Tesaro(TSRO)- NASDAQ
  • Mon, Sep. 12, 10:45 AM
    • The FDA designates TESARO's (TSRO) niraparib for Fast Track review for the treatment of recurrent platinum-sensitive ovarian, fallopian tube and peritoneal cancer. The company has initiated its rolling New Drug Application (NDA) submission and expects to complete the filing in Q4.
    • Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the NDA.
    • Niraparib is an orally administered PARP inhibitor.
    | Mon, Sep. 12, 10:45 AM
  • Tue, Aug. 23, 3:52 PM
    • Battered and bruised Clovis Oncology (CLVS +31%) recaptures some its former glory on the news that the FDA has accepted for review its New Drug Application (NDA) seeking approval of Breakthrough Therapy-tagged rucaparib for the treatment of advanced ovarian cancer in patients with BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations and who have been treated with least two chemo regimens.
    • The NDA has Priority Review status which shortens the review clock to six months from the usual 10 months. The agency's action date (PDUFA) is February 23, 2017.
    • In two late-stage studies, the overall objective response rate for rucaparib-treated ovarian cancer patients was 54% (n=57/106).
    • Rucaparib is a small molecule poly ADP-ribose polymerase (PARP) inhibitor that specifically binds to PARP-1 and PARP-2. PARPs are proteins that play a key role in repairing single-strand breaks in DNA. By inhibiting their action, multiple DNA breaks form during the replication process in tumor cells that have the BRCA1, BRCA2 or PALB2 mutation which leads to cell death.
    • Clovis had lost ~90% of its value since late 2015 when it stumbled with rociletinib. Shares have rebounded of late.  They are up more than 113% since bottoming at $11.57 on June 27.
    • PARP inhibitor competitor TESARO (TSRO -5.9%) slumps on the news.
    | Tue, Aug. 23, 3:52 PM | 18 Comments
  • Fri, Aug. 19, 8:01 AM
    • Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $15 (112% upside) price target by Cantor Fitzgerald.
    • Karyopharm Therapeutics (NASDAQ:KPTI) initiated with Buy rating and $15 (92% upside) price target by H.C. Wainwright.
    • Mediwound Ltd. (NASDAQ:MDWD) initiated with Outperform rating and $14 (75% upside) price target by Wells Fargo.
    • SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $15 (436% upside) price target by Guggenheim Securities.
    • Patheon NV (Pending:PTHN) initiated with Neutral rating and $30 (7% upside) price target by Credit Suisse. Initiated with Buy rating and $32 (14% upside) price target by Jefferies. Initiated with Overweight rating and $31 (11% upside) price target by Morgan Stanley.
    • GlycoMimetics (NASDAQ:GLYC) initiated with Outperform rating by Cowen and Company. Initiated with Outperform rating and $32.50 (306% upside) price target by Raymond James.
    • Audentes Therapeutics (Pending:BOLD) initiated with an Outperform rating by Cowen and Company. Initiated with Outperform rating and $20 (33% upside) price target by Wedbush.
    • Mallinckrodt (NYSE:MNK) initiated with Buy rating and $95 (19% upside) price target by Stifel Nicolaus.
    • TESARO (NASDAQ:TSRO) initiated with Outperform rating and $122 (28% upside) price target by RBC Capital.
    | Fri, Aug. 19, 8:01 AM | 1 Comment
  • Thu, Aug. 4, 4:27 PM
    • Tesaro (NASDAQ:TSRO): Q2 EPS of -$1.28 beats by $0.43.
    • Revenue of $36.56M beats by $31.58M.
    • Press Release
    | Thu, Aug. 4, 4:27 PM | 1 Comment
  • Wed, Aug. 3, 5:35 PM
  • Fri, Jul. 22, 8:31 AM
    • OncoSec Medical (NASDAQ:ONCS) initiated with Buy rating and $6 (253% upside) price target by Rodman & Renshaw.
    • Invivo Therapeutics Holdings (NASDAQ:NVIV) initiated with Buy rating and $23.25 (254% upside) price target by Ladenburg Thalmann.
    • TESARO (NASDAQ:TSRO) initiated with Outperform rating and $105 (14% upside) price target by Baird.
    • Selecta Biosciences (Pending:SELB) initiated with Buy rating and $23 (64% upside) price target by Stifel Nicolaus.
    • Syros Pharmaceuticals (NASDAQ:SYRS) initiated with Neutral rating and $10 (11% downside risk) price target by H.C. Wainwright.
    • Voyager Therapeutics (NASDAQ:VYGR) initiated with Buy rating and $33 (161% upside) price target by Stifel Nicolaus.
    • AveXis (NASDAQ:AVXS) initiated with Market Perform rating by Wells Fargo.
    • Celgene (NASDAQ:CELG) initiated with Buy rating and $150 (40% upside) price target by Stifel Nicolaus.
    • ReWalk Robotics (NASDAQ:RWLK) initiated Overweight rating and $10 (49% upside) price target by Piper Jaffray.
    | Fri, Jul. 22, 8:31 AM
  • Fri, Jul. 1, 10:28 AM
    • GlaxoSmithKline (NYSE:GSK) upgraded to Buy from Neutral by Citigroup. Price target is 1800p (14% upside).
    • Alexion Pharmaceuticals (NASDAQ:ALXN) upgraded to Buy from Neutral by Citigroup. Price target is $154 (29% upside).
    • IPG Photonics (NASDAQ:IPGP) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $90 (13% upside) from $85.
    • Centene (NYSE:CNC) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $86 (21% upside) from $84.
    • Pacira Pharmaceuticals (NASDAQ:PCRX) downgraded to Hold from Buy by Brean Capital.
    • TESARO (NASDAQ:TSRO) downgraded to Hold from Buy by Jefferies.
    • Esperion Therapeutics (NASDAQ:ESPR) downgraded to Equal Weight from Overweight with a $13 (26% upside) price target (from $28) by Barclays. Downgraded to Neutral from Overweight with a $15 (46% upside) price target (from $50) by JPMorgan. Downgraded to Underperform from Neutral with a $10 (0% upside) price target (from $23) by Credit Suisse.
    • HeartWare International (NASDAQ:HTWR) downgraded to Market Perform from Outperform by Wells Fargo. Downgraded to Neutral from Buy with a $58 (0% upside) price target (from $60) by SunTrust Robinson Humphrey.
    • Regulus Therapeutics (NASDAQ:RGLS) downgraded to Market Perform from Outperform by BMO Capital. Price target lowered to $4 (30% upside) from $16.
    • HealthSouth (NYSE:HLS) downgraded to Underweight from Equal Weight by Barclays. Price target lowered to $42 (8% upside) from $45.
    • SciQuest (NASDAQ:SQI) downgraded to Market Perform from Outperform by Raymond James.
    • Quest Diagnostics (NYSE:DGX) downgraded to from Neutral to Sell by Jyske Bank.
    | Fri, Jul. 1, 10:28 AM | 5 Comments
  • Thu, Jun. 30, 9:42 AM
    • TESARO (TSRO -3.6%announces the initiation of an underwritten public offering of $300M of common stock. Price, volume and terms have yet to be released.
    • Update: On July 1, the company announced that its offering is 4.65M shares of common stock at $81/share. Underwriters over-allotment is an additional 697.5K shares. Net proceeds should be ~$355.6M. Closing date is July 7. Yesterday's close was $84.12.
    | Thu, Jun. 30, 9:42 AM | 3 Comments
  • Wed, Jun. 29, 12:46 PM
    | Wed, Jun. 29, 12:46 PM
  • Wed, Jun. 29, 11:10 AM
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  • Wed, Jun. 29, 9:24 AM
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  • Wed, Jun. 29, 9:16 AM
    | Wed, Jun. 29, 9:16 AM | 3 Comments
  • Wed, Jun. 29, 9:05 AM
    • TESARO (NASDAQ:TSRO) is up 69% premarket on robust volume in response to its announcement of positive results in a Phase 3 clinical trial, NOVA, assessing PARP inhibitor niraparib in women with ovarian cancer, including those who are germline BRCA mutation carriers and those who are not germline BRCA carriers but who have homologous recombination deficient (HRD) tumors [as determined by Myriad Genetics' (NASDAQ:MYGN) myChoice HRD test].
    • NOVA was a ~500-subject, double-blind, placebo-controlled study in patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy.
    • Patients treated with niraparib experienced median progression-free survival (PFS) of 21.0 months compared to 5.5 months for placebo (p<0.0001) with 62% less risk of dying in the study period (hazard ratio = 0.38).
    • The most common treatment-emergent grade 3 (serious) or grade 4 (disabling or life threatening) adverse events were thrombocytopenia (28.3%), anemia (24.8%) and neutropenia (11.2%). The discontinuation rate was 14.7% for niraparib versus 2.2% for placebo.
    • There is no currently approved therapy in the U.S. for maintenance treatment of patients with recurrent ovarian cancer following response to platinum.
    • The company plans to file regulatory submissions in the U.S. and Europe in Q4.
    | Wed, Jun. 29, 9:05 AM | 7 Comments
  • Fri, Jun. 3, 7:37 AM
    • Bayer (OTCPK:BAYRY) and Espoo, Finland-based Orion expand their 2014 agreement to jointly develop BAY-1841788 (ODM-201) in prostate cancer, currently in Phase 3 development (ARAMIS study) for the treatment of high-risk non-metastatic castration-resistant prostate cancer.
    • The new indication will be for the treatment of newly diagnosed metastatic hormone-sensitive prostate cancer, in combination with docetaxel, in men who are starting first-line hormone therapy.
    • A Phase 3 study, called ARASENS, will begin enrolling patients in late Q4. The double-blind, placebo-controlled trial will randomize ~1,300 subjects 1:1 to receive either BAY-1841788 (ODM-201) or placebo in combination with an androgen deprivation therapy of the investigator's choice started no more than 12 weeks before randomization. The primary endpoint is overall survival.
    • BAY-1841788 is an oral androgen receptor antagonist.
    • Prostate cancer-related tickers: (NASDAQ:MDVN)(OTCPK:ALPMY)(NYSE:VRX)(NASDAQ:TTHI)(NASDAQ:EDAP)(NASDAQ:TKAI)(NYSE:JNJ)(NASDAQ:TSRO)(NYSE:AZN)(NASDAQ:EGRX)(NASDAQ:OGXI)
    | Fri, Jun. 3, 7:37 AM
  • Fri, May 20, 7:32 AM
    • Arrowhead Pharmaceuticals (NASDAQ:ARWR) initiated with Buy rating and $12 (140% upside) price target by Chardan Capital.
    • Amicus Therapeutics (NASDAQ:FOLD) initiated with Buy rating and $10 (45% upside) price target by Bank of America.
    • Quorum Health (NYSE:QHC) initiated with Equal Weight rating and $12 (2% upside) price target by Morgan Stanley.
    • TESARO (NASDAQ:TSRO) initiated with Outperform rating and $56 (30% upside) price target by Credit Suisse.
    • Prothena (NASDAQ:PRTA) initiated with Overweight rating and $60 (47% upside) price target by Barclays.
    • Mazor Robotics (NASDAQ:MZOR) upgraded to Outperform from Market Perform by Wells Fargo. Price target raised to $15-17 (14% upside from midpoint) from $10-13.
    • Eli Lilly (NYSE:LLY) upgraded to Strong Buy with a price target of $88.67 (19% upside) by the Vetr Community.
    • Haemonetics (NYSE:HAE) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $29 (5% upside) from $25.
    • Nanosphere (NASDAQ:NSPH) downgraded to Neutral from Buy by Rodman & Renshaw. Price target lowered to $1.35 (2% upside) from $2.00.
    • Anacor Pharmaceuticals (NASDAQ:ANAC) downgraded to Neutral from Buy by Mizuho Securities. Price target set at $99.25 (0% upside).
    • Globus Medical (NYSE:GMED) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $21 (10% downside risk) from $26.
    • EPIRUS Biopharmaceuticals (NASDAQ:EPRS) downgraded to Market Perform from Outperform by Leerink Swann. Price target lowered to $0.75 (27% upside).
    | Fri, May 20, 7:32 AM | 10 Comments
  • Thu, May 5, 4:42 PM
    • Tesaro (NASDAQ:TSRO): Q1 EPS of -$2.22 misses by $0.53.
    • Revenue of $0.31M misses by $2.17M.
    • Press Release
    | Thu, May 5, 4:42 PM