Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs May 19) * ADC Therapeutics SA (NYSE: ADCT) (IPOed May 15) * Allogene Therapeutics Inc (NASDAQ: ALLO) * Arcturus Therapeutics Ltd (NASDAQ: ARCT) * Bio-Rad Laboratories, Inc. (NYSE: BIO) * BioXcel Therapeutics Inc (NASDAQ: BTAI) * ChemoCentryx Inc (NASDAQ: CCXI) * Evoke Pharma Inc (NASDAQ: EVOK) * I-Mab ADR (NASDAQ: IMAB) * Imara Inc (NASDAQ: IMRA) * Intellia Therapeutics Inc (NASDAQ: NTLA) * Neurocrine Biosciences, Inc. (NASDAQ: NBIX) * Syndax Pharmaceuticals Inc (NASDAQ: SNDX) * Translate Bio Inc (NASDAQ: TBIO) * Twist Bioscience Corp (NASDAQ: TWST) * United Therapeutics Corporation (NASDAQ: UTHR) * VBI Vaccines Inc (NASDAQ: VBIV) * Vermillion, Inc. (NASDAQ: VRML) * Zai Lab Ltd (NASDAQ: ZLAB) * Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)Down In The Dumps (Biotech Stocks Hitting 52-week Lows May 19) * Lyra Therapeutics Inc (NASDAQ: LYRA) (IPOed May 1)Stocks In Focus Myriad Announces FDA Approval For Companion Diagnostic Test For Prostate Cancer Myriad Genetics, Inc. (NASDAQ: MYGN) said the FDA approved the BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza.Lynparza is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca plc (NYSE: AZN) and Merck & Co., Inc. (NYSE: MRK).In pre-market trading Wednesday, Myriad shares were advancing 8.21% to $15.68.Aldeyra To Advance Two Pipeline Assets Into Clinical Trials For COVID-19 Treatment Aldeyra Therapeutics Inc (NASDAQ: ALDX) announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19, and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.Aldeyra announced that ADX-1612 has demonstrated nanomolar potency similar to or greater than that of remdesivir in an in vitro model. Complementary to the nucleic acid inhibition mechanism of action of remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection, and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19. Pending FDA feedback, the company expects to file an IND the third quarter of 2020.The company said ADX-629 has completed pre-IND discussions with the Pulmonary Division of the FDA, and an IND application is expected to be submitted in June 2020.In pre-market trading, shares were up 23.70% to $4.75.Eiger's NDA For Progeria Drug Accepted For Accelerated Review Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) said the FDA accepted its NDA for an accelerated review of Zokinvy for treatment of Progeria and Progeroid Laminopathies. The PDUFA action date has been fixed for Nov. 20. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss this application.View more earnings on IBBRelated Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan StanleyBio-Techne Announces Pact to Develop and Scale Up Serology Test Kits For Coronavirus BIO-TECHNE Corp (NASDAQ: TECH) and Kantaro Biosciences, the commercial affiliate of the Mount Sinai Health System in New York, announced a partnership to initiate scaled manufacturing and distribution of testing kits based on the Mount Sinai-developed COVID-19 serology test.Bio-Techne said it has partnered with Kantaro to develop a test kit based on the Mount Sinai test and to scale up, manufacture, sell and distribute these kits. Initial kit production capacity is expected to enable laboratories to conduct in excess of 10 million tests monthly in July, scaling to higher capacity in subsequent months..Offerings Ocular Therapeutix Inc (NASDAQ: OCUL) said it has commenced an underwritten public offering of its common stock. All of the shares in the offering are to be sold by the company. The company also said the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.The stock fell 4.65% to $6.15 in after-hours trading.Medigus Ltd. (NASDAQ: MDGS) said it has priced its underwritten public offering of 3.33 million ADSs at a price of $1.50 per ADS. Each pre-funded warrant that allows purchase of one ADS is priced at $1.499 per pre-funded warrant. The company noted that the pre-funded warrants are exercisable at any time after the date of issuance upon payment of the exercise price of $0.001 per ADS.The stock slipped 10.24% to $2.63 in after-hours trading.VolitionRX Ltd (NYSE: VNRX) said it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares are being offered by the company.In after-hours trading, the stock fell 7.30% to $2.92.On The Radar Earnings Mediwound Ltd (NASDAQ: MDWD) (before the market open) China Biologic Products Holdings Inc (NASDAQ: CBPO) (after the close) Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the close)See more from Benzinga * The Daily Biotech Pulse: FDA Nod For Roche, Arbutus Releases Positive Readout For HBV Therapy, Moderna Announces .34B Common Stock Offering * The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows * The Daily Biotech Pulse: Co-Diagnostics Earnings, NantKwest Plans Pancreatic Cancer Study, ADC Therapeutics IPO(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported financial results for the fourth quarter and full year 2019 and provided a business update.
As of late, it has definitely been a great time to be an investor Eiger BioPharmaceuticals
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the first patients have been dosed in a Phase 2 study of peginterferon lambda (Lambda) in outpatients with mild COVID-19 at the Stanford University School of Medicine.
Whilst it may not be a huge deal, we thought it was good to see that the Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR...
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Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that it has completed submission to the U.S. Food and Drug Administration (FDA) of a New Drug Application (NDA) for lonafarnib for the treatment of Progeria and Progeroid Laminopathies. The FDA previously granted Breakthrough Therapy Designation and Rare Pediatric Disease Designation to lonafarnib, which enables eligibility for Priority Review, if relevant criteria are met. Eiger expects to hear from FDA regarding submission acceptance and Priority Review within 60 days.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a late-stage clinical biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced the appointment of Eldon Mayer as Executive Vice President and Chief Commercial Officer. Mr. Mayer is a pharmaceutical industry veteran with broad commercial experience in large and specialty pharma across multiple therapeutic areas, including both orphan and larger markets, with multiple successful exits by acquisition.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for accelerated review of Zokinvy™ (lonafarnib) for treatment of Progeria and Progeroid Laminopathies. The FDA granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 20, 2020. The FDA is not currently planning to hold an advisory committee meeting to discuss this application. Zokinvy for treatment of Progeria and Progeroid Laminopathies has been granted Rare Pediatric Disease Designation.
Eiger (EIGR) completes rolling submission of the NDA seeking approval for lonafarnib as a treatment for progeria and progeroid laminopathies, ultra-rare diseases causing accelerated aging in children.
- 53% of Patients Achieve Undetectable or BLOQ HDV RNA at Week 24 - Median Decline of HDV RNA: -3.4 Log at Week 24 - 95% of Patients Achieve > 2 Log Decline in HDV RNA at Week 24 PALO ALTO, Calif. , ...
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a late-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today updated on progress across its product pipeline, including clinical and regulatory program planned milestones, and commercial preparation.
PALO ALTO, Calif., Nov. 15, 2019 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that Eiger management will present a corporate update at the Jefferies 2019 London Healthcare Conference on November 20, 2019 from 4:00-4:35 PM GMT in London. Eiger is a late stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist. The company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection.
Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that Eiger management will present a corporate update at the Jefferies Virtual Healthcare Conference on June 4, 2020 from 9:30-9:55 PM ET.
Eiger BioPharmaceuticals (EIGR) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.
Insiders invest in JPMorgan, Simply Good Foods, Eiger BioPharmaceuticals and Geron Continue reading...
Potential Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) shareholders may wish to note that the Founder, Jeffrey Glenn...
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today provided an update on the impact of the rapidly progressing global COVID-19 (SARS-CoV-2) pandemic. Eiger has put into place remote operations and new policies to maintain the safety and well-being of our employees, while working to maintain business continuity as this unprecedented global situation continues to evolve. The company has taken appropriate steps to ensure the safety of patients and the integrity of the HDV Phase 3 D-LIVR trial. We have also begun supporting multiple Investigator-Sponsored Studies of Peginterferon Lambda in COVID-19.
In the span of eight days last month, CytomX Therapeutics Inc. landed a collaboration with Astellas Pharma and captured a $40 million milestone payment from AbbVie Inc. as it preps for a mid-stage cancer clinical trial. “It’s a challenging time for our industry,” said CytomX President and CEO Sean McCarthy.
Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a late stage clinical biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that it has initiated submission of a New Drug Application (NDA) for Lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies to the U.S. Food & Drug Administration (FDA) under the Rolling Review Process. Lonafarnib, an oral farnesyltransferase inhibitor (FTI), has demonstrated extended survival in children and young adults with Progeria, an ultra-rare and fatal disease that causes premature aging in children. Without treatment, children with Progeria die of heart disease at an average age of 14.5 years.