BioCentury | Mar 3, 2020
Product Development

Following Phase III readout, Karyopharm seeks approval of Xpovio for second-line MM

Karyopharm gained $11.38 (70%) to $27.72 on Monday, adding about $746 million in market value, after announcing that Xpovio selinexor met the primary endpoint of improving PFS in the confirmatory Phase III BOSTON trial to...
BioCentury | Feb 19, 2020
Regulation

Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label. The agency will consider granting accelerated approval to Xpovio selinexor to...
BC Extra | Jul 3, 2019
Company News

After negative panel vote, FDA approves Karyopharm's multiple myeloma drug

FDA evidently saw enough data from an ongoing confirmatory trial to grant accelerated approval to Karyopharm's Xpovio selinexor to treat relapsed or refractory multiple myeloma. During the drug's extended review, the new data added to...
BC Extra | Mar 15, 2019
Company News

Karyopharm gets bump as FDA extends review of selinexor

Karyopharm gained 7% on Friday after it said FDA has extended by three months its review of selinexor, which is under Priority Review to treat multiple myeloma. Its PDUFA date is now July 6. Karyopharm...
BC Week In Review | Mar 1, 2019
Clinical News

ODAC backs delay for Karyopharm’s selinexor

With uncertainty regarding the benefits and toxicity concerns with multiple myeloma candidate selinexor from Karyopharm Therapeutics Inc. (NASDAQ:KPTI), FDA's Oncologic Drugs Advisory Committee voted 8-5 that FDA should delay a decision on the product's approval...
BC Extra | Feb 26, 2019
Company News

ODAC backs delay for Karyopharm’s selinexor

With uncertainty regarding the benefits and toxicity concerns with multiple myeloma candidate selinexor from Karyopharm Therapeutics Inc. (NASDAQ:KPTI), FDA's Oncologic Drugs Advisory Committee voted 8-5 that FDA should delay a decision on the product's approval...
BC Extra | Feb 22, 2019
Company News

Karyopharm down as FDA reviewers cast doubt on selinexor's benefit

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) lost $3.90 (43%) to $5.07 on Friday after FDA reviewers wrote in briefing documents that it is unclear whether treatment with selinexor provides a clinically meaningful benefit that outweighs the risks...
BC Week In Review | Jan 4, 2019
Financial News

China's Antengene raises $120M series B round

Antengene Corp. (Shanghai, China) completed a $120 million series B round on Jan. 2 to fund development of its two lead cancer compounds, selinexor and ATG-008. Boyu Capital and FountainVest led the round, with participation...
BC Extra | Jan 2, 2019
Financial News

China's Antengene raises $120M series B round

Antengene Corp. (Shanghai, China) completed a $120 million series B round to fund development of its two lead cancer compounds, selinexor and ATG-008. Boyu Capital and FountainVest led the round, with participation by Celgene Corp....
BC Week In Review | Oct 11, 2018
Clinical News

Karyopharm's selinexor gets Priority Review for penta-refractory MM

FDA granted Priority Review to an NDA from Karyopharm Therapeutics Inc. (NASDAQ:KPTI) for selinexor to treat penta-refractory multiple myeloma. Its PDUFA date is April 6, 2019. Karyopharm is seeking accelerated approval of the compound based...
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