Company Product Description Indication Status
Adaptimmune Therapeutics plc, of Oxfordshire, U.K. ADP-A2M4 SPEAR T-cell therapy Soft tissue sarcomas FDA granted regenerative medicine advanced therapy designation
Advaxis Inc., of Princeton, N.J. ADXS-504 ADXS-HOT candidate  Prostate cancer Submitted IND to the FDA for a phase I study
Aerie Pharmaceuticals Inc., of Durham, N.C. Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% Rho kinase inhibitor and prostaglandin Reduction of intra-ocular pressure in open-angle glaucoma Submitted marketing authorization application with EMA
Alimera Sciences Inc., of Atlanta Iluvien (fluocinolone acetonide intravitreal implant) Corticosteroid delivered via sustained-release intravitreal implant Non-infectious uveitis  Benelux countries granted marketing authorization for use to prevent relapse in recurrent non-infectious uveitis affecting posterior segment of the eye
Amarin Corp. plc, of Dublin Vascepa (icosapent ethyl) Ethyl ester of eicosapentaenoic acid High triglyceride levels EMA validated marketing authorization application seeking approval to reduce risk of cardiovascular events in high-risk patients who have their cholesterol levels controlled with statin treatment but have elevated triglycerides, 135 mg/dL or above, and other cardiovascular risk factors
Atreca Inc., of Redwood City, Calif. ATRC-101 Monoclonal antibody targeting a ribonucleoprotein complex Solid tumors FDA cleared the IND to start a phase Ib trial in early 2020
Bridgebio Pharma Inc., of Boston, and subsidiary Origin Biosciences Fosdenopterin (BBP-870/ORGN-001) cPMP substrate replacement therapy Molybdenum cofactor deficiency type A Initiated a rolling NDA submission to the FDA
Bristol-Myers Squibb Co., of  Princeton, N.J., and Acceleron Pharma Inc., of Cambridge,  Mass. Reblozyl (luspatercept-aamt) Erythroid maturation agent Myelodysplastic syndromes FDA said its Oncologic Drugs Advisory Committee will review supplemental BLA at Dec. 18, 2019, meeting
Dynavax Technologies Corp., of Emeryville, Calif. Heplisav-B Vaccine combining hepatitis B surface antigen with TLR9 agonist Hepatitis B Filed a report on a cumulative analysis of its postmarketing study for review by the FDA
Heron Therapeutics Inc., of San Diego HTX-011  Dual-acting, fixed-dose combination of bupivacaine with low dose of nonsteroidal anti-inflammatory meloxicam Postoperative pain Health Canada granted new drug submission priority review status
Immunomedics Inc., of Morris Plains, N.J. Sacituzumab govitecan Antibody-drug conjugate targeting TROP2 Metastatic triple-negative breast cancer Resubmitted BLA to FDA seeking accelerated approval for use in patients who have received at least 2 prior therapies for metastatic disease
Lumosa Therapeutics Co. Ltd., of Taipei, Taiwan LT-1001 (Naldebain) Prodrug of nalbuphine Moderate to severe postoperative pain FDA accepted IND for comparative bioavailability study expected to fulfil premarket confirmatory trial requirement under the 505(b)(2) pathway
Outlook Therapeutics Inc., of Cranbury, N.J. ONS-5010 Ophthalmic formulation of VEGF inhibitor bevacizumab Branch retinal vein occlusion and diabetic macular edema Received agreement from the FDA on 3 special protocol assessments for 3 additional registrational trials, covering protocols for Norse 4 in BRVO and Norse 5 and 6 for DME; studies are expected to start in 2020
Owp Pharmaceuticals Inc., of Naperville, Ill. Liquid formulation of lamotrigine Sodium channel blocker Epilepsy and bipolar disorder Received IND approval from the FDA; aims to advance via a 505(b)(2) pathway
Puma Biotechnology Inc., of Los Angeles, and partner Specialised Therapeutics Asia Pte Ltd., of Singapore Nerlynx (neratinib) HER2-targeting therapy Breast cancer Received marketing approval in Singapore for extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy
SK Life Science Inc., of Paramus, N.J., a subsidiary of SK Biopharmaceuticals Co. Ltd. SKL-24741 Inhibits voltage-gated sodium channel Epilepsy FDA accepted IND for a phase I trial to launch in 2020

Notes

For more information about individual companies and/or products, see Cortellis.

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