La catena delle opzioni mostra i dati chiave delle opzioni azionarie di Supernus Pharmaceuticals a vari prezzi di esercizio e date di scadenza. I trader utilizzano queste informazioni per analizzare potenziali operazioni e valutare il sentiment del mercato per Supernus Pharmaceuticals..

Supernus Pharmaceuticals (NASDAQ:SUPN) Azioni, Catena delle Opzioni

Supernus Pharmaceuticals

Supernus Pharmaceuticals Inc is a specialty pharmaceutical company. The company is engaged in developing and commercializing products for the treatment of central nervous system diseases, including neurological and psychiatric disorders. The Company's diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. The company products include Trokendi XR, Oxtellar XR, Qelbree, APOKYN, XADAGO, MYOBLOC, GOCOVRI, and Osmolex ER.

Supernus Pharmaceuticals, Inc. - Common Stock

Supernus Pharmaceuticals Inc

SUPERNUS PHARMACEUTICALS ORD

News

Guidance

SUPN

Supernus Pharmaceuticals Sees FY24 Total Revenue $630M-$650M Vs $619.505M Est.

Supernus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) reported quarterly earnings of $0.69 per share which beat the analyst consensus estimate of $0.02 by 3350 percent. The company reported quarterly sales of $175.689 million which beat the analyst consensus estimate of $157.298 million by 11.69 percent. This is a 14.17 percent increase over sales of $153.880 million the same period last year.

Earnings

Earnings Beats

Supernus Pharmaceuticals Q3 2024 GAAP EPS $0.69 Beats $0.02 Estimate, Sales $175.689M Beat $157.298M Estimate

Biotech

General

Supernus Pharmaceuticals From A Phase 2 Study For Its SPN-820 That Shows AN 80% Decrease In Suicidal Ideation In Adults

Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms
SPN-820 was well-tolerated with few adverse events
SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression
Company to host webcast today at 4:30 p.m. ET to discuss the topline data
Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression expected first-half 2025
ROCKVILLE, Md., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder. The study examined the safety and tolerability of SPN-820 2400 mg given once every 3 days as an adjunctive treatment to the current baseline antidepressant therapy, as well as assessed the rapid onset of improvement in depressive symptoms. The analysis is based on 40 enrolled subjects, of which 38 completed the 10-day treatment period.
Summary of the Data
<ul>
<li>Clinically meaningful improvement of –6.1 at two hours and –9.6 at Day 10 on the Hamilton Depression Rating Scale-6 Items (HAM-D6) total score.</li>
<li>Clinically meaningful improvement of –16.6 at four hours and –22.9 at Day 10 on the Montgomery Åsberg Depression Rating Scale (MADRS) total score.</li>
<li>Suicidal ideation decreased by 80% (12.5% with suicidal ideation at baseline decreased to 2.6% with suicidal ideation at Day 10).</li>
<li>SPN-820 was well-tolerated with few adverse events (AEs) and had acceptable tolerability with a discontinuation rate of 2.5% due to AEs.
<ul>
<li>Most common AEs related to the drug included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed. &nbsp;</li>
</ul>
</li>
</ul>

Supernus Reports Data From Open-Label Phase 2a Study Of SPN-820 In Adults With Major Depressive Disorder; Phase 2a Study Demonstrated Rapid And Substantial Decrease In Depressive Symptoms; SPN-820 Was Well-Tolerated With Few Adverse Events

Piper Sandler downgraded Supernus Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>), saying that the anticipated surge in Qelbree prescriptions during the back-to-school season has not <a target="_blank" href="https://www.benzinga.com/quote/supn" rel="noreferrer noopener">materialized as expected</a>.
&#8220;That has us rethinking our assumptions regarding the longer-term (LT) sales/volume growth trajectory of the product,&#8221; the analyst adds.
Qelbree (viloxazine) is indicated to treat attention deficit hyperactivity disorder in children and adults.
In the second quarter of 2024, net sales of Qelbree&nbsp;increased 92% year over year to $59.4 million, and total IQVIA <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40201595/supernus-announces-second-quarter-2024-financial-results" rel="noreferrer noopener">prescriptions were 184,342, up 26%.</a>
Piper writes that the management&#8217;s focus on optimizing Qelbree&#8217;s net economics, such as reducing copay assistance, suggests that future volume growth may be more modest. While initial estimates projected peak sales nearing $500 million, Piper writes that $400 million is a more realistic target.
The Piper analyst writes that Qelbree is growing and highlights that YTD prescriptions increased 91% in 2023 compared to 2022.
Piper has downgraded Supernus Pharmaceuticals to Neutral from Overweight, with a price target of $36, <a target="_blank" href="https://www.benzinga.com/quote/SUPN/analyst-ratings" rel="noreferrer noopener">down from $41</a>.
Quarter-to-date prescriptions have grown by about 1% in the third quarter of 2024 compared to the second quarter, following a 4% increase in the second quarter over the first quarter. In contrast, prescriptions for all ADHD products have declined sequentially by around 2% quarter-to-date in the third quarter.
A Piper analyst expects volume growth for Qelbree to accelerate during the back-to-school season but anticipates a slower growth trajectory than initially expected, prompting a reassessment of the drug&#8217;s peak sales potential.
In August, the FDA acknowledged the resubmission of the new drug application (NDA) for the company&#8217;s apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40436887/supernus-announces-spn-830-apomorphine-infusion-device-nda-accepted-for-review-by-fda" rel="noreferrer noopener">Parkinson&#8217;s disease</a>.
The resubmission is now filed, with a user fee goal date (PDUFA date) of February 1, 2025.
In April, the FDA issued a Complete Response Letter&nbsp;related to SPN-830, requiring additional information&nbsp;regarding the product quality and the master file for <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38143447/supernus-pharmaceuticals-faces-second-fda-rejection-for-investigational-device-for-parkinsons-dis" rel="noreferrer noopener">the infusion device</a>.
Price Action: SUPN stock is down 7.17% at $31.09 at last check Wednesday.
Photo via Shutterstock
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/09/40818732/chinese-ev-manufacturers-byd-and-geely-storm-frankfurt-fair-as-eu-tariffs-threaten-to-crimp-thei" target="_blank" rel="noreferrer noopener">Chinese EV Manufacturers BYD And Geely Storm Frankfurt Fair As EU Tariffs Threaten To Crimp Their Global EV Push: Report</a>.</li>
</ul>

Analyst Color

Equities

Downgrades

Health Care

Price Target

Analyst Ratings

Movers

Trading Ideas

ADHD Drug Maker Supernus Pharmaceuticals Downgraded On Slower Prescription Growth For Its Top-Selling Drug

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our analyst ratings page.
<ul>
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst/58a5e02a43eaaa00018d939e/edward-white">HC Wainwright &amp; Co. analyst Edward White</a> downgraded the rating for Adicet Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACET#NASDAQ">ACET</a>) from Buy to Neutral. Adicet Bio shares fell 3.4% to close at $1.43 on Tuesday. <a href="https://www.benzinga.com/quote/DACETPZ/analyst-ratings">See how other analysts </a><a href="https://www.benzinga.com/quote/ACET/analyst-ratings">view </a><a href="https://www.benzinga.com/quote/DACETPZ/analyst-ratings">this stock</a>.</li>
<li>B of A Securities analyst Graham Perry downgraded Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) from Buy to Neutral and lowered the price target from $135 to $130. Novartis shares fell 0.2% to close at $116.99 on Tuesday. <a href="https://www.benzinga.com/quote/NVS/analyst-ratings">See how other analysts view this stock</a>.</li>
<li><a href="https://www.benzinga.com/topic/david-amsellem">Piper Sandler analyst David Amsellem</a> downgraded the rating for Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) from Overweight to Neutral and cut the price target from $41 to $36. Supernus Pharmaceuticals shares fell 1.2% to close at $33.49 on Tuesday. <a href="https://www.benzinga.com/quote/SUPN/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Truist Securities analyst Gregory Fraser downgraded ANI Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ANIP#NASDAQ">ANIP</a>) from Buy to Hold and slashed the price target from $80 to $60. ANI Pharmaceuticals shares fell 5.1% to close at $55.48 on Tuesday. <a href="https://www.benzinga.com/quote/ANIP/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying NVS stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="537" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-1024x537.png" alt="" class="wp-image-542353" style="width:625px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-1024x537.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-300x157.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88-768x402.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11091806/image-88.png 1292w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Read Next:<a href="https://www.benzinga.com/news/24/09/40792510/jim-cramer-says-aes-is-very-inexpensive-recommends-buying-this-industrial-stock"> </a>
<ul>
<li><a href="https://www.benzinga.com/news/24/09/40792510/jim-cramer-says-aes-is-very-inexpensive-recommends-buying-this-industrial-stock">Jim Cramer Says AES Is &#8216;Very Inexpensive&#8217;, Recommends Buying This Industrial Stock</a></li>
</ul>

Markets

ACET

ANIP

RLAY

This Novartis Analyst Is No Longer Bullish; Here Are Top Downgrades For Wednesday

WIIM

Supernus Pharmaceuticals shares are trading lower after Piper Sandler downgraded the stock from Overweight to Neutral and lowered its price target from $41 to $36.

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page.</a>
<ul>
<li>Ascendiant Capital raised the price target for Atossa Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATOS#NASDAQ">ATOS</a>) from $6.25 to $6.5. Ascendiant Capital analyst Edward Woo maintained a Buy rating. Atossa Therapeutics shares gained 7.4% to close at $1.46 on Tuesday. <a href="https://www.benzinga.com/quote/atos/analyst-ratings">See how other analysts view this stock.</a></li>
<li>B of A Securities cut the price target for Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) from $135 to $130. B of A Securities analyst Graham Perry downgraded the stock from Buy to Neutral. Novartis shares fell 0.2% to close at $116.99 on Tuesday. <a href="https://www.benzinga.com/quote/NVS/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Keefe, Bruyette &amp; Woods raised Camden National Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CAC#NYSE">CAC</a>) price target from $40 to $41. Keefe, Bruyette &amp; Woods analyst Damon Delmonte maintained a Market Perform rating. Camden National shares fell 0.3% to close at $37.78 on Tuesday. <a href="https://www.benzinga.com/quote/CAC/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Piper Sandler cut Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) price target from $41 to $36. Piper Sandler analyst David Amsellem downgraded the stock from Overweight to Neutral. Supernus Pharmaceuticals shares fell 1.2% to close at $33.49 on Tuesday. <a href="https://www.benzinga.com/quote/SUPN/analyst-ratings">See how other analysts view this stock.</a></li>
<li>B of A Securities raised the price target for AppLovin Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APP#NASDAQ">APP</a>) from $100 to $120. B of A Securities analyst Omar Dessouky maintained a Buy rating. AppLovin shares fell 0.1% to close at $86.23 on Tuesday. <a href="https://www.benzinga.com/quote/APP/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Stifel boosted Krystal Biotech, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KRYS#NASDAQ">KRYS</a>) price target from $204 to $220. Stifel analyst Dae Gon Ha maintained a Buy rating. Krystal Biotech shares fell 1.4% to close at $185.00 on Tuesday. <a href="https://www.benzinga.com/quote/KRYS/analyst-ratings">See how other analysts view this stock.</a></li>
<li>BMO Capital cut Dave &amp; Buster&#8217;s Entertainment, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PLAY#NASDAQ">PLAY</a>) price target from $65 to $55. BMO Capital analyst Andrew Strelzik maintained an Outperform rating. Dave &amp; Buster&#8217;s shares fell 0.8% to close at $29.86 on Tuesday. <a href="https://www.benzinga.com/quote/PLAY/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Wedbush cut the price target for GameStop Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GME#NYSE">GME</a>) from $11 to $10. Wedbush analyst Michael Pachter maintained an Underperform rating. GameStop shares fell 3.3% to close at $23.45 on Tuesday. <a href="https://www.benzinga.com/quote/GME/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Truist Securities boosted Academy Sports and Outdoors, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASO#NASDAQ">ASO</a>) price target from $60 to $63. Truist Securities analyst Joseph Civello maintained a Buy rating. Academy Sports shares gained 5.2% to close at $55.38 on Tuesday. <a href="https://www.benzinga.com/quote/ASO/analyst-ratings">See how other analysts view this stock.</a></li>
<li>BMO Capital cut Domino&#8217;s Pizza, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DPZ#NYSE">DPZ</a>) price target from $525 to $510. BMO Capital analyst Andrew Strelzik maintained an Outperform rating. Domino&#8217;s shares fell 0.8% to close at $416.77 on Tuesday. <a href="https://www.benzinga.com/quote/DPZ/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying DPZ stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="534" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11090617/image-87-1024x534.png" alt="" class="wp-image-542314" style="width:481px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11090617/image-87-1024x534.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11090617/image-87-300x156.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11090617/image-87-768x400.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/09/11090617/image-87.png 1276w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>

Pre-Market Outlook

ATOS

KRYS

PLAY

Domino's Pizza To $510? Here Are 10 Top Analyst Forecasts For Wednesday

Piper Sandler analyst David Amsellem downgrades Supernus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) from Overweight to Neutral and lowers the price target from $41 to $36.

Piper Sandler Downgrades Supernus Pharmaceuticals to Neutral, Lowers Price Target to $36

Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>), 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) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease (PD). The resubmission is now considered filed, with a user fee goal date (PDUFA date) of February 1, 2025.

Government

Regulations

FDA Accepts Supernus Pharmaceuticals' Resubmission for Parkinson's Treatment Device, Decision Expected by February 2025

Supernus Raises 2024 Total Revenue Guidance From $580M-$620M To $600M-$625M vs $600.12M Est.

Supernus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) reported quarterly earnings of $0.36 per share which beat the analyst consensus estimate of $0.05 by 620 percent. The company reported quarterly sales of $168.300 million which beat the analyst consensus estimate of $148.851 million by 13.07 percent. This is a 24.15 percent increase over sales of $135.563 million the same period last year.

Supernus Pharmaceuticals Q2 2024 GAAP EPS $0.36 Beats $0.05 Estimate, Sales $168.300M Beat $148.851M Estimate

Supernus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease (PD).

Supernus Resubmits NDA To FDA For SPN-830 Apomorphine Infusion Device

Supernus Pharmaceuticals Announces Interim Analysis Data From Phase 2a Clinical Study Of SPN-817 For Treatment-Resistant Seizures

Supernus Pharmaceuticals Reiterates FY24 Revenue $580M-$620M Vs $601.461M Est.

Supernus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) reported quarterly sales of $143.600 million which missed the analyst consensus estimate of $145.832 million by 1.53 percent. This is a 6.61 percent decrease over sales of $153.764 million the same period last year.

Earnings Misses

Supernus Pharmaceuticals Q1 Sales $143.600M Miss $145.832M Estimate

M8 Pharmaceuticals, an&nbsp;Acino company ('M8') announces that the company has signed an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. (NASDAQ:<a href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) ('Supernus'), a biopharmaceutical company focused on the development and commercialization of products for the treatment of diseases of the central nervous system (CNS), to seek regulatory approval and commercialize Qelbree&#xAE; (Viloxazine XR) under M8's trademark in Latin America.
Qelbree&#xAE; (viloxazine extended-release capsule) which is approved in the United States is an extended-release formulation of viloxazine, a selective norepinephrine reuptake inhibitor to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Unlike most ADHD medications on the market, this medication is a non-stimulant option.
Qelbree&#xAE; (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of four pivotal trials,1-4 Qelbree&#xAE; was approved by the US Food and Drug Administration (FDA) in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. Qelbree&#xAE; is also currently being studied in several phase 4 clinical trials, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023). A second phase 4 clinical trial in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial is studying the impact of Qelbree&#xAE; on co-morbid mood symptoms prevalent in patients with ADHD.
This strategic partnership is aligned with Acino's mission to provide Latin American patients access to innovative medicines and strengthen its leadership position in the central nervous system therapeutic space. The collaboration will provide prescribers with a new option to improve the ADHD treatment paradigm for millions of patients.
"Supernus ran an extensive process to find the right partner Qelbree&#xAE; to seek regulatory approval and successful commercialization in Mexico and Brazil" said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD."
"We are delighted to announce this collaboration with Supernus, a company with a fantastic track record of innovation in the CNS space and a robust pipeline of novel medicines to treat psychiatric and neurological disorders" said Joel Barlan, Head of Latin America at Acino.&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

Global

M8 Pharmaceuticals Signs An Exclusive Licensing Agreement With Supernus Pharmaceuticals To Seek Regulatory Approval And Commercialize Qelbree Under M8's Trademark In Latin America

On Monday,&nbsp;Supernus Pharmaceuticals Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the continuous treatment of motor fluctuations (&#8220;off&#8221; episodes) in&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/04/g38140215/supernus-provides-regulatory-update-for-spn-830" rel="noreferrer noopener">Parkinson&#8217;s disease (PD)</a>.
The FDA has issued a Complete Response Letter (CRL) in response to the company&#8217;s New Drug Application (NDA) for SPN-830.&nbsp;
The CRL indicates that the review cycle for the application is complete but that the application still needs to be prepared for approval in its present form.
The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA.&nbsp;
<ul>
<li>The first area relates to product quality. The company recently submitted additional product quality data to the FDA, which it has not yet reviewed.&nbsp;</li>
<li>&nbsp;The second relates to the master file for the infusion device, which is proprietary to the device manufacturer.&nbsp;</li>
</ul>
The company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830.&nbsp;
No clinical safety or efficacy issues were identified as a requirement for approval.&nbsp;
The FDA completed in February 2024 a preapproval inspection of the device manufacturer&#8217;s facility.
In October 2022, the FDA granted a CRL for the SPN-830 marketing application when the agency said it required additional information and analysis related to the infusion device and drug product, including labeling, product quality and manufacturing, device performance,&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/22/10/29200988/fda-rejects-supernus-pharmas-minimally-invasive-parkinsons-therapy" rel="noreferrer noopener">and risk analysis</a>.
In October 2023, Supernus Pharmaceuticals&nbsp;<a target="_blank" href="https://ir.supernus.com/news-releases/news-release-details/supernus-resubmits-nda-spn-830-apomorphine-infusion-device-0" rel="noreferrer noopener">resubmitted</a>, and in November, the FDA&nbsp;<a target="_blank" href="https://ir.supernus.com/news-releases/news-release-details/supernus-announces-spn-830-apomorphine-infusion-device-nda" rel="noreferrer noopener">acknowledged</a>&nbsp;the resubmission of the application for SPN-830.
SUPN stock fell as much as 9% during the premarket session.
Price Action: SUPN shares are down 1.61% at $33.01 on the last check Monday.
Photo by Louis Reed via Unsplash

Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease

Supernus Pharmaceuticals shares are trading lower after the company announced the FDA has issued a Complete Response Letter in response to the company's New Drug Application for SPN-830.

<h3>Gainers</h3>
<ul>
<li>Longeveron (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) shares moved upwards by 75.0% to $3.85 during Monday's pre-market session. The market value of their outstanding shares is at $9.6 million. </li>
<li>PetVivo Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PETV#NASDAQ">PETV</a>) stock increased by 17.09% to $1.22. The company's market cap stands at $20.4 million. </li>
<li>SHL Telemedicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SHLT#NASDAQ">SHLT</a>) stock moved upwards by 13.26% to $6.49. The company's market cap stands at $106.3 million. </li>
<li>Pluri (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PLUR#NASDAQ">PLUR</a>) stock moved upwards by 12.02% to $6.15. The market value of their outstanding shares is at $32.1 million. </li>
<li>Novo Integrated Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVOS#NASDAQ">NVOS</a>) shares moved upwards by 11.35% to $0.5. The company's market cap stands at $8.8 million. </li>
<li>Ocugen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCGN#NASDAQ">OCGN</a>) stock moved upwards by 8.19% to $1.98. The company's market cap stands at $508.0 million. As per the press release, Q4 earnings came out 4 days ago. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>BioRestorative Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BRTX#NASDAQ">BRTX</a>) stock fell 18.8% to $1.08 during Monday's pre-market session. The company's market cap stands at $7.3 million. </li>
<li>Supernus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SUPN#NASDAQ">SUPN</a>) stock fell 16.34% to $28.07. The company's market cap stands at $1.5 billion. </li>
<li>Virpax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRPX#NASDAQ">VRPX</a>) stock fell 11.32% to $3.45. The market value of their outstanding shares is at $4.0 million. </li>
<li>Adial Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADIL#NASDAQ">ADIL</a>) stock fell 11.21% to $1.03. The market value of their outstanding shares is at $1.7 million. </li>
<li>G1 Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTHX#NASDAQ">GTHX</a>) shares declined by 10.33% to $4.29. The market value of their outstanding shares is at $223.7 million. </li>
<li>GlucoTrack (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GCTK#NASDAQ">GCTK</a>) shares decreased by 9.81% to $0.45. The company's market cap stands at $12.0 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

ADIL

BRTX

GCTK

GTHX

LGVN

NVOS

OCGN

PETV

PLUR

SHLT

VRPX

12 Health Care Stocks Moving In Monday's Pre-Market Session

In a report released today, Annabel Samimy from Stifel Nicolaus maintained a Hold rating on Supernus Pharmaceuticals (SUPN – Research Report), with...

Stifel Nicolaus Reaffirms Their Hold Rating on Supernus Pharmaceuticals (SUPN)

TD Cowen analyst Stacy Ku maintained a Buy rating on Supernus Pharmaceuticals (SUPN – Research Report) today and set a price target of $43.00. The ...

Supernus Pharmaceuticals (SUPN) Gets a Buy from TD Cowen

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Supernus Pharmaceuticals (SUPN – Research Report) an...

Analysts Offer Insights on Healthcare Companies: Supernus Pharmaceuticals (SUPN) and Tyra Bioscience (TYRA)

Supernus (SUPN) announced data in a poster presentation at Psych Congress 2024 with new data from its exploratory open-label Phase 2a clinical stud...

Supernus announces data from SPN-820 study

TD Cowen analyst Stacy Ku maintained a Buy rating on Supernus Pharmaceuticals (SUPN – Research Report) yesterday and set a price target of $43.00. ...

Strong Q3 Performance and Promising Future for Supernus Pharmaceuticals Backed by Qelbree's Success

Supernus Pharmaceuticals, Inc. (SUPN) Q3 2024 Earnings Call Transcript

Supernus Pharmaceuticals ( ($SUPN) ) has released its Q3 earnings. Here is a breakdown of the information Supernus Pharmaceuticals presented to its...

Supernus Pharmaceuticals Reports Strong Q3 2024 Results

In a report released today, David Amsellem from Piper Sandler reiterated a Hold rating on Supernus Pharmaceuticals (SUPN – Research Report), with a...

Piper Sandler Sticks to Its Hold Rating for Supernus Pharmaceuticals (SUPN)

Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on Supernus Pharmaceuticals (SUPN – Research Report),...

Comments

Supernus Pharmaceuticals

Supernus Pharmaceuticals (SUPN) Opzioni

Supernus Pharmaceuticals (NASDAQ:SUPN) Azioni, Catena delle Opzioni

Notizie

PARTNER/COLLABORATORE

BENZINGA NEL MONDO