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Supernus Pharmaceuticals, Inc. (SUPN)

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  • R
    AS a psych,many of us have been looking for a med that can do the same things as stimulant meds without stimulating the adult .A great advance in medicine and should be a winner .We will see .
  • l
    5/2 Qelbree news: $400 Million/yr revenue by '26:


    With FDA approval, Supernus' Qelbree is the first nonstimulant ADHD med for adults in 2 decades

    By Zoey BeckerMay 2, 2022 12:10pm
    ADHDSupernus PharmaceuticalsQelbree
    Supernus ADHD campaign

    Approximately 10 million adults in the U.S. have an ADHD diagnosis. Supernus started a campaign for its launch in children last year. (Supernus Pharmaceuticals)
    Approximately 10 million American adults with an attention-deficit hyperactivity disorder (ADHD) diagnosis have a new option for treatment without a stimulant’s side effects, thanks to a new FDA approval for Supernus Pharmaceuticals.

    Qelbree, Supernus’ once-a-day pill, won FDA approval Friday to treat adults with ADHD. The approval is the first for a nonstimulant ADHD treatment for adults in 20 years, and it follows the med's original FDA nod in children between the ages of 6 and 17 last April.

    “Until today, nonstimulant ADHD options for adults have been very limited,” Greg Mattingly, M.D., founding partner of St. Charles Psychiatric Associates, said in a statement. “This approval is positive news and offers a new novel option for the millions of American adults who are trying to find the right treatment to manage their ADHD symptoms.

    WEBINAR: TUESDAY, MAY 10, 2022 | 2PM ET / 11AM PT

    Studies of the drug proved safety and tolerability, but the most notable difference from other ADHD medications is the abuse potential, or lack thereof—no evidence of abuse potential was found in clinical studies, Supernus said. Nonstimulant ADHD meds don't cause side effects such as agitation or sleeplessness sometimes associated with stimulants.

    Qelbree is only the fourth non-controlled ADHD medicine to win FDA approval, Supernus CEO and President Jack Khattar told Fierce Pharma last April. After winning its original FDA approval in children, Supernus started an awareness campaign in the fall.

    Adults are now the prime market for ADHD drugs in U.S.
    A nonstimulant ADHD medication for adults hasn’t been introduced since 2002, when the FDA first approved Eli Lilly’s Strattera. The drug lost its patent in 2017, allowing generics to flood the market.

    The adult ADHD population represents a largely untapped market for a nonstimulant therapy, Jefferies analysts wrote in a note last summer. In the children population, about 22% to 23% of patients were on a nonstimulant, compared with just 8% for adults, the analysts wrote at the time.

    The analysts have predicted Qelbree could generate about $400 million in sales by 2026.
  • P
    Thought the decision on adult use of Quellbree was due on April 24th....?
  • T
    hmmm - Horrible movement considering the news IMO
  • J
    Q1 2022
    Report Date 05/09/22
    Consensus Estimate EPS
    (3 Analysts) $0.24
    Adjusted Actual EPS $0.43
    EPS Difference +0.19
  • F
    Hi - does anyone know what happened with FDA today ????
  • Y
    Yahoo Finance Insights
    Supernus Pharmaceuticals is up 4.98% to 29.29
  • d
    is the intangible asset increase based off the purchase, is the inventory gain also part of that same m&a
  • P
    BIG material announcement coming up....and the stock gets crushed downwards....Seen that before MF'ers
  • A
    This is a solid company with nothing but positives year over year. SUPN meets the normal “check box” for a quality investment (with exception of no DIV). I attribute the low price due to the shares being vastly owned by institutions and when coupled with generally low affects the price of the stock when these investors make a move. Considering the current sentiment of the market, institutional investors are reducing equity positions in anticipation of slowing economy/end of market cycle (if not recession). I think most made this move last year, so not much more downside than this.
    This presents a BUY opportunity for us retail investors.
    I’m in at limit buys of: $35.50, $34, and large final position at $30.
    Bullish on the long position.
  • l
    4/2 SUPN News:

    Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD

    Supernus Pharmaceuticals, Inc.
    Fri, April 2, 2021, 1:58 PM

    Qelbree (viloxazine extended-release capsules) represents the first novel non-stimulant treatment for ADHD in a decade

    Supernus plans to make Qelbree available in the U.S. in 2Q 2021

    ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

    “Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD,” said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. “Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile. We are grateful to the patients, families and their care givers who participated in and supported our research.”

    “ADHD is one of the most common mental health issues in the U.S.,” said Andrew J. Cutler, M.D., Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University, and Chief Medical Officer, Neuroscience Education Institute. “The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.”

    The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years. In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a supplemental New Drug Application to the FDA for Qelbree in adults in the second half of 2021.
  • Q
    $NEOS conversation
    Supernus buys CNS portfolio for $530M. I guess that would make $NEOS buyout by $SUPN in near future less likely.
    Supernus Pharmaceuticals (NASDAQ:SUPN) agrees to acquire the central nervous system portfolio of US WorldMeds, a privately held biopharmaceutical company, for $530M.Price consists of a $300M upfront c
    Supernus Pharmaceuticals (NASDAQ:SUPN) agrees to acquire the central nervous system portfolio of US WorldMeds, a privately held biopharmaceutical company, for $530M.Price consists of a $300M upfront c
  • H
    Second quarter 2021 total revenues of $141.3 million, a 12% increase compared to 2020

    Qelbree™ launched in the U.S. for pediatric ADHD at the end of May 2021

    Qelbree sNDA for adult ADHD submitted to the FDA

    SPN-830 (apomorphine infusion pump) NDA resubmission anticipated in the second half of 2021

    ER is $0.43/share.
    SUPN has more than $800 million in cash, while its market value is only $1.4 billion! What a discount!
  • l
    Report out: Viloxazine- ER PIII trial results in childrean and adolescents published. Excellent efficacy and safety reported from 4 trials:

    Neuropsychiatr Dis Treat. 2021 Jun 3;17:1751-1762. doi: 10.2147/NDT.S312011. eCollection 2021.

    The Effect of Viloxazine Extended-Release Capsules on Functional Impairments Associated with Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents in Four Phase 3 Placebo-Controlled Trials

    Azmi Nasser 1, Joseph T Hull 1, Tesfaye Liranso 2, Gregory D Busse 3, Zare Melyan 3, Ann C Childress 4, Frank A Lopez 5, Jonathan Rubin 6

    1Department of Clinical Research, Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
    2Department of Biostatistics, Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
    3Department of Medical Affairs, Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
    4Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV, USA.
    5Children's Developmental Center, Winter Park, FL, USA.
    6Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
    PMID: 34113106 PMCID: PMC8184252 DOI: 10.2147/NDT.S312011
    Free PMC article

    Purpose: The ADHD Rating Scale (ADHD-RS) assesses 18 symptoms of inattention and hyperactivity/impulsivity and has been used in many clinical trials to evaluate the treatment effect of drugs on ADHD. The fifth edition of this scale (ADHD-RS-5) also assesses the impact of inattention and hyperactivity/impulsivity symptoms on six domains of functional impairment (FI): family relationships, peer relationships, completing/returning homework, academic performance at school, controlling behavior at school, and self-esteem. Here, we report the effect of viloxazine extended-release capsules (viloxazine ER), a novel nonstimulant treatment for ADHD in children and adolescents (ages 6-17 years), on FI from a post hoc analysis of four randomized, double-blind, placebo-controlled Phase 3 clinical trials (N=1354).

    Patients and methods: ADHD-RS-5 investigator ratings of ADHD symptoms and FIs were conducted at baseline and weekly post-baseline for 6-8 weeks in the four trials. Change from baseline (CFB) in ADHD-RS-5 FI scores (Total score [sum of 12 FI items] and Inattention and Hyperactivity/Impulsivity subscale scores [sum of 6 corresponding FI items]) and the 30% and 50% Responder Rates (ADHD-RS-5 FI Total score) were compared between viloxazine ER and placebo.

    Results: The reduction (improvement) in ADHD-RS-5 FI scores (Total and subscale scores) and the percentage of responders (30% and 50%) at Week 6 were significantly greater in each viloxazine ER dose group vs placebo. In the 100-400 mg/day viloxazine ER groups, improvements were found as early as Week 1 (100-mg/day) or Week 2 (200-, 400-mg/day) of treatment. Analysis of individual items of ADHD-related FIs demonstrated that the effect of viloxazine ER was observed across all domains of impairment.

    Conclusion: Significant improvements observed in ADHD-related FIs are consistent with the reduction in inattention and hyperactivity/impulsivity symptoms demonstrated in the viloxazine ER Phase 3 pediatric trials. Therefore, viloxazine ER provides clinically meaningful improvement of ADHD symptoms and functioning in children and adolescents with ADHD, starting as early as Week 1-2 of treatment.
  • R
    Clayton, I've been in since 2012 with a $8 average, holding until $75-$100 or buyout.
  • l
    SUPN beats on EPS, revenue; positive guidance for '19; pipeline advancing nicely. IMO: Based on the above, SUPN poised to see significant pps appreciation in '19.
  • l
    SUPN beats by +174% on EPS; by 18% on revenue.
    Guides upward for '20: $500-525 Million in revenues; $145-160 Million in earnings.
    Great prospects in '21 and beyond.
  • T
    I don't get why this stock is selling at half of its 5 year expected growth rate. It also beats expectations.

    Any thoughts?
  • M
    Supernus Pharmaceuticals, Inc. (SUPN) is a pharmacy company that looks to be nearly unstoppable.

    The company has been extremely reliable at meeting consistent and high net-income over the last 5 years, rising from $13.94m in 2015, to $113.06m in 2019.

    Although the company dropped into a negative cashflow in 2019, their cash levels are still at a near high of $347.07m.

    The company did take on debt in 2018, however in comparison to its net assets they are still at healthy liquidity ($345.17m to $1.16bn; 0.298).

    2021 expects to see net-income dip, however revenue has been estimated by analysts at $589.27m, compared to $392.76m recorded in 2019.

    Shares are currently $29.94, considerably lower than their peak of $59.85 a share in June 2018.
  • m
    Very surprised this company is trading so poorly. I have traded SUPN a number of times and currently have no position but am getting interested again. Seems like the fundamentals are sound and SUPN IMO should be at least $40 a share if not $45. I have not seen anything negative developing since the last ER. Has anyone heard of anything negative?