Pipeline

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

 

New Pipeline Updates from Pfizer, Sanofi and Acorda

January 7, 2019

Company Drug/Device Medical Condition Status
Pfizer, Inc. PF-06651600 (oral JAK3 inhibitor) moderate to severe alopecia areata Phase II/III trial initiated enrolling 660 subjects
Slayback Pharma LLC Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth ANDA approval granted by the FDA
I-Mab Biopharma TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) autoimmune and inflammatory diseases IND approval granted by the FDA
Cardiva Medical, Inc. VASCADE MVP Venous Vascular Closure System electrophysiology procedures PMA approval granted by the FDA
Eiger BioPharmaceuticals, Inc. lonafarnib hepatitis delta virus (HDV) infection PRIME (PRIority MEdicines) designation granted by the EMA
Horizon Pharma plc RAVICTI (glycerol phenylbutyrate) Oral Liquid infants younger than two months of age living with a urea cycle disorder (UCD) sNDA approval granted by the FDA
Edwards Lifesciences Corporation SAPIEN 3 Ultra system transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery Approval granted by the FDA
Sanofi and Merck Vaxelis (ready-to-use hexavalent vaccine) prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b Approval granted by the FDA
Alexion Pharmaceuticals Ultomiris paroxysmal nocturnal hemoglobinuria (PNH) Approval granted by the FDA
Stemline Therapeutics Elzonris blastic plasmacytoid dendritic cell neoplasm (BPDCN) Approval granted by the FDA
Teva Pharmaceutical Industries Ltd. ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder asthma and COPD Approval granted by the FDA
Acorda Inbrija intermittent treatment of OFF episodes in Parkinson’s disease patients taking Carbidopa/Levodopa Approval granted by the FDA
Merck KEYTRUDA recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) Approval granted by the FDA
Veloxis Pharmaceuticals Envarsus XR (tacrolimus extended-release tablets) organ rejection in kidney transplant patients Approval granted by the FDA
AstraZeneca and Merck LYNPARZA deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer Approval granted by the FDA
Medtronic plc InterStim smart programmer overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention Approval granted by the FDA
Celltrion, Inc. and Teva Pharmaceuticals Industries Limited HERZUMA (trastuzumab-pkrb) treatment of HER2-overexpressing breast cancer for certain indications Approval granted by the FDA

 

New Pipeline Updates from Concert, Spiral and Daiichi Sankyo

December 31, 2018

Company Drug/Device Medical Condition Status
Concert Pharmaceuticals CTP-692 schizophrenia Phase I trial initiated enrolling 80 healthy volunteers
Spiral Therapeutics LPT99 inner ear disorders Phase I trial initiated enrolling 32 healthy adult subjects
Daiichi Sankyo Company, Ltd. quizartinib, a FLT3 inhibitor and an MDM2 inhibitor, milademetan (DS-3032) relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) or newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy Phase I trial initiated enrolling up to 110 subjects in the U.S., EU and Japan
Carmot Therapeutics CT-868 type 2 diabetes Phase I trial initiated enrolling overweight or obese but otherwise healthy volunteers and subjects
Viriom, Inc. VM1500A once monthly injectable HIV Phase I trial initiated enrolling up to 36 HIV-uninfected volunteers in Moscow, Russia
CStone Pharmaceuticals CS1001 advanced solid tumors Phase I trial initiated enrolling subjects in the U.S.
MiNATherapeutics MTL-CEBPA in combination with Sorafenib advanced liver cancer Phase Ib trial initiated enrolling 38 subjects in the U.K., Singapore and Taiwan
Actuate Therapeutics, Inc. 9-ING-41 refractory hematologic malignancies or solid tumors Phase I/II trial initiated
Vedanta Biosciences VE303 recurrent Clostridium difficile infection (rCDI) Phase II trial initiated enrolling up to 146 subjects with a recent diagnosis of rCDI
Hookipa Pharma, Inc. HB-101 cytomegalovirus (CMV) Phase II trial initiated enrolling 150 male and female subjects aged 18 years or older at 35 sites worldwide
Pear Therapeutics, Inc. Pear-004 schizophrenia Phase II trial initiated
Ayala Pharmaceuticals, Inc. AL101 adenoid cystic carcinoma (ACC) bearing Notch activated mutations Phase II trial initiated enrolling subjects at eight sites in the U.S.
Isofol Medical AB arfolitixorin metastatic colorectal cancer (mCRC) Phase III trial initiated enrolling 440 subjects aged 18 years or older
Corbus Pharmaceutical Holdings, Inc. lenabasum dermatomyositis Phase III trial initiated enrolling 150 subjects
Rakuten Aspyrian ASP-1929 recurrent local regional head and neck squamous cell carcinomas (HNSCC) Phase III trial initiated enrolling 275 subjects at 75 sites in the U.S., Europe and Asia
CathWorks FFRangio System multi-vessel coronary artery disease 510(k) clearance granted by the FDA
Retia Medical, LLC Argos Cardiac Output (CO) Monitor cardiac output monitoring 510(k) clearance granted by the FDA
Arch Therapeutics, Inc. AC5 Topical Gel partial and full-thickness wounds 510(k) clearance granted by the FDA
Amgen Nplate (romiplostim) immune thrombocytopenia (ITP) sBLA approval granted by the FDA

 

New Pipeline Updates from Genentech, Planmed Oy, and Gibson Oncology

December 17, 2018

Company Drug/Device Medical Condition Status
Bio-Thera Solutions BAT4306F CD-20-positive B-cell non-Hodgkins lymphoma Phase I trial initiated
Alligator Bioscience ATOR-1015 advanced solid tumor disease Phase I trial initiated enrolling up to 53 subjects at five clinics in Sweden and Denmark
Rodin Therapeutics RDN-929 snyaptopathies, a group of over 100 brain diseases characterized by synaptic loss and disfunction Phase I trial initiated
Protagonist Therapeutics, Inc. PN-10943 inflammatory bowel disease Phase I trial initiated
Aridis Pharmaceuticals AR-501 (gallium citrate) chronic bacterial lung infections in patients with Cystic Fibrosis Phase I/II trial initiated enrolling 96 (48 healthy and 48 with Cystic Fibrosis) subjects
Constellation Pharmaceuticals, Inc. CPI-1205 metsastic castration-resistant prostate cancer (mCRPC) Phase II trial initiated enrolling up to 35 subjects
KaNDy Therapeutics NT-814 troublesome post-menopausal symptoms, including hot flashes Phase II trial initiated enrolling up to 165 menopausal subjects aged 40 to 65 years
Levo Therapeutics, Inc. intranasal carbetocin (LV-101) Prader-Willi syndrome (PWS) Phase III trial initiated
Generex Biotechnology Corporation AE37 plus Keytruda (pembrolizumab) triple negative breast cancer IND clearance granted by the FDA
Virtus Pharmaceuticals, LLC generic Levorphanol Tartrate 2 mg tablets severe pain ANDA approval granted by the FDA
Asana Biosciences Janus Kinase (JAK) and Spleen Tyrosine Kinase (SYK) dual inhibitor ASN002 moderate-to-severe atopic dermatitis Fast Track Designation granted by the FDA
Gibson Oncology, LLC LMP-400 small molecule topoisomerase 1inhibitor Ewing sarcoma Rare Pediatric Disease Designation (RPDD) granted by the FDA
Sandoz, Inc. and Pear Therapeutics, Inc. reSET-O Opioid Use Disorder (OUD) Clearance granted by the FDA
Planmed Oy new features and intended uses of Planmed Verity orthopedic imaging solution reconstructive surgeries Approval granted by the FDA
Genentech Tecentriq and Avastin metastatic non-squamous non-small cell lung cancer (NSCLC) Approval granted by the FDA
Mayne Pharma Group Limited Tolsura (SUBA-itraconazole) systemic fungal infections Approval granted by the FDA

 

New Pipeline Updates from Seattle Genetics, Novartis, Vybion and Notal Vision

December 10, 2018

Company Drug/Device Medical Condition Status
Innovent Biologics, Inc. IBI101, a recombinant fully human anti-OX40 monoclonal antibody (mAb) drug candidate Advanced solid tumors FDA approved Investigational New Drug (IND) application and plans to initiate Phase I clinical trial based on results from China Phase I trial
Sunny Pharmtech, Inc. and Vitruvius Therapeutics, Inc. Aminocaproic Acid Tablets 500 mg and 1000 mg tablets Fibrinolysis FDA approved Abbreviated New Drug Application (ANDA)
Vybion, Inc. INT41 Huntington’s disease FDA granted Orphan Drug designation
Ocular Therapeutix™, Inc. RP-L201 DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg Occular pain following eye surgery
Notal Vision, Ltd. Notal Vision Home-based Optical Coherence Tomography (OCT) System Home testing between doctor ntra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative age-related macular degeneration (eAMD) FDA granted Breakthrough Device designation
Mirati Therapeutics, Inc. MRTX849 Cancers driven by KRAS G12C mutations FDA has cleared the company’s Investigational New Drug (IND) application to initiate Phase I/II Trial
AbbVie Rovalpituzumab Tesirine (Rova-T) Second-line therapy for advanced small-cell lung cancer Halted Phase III trial due to shorter overall survival in the Rova-T arm
Genentech, Inc. Kadcyla® (ado-trastuzumab emtansine) HER2-positive early Breast cancer (EBC) Phase III KATHERINE trial met its primary end-point, significantly reducing risk of recurrence or death compared to Herceptin® (trastuzumab) as an adjuvant treatment
Global Blood Therapeutics Voxelotor Sickle cell disease in patients 12 and older Interim analysis of its Phase III HOPE study showed patients experienced “rapid, robust and sustained improvements in hemoglobin levels and measures of hemolysis with a favorable safety and tolerability profile”
Seattle Genetics Adcetris Previously untreated systemic anaplastic large cell lymphoma Granted approved by FDA
Novartis ligelizumab (QGE031) Chronic spontaneous urticartia (CSU) whose symptoms are inadequately controlled by H1-antihistamines Taking it into Phase III trials after a mid-stage trial showed out-performed Xolair
Janssen Pharmaceutical IMBRUVICA® (ibrutinib) plus rituximab Chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL) Phase III trial results: significantly prolonged PFS compared to FCR in previously untreated patients aged 70 years or younger with CLL/SLL
Exelixis, Inc. and IPSEN Cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) previously untreated advanced HCC Previously untreated advanced hepatocellular carcinoma (HCC) initiation of COSMIC-312, a Phase III pivotal trial of this med versus sorafenib

 

New Pipeline Updates from Allergan, Bayer, Genentech and Pfizer

December 3, 2018

Company Drug/Device Medical Condition Status
GlycoMimetics Uproleselan (GMI-1271) Relapsed/refractory acute myeloid leukemia First patient enrolled in global Phase III trial
Sollis Therapeutics Clonidine micropellet Sciatica pain First patient enrolled in the RePRIEVE-CM trial
Stallergenes Greer Sublingual allergy immunotherapy tablet STAGR320 House dust mite (HDM)-induced allergic rhinitis Phase III trial met its primary endpoint with statistical significance in patients treated with STAGR320 compared to patients on placebo
Rocket Pharmaceuticals RP-L201 Severe Leukocyte Adhesion Deficiency-I FDA approved IND for Phase I trial
Pliant Therapeutics PLN-74809 Primary sclerosing cholangitis Granted Orphan Drug designation by FDA
Allergan Avycaz Complicated urinary tract infections and complicated intra-abdominal infections FDA accepted for review sNDA to expand label indication
NovImmune S.A. Gamifant® (emapalumab-lzsg) Primary hemophagocytic lymphohistiocytosis Granted approval by FDA
Pfizer Daurismo™ (glasdegib), to be used in combination with low-dose cytarabine (LDAC) Newly diagnosed acute myeloid leukemia in adults 75 years or older Granted approval by FDA
AbbVie and Genentech Venclexta® (venetoclax) Newly diagnosed acute myeloid leukemia in adults 75 years or older who cannot tolerate intensive chemotherapy Granted accelerated approval by FDA
Synthetic Biologics Synthetic Biologics Antibiotic-mediated Clostridium difficile infection Successfully completed End-of-Phase II meeting; Phase III go-ahead from FDA
Bayer and Loxo Oncology Vitrakvi (larotrectinib) Solid tumors with NTRK gene fusion Granted approval by FDA
HighTide Therapeutics HTD1801 Nonalcoholic steatohepatitis Fast Track designation granted by FDA