Orphazyme A/S, a biopharmaceutical company, develops therapies for the treatment of neurodegenerative orphan diseases. The company focuses on the amplification of heat-shock proteins to develop and commercialize therapeutics for diseases caused by protein misfolding and aggregation, and lysosomal dysfunction, including lysosomal storage and neuromuscular degenerative diseases. Its lead candidate is the Arimoclomol, which is in clinical development for four orphan diseases, including Niemann-Pick disease type C, Amyotrophic Lateral Sclerosis, Inclusion Body Myositis, and Gaucher disease. The company was incorporated in 2009 and is headquartered in Copenhagen, Denmark.
IPO Year: 2020
Exchange: NASDAQ
Website: orphazyme.com
LOS ANGELES--(BUSINESS WIRE)--CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that Orphazyme A/S (NASDAQ: ORPH) ("Orphazyme") has announced the appointment of Christophe Bourdon as its new Chief Executive Officer, effective as of April 1, 2021. This appointment comes as Orphazyme awaits potential Food and Drug Administration ("FDA") approval of arimoclomol for the treatment of Niemann-Pick disease Type C ("NPC"). CytRx has an agreement with Orphazyme that can yield potential milestone payments and future single and doubl
SC 13G/A - Orphazyme A/S (0001764791) (Subject)
SC 13G - Orphazyme A/S (0001764791) (Subject)
SC 13G - Orphazyme A/S (0001764791) (Subject)
SC 13G - Orphazyme A/S (0001764791) (Subject)
Guggenheim downgraded Orphazyme from Buy to Sell
BofA Securities downgraded Orphazyme from Neutral to Underperform and set a new price target of $5.00 from $13.00 previously
Notes CytRx's Core Assets Are Unaffected by European Medicines Agency's Assessment of Arimoclomol Highlights Positive Developments Regarding Company's Core Assets, Including Aldoxorubicin CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today commented on Orphazyme A/S's (NASDAQ:ORPH) ("Orphazyme") announced update on the ongoing review of the Marketing Authorisation Application for its investigational product candidate, arimoclomol, for the treatment of Niemann-Pick disease type C ("NPC") by the Committee for Medicinal Products for Human Use ("CHMP") of the
Orphazyme Intends to Request a Type C Meeting in Q2 2022 Orphazyme Plans to Resubmit the NDA During H2 2022, Subject to FDA Discussions European Medicines Agency Opinion Expected in Q1 2022 CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted Orphazyme A/S's (NASDAQ:ORPH) ("Orphazyme") announced update on the process and anticipated timelines for resubmission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its investigational product candidate, arimoclomol, for the treatment of Niemann-Pick disease type
CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today commented on its results for the quarter ended September 30, 2021. In addition, CytRx recapped corporate developments as well as matters pertaining to its agreements with ImmunityBio, Inc. (NASDAQ:IBRX) ("ImmunityBio") and Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme"). The Company's 10-Q was filed today. Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented: "We continued to prudently manage our capital and streamlined operations while awaiting potential developments with
FDA Recommends Orphazyme Provides Supplemental Information and Analyses FDA Offers to have Further Interactions with Orphazyme to Identify Path to Resubmission for Arimoclomol in NPC CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today commented on Orphazyme A/S's (NASDAQ:ORPH) ("Orphazyme") encouraging regulatory update following its recently held Type A meeting with the U.S. Food and Drug Administration ("FDA") on arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease Type C ("NPC"). Arimoclomol, CytRx'
12-Month Study of Arimoclomol Showed a Clinically Meaningful Treatment Effect, Corresponding to a Reduction in Disease Progression Highlights Arimoclomol is Under Regulatory Review in Europe, With a Decision Expected in Q4 2021 Notes Orphazyme Stated it Continues to Evaluate a Path Forward for Arimoclomol in the U.S. CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today highlighted that Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme") published the results from a Phase 2/3 trial of arimoclomol, an investigational heat-shock protein amplifier, in Niem
CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today commented on its results for the second quarter ended June 30, 2021. In addition, CytRx recapped corporate developments as well as matters pertaining to its agreements with ImmunityBio, Inc. (NASDAQ:IBRX) ("ImmunityBio") and Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme"). The Company's 10-Q was filed today. Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, commented: "We took important steps to enhance our capital position and further strengthen our corporate governance during th
New Director Dr. Jennifer K. Simpson Added to CytRx Board of Directors CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today announced that based on results from its 2021 Annual Meeting of Stockholders (the "Annual Meeting"), both of the Company's Class III director candidates – Joel K. Caldwell, CPA and Jennifer K. Simpson, Ph.D. – have been elected to the Board of Directors (the "Board"). Additional information pertaining to the Company's Annual Meeting results can be found on the Form 8-K filed with the U.S. Securities and Exchange Commission
CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today announced the closing of its previously announced sale of its securities pursuant to a securities purchase agreement (the "Purchase Agreement") to a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million. The Investor is independent of the Company's Board of Directors and management team. The Company intends to use the net proceeds of the offering for working capital purposes. Under the terms of the Purchase Agreement, CytRx
CytRx Corporation (OTCQB:CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today announced that it has entered into a securities purchase agreement (the "Purchase Agreement") with a single healthcare-focused institutional investor (the "Investor") for aggregate gross proceeds of approximately $10 million. Under the terms of the Purchase Agreement, CytRx has agreed to sell 2,000,000 shares of its common stock at a purchase price of $0.88 per share for total gross proceeds of approximately $1.76 million in a registered direct offering and 8,240 shares of Series C 10.00% Conve
CytRx Corporation (OTCQB:CYTR) ("CytRx"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S (NASDAQ:ORPH) ("Orphazyme") announced it has received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") following its review of the new drug application for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C ("NPC"). Orphazyme's announcement disclosed that the FDA issued the CRL based on needing additional qualitative and quantitative evidence to further substantiate the validity and interpretation o
Orphazyme A/S in restructuring (ORPHA.CO) ("Orphazyme" or the "Company"), a late-stage biopharmaceutical company, has today received a notice from The Bank of New York Mellon, as depositary (the "Depositary"), that a notification has been sent to holders of American Depositary Shares ("ADSs") evidenced by American Depositary Receipts ("ADRs") representing deposited common shares of the Company, regarding termination of the Deposit Agreement dated September 28, 2020 among the Company, the Depositary, and Owners and ADR Holders (the "Deposit Agreement"). Owners and beneficial owners of the above ADRs ("ADR Holders") have on April 5, 2022 been notified by the Depositary that the Depositary wil
-Reuters
Orphazyme A/S (NASDAQ:ORPH) has decided to withdraw its European Marketing Application for arimoclomol for Niemann-Pick disease Type C (NPC) ahead of a final vote and opinion by the CHMP scheduled for later this month. "Today's decision to withdraw the MAA enables us to consider the best possible path forward for arimoclomol," commented Orphazyme Chief Executive Officer Anders Vadsholt. The decision follows CHMP's negative trend vote on arimoclomol application following an Oral Explanation. Orphazyme is currently under an in-court restructuring and has reduced its workforce by approximately 50% to reduce costs. As part of the pursuit of a regulatory pathway in the U.S., the Company co
Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Merck's Keytruda Monotherapy Approved For A Type Of Endometrial Cancer Merck & Co., Inc. (NYSE:MRK) said the U.S. Food and Drug Administration has approved its cancer immunotherapy as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by a FDA-approved test. These patients should have had disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Merck shares were up 0.18% to $79.20 in premarket trading. Pfizer
Gainers Smart for Life, Inc. (NASDAQ:SMFL) rose 75.3% to $1.63 in pre-market trading. Smart For Life recently said it is launching various products under the Doctors Scientific Organica brand on Amazon Singapore. Alzamend Neuro, Inc. (NASDAQ:ALZN) shares rose 21.6% to $1.35 in pre-market trading. Meiwu Technology Company Limited (NASDAQ:WNW) rose 22.4% to $1.20 in pre-market trading. SuperCom Ltd. (NASDAQ:SPCB) rose 22.2% to $0.8448 in pre-market trading after jumping more than 25% on Monday. Enservco Corporation (NYSE:ENSV) rose 18.9% to $4.03 in pre-market trading after gaining around 18% on Monday. OneConnect Financial Technology Co., Ltd. (NASDAQ:OCFT) rose 15.6% to $1.93 in pre
Gainers Allarity Therapeutics (NASDAQ:ALLR) stock rose 25.3% to $2.84 during Monday's after-market session. The market value of their outstanding shares is at $22.9 million. DarioHealth (NASDAQ:DRIO) stock rose 15.4% to $7.49. The market value of their outstanding shares is at $162.0 million. The company's, Q4 earnings came out today. Stealth BioTherapeutics (NASDAQ:MITO) stock rose 9.11% to $0.73. The market value of their outstanding shares is at $42.0 million. Regulus Therapeutics (NASDAQ:RGLS) shares increased by 9.05% to $0.3. The market value of their outstanding shares is at $43.7 million. NexGel (NASDAQ:NXGL) stock rose 8.87% to $2.27. The market value of their outstanding share
-Reuters
Gainers Kidpik Corp. (NASDAQ:PIK) shares surged 158.2% to settle at $4.75 on Thursday after the company announced a partnership with The Walt Disney Co. Cuentas Inc. (NASDAQ:CUEN) gained 54.6% to close at $1.70. Marrone Bio Innovations, Inc. (NASDAQ:MBII) jumped 49.7% to close at $1.05 on Thursday. Bioceres Crop Solutions Corp and Marrone Bio Innovations reported a merger deal. TC Biopharm (Holdings) Plc (NASDAQ:TCBP) gained 45% to settle at $1.45 after the company reported FDA orphan drug status was granted for OmniImmune. Allego N.V. (NASDAQ:ALLG) shares surged 42.4% to settle at $9.20 on Thursday. Spartan Acquisition Corp. III reported the completion of its business combination wi
6-K - Orphazyme A/S (0001764791) (Filer)
20-F - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
NT 20-F/A - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
6-K - Orphazyme A/S (0001764791) (Filer)
NT 20-F - Orphazyme A/S (0001764791) (Filer)