Thu, Oct. 22, 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).
Thu, Oct. 22, 6:01 AM
Wed, Oct. 21, 5:30 PM
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Tue, Aug. 25, 9:19 AM| Tue, Aug. 25, 9:19 AM | 7 Comments
Mon, Aug. 24, 5:36 PM
Mon, Aug. 24, 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.
Thu, Jul. 30, 6:06 AM
Wed, Jul. 29, 5:30 PM
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Tue, Jun. 16, 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.
Tue, Jun. 2, 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.
Wed, May 27, 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.
Thu, Apr. 30, 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.
Thu, Apr. 30, 6:07 AM
Wed, Apr. 29, 5:30 PM
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Wed, Apr. 22, 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).
Thu, Feb. 26, 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%)
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