Organizational Transitions, Patient Enrollment, Initiation of Clinical Programs, Financial Outlook, and Corporate Updates - Analyst Notes on Insmed, Akebia, Retrophin, Agios and Spectranetics
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NEW YORK, April 23, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Insmed Incorporated (NASDAQ: INSM), Akebia Therapeutics, Inc. (NASDAQ: AKBA), Retrophin, Inc. (NASDAQ: RTRX), Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) and The Spectranetics Corporation (NASDAQ: SPNC). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/1455-100free.
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Insmed Incorporated Analyst Notes
On April 2, 2014, Insmed Incorporated (Insmed) announced organizational transitions and appointments with an aim to better align the organization with the Company's growth opportunities. The Company is seeing opportunities such as the potential commercialization of Insmed's lead product candidate, ARIKAYCE. Under the organizational changes announced, Dr. Renu Gupta, Executive Vice President, Development and Chief Medical Officer, will move to a new role as Special Advisor to the CEO, assisting in evaluating important science and development matters related to ARIKAYCE and advising on other potential ground-breaking scientific advances in the field of pulmonary and infectious disease. Among the leadership changes announced by the Company, the appointments were of John Goll as Vice President, Corporate Controller; Drayton Wise as Senior Director of Commercial Operations; Jill Dolgin as Senior Director of Patient Advocacy and Public Policy; Kevin McDermott as Head of Global Market Access; and Kevin Schutz as Senior Director, Regulatory Affairs. The full analyst notes on Insmed are available to download free of charge at:
http://www.analystsreview.com/1455-INSM-23Apr2014.pdf
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Akebia Therapeutics, Inc. Analyst Notes
On April 15, 2014, Akebia Therapeutics, Inc. (Akebia) announced the completion of the enrollment of a 200-patient Phase 2b study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis. AKB-6548 is designed to achieve a coordinated and natural increase in red blood cell production and iron utilization that is similar to the body's adaptive response to hypoxia, or low oxygen levels, resulting from modest increases in altitude. John P. Butler, President and CEO of Akebia, said, "The completion of enrollment in our Phase 2b study for AKB-6548 is an important milestone for Akebia, and we are working to develop a clinical data package that can position AKB-6548 as the best-in-class new therapy for the treatment of anemia secondary to CKD." Akebia expects to announce results from the Phase 2b study in Q4 2014. The full analyst notes on Akebia are available to download free of charge at:
http://www.analystsreview.com/1455-AKBA-23Apr2014.pdf
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Retrophin, Inc. Analyst Notes
On April 14, 2014, Retrophin, Inc. (Retrophin) reported revisions to its revenue outlook for 2014 and 2015. The Company now anticipates 2014 revenue to range from $19 million to $21 million, compared to its previous revenue forecast of $10 million to $12 million. 2015 revenue is anticipated to be in the range of $35 million to $40 million, compared to its previous forecast of $19 million to $21 million. "Reimbursement of Chenodal has remained robust, and initial efforts to find undiagnosed cerebrotendinous xanthomatosis (CTX) patients are promising," said Martin Shkreli, Founder and CEO of Retrophin. Further, the Company reported that despite several investigator-sponsored IND filings for RE-024 in the U.S., the U.S. FDA has been unwilling to grant a clinical trial through this mechanism. Retrophin has also begun trial initiation activities for Phase III trials of RE-034 in Infantile Spasms and Membranous Nephropathy. The full analyst notes on Retrophin are available to download free of charge at:
http://www.analystsreview.com/1455-RTRX-23Apr2014.pdf
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Agios Pharmaceuticals, Inc. Analyst Notes
On April 17, 2014, Agios Pharmaceuticals, Inc. (Agios) announced the initiation of the Phase 1 study of AG-348, a first-in-class PKR activator for Pyruvate Kinase Deficiency, focused to cover the unmet need among patients with PK deficiency as there is no therapy available to treat the underlying disease. "Today's announcement marks the initiation of our first clinical program in IEMs and our third as a company," said David Schenkein, M.D., CEO of Agios. "Agios believes in the potential of small molecules to become disease-modifying therapeutics for rare genetic disorders by targeting the specific metabolic defects driving these diseases. We expect that the results from this healthy volunteer study will enable us to move AG-348 rapidly into a study in patients with PK deficiency." The full analyst notes on Agios are available to download free of charge at:
http://www.analystsreview.com/1455-AGIO-23Apr2014.pdf
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The Spectranetics Corporation Analyst Notes
On April 10, 2014, The Spectranetics Corp. (Spectranetics) announced that two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads have been granted FDA clearance. The TightRail and The SightRail, the two platforms in question, incorporate innovative designs for mechanical extraction. Spectranetics CEO Scott Drake commented, "Our confidence in the long-term strength of this business continues to be driven by the launch of our mechanical tools portfolio and increasing contribution from our sales force expansion." The new platforms represent the Company's entry into the mechanical extraction device market and complement the laser-based technology that established its leading position in lead extraction. The full analyst notes on Spectranetics are available to download free of charge at:
http://www.analystsreview.com/1455-SPNC-23Apr2014.pdf
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