Farmas USA

iba a decir lo mismo
Futuros -0.7%

Lo de la vuelta también? Jejeje

Bueno, allá van las fases 3 para 2016 que destaca JMP Capital (es extensísimo...)

1a Parte: 1Q, 2Q o 1H2016

¡ Gilead Sciences, sometime before the end of January, Phase III data on TAF in both antigen positive and antigen-negative HBV;

¡ AbbVie, sometime during 1Q16, Phase III data on elagolix for the treatment of endometriosis;

¡ AbbVie, sometime during 1Q16, Phase III DAWN study data on Imbruvica for the treatment of indolent NHL;

¡ Alder Biopharmaceuticals, sometime during 1Q16, data from two Phase IIb trials of ALD403 for the treatment of chronic migraine (one trial will examine a self-administered version of the drug in healthy volunteers);

¡ Alkermes PLC, sometime during 1Q16, data from two Phase III trials, FORWARD-3 and FORWARD-4, exploring the combination of ALKS 5461 and buprenorphine for the treatment of major depressive disorder (MDD);

¡ Astra Zeneca PLC (AZN, NC), sometime during 1Q16, data from the Phase II ATLANTIC study of durvalumab (MEDI 4736) for the treatment of NSCLC (more I/O);

¡ Bavarian Nordic, sometime during 1Q16, interim data from the Phase III PROSPECT trial of Prostvac VF Tricom for the treatment of prostate cancer;

¡ BioMarin Pharmaceuticals, sometime during 1Q16, data from two Phase III trials, PRISM 301 and 302, of PEG-PAL for PKU;

¡ Carbylan Therapeutics, sometime during 1Q16, data from Phase III COR1.1 of Hydros and Hydros-TA for osteoarthritis (the company will also start the Phase III COR1.2 during 1H16);

¡ Celator Pharmaceuticals (CPXX, NC), sometime during 1Q16, data from Phase III study of Vyxeos (CPX-351) for the treatment of AML;

¡ Eleven Biotherapeutics (EBIO, NC), sometime during 1Q16, data from Phase III study of EBI-005 for the treatment of allergic conjunctivitis;

¡ Nektar Therapeutics (NKTR, NC), sometime during 1Q16, data from the first Phase III study of NKTR-181 (mu-opioid analgesic) for the treatment of chronic pain;

¡ Northwest Biotherapeutics (NWBO, NC), sometime during 1Q16, interim efficacy analysis from the Phase III trial of DC-Vax Brain for the treatment of brain cancer (malignant glioma, anaplastic astrocytoma and glioblastoma);

¡ Portola Pharmaceuticals, sometime during 1Q16, data from Phase III APEX trial of betrixaban for the treatment of venous thromboembolism (VTE);

¡ Regeneron Pharmaceuticals, sometime during 1Q16, data from the first Phase III study of dupilumab for atopic dermatitis, and;

¡ Sanofi (SNY, NC), sometime during 1Q16, data from Phase II study in the younger population of Type I diabetics treated with LX4211 (sotagliflozin from Lexicon Pharmaceuticals).

¡ BioCryst Pharmaceuticals (BCRX, MO, $17 PT, Bayko), between January and April, Phase II/III results from the OPuS-2 trial of avoralstat for the treatment of hereditary angioedema (HAE);

¡ Celldex Therapeutics (CLDX, NC), between January and April, Phase III results from the ACT IV trial of Rintega (rindopepimut) for the treatment of brain cancer (malignant glioma, anaplastic astrocytoma and glioblastoma);

¡ Dynavax Technologies (DVAX, NC), between January and April, Phase III data from the HBV-23 immunogenicity trial of HEPLISAV-B for vaccination against hepatitis B virus (HBV) infection;

¡ ArQule (ARQL, NC), sometime in April or May, interim analysis of the Phase III METIV-HCC study of tivantinib for the treatment of HCC including secondary metastases;

¡ Keryx Biopharmaceuticals (KERX, MO, $19 PT), sometime in April or May, final results of the Phase III NDD-CKD study of Auryxia for the anemia of chronic renal failure in patients not on dialysis;

¡ AcelRx Pharmaceuticals (ACRX, NC), between January and June, results of the Phase III trial of ER patients treated with ARX-04 (sublingual sufentanil) for the treatment of moderate to severe pain;

¡ Achaogen (AKAO, NC), between January and June, interim results of two Phase III trials of plazomicin for septicemia/bacteremia and hospital acquired pneumonia (HAP);

¡ Amgen, between January and June, results of the Phase III FRAME trial of romosozumab for the treatment of post-menopausal osteoporosis (PMO);

¡ Amicus Therapeutics (FOLD, NC), between January and June, results of the Phase III SD-005 trial of Zorblisa (scioderm) for the treatment of epidermolysis bullosa;

¡ Array Biopharma (ARRY, NC), between January and June, results of the Phase III COLUMBUS trial of the combination of binimetinib (ARRY-162, MEK inhibitor) and encorafenib (LGX-818, BRAF inhibitor) for the treatment of melanoma;

¡ Array Biopharma, between January and June, results of the Phase III AfFIRM trial of filanesib (ARRY-520) for the treatment of relapsed/refractory multiple myeloma;

¡ AstraZeneca, between April and June, results of the Phase III POLO study of Lynparza (olaparib) for the treatment of pancreatic cancer as well as Phase III results of the OlympiAD trial of Lynparza for the treatment of breast cancer;

¡ AstraZeneca will also release top-line results of the Phase II SELECT-2 trial of selumetinib (MEK inhibitor licensed from Array) for the treatment of NSCLC between April and June;

¡ AstraZeneca (busy time period for the company), between April and June, will release top-line results of the Phase III trial of benralizumab (anti-IL5 antibody) for the treatment of asthma;

¡ Auris Medical AG (EARS, MO, $12 PT, Bayko), between April and June, will release top-line results of two Phase III trials, TACT2 and TACT3, of AM-101 for the treatment of tinnitus;

¡ Bayer AG, during 1H16, will present top-line data from two Phase III trials, INHALE1 andINHALE2, of amikacin inhale (Nektar 061) for the treatment of hospital acquired pneumonia;

¡ bluebird bio (BLUE, NC), during 1H16, will present top-line data from the Phase II/III Starbeam trial of Lenti-D (lentiviral vector encoding ABCD1 cDNA) for the treatment of adrenomyeloneuropathy/ adrenoleukodystrophy;

¡ Cara Therapeutics, during 1H16, will present top-line data from the CLIN3001 trial of CR845 for the treatment of post-surgical pain, and well as an interim analysis of a second Phase III trial of CR845 for the same indication;

¡ Celgene, during 1H16, will present top-line data from the Phase III CLL-002 study of Revlimid for the maintenance treatment of relapsed (second line) CLL;

¡ GW Pharmaceuticals (GWPH, between April and June, will present data from two Phase III trials, GWEP1414 and GWEP1423, of Epidolex (cannabidiol), for the treatment of Lennox-Gastaut Syndrome;

¡ Innocoll, between April and June, will present data from two Phase III trials, MATRIX-1 and MATRIX-2, of XaraColl for the treatment of post-surgical pain;

¡ NewLink Genetics (NLNK, NC) will present top-line results from a Phase IIb/III trial of hyperacute lung (tergenpantucel-L) for the treatment of relapsed Stage IIIb/IV NSCLC;

¡ Novartis has a slew of data releases during 1H16 for a swath of molecularly targeted therapies, including: Phase III data from the BELLE3 trial of buparlisib (pan-Class I PI3 kinase inhibitor) in combination with fulvestrant for the treatment of locally advanced or metastatic HR+/HER2- breast cancer that has progressed after treatment with an aromatase inhibitor; Phase III ASPIRE results of Promacta (eltrombopag) for the treatment of MDS; Phase II/III results from the RESILIENT study of BYM338 (targets activin receptor IIB) for the treatment of sporadic inclusion body myositis (sIBM), and; Phase III results of the Phase III MONALEESA study of LEE011 (ribociclib) in combination with letrozole for the treatment of HR+/HER2- advanced breast cancer who have received no prior therapy for advanced disease.

¡ OPKO Health (OPK, during 1H16, will disclose top-line data from the Phase III trial of Lagova (CTP-modified human growth hormone, partnered with Pfizer) for the treatment of short stature/hormone deficiency;

¡ Shire Pharmaceuticals, during the April-June timeframe, will present Phase II/III data from the AIM-IT trial of SHP609 (idursulfase) for intrathecal injection for the treatment of MPS II/Hunter Syndrome (SHP609 has both orphan and fast track designation);

¡ Synergy Pharmaceuticals (SGYP, NC), sometime during 1H16, will present the top-line, Phase III data from Study 1 of plecanitide (peptidic guanyl cyclase C agonist) for the treatment of irritable bowel syndrome (IBS);

¡ TauRx, a privately-held biopharmaceutical company based in Singapore, will present top-line, Phase III data of LMTX, a disruptor of Tau proteins, for the treatment of Alzheimer’s disease sometime during 1H16 (if the data are positive, the results could disrupt what we think we know about the disease);

¡ Tesaro (TSRO, NC), sometime between April and June, will present data from two trials of the PARP inhibitor, niraparib, for the treatment of ovarian cancer-a Phase III, randomized trial (NOVA) for the maintenance use of niraparib in platinum sensitive ovarian cancer, and a singlearm, open label Phase II trial (QUADRA) in patients with advanced, relapsed, high grade serous ovarian cancer with three or more prior lines of therapy;

¡ Teva Pharmaceuticals (TEVA, NC) will disclose interim top-line Phase II/III results from the ARM-TD study of Austedo (deutetrabenazine) for the treatment of tardive dyskenesia (TD) sometime during 1H16;

¡ TG Therapeutics (TGTX, NC) should report sometime during 1H16 the top-line results of the Phase III GENUINE study that examines the use of the anti-CD20 antibody, ublituximab (TG-1101), in conjunction with Imbruvica for the treatment of previously treated, high risk CLL/SLL,

¡ Tonix Pharmaceuticals (TNXP, NC) will release top-line data from the Phase III AFFIRM trial of cyclobenzaprine (TNX-102, Tonmya) for the treatment of fibromyalgia during 2Q16;

2a Parte: 3Q , 4Q o 2h2016

¡ Aerie should also report out the top-line results of the Phase III MERCURY 1 trial of Roclatan for the treatment of glaucoma or ocular hypertension late in 3Q16 or early in 4Q16;

¡ Alexion Pharmaceuticals, one of the megacap leaders, should report out the first of three Phase III trials designed to extend the company’s Soliris franchise, with top-line results for the Myasthenia Gravis indication reading out between June and September;

¡ Alkermes PLC will read out the third of three Phase III trials of ALKS 5461 plus buprenorphine for the treatment of MDD sometime between late 2Q16 and the end of 3Q16;

¡ Anthera Pharmaceuticals (ANTH, NC) will release Phase III top-line results of the CHABLIS-SC1 study of blisibimod (a peptibody drug licensed from Amgen) for the treatment of lupus (SLE) sometime during 3Q16 (the second Phase III, known as BRIGHT-SC for the treatment of IgA nephropathy should read out during 2H16);

¡ CoLucid Pharmaceuticals (CLCD, NC) will present top-line data from the Phase III SAMURAI study of lasmiditan for the treatment of migraine sometime during 3Q16 ( second Phase III will start during 1H16 with a readout during 2H17);

¡ GW Pharmaceutical will present data from the fourth Phase III GWEP1424 study of epidolex for the treatment of Dravet Syndrome sometime during 2Q16 and 3Q16;

¡ Immunomedics (IMMU, NC) will present top-line Phase III data from the PANCRIT study of yttrium-90 clivatuzumab tetraxetan (anti-MUC-1) for third-fifth line pancreatic cancer sometime between 2Q16 and 3Q16;

¡ Infinity Pharmaceuticals (INFI, MO, $24 PT) will present data from the Phase II registrationdirectedDYNAMO study of duvelisib (PI3 gamma/delta kinase inhibitor) for the treatment of refractory indolent non-Hodgkin lymphoma sometime during 3Q16;

¡ Innocoll will release top-line data from two Phase III trials, COACT-1 and -2, of Cogenzia (gentamicin collagen sponge) for the treatment of diabetic foot ulcers during 3Q16;

¡ Insmed (INSM, MO, $24 PT, Bayko) will release top-line Phase III data from the MAC-NTM trial of Arikayce (liposomal amikacin) for the treatment of respiratory tract infections sometime between 2Q16 and 3Q16;

¡ Intra-Cellular Therapies (ITCI, MO, $62 PT, Butler) will present Phase III data sometime between 2Q16 and 3Q16 from the Phase III 302 study of ITI-007 for the treatment of schizophrenia;

¡ Marinus Pharmaceuticals (MRNS, MO, $14 PT, Butler) will release top-line Phase III results from the 1042-0603 study of ganoxalone (allosteric modulator of GABA-A) for the treatment of partial seizures (epilepsy) sometime between 2Q16 and 3Q16;

¡ Novartis will release top-line Phase III data from the EXPAND study of siponimod (S1P receptor modulator) for the treatment of multiple sclerosis sometime between 2Q16 and 3Q16 with potential read-through implications for BIIB and CELG;

¡ Novavax (NVAX, NC) will report out top-line results from the Phase III RESOLVE study of RSV F Vaccine for the prevention of RSV lower respiratory tract disease in older adults during 3Q16;

¡ Rigel Pharmaceuticals (RIGL, NC) will present top-line data from two Phase III trials (FIT 047 and 048) of fostamatinib disodium (SYK inhibitor) for the treatment of ITP (idiopathicthrombocytopenia purpura);

¡ Ultragenyx Pharmaceuticals (RARE, MO, $125 PT, Bayko) will present top-line data from the Phase III study of UX003 enzyme replacement trial for the treatment of MPS VII between 2Q16 and 3Q16 (UX003 has both orphan status and fast track designation);

¡ Ultragenyx Pharmaceuticals will also present top-line data from the Phase III pediatric study of UX003 enzyme replacement trial for the treatment of MPS VII during 4Q16, and;

¡ Versartis (VSAR, NC) will present data from two separate registration-directed trials of somavaratan (VRS-317, a once-monthly human growth hormone) for the treatment of short stature with the first being a Phase II/III Japanese study due in 2Q16/3Q16 and the second being an interim (six-month) analysis of a Phase III trial during 4Q16.

¡ Alexion will issue top-line data from two Phase III, label-expanding trials of Soliris (eculizumab)-one Phase III study (Study 301) examining the use of Soliris for the treatment of neuromyelitis optica (NMO), and the second (PROTECT study) for the treatment of delayed graft function;

¡ Amgen also will issue top-line data from two Phase III trials sometime during 2016-the second Phase III BRIDGE study of romosozumab for the treatment of osteoporosis/osteopenia (the third trial, known as ARCH, will read out sometime during 2017), and the Phase IIb study of AMG334 for the prevention of migraine;

¡ Astellas (ALPMY, NC) will present top-line data sometime during 2H16 for ASP0113 (also known as TransVax or VCL-CB01), a therapeutic vaccine for the treatment of CMV infection;

¡ Incyte (INCY, MO, $133 PT, Bayko) will release data from the Phase III JANUS-1 trial of Jakafi (ruxolitinib) for the treatment of pancreatic cancer (the company will also release data from several Phase II trials in a variety of solid tumors during 2016, while data from JANUS-2 is expected during 2017);

¡ Inotek (ITEK, NC) will release during 4Q16 top-line results from a Phase III study of INO-8875 (trabodenoson, adenosine A1 agonist) for the treatment of glaucoma/ocular hypertension, entering what appears to an increasingly competitive space;

¡ La Jolla Pharmaceuticals (LJPC, NC), competing with a number of other companies in the oldest company without ever developing a successful product (other contenders include Immunomedics and XOMA), will release during 4Q16 top-line data from the Phase III ATHOS study of LJPC-501 (proprietary formulation of angiotensin 1) for the treatment of orthostatic hypertension;

¡ Medivation (MDVN, MO, $65 PT) will present data during 4Q16 from the Phase II ABRAZO study of talazoparib (PARP inhibitor) for the treatment of locally advanced and/or metastatic breast cancer patients with BRA mutations;

¡ Nektar Therapeutics will release data during 4Q16 from the second Phase III trial of NKTR-181 for the treatment of chronic pain;

¡ NewLink Genetics will present data sometime during 2016 from two Phase III trials, IMPRESS and PILLAR, of HyperAcute Pancreas (algenpantucel-L) for the treatment of pancreatic cancer;

¡ Ophtotech Corp. (OPHT, during 4Q16, will unveil Phase III results from two Phase III trials, OPH1002 and OPH1003, of Fovista (pegpleranib sodium) in combination with Lucentis (ranibizumab) vs. Lucentis alone for wet age-related macular edema;

¡ PTC Therapeutics (PTCT, NC) will present during 2H16 data from the Phase III ACT CF study of Translarna (ataluren) for treatment of patients with nonsense mutation cystic fibrosis (CF);

¡ SAGE Therapeutics (SAGE, NC) will describe top-line results of the Phase III STATUS study of SAGE-547 (allopregnalone) for the treatment of seizure disorders (epilepsy) sometime during 2H16;

¡ Synergy Pharmaceuticals will reveal Phase III results from the Phase III Study 2 of plecanatide for the treatment of IBS-C during 2H16;

¡ Teva Pharmaceuticals will disclose interim top-line Phase III results from the AIM-TD study of Austedo (deutetrabenazine) for the treatment of tardive dyskenesia (TD) sometime during 2016 (presumably after the results of the ARM-TD study);

¡ Theravance Biopharma (THRX, NC) will present top-line data during 2016 from two Phase III studies of TP-4208 (GSK-1160724, long acting antimuscarinic antagonist (LAMA)) for the treatment of COPD;

¡ Tokai Pharmaceuticals (TKAI, NC) will present the first Phase III data during 4Q16 from the ARMOR3-SV study of galeterone (TOK-001, inhibitor of androgen receptor and CYP17 lyase) for the treatment of AR-V7 expressing metastatic (M1) prostate cancer vs. Xtandi (enzalutamide);

¡ Versartis will present Phase III data from the VELOCITY trial of Somavert (somavaratan) for the treatment of short stature/growth hormone deficiency during 4Q16;

¡ Vertex Pharmaceuticals (VRTX, MO, $140 PT, Bayko) will have a busy 2016, with data from the Phase II CLEAN-CF trial of VX-371 due during mid-2016 as well as the Phase III study of the combination of VX-661 and Kalydeco (ivacaftor) in patients with minimal CFTR function slated

¡ Zogenix (ZGNX, NC) will present data from two Phase III trials (one US, one Europe) of brabafen (low dose fenfluramine) for the treatment of Dravet syndrome.

Sera hoy el día de regreso a NVAX , por debajo de 7,5$?....se admiten apuestas , ya que esto parece una lotería .....😉

si el SP500 PERDIERA los 1990 se va a liar parda

Creo encuesta. ¿Mercado alcista o bajista para este trimestre?

http://doodle.com/poll/r3mpaxczuhm3r28d

Artículo de Hugo Ferrer

http://inbestia.com/analisis/el-sector-industrial-americano-en-recesion-signo-de-recesion-en-toda-la-economia

Cual es el horizonte temporal? Todo 2016? Entonces me decantaría por decir que lateral (pero veo que no es una opción...). Posiblemente bajistas q1 y q3 y alcistas q2 y q4 (para las presidenciales habrá que vestir bonitos a los índices), pero en el conjunto de 2016 lateral.