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Apr. 29, 2015, 5:30 PM
- AAWW, AB, ABC, ACIW, ACOR, ADP, AIT, ALKS, ALLE, AMT, ANR, APD, ARG, ARW, AVP, AWI, BCE, BDC, BG, BKCC, BLL, BWA, BZH, CAH, CCE, CDK, CELG, CI, CL, CME, COMM, COP, CRR, CRS, CSH, CTCM, CVI, CVRR, CWEI, CY, DBD, DIN, DLPH, EME, EPD, ERJ, EXLS, FCN, FIS, FMS, FSS, GEO, GG, GLOP, GNC, GNRC, GOV, GTI, GTLS, HAR, HEES, HST, HUN, I, IDA, IMAX, INCY, INGR, IRDM, ITC, ITG, IVZ, LBY, LKQ, LLL, LPLA, MD, MGLN, MINI, MLM, MMC, MOS, MPC, MPLX, MSCI, MTRN, MVIS, NBIX, NI, NOK, NTCT, NVO, NYT, OAK, ODFL, OMG, PBI, PCRX, PES, PF, POT, PSX, PSXP, PWE, PWR, RDS.A, RDWR, RGLD, RGS, ROK, RYL, SCG, SEE, SHPG, SMP, SNAK, SNE, SNMX, STM, STRZA, TASR, TDY, TEVA, TFX, THRM, TKR, TWC, TWI, UAN, UFS, UPL, VA, VAC, VGR, VIAB, VLY, VNTV, WRLD, WST, WWE, XEL, XOM, XYL, ZMH
Apr. 22, 2015, 4:04 PM
- Hedge fund investor Kyle Bass, head of Dallas, TX-based Hayman Capital Management L.P., files a challenge to a key patent covering Biogen's (BIIB +0.6%) $2.9B Tecifera (dimethyl fumarate). Specifically, he is challenging the validity of U.S. Patent No. 8,759,393 entitled, "Utilization of Dialkylfumarates."
- Mr. Bass founded the group, Coalition for Affordable Drugs, which is targeting the '393 patent via a process called inter partes review, a type of patent challenge allowed by the 2012 American Invents Act. It was designed as a way to curtail the ballooning number of lawsuits by patent trolls. According to him, the group's raison d'etre is to stop companies from over-pricing drugs based on evergreening patents.
- Other companies in the crosshairs of the Coalition for Affordable Drugs include Shire (NASDAQ:SHPG) and Acorda Therapeutics (NASDAQ:ACOR).
Feb. 26, 2015, 10:23 AM
- The European Commission approves Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). The drug was developed by Newron Pharmaceuticals S.p.A. and will be commercialized by privately-held Zambon S.p.A., both based in Italy.
- Xadago's specific indication is for the treatment of mid-to-late stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicines.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- PD-related tickers: (SNY -2.9%)(ABBV -0.2%)(IPXL -0.5%)(NDRM +1.2%)(XNPT)(OTCPK:BIOZF)(ACOR -1.6%)(OTCQX:RHHBY -0.4%)(PRTA -3.4%)(ADMS -2.5%)(TEVA)(OTCQX:CYNAF -0.9%)(OTCQB:TTNP +2.9%)
Feb. 12, 2015, 9:59 AM
- Acorda Therapeutics (ACOR -1.3%) Q4 results: Revenues: $117.9M (+27.3%); COGS: $25.1M (+35.7%); R&D Expense: $25.9M (+81.1%); SG&A: $56.5M (+20.2%); Operating Income: $1.2M (-90.6%); Net Income: $0.3M (-95.2%); EPS: $0.01 (-93.3%).
- FY2014 results: Revenues: $401.5M (+19.4%); COGS: $80.6M (+21.0%); R&D Expense: $73.5M (+36.4%); SG&A: $201.8M (+8.8%); Operating Income: $36.4M (+19.7%); Net Income: $17.7M (+7.9%); EPS: $0.42 (+7.7%); Quick Assets: $307.6M (-16.2%).
- 2015 Guidance: AMPYRA Net Revenue: $405M - 420M; R&D Expense: $150M - 160M; SG&A Expense: $180M - 190M.
Feb. 12, 2015, 6:16 AM
- Acorda Therapeutics (NASDAQ:ACOR): Q4 EPS of $0.01 may not be comparable to consensus of $0.14.
- Revenue of $117.87M (+27.3% Y/Y) beats by $7.11M.
Feb. 11, 2015, 5:30 PM
- AAP, AAWW, AB, ACOR, ANR, APA, AVP, BG, BWA, CAB, CCE, COR, CPLA, CS, CVE, DBD, DPS, FAF, FLO, GNC, HE, HERO, HIMX, HSP, IFF, INCY, JAH, K, LMNS, LNCE, LPNT, MANU, MDWD, MFA, MFC, MHFI, MINI, MPEL, MPW, NCI, NLSN, NNN, NRP, NWE, PDS, PNK, Q, RDN, RTIX, RWLK, RYN, SCOR, SHPG, SKYW, SNI, SON, SPW, STC, THS, TIME, TU, VG, VNTV, WD, WSO, WWAV, WWE
Feb. 9, 2015, 12:21 PM
- The following are healthcare companies whose after-tax margins have expanded the past three quarters and trade at least 500K shares per day:
- (ACOR -0.7%)(BCR -1.5%)(BIIB -0.2%)(CAH -1.2%)(CPHD +1.3%)(EVHC -1.6%)(ILMN +0.7%)(JAZZ -1.7%)(LCI +7.3%)(MNK -0.5%)(SHPG -2.9%)(SYK -0.2%)(TMO -0.7%)(UTHR +1.4%)(VRX).
- This is not a list of "Buy" recommendations, but rather a targeted list of firms that may be suitable for more in-depth research.
Jan. 12, 2015, 8:52 AM
Dec. 15, 2014, 11:52 AM
- Acorda Therapeutics (ACOR -1.3%) enrolls the first patient in a Phase 3 clinical trial assessing the safety and efficacy of dalfampridine for the treatment of post-stroke walking deficits (PSWD). The multi-center, double-blind, randomized study will enroll ~540 patients who have had an ischemic stroke at least six months prior to enrollment. The primary endpoint is the percentage of patients taking dalfampridine who demonstrate at least a 20% improvement in the 2 Minute Walk Test compared to those receiving placebo after 12 weeks of treatment.
- About 3.5M stroke survivors in the U.S. have mobility issues. There are no commercially-available medications for these impairments.
- Ampyra (dalfampridine) is currently approved as a treatment to improve walking in patients with multiple sclerosis.
Dec. 10, 2014, 8:06 AM
- The Phase 3 study of Acorda Therapeutics' (NASDAQ:ACOR) CVT-301 for the treatment of OFF episodes in patients with Parkinson's disease (PD) is underway with the enrollment of the first patient. An OFF episode is a period of time during which PD symptoms such as tremor, muscle stiffness and slow movement reemerge despite taking PD medications.
- CVT-301 is a self-administered inhaled therapy that delivers a precise dose of levodopa through the lungs to return PD patients to an ON state.
- The multi-center, double-blind, randomized Phase 3 trial will enroll ~345 subjects across three treatment arms: 50 mg, 35 mg or placebo. The primary endpoint is improvement on the Unified Parkinson's Disease Rating Scale (UPDRS) Part III.
- Acorda obtained the rights to CVT-301 via its acquisition of Civitas Therapeutics.
- Previously: Acorda to buy biopharma firm (Sept. 24, 2014)
- PD-OFF-related tickers: (OTCQX:CYNAF) (NASDAQ:NDRM) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRTA) (OTCQX:RHHBY)
Oct. 31, 2014, 8:32 AM
- Acorda Therapeutics (ACOR +0.8%) Q3 results: Revenues: $106M (+24.7%); COGS: $20.7M (+19.0%); R&D Expense: $16.6M (+20.3%); SG&A: $47.8M (+13.0%); Operating Income: $20.8M (+82.5%); Net Income: $12M (+60.0%); EPS: $0.28 (+55.6%); Quick Assets: $766.4M (+108.7%).
- 2014 Guidance: AMPYRA Net Revenue: $345M - 350M from $328M - 335M.
Oct. 30, 2014, 6:13 AM
- Acorda Therapeutics (NASDAQ:ACOR): Q3 EPS of $0.65 may not be comparable to consensus of $0.05.
- Revenue of $105.96M (+24.8% Y/Y) beats by $11.26M.
Oct. 29, 2014, 5:30 PM
- ABC, ABMD, ACIW, ACOR, ALLE, ALU, AMAG, AMT, ANR, APD, APO, ATK, AUDC, AVP, BCO, BG, BGCP, BLL, BWA, CAH, CARB, CBM, CEVA, CI, CME, CNSL, COP, COR, CRCM, CRNT, CRR, CVI, CVRR, DBD, DFT, DHX, DST, EPD, EXLS, FCH, FCN, FIG, FIS, GBX, GEL, GG, GLOP, GNC, GOV, GTI, GTLS, HAR, HEES, HGG, HST, I, IDA, IDCC, INCY, INGR, IQNT, IRDM, IRM, ITC, IVZ, JCI, K, KCG, KEM, KMT, LAD, LECO, LKQ, LLL, LPLA, LRN, MA, MD, MDC, MDXG, MGM, MMYT, MO, MOD, MOS, MPC, MPLX, MPW, MSCI, MZOR, NEO, NGD, NI, NILE, NOV, NVO, NYT, O, OAK, OCN, ODFL, OXF, PBI, PCRX, PEG, Q, RDEN, RDN, RDS.A, RFP, RGLD, RTIX, SCG, SHOO, SMP, SNAK, SPAR, SSE, STRA, STRZA, SUI, TASR, TEVA, THRM, TRI, TWC, UAN, UPL, USAC, VICL, VNTV, WLT, WST, WWE, XEL
Oct. 23, 2014, 12:21 PM
- Acora Therapeutics (ACOR +7%) will report Q3 results on October 30 before the open. The conference call will begin at 8:30 am ET.
- Consensus view is EPS of $0.05 on revenues of $95M.
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Sep. 24, 2014, 12:46 PM
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