Key Developments: Arena Pharmaceuticals Inc (ARNA.OQ)

ARNA.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Arena Pharmaceuticals Inc Announces BELVIQ (Lorcaserin HCl) New Drug Submission In Canada
Wednesday, 26 Jun 2013 11:00am EDT 

Arena Pharmaceuticals Inc announced that Eisai Limited (based in Mississauga, Ontario), a subsidiary of Eisai Inc., has submitted a New Drug Submission (NDS) for BELVIQ (lorcaserin HCl) with Health Canada. BELVIQ is being evaluated in Canada as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management (including weight loss and weight maintenance) in adult obese patients (initial body mass index, or BMI, ≥ 30 kg/m2), or overweight patients (initial BMI ≥ 27 kg/m2) in the presence of at least one additional cardiovascular risk factor (e.g., hypertension, dyslipidemia, type 2 diabetes, or sleep apnea). In connection with the NDS, Arena will receive a payment of $500,000 from Eisai.  Full Article

Arena Pharmaceuticals Inc Initiates Phase1 Clinical Trial of APD334 for Autoimmune Diseases
Friday, 5 Apr 2013 08:00am EDT 

Arena Pharmaceuticals Inc announced the initiation of dosing in a Phase 1 clinical trial of APD334, an oral drug candidate that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. This randomized, double-blind and placebo-controlled Phase 1 trial will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD334 in up to 64 healthy adult volunteers.  Full Article

Arena Pharmaceuticals Inc Reaffirms FY 2012 Revenue Guidance-Conference Call
Tuesday, 6 Nov 2012 10:00pm EST 

Arena Pharmaceuticals Inc announced that for fiscal 2012, it expects revenue to be in the range of $91 million to $97 million, which includes amortization of the $5 million upfront payment from Ildong. This revenue guidance also includes $65 million from Eisai following DEA scheduling. If the Company do not receive DEA scheduling in 2012, it expects revenues for fiscal 2012 to be $65 million lower. This guidance does not include any of the revenue under marketing agreement with Eisai such as product sales of BELVIQ, or from any new collaboration we enter into in 2012.  Full Article

Arena Pharmaceuticals Inc Raises FY 2012 Revenue Guidance
Thursday, 9 Aug 2012 04:05pm EDT 

Arena Pharmaceuticals Inc announced an update to its fiscal 2012 financial guidance. Arena increased its fiscal 2012 revenue guidance from $66-$72 million to $91-$97 million, which includes the $20.0 million milestone payment received from Eisai for the inclusion in the FDA-approved prescribing information of the BLOOM-DM data and, although the timing remains uncertain, $65.0 million for milestone payments that Arena will receive from Eisai following DEA scheduling designation and delivery of BELVIQ launch supply.  Full Article

Arena Pharmaceuticals, Inc. And Eisai Announce FDA Approval Of BELVIQ for Chronic Weight Management In Adults who are Overweight With Comorbidity Or Obese
Wednesday, 27 Jun 2012 01:13pm EDT 

Arena Pharmaceuticals, Inc. and Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved BELVIQ (pronounced BEL-VEEK) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). The indication includes the following limitations of use: The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss and the effect of BELVIQ on cardiovascular morbidity and mortality have not been established. Three double-blind, randomized, placebo-controlled trials demonstrated that BELVIQ along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year and managing the weight loss for up to two years. The FDA has recommended that BELVIQ be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review the FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when BELVIQ will be available to patients and physicians in the United States.  Full Article

Consumer Group Urges FDA To Reject Arena Pharmaceuticals' Diet Drug-Reuters
Tuesday, 26 Jun 2012 05:47pm EDT 

Reuters reported that watchdog group Public Citizen urged U.S. regulators on June 26, 2012, not to approve Arena Pharmaceuticals' experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage. The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by June 27, 2012. Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's FDA advisory panel meeting on lorcaserin raised serious concerns about evidence of increased valve disease risks in patients who used the drug in clinical trials. The panel of independent experts voted 18 to 4 to recommend approval of the pill despite the concerns.  Full Article

Arena Pharmaceuticals Announces Exercise Of Over-Allotment Option And Completion Of Public Offering Of Common Stock
Monday, 21 May 2012 04:01pm EDT 

Arena Pharmaceuticals announced the completion of an underwritten public offering of 12,650,000 shares of its common stock, including 1,650,000 shares sold pursuant to the full exercise of an over-allotment option previously granted to the underwriters. All of the shares were offered by Arena at a price to the public of $5.50 per share. The gross proceeds to Arena from this offering were approximately $69.6 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by Arena. Arena anticipates using the net proceeds from the offering for general corporate purposes, which may include expenses related to the commercialization of lorcaserin, if approved, as well as for research and development expenses, capital expenditures, working capital, and general and administrative expenses. Jefferies & Company, Inc. and Piper Jaffray & Co. acted as joint book-running managers for the offering. BMO Capital Markets acted as a co-manager for the offering.  Full Article

Arena Pharmaceuticals Prices Public Offering of Common Stock
Wednesday, 16 May 2012 08:50am EDT 

Arena Pharmaceuticals announced the pricing of an underwritten public offering of 11,000,000 shares of its common stock, offered at a price to the public of $5.50 per share. The gross proceeds to Arena from this offering are expected to be $60.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Arena. Arena has granted the underwriters a 30-day option to purchase up to an aggregate of 1,650,000 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about May 21, 2012, subject to customary closing conditions. Arena anticipates using the net proceeds from the offering for general corporate purposes, which may include expenses related to the commercialization of lorcaserin, if approved, as well as for research and development expenses, capital expenditures, working capital, and general and administrative expenses. Jefferies & Company, Inc. and Piper Jaffray & Co. are acting as joint book-running managers for the offering. BMO Capital Markets is acting as a co-manager for the offering.  Full Article

Arena Pharmaceuticals Proposes Public Offering of Common Stock
Tuesday, 15 May 2012 04:01pm EDT 

Arena Pharmaceuticals announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies & Company, Inc. and Piper Jaffray & Co. are acting as joint book-running managers for the offering. BMO Capital Markets is acting as a co-manager for the offering.  Full Article

FDA Accepts Resubmission Of Arena Pharmaceuticals And Eisai Inc's Lorcaserin New Drug Application
Tuesday, 10 Jan 2012 08:01am EST 

Arena Pharmaceuticals and Eisai Inc. announced that the US Food and Drug Administration (FDA) has accepted for filing and review Arena's resubmission of the New Drug Application (NDA) for lorcaserin. The FDA considers the resubmission a complete, class 2 response, and assigned a new Prescription Drug User Fee Act (PDUFA) target date of June 27, 2012. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition. Arena submitted the original NDA for lorcaserin in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011.  Full Article

Arena withdraws diet drug application in Europe; shares fall

- Arena Pharmaceuticals Inc withdrew an application to market its anti-obesity drug in the European Union, sending its shares down 15 percent in after-hours trading.

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