20:38 , Jul 3, 2019 |  BC Extra  |  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...
00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
14:29 , Mar 15, 2019 |  BC Extra  |  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...
01:33 , Mar 1, 2019 |  BC Week In Review  |  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...
23:05 , Feb 26, 2019 |  BC Extra  |  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...
22:19 , Feb 22, 2019 |  BC Extra  |  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...
02:49 , Jan 5, 2019 |  BioCentury  |  Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
17:03 , Jan 4, 2019 |  BC Week In Review  |  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...
21:56 , Jan 2, 2019 |  BC Extra  |  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....