Wed, Jun. 22, 8:38 AM
- Karyopharm Therapeutics (NASDAQ:KPTI) announces the dosing of the first patient in a Phase 1 clinical trial evaluating KPT-9274 in patients with advanced solid malignancies (including sarcoma, colon and lung cancer) or Non-Hodgkin's Lymphoma (NHL) whose disease has relapsed after standard treatment.
- This first trial will enroll up to 175 patients. The primary endpoints are to determine the recommended Phase 2 dose and the maximum tolerated dose of KPT-9274 administered alone and with extended release niacin, and to evaluate safety and tolerability. The key secondary endpoint is to assess anti-tumor activity in patients predicted to be more sensitive to PAK4/NAMPT inhibition, including those with NAPRT-deficient tumors and tumors harboring IDH1 mutations.
- According to ClinicalTrials.gov, the primary endpoint is overall response rate. The estimated final data collection date for the primary outcome measure is May 2017. The estimated study completion date is December 2017.
- Small molecule KPT-9274 inhibits two enzymes, p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT). Co-inhibition of both targets is believed to fight cancer through the suppression of beta-catenin by blocking PAK4, leading to immune cell activation and restriction of tumor growth, energy depletion via NAMPT inhibition, blockade of DNA repair, cell cycle arrest and ultimately apoptosis (cell death).
Fri, May 27, 4:56 PM
- Globus Medical (NYSE:GMED) initiated with Equal Weight Rating and $26 (8% upside) price target by Barclays.
- TG Therapeutics (NASDAQ:TGTX) initiated with Buy rating $18 (133% upside) price target by SunTrust Robinson Humphrey.
- Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Outperform rating and $13 (35% upside) price target by Raymond James.
- SAGE Therapeutics (NASDAQ:SAGE) initiated with Sell rating and $18 (43% downside risk) price target by Chardan Capital.
- Viking Therapeutics (NASDAQ:VKTX) initiated with Buy rating with a $5 (285% upside) price target by Maxim Group.
- Fibrocell Science (NASDAQ:FCSC) resumed with Buy rating and $7 (229% upside) price target by Roth Capital Partners.
- Asterias Biotherapeutics (NYSEMKT:AST) initiated with Buy rating and $5.50 (61% upside) price target by Chardan Capital.
- Quorum Health (NYSE:QHC) initiated with Market Perform rating and $14 (6% upside) price target by Avondale Partners.
- Radius Health (NASDAQ:RDUS) initiated with Buy rating and $55 (57% upside) price target by H.C. Wainwright.
- Johnson & Johnson (NYSE:JNJ) initiated with Sell rating and $94 (17% downside risk) price target by Standpoint Research.
- NuVasive (NASDAQ:NUVA) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $63 (15% upside) from $58.
- Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Buy from Hold with a $125 (2% upside) price target by Argus Research.
- Relypsa (NASDAQ:RLYP) upgraded to Equal Weight from Underweight with a $9 (50% downside risk) price target by Morgan Stanley. To be adjusted after ZS-9 rejection.
- Ionis Pharmaceuticals (NASDAQ:IONS) downgraded to Market Perform from Outperform by BMO Capital Markets. Price target lowered to $26 (18% upside) from $55.
- Patterson Companies (NASDAQ:PDCO) downgraded to Hold from Buy by Evercore ISI. Price target lowered to $48.50 (0% upside) from $49.50.
- United Therapeutics (NASDAQ:UTHR) downgraded to Sell from Hold with a $114 (3% downside risk) price target by Argus Research.
- Boston Scientific (NYSE:BSX) downgraded to Neutral from Buy with a $24.20 (7% upside) price target by BTIG Research.
- Neovasc (NASDAQ:NVCN) downgraded to Neutral from Buy by Ladenburg Thalmann. Price target removed.
Mon, May 9, 7:32 AM
Tue, May 3, 5:37 PM
Mon, Mar. 14, 7:32 AM
Thu, Jan. 14, 7:41 AM
- Karyopharm (NASDAQ:KPTI) commences a Phase 2/3 clinical trial, SEAL, assessing oral selinexor in patients with advanced liposarcoma, a rare cancer that originates in fat cells in deep soft tissue.
- SEAL is a multicenter, double-blind, placebo-controlled study that will randomize 50 patients to receive either 60 mg of selinexor or placebo twice weekly per six-week cycle until cancer progression or intolerability. The primary endpoint is progression-free survival. Top-line results from the Phase 2 portion are expected in early 2017.
- The data supporting the initiation of the study was generated in a Phase 1b trial that showed 14 of 18 patients with liposarcoma experienced a longer period of stable disease compared to their most recent therapy. Six achieved stable disease for greater than four months. The survival rate for recurrent and high-grade forms of liposarcoma is less than 5%.
- Selinexor is a SINE (Selective Inhibitor of Nuclear Export) compound. It binds to and inhibits the nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression. It is also under development for the treatment of multiple myeloma, diffuse large B-cell lymphoma and acute myeloid leukemia.
Wed, Jan. 6, 12:45 PM
Nov. 10, 2015, 5:40 PM
Nov. 9, 2015, 7:32 AM
- Karyopharm Therapeutics (NASDAQ:KPTI): Q3 EPS of -$0.85 beats by $0.02.
- Revenue of $0.08M (+300.0% Y/Y) beats by $0.01M.
Aug. 10, 2015, 12:45 PM
Aug. 10, 2015, 7:32 AM
- Karyopharm Therapeutics (NASDAQ:KPTI): Q2 EPS of -$0.92 misses by $0.15.
- Revenue of $0.15M (+650.0% Y/Y) beats by $0.06M.
Jul. 20, 2015, 5:39 PM
Jun. 22, 2015, 8:13 AM
- Interim results from a Phase 1 study assessing Karyopharm Therapeutics' (NASDAQ:KPTI) lead product candidate, selinexor (KPT-330), in relapsed refractory diffuse large B-cell lymphoma (DLBCL) showed a 43% overall response rate in 14 evaluable patients (n=6/14). There were two complete responses and four partial responses. Two additional patients had stable disease. The data were presented at the 13th International Conference on Malignant Lymphoma in Lugano, Switzerland.
- Selinexor binds to and inhibits nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus. This amplifies their tumor suppression capabilities and leads to selective apoptosis (cell death) in cancer cells.
Jun. 15, 2015, 7:47 AM
- A Phase 1b study evaluating Karyopharm's (NASDAQ:KPTI) lead product candidate, selinexor (KPT-330), in heavily pre-treated patients with diffuse large B-cell lymphoma showed an overall response rate of 43% in patients on study at least one month and a 31% overall response rate across all doses in the intent-to-treat population. The median duration of response was greater than nine months. Median overall survival and progression-free survival were 4.6 months and 1.7 months, respectively.
- The data were presented at the 20th Congress of the European Hematology Association in Vienna, Austria.
- Selinexor is a SINE (Selective Inhibitor of Nuclear Export) compound. It binds to and inhibits the nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression.
- Clinical development is ongoing.
May 11, 2015, 7:20 AM
- Karyopharm Therapeutics (NASDAQ:KPTI): Q1 EPS of -$0.74 misses by $0.01.
Mar. 16, 2015, 7:15 AM
- Karyopharm Therapeutics (NASDAQ:KPTI): Q4 EPS of -$0.79 misses by $0.14.
- Revenue of $16K (-23.8% Y/Y) misses by $24K.
Karyopharm Therapeutics, Inc. is a clinical-stage pharmaceutical company. It is focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Its selective inhibitors of nuclear export... More
Industry: Drug Manufacturers - Major
Country: United States
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