SUPN Supernus Pharmaceuticals Inc.

29.22
+0.43  (+1%)
Previous Close 28.79
Open 28.74
52 Week Low 13.12
52 Week High 27.5535
Market Cap $1,539,459,236
Shares 52,685,121
Float 35,239,789
Enterprise Value $1,601,194,235
Volume 690,133
Av. Daily Volume 671,939
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Drug Pipeline

Drug Stage Notes
SPN-812 (adult)
ADHD
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 22, 2020.
SPN-830
Motor fluctuations in Parkinson’s disease (PD)
NDA Filing
NDA Filing
Refusal to file letter announced November 9, 2020.
SPN-812 (P301)
ADHD
CRL
CRL
CRL announced November 9, 2020.
SPN-820
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
SPN-604
Bipolar depression
Phase 3
Phase 3
Phase 3 development has been terminated - May 5, 2020.
SPN-810 (P302)
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 25, 2020.
SPN-810
Impulsive Aggression in ADHD
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - November 5, 2019.
Oxtellar XR
Epilepsy
Approved
Approved
FDA approval announced December 14, 2018 to expand label to include monotherapy treatment.
Trokendi
Migraine
Approved
Approved
Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017.
Trokendi
Epilepsy
Approved
Approved
Approved Aug 19, 2013.
Oxtellar
Epilepsy
Approved
Approved
Approved October 22, 2017.

Latest News

  1. ROCKVILLE, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will present at the J.P. Morgan 39th Annual Healthcare Conference on Thursday, January 14, 2021, at 9:10 a.m. ET, and will be available for virtual investor meetings.

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company's website after the conference.

    About Supernus Pharmaceuticals, Inc.

    ROCKVILLE, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will present at the J.P. Morgan 39th Annual Healthcare Conference on Thursday, January 14, 2021, at 9:10 a.m. ET, and will be available for virtual investor meetings.

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company's website after the conference.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

    See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

    All trademarks are the property of their respective owners.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



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    • Met primary endpoint with robust statistical significance

    • Showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance

    • Showed statistically significant onset of action as early as week 2

    • Had a good safety and tolerability profile throughout the study

    • Topline data confirm positive results from prior Phase IIa study in adults and Phase III studies of SPN-812 in children and adolescents

    ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for…

    • Met primary endpoint with robust statistical significance



    • Showed efficacy on both hyperactivity/impulsivity and inattention subscales with statistical significance



    • Showed statistically significant onset of action as early as week 2



    • Had a good safety and tolerability profile throughout the study



    • Topline data confirm positive results from prior Phase IIa study in adults and Phase III studies of SPN-812 in children and adolescents

    ROCKVILLE, Md., Dec. 22, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD).

    At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating Scale (AISRS). In addition to meeting the primary efficacy endpoint, the Phase III study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness (CGI-S) Scale at week 6. The active dose was well tolerated.

    SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age. As announced in November, 2020, the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The Company will be meeting with the FDA in January 2021 to discuss the CRL. Assuming approval for pediatrics, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.

    "These compelling data in adults will be important for our planned sNDA submission to make this treatment option available, if approved by the FDA, to the adult ADHD patient population, which represents approximately half of the total ADHD market in the U.S.," stated Jack Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. "We now have positive Phase III data proving the efficacy and safety of SPN-812 in a broad range of ADHD patient populations; children 6-11 years old, adolescents 12-17 years old, and adults."

    About the P306 Study

    The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in adult patients diagnosed with ADHD. The study had a two-arm flexible dose design where treatment was administered orally once a day over six weeks, including the titration phase up to a total daily dose of 600mg SPN-812 or matched placebo.

    A total of 374 adult patients were randomized across placebo and a daily dose of SPN-812 starting with 200mg with flexible dose administration up to 600mg. The primary objective was to assess the effect of SPN-812 in reducing the symptoms of ADHD. The primary outcome measure was the change from baseline to the end of the study in the AISRS. Safety and tolerability of SPN-812 were assessed by the monitoring of adverse events (AEs), clinical laboratory tests, vital signs, ECGs, suicidality and physical examinations. Patients who completed the study were offered the opportunity to continue into an ongoing open-label safety extension study.

    Topline Results

    At the end of the study, SPN-812 reached statistical significance compared to placebo in the primary endpoint. Patients receiving SPN-812 had a -15.5 point change from baseline in the primary endpoint compared to -11.7 for placebo at week 6 (p=0.0040).

    This primary result, based on a Mixed Model Repeated Measures (MMRM) analysis using the Full Analysis Set (FAS) population, was confirmed by sensitivity analysis with a p-value of 0.0085.

    The study demonstrated fast onset of action, reaching statistical significance as early as week 2 with a p-value of 0.0397, and maintaining statistical significance through the end of the trial at week 6.

    Similar to the previously reported studies in pediatric patients 6 to 17 years of age, at the end of the P306 study, SPN-812 reached statistical significance compared to placebo on the hyperactivity/impulsivity and inattention subscales of the AISRS with p-values of 0.0380 and 0.0015, respectively.

    In addition, SPN-812 met the CGI-S secondary endpoint with a p-value of 0.0023 compared to placebo at week 6 and showed significant improvement as early as week 2 with a p-value of 0.0203.

    Safety and tolerability

    Overall, the trial exhibited a good safety and tolerability profile. Adverse events (AEs) were primarily mild to moderate leading to a low placebo-adjusted discontinuation rate due to AEs in the SPN-812 group of 4.1% (9.0% for SPN-812 compared to 4.9% in the placebo group). Treatment related AEs that reported at more than or equal to 5% for SPN-812 were insomnia, fatigue, decreased appetite, nausea, headache, and dry mouth.

    Topline data for the P306 study can be accessed by visiting 'Events & Presentations' in the Investor Relations section of the Company's website at www.supernus.com.

    About SPN-812

    SPN-812 is a novel non-stimulant for the treatment of ADHD. Based on data generated to date, the Company believes SPN-812 could be a well-differentiated ADHD treatment due to its different pharmacological and pharmacokinetic profile. The active ingredient in SPN-812, viloxazine hydrochloride, has an extensive safety record in Europe, where it was previously marketed for many years as an antidepressant.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

    See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

    All trademarks are the property of their respective owners.

    Forward-Looking Statements:

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements include expectations regarding the Company's future interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL regarding the NDA for SPN-812 for the treatment of ADHD in pediatric patients 6 to 17 years of age and the Company's plans to address them, the Company's future resubmission of the NDA for SPN-812, the potential approval of the NDA for SPN-812 following resubmission, the planned submission of an sNDA to the FDA for SPN-812 in adults and the potential benefits and commercialization of SPN-812. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its products and product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs; potential funding sources; the Company's staffing needs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Jim Kelly, Executive Vice President and CFO

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    Or

    Investor Contact:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:

     



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  2. ROCKVILLE, Md., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020. The Company will also host investor meetings on Thursday, December 3, 2020.

    The pre-recorded fireside chat can be accessed beginning November 23, 2020 by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay of this fireside chat will be available for 60…

    ROCKVILLE, Md., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020. The Company will also host investor meetings on Thursday, December 3, 2020.

    The pre-recorded fireside chat can be accessed beginning November 23, 2020 by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay of this fireside chat will be available for 60 days on the Company's website after the conference.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

    See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

    All trademarks are the property of their respective owners.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Jim Kelly, EVP & Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:



    Primary Logo

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  3. ROCKVILLE, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will present an overview and update, as well as host investor meetings, at the following virtual investor conferences in November 2020.

    Stifel 2020 Healthcare Conference
    Date: Monday, November 16, 2020
    Presentation Time: 9:20 a.m. ET

    Jefferies Virtual London Healthcare Conference
    Date: Tuesday, November 17, 2020
    Presentation Time: 1:45 p.m. ET

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the…

    ROCKVILLE, Md., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company's management will present an overview and update, as well as host investor meetings, at the following virtual investor conferences in November 2020.

    Stifel 2020 Healthcare Conference

    Date: Monday, November 16, 2020

    Presentation Time: 9:20 a.m. ET

    Jefferies Virtual London Healthcare Conference

    Date: Tuesday, November 17, 2020

    Presentation Time: 1:45 p.m. ET

    A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company's website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company's website after the conference.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

    See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

    All trademarks are the property of their respective owners.

    CONTACTS:

    Jack A. Khattar, President and CEO

    Jim Kelly, Executive Vice President and CFO

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    or

    INVESTOR CONTACT:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:

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  4. ROCKVILLE, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced regulatory updates for SPN-812 (viloxazine hydrochloride) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age, and SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson's disease (PD).

    SPN-812 - Novel non-stimulant for the treatment of ADHD

    The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for…

    ROCKVILLE, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced regulatory updates for SPN-812 (viloxazine hydrochloride) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age, and SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson's disease (PD).

    SPN-812 - Novel non-stimulant for the treatment of ADHD

    The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients 6 to 17 years of age. The FDA issued a CRL to indicate that the review cycle for the application is complete and that the application is not ready for approval in its present form.

    The primary issue cited in the SPN-812 CRL relates to the Company's in-house laboratory that conducts analytical testing, which recently moved to a new location. The Company plans to discuss with the FDA the contents of the CRL and clarify to the FDA that the application does not rely solely on this facility for product release. We plan to discuss with the agency the steps required for the resubmission of the NDA for SPN-812. Importantly, no clinical safety or efficacy issues were identified during the review.

    SPN-830 (apomorphine infusion pump) - Continuous treatment of motor fluctuations ("on-off" episodes) in PD

    The Company received a Refusal to File (RTF) letter from the FDA regarding its NDA for SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in Parkinson's disease (PD). In its review of the NDA, which was submitted in September 2020, the FDA determined that the NDA was not sufficiently complete to permit a substantive review. In the letter, the FDA requested certain documents and reports to be submitted in support of the application.

    The Company plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN-830.   

    "On SPN-812, we look forward to collaborating with the FDA to clarify and resolve the facility matter and put SPN-812 back on track to help the millions of children and adolescents in the U.S. with ADHD," said Jack Khattar, President and CEO of Supernus. "Regarding SPN-830, we remain confident in the data package for SPN-830 and its promise as an important treatment option for PD patients who experience motor fluctuations associated with on-off episodes. We are fully committed to working with the FDA to address its letter and successfully refile our SPN-830 NDA."

    The Company plans to provide updates on the NDA status and expected launch timing for both SPN-812 and SPN-830 once it has had further discussions with the FDA and has agreed on the path forward for each program.

    Full Year 2020 Financial Guidance

    The Company reiterates its full year 2020 net product sales and research and development expenses guidance and provides an update to its full year 2020 selling, general and administrative expenses and operating earnings (GAAP) guidance to reflect the expected impact of the SPN-812 CRL on the fourth quarter of 2020. SPN-812 commercial launch preparation activities continue and Supernus expects to achieve the following financial objectives in 2020:

    Full Year 2020 Financial Objectives Full Year 2020 Guidance             

    ($ in millions)
    Net product sales$500 - $525
    Research and development expenseApproximately $75
    Selling, general and administrative expenses$205 – $215, as compared to prior guidance of

    $215 - $225
    Amortization of intangible assets$16
    Operating earnings (GAAP)(1)$155 - $170, as compared to prior guidance of

    $145 - $160

    (1) Generally accepted accounting principles (GAAP). Operating earnings including amortization of intangible assets.

    About Supernus Pharmaceuticals, Inc.

    Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy; Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy; APOKYN® (apomorphine hydrochloride injection) for the acute treatment of hypomobility in advanced Parkinson's disease (PD); MYOBLOC® (rimabotulinumtoxinB) for the treatment of cervical dystonia and treatment of chronic sialorrhea in adults; and XADAGO® (safinamide) as an adjunctive treatment to levodopa/carbidopa in PD patients with hypomobility. The Company is also developing several product candidates to address large market opportunities in the CNS market, including SPN-812 for the treatment of ADHD; SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations ("on-off" episodes) in PD; SPN-820 for treatment-resistant depression; and SPN-817 for the treatment of epilepsy.

    See full Prescribing Information for our products here: Trokendi XR, Oxtellar XR, APOKYN, MYOBLOC, and XADAGO.

    All trademarks are the property of their respective owners.

    Forward-Looking Statements:

    This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These forward-looking statements include expectations regarding the Company's future interactions and communications with the FDA, including its expectation to discuss with the FDA the issues raised in the CRL regarding the NDA for SPN-812 for the treatment of ADHD in pediatric patients 6 to 17 years of age and the Company's plans to address them, the Company's future resubmission of the NDA for SPN-812, the potential approval of the NDA for SPN-812 following resubmission and the potential benefits and commercialization of SPN-812, and the Company's expectation to discuss with the FDA the issues raised in the RTF letter relating to the NDA for SPN-830 (apomorphine infusion pump) and the Company's plans to address them, the Company's future resubmission of the NDA for SPN-830, the potential approval of the NDA for SPN-830 following resubmission and the potential benefits and commercialization of SPN-830. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company's ability to sustain and increase its profitability; the Company's ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company's corporate strategy; the Company's future financial performance and projected expenditures; the Company's product research and development activities, including the timing and progress of the Company's clinical trials, and projected expenditures; the Company's ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company's product candidates; the Company's ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company's expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company's product candidates; the accuracy of the Company's estimates of the size and characteristics of the markets that may be addressed by its products and product candidates; the Company's ability to increase its manufacturing capabilities for its products and product candidates; the Company's projected markets and growth in markets; the Company's product formulations and patient needs; potential funding sources; the Company's staffing needs; and other risk factors set forth from time to time in the Company's filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

    CONTACT:

    Jack A. Khattar, President and CEO

    Jim Kelly, EVP and Chief Financial Officer

    Supernus Pharmaceuticals, Inc.

    Tel: (301) 838-2591

    Or

    Investor Contact:

    Peter Vozzo

    Westwicke, an ICR Company

    Office: (443) 213-0505

    Mobile: (443) 377-4767

    Email:

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