monjuvi (tafasitamab-cxix) in combination with lenalidomide	relapsed or refractory diffuse large B-cell lymphoma	approved by the FDA
Medtronic	InterStim Micro neurostimulator and InterStim SureScan MRI leads	rechargeable device to deliver sacral neuromodulation (SNM) therapy for treating overactive bladder, fecal incontinence and nonobstructive urinary retention	approved by the FDA
Stryker	Neuroform Atlas Stent System	patients with aneurysms in the back of the brain	approved by the FDA