Pipeline

April 12, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
OSE Immunotherapeutics CoVepiT COVID-19 vaccine approval received from the Belgian Federal Agency for Medicines and Health Products for phase 1 trial
AzurRx Biopharma micronized niclosamide (FW-1022) COVID-19-related gastrointestinal infections initiation of phase 2 trial
The Cancer Research Institute

RevImmune		 interleukin-7 (IL-7) cancer patients with COVID-19 first patients dosed in phase 2 trial
Novavax NVX-CoV2373 COVID-19 vaccine initiation of phase 2b and 3 trials
Abbott BinaxNOW COVID-19 Ag Self Test detection of COVID-19 infection Emergency Use Authorization (EUA) granted by the FDA
Baebies FINDER 1.5 Instrument and FINDER SARS-CoV-2 Test – RT-PCR detection of COVID-19 infection EUA granted by the FDA
Quidel QuickVue At-Home OTC COVID-19 Test detection of COVID-19 infection EUA granted by the FDA
Other Trials and Actions
Arcellx ACLX-001 multiple myeloma IND approved by the FDA
BioInvent International BI-1808 ovarian cancer, nonsmall-cell lung cancer and cutaneous T-cell lymphoma IND approved by the FDA
Landos Biopharma omilancor (BT-11) eosinophilic esophagitis IND approved by the FDA
Tarus Therapeutics TT-10 advanced solid tumors IND approved by the FDA
Antengene Corporation ATG-019 (monotherapy or combined with niacin ER) advanced solid tumors or nonHodgkin lymphoma IND approved by the China National Medical Products Administration
BlueRock Therapeutics MSK-DA01 Cell Therapy advanced Parkinson's disease approval received from Health Canada for a phase 1 trial
Azafaros AZ-3102 GM1 and GM2 gangliosidoses first cohort dosed in phase 1 trial
Celon Pharma CPL’280 diabetes and diabetic neuropathy completion of phase 1 trial
I-Mab

ABL Biotechnologies		 TJ-L14B/ABL503 locally advanced or metastatic solid tumors first patient dosed in phase 1 trial
Nascent Biotech pritumumab brain cancer, including malignant primary brain tumors and adult brain metastases initiation of phase 1 trial
TeneoBio

Janssen		 JNJ-75348780 B-cell lymphoid malignancies first patients dosed in phase 1 trial
Pinteon Therapeutics PNT001 acute traumatic brain injury first patient dosed in phase 1b trial
SpringWorks Therapeutics nirogacestat nirogacestat in combination with teclistamab first patient dosed in phase 1b trial
Daiichi Sankyo DS-1594 relapsed/refractory acute myeloid leukemia and acute lymphoblastic leukemia initiation of phase 1/2 trial
Gracell Biotechnologies GC007g B-cell acute lymphoblastic leukemia first patient enrolled in phase 1/2 trial
Molecular Partners ensovibep patients with symptomatic COVID-19 first patient dosed in phase 2a trial
Recognify Life Sciences/atai Life Sciences RL-007 cognitive impairment associated with schizophrenia initiation of phase 2a trial
AEON Biopharma ABP-450 (prabotulinumtoxinA) injection cervical dystonia first patients dosed in phase 2 trial
Aptinyx NYX-458 patients with mild cognitive impairment and mild dementia associated with Parkinson’s disease and dementia with Lewy bodies restarted patient screening in phase 2 trial
Chinook Therapeutics atrasentan patients with proteinuric glomerular disease who are at risk of progressive loss of renal function first patient dosed in phase 2 trial
Daiichi Sankyo

AstraZeneca		 Enhertu (trastuzumab deruxtecan) HER2 overexpressing locally advanced, unresectable or metastatic colorectal cancer with progression following treatment with standard-of-care chemotherapy first patient dosed in phase 2 trial
Enzychem Lifesciences EC-18 chemoradiation induced oral mucositis patient enrollment complete in stage 2 of phase 2 trial
Kadmon belumosudil diffuse cutaneous systemic sclerosis first patient dosed in phase 2 trial
Ocuphire Pharma APX3330 nonproliferative diabetic retinopathy and mild proliferative diabetic retinopathy initiation of phase 2 trial
Ionis Pharmaceuticals ION363 amyotrophic lateral sclerosis with mutations in the fused-in sarcoma gene initiation of phase 3 trial
Relmada Therapeutics REL-1017 adjunctive treatment for major depressive disorder initiation of phase 3 trial
Da Volterra DAV132 prevention of clostridioides difficile infection in high-risk patients Fast-Track designation granted by the FDA
Passage Bio PBKR03 Krabbe disease Orphan Drug designation granted by the European Commission
Taiho Oncology futibatinib (TAS-120) treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements, including gene fusions Breakthrough Therapy designation granted by the FDA
Sanofi Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone treatment of patients with relapsed refractory multiple myeloma who have received one to three prior lines of therapy approved by the FDA for expanded indication
Supernus Pharmaceuticals Qelbree (viloxazine extended-release capsules) attention deficit hyperactivity disorder in pediatric patients 6 to 17 years of age approved by the FDA
United Therapeutics Tyvaso (treprostinil) Inhalation Solution pulmonary hypertension associated with interstitial lung disease approved by the FDA
Bausch and Lomb ClearVisc dispersive ophthalmic viscosurgical device ophthalmic surgery approved by the FDA
Chemence Medical Exofin fusion skin closure system topical adhesive to close and seal incisions approved by the FDA
NuVasive NuVasive Simplify Cervical Artificial Disc two-level cervical total disc replacement approved by the FDA
Respinova Pulsehaler inhaler for patients with respiratory diseases approved by the FDA
Vysioneer VBrain, AI-powered tumor autocontouring solution radiotherapy treatment approved by the FDA

 

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