News
SUPN
29.00
-1.46%
-0.43
Weekly Report: what happened at SUPN last week (0408-0412)?
Weekly Report · 2d ago
Analysts’ Opinions Are Mixed on These Healthcare Stocks: Argenx Se (ARGX), Neogen (NEOG) and Supernus Pharmaceuticals (SUPN)
TipRanks · 2d ago
BUZZ-U.S. STOCKS ON THE MOVE-Perpetua Resources, Huntington Bancshares, FuelCell Energy
Wall Street's main stock indexes advanced in choppy trading on Monday. The Dow Jones Industrial Average was up 0.10% at 38,942.47. The top three S&P 500 percentage gainers were Albemarle, Tesla and Tesla. Boeing and Boeing Co were among the biggest decliners.
Reuters · 04/08 18:05
Supernus Pharmaceuticals Shares Slip 6.9% After FDA Says Drug Application Not Ready
Supernus Pharmaceuticals shares are down 6.9% in afternoon trading. The company's new drug application for a device to treat "off" episodes in Parkinson's disease is not ready for approval. The stock is still up about 8% since the start of the year. The FDA says the company's product quality and the infusion device require further review.
Dow Jones · 04/08 17:49
BUZZ-U.S. STOCKS ON THE MOVE-JPMorgan, Ameresco, Copper miners
Wall Street's main stock indexes advanced in choppy trading on Monday. The Dow Jones Industrial Average was up 0.10% at 38,941.91. The top three S&P 500 percentage gainers were Tesla, GE and Ameresco. Treasury yields retreated from session highs as investors awaited the Fed's rate outlook.
Reuters · 04/08 16:11
Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson's Disease
Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) announced a regulatory update for SPN-830, an investigational apomorphine infusion device under FDA review for the treatment of motor fluctuations in Parkinson's disease. The FDA has issued a Complete Response Letter in response to the company's New Drug Application for the device. SUPN stock fell as much as 9% during the premarket session.
Benzinga · 04/08 14:11
BUZZ-U.S. STOCKS ON THE MOVE-Ocugen, Model N, Fastly
Futures tracking Wall Street's main indexes were largely muted on Monday. Treasury yields rose on rising bets that the U.S. Federal Reserve could delay interest-rate cuts this year. Dow e-minis were up 0.13% in early trading. Ocugen up 9.8% on FDA approval of gene therapy for Parkinson's disease.
Reuters · 04/08 13:50
Supernus stock slides as FDA rejects Parkinson's disease infusion device
Supernus Pharmaceuticals stock slides as FDA rejects Parkinson's disease infusion device. The U.S. Drug regulator rejected its experimental apomorphine infusion device for the continuous treatment of motor fluctuations associated with Parkinson’s disease. Supernus shares dipped 11% premarket on Monday.
Seeking Alpha · 04/08 12:39
BUZZ-Supernus down as FDA declines nod to its Parkinson's disease drug-device combo
Shares of Supernus Pharmaceuticals fall 10.6% to $30 premarket. Company says U.S. FDA declines to approve application for Parkinson's disease drug-device combo. No clinical safety or efficacy issues were identified, company says. Stock up 16% YTD.
Reuters · 04/08 12:29
UPDATE 2-US FDA declines to approve Supernus' Parkinson's combination again
US FDA declines to approve Supernus Pharmaceuticals' Parkinson's combination again. This is the second time the regulator has refused to approve the company's pump-based treatment. The company's shares down 9% in early trade. Abbvie is also developing a similar treatment for Parkinson's disease.
Reuters · 04/08 12:21
CORRECTED-UPDATE 2-US FDA declines to approve Supernus' Parkinson's combination again (April 8)
US FDA declines to approve Supernus Pharmaceuticals' Parkinson's combination again. This is the second time the regulator has refused to approve the company's pump-based treatment. The company's shares down 9% in early trade. The drug-device combination aims to treat movement-related symptoms of Parkinson's disease.
Reuters · 04/08 12:21
12 Health Care Stocks Moving In Monday's Pre-Market Session
Gainers Longeveron (NASDAQ:LGVN) shares moved upwards by 75.0% to $3.85 during Monday's pre-market session. PetVivo Hldgs stock increased by 17.09% and SHL Telemedicine stock moved up by 13.26%. Losers include Supernus Pharmaceuticals and G1 Therapeutics.
Benzinga · 04/08 12:09
Supernus Provides Regulatory Update For SPN-830, FDA Has Issued A CRL In Response To The Co's NDA For Spn-830 Indicating That The Review Cycle For The Application Is Complete, But That The Application Is Not Ready For Approval In Its Present Form.
Supernus Pharmaceuticals, Inc. Announces a regulatory update for SPN-830. The FDA has issued a Complete Response Letter in response to the Company's New Drug Application for the treatment of motor fluctuations in Parkinson's disease. The company says the application is not ready for approval in its present form.
Benzinga · 04/08 12:06
SUPERNUS PHARMACEUTICALS INC: FDA HAS ISSUED CRL IN RESPONSE TO COMPANY'S NEW DRUG APPLICATION (NDA) FOR SPN-830
Reuters · 04/08 12:00
SUPERNUS: ADDITIONAL INFORMATION TO BE PROVIDED TO FDA WHICH RELATES TO PRODUCT QUALITY, MASTER FILE FOR INFUSION DEVICE
Reuters · 04/08 12:00
Weekly Report: what happened at SUPN last week (0401-0405)?
Weekly Report · 04/08 11:27
Weekly Report: what happened at SUPN last week (0325-0329)?
Weekly Report · 04/01 11:25
Biotech Stocks Facing FDA Decision In April 2024
NASDAQ · 03/28 14:54
Weekly Report: what happened at SUPN last week (0318-0322)?
Weekly Report · 03/25 11:28
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About SUPN
Supernus Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Its 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 is also developing a range of novel CNS product candidates, including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. Its commercial products, including Qelbree (viloxazine), GOCOVRI (amantadine), Oxtellar XR (oxcarbazepine), Trokendi XR (topiramate), APOKYN (apomorphine hydrochloride injection) and others. Qelbree (viloxazine) is a novel non-stimulant product indicated for the treatment of ADHD.