• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
PublishDashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI employees
    Legal
    Terms of usePrivacy policyCookie policy

    Eloxx Pharmaceuticals Reports Independent Confirmation of Positive Biopsy Results in All Patients Treated with ELX-02 in Phase 2 Clinical Study for Alport Syndrome

    9/18/23 7:00:00 AM ET
    $ELOX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $ELOX alert in real time by email

    Highly regarded renal pathologist and transmission electron microscopy (TEM) expert independently confirms previously reported qualitative assessment by Mayo Clinic of TEM biopsy scans

    All three patients treated with ELX-02 showed a visual improvement in podocyte foot process effacement post-treatment in kidney biopsies demonstrating the disease modifying effect of ELX-02

    Podocyte foot process effacement is a hallmark of Alport syndrome

    Eloxx intends to gain alignment with U.S. Food and Drug Administration (FDA) on design of pivotal trial and potential for seeking Breakthrough Therapy Designation

    WATERTOWN, Mass., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported additional independent confirmation on the positive TEM assessment results from its proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Alport syndrome after eight weeks of treatment. Visual assessment of TEM images from kidney biopsies showed an improvement in foot process effacement in all three treated patients consistent with disease regression. Alport syndrome is a rare genetic kidney disorder caused by mutations in COL4A3/4/5 genes, characterized by podocyte injury and impaired kidney filter function leading to proteinuria.

    Additional independent confirmation has now been reported. The qualitative assessment of images of pre- and post-treatment kidney biopsies from the three patients in the Phase 2 clinical trial noted:

    • Patient 4401-01 and Patient 4401-02: All images showed more regions of glomerular basement membranes in post-treatment biopsies covered by intact foot processes, consistent with partial improvement of podocyte injury in those biopsies. As previously announced, Patient 4401-02 achieved remission based on Urine-Protein Creatine ratio (UPCR).
    • Patient 4402-01: Post-treatment images showed wider areas of intact foot processes compared with either pre- or post-treatment images for Patient 4401-01 and Patient 4401-02. 

    These findings are generally consistent with previous assessments, providing stronger evidence of protein restoration and the disease modifying effect of ELX-02 and potential for improvement in proteinuria with longer duration of treatment.

    "We are incredibly pleased with this additional confirmation from a globally renowned expert in interpreting the findings from kidney biopsies," said Sumit Aggarwal, President and Chief Executive Officer of Eloxx. "We look forward to initiating a pivotal trial as we believe ELX-02 has the potential to make a meaningful impact on the lives of patients with Alport syndrome."

    Eloxx previously announced achievement of a rapid and sustained remission in one patient in the Phase 2 clinical trial. Based on the results from the Phase 2 trial, Eloxx intends to gain alignment with the FDA on the design of pivotal trial for ELX-02 for the treatment of Alport syndrome with nonsense mutations and the potential for seeking Breakthrough Therapy Designation. Eloxx recently submitted an Investigational New Drug application (IND) to the FDA for ELX-02 for the treatment of Alport syndrome with nonsense mutations. The IND, if allowed, would enable the inclusion of U.S.-based sites in the planned pivotal trial.

    About Alport syndrome

    Alport syndrome is a genetic disorder characterized by kidney disease with high levels of proteinuria, hearing loss and eye abnormalities caused by mutations in the genes (COL4A3, COL4A4, and COL4A5) needed for production of type 4 collagen. Approximately 6% to 7% of Alport syndrome patients, or approximately 9,400 to 12,750 individuals, are estimated to have nonsense mutations. These patients have significantly worse clinical outcomes than other patients with Alport syndrome and have no disease modifying treatment options.

    About Eloxx Pharmaceuticals

    Eloxx Pharmaceuticals, Inc. is engaged in the science of ribosome modulation, leveraging its innovative TURBO-ZM™ chemistry technology platform in an effort to develop novel Ribosome Modulating Agents (RMAs) and its library of Eukaryotic Ribosome Selective Glycosides (ERSGs). Eloxx's lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in Phase 2 clinical development for the treatment of Alport syndrome in patients with nonsense mutations. For more information, please visit www.eloxxpharma.com.

    Forward-looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including without limitation, statements regarding the potential of our product candidate to treat Alport syndrome and intentions regarding communications with FDA for alignment on a potential pivotal trial and a Breakthrough Therapy Designation submission are forward-looking statements. Forward-looking statements can be identified by the words "aim," "may," "will," "would," "should," "expect," "explore," "plan," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential," "seeks," or "continue" or the negative of these terms similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on management's current plans, estimates, assumptions and projections based on information currently available to us. Forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and actual results or outcomes may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to: our ability to progress any product candidates in preclinical or clinical trials; the uncertainty of clinical trial results and the fact that positive results from preclinical studies are not always indicative of positive clinical results; the scope, rate and progress of our preclinical studies and clinical trials and other research and development activities; the competition for patient enrollment from drug candidates in development; the impact of the global COVID-19 pandemic on our clinical trials, operations, vendors, suppliers, and employees; our ability to obtain the capital necessary to fund our operations; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain financial in the future through product licensing, public or private equity or debt financing or otherwise; our ability to meet the continued listing requirements of the Nasdaq Capital Market; general business conditions, regulatory environment, competition and market for our products; and business ability and judgment of personnel, and the availability of qualified personnel and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2023, as any such factors may be updated from time to time in our other filings with the SEC, accessible on the SEC's website at www.sec.gov and the "Financials & Filings" page of our website at https://investors.eloxxpharma.com/financials-filings.

    All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

    Contact

    Investors

    John Woolford

    [email protected]

    443.213.0506

    Media

    Laureen Cassidy

    [email protected]

    SOURCE: Eloxx Pharmaceuticals, Inc.



    Primary Logo

    Get the next $ELOX alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $ELOX

    DatePrice TargetRatingAnalyst
    12/17/2021$4.00Outperform
    Oppenheimer
    11/18/2021$2.00 → $1.00Neutral
    HC Wainwright & Co.
    11/11/2021$3.00 → $2.00Neutral
    HC Wainwright & Co.
    6/30/2021$3.10Buy
    Mizuho
    More analyst ratings

    $ELOX
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • Eloxx Pharmaceuticals Announces Key Corporate Accomplishments

      Data from Eloxx's proof-of-concept trial in patients with nonsense mutation Alport Syndrome (NMAS) presented in late-breaking presentation at American Society of Nephrology (ASN) Kidney Week New protein analyses confirm production of both collagen alpha 4 and collagen alpha 5 in patients post treatment with ELX-02 Results justify the need to conduct a larger clinical trial of ELX-02 in NMAS to confirm clinical benefit U.S. Food and Drug Administration (FDA) allows for continued dosing of subjects in Phase 1 trial of ZKN-013 WATERTOWN, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (OTC:ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases w

      11/12/24 4:05:00 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Eloxx Pharmaceuticals Provides Pipeline and Financing Updates

      First two subjects dosed in Phase 1 clinical trial of ZKN-013; ZKN-013 is being developed for the potential treatment of rare dermatological and other diseases associated with nonsense mutations Positive written FDA feedback and guidance from a pre-Investigational New Drug Application (PIND) meeting provides pathway to IND application submission to initiate a Phase 2 clinical trial in the US with ELX-02 in patients with nonsense mutation alport syndrome (NMAS) Secured binding commitment for additional $3.2 million financing to advance our clinical programs WATERTOWN, Mass., July 11, 2024 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (OTC:ELOX), a leader in ribosomal RNA-targeted gene

      7/11/24 11:46:35 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Eloxx Pharmaceuticals Provides ELX-02 and ZKN-013 Program Updates

      ELX-02 Granted Orphan Drug Designation (ODD) from U.S. Food and Drug Administration (FDA) for Treatment of Alport Syndrome Pre-Investigational New Drug (IND) Meeting Requested with U.S. FDA for ELX-02 to Discuss Planned next Study In Nonsense Mutation Alport Syndrome Signed Global Licensing Partnership for ZKN-013 with Almirall Pharmaceuticals with $3M upfront and up to $470M in milestones and Tiered Royalties on Global Sales New Paper Published on Autosomal Dominant Polycystic Kidney Disease (ADPKD) shows that ELX-02 treatment prevents cyst formation in diseased PKD organoids with nonsense mutations and a single healthy gene copy WATERTOWN, Mass., April 16, 2024 (GLOBE NEWSWI

      4/16/24 7:30:00 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • Oppenheimer initiated coverage on Eloxx Pharmaceuticals with a new price target

      Oppenheimer initiated coverage of Eloxx Pharmaceuticals with a rating of Outperform and set a new price target of $4.00

      12/17/21 5:45:41 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • HC Wainwright & Co. reiterated coverage on Eloxx Pharmaceuticals with a new price target

      HC Wainwright & Co. reiterated coverage of Eloxx Pharmaceuticals with a rating of Neutral and set a new price target of $1.00 from $2.00 previously

      11/18/21 6:16:16 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • HC Wainwright & Co. reiterated coverage on Eloxx Pharmaceuticals with a new price target

      HC Wainwright & Co. reiterated coverage of Eloxx Pharmaceuticals with a rating of Neutral and set a new price target of $2.00 from $3.00 previously

      11/11/21 6:39:05 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    SEC Filings

    See more
    • SEC Form NT 10-Q filed by Eloxx Pharmaceuticals Inc.

      NT 10-Q - Eloxx Pharmaceuticals, Inc. (0001035354) (Filer)

      11/19/24 4:01:28 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Eloxx Pharmaceuticals Inc. filed SEC Form 8-K: Leadership Update, Financial Statements and Exhibits

      8-K - Eloxx Pharmaceuticals, Inc. (0001035354) (Filer)

      10/17/24 4:01:29 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • SEC Form NT 10-Q filed by Eloxx Pharmaceuticals Inc.

      NT 10-Q - Eloxx Pharmaceuticals, Inc. (0001035354) (Filer)

      8/14/24 4:01:27 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • Director Walts Alan Edmund was granted 12,000 shares, increasing direct ownership by 1,274% to 12,942 units (SEC Form 4)

      4 - Eloxx Pharmaceuticals, Inc. (0001035354) (Issuer)

      10/17/24 4:02:21 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Director Androski Lindsay was granted 12,000 shares (SEC Form 4)

      4 - Eloxx Pharmaceuticals, Inc. (0001035354) (Issuer)

      10/17/24 4:01:56 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Director Rubin Steven D was granted 12,000 shares (SEC Form 4)

      4 - Eloxx Pharmaceuticals, Inc. (0001035354) (Issuer)

      10/17/24 4:01:36 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    Leadership Updates

    Live Leadership Updates

    See more
    • Cognito Therapeutics Appoints Greg Weaver as Chief Financial Officer

      Cognito Therapeutics, a pioneer developing disease-modifying therapeutics to treat CNS diseases, today announced the appointment of Greg Weaver as Chief Financial Officer (CFO), to lead all finance-related and investor relations functions at the Company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231017630946/en/Greg Weaver, CFO, Cognito Therapeutics (Photo: Business Wire) Mr. Weaver is a highly accomplished finance executive who brings more than 30 years of life sciences, financial and operations experience to Cognito. Most recently, he served as CFO of Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical-stage oncology comp

      10/17/23 8:00:00 AM ET
      $ATAI
      $ATOS
      $ELOX
      Biotechnology: Pharmaceutical Preparations
      Health Care
      Biotechnology: Biological Products (No Diagnostic Substances)
    • Atossa Appoints Life Sciences Financial and Operations Industry Veteran Greg Weaver as Chief Financial Officer

      SEATTLE, June 01, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a current focus on breast cancer, today announces the appointment of Greg Weaver as the Company's new Chief Financial Officer (CFO). Mr. Weaver succeeds Kyle Guse. A short video interview with Mr. Weaver about his background and vision for Atossa can be found here: https://youtu.be/G6ZzHLh-qsQ Mr. Weaver brings more than 30 years of life sciences, financial and operations experience to the Company. Recently, he served as CFO of privately held BioIntelliSense, a commerc

      6/1/23 9:10:00 AM ET
      $ATAI
      $ATOS
      $ELOX
      Biotechnology: Pharmaceutical Preparations
      Health Care
      Biotechnology: Biological Products (No Diagnostic Substances)
    • Eloxx Pharmaceuticals Announces Changes to Board of Directors

      Lindsay Androski, JD, MBA brings significant experience growing biotech companies through her roles as an executive at Roivant Social Ventures Gadi Veinrib, Ran Nussbaum, Dr. Zafrira Avnur, Dr. Rajesh Parekh and Dr. Jasbir Seehra step down from the Eloxx board WATERTOWN, Mass., July 05, 2022 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced the appointment of Lindsay Androski, JD, MBA to its board of directors and as a member of the Board's Audit Committee and Compensation Committee. Current board members Gadi Veinrib, Ran Nussbaum, Dr. Zafrira Avnur, Dr. Rajesh Parekh and Dr.

      7/5/22 8:00:00 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • Amendment: SEC Form SC 13D/A filed by Eloxx Pharmaceuticals Inc.

      SC 13D/A - Eloxx Pharmaceuticals, Inc. (0001035354) (Subject)

      8/20/24 8:13:16 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • SEC Form SC 13G/A filed by Eloxx Pharmaceuticals Inc. (Amendment)

      SC 13G/A - Eloxx Pharmaceuticals, Inc. (0001035354) (Subject)

      2/13/23 4:52:16 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • SEC Form SC 13G/A filed by Eloxx Pharmaceuticals Inc. (Amendment)

      SC 13G/A - Eloxx Pharmaceuticals, Inc. (0001035354) (Subject)

      2/14/22 6:18:22 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care

    $ELOX
    Financials

    Live finance-specific insights

    See more
    • Eloxx Pharmaceuticals Reports Topline Results from Phase 2 Combination Clinical Trial of ELX-02 in Class 1 Cystic Fibrosis (CF) Patients

      Combination of subcutaneous ELX-02 with ivacaftor did not achieve statistical significance for efficacy endpoints in Phase 2 study in Class 1 CF ELX-02 was well tolerated with no drug-related serious adverse events observed Evidence of activity for ELX-02 observed; efficacy signal potentially confounded by variability due to low drug exposure Path forward for ELX-02 for the treatment of Class 1 CF to be determined together with CF Foundation Company to host conference call and webcast today, September 14, 2022, at 4:30 p.m. ET WATERTOWN, Mass., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare d

      9/14/22 4:05:00 PM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Eloxx Pharmaceuticals Reports Positive Topline Results from Monotherapy Arms of Phase 2 Clinical Trial of ELX-02 in Class 1 Cystic Fibrosis Patients

      ELX-02 monotherapy dosed at 1.5mg/kg/day demonstrated a statistically significant 5.4mmol/L mean sweat chloride reduction, an established surrogate for restoration of CFTR biological activity ELX-02 monotherapy results support advancement of ELX-02 into Phase 3 clinical development First patient dosed in Phase 2 ELX-02 expansion treatment arms evaluating combination with ivacaftor; topline data expected by the end of the first half of 2022 Company to host conference call and webcast Wednesday, November 17, 2021 at 8:30 am ET WATERTOWN, Mass., Nov. 17, 2021 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ:ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare dise

      11/17/21 7:00:00 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care
    • Eloxx Pharmaceuticals Acquires Zikani Therapeutics

      Combined Company to be Leader in Ribosomal RNA-Targeted Genetic Therapy Bringing Together Complementary Platforms Maximizes Potential for ELX-02 for Cystic Fibrosis in Phase 2 Development Adds Preclinical Stage Pipeline in Rare Diseases and Oncology Targeting RNA and Ribosomal Mutations Expects to File IND for First Oral Drug to Treat Patients with Recessive Dystrophic and Junctional Epidermolysis Bullosa (RDEB and JEB) Sumit Aggarwal, Zikani President and CEO, to Lead the Combined Company Eloxx to Issue Approximately 7.6 Million Shares to Zikani Stockholders Company to Host Investor Call at 8:30 a.m. ET, April 1 WALTHAM, Mass. and WATERTOWN, Mass., April 01, 2021 (GLOBE NEWSWIRE

      4/1/21 7:45:00 AM ET
      $ELOX
      Biotechnology: Biological Products (No Diagnostic Substances)
      Health Care