Pipeline

March 8, 2021
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
eXIthera Pharmaceuticals EP-7041 thrombosis prevention in critically ill patients with COVID-19 IND approved by the FDA for phase 2 trial
Sorrento Therapeutics intranasal STI-2099 (COVIDROPS) mild COVID-19 IND approved by the FDA
Altimmune AdCOVID single-dose intranasal COVID-19 vaccine commencement of patient enrollment in phase 1 trial
AIVITA Biomedical AV-COVID-19 personalized COVID-19 vaccine completion of phase 1 trial
Novavax

Takeda		 NVX-CoV2373 COVID-19 vaccine first patients dosed in phase 2 trial in Japan
Johnson & Johnson single-shot COVID-19 vaccine COVID-19 Emergency Use Authorization granted by the FDA
Other Trials and Actions
Flexion Therapeutics FX301 postoperative pain in patients undergoing bunionectomy IND approved by the FDA
Molecular Targeting Technologies EBTATE (177Lu-DOTA-EB-TATE) neuroendocrine tumors IND approved by the FDA
QureBio (no website available) Q-1802 advanced solid tumors IND approved by the FDA
TissueTech TTBT01 dry eye disease IND approved by the FDA for phase 2 trial
Hangzhou Sciwind Biosciences XW003 nonalcoholic steatohepatitis IND approved by China’s National Medical Products Administration
Wellmarker Bio WM-S1-030 advanced cancer trial approved by the Australian Therapeutic Goods Administration
Innovent IBI322 advanced malignancies first patient dosed in phase 1a trial in the U. S
Prometheus Biosciences PRA023 inflammatory bowel disease first patients dosed in multiple ascending-dose (MAD) portion of phase 1a trial
AbFero Pharmaceuticals SP-420 myelodysplastic and myelofibrosis patients with transfusional iron overload initiation of phase 1 trial
Apollomics APL-106 (uproleselan injection) relapsed or refractory acute myeloid leukemia first patient enrolled in phase 1 trial in China
Forendo Pharma FOR-6219 endometriosis completion of phase 1 trials
Kymera Therapeutics KT-474 atopic dermatitis or hidradenitis suppurativa initiation of patient dosing in single ascending-dose (SAD) portion of phase 1 trial
Pipeline Therapeutics PIPE-307 multiple sclerosis initiation of phase 1 trial
Clearside Biomedical CLS-AX (axitinib injectable suspension) neovascular age-related macular degeneration completion of patient dosing in first cohort of phase 1/2a trial
Cyclo Therapeutics Trappsol Cyclo Niemann-Pick disease type C1 completion of last patient last visit in phase 1/2 trial
Kronos Bio KB-0742 MYC gene-amplified solid tumors first patient dosed in phase 1/2 trial
Transgene

BioInvent		 BT-001 solid tumors first patients enrolled in phase 1/2 trial
Dicerna

Roche		 RG6346 chronic hepatitis B virus infection initiation of phase 2 trial
Highlight Therapeutics BO-112 patients with unresectable or metastatic melanoma that have previously progressed to checkpoint inhibitors first patients enrolled in phase 2a trial
Annexon ANX007 geographic atrophy first patients dosed in phase 2 trial
Assembly Biosciences

Arbutus Biopharma		 vebicorvir in combination with AB-729 chronic hepatitis B infection initiation of phase 2 trial
BioMarin Pharma vosoritide achondroplasia patient enrollment complete in phase 2 trial
BiomX BX001 mild-to-moderate acne first patient dosed in phase 2 trial
BioXcel Therapeutics BXCL501 delirium-related agitation initiation of phase 2 trial
Marker Therapeutics MT-401 patients with acute myeloid leukemia following an allogeneic stem-cell transplant in both the adjuvant and active disease settings first patient treated in phase 2 trial
Ocular Therapeutix OTX-DED (dexamethasone intracanalicular ophthalmic insert) short-term treatment for signs and symptoms of dry eye disease first patient dosed in phase 2 trial
Pharvaris PHVS416 hereditary angioedema due to C1-inhibitor deficiency type 1 and 2 first patient dosed in phase 2 trial
Longeveron Lomecel-B infusion aging frailty completion of phase 2b trial
Seres Therapeutics SER-287 mild-to-moderate ulcerative colitis completion of patient enrollment in phase 2b trial
ADial Therapeutics AD04 alcohol use disorder in persons with certain target genotype 50 percent enrollment reached in phase 3 trial
I-Mab eftansomatropin alfa (TJ101) pediatric growth hormone deficiency first patient dosed in phase 3 trial in China
Exicure cavrotolimod (AST-008) Merkel cell carcinoma Orphan Drug designation granted by the FDA
Oblato OKN-007 diffuse intrinsic Pontine glioma Fast-Track designation granted by the FDA
Anuncia ReFlow System Mini cerebrospinal fluid disorders requiring shunting Breakthrough Device designation granted by the FDA
MedAlliance SELUTION SLR, sustained limus release DEB catheter atherosclerotic lesions in native coronary arteries Breakthrough Device designation granted by the FDA
AbbVie Humira (adalimumab) moderate-to-severe active ulcerative colitis in children age 5 and older approved by the FDA for expanded indication
Bridge BioPharma

Origin Biosciences		 Nulibry (fosdenopterin) for injection molybdenum cofactor deficiency (MoCD) type A approved by the FDA
KemPharm Azstarys (serdexmethylphenidate) attention deficit hyperactivity disorder (ADHD) in patients age 6 and older approved by the FDA
Oncopeptides Pepaxto (melphalan flufenamide relapsed or refractory multiple myeloma approved by the FDA
Pfizer Lorbrena (lorlatinib) first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive nonsmall-cell lung cancer approved by the FDA for expanded indication
Sarepta Therapeutics Amondys 45 (casimersen) Duchenne muscular dystrophy patients with a confirmed mutation amenable to exon 45 skipping approved by the FDA
Accufix Surgical Accu-Joint system patients with degenerative and posttraumatic arthritis in the metatarsophalangeal joint approved by the FDA
Vascular Grafts Solutions VIOLA device clampless proximal anastomosis in coronary artery bypass grafting approved by the FDA

 

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