UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 3, 2014
Arena Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-31161 |
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23-2908305 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
6154 Nancy Ridge Drive, San Diego, California 92121
(Address of principal executive offices) (Zip Code)
858.453.7200
(Registrants telephone number, including area code)
N/A
(Former name or
former address, if changed since last report)
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
In this report, Arena Pharmaceuticals, Arena, Company, we,
us and our refer to Arena Pharmaceuticals, Inc., and/or one or more of our wholly owned subsidiaries, unless the context otherwise provides. Arena Pharmaceuticals®
and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of our wholly owned
subsidiary, Arena Pharmaceuticals GmbH.
Item 2.02 |
Results of Operations and Financial Condition. |
On November 3, 2014, we issued a press release
reporting our financial results for the third quarter ended September 30, 2014. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
On November 3, 2014, Eisai Inc. and we announced top-line results from the Phase 2 trial
investigating lorcaserin HCl, a serotonin 2C receptor agonist, for smoking cessation. The trial demonstrated statistically significant improvement over placebo in reducing the number of patients who smoke after 12 weeks of treatment. The detailed
results of the trial are expected to be presented at a future scientific meeting.
Lorcaserin is an investigational product for smoking cessation. The
efficacy and safety of lorcaserin for smoking cessation have not been established.
The 12-week, randomized, double-blind, placebo-controlled trial
assessed the efficacy and safety of lorcaserin as a potential aid to smoking cessation. In the trial, 603 active smokers were randomized to receive lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo in a 1:1:1 ratio. Patients at
baseline were dependent on nicotine and averaged 18 cigarettes per day. Patients were dosed for two weeks before attempting to quit around Day 15 of the trial and received smoking cessation counseling during the trial.
The primary objective of the trial was assessment of smoking cessation efficacy. The carbon monoxide confirmed continuous abstinence rate (CAR), defined as no
reported smoking or other nicotine use and an end-expiratory exhaled carbon monoxide measurement of less than or equal to ten parts per million, measured during the last four weeks of the trial (Weeks 9-12), was the basis for determining efficacy.
The primary endpoint was achieved by 5.6%, 8.7%, and 15.3% of patients in the placebo, QD and BID groups, respectively (p-value = 0.003 and odds ratio = 3.02 for BID vs. placebo; the result for QD vs. placebo was not statistically significant).
Secondary objectives for the trial included assessment of body weight change and of safety and tolerability. At Week 12 in the MITT population, there was a
statistically significant difference in weight between lorcaserin BID and placebo (-0.98 kg and -0.01 kg, respectively, p-value = 0.0004).
The
overall adverse event profile appears similar to the profile in previous trials of lorcaserin, with the most common adverse events being headache, nausea, constipation, dizziness and dry mouth.
Eisai and we share the development costs of the smoking cessation development program.
About Lorcaserin for Smoking Cessation
Internally
discovered at Arena, lorcaserin is believed to selectively activate serotonin 2C receptors in the brain. Preclinical data suggest that serotonin 2C receptors may modulate the mesolimbic dopaminergic reward system. The exact mechanism of action of
lorcaserin is not known.
Forward-Looking Statements
Certain statements in this Form 8-K are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include
statements about the advancement, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin, including as a potential aid for smoking cessation; future presentation of the trial results; and rights,
obligations and activities under the marketing and supply agreement among Eisai and us. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from our
expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: top-line results are not comprehensive and are based on a preliminary analysis of then
available data, and findings and conclusions related to the trial are subject to change following a more comprehensive review of the data; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and
the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; our revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding
estimates or accounting policies may result in changes to our guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with
another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and our business prospects; government and commercial
reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements;
unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than us or others, request additional
information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of our research and development may not meet regulatory requirements or otherwise be sufficient
for (or we or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; our ability to obtain and defend patents; the timing, success and cost of our research and development; results of
clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and
satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by our forward-looking statements are disclosed in our filings with the
Securities and Exchange Commission. These forward-looking statements represent our judgment as of the time of the filing of this Form 8-K. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required
under applicable law.
Item 9.01 |
Financial Statements and Exhibits. |
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99.1 |
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Press release issued November 3, 2014, reporting financial results for the third quarter ended September 30, 2014 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Date: November 3, 2014 |
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Arena Pharmaceuticals, Inc. |
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By: |
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/s/ Steven W. Spector |
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Steven W. Spector |
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Executive Vice President, General Counsel and Secretary |
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press release issued November 3, 2014, reporting financial results for the third quarter ended September 30, 2014 |
Exhibit 99.1
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Contact: Arena Pharmaceuticals, Inc.
Craig M. Audet, Ph.D., Senior Vice President, Operations &
Head of Global Regulatory Affairs caudet@arenapharm.com 858.453.7200, ext. 1612 |
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Media Contact: Russo Partners
David Schull, President
david.schull@russopartnersllc.com
858.717.2310 |
www.arenapharm.com
Arena Pharmaceuticals Provides
Corporate Update and
Reports Third Quarter 2014 Financial Results
Conference Call and Webcast Scheduled for Today at 8:30 a.m. Eastern Time
SAN DIEGO, CA, November 3, 2014 - Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today provided a corporate update and reported financial results for the
third quarter ended September 30, 2014.
The third quarter saw continued growth for
BELVIQ® with prescriptions increasing by approximately 30% over the previous quarter, said Jack Lief, Arenas President and Chief Executive Officer. More
recently, we met our goal of completing and reporting on top-line results from our trials evaluating coadministration of lorcaserin and phentermine and lorcaserin for smoking cessation, both of which delivered promising data. Looking forward, we are
excited by the potential advancement of our lorcaserin life cycle programs as well as additional progress in our other research and development programs.
Third Quarter and Recent Developments
BELVIQ® (lorcaserin HCl) CIV US Commercial Update
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IMS Health estimates that approximately 143,000 prescriptions for BELVIQ were filled in the third quarter of 2014, representing growth of approximately 30% in total prescriptions as compared to the previous quarter.
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Eisai recorded net product sales for BELVIQ of $16.8 million in the third quarter of 2014. |
BELVIQ
Additional Developments
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Arena and Eisai announced top-line results of a pilot study to assess the safety of lorcaserin, when coadministered with phentermine. The results of the investigational study demonstrate that the short-term combination
of lorcaserin plus phentermine does not appear to be associated with an exacerbation in the proportion of pre-specified adverse events compared to therapy with lorcaserin alone. |
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Arena and Eisai announced top-line results from the Phase 2 trial investigating lorcaserin for smoking cessation. This proof-of-concept trial provided what is believed to be the first clinical evidence that a selective
serotonin 2C agonist may have a treatment effect for smoking cessation. |
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Arena completed dosing in two Phase 1 clinical studies evaluating a lorcaserin 20 mg extended release tablet. |
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Arena and Eisai presented multiple posters on lorcaserin research findings at the American Society of Bariatric Physicians 64th Annual Obesity and Associated
Conditions Symposium and at the American College of Clinical Pharmacy Annual Meeting, both held in Austin, Texas. |
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Arena and Eisai announced that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical trials of BELVIQ was published in the October issue of Postgraduate Medicine. In the pooled analysis, BELVIQ 10
mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters. |
Arena Research & Development
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Initiated enrollment in a Phase 1 multiple-ascending dose trial of APD334, Arenas S1P1 receptor agonist intended for the treatment of autoimmune diseases. |
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Ralinepag (formerly known as APD811) granted orphan drug status by the US Food and Drug Administration for the treatment of pulmonary arterial hypertension. |
Third Quarter 2014 Financial Results
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Revenues totaled $8.2 million, including $5.7 million in net product sales of BELVIQ, of which $5.2 million represented 31.5% of Eisais net product sales and $0.5 million related to redemptions of the 15-day free
voucher. |
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Research and development expenses totaled $24.5 million. |
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General and administrative expenses totaled $8.0 million. |
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Gain on sale of available-for-sale securities of $16.3 million related to Arenas investment in TaiGen. |
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Net loss was $10.7 million, or $0.05 per share. |
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At September 30, 2014, cash and cash equivalents totaled $188.3 million. |
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At September 30, 2014, approximately 220.1 million shares of common stock were outstanding. |
Scheduled Conference Call and Webcast
Arena will host a
conference call and webcast to provide a corporate update and report third quarter 2014 financial results today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). The conference call may be accessed by dialing 877.643.7155 for domestic callers
and 914.495.8552 for international callers. Please specify to the operator that you would like to join the Arena Pharmaceuticals Third Quarter 2014 Financial Results Call. The conference call will be webcast live under the investor
relations section of Arenas website at www.arenapharm.com and will be archived there for 30 days following the call. Please connect to Arenas website several minutes prior to the start of the broadcast to ensure adequate time for any
software download that may be necessary.
Upcoming Conference Participation
Arena is planning to participate at upcoming investment and industry conferences, including:
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2014 Credit Suisse Healthcare Conference, November 10-13, 2014, Phoenix, Arizona |
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The Stifel Healthcare Conference 2014, November 18-19, 2014, New York, New York |
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26th Annual Piper Jaffray Healthcare Conference, December 2-3, 2014, New York, New York |
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J.P. Morgan 33rd Annual Healthcare Conference, January 12-15, 2015, San Francisco, California |
About BELVIQ® (lorcaserin HCl) CIV
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of
action is not known.
BELVIQ is approved by the US Food and Drug Administration to be used along with a reduced-calorie diet and increased physical
activity for chronic weight management in adult patients with an initial body mass index of:
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30 kg/m2 or greater (obese), or |
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27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
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Limitations of Use:
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The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations have not been
established. |
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The effect of BELVIQ on cardiovascular morbidity and mortality has not been established. |
In clinical trials,
the most common adverse reactions for patients without diabetes treated with BELVIQ were headache, dizziness, fatigue, nausea, dry mouth, and constipation, and, in patients with diabetes, the most common adverse reactions were hypoglycemia,
headache, back pain, cough, and fatigue.
For additional information about BELVIQ, including important safety information, click here for the full
Prescribing Information or visit www.BELVIQ.com.
Arena has granted exclusive marketing and distribution rights for BELVIQ to Eisai Inc. and Eisai
Co., Ltd., for most territories worldwide; to Ildong Pharmaceutical Co., Ltd., for South Korea; to CY Biotech Company Limited for Taiwan; and to Teva Pharmaceutical Industries Ltd.s local Israeli subsidiary, Abic Marketing Limited, for Israel.
Composition of matter patents for BELVIQ are issued in major jurisdictions globally that, in most cases, are capable of continuing into at least 2023.
About Arena Pharmaceuticals
Arena is embracing the
challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arenas internally discovered drug, BELVIQ® (lorcaserin HCl), is
approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arenas US operations are located in San Diego, California, and its operations outside of
the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arenas website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are
registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements
include statements about the advancement, therapeutic indication, use, safety, efficacy, mechanism of action, and potential of BELVIQ or lorcaserin, including when coadministered, for smoking cessation and in different formulation; advancement of
lorcaserin life cycle programs; progress, potential therapeutic indication and other aspects of the research and development programs; a selective serotonin 2C agonists treatment effect for smoking cessation; participation at conferences;
patent coverage; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arenas focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop
compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arenas expectations. Factors that could cause
actual results to differ materially from the forward-looking statements include, but are not limited to, the following: top-line results are not comprehensive and are based on a preliminary analysis of then available data, and findings and
conclusions related to the trial are subject to change following a more comprehensive review of the data; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of
BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arenas revenues will be based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or
accounting policies may result in changes to Arenas guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing when expected or ever in combination with
another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arenas business prospects; government and
commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative
arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others,
request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arenas research and development may not meet regulatory
requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arenas ability to obtain and defend patents; the timing, success
and cost of Arenas research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in
the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arenas
forward-looking statements are disclosed in Arenas filings with the Securities and Exchange Commission. These forward-looking statements represent Arenas judgment as of the time of this release. Arena disclaims any intent or obligation
to update these forward-looking statements, other than as may be required under applicable law.
Arena Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
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Three months ended September 30, |
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Nine months ended September 30, |
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2014 |
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2013 |
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2014 |
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2013 |
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(unaudited) |
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(unaudited) |
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Revenues |
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Net product sales |
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$ |
5,726 |
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$ |
2,011 |
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$ |
12,137 |
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$ |
3,330 |
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Eisai collaborative revenue |
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2,133 |
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973 |
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14,034 |
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68,933 |
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Manufacturing services |
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158 |
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443 |
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1,184 |
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2,181 |
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Other collaborative revenue |
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147 |
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151 |
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424 |
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434 |
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Total revenues |
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8,164 |
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3,578 |
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27,779 |
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74,878 |
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Operating Costs & Expenses |
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Cost of product sales |
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1,755 |
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460 |
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4,049 |
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1,514 |
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Cost of manufacturing services |
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81 |
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632 |
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1,124 |
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3,286 |
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Research & development |
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24,508 |
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14,592 |
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72,521 |
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47,428 |
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General & administrative |
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8,029 |
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7,760 |
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25,198 |
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23,614 |
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Total operating costs & expenses |
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34,373 |
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23,444 |
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102,892 |
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75,842 |
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Interest & Other Income (Expense) |
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Interest income |
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16 |
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28 |
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69 |
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68 |
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Interest expense |
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(1,723 |
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(1,768 |
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(5,205 |
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(5,333 |
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Gain from valuation of derivative liabilities |
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2,593 |
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4,100 |
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3,489 |
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10,101 |
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Gain on sale of available-for-sale securities |
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16,276 |
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0 |
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49,553 |
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0 |
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Other |
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(1,625 |
) |
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306 |
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(1,240 |
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152 |
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Total interest & other income, net |
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15,537 |
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2,666 |
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46,666 |
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4,988 |
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Net income (loss) |
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$ |
(10,672 |
) |
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$ |
(17,200 |
) |
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$ |
(28,447 |
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$ |
4,024 |
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Net income (loss) per share: |
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Basic |
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$ |
(0.05 |
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$ |
(0.08 |
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$ |
(0.13 |
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$ |
0.02 |
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Diluted |
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$ |
(0.05 |
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$ |
(0.08 |
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$ |
(0.13 |
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$ |
0.02 |
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Shares used in calculating net income (loss) per share: |
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Basic |
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219,866 |
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218,316 |
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219,592 |
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217,923 |
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Diluted |
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219,866 |
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218,316 |
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219,592 |
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224,354 |
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Arena Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet Data
(In thousands)
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September 30, 2014 |
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December 31, 2013 |
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(unaudited) |
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1 |
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Assets |
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Cash & cash equivalents |
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$ |
188,328 |
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$ |
221,878 |
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Accounts receivable |
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2,914 |
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10,602 |
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Inventory |
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11,861 |
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12,759 |
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Prepaid expenses & other current assets |
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5,974 |
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3,571 |
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Land, property & equipment, net |
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75,489 |
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77,388 |
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Acquired technology & other non-current assets |
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12,106 |
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13,609 |
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Total assets |
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$ |
296,672 |
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$ |
339,807 |
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Liabilities & Stockholders Equity |
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Accounts payable & accrued liabilities |
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$ |
32,395 |
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$ |
30,827 |
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Total deferred revenues |
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114,961 |
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139,190 |
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Total derivative liabilities |
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1,403 |
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4,892 |
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Total lease financing obligations & other long-term liabilities |
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71,627 |
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73,041 |
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Total stockholders equity |
|
|
76,286 |
|
|
|
91,857 |
|
|
|
|
|
|
|
|
|
|
Total liabilities & stockholders equity |
|
$ |
296,672 |
|
|
$ |
339,807 |
|
|
|
|
|
|
|
|
|
|
1 |
The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date. |
###
Arena Pharmaceuticals (NASDAQ:ARNA)
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Arena Pharmaceuticals (NASDAQ:ARNA)
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