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Tue, Jan. 19, 6:58 AM
- Acorda Therapeutics (NASDAQ:ACOR) makes an all-cash tender offer of €0.2946 per share on the Nasdaq Helsinki index for Biotie Therapies (NASDAQ:BITI). The offer price per ADS is €23.5680 or $25.60 based on a dollar/euro exchange rate of 1.0864, representing a 94% premium over Friday's close of $13.20.
- Acorda CEO Dr. Ron Cohen says, "Our acquisition of Biotie positions Acorda as a leader in Parkinson's disease therapeutic development, with three clinical-stage compounds that have the potential to improve the lives of people with Parkinson's. Tozadenant, Biotie's most advanced clinical program, is a promising therapy being developed to reduce daily OFF time. Adenosine A2a receptor antagonists may be the first new class of drugs approved for the treatment of Parkinson's in the U.S. in over 20 years. Tozadenant is a compelling opportunity with potential market exclusivity to 2030. We are targeting an NDA filing by the end of 2018."
- The deal also includes Phase 2-stage SYN-120 for Parkinson's dementia, BTT1023 for primary sclerosing cholangitis and Selincro for the reduction of alcohol consumption (marketed by Lundbeck A/S in certain European countries).
Dec. 10, 2015, 11:24 AM
- Acorda Therapeutics (ACOR +0.4%) settles its patent infringement lawsuit against Hyderabad, India-based Aurobindo Pharma that resulted from the latter's filing of an Abbreviated New Drug Application (ANDA) seeking clearance for a generic version of Ampyra (dalfampridine) Extended-Release Tablets.
- Under the terms of the settlement, Aurobindo will be permitted to market a generic formulation of Ampyra in the U.S. at a specific date in 2027, or earlier under certain circumstances.
- The latest expiring patent covering Ampyra is May 2027 per the FDA's Orange Book.
Dec. 3, 2015, 8:13 AM
- Acorda Therapeutics (NASDAQ:ACOR) commences a 32-subject Phase 1 single ascending dose study assessing the safety, tolerability and pharmacokinetics of CVT-427 at four different dosages in healthy volunteers. According to clinicaltrials.gov, the estimated study completion date is February 2016.
- CVT-427, under development for the treatment of migraines, is a novel inhaled formulation of zolmitriptan based on the company's ARCUS technology platform, a dry powder pulmonary delivery system. Triptans, the leading class of drugs for acute treatment of migraines, are usually administered in pill form.
- CVT-427's value proposition is a more rapid onset of action versus a pill and avoidance of relying on the digestive system to deliver the drug. As many as 90% of migraine sufferers have experienced nausea at least once during an attack with more than 50% routinely experiencing nausea that is so debilitating that they delay or forgo taking an oral medication.
- Migraines affect 36M Americans and over 40M Europeans.
Oct. 22, 2015, 9:50 AM
- Acorda Therapeutics (ACOR +5.3%) Q3 results: Revenues: $148.2M (+39.8%); COGS: $24.9M (+20.3%); R&D Expense: $43.4M (+161.4%); SG&A: $51.1M (+6.9%); Operating Income: $25.7M (+23.6%); Net Income: $3.9M (-66.4%); EPS: $0.09 (-67.9%); Quick Assets: $323.4M (+5.1%).
- 2015 Guidance: AMPYRA Net Revenue: $420M - 430M from $410M - 420M; R&D Expense: $140M - 150M (unch); SG&A Expense: $180M - 190M (unch).
Oct. 22, 2015, 6:01 AM
- Acorda Therapeutics (NASDAQ:ACOR): Q3 EPS of $0.31 beats by $0.16.
- Revenue of $148.2M (+39.9% Y/Y) beats by $32.68M.
Oct. 21, 2015, 5:30 PM
- AB, ACAT, ACOR, ADS, AEP, ALK, APOL, ASPS, BCC, BEN, BHE, BMS, CAB, CAM, CAT, CBU, CEMP, COR, CRS, CY, DAN, DGX, DHR, DLX, DNKN, DOW, DPS, DST, EQM, EQT, FAF, FCX, FNB, GMT, GPK, GRA, HBAN, HUB.B, IVC, JNS, LAZ, LLY, LUV, MCD, MHO, MINI, MJN, MMM, NDAQ, NUE, NWE, ORI, PCP, PDS, PENN, PH, PHM, PRLB, PTEN, R, RCI, RS, RTN, SIRI, SJR, SNA, SQNS, STC, SWK, TCB, TROW, UA, UAL, UNP, USG, UTEK, WAB, WBC, WCC, XRS
Aug. 25, 2015, 9:19 AM| Aug. 25, 2015, 9:19 AM | 7 Comments
Aug. 24, 2015, 5:36 PM
Aug. 24, 2015, 5:35 PM
- Acorda Therapeutics (NASDAQ:ACOR) +24.3% AH after the U.S. Patent and Trademark Office denies a patent challenge against the company from Kyle Bass' Coalition For Affordable Drugs of ACOR's multiple sclerosis drug Ampyra.
- The board declines to begin a review of the patent, which expires in 2025; the decision is not subject to appeal.
- Ampyra is the only prescription medicine indicated to help improve walking in adults with MS.
Jul. 30, 2015, 6:06 AM
- Acorda Therapeutics (NASDAQ:ACOR): Q2 EPS of $0.31 beats by $0.14.
- Revenue of $113.71M (+17.1% Y/Y) beats by $2.87M.
Jul. 29, 2015, 5:30 PM
- AAWW, AB, ACI, ACIW, ACOR, ACRE, ADP, ALKS, ALLE, ALU, ALXN, AMRC, APD, AVP, AWI, AZN, BC, BCO, BG, BLL, BUD, BWA, BWEN, CAH, CBB, CBM, CBR, CCE, CCJ, CEVA, CI, CL, CME, COP, COT, CPN, CRL, CRR, CRS, CSH, CVE, CVI, CVRR, DBD, DCIX, DFT, DLPH, EDR, EME, ENTG, EPD, ERJ, ESI, EXLS, FCAU, FCN, FIG, FMS, GG, GHM, GLOP, GLPI, GNC, GOV, GTLS, GVA, HEES, HOT, HP, HST, I, IART, IDA, IDCC, IDXX, INGR, IRDM, IRM, IT, ITC, IVZ, KMT, LBY, LINE, LKQ, LLL, MD, MDLZ, MDP, MDXG, MMYT, MOBL, MPC, MPLX, MSCI, MTRN, MWW, NAVB, NICE, NMM, NNN, NOK, NTCT, ODFL, OSK, OXY, PBI, PCRX, PES, PF, PG, PNK, PNW, POT, PRFT, PWE, RDS.A, RFP, RTIX, RYAM, RYL, SC, SCG, SEE, SHOO, SHOP, SMP, SNE, SNMX, SSYS, SUI, SWK, TASR, TDY, TE, TEX, TFX, TKR, TMUS, TWC, TWI, UAN, UFS, UPL, VA, VG, VICL, VLO, VLY, WST, WWE, XEL, XRAY, XYL, YNDX, ZBH
Jun. 16, 2015, 10:38 AM
- A Phase 2b study assessing Acorda Therapeutics' (ACOR +2%) CVT-301, an inhaled levodopa, met its primary endpoint of demonstrating improved motor function in Parkinson's disease (PD) patients experiencing an OFF episode, which is a period in which PD-associated motor symptoms re-emerge.
- The trial randomized 86 subjects to self-administer CVT-301 or placebo as an adjunct to oral PD medications. Efficacy was measured by the Unified Parkinson's Disease Rating Scale Part 3 (UPDRS III). The higher the score the more severe the symptoms. Patients receiving CVT-301 showed a statistically significant reduction in average UPDRS III motor scores versus placebo (p<0.01) across all measured time points.
- The data were presented at the 19th International Congress of Parkinson's Disease and Movement Disorders in San Diego, CA.
Jun. 2, 2015, 10:45 AM
- In a regulatory filing, Acorda Therapeutics (ACOR -3.2%) discloses that it instituted a hold on its Phase 1b clinical trial assessing cimaglermin alfa in heart failure due to a case of hepatotoxicity defined by elevated liver enzymes and bilirubin. There was one case of liver toxicity in the earlier Phase 1 that resolved within several days. The company is investigating the pathological basis for the liver effects.
- Cimaglermin alfa is a neuregulin, a family of naturally occurring protein growth factors that have multiple effects on the nervous and cardiovascular systems.
May 27, 2015, 8:59 AM
- Based on discussions with the FDA, Acorda Therapeutics (NASDAQ:ACOR) clarifies the development path for its Plumiaz (diazepam) Nasal Spray for the treatment of stable epileptic patients who are experiencing increased seizure activity, known as seizure clusters or acute repetitive seizures (ARS). The company originally submitted its New Drug Application (NDA) in 2013, but received a Compete Response Letter (CRL) from the agency stating that additional clinical work would be required before approval.
- Three clinical trials will support the refiling of the NDA. The first is a 52-week, open-label study assessing the safety and tolerability of Plumiaz in ~100 patients. It was started in late 2014 and should be completed by H2 2016. The second is a pharmacokinetic dose proportionality study in healthy adults that is on tap to begin next quarter and should be completed in H1 2016. The third is an open-label, randomized, crossover study to assess the bioavailability, safety and tolerability of Plumiaz compared to diazepam rectal gel (Valeant Pharmaceuticals' Diastat) in ~120 subjects that will commence this quarter and finish in Q4 2016. If all are completed successfully, the NDA will be filed in Q1 2017.
- The company believes peak U.S. sales could surmount $200M per year.
Apr. 30, 2015, 11:31 AM
- Acorda Therapeutics (ACOR -4.6%) Q1 results: Revenues: $99.9M (+24.1%); COGS: $18.6M (+18.5%); R&D Expense: $30.6M (+111.0%); SG&A: $48.8M (+4.1%); Operating Loss: ($1.3M) (-138.2%); Net Loss: ($3.1M) (-542.9%); Loss Per Share: ($0.07) (-450.0%); Quick Assets: $299.7M (-2.6%).
- 2015 Guidance: AMPYRA Net Revenue: $405M - 420M; R&D Expense: $150M - 160M; SG&A Expense: $180M - 190M.
Apr. 30, 2015, 6:07 AM
- Acorda Therapeutics (NASDAQ:ACOR): Q1 EPS of $0.15 beats by $0.01.
- Revenue of $99.85M (+24.0% Y/Y) misses by $0.37M.
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