Pipeline

New Pipeline Updates from Genentech, Alvotech and Sonavex

March 18, 2019

Company Drug/Device Medical Condition Status
Rocket Pharmaceuticals, Inc. RP-L102 Fanconi Anemia (FA) Phase I trial initiated enrolling 2 FA pediatric subjects
Infinity Pharmaceuticals, Inc. IPI-549 triple negative breast cancer (TNBC) and renal cell cancer (RCC) Phase II trial initiated
Theravance Biopharma, Inc. TD-1473 moderately to severely active ulcerative colitis Phase IIb/III trial initiated
Biohaven Pharmaceutical Holding Company Ltd. troriluzole Spinocerebellar Ataxia (SCA) Phase III trial initiated enrolling 230 subjects at approximately 22 sites in the U.S.
Alvotech AVT02 moderate to severe chronic plaque psoriasis Phase III trial initiated enrolling 400 subjects at approximately 30 sites in Europe
Helsinn Group anamorelin advanced NSCLC with cachexia Phase III trial initiated
Santhera Pharmaceuticals AG Raxone Leber’s hereditary optic neuropathy (LHON) Phase IV trial initiated enrolling 197 subjects in 31 sites across nine European countries and the U.S.
Nvision Biomedical Technologies Vector Hammertoe Correction System foot and ankle procedures 510(k) clearance granted by the FDA
Sonavex, Inc. EchoSure blood flow monitoring 510(k) clearance granted by the FDA
Instrumentation Laboratory GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management (iQM) rapid basic metabolic panel (BMP) testing at the point of care for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress and arrhythmias 510(k) clearance granted by the FDA
Purdue Pharma L.P. nalmefene hydrochloride (HCl) injection emergency treatment of known or suspected opioid overdose Fast Track designation granted by the FDA
Alkem Laboratories Limited Valsartan (generic Diovan) high blood pressure and heart failure Approval granted by the FDA
Aerie Pharmaceuticals, Inc. Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% open-angle glaucoma or ocular hypertension Approval granted by the FDA
Genentech Tecentriq (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albuminbound); nab-paclitaxel]) unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test Approval granted by the FDA
Pfizer, Inc. TRAZIMERA (trastuzumab-qyyp) human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma Approval granted by the FDA

 

New Pipeline Updates from Forbius, Inovio and Janssen

March 11, 2019

Company Drug/Device Medical Condition Status
AOBiome Therapeutics, Inc. B244 pediatric patients with atopic dermatitis (eczema) Phase Ib trial initiated enrolling 36 subjects aged 2 to 17 years
Forbius AVID200 diffuse cutaneous systemic sclerosis (SSc) Phase Ib trial initiated
I-Mab Biopharma TJ107 (HyLeukin) advanced solid tumors Phase Ib/IIa trial initiated enrolling 58 subjects in China
Odonate Therapeutics, Inc. tesetaxel locally advanced or metastatic breast cancer (LA/MBC) Phase II trial initiated enrolling 125 subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive disease who have not previously received a taxane
Eidos Therapeutics, Inc. AG10 transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) Phase III trial initiated enrolling 510 subjects with symptomatic ATTR-CM, associated with either wild-type or mutant TTR, with New York Heart Association Class I-III symptoms
Inovio VGX-3100 cervical dysplasia caused by human papillomavirus (HPV) Phase III trial initiated enrolling adult female subjects with HPV 16/18 positive biopsy-proven cervical HSIL, otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3
Acceleron Pharma, Inc. ACE-083 Charcot-Marie-Tooth disease (CMT) Orphan Drug designation granted by the FDA
Mitochon Pharmaceuticals MP-101 Huntington’s Disease Orphan Drug designation granted by the FDA
Celgene Corporation fedratinib myelofibrosis Priority Review granted by the FDA
NKMax America SNK01 refractory cancer IND approval granted by the FDA
Breckenridge Pharmaceutical, Inc. Imatinib Mesylate Tablets cancer ANDA approval granted by the FDA
Janssen Spravato major depressive disorder Approval granted by the FDA
Baxter International, Inc. eptifibatide acute coronary syndrome (ACS) Approval granted by the FDA
Adlon Therapeutics, L.P.m Adhansia XR (methylpheni-date hydrochloride) extended-release capsules CII Attention-Deficit/Hyperactivity Disorder (ADHD) Approval granted by the FDA

 

New Pipeline Updates from Agfa, Eisai and Axilum Robotics

March 4, 2019

Company Drug/Device Medical Condition Status
Phoenix Tissue Repair, Inc. PTR-01 recessive DEB (RDEB) Phase I/II trial initiated enrolling 14 subjects
Immunic AG IMU-838 relapsing-remitting multiple sclerosis (RRMS) Phase II trial initiated enrolling 200 subjects in more than 40 centers across four European countries
Debiopharm International SA afabicin (Debio 1450) staphylococcal bone and joint infections (NCT03723551) Phase II trial initiated enrolling 60 subjects with bone or joint infection (BJI)
Mycovia Pharmaceuticals VT-1161 recurrent vulvovaginal candidiasis (RVVC) Phase III trial initiated enrolling 180 subjects in 45 sites in the U.S.
Axilum Robotics TMS-Cobot TS MV Transcranial Magnetic Stimulation (TMS) for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode 510(k) clearance granted by the FDA
Agfa DR 800 multipurpose imaging system with tomosynthesis radiography, fluoroscopy, tomography and advanced clinical applications 510(k) clearance granted by the FDA
Imbrium Therapeutics L.P. and Mundipharma EDO GmbH etoposide toniribate relapsed refractory biliary tract cancer Orphan Drug designation granted by the FDA
Heron Therapeutics, Inc. CINVANTI (aprepitant) injectable emulsion intravenous (IV) use sNDA approval granted by the FDA
Eisai, Inc. labeling update for BELVIQ (lorcaserin HCl) obesity sNDA approval granted by the FDA
Alkermes plc and Biogen, Inc. diroximel fumarate (BIIB098) Multiple Sclerosis (MS) NDA approval granted by the FDA
Taiho Oncology LONSURF (trifluridine/tipiracil) adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy Approval granted by the FDA
Spirosure, Inc. Fenom Pro asthma Clearance granted by the FDA
Bausch + Lomb LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% postoperative inflammation and pain following ocular surgery Approval granted by the FDA
BIOTRONIK Orsiro drug-eluting stent (DES) system coronary artery disease Approval granted by the FDA

 

New Pipeline Updates from Genentech, Medtronic and Biohaven Pharmaceutical

February 25, 2019

Company Drug/Device Medical Condition Status
Ocular Therapeutix, Inc. OTX-TKI (tyrosine kinase inhibitor implant) wet Age-related Macular Degeneration (AMD) Phase I trial initiated
Inhibrx, Inc. INBRX-105 PD-L1 expressing tumors Phase I trial initiated
Fusion Pharmaceuticals [225Ac]-FPI-1434 advanced solid tumors Phase I trial initiated enrolling up to 30 subjects
Five Prime Therapeutics, Inc. FPA150 (FPA150-001; NCT03514121) breast, ovarian and endometrial cancers that over-express B7-H4 Phase Ib trial initiated
Advaxis, Inc. ADXS-503 non-small cell lung cancer (NSCLC) Phase I/II trial initiated enrolling 50 subjects at up to 20 sites in the U.S.
Lipocine, Inc. LPCN 1144 non-alcoholic steatohepatitis (“NASH”) with biopsy Phase II trial initiated enrolling male hypogonadal biopsy-confirmed NASH subjects with grade F2/F3 fibrosis
Debiopharm International SA Debio 1347 solid tumors harboring an FGFR fusion (NCT03834220) Phase II trial initiated enrolling subjects with advanced or metastatic tumors whose cells show specific FGFR gene alterations, namely FGFR1, FGFR2 or FGFR3 gene fusions
Novus Therapeutics, Inc. OP0201 otitis media Phase IIa trial initiated enrolling 50 pediatric patients, 6 to 24 months of age, with acute otitis media
Biohaven Pharmaceutical Holding Company Ltd. troriluzole generalized anxiety disorder (GAD) Phase III trial initiated enrolling 372 subjects in 50 sites in the U.S.
Biohaven Pharmaceutical Holding Company Ltd. verdiperstat (previously BHV-3241) multiple system atrophy (MSA) Orphan Drug designation granted by the FDA
Ocugen, Inc. OCU400 NR2E3 mutation-associated retinal degenerative disease Orphan Drug designation granted by the FDA
Modis Therapeutics MT1621 thymidine kinase 2 deficiency (TK2d) Breakthrough Therapy designation granted by the FDA
Medtronic plc Personalized Closed Loop (PCL) insulin pump system diabetes Breakthrough Device designation granted by the FDA
Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test Alzheimer’s Disease Breakthrough Device designation granted by the FDA
ARS Pharmaceuticals, Inc. ARS-1 severe allergic reactions that could lead to anaphylaxis Fast Track designation granted by the FDA
Foldax, Inc. Tria surgical aortic heart valve aortic valve disease IDE approval granted by the FDA
Genentech polatuzumab vedotin in combination with bendamustine plus Rituxan (rituximab) (BR) relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Priority Review granted by the FDA
Genentech entrectinib adult and pediatric subjects with neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors who have either progressed following prior therapies or as initial therapy when there are no acceptable standard therapies, and for the treatment of subjects with metastatic, ROS1-positive non-small cell lung cancer (NSCLC) Priority Review granted by the FDA
Novo Nordisk Esperoct (turoctocog alfa pegol) formerly known as N8-GP hemophilia A BLA approval granted by the FDA
Merck KEYTRUDA (pembrolizumab) adjuvant treatment of subjects with melanoma with involvement of lymph node(s) following complete resection BLA approval granted by the FDA
Xellia Pharmaceuticals Premixed Vancomycin Injection in a Ready-to-Use (RTU) bag septicaemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in adult and pediatric subjects (one month and older) NDA approval granted by the FDA
Nexus Pharmaceuticals, Inc. Prochlorperazine Edisylate Injection, USP schizophrenia and severe nausea and vomiting Approval granted by the FDA

 

New Pipeline Updates from RDD Pharma, Pulmatrix and IntraBio

February 18, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-402 (loncastuximab tesirine) plus AstraZeneca’s IMFINZI (durvalumab) advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL) Phase I trial initiated enrolling 75 subjects
Exelixis, Inc. XL092 cancer Phase I trial initiated
ReGenTree, LLC and Ora, Inc. RGN-259 dry eye syndrome Phase III trial initiated enrolling 700 subjects
LASEROPTEK Co., Ltd. PicoLO picosecond Nd:YAG laser dermatology and general and plastic surgery 510(k) clearance granted by the FDA
Grifols, S.A. Procleix Babesia assay blood screening 510(k) clearance granted by the FDA
Finch Therapeutics Group, Inc. CP101 recurrent Clostridium difficile (C. difficile) infection Breakthrough Therapy designation granted by the FDA
RDD Pharma, Inc. RDD-0315 fecal incontinence in spinal cord injury Fast Track designation granted by the FDA
Neurotech Pharmaceuticals, Inc. NT-501 (Renexus) macular telangiectasia type 2 (MacTel) Fast Track designation granted by the FDA
IntraBio, Inc. IB1001 GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) IND approval granted by the FDA
Pulmatrix, Inc. Pulmazole (PUR1900) allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma IND approval granted by the FDA
Precigen, Inc. PRGN-3005 advanced-stage platinum-resistant ovarian cancer IND approval granted by the FDA
Janssen Pharmaceutical Companies of Johnson & Johnson Darzalex (daratumumab) split-dosing regimen multiple myeloma BLA approval granted by the FDA
Sanofi Cablivi (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression acquired thrombotic thrombocytopenic purpura (aTTP) in adults BLA approval granted by the FDA
Medtronic expanded indication for Pipeline Flex embolization device brain aneurysm Approval granted by the FDA
Orthofix Medical, Inc. M6-C artificial cervical disc cervical disc degeneration Approval granted by the FDA

 

New Pipeline Updates from Cook Medical, Verseon and BioLineRx

February 11, 2019

Company Drug/Device Medical Condition Status
AtriCure, Inc. cryoICE Ablation System atrial fibrillation (Afib) Phase I trial initiated enrolling up to 150 subjects at up to 20 centers in the U.S. with persistent and long-standing persistent atrial fibrillation undergoing cardiac surgical procedure(s) for heart valve repair or replacement and/or coronary artery bypass procedures
Verseon VE-1902 coronary artery disease Phase I trial initiated enrolling 100-120 healthy volunteers
Actinium Pharmaceuticals, Inc. Actimab-A and venetoclax Acute Myeloid Leukemia (AML) Phase I/II trial initiated enrolling subjects with relapsed or refractory AML that have been previously treated with venetoclax and subjects that have never received venetoclax
Orphan Technologies OT-58 classical homocystinuria Phase II trial initiated enrolling up to 20 subjects
Neurana Pharmaceuticals tolperisone acute muscle spasms of the back Phase II trial initiated enrolling 400 subjects
BioLineRx Ltd. BL-8040 pancreatic cancer Orphan Drug Designation granted by the FDA
REGENXBIO, Inc. RGX-181 late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2)
disease
Rare Pediatric Disease Designation granted
by the FDA
Pharnext SA PXT3003 Charcot-Marie-Tooth disease Type 1A (CMT1A) Fast Track Designation granted by the FDA
Teleflex Incorporated MANTA Vascular Closure Device large bore femoral arterial access site closure PMA granted by the FDA
Flowonix Medical, Inc. Flowonix Maestro Software for Clinician Programmers used to program Prometra Pump Systems intrathecal infusion
of drug therapy
Approval granted by the FDA
Cook Medical Zenith Dissection Endovascular System Type B dissections of the descending thoracic aorta Approval granted by the FDA
Mylan N.V. generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) Approval granted by the FDA

New Pipeline Updates from Merck, AbbVie and MGB Biopharma

February 4, 2019

Company Drug/Device Medical Condition Status
Dicerna Pharmaceuticals, Inc. DCR-HBVS chronic hepatitis B virus (HBV) Phase I trial initiated enrolling healthy volunteers and subjects with non-cirrhotic chronic HBV
Navitor Pharmaceuticals, Inc. NV-5138 Treatment-Resistant Depression (TRD) Phase Ib trial initiated enrolling up to 88 subjects, including healthy volunteers and those diagnosed with TRD
Theravance Biopharma, Inc. ampreloxetine (TD-9855) symptomatic neurogenic orthostatic hypotension (nOH) Phase III trial initiated enrolling 188 subjects with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson’s disease (PD) and pure autonomic failure (PAF)
Qualigen, Inc. FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay diagnosis and treatment of men’s health 510(k) clearance granted by the FDA
Merck V114 prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age Breakthrough Therapy Designation granted by the FDA
C2N Diagnostics brain amyloidosis blood test screening for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis Breakthrough Device Designation granted by the FDA
BioInvent International AB BI-1206 mantle cell lymphoma (MCL) Orphan Drug Designation granted by the FDA
Eureka Therapeutics, Inc. ET140202 ARTEMIS T-cell therapy AFP-positive patients with advanced hepatocellular carcinoma (HCC) IND approval granted by the FDA
MGB Biopharma MGB-BP-3 Clostridium difficile-associated diarrhea (CDAD) IND approval granted by the FDA
CorMatrix Cardiovascular, Inc. Cor TRICUSPID ECM cardiac valve adults with endocarditis and for pediatric patients with congenital heart valve disease IDE approval granted by the FDA
Amerigen Pharmaceuticals, Limited generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) attention deficit hyperactivity disorder (ADHD) ANDA approval granted by the FDA
AbbVie and Promius Pharma, LLC TOSYMRA (previously known as DFN-02) acute treatment of migraine with or without aura in adults NDA approval granted by the FDA
Dr. Reddy’s Laboratories Ltd. and Janssen Pharmaceutical Companies of Johnson & Johnson IMBRUVICA (ibrutinib) in combination with Roche’s obinutuzumab (GAZYVA) adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) NDA approval granted by the FDA

 

New Pipeline Updates from AgeneBio, Second Genome and Imperative Care

January 28, 2019

Company Drug/Device Medical Condition Status
Ironwood Pharmaceuticals IW-6463 serious and orphan Central Nervous System (CNS) disorders Phase I trial initiated enrolling healthy volunteer subjects
Concert Pharmaceuticals CTP-692 adjunctive treatment for schizophrenia Phase I trial initiated
Curis, Inc. CA-170 (oral dual inhibitor of VISTA and PDL1) mesothelioma Phase I trial initiated
Second Genome, Inc. SGM-1019 nonalcoholic steatohepatitis (NASH) Phase II trial initiated enrolling 100 subjects in the U.S.
Bio-Thera Solutions BAT1806 (tocilizumab biosimilar) Rheumatoid Arthritis (RA) Phase III trial initiated enrolling more than 600 subjects around the world
AgeneBio AGB101 amnestic Mild Cognitive Impairment due to Alzheimer’s Disease (MCI due to AD) Phase III trial initiated enrolling 830 subjects in the U.S., Canada and Europe
Daiichi Sankyo Company, Limited [fam-] trastuzumab deruxtecan (DS-8201) HER2 low, unresectable and/or metastatic breast cancer Phase III trial initiated enrolling 540 subjects at approximately 160 sites in regions including, but not limited to, North America, Western Europe and Asia
Imperative Care, Inc. neurovascular access catheters minimally invasive neurovascular procedures for aneurysms, stroke and other brain blood vessel conditions 510(k) clearance granted by the FDA
Rebound Therapeutics Corporation AURORA Surgiscope System single-use disposable Neurosurgical Endoscope for minimally invasive access, visualization and illumination of the target neuro anatomy 510(k) clearance granted by the FDA
Aerie Pharmaceuticals, Inc. AR-1105 (dexamethasone intravitreal implant) macular edema due to Retinal Vein Occlusion (RVO) IND approval granted by the FDA
I-Mab Biopharma TJD5 (TJ004309) advanced solid tumors IND approval granted by the FDA
Nexus Pharmaceuticals, Inc. Busulfan Injection chronic myelogenous leukemia ANDA approval granted by the FDA
Biom’up HEMOBLAST Bellows Laparoscopic Applicator minimally-invasive procedures PMA approval granted by the FDA
Sanofi Pasteur 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to children age 6 through 35 months influenza Approval granted by the FDA

 

New Pipeline Updates from OSSIO, TransEnterix and Abbott

January 21, 2019

Company Drug/Device Medical Condition Status
ADC Therapeutics ADCT-601 advanced or metastatic solid tumors Phase I trial initiated enrolling 75 subjects
Mirati Therapeutics, Inc. MRTX849 advanced solid tumors that harbor KRAS G12C mutations Phase I/II trial initiated
Promentis Pharmaceuticals, Inc. SXC-2023 moderate to severe trichotillomania in adults Phase II trial initiated enrolling 100 subjects in the U.S.
Innovent Biologics, Inc. Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) in combination with capecitabine and oxaliplatin advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) Phase III trial initiated enrolling 650 subjects in China
TransEnterix Senhance Ultrasonic System minimally invasive surgery 510(k) clearance granted by the FDA
OSSIO OSSIOfiber Bone Pin stability and secure bone fixation during the orthopedic healing process 510(k) clearance granted by the FDA
Mundipharma International Flutiform pMDI asthma treatment in children five years of age or older Approval granted by the EMA
Bristol-Myers Squibb Company Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC) Approval granted by the EMA
iSchemaView RAPID neuroimaging platform stroke patients who are likely to benefit from endovascular thrombectomy (clot removal) 510(k) clearance granted by the FDA
Novartis crizanlizumab (SEG101) prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD) Breakthrough Therapy Designation granted by the FDA
Exelixis, Inc. CABOMETYX (cabozantinib) tablets hepatocellular carcinoma (HCC) NDA approval granted by the FDA
AIVITA Biomedical anti-PD1 monoclonal antibodies in combination with AV-MEL-1 metastatic melanoma IND approval granted by the FDA
NeoImmuneTech, Inc. and Genexine Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) high-risk skin cancers IND approval granted by the FDA
Zydus Cadila Amlodipine in combination with Atorvastatin high blood pressure and lowering cholesterol ANDA approval granted by the FDA
Amneal Pharmaceuticals, Inc. generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours mild to moderate dementia caused by Alzheimer’s or Parkinson’s disease ANDA approval granted by the FDA
Abbott Amplatzer Piccolo Occluder patent ductus arteriosus (PDA) in premature babies and newborns Approval granted by the FDA
Sanofi Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) repeat vaccination to help protect against tetanus, diphtheria and pertussis Approval granted by the FDA

 

New Pipeline Updates from Galapagos NV, StemCyte and MicroVention

January 14, 2019

Company Drug/Device Medical Condition Status
Oppilan Pharma Ltd. OPL-002 inflammatory bowel disease (IBD) Phase I trial initiated enrolling 72 subjects
Pliant Therapeutics, Inc. PLN-74809 idiopathic pulmonary fibrosis Phase I trial initiated enrolling 90 healthy subjects
Deciphera Pharmaceuticals, Inc. rebastinib in combination with carboplatin advanced or metastatic solid tumors Phase Ib/II trial initiated enrolling 117 subjects (18 subjects in Part 1 and 99 subjects in Part 2)
Protagonist Therapeutics, Inc. PTG-300 beta thalassemia Phase II trial initiated enrolling 84 adolescent and adult subjects
Galapagos NV GLPG1690 systemic sclerosis (SSc, or scleroderma) Phase IIa trial initiated enrolling 30 subjects with diffuse cutaneous SSc
Urovant Sciences vibegron abdominal pain due to irritable bowel syndrome (IBS) Phase IIa trial initiated enrolling 200 female subjects
Seres Therapeutics, Inc. SER-287 active mild-to-moderate ulcerative colitis Phase IIb trial initiated enrolling 200 subjects
Pfizer, Inc. PF-06651600 moderate to severe alopecia areata Phase IIb/III trial initiated enrolling 660 subjects
NeuroBo Pharmaceuticals, Inc. NB-01 diabetic neuropathic pain Phase III trial initiated enrolling 717 adult subjects at 80 sites in the U.S.
Tivic Health Systems, Inc. ClearUP sinus pain due to allergic rhinitis (hay fever) 510(k) clearance granted by the FDA
StemCyte Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood Mononuclear Stem Cells (UCBMNC) (MC001) spinal cord injury IND approval granted by the FDA
MicroVention, Inc. WEB Aneurysm Embolization System intracranial wide neck bifurcation aneurysms PMA approval granted by the FDA
Rainier Therapeutics, Inc. vofatamab advanced or metastatic urothelial cell carcinoma (bladder cancer) that is positive for FGFR3 mutation and/or fusion Fast Track Designation granted by the FDA
Grifols Erytra Eflexis blood grouping Approval granted by the FDA