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Home » Pipeline

Pipeline

November 23, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
RedHill Biopharma orally administered RHB-107 (upamostat) patients with symptomatic COVID-19 who do not require hospitalization IND approved by the FDA for phase 2/3 trial
Ampio Pharmaceuticals inhaled Ampion COVID-19 third cohort treated in phase 1 trial
Selva Therapeutics SLV213 treatment of COVID-19 first patients dosed in phase 1 trial
Revelation Biosciences REVTx 99 treatment and prevention of respiratory viral infection, including SARS CoV 2 infection dosing complete in first cohort of phase 1 trial
BioLineRx Motixafortide acute respiratory distress syndrome secondary to COVID-19 and other respiratory viral infections initiation of phase 1b trial
Nordic Nanovector Betalutin (177Lu lilotomab satetraxetan) in combination with rituximab i second-line follicular lymphoma final two patients enrolled into second safety cohort of phase 1trial
NorthSea Therapeutics SEFA-1024 hypertriglyceridemia first patient dosed in phase 1 trial
Biological E.

Dynavax

Baylor College of Medicine
COVID-19 subunit vaccine candidate COVID-19 vaccine initiation of phase 1/2 trial in India
Inovio INO-4800 COVID-19 vaccine initiation of phase 2 portion of phase 2/3 trial
RedHill Biopharma opaganib (Yeliva, ABC294640) patients hospitalized with severe COVID-19 pneumonia enrollment complete in phase 2 trial
BioNTech

Pfizer
BNT162b2 mRNA-based COVID-19 vaccine candidate completion of phase 3 trial
Tulip Medical autologous stem/stromal cells derived from fat restoration of respiratory function in adults with lung damage from COVID-19 initiation of clinical trial
Lucira Health Lucira COVID-19 All-In-One Test Kit COVID-19 rapid diagnostic test for self-testing at home Emergency Use Authorization granted by the FDA
Other Trials and Actions
ATAI Life Sciences Neuronasal N-acetylcysteine (NAC) acute mild traumatic brain injury IND approved by the FDA
Dicerna Pharmaceuticals

Eli Lilly
LY3561774 cardiometabolic disease IND approved by the FDA
Istari Oncology PVSRIPO immunotherapy treatment-refractory melanoma IND approved by the FDA
Jounce Therapeutics JTX-8064 solid tumors IND approved by the FDA
Nanobiotix NBTXR3 activated by radiation therapy patients with recurrent or metastatic head and neck squamous cell carcinoma with limited PD-L1 expression or refractory to PD-1 blockade IND approved by the FDA
Nanobiotix NBTXR3 activated by SBRT re-irradiation patients with inoperable, locoregional recurrent head and neck squamous cell carcinoma (HNSCC) or second primary HNSCC, previously treated with definitive radiation therapy and without radiographic evidence of metastases IND approved by the FDA
NeoImmuneTech NT-I7 (efineptakin alfa) and atezolizumab (Tecentriq) patients with previously untreated, PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer IND approved by the FDA
TISSIUM vascular sealant achieving hemostasis and preventing postoperative bleeding following peripheral vascular surgeries IDE approved by the FDA
AlzeCure Pharma ACD856 Alzheimer's disease approval from the regulatory authorities in Sweden to initiate a phase 1 study
EicOsis Human Health EC5026 moderate to severe pain phase 1a trial complete
BridgeBio

Navire Pharma
BBP-398 solid tumors driven by mutations in the MAPK signaling pathway first patient dosed in phase 1 trial
Nkarta NKX101 immunotherapy relapsed/refractory acute myeloid leukemia or higher-risk myelodysplastic syndromes first patient dosed in phase 1 trial
PTC Therapeutics PTC518 Huntington's disease initiation of phase 1 trial
Pionyr Immunotherapeutics PY314 solid tumors initiation of phase 1 trial
Precigen PRGN-3005 UltraCAR-T cells advanced ovarian cancer first patients dosed in the intraperitoneal arm of ongoing phase 1 trial
Precigen PRGN-3006 UltraCAR-T cells relapsed or refractory acute myeloid leukemia and higher risk myelodysplastic syndrome first patients dosed in phase 1/1b trial
CG Oncology CG0070 in combination with Opdivo (nivolumab) muscle-invasive bladder cancer in cisplatin-ineligible patients first patient treated in phase 1b trial
Kangpu Biopharmaceuticals KPG-818 systemic lupus erythematosus initiation of phase 1b/2a trial
KAHR

Roche
DSP107 solid tumors first patient dosed in phase 1/2 trial
Takeda Pharmaceuticals mezagitamab (TAK-079) generalized myasthenia gravis first patient dosed in phase 2 trial
Cerebral Therapeutics intracerebroventricular drug delivery of CT-010 medically refractory epilepsy first patient enrolled in phase 2b trial
Kodiak Sciences KSI-301 neovascular (wet) age-related macular degeneration enrollment complete in phase 2b/3 trial
AZTherapies ALZT-OP1 early stage Alzheimer’s disease completion of last patient/last visit in phase 3 trial
Corvia Medical Corvia Atrial Shunt (IASD) to reduce elevated left atrial pressures randomization complete in phase 3 trial
DeNovo Biopharma DB102 newly diagnosed high-risk diffuse large B-cell lymphoma patients with the biomarker DGM1 enrollment complete in phase 3 trial
Milestone Pharmaceuticals etripamil nasal spray paroxysmal supraventricular tachycardia first patient enrolled in phase 3 trial
Palladio Biosciences lixivaptan patients with autosomal dominant polycystic kidney disease who previously discontinued therapy with tolvaptan due to liver toxicity first patient dosed in phase 3 trial
SIFI polihexanide 0.08% acanthamoeba keratitis enrollment complete in phase 3 trial
TissueTech TTAX01 advanced nonhealing diabetic foot ulcers initiation of phase 3 trial
Sommetrics aerSleep II sleep apnea Breakthrough Device designation granted by the FDA
Kiniksa Pharmaceuticals vixarelimab pruritus associated with prurigo nodularis Breakthrough Therapy designation granted by the FDA
ViiV Healthcare cabotegravir HIV pre-exposure prophylaxis Breakthrough Therapy designation granted by the FDA
Agios Pharmaceuticals mitapivat sickle cell disease Orphan Drug designation granted by the FDA
Amylyx Pharmaceuticals AMX0035 Wolfram syndrome Orphan Drug designation granted by the FDA
Sanofi rilzabrutinib immune thrombocytopenia Fast Track designation granted by the FDA
Agilent Technologies PD-L1 IHC 22C3 pharmDx companion diagnostic to aid in identification of TNBC patients eligible for treatment with Keytruda approved by the FDA
Merck Keytruda (pembrolizumab) patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 approved by the FDA
SafKan Health OtoSet Ear Cleaning System removal of impacted earwax approved by the FDA
UCB Pharma Vimpat (lacosamide) CV adjunctive therapy for primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older approved by the FDA for expanded indication
UCB Pharma Vimpat injection intravenous use in children four years of age and older with PGTCS approved by the FDA for expanded indication

 

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