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Acorda Therapeutics (ACOR) Tops Q1 EPS by 12c; Updates on Pipeline

May 6, 2014 6:06 AM EDT

Acorda Therapeutics (NASDAQ: ACOR) reported Q1 EPS of $0.21, $0.12 better than the analyst estimate of $0.09. Revenue for the quarter came in at $80.52 million versus the consensus estimate of $81.3 million.

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended March 31, 2014, the Company reported AMPYRA net revenue of $72.5 million compared to $62.3 million for the same quarter in 2013.

ZANAFLEX CAPSULES®(tizanidine hydrochloride), ZANAFLEX® (tizanidine hydrochloride) tablets and authorized generic capsules - For the quarter ended March 31, 2014, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $3.1 million compared to $4.4 million for the same quarter in 2013.

FAMPYRA® (prolonged-release fampridine tablets) - For the quarter ended March 31, 2014, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.4 million, compared to $2.9 million for the same quarter in 2013. Royalties in 2013 included a favorable adjustment of $1.0 million from the establishment of pricing in Germany.

PIPELINE UPDATE

  • In May, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZ™ (diazepam) Nasal Spray for the treatment of people with epilepsy who experience cluster seizures. The Company is evaluating the CRL and expects to work closely with the FDA to address the items outlined in the letter, which will include additional clinical work, and refile the NDA. Based on the requirements noted in the letter, the Company does not expect PLUMIAZ to receive FDA approval in 2014.
  • In April, the Company announced that additional data on QD (once-daily) dalfampridine extended release tablets are needed before starting a Phase 3 trial in post-stroke walking deficits, and now expects to begin the trial in the second half of 2014. Previously the Company had projected study initiation in the second quarter of 2014. The developer of the once-daily formulation informed the Company of an alcohol dose dumping finding in vitro and the Company will need to perform a short clinical study to determine whether this also exists in vivo. The clinical study will be conducted in healthy volunteers and is expected to be completed in the third quarter of 2014.
  • In April, the Company announced that it has completed its review of certain preclinical data and that the Phase 1b clinical trial of GGF2 in chronic heart failure will resume recruitment. The single-intravenous infusion trial is assessing tolerability of three dose levels of GGF2 and also includes several exploratory efficacy measures. The Company expects that the trial will be completed in 2015.
  • The Company has completed the dose escalation portion of the Phase 1b rHIgM22 clinical trial, with no serious or limiting adverse events reported. The second portion of this study will explore safety, tolerability and efficacy endpoints for six months in additional patients at the two highest doses achieved in the dose escalation portion of the trial. Enrollment in the second part of the trial is almost complete.

For earnings history and earnings-related data on Acorda Therapeutics (ACOR) click here.



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