Company Product Description Indication Status
Immunovative Therapies Ltd., of Jerusalem, and Mirror Biologics Inc., of Phoenix, Ariz. Allostim Universal antiviral vaccine  Respiratory viral infections, including COVID-19 and influenza  FDA cleared the phase I/II trial for healthy elderly adults
Karuna Therapeutics Inc., of Boston Karxt Oral co-formulation of xanomeline (muscarinic receptor agonist) and trospium (muscarinic receptor antagonist) Acute psychosis in patients with schizophrenia Announced the completion of end-of-phase II meeting with the FDA that supports the progression of Karxt into phase III development
Karyopharm Therapeutics Inc., of Newton, Mass. Xpovio (selinexor) SINE compound Relapsed or refractory diffuse large B-cell lymphoma Approved by FDA for use in adults with DLBCL, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy
Marker Therapeutics Inc., of Houston Zelenoleucel (MT-401) Multitumor-associated antigen-specific T-cell therapy Acute myeloid leukemia Received approval from the U.S. Adopted Names (USAN) Council for zelenoleucel as the nonproprietary name for MT-401
Myovant Sciences Ltd., of Basel, Switzerland Relugolix  Oral gonadotropin-releasing hormone receptor antagonist Advanced prostate cancer  NDA for once-daily, oral relugolix (120 mg) was granted priority review by the FDA
Novaremed AG, of Basel, Switzerland NRD-135S.E1 Allosteric modulator of Lyn kinase Painful diabetic peripheral neuropathy  FDA approved the IND application to initiate a phase II study
Pharmacyclics LLC, of Sunnyvale, Calif., an Abbvie company Imbruvica (ibrutinib) Bruton's tyrosine kinase inhibitor Waldenström’s macroglobulinemia  Submitted an sNDA to the FDA for Imbruvica in combination with rituximab 
Polynoma LLC, of San Diego, unit of CK Life Sciences International (Holdings) Inc. Seviprotimut-L Polyvalent, shed melanoma antigen vaccine Melanoma Received FDA fast track designation 
Reneo Pharmaceuticals Inc., of San Diego REN-001 PPAR-delta agonist Primary mitochondrial myopathies FDA granted orphan drug designation 
Renibus Therapeutics Inc., of Dallas RBT-6  Stannous protoporphyrin COVID-19 FDA granted fast track designation 
Santhera Pharmaceuticals AG, of Pratteln, Switzerland Idebenone Oxidoreductase inhibitor Duchenne muscular dystrophy U.K.’s MHRA renewed for a further year the Early Access to Medicines Scheme scientific opinion 

Notes

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

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