Company Product Description Indication Status
Abbvie Inc., of North Chicago Rinvoq (upadacitinib) Jak1 tyrosine kinase inhibitor Rheumatoid arthritis EC approved for treatment of adults with moderate to severe active RA who have responded inadequately to, or who are intolerant to 1 or more disease-modifying antirheumatic drugs
Adamis Pharmaceuticals Corp., of San Diego Zimhi (naloxone) Opioid antagonist Drug overdose Provided responses to the comments included in 11/22/19 CRL; awaiting requested type A meeting with FDA
Advicenne SA, of Nimes, France ADV-7103 Prolonged-release granule formulation of sodium citrate and sodium carbonate Cystinuria EMA granted orphan status
Astellas Pharma Inc., of Tokyo, and Seattle Genetics Inc., of Bothell, Wash. Padcev (enfortumab vedotin-ejfv) Poliovirus receptor-related protein 4 inhibitor Metastatic bladder cancer FDA approved for treatment of adults with locally advanced or metastatic urothelial cancer after PD-1/L1 inhibitor and a platinum-containing chemotherapy
Brainstorm Cell Therapeutics Inc., of New York Nurown Autologous mesenchymal stem cell therapy Multiple sclerosis DSMB unanimously concluded phase II study should continue as planned without any protocol modification.
Bristol-Myers Squibb Co., of Princeton, N.J. Lisocabtagene maraleucel Autologous anti-CD-19 CAR T‑cell immunotherapy B-cell lymphoma Submitted BLA for the treatment of adult patients with R/R large B-cell lymphoma after at least 2 prior therapies
Cytokinetics Inc., of South San Francisco Reldesemtiv  Fast skeletal muscle troponin activator Amyotrophic lateral sclerosis FDA granted orphan status
Daré Bioscience Inc., of San Diego DARE-BV1 Bio-adhesive intra-vaginal gel formulated with 2% clindamycin phosphate Bacterial vaginosis FDA cleared IND for pivotal phase III study, to start in 2020
Epizyme Inc., of Cambridge, Mass. Tazemetostat EZH2 inhibitor Follicular lymphoma Submitted NDA for treatment of patients with R/R follicular lymphoma who've received at least 2 prior lines of therapy
F. Hoffmann-La Roche Ltd., of Basel, Switzerland Kadcyla (trastuzumab emtansine)  Antibody-drug conjugate  HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment EC approved as an adjuvant treatment 
Geron Corp., of Menlo Park, Calif. Imetelstat  Telomerase inhibitor Myelofibrosis  Plans to submit several phase III trial design proposals in R/R MF and to have further discussions with the FDA regarding potential regulatory approval pathways
Mesoblast Ltd., of Melbourne, Australia Revascor (rexlemestrocel-L) Congestive heart failure Allogeneic, adult mesenchymal precursor cells At final meeting, independent data monitoring committee recommended phase III trial continue as planned; target last patient/last visit at the end of January 2020
Neximmune Inc., of Gaithersburg, Md. NEXI-002 T-cell therapy Multiple myeloma Phase I/II trial will begin enrolling MM patients who have failed >3 previous lines of therapy
Orphazyme A/S, of Copenhagen, Denmark Arimoclomol  Hsp70 stimulator Sporadic inclusion body myositis FDA granted fast track designation
Tetra Bio-Pharma Inc., of Ottawa, Canada Caumz (PPP-011) Medicinal cannabis Advanced cancer pain Additional data was provided to the FDA which demonstrated that a surrogate endpoint could be used to support drug approval under the accelerated approval pathway; FDA determined the data were substantial and that the FDA needed additional time to complete a review, which now includes consulting its surrogate endpoint committee; the company anticipates that the FDA will complete its review before the end of January 2020
Urogen Pharma Ltd., of New York UGN-101 (mitomycin gel)  Reformulation of mitomycin  Low-grade upper tract urothelial cancer  FDA granted granted priority review for NDA


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

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