| Date | Title | | | 08/05/10 | Alkermes Reports First Quarter Fiscal 2011 Financial Results| -- Company Preparing for FDA Action in October on VIVITROL® and BYDUREON(TM) --
-- Financial Strength Enables Early Redemption of All Outstanding Debt --
WALTHAM, Mass., Aug 05, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today reported financial results for its first quarter of fiscal 2011, which ended on June 30, 2010.
Financial highlights:
Quarterly revenues of $42.3 million, driven by strong manufacturing and royalty revenues from RISPERDAL® CONSTA®. Worldwide ... |
|  | | 07/29/10 | Alkermes to Host Conference Call to Discuss Financial Results for
First Quarter of Fiscal 2011| WALTHAM, Mass., Jul 29, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) will host a conference call at 4:30 p.m.
ET on Thursday, August 5, 2010, to discuss the company's financial
results for the first quarter of fiscal 2011. Management will review the
quarter and provide an update on the company.
The conference call will be webcast on the investor relations section of
Alkermes' website at www.alkermes.com
or may be accessed by dialing 1-888-424-... |
| | | 06/26/10 | BYDUREON™ Safety and Tolerability Pooled Summary Data Presented at ADA 2010|
ORLANDO, Fla., June 26, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results of an analysis of pooled safety data from three completed randomized controlled trials that showed the investigational product BYDUREON™ (exenatide extended-release for injectable suspension), dosed once weekly, was generally well-tolerated with a low discontinuation rate due to serious adverse events sim... |
| | | 06/17/10 | Alkermes Announces Notification of Tentative FDA Advisory Committee Meeting to Review VIVITROL® for Opioid Dependence| WALTHAM, Mass., Jun 17, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence. Notification of this potential advisory committee mee... |
| | | 06/15/10 | DURATION-4 Study Results: BYDUREON™ Efficacy and Tolerability Profile Extended to Monotherapy Treatment| SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Jun 15, 2010 (BUSINESS WIRE) --Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON™ (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.
This 26-week clinical study comp... |
| | | 06/02/10 | Alkermes' Corporate Presentation to be Webcast at Two Upcoming Conferences| WALTHAM, Mass., Jun 02, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live at the Bank of America Merrill Lynch Smid Cap Conference on Wednesday, June 9, 2010, at 2:30 p.m. ET from the InterContinental Hotel in Boston. In addition, Alkermes' corporate presentation will be webcast live at the Jefferies Global Life Sciences Conference on Thursday, June 10, 2010, at 4:30 p.m. ET from the Grand Hyatt Hotel in New York City. The p... |
| | | 05/25/10 | Alkermes Announces Priority Review by FDA for VIVITROL® for Opioid Dependence|
-- FDA Designation Underscores Need for New Treatment Options --
-- Potential First and Only Non-Narcotic, Non-Addictive Medication for Opioid Dependence Available in a Once-Monthly Formulation --
WALTHAM, Mass., May 25, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and D... |
| | | 05/19/10 | Data on VIVITROL® to be Presented at Upcoming American Psychiatric Association Annual Meeting| WALTHAM, Mass., May 19, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today announced that new data from several company-sponsored studies of naltrexone for extended-release injectable suspension (XR-NTX) are scheduled to be presented at the 2010 American Psychiatric Association (APA) Annual Meeting in New Orleans, May 22-26, 2010.
XR-NTX is marketed by Alkermes as VIVITROL® and is approved in the U.S. for the treatment of alcohol dependence. The company recently submitted a supplementa... |
| | | 05/13/10 | Alkermes Reports Financial Results for Fiscal 2010 and Provides Financial Expectations for Fiscal 2011| -- Reports Record RISPERDAL® CONSTA® Revenue in Fiscal 2010 --
-- Strong Financial Position Enables Rapid Pipeline Expansion --
WALTHAM, Mass., May 13, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today reported financial results for its fiscal year ended March 31, 2010, and provided financial expectations for fiscal 2011.
Financial highlights:
Total revenues of $178.3 million for fiscal 2010.
Record manufacturing and royalty revenues from RISPERDAL® CONSTA® of $146.0 mil... |
| | | 05/06/10 | BYDUREON™ FDA Review Timeline Set with PDUFA Action Date of October 22, 2010| SAN DIEGO, INDIANAPOLIS, & WALTHAM, Mass., May 06, 2010 (BUSINESS WIRE) --Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
"If approved, BYDUREON ... |
| | | 05/05/10 | Alkermes to Host Conference Call to Discuss Fiscal Year 2010
Financial Results| WALTHAM, Mass., May 05, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) will host a conference call at 4:30 p.m.
ET on Thursday, May 13, 2010, to discuss the company's financial results
for the fiscal year ended March 31, 2010. Management will also provide
financial expectations for fiscal year 2011.
The conference call will be webcast on the investor relations section of
Alkermes' website at www.alkermes.com
or may be accessed by dialing 1-888-424... |
| | | 04/26/10 | Alkermes to Provide Update on Advancing Product Portfolio and
Proprietary Platforms at R&D Day| -- Announcement of BYDUREON(TM) Royalty Rate --
-- Pipeline Highlights Include New Long-Acting Olanzapine
Antipsychotic Candidate; Expanded Indications for ALKS 33, Including
Binge Eating Disorder; and Phase 2 Initiation of ALKS 37 for
Treatment
of Opioid-Induced Constipation --
WALTHAM, Mass. & NEW YORK, Apr 26, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today will present an update on the
progress of its late-stage and emerging clinical pro... |
| | | 04/22/10 | Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON™| Classification of Submission and New PDUFA Action Date Expected Within 14 Days, per FDA Guidelines
SAN DIEGO, INDIANAPOLIS & WALTHAM, Mass., Apr 22, 2010 (BUSINESS WIRE) --Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submis... |
| | | 04/19/10 | Alkermes to Webcast R&D Day on Monday, April 26, 2010| WALTHAM, Mass., Apr 19, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today announced that it will webcast its Research and Development (R&D) Day being held on Monday, April 26, 2010, at the Nasdaq MarketSite. The webcast will begin at 12:30 p.m. ET and will run until approximately 3:00 p.m. ET. At the meeting, members of the Alkermes team and a guest speaker will provide an update on the company's growing pipeline, proprietary platforms and overview the scientific rationale underlyin... |
| | | 04/13/10 | Alkermes Submits Supplemental New Drug Application for VIVITROL® for the Treatment of Opioid Dependence| -- Potential to Improve Treatment Options as the First and Only Non-Narcotic, Non-Addictive Medication for Opioid Dependence --
-- Company Requests Six Month Priority Review --
WALTHAM, Mass., Apr 13, 2010 (BUSINESS WIRE) --Alkermes, Inc. (NASDAQ: ALKS) today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dep... |
| | | 03/17/10 | Alkermes Announces Initiation of Multidose Phase 1 Clinical Study of ALKS 37 for the Treatment of Opioid-Induced Constipation| WALTHAM, Mass., Mar 17, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily or... |
| | | 03/15/10 | Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission| -BYDUREON™ (exenatide for extended-release injectable suspension) Proposed Name-
SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., March 15, 2010 /PRNewswire via COMTEX News Network/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide for extended-release injectable su... |
| | | 03/02/10 | Alkermes' Corporate Presentation to be Webcast at the Cowen and Company 30th Annual Health Care Conference| WALTHAM, Mass., Mar 02, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live at the Cowen and Company 30th Annual Health Care Conference on Monday, March 8, 2010, at 2:30 p.m. ET from the Boston Marriott Copley Place. The presentation may be accessed under the investor relations tab at www.alkermes.com. The presentation will be archived for 14 days.
Alkermes, Inc. is a fully integrated biotechnology company committed to deve... |
| | | 02/25/10 | Exenatide Once Weekly New Drug Application Review Extended by FDA Due to Weather-Related Closure| SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Feb 25, 2010 (BUSINESS WIRE) -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA). The revised action date is the result of the FDA's decision to allow five additional days ... |
| | | 02/16/10 | Alkermes Announces Positive Results for Phase 1 Study of New Drug Candidate for Treatment of Opioid-Induced Constipation|
- ALKS 37 Targets Gastrointestinal Track with Limited Systemic Exposure-
- Company Plans to Initiate Additional Clinical Studies in First Half of Calendar 2010 -
WALTHAM, Mass., Feb 16, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced positive topline data from a phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioi... |
| | | 02/04/10 | Alkermes Unveils Long-Acting Injectable Proprietary Platform for Treatment of Schizophrenia and Other CNS Disorders| - Company's Lead Candidate, ALKS 9070, is an Extended-Release, Once-Monthly Version of Aripiprazole -
- Platform Expands CNS Franchise and Leverages Expertise in Extended-Release Medications -
WALTHAM, Mass., Feb 04, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today announced that it has developed a novel, proprietary LinkeRx(TM) technology platform to enable the creation of injectable extended-release versions of antipsychotics and other central nervous system (CNS) therapies. Th... |
| | | 02/04/10 | Alkermes Reports Third Quarter Fiscal 2010 Financial Results|
-- Record Sales of RISPERDAL® CONSTA® --
-- Company Expands Proprietary Pipeline to Include Long-Acting Versions of Two Blockbuster Medications --
WALTHAM, Mass., Feb 04, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today reported financial results for its third quarter of fiscal 2010, which ended on December 31, 2009.
Financial highlights:
Quarterly revenues of $44.2 million, driven by record manufacturing and royalty revenues from RISPERDAL® CONSTA® . Worldwide sales o... |
| | | 02/01/10 | Alkermes' Corporate Presentation to be Webcast at the BIO CEO & Investor Conference| WALTHAM, Mass., Feb 01, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live by the Biotechnology Industry Organization on Monday, February 8, 2010, at 3:00 p.m. ET from The Waldorf Astoria Hotel in New York City. The presentation may be accessed under the investor relations tab at www.alkermes.com. The presentation will be archived for 14 days.
Alkermes, Inc. is a fully integrated biotechnology company committed to developi... |
| | | 01/28/10 | Alkermes to Host Conference Call to Discuss Financial Results for Third Quarter of Fiscal 2010| WALTHAM, Mass., Jan 28, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) will host a conference call at 4:30 p.m. ET on Thursday, February 4, 2010, to discuss the company's financial results for the third quarter of fiscal 2010. Management will review the quarter and provide an update on the company.
The conference call will be webcast on the investor relations section of Alkermes' website at http://www.alkermes.com/ or may be accessed by dialing 1-888-424-8151 for domestic callers and 1-... |
| | | 01/06/10 | Alkermes' Corporate Presentation to be Webcast at the 28th Annual JPMorgan Healthcare Conference| CAMBRIDGE, Mass., Jan 06, 2010 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) announced today that its corporate presentation will be webcast live by JPMorgan on Wednesday, January 13, 2010 at 8:30 a.m. PT (11:30 a.m. ET) from the Westin St. Francis Hotel in San Francisco. The presentation may be accessed under the investor relations tab at www.alkermes.com. The presentation will be archived for 14 days.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innov... |
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