Pipeline

New Pipeline Updates from Triple-Gene LLC, Aptinyx Inc. and Celgene Corporation

November 18, 2019

Company Drug/Device Medical Condition Status
Triple-Gene LLC INXN-4001 heart failure Phase 1 trial initiated enrolling 12 stable subjects with implanted Left Ventricular Assist Device (LVAD)
Cerveau Technologies Inc. [F18]MK-6240 neurodegenerative diseases Phase 1 trial initiated enrolling healthy volunteers and subjects with Mild Cognitive Impairment (MCI) and with Alzheimer’s Disease (AD) at Kobe City Medical Center General Hospital in Japan

Aravive, Inc.

AstraZeneca

AVB-500 in combination with durvalumab platinum-resistant, recurrent epithelial ovarian cancer Phase 1/2 trial initiated
Turning Point Therapeutics, Inc. TPX-0046 advanced solid tumors Phase 1/2 trial initiated enrolling 350 TKI-treatment naïve and -pretreated subjects with RET-altered non-small-cell lung, thyroid and other advanced cancers
Dragonfly Therapeutics, Inc. DF1001 advanced solid tumors Phase 1/2 trial initiated enrolling subjects with locally advanced or metastatic solid tumors who express HER2
Turning Point Therapeutics, Inc. repotrectinib solid tumors Phase 1/2 trial initiated enrolling 75 pediatric patients with ALK-, NTRK- and ROS1-positive solid tumors

VBI Vaccines

Brii Biosciences

BRII-179 (VBI-2601) chronic hepatitis B virus (HBV) infection Phase 1b/2a trial initiated enrolling 65 subjects
xBiotech USA, Inc. bermekimab severe Atopic Dermatitis (AD) Phase 2 trial initiated

AVEO Oncology

Biodesix, Inc.

ficlatuzumab in combination with high-dose cytarabine relapsed and refractory acute myeloid leukemia (AML) Phase 2 trial initiated enrolling 60 adult subjects with AML who failed induction chemotherapy or who achieved a complete response, but relapsed within one year
Aptinyx Inc. NYX-2925 painful diabetic peripheral neuropathy (DPN) Phase 2 trial initiated enrolling 200 subjects with advanced DPN
Aptinyx Inc. NYX-2925 fibromyalgia Phase 2 trial initiated enrolling 300 subjects
Viracta Therapeutics, Inc. nanatinostat in combination with valganciclovir relapsed/refractory Epstein-Barr virus (EBV)-positive lymphoid malignancies Fast Track designation granted by the FDA
X4 Pharmaceuticals, Inc. mavorixafor (X4P-001) WHIM (Warts, Hypogammaglobulinemia, Infections and Myelokathexis) syndrome Breakthrough Therapy Designation granted by the FDA
Celgene Corporation Reblozyl (luspatercept–aamt) anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions Approval granted by the FDA

 

New Pipeline Updates from Amgen, Ichnos Sciences and GE Healthcare

November 11, 2019

Company Drug/Device Medical Condition Status
BioCryst Pharmaceuticals, Inc. BCX9250 fibrodysplasia ossificans progressive (FOP) Phase 1 trial initiated enrolling healthy subjects
Revolution Medicines, Inc.

Amgen

RMC-4630 in combination with AMG 510 advanced solid tumors Phase 1b trial initiated enrolling subjects with advanced solid tumors harboring the KRASG12C mutation
X4 Pharmaceuticals, Inc. X4P-001 Severe Congenital Neutropenia (SCN) Phase 1b trial initiated enrolling 45 subjects with SCN and other selected congenital neutropenia disorders
CohBar, Inc. CB4211 nonalcoholic steatohepatitis (NASH), NAFLD and obesity Phase 1b trial initiated enrolling 20 obese subjects with NAFLD
Cartesian Therapeutics Descartes-08 generalized myasthenia gravis (GMG) Phase 1/2 trial initiated
Ichnos Sciences ISC 27864 osteoarthritic pain Phase 2b trial initiated enrolling 624 adult subjects with moderate osteoarthritic pain of the knee and/or hip at sites in India.
Ichnos Sciences ISB 830 atopic dermatitis Phase 2b trial initiated enrolling 312 adult subjects with moderate to severe atopic dermatitis at sites in the U.S., Canada and Europe
RhoVac AB RV001 prostate cancer Phase 2b trial initiated enrolling 175 subjects at multiple centers in Denmark, Finland, Sweden, United Kingdom, Belgium, Germany and the U.S.
Biohaven Pharma Holding Company Ltd. troriluzole Alzheimer’s disease Phase 2/3 trial initiated enrolling subjects with mild to moderate Alzheimer’s disease
CymaBay Therapeutics, Inc. seladelpar Primary Biliary Cholangitis (PBC) Phase 3 trial initiated enrolling 240 subjects in over 20 countries
Revance Therapeutics, Inc. DaxibotulinumtoxinA for Injection (DAXI) isolated cervical dystonia (CD) Phase 3 trial initiated enrolling 301 subjects at 60 sites in the U.S., Canada and Europe
EpicentRX, Inc. RRx-001 small cell lung cancer Phase 3 trial initiated enrolling 126 subjects with third-line and beyond small cell lung cancer
Okami Medical Inc. LOBO Vascular Occlusion System occlusion of peripheral blood vessels 510(k) approval granted by the FDA
Autolus Therapeutics plc AUTO1 acute lymphoblastic leukemia (ALL) Orphan drug designation granted by the FDA
Sanofi Fluzone High-Dose Quadrivalent (Influenza Vaccine) prevention of influenza disease caused by influenza A and B strains contained in the vaccine in subjects 65 years of age and older sBLA approval granted by the FDA
RedHill Biopharma Ltd. Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg Helicobacter pylori (H. pylori) infection in adults Approval granted by the FDA
GE Healthcare Clariscan intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity Approval granted by the FDA
Crescita Therapeutics Inc. Pliaglis (enhanced formulation) superficial dermatological procedures Approval granted by the FDA
Sandoz Ziextenzo (pegfilgrastim) infection in cancer patients Approval granted by the FDA

 

New Pipeline Updates from XBiotech Inc., BeyondSpring Inc. and GlaxoSmithKline

November 4, 2019

Company Drug/Device Medical Condition Status
Mustang Bio, Inc. MB-108 (oncolytic virus C134) recurrent glioblastoma multiforme Phase 1 trial initiated enrolling 24 subjects at the University of Alabama at Birmingham
Replimune Group Inc. RP2 as a single agent and in combination with Opdivo (nivolumab) advanced solid tumors Phase 1 trial initiated
Linnaeus Therapeutics, Inc. LNS8801 advanced solid and hematologic cancers Phase 1/2 trial initiated
XBiotech Inc. bermekimab moderate to severe Hidradenitis Suppurativa (HS) Phase 2 trial initiated enrolling 150 subjects at multiple international sites
Arena Pharmaceuticals, Inc. etrasimod moderate-to-severe atopic dermatitis (AD) Phase 2 trial initiated enrolling 120 subjects at sites across the U.S., Canada and Australia
CytomX Therapeutics, Inc. CX-072 in combination with the anti-CTLA-4 antibody YERVOY (ipilimumab) relapsed or refractory melanoma Phase 2 trial initiated enrolling subjects with unresectable or metastatic melanoma whose disease has progressed or relapsed following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
SpringWorks Therapeutics, Inc. mirdametinib (formerly PD-0325901) neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (NF1-PN) Phase 2b trial initiated enrolling subjects two years of age and older with an inoperable NF1-associated PN causing significant morbidity
Zosano Pharma Corporation C213 cluster headache Phase 2/3 trial initiated enrolling 120 subjects
BeyondSpring Inc. Plinabulin prevention of chemotherapy-induced neutropenia (CIN) Phase 3 trial initiated enrolling subjects receiving TAC (taxotere, doxorubicin and cyclophosphamide) chemotherapy plus Neulasta vs. TAC plus Plinabulin and Neulasta
Talaris Therapeutics, Inc. FCR001 living donor kidney transplant (LDKT) Phase 3 trial initiated enrolling 120 adult LDKT recipients at multiple sites across the U.S.
Rafael Pharmaceuticals, Inc. CPI-613 (devimistat) metastatic pancreatic cancer Phase 3 trial initiated enrolling subjects at four sites in South Korea
AVROBIO, Inc. AVR-RD-02 Gaucher disease Orphan Drug designation granted by the FDA
Mirum Pharmaceuticals, Inc. maralixibat pruritus associated with Alagille syndrome (ALGS) in subjects one year of age and older Breakthrough Therapy designation granted by the FDA
SurModics, Inc. Sundance sirolimus-coated balloon (SCB) catheter below-the-knee (BTK) arterial lesions in subjects suffering from critical limb ischemia (CLI) and infrapopliteal arterial disease Breakthrough Device designation granted by the FDA
Allergan plc BOTOX (onabotulinumtoxinA) lower limb spasticity, excluding spasticity caused by cerebral palsy (CP) in pediatric subjects two to 17 years of age sBLA approval granted by the FDA
SunGen Pharmaceuticals Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g) production of anesthesia of accessible mucous membranes of the oropharynx, an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites ANDA approval granted by the FDA
GlaxoSmithKline Zejula (niraparib) advanced ovarian, fallopian tube or primary peritoneal cancer Approval granted by the FDA
Melinta Therapeutics BAXDELA (delafloxacin) adult subjects with community-acquired bacterial pneumonia (CABP) Approval granted by the FDA

Biogen Inc.

Alkermes plc

VUMERITY (diroximel fumarate) relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease Approval granted by the FDA

 

New Pipeline Updates from Aristea Therapeutics, Novartis and Janssen

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

 

New Pipeline Updates from NeuClone, Diamyd Medical and SurgiMab

October 21, 2019

Company Drug/Device Medical Condition Status
NeuClone NeuLara plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis Phase 1 trial initiated enrolling 200 healthy subjects
Alder BioPharmaceuticals, Inc. ALD1910 Migraine Phase 1 trial initiated enrolling 100 healthy subjects between the ages of 18 and 55
Amphivena Therapeutics, Inc. AMV564 Tumors Phase 1 trial initiated enrolling subjects in San Antonio, TX, MD Anderson Cancer Center and Peninsula Cancer Institute in Newport News, VA
Nektar Therapeutics NKTR-255 relapsed or refractory non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) Phase 1 trial initiated enrolling 40 subjects
DiaMedica Therapeutics Inc. DM199 Chronic kidney disease Phase 2 trial initiated enrolling 60 African American subjects with CKD caused by IgA nephropathy (IgAN) and hypertensive with CKD at 10 sites in the U.S.
PhaseBio Pharmaceuticals PB2452 with low-dose aspirin blood thinning Phase 2b trial initiated enrolling 200 elderly subjects aged 50-80
Diamyd Medical Diamyd Latent Autoimmune Diabetes in Adults (LADA) Phase 2 trial initiated enrolling 15 subjects newly diagnosed with LADA not yet on insulin therapy at the Norwegian University of Science and Technology in Trondheim
Can-Fite BioPharma Ltd. Namodenoson Nonalcoholic steatohepatitis (NASH)/nonalcoholic fatty liver disease (NAFLD) Phase 2 trial initiated enrolling 60 subjects with NAFLD with or without NASH
Denovo Bipharma LLC DB102 glioblastoma (GBM) in combination with radiation and temozolomide Phase 2b trial initiated enrolling 200 patients with newly-diagnosed GBM
Boehringer Ingelheim BI 1265162 cystic fibrosis Phase 2 trial initiated enrolling subjects with relapsed or refractory lymphoma at sites in the U.S. and Europe
Hope Biosciences HB-adMSCs Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy Phase 1/2 trial initiated enrolling 24 subjects
Imbrium Therapeutics IMB-115 insomnia associated with alcohol cessation (IAAC) Phase 2 trial initiated enrolling adults with moderate or severe alcohol use disorder (AUD) experiencing IAAC
Diffusion Pharmaceuticals TSC stroke Phase 2 trial initiated enrolling 160 subjects at 23 hospitals in the Virginia and Los Angeles County
Amygdala Neurosciences ANS-6637 alcohol use disorder AUD) Phase 2 trial initiated enrolling 81 treatment seeking subjects with at least moderate alcohol use disorder at three sites
Novavax Inc. NanoFlu Influenza Phase 3 trial initiated enrolling 2,650 adult subjects aged 65 and over at 19 sites in the U.S.
Axsome Therapeutics, Inc. AXS-05 major depressive disorder (MDD) Phase 3 trial initiated enrolling 300 subjects with moderate to severe MDD
SurgiMab SGM-101 colorectal cancer Phase 3 trial initiated enrolling 300 subjects with colorectal cancer in ten clinical centers in Europe and the U.S.
AstraZeneca DS-8201 breast cancer Priority review granted by the FDA
Akorn, Inc. betamethasone dipropionate lotion USP (augmented) inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses ANDA approval granted by the FDA
Subtle Medical SubtleMR image processing to improve medical imaging 510 (k) clearance granted by the FDA
Cleveland Diagnostics, Inc. IsoPSA prostate cancer diagnostic test Breakthrough device designation granted by the FDA
Genentech, Inc. Xofluza influenza complications Approval granted by the FDA
Noven Pharmaceuticals, Inc. SECUADO transdermal drug delivery system schizophrenia Approval granted by the FDA
Janssen Pharmaceuticals XARELTO (rivaroxaban) blood clots Approval granted by the FDA
Eli Lilly Reyvow migraines Approval granted by the FDA

 

New Pipeline Updates from Debiopharm, Oncologie and Clinuvel

October 14, 2019

Company Drug/Device Medical Condition Status
Yumanity Therapeutics YTX-7739 Parkinson’s disease Phase 1 trial initiated enrolling 40 healthy subjects
Medivir AB birinapant and radiation therapy Head and Neck Squamous Cell Carcinoma (HNSCC) Phase 1 trial initiated enrolling subjects with recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)
Debiopharm Debio 1143, with Keytruda (pembrolizumab) Pancreatic and colorectal cancer Phase 1 trial initiated enrolling 46 subjects without other available therapeutic options
City of Hope chimeric antigen receptor (CAR) T cells in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) glioblastoma Phase 1 trial initiated
Hutchinson China MediTech Limited HMPL-523 relapsed or refractory lymphoma Phase 1/1b trial initiated doising subjects with relapsed or refractory lymphoma at sites in the U.S. and Europe
Nektar Therapeutics NKTR-358 (LY3471851) psoriasis Phase 1b trial initiated enrolling 40 subjects with plaque psoriasis
Nektar Therapeutics NKTR-358 (LY3471851) atopic dermatitis Phase 1b trial initiated enrolling 40 subjects with atopic dermatitis
DURECT Corporation DUR-928 non-alcoholic steatohepatitis (NASH) Phase 1b trial initiated enrolling 60 subjects with non-alcoholic steatohepatitis (NASH) with stage 1-3 fibrosis at multiple centers in the U.S.
AVROBIO, Inc. investigational gene therapy cystinosis Phase 1/2 trial initiated four adult subjects and a potential follow-on cohort of two adults or adolescents at least 14 years of age who are currently being treated with cysteamine at UC San Diego
IDEAYA Biosciences, Inc. cutaneous melanoma harboring a GNAQ or GNA11 (GNAQ/11) mutation solid tumors Phase 1/2 trial initiated
Minoryx Therapeutics MIN-102 Friedreich’s Ataxia Phase 2 trial initiated enrolling 39 subjects ages 12-60 with Friedreich’s Ataxia in four European countries
Oncologie bavituximab in combination with KEYTRUDA (pembrolizumab) gastroesophageal cancer Phase 2 trial initiated enrolling 80 subjects with advanced gastric or gastroesophageal cancer in the U.S., UK, South Korea and Taiwan
Frequency Therapeutics FX-322 Sensorineural Hearing Loss (SNHL) Phase 2a trial initiated enrolling 96 adult subjects ages 18 to 65 with stable SNHL at 12 sites in the U.S.
DURECT Corporation topical DUR-928 mild to moderate plaque psoriasis Phase 2a trial enrolling 20 subjects in the U.S.
Graybug Vision, Inc. GB-102 wet age-related macular degeneration (AMD) Phase 2b trial initiated enrolling 160 subjects with wet AMD at more than 100 sites in the U.S.
iLiAD Biotechnologies, LLC BPZE1 pertussis Phase 2b trial initiated enrolling 300 healthy subjects
Dermira, Inc. lebrikizumab moderate to severe atopic dermatitis Phase 3 trial initiated enrolling 800 adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis at 200 sites in the U.S., Europe and Asia
Galderma nemolizumab moderate to severe atopic dermatitis Phase 3 trial initiated
Seattle Genetics, Inc. tucatinib in combination with ado-trastuzumab emtansine (T-DM1, Kadcyla) breast cancer Phase 3 trial initiated enrolling up to 460 subjects with unresectable locally-advanced or metastatic HER2+ breast cancer
Beckman Coulter, Inc. DxA 5000 pre-analytical sample quality detection 510 (k) clearance granted by the FDA
Frequency Therapeutics FX-322 sensorineural hearing loss (SNHL) Fast Track designation granted by the FDA
Novartis Beovu (brolucizumab-dbll) wet age-related macular degeneration (AMD) Approval granted by the FDA
Clinuvel Scenesse (afamelanotide) erythropoietic protoporphyria (EPP) Approval granted by the FDA
Gilead Descovy HIV pre-exposure prophylaxis Approval granted by the FDA
AstraZeneca FASENRA pen (benralizumab) severe eosinophilic asthma Approval granted by the FDA
Galderma AKLIEF (trifarotene) Cream acne Approval granted by the FDA
Octapharma USA WILATE hemophilia A Approval granted by the FDA

 

New Pipeline Updates from Oncternal, Adrenomed and AbbVie

October 7, 2019

Company Drug/Device Medical Condition Status
Themis Bioscience and ZIKAVAX Second-generation Zika vaccine Zika virus Phase 1 study initiated enrolling 48 healthy subjects
Noveome Biotherapeutics, Inc. ST266 intraocular hypertension Phase 1 trial initiated enrolling subjects at the University of Pennsylvania who have been diagnosed with intraocular hypertension who have not yet developed optic nerve damage
Clover Biopharmaceuticals SCB-313 malignant ascites Phase 1 trial initiated enrolling subjects in China
Oncternal Cirmtuzumab in combination with Ibrutinib Mantel cell lymphoma (MCL) Phase 1b expansion cohort trial initiated to confirm the RDR
AVEO Oncology AstraZeneca Tivozanib (FOTIVDA) and Durvalumab (IMFINZI) hepatocellular carcinoma (HCC) Phase 1b/2 trial initiated enrolling 50 subjects with hepatocellular carcinoma (HCC) who have not received prior systemic therapy
Checkmate Pharmaceuticals Inc. CMP-001 in combination with BAVENCIO (avelumab), utomilumab (4-1BB agonist) and PF-04518600 (OX40 agonist) Squamous Cell Carcinoma of the Head and Neck (SCCHN) Phase 1b/2 trial initiated enrolling 60 subjects with Squamous Cell Cancer of the Head and Neck (SCCHN)
Adrenomed Adrecizumab septic shock Phase 2 trial initiated enrolling 300 subjects with early septic shock and elevated blood levels of Adrenomedullin
Oncopeptides AB melflufen with dexamethasone relapsed/refractory multiple myeloma (RRMM) Phase 2 trial initiated enrolling 150 subjects
North Sea Therapeutics Icosabutate NASH (Non-alcoholic Steatohepatitis) Phase 2b trial initiated enrolling 264 subjects
Immutep eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA(R) (or pembrolizumab, an anti-PD-1 therapy) Non-small cell lung cancer (NSCLC) Phase 2 expansion cohort trial initiated enrolling 19 subjects with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line in 13 study centers across the U.S., Europe and Australia
Cortexyme COR388 Alzheimer’s Disease Phase 2/3 trial initiated enrolling 570 subjects in U.S. and Europe
Incyte ruxolitinib cream vitiligo Phase 3 trial initiated enrolling 300 adolescent and adult subjects ages 12 and older who have been diagnosed with non-segmental vitiligo
Galmed Pharmaceuticals Ltd. SCD1 modulator Aramchol nonalcoholic steatohepatitis (“NASH”) and fibrosis Phase 3/4 trial initiated enrolling 2,000 subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes at 185 sites in the U.S., Europe, Latin America and Asia.
Luminex Corporation ARIES MRSA Assay methicillin-resistant Staphylococcus aureus (MRSA) 510 (k) clearance granted by the FDA
Exogenesis Corporation Exogenesis Hernia Mesh soft tissue repair, abdominal wall hernias and abdominal wall deficiencies 510 (k) clearance granted by the FDA
(LAS) Laser Associated Sciences FlowMet-R peripheral artery disease (PAD) 510 (k) clearance granted by the FDA
Janssen Pharmaceuticals INVOKANA (canagliflozin) Heart failure in patients with type 2 diabetes (T2D) and DKD Approval granted by the FDA
Janssen Pharmaceuticals Darzalex multiple myeloma Approval granted by the FDA
AbbVie MAVYRET (glecaprevir/pibrentasvir) naïve chronic hepatitis C (HCV) with
cirrhosis or with compensated cirrhosis
Approval granted by the FDA
Genentech Rituxan (rituximab) injection granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones) Approval granted by the FDA

 

New Pipeline Updates from Neuralstem Inc., Annexon Biosciences and Abiomed

September 30, 2019

Company Drug/Device Medical Condition Status
BioLineRx Ltd. AGI-134 solid tumors Phase 1/2a trial initiated enrolling subjects at 15 sites in the U.S., U.K. and Israel
Neuralstem Inc. NSI-566 chronic ischemic stroke Phase 2 trial initiated enrolling 22 subjects with sustained chronic motor deficits due to an ischemic stroke
Oragenics, Inc. AG013 severe oral mucositis Phase 2 trial initiated enrolling 200 subjects at 59 sites in the U.S. and Europe
ImaginAB, Inc. 89Zr-Df-IAB22M2C cancer Phase 2 trial initiated enrolling subjects with advanced and metastatic cancer at the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham
Oncopeptides AB melflufen in combination with dexamethasone relapsed/refractory multiple myeloma (RRMM) Phase 2 trial initiated enrolling 150 subjects
Rigel Pharmaceuticals, Inc.
Kissei Pharmaceuticals Co., Ltd.
fostamatinib disodium hexahydrate chronic immune thrombocytopenia (ITP) Phase 3 study initiated enrolling adult subjects with ITP
Protalix BioTherapeutics, Inc.
Chiesi Farmaceutici S.p.A.
PRX 102 (pegunigalsidase alfa) Fabry disease with impaired renal function Phase 3 trial initiated enrolling subjects previously treated with an enzyme replacement therapy: agalsidase alfa or agalsidase beta
Ocular Therapeutix, Inc. DEXTENZA allergic conjunctivitis (AC) Phase 3 trial initiated enrolling 80 subjects
Annexon Biosciences ANX005 Guillain-Barré Syndrome (GBS) Fast Track approval granted by the FDA
Merck & Company PIFELTRO (in combination with other antiretroviral agents) HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Merck & Company DELSTRIGO HIV-1 in adult subjects who are virologically suppressed sNDA approval granted by the FDA
Abiomed Impella 5.5 with SmartAssist minimally invasive forward flow heart pump residual myocardial function PMA approval granted by the FDA
Novo Nordisk Rybelsus (semaglutide) oral tablets type 2 diabetes Approval granted by the FDA
Exact Sciences Corp. Cologuard noninvasive colorectal cancer screening test for subjects ages 45 and older Approval granted by the FDA
Bavarian Nordic A/S Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating smallpox and monkeypox disease in adults 18 years of age and older Approval granted by the FDA

 

New Pipeline Updates from Immunic, Pulmatrix and Janssen

September 23, 2019

Company Drug/Device Medical Condition Status
Clover Biopharmaceuticals, Inc. SCB-313 peritoneal carcinomatosis Phase 1 trial initiated enrolling subjects in China
Immunic IMU-935 various inflammatory and autoimmune diseases Phase 1 trial initiated
Benitec Biopharma BB-301 Oculopharyngeal Muscular Dystrophy (OPMD) Phase 1 trial initiated
Transgene TG4050 HPV negative, squamous cell carcinoma of the head and neck (SCCHN) Phase 1 trial initiated enrolling subjects that have received an adjuvant (first line) therapy in the UK and France
Transgene TG4050 ovarian cancer Phase 1 trials initiated enrolling subjects after first-line surgery and chemotherapy in France and the U.S.
Poxel SA PXL065 Non-alcoholic steatohepatitis (NASH) Phase 1b trial initiated enrolling 30 healthy subjects
Applied Molecular Transport AMT-101 Ulcerative Colitis Phase 1b trial initiated enrolling 20 adult subjects in Europe
NOXXON NOX-A12 in combination with radiotherapy Brain cancer Phase 1/2 trial recruiting newly diagnosed patients with brain tumors who would not benefit from the current standard of care of chemoradiotherapy and whose tumors cannot be fully resected by surgery in Germany
REVOLUTION Medicines RMC-4630 in combination with cobimetinib (Cotellic) relapsed/refractory solid tumors harboring specific genomic mutations Phase 1b/2 trial initiated
Momotaro-Gene MTG201 in combination with PD-1 inhibitor nivolumab (Opdivo) relapsed malignant pleural mesothelioma Phase 2 trial initiated enrolling 12 subjects with malignant mesothelioma who have failed front-line systemic platin-based chemotherapy at Baylor College of Medicine in Houston, Texas
Pulmatrix Pulmazole Allergic Bronchopulmonary Aspergillosis (ABPA) Phase 2 trial initiated enrolling 64 subjects with asthma
Graybug Vision, Inc. GB-102 macular edema (ME) secondary to Diabetic Macular Edema (DME) or Retinal Vein Occlusion (RVO) Phase 2a trial initiated enrolling 20 subjects at six centers in the U.S.
Alnylam Pharmaceuticals, Inc. patisiran transthyretin amyloidosis (ATTR amyloidosis) with cardiomyopathy Phase 3 study initiated enrolling 300 adult subjects with ATTR amyloidosis (hereditary or wild type) with cardiomyopathy
Apollo Endosurgery, Inc. Polypropylene Suture-Anchor Assembly pass and anchor suture in the gastrointestinal tract 510(k) Clearance granted by the FDA
Janssen Erleada metastatic castration-sensitive prostate cancer (mCSPC) Supplemental New Drug Application granted by the FDA

Merck

Eisai

Keytruda in combination with Lenvima advanced endometrial carcinoma Approval granted by the FDA
Xeris Pharmaceuticals GVOKE (glucagon) injection severe hypoglycemia Approval granted by the FDA

 

New Pipeline Updates from Selvita, Alector, Inc. and Netech

September 16, 2019

Company Drug/Device Medical Condition Status
Selvita SEL120 acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) Phase 1b trial initiated enrolling subjects at sites across the U.S.
VBI Vaccines Inc. VBI-1901 in combination with GlaxoSmithKline’s proprietary AS01B adjuvant system recurrent glioblastoma (GBM) Phase 2a trial initiated enrolling 20 subjects with first-recurrent GBM only
Recardio, Inc. dutogliptin in combination with filgrastim post-myocardial infarction Phase 2 trial initiated enrolling 140 subjects at specialized cardiology centers located throughout Europe and the U.S.
Alector, Inc. AL001 frontotemporal dementia (FTD) with specific genetic mutations, including the granulin gene (FTD-GRN) Phase 2 trial initiated enrolling 32 subjects with FTD-GRN and an additional cohort of FTD subjects with a C9orf72 mutation (FTD-C9orf72)
Biohaven Pharma Holding Company Ltd. vazegepant acute treatment of migraine Phase 2/3 trial initiated
Lipidor AB Calcipotriol/AKVANO 50 µg/g cutaneous solution (AKP01) mild to moderate psoriasis Phase 3 study initiated enrolling 277 subjects at 14 clinics across India
Functional Neuromodulation fornix (DBS-f) mild Alzheimer's Disease Phase 3 study initiated enrolling 210 people 65 years or older with mild Alzheimer's disease at 14 study sites in the U.S., Canada and Germany
EMD Serono evobrutinib relapsing multiple sclerosis (RMS) Two phase 3 studies initiated enrolling 1,900 adult subjects
Nevakar Inc. NVK-002 slow the progression of myopia in children Phase 3 study initiated enrolling 576 child subjects aged 3 to 17 years in Asia, the U.S. and Europe
Netech Delta 3300 arrhythmia 510(k) approval granted by the FDA
Merck KGaA tepotinib metastatic non-small cell lung cancer (NSCLC) Breakthrough Therapy Designation granted by the FDA
Horizon Therapeutics plc teprotumumab active thyroid eye disease (TED) Priority Review granted by the FDA
Almirall LLC Aczone 7.5% topical gel acne vulgaris Approval granted by the FDA
Jenkins Eye Care AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) cataract Approval granted by the FDA
Axonics Modulation Technologies, Inc. implantable rechargeable sacral neuromodulation (“SNM”) device urinary and bowel dysfunction Approval granted by the FDA
Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) capsules interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD) Approval granted by the FDA