Newton, MA (Press Release) – Karyo­pharm Thera­peutics Inc. (Nasdaq:KPTI), an inno­va­tion-driven pharma­ceu­tical com­pany, to­day an­nounced it has sub­mitted a supple­mental New Drug Appli­ca­tion (sNDA) to the U.S. Food and Drug Admin­istra­tion (FDA) seek­ing ap­prov­al for XPOVIO® (seli­nexor), its first-in-class, oral Sel­ective Inhibitor of Nuclear Export (SINE) com­pound, as a new treat­ment for pa­tients with pre­vi­ously treated mul­ti­ple myeloma.

“Earlier this year, we reported pos­i­tive top-line results from the pivotal Phase 3 BOSTON study eval­u­ating the com­bi­na­tion of XPOVIO (seli­nexor), once-weekly Velcade® (bor­tez­o­mib) and low-dose dexa­meth­a­sone (SVd) as a sec­ond line treat­ment for patients …

It had been almost two months since I stopped treat­ment, and it seemed to be going well. Then I crashed, hard. I woke up in the small hours of the morning feeling miserable, heart flutters, elevated pulse rate, sore all over. It was the same in the morning after a fitful sleep. No appetite, breathless with any movement. Not fun. Like detoxing all over again.

I was better the next day, not 100 per­cent (whatever that is anymore), but reason­ably functional. The crash might have been caused by my pushing a little too hard the evening before, …

• Bristol Myers Squibb to host an in­vestor call to­day at 8:00 a.m. EDT
• bluebird bio to host an in­vestor call to­day at 8:45 a.m. EDT

Princeton, NJ and Cambridge, MA (Press Release) – Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) to­day an­nounced that the com­pa­nies re­ceived a Refusal to File letter from the U.S. Food and Drug Admin­istra­tion (FDA) re­gard­ing the Biologics License Appli­ca­tion (BLA) for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pre-treated re­lapsed and re­frac­tory mul­ti­ple myeloma, which was sub­mitted in March 2020.

Upon pre­lim­i­nary review, the FDA de­ter­mined that the Chemistry, Manufacturing and Control (CMC) module of the BLA re­quires fur­ther …

• IKEMA trial results released early based on recom­men­da­tion of an Independent Data Monitoring Com­mit­tee
• Addition of Sarclisa sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to car­filz­o­mib and dexa­meth­a­sone alone
• Results will be sub­mitted to an upcoming medical meeting and form the basis for regu­la­tory sub­missions later this year

Paris, France (Press Release) – The Phase 3 IKEMA clin­i­cal trial eval­u­ating Sarclisa® (isatuximab) added to car­filz­o­mib and dexa­meth­a­sone met the pri­mary end­point at its first planned interim analysis, demonstrating sig­nif­i­cantly prolonged pro­gres­sion-free sur­vival com­pared to standard of care car­filz­o­mib and dexa­meth­a­sone alone in patients with re­lapsed multiple myeloma. There were no new safety signals identified in this study.

“When Sarclisa was added to standard-of-care treat­ment car­filz­o­mib and dexa­meth­a­sone in this phase 3 trial, results clearly dem­onstrated a sig­nif­i­cant re­duc­tion in …

Shanghai, China and Rockville, MD (Press Release) – I-Mab (NASDAQ: IMAB), a clin­i­cal stage bio­pharma­ceu­tical com­pany com­mit­ted to the discovery, de­vel­op­ment and com­mer­cial­iza­tion of novel or highly dif­fer­en­ti­ated biologics to treat dis­eases with sig­nif­i­cant unmet med­i­cal needs, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR), to­day jointly an­nounced that the first patient has been dosed in a phase 3 clin­i­cal study in main­land China to eval­u­ate MorphoSys’ inves­ti­ga­tional human CD38 anti­body TJ202 / MOR202 in com­bi­na­tion with lena­lido­mide plus dexa­meth­a­sone in patients with re­lapsed or re­frac­tory multiple myeloma (r/r …

Initiation of the clin­i­cal trial triggers $50 million mile­stone pay­ment from AbbVie

South San Francisco, CA (Press Release) – Harpoon Thera­peutics, Inc. (NASDAQ: HARP), a clin­i­cal-stage immuno­therapy com­pany devel­op­ing a novel class of T cell engagers, to­day announced that the first patient has been dosed with HPN217 in a Phase 1/2 clin­i­cal trial focused on re­lapsed, re­frac­tory multiple myeloma (RRMM). HPN217 is being devel­oped under a global license and option agree­ment with AbbVie Inc. (NYSE:ABBV) and dosing of the first patient in a clin­i­cal trial has triggered a $50 million mile­stone pay­ment to Harpoon. HPN217 targets B-cell maturation an­ti­gen (BCMA), a well-validated an­ti­gen ex­pressed …

Shanghai, China (Press Release) – CARsgen Thera­peutics Co., Ltd., a clin­i­cal-stage bio­pharma­ceu­tical com­pany, to­day an­nounced the Euro­pean Medicines Agency (EMA) Com­mit­tee for Orphan Medicinal Products (COMP) adopted a pos­i­tive opinion on CARsgen's appli­ca­tion for orphan desig­na­tion of its inves­ti­ga­tional CT053 CAR T-cell ther­apy, fully human anti-BCMA (B cell maturation an­ti­gen) au­tol­o­gous chi­meric an­ti­gen re­cep­tor (CAR) T cells for the treat­ment of mul­ti­ple myeloma. CT053 was pre­vi­ously granted orphan drug desig­na­tion by the US Food and Drug Admin­istra­tion in August 2019.

"The COMP's adoption of a pos­i­tive opinion for CT053 orphan drug desig­na­tion is …