Shanghai, China (Press Release) – I-Mab Bio­pharma (I-Mab), a China-based clin­i­cal stage bio­pharma­ceu­tical com­pany ex­clu­sively focused on the devel­op­ment of inno­va­tive biologics in immuno-oncology and auto­immune dis­eases, and German biopharma com­pany MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), to­day an­nounced that the first patient dosing (FPD) has been achieved in a phase 2 multi-center clin­i­cal study in Taiwan to eval­u­ate an inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in patients with re­lapsed or re­frac­tory multiple myeloma. TJ202 / MOR202 is an anti­body devel­oped by MorphoSys AG. I-Mab owns the ex­clu­sive …

• PDUFA Action Date Extended by Three Months to July 6, 2019
• FDA Has Requested Additional Existing Information for Review

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies …

Suzhou, China (Press Release) – CStone Pharma­ceu­ticals (Suzhou) Co., Ltd. ("CStone", stock code: 2616.HK) announced that the National Medical Products Admin­istra­tion (NMPA) recently approved com­pany's histone deacetylase 6 (HDAC6) selective inhibitor CS3003 for Phase I clin­i­cal trial in China. This is a multi-center, Phase I dose escalation study synchronously conducted in China and Australia in patients with ad­vanced solid tumors and re­lapsed or refractory multiple myeloma.

Dr. Frank Jiang, Chairman and CEO, commented: "CS3003 is the ninth drug can­di­date of CStone with Investigational New Drug approval obtained in China. At present, there …

Stamford, CT (Press Release) – Imbrium Therapeutics L.P., a clin­i­cal-stage bio­pharma­ceu­tical com­pany and operating sub­sid­i­ary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that they have enrolled the first patient in the expansion stage of a Phase 1/2 clin­i­cal trial of tino­sta­mus­tine, an inves­ti­ga­tional treat­ment, in patients with re­lapsed refractory (R/R) hema­to­logic malig­nan­cies in the U.S. and Europe.

Following a dose escalation trial to estab­lish­ tolerability, this expansion phase seeks to in­ves­ti­gate the over­all response rate, duration of response and safety of five cohorts of patients with R/R cancers, …

Shanghai, China (Press Release) – CARsgen Therapeutics, a clin­i­cal-stage com­pany committed to devel­op­ing chi­meric an­ti­gen re­cep­tor T cell ther­a­pies for cancer, today announced that one of its leading drug can­di­dates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treat­ment of patients suffering from re­lapsed / refractory multiple myeloma (rrMM), has received Inves­ti­ga­tional New Drug (IND) clearance from the National Medical Products Admin­istra­tion (NMPA).

"At the American Society of Hematology meeting in December 2018, our col­lab­o­rator, Dr. Songfu Jiang presented en­cour­ag­ing safety and efficacy data in patients with rrMM who received CT053 …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage phar­ma­ceu­tical com­pany, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) Onco­logic Drugs Advisory Committee (ODAC) met to discuss the New Drug Application (NDA) for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­­pound. The NDA, which is cur­rently under Priority Review by the FDA, is seeking accelerated approval for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with re­lapsed refractory multiple myeloma who have received at least three prior ther­a­pies and whose disease is refractory to …

Newton, MA (Press Release) – Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clin­i­cal-stage pharma­ceu­tical com­pany, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Admin­istra­tion (FDA) is scheduled to review data sup­porting the Company’s New Drug Application (NDA) requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) com­pound, at a meeting on February 26, 2019 at 12:30 p.m. ET. The proposed indi­ca­tion to be discussed at this upcoming ODAC meeting is for selinexor in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients with refractory …