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Home » Pipeline

Pipeline

October 28, 2019
Company Drug/Device Medical Condition Status
Cyclo Therapeutics, Inc. Trappsol Cyclo Niemann-Pick Disease Type C (NPC) Phase 1 trial initiated enrolling 12 subjects with NPC age 18 years and older at UCSF Benioff Children’s Hospital in Oakland, CA
Adverum Biotechnologies, Inc. ADVM-022 wet age-related macular degeneration (wet AMD) Phase 1 trial initiated enrolling subjects with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment at eight sites across the U.S.
Cerevel Therapeutics CVL-231 schizophrenia Phase 1b trial initiated enrolling 100 subjects age 18 to 50
Axsome Therapeutics, Inc. AXS-12 narcolepsy Phase 2 trial initiated enrolling 20 subjects at multiple sites
ADC Therapeutics SA ADCT-301 (camidanlumab tesirine) relapsed or refractory Hodgkin lymphoma (HL) Phase 2 trial initiated enrolling 100 subjects at multiple sites
Aristea Therapeutics RIST4721 palmoplantar pustulosis (PPP) Phase 2a trial initiated
HighTide Therapeutics, Inc. HTD1801 nonalcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM) Phase 2a trial initiated enrolling 100 subjects with NASH and T2DM at 17 sites in the U.S.
MacroGenics, Inc. margetuximab HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer Phase 2/3 trial initiated enrolling subjects with HER2-positive and PD-L1-positive tumors at global sites
Myovant Sciences relugolix combination therapy endometriosis-associated pain Phase 3 trial initiated enrolling 600 female subjects ages 18 to 50 at sites in the U.S.
Urovant Sciences, Inc. Vibergron overactive bladder (OAB) Phase 3 (part 2) trial initiated enrolling 1,000 male subjects with OAB and benign prostatic hyperplasia (BPH)
Odontate Therapeutics, Inc. tesetaxel metastatic breast cancer Phase 3 trial initiated enrolling 600 subjects with HER2 negative, hormone receptor positive metastatic breast cancer
FibroGen, Inc. pamrevlumab unresectable locally advanced pancreatic cancer (LAPC) Phase 3 trial initiated enrolling 260 subjects
Canon Medical Systems USA, Inc. Advanced Intelligent Clear-IQ Engine (AiCE) image reconstruction 510 (k) clearance granted by the FDA
Garwood Medical Devices BioPrax knee replacement Breakthrough Device designation granted by the FDA
CorFlow Therapeutics AG CoFI (CorFlow Controlled Flow Infusion) System coronary microcirculation after standard stent implantation Breakthrough Device designation granted by the FDA
BerGenBio AS bemcentinib acute myeloid leukemia Fast track designation granted by the FDA
Heron Therapeutics, Inc. CINVANTI (aprepitant) injectable emulsion for intravenous (IV) prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly emetogenic cancer chemotherapy (HEC) and MEC sNDA approval granted by the FDA
Vertex Pharamceuticals Inc. Trikafta cystic fibrosis Approval granted by the FDA
Novartis Beovu (brolucizumab) wet age-related macular degeneration Approval granted by the FDA
AstraZeneca Farxiga (dapagliflozin) type 2 diabetes Approval granted by the FDA
Alexion Pharmaceuticals, Inc. ULTOMIRIS (ravulizumab-cwvz) atypical hemolytic uremic syndrome (aHUS) Approval granted by the FDA
Janssen Stelara (ustekinumab) moderately to severely active ulcerative colitis Approval granted by the FDA
Foamix Pharamceuticals, Ltd. AMZEEQ (minocycline) topical foam, 4% moderate to severe acne vulgaris Approval granted by the FDA
Eton Pharmaceuticals, Inc. Biorphen (phenylephrine) hypotension during anesthesia Approval granted by the FDA

 

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