-=Acorda Therapeutics (ACOR) : INBRIJA to be commercialized in Spain

 

ARDSLEY, N.Y., July 22, 2021--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has entered into distribution and supply agreements with Esteve Pharmaceuticals S.A (ESTEVE) to commercialize INBRIJA® 33 mg (levodopa inhalation powder, hard capsules) in Spain. INBRIJA is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. 

Under the terms of the supply agreement, ACORDA will receive a significant double-digit percent of the selling price of INBRIJA in Spain in exchange for supply of the product. ESTEVE will have the exclusive distribution rights to INBRIJA in the territory and ACORDA will supply the product to ESTEVE. ESTEVE expects to launch INBRIJA in Spain in the fourth quarter of 2022.

According to current population estimates, there are at least 300,000 people living with Parkinson's disease in Spain, and there is one new case per 10,000 people per year; these incidence and prevalence rates are similar to those in the rest of Europe.

This week's biggest % winners & losers : July 29 - Aug 2, 19 (wk 31)

The following are this week's top percentage gainers and losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top % gainers

• Healthcare: MYGN (47.08 +62.74%), APHA (7.33 +33.27%), ACAD (28.73 +23.09%), CHRS (20.02 +19.95%), MEDP (76.48 +19.95%)
• Industrials: ENPH (29.12 +40%), QUAD (11.39 +37.39%), ACCO (9.64 +18.57%)
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• Financials: CURO (12.7 +21.76%), COOP (9.04 +16.8%)
• Energy: NBR (2.62 +19.09%)

This week's top % losers

• Healthcare: ACOR (3.10 -54.28%),  FLDM (8.05 -32.41%), ABMD (200.62 -26.42%), VAPO (14.55 -26.22%)
• Materials: OI (12.38 -30.06%)
• Industrials: FLR (22.67 -31.2%), GVA (31.22 -30.06%), NSP (102.61 -29.05%), AAWW (32.75 -28.31%)
• Consumer Discretionary: ASNA (0.33 -25.4%)
• Information Technology: TWOU (13.68 -61.54%), PS (18.62 -39.41%)
• Energy: MDR (5.38 -47.46%), SPN (0.54 -34.01%), ESV (5.02 -30.95%)

-=Acorda Therapeutics (ACOR) reported earnings on Thur 1 Aug 2019 (a/h)

Acorda Therapeutics (ACOR) came out with a quarterly loss of $0.55 per share versus the Zacks Consensus Estimate of a loss of $1.06. This compares to earnings of $1.40 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of 48.11%. A quarter ago, it was expected that this drugmaker would post a loss of $0.97 per share when it actually produced a loss of $0.56, delivering a surprise of 42.27%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Acorda, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $50.05 million for the quarter ended June 2019, surpassing the Zacks Consensus Estimate by 91.32%. This compares to year-ago revenues of $153.30 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Acorda shares have lost about 55.5% since the beginning of the year versus the S&P 500's gain of 18.9%.

=Acorda (ACOR) : FDA delays review of Parkinson's treatment

Shares of Acorda Therapeutics(ACOR) slid 19% Thursday, after the company said the U.S. Food and Drugs Administration has extended the review period for a treatment for symptoms of Parkinson Disease. The extension comes after Acorda submitted additional information on its Inbrija, an inhaled levodopa therapy that aims to reduce off times, or the periods when standard levodopa treatment stops working. The FDA determined that the additional information constituted a major amendment that would take longer to review. The regulator moved the review date back to Jan. 5, 2019 from Oct. 5, 2018. Parkinson's is a progressive neurodegenerative disorder that affects about 1 million people in the U.S. and 1.2 million people in Europe. Acorda shares have fallen 13.8% in 2018, while the S&P 500 SPX, +0.04% has gained 8.1%.

=Acorda Therapeutics (ACOR) : FDA rejects application for Parkinson's treatment

Acorda Therapeutics received a Refusal to File letter from the FDA regarding its NDA for INBRIJA; co will seek immediate guidance, including a Type A meeting with the FDA, to respond to the issues

• Upon its preliminary review, FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review. FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF.
• The Company will seek immediate guidance, including a Type A meeting with the FDA, to respond to the issues, which it believes are addressable, and to seek clarification of what additional information will be required. The FDA has not requested or recommended additional clinical efficacy or safety studies.

This week's biggest % winners & losers : Oct 19 - 23, 15 (wk 43)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare:ADAP (9.71 +33.38%),NWBO (5.14 +22.67%),ATHN (163.37 +22.02%), QSII (15.05 +21.18%),NEO (7 +19.05%), ACOR (36.14 +17.38%),INFI(10.41 +17.1%),ONCE (61.81 +17.04%)
• Materials:SA (8.91 +29.32%),BCC (32.87 +17.06%)
• Industrials:TBI (28.69 +27.85%),HA (34.84 +17.66%)
• Consumer Discretionary:LILA (40.96 +19.28%),LILAK (40.95 +17.27%)
• Information Technology:NTGR (41.85 +29.57%),GIMO (27.23 +23.72%),KLAC (65.35 +23.37%),QLGC (13.25 +22.57%)
• Energy:HLX (6.39 +20.57%)
• Telecommunication Services:EGHT (10.59 +17.28%)

This week's top 20 % losers

• Healthcare: OCUL (7.18 -55.95%),ENTA (24.01 -40.44%),CYH (28.71 -31.51%),PTCT (25.6 -27.38%),RLYP (13.8 -26.08%),MMSI (17.91 -25.9%),NVCR (19.52 -24.87%),RMTI (10.25 -23.85%),RGNX (14.15 -23.72%),EVHC (27.57 -22.79%),BDSI (5.28 -22.35%)
• Industrials:HURN (46.62 -26.33%)
• Consumer Discretionary:EROS (14.65 -44.55%),SKX (31.64 -29.92%),APOL(7.42 -28.24%),PSO (13.69 -25.72%),CAB (33.6 -23.02%),ACAT (19.9 -21.34%)
• Information Technology:P (12.39 -37.77%),RMBS (10.65 -22.66%)

Acorda Therapeutics (ACOR) reported earnings on 10/22/15 b/o

** charts after earnings **

• Acorda Therapeutics (ACOR)  (biotechnology)

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