Patients Dosed in Arena Study - Analyst Blog
10 4월 2013 - 2:55AM
Zacks
Arena Pharmaceuticals, Inc. (ARNA) recently
announced that patient dosing in a randomized, double-blind and
placebo-controlled phase I study being conducted on APD334 has
commenced.
The phase I study will focus on the safety, tolerability and
pharmacokinetics of single-ascending doses of APD334. The
candidate, which targets the sphingosine 1-phosphate subtype 1
(S1P1) receptor, may have the potential to be developed for
autoimmune diseases like multiple sclerosis, psoriasis and
rheumatoid arthritis.
While Arena Pharma is working on advancing its pipeline, we
expect the company’s main focus to remain on the commercialization
of its obesity drug, Belviq, in the US. Belviq gained Food and Drug
Administration (FDA) approval in Jun 2012 for chronic weight
management in adults who are overweight with a comorbidity or
obese. Arena Pharma has an agreement with Eisai
Inc. (ESALY) for the commercialization of Belviq in the
US.
We expect investor focus to remain on the launch of Belviq in
the US. The US Drug Enforcement Administration (DEA) issued a
notice proposing that Belviq should be placed in Schedule IV of the
Controlled Substances Act.
As far as the EU is concerned, Arena Pharma has responded to a
Day 180 List of Outstanding Issues issued by the European Medicines
Agency’s (EMA) Committee for Medicinal Products for Human Use
(CHMP) earlier this year. The CHMP raised objections regarding
non-clinical as well as clinical issues including tumors in rats,
valvulopathy and psychiatric events. A response from the CHMP
should be out in the first half of 2013.
Arena Pharma currently carries a Zacks Rank #3 (Hold). Companies
that look more attractive include Cytokinetics
Inc. (CYTK) and Osiris Therapeutics
(OSIR). Both are Zacks Rank #1 (Strong Buy) stocks.
ARENA PHARMA (ARNA): Free Stock Analysis Report
CYTOKINETCS INC (CYTK): Free Stock Analysis Report
EISAI CO LTD (ESALY): Get Free Report
OSIRIS THERAPTC (OSIR): Free Stock Analysis Report
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Eisai (PK) (USOTC:ESALY)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Eisai (PK) (USOTC:ESALY)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024