Acorda Therapeutics, Inc. (ACOR)

https://marketexclusive.com/...-run-money-migraine-drug-market/69612/

Acorda Therapeutics Inc (NASDAQ:ACOR) inhaled migraine candidate CVT-427 is seen by Janney analyst Ken Trbovich

... (automatisch gekürzt) ...

https://marketexclusive.com/...-run-money-migraine-drug-market/69612/

 

http://finance.yahoo.com/quote/ACOR/profile?p=ACOR

Acorda Therapeutics, Inc., a biopharmaceutical company, identifies, develops, and commercializes novel therapies for neurological disorders

... (automatisch gekürzt) ...

http://finance.yahoo.com/quote/ACOR/profile?p=ACOR

 

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced Phase 3 clinical data of CVT-301, showing a statistically significant improvement in motor function in people with Parkinson’s disease experiencing OFF periods. CVT-301 is an investigational, inhalable formulation of levodopa (L-dopa). It is being studied as a treatment for OFF periods in people with Parkinson’s disease taking an oral carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms.

“We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive Phase 2b results,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We would like to express our gratitude to the study volunteers and clinical investigators who participated in this trial to advance our understanding of this potentially important therapy for people with Parkinson’s.”

The SPAN-PD trial had three arms: CVT-301 84 mg and 60 mg doses (equivalent to 50 mg and 35 mg fine particle doses, respectively), and placebo. The primary endpoint of the study was the change at Week 12 in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the 84 mg dose. UPDRS III change for the 84 mg dose was -9.83 compared to -5.91 for placebo (p=0.009). UPDRS III is a validated scale, which measures Parkinson’s motor impairment.

The safety profile of CVT-301 in this study was consistent with that observed in the Phase 2b trial. Spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) tests showed no notable pulmonary safety signals. The Company is currently conducting two studies to assess the long-term safety profile of CVT-301. Up to 12-month data from these studies are expected by the end of the first quarter of 2017.

The Company plans to file a New Drug Application (NDA) in the United States by the end of the second quarter of 2017, pending results of the long-term safety studies. The Company also plans to file a Marketing Authorization Application (MAA) in Europe by the end of 2017, pending additional data analyses.

Peter LeWitt, M.D., M.Med.Sc., Director of the PD and Movement Disorders Program at Henry Ford Hospital and lead investigator of the study said, “The re-emergence of Parkinson’s disease symptoms has a major negative impact on the lives of people with this disease, as well as on their families and care partners. Managing symptoms of OFF periods continues to be a significant unmet need for people taking oral carbidopa/levodopa regimens. Delivering levodopa by the pulmonary route offers an important treatment option for people with Parkinson’s disease.”

Detailed trial results will be presented at a future medical meeting.  

https://seekingalpha.com/news/...tive-results-parkinsons-disease-drug  

Gab es dann gestern auch schon! Könnte bald richtig rocken hier!  

 

http://www.analystratings.com/articles/...a-buy-rating-from-cowen-co/  

https://www.streetinsider.com/Corporate+News//...atents/14592158.html  

FDA erteilt Zulassung, Aktien interessiert es nicht

https://endpts.com/...da-ok-so-does-that-make-them-a-takeover-target/

 

Acorda meldet Zahlen für 2018

• Q4/18 Umsätze  ~69 Mio. $ (vgl. 188 Mio. $ in Q4/17)
  
  • Ampyra verlor Exklusivität
    
  • Generika eroberten den Markt
    
• 2018 Umsätze ~471 Mio. $ (vgl. 588 Mio. $)
  
• Q4/18 Gewinn ~10 Mio. $ (EPS 0,20$)
  
• 2018 Gewinn ~34 Mio. $ (EPS 0,71$)
  

http://ir.acorda.com/investors/investor-news/...End-2018/default.aspx

 

https://seekingalpha.com/news/...cs-chief-business-officer-bids-adieu  

sucht weiter seinen Boden  

Ampyra Umsätze fallen um 60%

• Umsätze 44 Mio. $
  
• Verlust 48 Mio. $
  
• Cash 343 Mio. $
  
• MK 479 Mio. $
  

http://ir.acorda.com/investors/investor-news/...-31-2019/default.aspx

 

• neues 52 Wochen-Tief bei 9,25$ markiert
  
• MK 451 Mio. $
  

 

• neues 52 Wochen-Tief
  
• MK 416 Mio. $
  

 

• neues 52 Wochen-Tief
  
• MK 345 Mio. $
  

 

Acorda Therapeutics meldet Zahlen für Q2/19

• Umsatz 50 Mio. $
  
• Verlust 27 Mio. $
  
• Cash 297 Mio. $
  
• MK 292 Mio. $
  
• MK = Cash
  

http://ir.acorda.com/investors/investor-news/...-30-2019/default.aspx

https://seekingalpha.com/news/...peutics-eps-beats-0_51-beats-revenue

 

• neues 52 Wochen-Tief
  
• MK 159 Mio. $
  

 

"In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline"

• Ampyra ~44 Mio. $ in Q2/19 von 150 Mio. $ in Q2/18
  

http://ir.acorda.com/investors/investor-news/...-30-2019/default.aspx

 

Ok, die Exklusivitätsrechte sind weg. Allerdings ist der Cashbestand doppelt so hoch wie die Mk...  

Wenn Generika auf den Markt kommen, dann sind Umsatzeinbrüche vorprogrammiert, darauf hat Acorda ja schon deutlich hingewiesen. Weniger Umsatz = mehr Verlust, bei gleichbleibenden Kosten. Hier fehlen zur Zeit einfach die positiven Katalysatoren. MK 118 Mio. $, aber wie will ACOR gegen den Trend stemmen? Neues 52 Wochen-Tief!
 

Restrukturierung --> 25% der Belegschaft soll entlassen werden

http://ir.acorda.com/investors/investor-news/...9-Update/default.aspx

 

Hier die vorraussichtlichen Umsatzzahlen für Q3/19

• INBRIJA 4,9 Mio. $ (kommerziell verfügbar seit 03/19)  
  
• AMPYRA 37,6 Mio. $
  
  • Vergleiche mit 137,8 Mio. $ in Q3/18  
    
• Cash 253 Mio. $
  
• MK 87 Mio. $
  

Ausblick Ausgaben 2019 vs. 2020

•  R&D expenses for the full year 2019 are expected to be $55 - $60 million,
  
  • reduced from $70 - $80 million
    
• SG&A expenses for the full year 2019 are expected to be $185 - $190 million,
  
  • reduced from $200 - $210 million  
    
• R&D expenses for the full year 2020 are expected to be $20 - $25 million
  
• and SG&A expenses for the full year 2020 are expected to be $160 - $165 million  
  

 

Habe gestern 4000 gekauft und dann gleich 3000 wieder zu 1,47 verkauft und heute für 1,59.
Man könnte ich mich ärgern. Allerdings findet man ganz schwer Nachrichten und Meldungen.  

https://seekingalpha.com/news/3514674-acorda-21-percent-q3-beat