Mon, Jan. 12, 8:52 AM| Comment!
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
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
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
Sep. 24, 2014, 10:01 AM
- Alkermes plc (ALKS +0.4%), through its subsidiary Alkermes, Inc., will reap some financial benefits from Acorda's (ACOR +17.3%) $525M acquisition of Civitas. It will receive $30M for the sale of certain commercial-scale pulmonary manufacturing equipment used by Civitas and ~$29M for its ~6% stake in the privately-held firm.
- The payments will not impact Alkermes' non-GAAP net income.
Sep. 24, 2014, 9:20 AM
Sep. 24, 2014, 8:51 AM
Sep. 24, 2014, 8:08 AM
- Acorda Therapeutics (NASDAQ:ACOR) acquires privately-held Chelsea, MA-based Civitas Therapeutics for $525M in cash. The transaction enables Acorda to obtain worldwide rights to CVT-301 (inhaled L-dopa), a Phase 3 product candidate for the treatment of OFF episodes in patients with Parkinson's disease. Estimated U.S. sales of CVT-301 are expected to be at least $500M.
- Acorda will hold a conference call this morning at 8:30 am ET to discuss the transaction.
Jul. 31, 2014, 8:40 AM
Jul. 31, 2014, 6:13 AM
Jul. 30, 2014, 5:30 PM
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Acorda Therapeutics, Inc. is a biopharmaceutical company. It is engaged in the identification, development & commercialization of novel therapies for the treatment of multiple sclerosis, spinal cord injury & other disorders of the central nervous system.
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