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ACOR

Acorda Therapeutics

$21.30

0.05 (0.24%)

06:05
11/21/16
11/21
06:05
11/21/16
06:05

Acorda Therapeutics to discontinue development of dalfampridine

Acorda Therapeutics announced that the MILESTONE clinical study did not show sufficient efficacy to support further development of dalfampridine to improve post-stroke walking difficulties. "We are disappointed by this outcome. The study indicated there was activity related to walking in people with PSWD, as suggested by the prior Phase 2 study, but overall this was not sufficiently clinically meaningful. I want to express our gratitude to the study participants, their care partners and clinicians, who gave their time and commitment to this research," said Ron Cohen, M.D., President and CEO of Acorda. "This outcome underscores the risks that companies in the biopharmaceutical industry must take in order to develop innovative medicines. Over the past three years, we have successfully diversified our pipeline portfolio to account for this risk. We plan to focus R&D resources on developing our promising late-stage Parkinson's disease therapies, CVT-301 and tozadenant, as well as advancing our earlier stage assets, CVT-427 in migraine, SYN120 in Parkinson's disease dementia, and rHIgM22 in MS." As part of the PSWD development program, a multi-dose pharmacokinetic study confirmed the Company has developed a potentially viable once-daily formulation of dalfampridine. The Company elected to stop enrollment and to conduct an unblinded analysis of the MILESTONE trial after reaching enrollment of 377 participants. This analysis included 368 participants who received either 10 mg or 7.5 mg of dalfampridine twice daily or placebo. The primary outcome measure of the study was the proportion of participants who showed at least a 20% improvement on the Two Minute Walk Test at Week 12 as compared to baseline. The 2MinWT measures the distance a subject can walk in 2 minutes, and is a validated scale used to assess walking capacity. The study found that 23 of 121 (19.0%) participants receiving 10 mg of dalfampridine BID and 17 of 121 (14.0%) participants receiving 7.5 mg of dalfampridine BID showed at least a 20% improvement on the 2MinWT, compared to 17 of 126 (13.5%) participants receiving placebo. In this study, dalfampridine was well tolerated in the post-stroke population. The safety profile overall was similar to that observed in multiple sclerosis clinical trials and post-marketing surveillance. The most common adverse events (greater than or equal to 5%) reported in this study were: falls (10 mg: 10.7%, 7.5 mg: 9.5%, placebo: 5.6%), urinary tract infections (10 mg: 9.0%, 7.5 mg: 6.3%, placebo: 2.4%), dizziness (10 mg: 3.3%, 7.5 mg: 7.9%, placebo: 2.4%) and fatigue (10mg: 2.5%, 7.5 mg: 3.2%, placebo: 6.3%). There were no seizures reported in the dalfampridine 10 mg group. There were 2 seizures reported in the 7.5 mg group and 3 reported in the placebo group.

  • 29

    Nov

ACOR Acorda Therapeutics
$21.30

0.05 (0.24%)

03/30/16
GSCO
03/30/16
DOWNGRADE
Target $10
GSCO
Neutral
Dimension Therapeutics downgraded to Neutral from Buy at Goldman
Goldman Sachs analyst Salveen Richter downgraded Dimension Therapeutics (DMTX) to Neutral saying other names in the sector offer better near-term opportunities. The analyst views Dimension as well-positioned in the gene therapy space, however. He lowered his price target for the shares to $10 from $12. Richter this morning also initiated SAGE Therapeutics (SAGE) with a Buy rating and Acorda Therapeutics (ACOR) with a Sell rating.
03/30/16
03/30/16
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Intercept (ICPT) initiated with an Outperform and a Neutral at Credit Suisse and Goldman, respectively. Goldman Sachs analyst Salveen Richter said investor expectations into the April 7 FDA panel for obeticholic acid in primary biliary cholangitis appear high. 2. Acorda Therapeutics (ACOR) initiated with a Sell at Goldman by analyst Salveen Richter, who said Acorda's lead product Ampyra is close to fully realizing its commercial opportunity and that intellectual property threats will present an overhang on the shares. 3. SAGE Therapeutics (SAGE) initiated with a Buy at Goldman due to the belief that the company is a key player in acute central nervous system disorders. 4. Rio Tinto (RIO) initiated with a Buy at Argus. 5. Square (SQ) initiated with a Buy at Mizuho. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
10/04/16
LEER
10/04/16
INITIATION
Target $25
LEER
Market Perform
Acorda Therapeutics reinstated with a Market Perform at Leerink
Leerink analyst Paul Matteis resumed coverage of Acorda Therapeutics with a Market Perform rating and $25 price target.
10/07/16
GSCO
10/07/16
NO CHANGE
GSCO
Smid-cap Biotech sector upgraded to Attractive from Neutral at Goldman
Goldman analyst Salveen Richter upgraded the Smid-cap biotechnology to Attractive and said he favors and companies with near-term pipeline data or regulatory events where he has conviction.Names he recommends are Buy rated BioMarin (BMRN), bluebird bio (BLUE), GW Pharma (GWPH), Incyte (INCY), Kite (KITE), and Sage (SAGE).

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