Home » Pipeline

Pipeline

July 13, 2020

Company	Drug/Device	Medical Condition	Status
COVID-19 Trials and Actions
Redhill Biopharma	opaganib	severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen	initiation of phase 2a trial
Celltex Therapeutics	Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)	COVID-19	initiation of phase 2 trial
DURECT Corp.	DUR-928	hospitalized COVID-19-infected patients with acute liver or kidney injury	initiation of phase 2 trial
EMD Serono/Merck	M5049	COVID-19 pneumonia	initiation of phase 2 trial
RevImmune	CYT107 immune therapy	COVID-19	initiation of phase 2 trial
Ridgeback Biotherapeutics	EIDD-2801	COVID-19	initiation of patient enrollment in phase 2 trial
Moderna	mRNA-1273 vaccine candidate	COVID-19	enrollment complete in phase 2 trial
Abivax SA	ABX464	COVID-19 elderly or high-risk patients	dosing of first patient in phase 2b/3 trial
Regeneron	REGN-COV2	hospitalized and nonhospitalized patients with COVID-19	initiation of phase 2/3 trial
Regeneron	REGN-COV2	uninfected people who have had close exposure to a COVID-19 patient	initiation of phase 3 trial
Golden Biotechnology	Antroquinonol (Hocena)	mild-to-moderate pneumonia in COVID-19 patients	IND approved by the FDA
Biophytis SA	Sarconeos (BIO101)	acute respiratory failure associated with COVID-19	IND approved by the FDA
Medicinova	MN-166 (ibudilast)	prevention of Acute Respiratory Distress Syndrome (ARDS) in patients with COVID-19	IND approved by the FDA
Babson Diagnostics	Babson Diagnostics aC19G1	detection of IgG antibodies to SARS-CoV-2	Emergency Use Authorization (EUA) granted by the FDA
Beckman Coulter	Access SARS-CoV-2 IgG assay	detection of IgG antibodies to SARS-CoV-2	EUA granted by the FDA
Centogene	SARS-CoV-2 RT-PCR test	detection of antibodies to SARS-CoV-2	EUA granted by the FDA
Kroger Health	COVID-19 Test Home Collection Kit	detection of antibodies to SARS-CoV-2	EUA granted by the FDA
Other Trials and Actions
Anavex Life Sciences	ANAVEX3-71 (AF710B)	neurodegenerative diseases	enrollment of first patient in phase 1 trial
Curis	CA-4948	patients with acute myeloid leukemia or high-risk myelodysplastic syndromes with spliceosome mutations	dosing of first patient in phase 1 trial
Ideaya Biosciences	IDE196 and binimetinib	metastatic uveal melanoma	dosing of first patient in phase 1 trial
Kadmon Holdings	KD033	metastatic or locally advanced solid tumors	dosing of first patient in phase 1 trial
PTC Therapeutics	PTC857	Parkinson's disease caused by a mutation in the GBA gene	dosing of first patient in phase 1 trial
TFF Pharmaceutical	tacrolimus inhalation powder	prophylactic treatment of lung transplant rejection	dosing of first patient in phase 1 trial
Transcenta Holding	TST001, a humanized Claudin18.2 (CLDN18.2) monoclonal antibody	advanced or metastatic solid tumors	dosing of first patient in phase 1 trial
Altimmune	NasoShield, single dose intranasal anthrax vaccine	anthrax	dosing of first patient in phase 1b trial
CohBar	CB4211	nonalcoholic steatohepatitis and obesity	reinitiation of patient enrollment in phase 1/2 study
NextCure	NC410	advanced or metastatic solid tumors	initiation of phase 1/2 trial
ZIOPHARM Oncology	Ad-RTS-hIL-12 with veledimex	pediatric brain tumors	dosing of first patient in phase 1/2 trial
Highlight Therapeutics	BO-112 with Keytruda	advanced stage solid tumors with liver metastases	dosing of first patient in phase 2a trial
Assembly Biosciences	ABI-H2158 with entecavir	treatment-naïve patients with HBeAg-positive chronic hepatitis B infection without cirrhosis	initiation of phase 2 trial
NovoCure	Tumor Treating Fields in combination with sorafenib	advanced liver cancer	enrollment complete in phase 2 trial
Outlook Therapeutics	ophthalmic formulation of bevacizumab	retinal diseases	enrollment complete in phase 2 trial
Palatin Technologies	PL9643	dry eye disease	reinitiation of patient enrollment in phase 2 study
Anavex Life Sciences	once-daily oral liquid ANAVEX2-73 (blarcamesine)	Rett syndrome	dosing of first patient in phase 2/3 trial
Galectin Therapeutics	belapectin (GR-MD-02)	NASH cirrhosis patients with clinical signs of portal hypertension with risk of developing esophageal varices	first patient enrolled in phase 2b/3 trial
Apellis Pharmaceutical	pegcetacoplan (APL-2)	treatment-naïve patients with paroxysmal nocturnal hemoglobinuria	enrollment complete in phase 3 trial
BrainStorm Cell Therapeutics	NurOwn (MSC-NTF cells)	amyotrophic lateral sclerosis	dosing complete in phase 3 trial
Corcept Therapeutics	relacorilant in combination with nab-paclitaxel	metastatic pancreatic cancer	enrollment of first patient in phase 3 trial
Abeona Therapeutics	EB-101	recessive dystrophic epidermolysis bullosa	reinitiation of patient enrollment in phase 3 trial
Exelixis	cabozantinib (Cabometyx) in combination with atezolizumab (Tecentriq)	patients with metastatic castration-resistant prostate cancer who have been previously treated with one novel hormonal therapy	initiation of phase 3 trial
IVERIC bio	Zimura (avacincaptad pegol)	geographic atrophy secondary to age-related macular degeneration	dosing of first patient in phase 3 trial
PolyPid	D-PLEX100	prevention of post-abdominal surgery incisional infection	enrollment of first patient in phase 3 trial
Aptose Biosciences	CG-806	acute myeloid leukemia	IND approved by the FDA
Rocket Pharmaceutical	RP-L401	infantile malignant osteopetrosis	IND approved by the FDA
Talaris Therapeutics	FCR001	diffuse systemic sclerosis	IND approved by the FDA
Nordic Nanovector	Betalutin (177Lu lilotomab satetraxetan)	adults with relapsed or refractory marginal zone lymphoma who have received at least two prior systemic therapies	Fast Track designation granted by the FDA
Neurogene	adeno-associated virus vector with engineered transgene encoding the human CLN5 gene	CLN5 Batten disease	Orphan Drug designation granted by the FDA
Oncternal Therapeutics	cirmtuzumab	mantle cell lymphoma chronic lymphocytic leukemia/small lymphocytic lymphoma	Orphan Drug designation granted by the FDA
Axsome Therapeutics	AXS-05	Alzheimer’s disease agitation	Breakthrough Therapy designation granted by the FDA
Concert Pharmaceutical	CTP-543	adults with moderate-to-severe alopecia areata	Breakthrough Therapy designation granted by the FDA
EspeRare	ER-004 protein replacement therapy	prenatal treatment of X-linked hypohidrotic ectodermal dysplasia	Breakthrough Therapy designation granted by the FDA
Rhythm Pharmaceutical	setmelanotide	pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity	Rare Pediatric Disease designation granted by the FDA
Senhwa Biosciences	silmitasertib	recurrent sonic hedgehog medulloblastoma	Rare Pediatric Disease designation granted by the FDA
Astex Pharmaceutical	Inqovi (decitabine and cedazuridine) tablets	myelodysplastic syndromes and chronic myelomonocytic leukemia	approved by the FDA
Boston Scientific	LUX-Dx Insertable Cardiac Monitor System	detection of arrhythmias	approved by the FDA
Chiasma	Mycapssa (octreotide) capsules	long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide	approved by the FDA
CoreLink	F3D-C2 Stand-alone Cervical System	anterior cervical discectomy and fusion procedures	approved by the FDA
Endo International	Qwo (collagenase clostridium histolyticum-aaes)	moderate to severe cellulite in the buttocks of adult women	approved by the FDA
Genentech	Phesgo (pertuzumab, trastuzumab and hyaluronidase–zzx)	metastatic and early stage HER2-positive breast cancer	approved by the FDA
Merck	Keytruda (pembrolizumab)	unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient colorectal cancer	approved by the FDA for additional indication
Merck Pfizer	Bavencio (avelumab)	locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy	approved by the FDA for additional indication
Osmotica Pharmaceutical	Upneeq (oxymetazoline hydrochloride ophthalmic solution)	acquired blepharoptosis	approved by the FDA
Ultragenyx Pharmaceutical	Dojolvi (UX007/triheptanoin)	patients with molecularly confirmed long-chain fatty acid oxidation disorders	approved by the FDA
ViiV Healthcare	Rukobia (fostemsavir) in combination with other antiretroviral (ARV) therapies	heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are failing their current ARV regimen due to resistance, intolerance or safety concerns	approved by the FDA
Zogenix	Fintepla (fenfluramine)	Dravat Syndrome	approved by the FDA