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• Ocuphire Pharma Announces Two Publications Supporting the APX3330 Program

  11/12/2020

  Emerging data on the benefits of Ref-1 inhibition via APX3330 have shown its potential to treat multiple inflammatory and angiogenic disease processes

• Larimar Therapeutics Reports Third Quarter 2020 Operating and Financial Results

  11/10/2020

  Phase 1 trials evaluating CTI-1601 as a treatment for Friedreich’s ataxia on track for topline data in 1H 2021 Received orphan drug d esignation for CTI-1601 from the European Commission Cash, cash equivalents, and marketable securities of $102. 3 million as of September 30, 2020

• Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Pancreatic Cancer

  11/10/2020

  Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s lead compound, CPI-613® (devimistat), for the treatment of metastatic pancreatic cancer. 

• Applied Therapeutics Announces Presentation of Pre-Clinical Data on AT-001 for the Treatment of Diabetic Cardiomyopathy at the American Heart Association (AHA) Scientific Sessions 2020

  11/9/2020

  Treatment with AT-001 normalizes cardiac energetics and improves cardiac function in a mouse model of Diabetic Cardiomyopathy (DbCM)

• Reata Announces Positive Results From Year 2 of the Pivotal Phase 3 CARDINAL Study of Bardoxolone Methyl in Patients with Alport Syndrome

  11/9/2020

  Reata Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced that the Phase 3 CARDINAL study of bardoxolone methyl in patients with chronic kidney disease caused by Alport syndrome met its primary and key secondary endpoints at the end of Year 2.

• Reata Pharmaceuticals, Inc. Announces Third Quarter 2020 Financial Results and Provides an Update on Business Operations and Clinical Development Programs

  11/9/2020

  Reata Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, announced financial results for the quarter ended September 30, 2020, and provided an update on the Company’s business operations and clinical development programs.

• Amylyx Pharmaceuticals Announces Last Patient Completes Final Study Visit in PEGASUS Trial of AMX0035 in Alzheimer’s Disease

  11/9/2020

  Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced that the last participant has completed the planned 24 weeks in the Phase II PEGASUS trial assessing the safety and biological activity of AMX0035 admini

• Poxel Announces Upcoming Poster Presentations at AASLD The Liver Meeting® 2020

  11/9/2020

  POXEL SA announced that results from its Phase 1b study of PXL065 and results from three preclinical studies for PXL770 will be presented as e-posters at The Liver Meeting® 2020 hosted by the American Association for the Study of Liver Diseases, which will be held virtually from November 13-16, 2020.

• Zogenix Provides Corporate Update and Reports Third Quarter 2020 Financial Results

  11/9/2020

  FINTEPLA® (fenfluramine) oral solution launched in the U.S. in late July for Dravet syndrome with high enrollment of physicians and patients into the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program

• Minovia Therapeutics to Participate at Upcoming Credit Suisse Healthcare Conference on November 12th

  11/9/2020

  Minovia Therapeutics to Participate at Upcoming Credit Suisse Healthcare Conference on November 12 th

• Proof of Concept Controlled Phase 2 Clinical Trial Data Evaluating ANAVEX®2-73 (blarcamesine) in Parkinson’s Disease Dementia Presented at CTAD 2020 Conference

  11/6/2020

  Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), today announced additional details on and presented the results from the proof of concept Phase 2 controlled trial evaluating the safety, tolerability, and efficacy of ANAVEX®2-73

• vTv Therapeutics Announces 2020 Third Quarter Financial Results and Update

  11/5/2020

  vTv Therapeutics Inc. (Nasdaq:VTVT) today reported financial results for the third quarter ended September 30, 2020, and provided an update on the progress of its clinical programs.

• Madrigal Pharmaceuticals Announces Completion of Enrollment in Phase 3 MAESTRO NAFLD-1 Trial and Reports 2020 Third Quarter Financial Results and Highlights

  11/5/2020

  Madrigal Pharmaceuticals, Inc. announced that it completed enrollment in its MAESTRO NAFLD-1 clinical trial of resmetirom in patients with presumed NASH who are diagnosed using non-invasive assessments.

• Cyclerion Therapeutics Reports Third Quarter 2020 Financial Results and Recent Corporate Updates

  11/5/2020

  Positive IW-6463 translational pharmacology study in healthy elderly subjects showed significant i mprovements in multiple measures associated with age-related cognitive decline and neurodegenerative diseases Company revamping its organization to focus on critical IW-6463 CNS program priorities; expects 2021 average cash use reduction of approximately 50% from Q3 2020 levels

• Stealth BioTherapeutics Reports Third Quarter 2020 Financial Results And Recent Business Highlights

  11/5/2020

  Secured a development funding agreement related to elamipretide Phase 2b dry AMD study enrollment completion targeted by year-end Barth NDA preparation underway SBT-272 shows promise in additional neurological disease preclinical models Management to host conference call today at 8:30am ET

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  FDA Awards Fast Track Designation to Multiple Non-COVID-19 Candidates

  11/4/2020

  While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.

• Stealth BioTherapeutics Announces Development Financing To Advance Elamipretide Clinical Trials

  11/4/2020

  Stealth to receive up to $35 million in upfront and near-term milestone payments, with the potential for additional payments subject to mutual agreement

• vTv Therapeutics Presents Baseline Characteristics of the Enrolled Subjects in the Elevage Study Suggesting Comparability to the Post-Hoc Diabetes Subgroup of the Phase 3 STEADFAST Study

  11/4/2020

  vTv Therapeutics Inc.  (Nasdaq: VTVT) today reported baseline characteristics for the enrolled subjects in the ongoing Elevage clinical study of azeliragon as a potential treatment for mild Alzheimer’s disease (AD) in people with type 2 diabetes (NCT03980730). The data demonstrate that the patients enrolled in Elevage (n=43) have similar baseline characteristics to those in the STEADFAST A-study type 2 diabetes (T2D) subgroup (NCT02080364) (

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  Clinical Catch-Up: October 26-30

  11/2/2020

  It was a particularly busy week for announcements about clinical trials, both related to COVID-19 and everything else. Here’s a look.

• Mission Therapeutics Appoints Dr Suhail Nurbhai as Chief Medical Officer

  11/2/2020

  Mission Therapeutics, a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes, has appointed Dr Suhail Nurbhai as Chief Medical Officer with immediate effect.