Clinical trials

Lyndra Therapeutics Presents Promising Phase 2 Data on Once-Weekly Oral Risperidone Treatment, LYN-005, in Development for Schizophrenia

Sunday, April 18, 2021 - 9:20pm

b'Lyndra Therapeutics , a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced results from its Phase 2 study of LYN-005, the Company\xe2\x80\x99s oral, ultra-long-acting, extended-release (ER) risperidone capsule, in development for the weekly treatment of schizophrenia.

Key Points: 
  • b'Lyndra Therapeutics , a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced results from its Phase 2 study of LYN-005, the Company\xe2\x80\x99s oral, ultra-long-acting, extended-release (ER) risperidone capsule, in development for the weekly treatment of schizophrenia.
  • The study included a lead-in period in which patients received IR risperidone tablets (2 mg or 4 mg) for 13 days in order to achieve a steady therapeutic state.
  • It affects approximately 2.2 million U.S. adults, often beginning in the late teens or early twenties.
  • For more information, visit the Company\xe2\x80\x99s website at www.lyndra.com .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210418005010/en/\n'

Elucid Presents Results of the EVAPORATE Study at ESC Preventive Cardiology 2021 Late Breakers

Saturday, April 17, 2021 - 2:50pm

The study evaluated the change in plaque characteristics using CTA in 55 statin-treated patients having data at all timepoints.

Key Points: 
  • The study evaluated the change in plaque characteristics using CTA in 55 statin-treated patients having data at all timepoints.
  • Advanced clinical insights from ElucidVivo equip physicians with critical information designed to enable precision medicine.
  • This unique information informs better treatment decisions by physicians leading to better patient outcomes, improved quality of care, and reduced healthcare costs.
  • To learn more visit https://www.elucidbio.com/ and follow us on LinkedIn .\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210417005003/en/\n'

Autobahn Therapeutics Presents Preclinical, Proof of Concept Data for ABX-002 for the Treatment of Adrenomyeloneuropathy

Saturday, April 17, 2021 - 1:00pm

The data will be highlighted in a poster presentation at the American Academy of Neurology Annual Meeting, which is being held virtually from April 17-22, 2021.

Key Points: 
  • The data will be highlighted in a poster presentation at the American Academy of Neurology Annual Meeting, which is being held virtually from April 17-22, 2021.
  • \xe2\x80\x9cAMN is a highly debilitating disease, leading to motor disabilities, fatigue, ataxia, sensory loss, adrenal insufficiency, incontinence and impotence, with no currently approved treatments.
  • Autobahn is leveraging its brain-targeting chemistry platform to unlock new therapeutic opportunities through precision tuning of the central exposure of its molecules.
  • The company\xe2\x80\x99s pipeline is led by ABX-002, a thyroid hormone receptor beta agonist for the treatment of adrenomyeloneuropathy (AMN), a rare genetic disorder.

Gyroscope Therapeutics Files Registration Statement for Proposed Initial Public Offering in the United States

Friday, April 16, 2021 - 10:38pm

b'Gyroscope Therapeutics, a clinical-stage gene therapy company focused on treating diseases of the eye, today announced it has filed a registration statement on Form F-1 (the \xe2\x80\x9cRegistration Statement\xe2\x80\x9d) with the U.S. Securities and Exchange Commission (the \xe2\x80\x9cSEC\xe2\x80\x9d) relating to a proposed initial public offering (\xe2\x80\x9cIPO\xe2\x80\x9d) in the United States of its American Depositary Shares (\xe2\x80\x9cADSs\xe2\x80\x9d), each representing one ordinary share.\nAll ADSs to be sold in the proposed IPO will be offered by Gyroscope.

Key Points: 
  • b'Gyroscope Therapeutics, a clinical-stage gene therapy company focused on treating diseases of the eye, today announced it has filed a registration statement on Form F-1 (the \xe2\x80\x9cRegistration Statement\xe2\x80\x9d) with the U.S. Securities and Exchange Commission (the \xe2\x80\x9cSEC\xe2\x80\x9d) relating to a proposed initial public offering (\xe2\x80\x9cIPO\xe2\x80\x9d) in the United States of its American Depositary Shares (\xe2\x80\x9cADSs\xe2\x80\x9d), each representing one ordinary share.\nAll ADSs to be sold in the proposed IPO will be offered by Gyroscope.
  • Gyroscope has applied to list its ADSs on the Nasdaq Global Select Market under the ticker symbol \xe2\x80\x9cVISN.\xe2\x80\x9d The number of ADSs to be offered and the pricing terms for the proposed IPO have not yet been determined.
  • The ADSs may not be sold nor may offers to buy be accepted prior to the time the Registration Statement becomes effective.
  • Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210416005566/en/\n'

Sesen Bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Friday, April 16, 2021 - 9:30pm

Each of the options was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Key Points: 
  • Each of the options was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4).\nVicineum, a locally administered fusion protein, is Sesen Bio\xe2\x80\x99s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
  • In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells.
  • Sesen Bio is currently in the follow-up stage of a Phase 3 registration trial in the US for the treatment of BCG-unresponsive NMIBC.
  • Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.

OKR Financial Raises $150 Million to Support Early-Stage Innovators With Immediate Capital

Friday, April 16, 2021 - 6:53pm

b'OKR Financial, one of Canada\xe2\x80\x99s leading providers of non-dilutive financing, is announcing its raise of $150 million to support growing businesses looking to access SR&ED tax credits, asset-based loans, government grants, or equity deals.

Key Points: 
  • b'OKR Financial, one of Canada\xe2\x80\x99s leading providers of non-dilutive financing, is announcing its raise of $150 million to support growing businesses looking to access SR&ED tax credits, asset-based loans, government grants, or equity deals.
  • Solving the problem of waiting for government agencies to process tax claims or grant applications, OKR Financial\xe2\x80\x99s help allows companies to access funding fast, extending the runway so these companies can continue to grow while they await their government funds.\nThe OKR team has strategically chosen to partner with Ayming Canada, a global consulting firm which helps businesses maximize government funding and tax credits.
  • This is where Ayming\xe2\x80\x99s expertise comes in,\xe2\x80\x9d says Harry Singh, President & Managing Partner of Ayming Canada.\nThe Scientific Research & Experimental Development (SR&ED) Tax Credit program provides over $3 billion to over 20,000 businesses annually, and there are over 2000 various government grants available, with more being announced all the time.
  • OKR operates a family of private funds that provide non-dilutive financing solutions to SMEs by leveraging Federal & Provincial SR&ED tax credits and Government funded programs, providing the pathway to equity financing when companies are ready to scale up.\n'

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma....

Friday, April 16, 2021 - 6:10pm

In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).\nOPDIVO can cause immune-mediated hepatitis.

Key Points: 
  • In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).\nOPDIVO can cause immune-mediated hepatitis.
  • Withhold OPDIVO depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
  • In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients.
  • Nivolumab plus chemotherapy versus chemotherapy as first-line treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma: first results of the CheckMate 649 study.

Aegis Life Announces Start of Phase 1/2 Trial of the Entos COVID-19 DNA Vaccine, Covigenix VAX-001, with First Participants Dosed

Friday, April 16, 2021 - 5:26pm

b'Aegis Life, Inc. announced today that the first participants have been dosed in a Phase 1/2 clinical trial with parent company Entos Pharmaceuticals\xe2\x80\x99 (Entos) Covigenix VAX-001, a novel DNA vaccine to stimulate immunity against SARS-CoV-2.

Key Points: 
  • b'Aegis Life, Inc. announced today that the first participants have been dosed in a Phase 1/2 clinical trial with parent company Entos Pharmaceuticals\xe2\x80\x99 (Entos) Covigenix VAX-001, a novel DNA vaccine to stimulate immunity against SARS-CoV-2.
  • View the full release here: https://www.businesswire.com/news/home/20210416005430/en/\nA participant receives a dose marking the start of Phase I trials for Aegis Life/Entos Pharmaceuticals COVID-19 DNA vaccine, Covigenix VAX-001.
  • Phase 1 will evaluate the safety and immunogenicity of the Covigenix VAX-001 DNA vaccine.
  • This breakthrough non-viral gene delivery platform allows us to rapidly prototype and advance DNA medicines through the clinical trial process.

Moderna to Report First Quarter Financial Results on Thursday, May 6, 2021

Friday, April 16, 2021 - 1:59pm

ET on Thursday, May 6, 2021 to reports its first quarter 2021 financial results, and provide a corporate update.\nTo access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 7487119.

Key Points: 
  • ET on Thursday, May 6, 2021 to reports its first quarter 2021 financial results, and provide a corporate update.\nTo access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 7487119.
  • A webcast of the call will also be available under \xe2\x80\x9cEvents and Presentations\xe2\x80\x9d in the Investors section of the Moderna website at investors.modernatx.com .
  • Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic.
  • Moderna has been named a top biopharmaceutical employer by Science for the past six years.

Global Virtual Clinical Trials Market (2020 to 2026) - by Study Type, Indication and Region - ResearchAndMarkets.com

Friday, April 16, 2021 - 1:25pm

b'The "Global Virtual Clinical Trials Market By Study Type, By Indication, By Region, Industry Analysis and Forecast, 2020 - 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6.5% CAGR during the forecast period.\nVirtual Clinical Trials (VCTs) are also known as remote or decentralized trails, are a comparatively new but still underused technique of carrying out clinical research taking complete benefit of technologies like apps, online social interaction platforms, and electronic monitoring tools.

Key Points: 
  • b'The "Global Virtual Clinical Trials Market By Study Type, By Indication, By Region, Industry Analysis and Forecast, 2020 - 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe Global Virtual Clinical Trials Market size is expected to reach $10 billion by 2026, rising at a market growth of 6.5% CAGR during the forecast period.\nVirtual Clinical Trials (VCTs) are also known as remote or decentralized trails, are a comparatively new but still underused technique of carrying out clinical research taking complete benefit of technologies like apps, online social interaction platforms, and electronic monitoring tools.
  • The market is significantly driven by growth in R&D activities, the growing digitization in healthcare, and the adoption of telehealth.
  • Moreover, advances in technology, collaborations between clinical research companies, biotechnology companies, and pharmaceutical and support initiatives from governments are expected to boost the market.\nVirtual clinical trials (VCT) abolish limitations presented by conventional clinical trials such as time-taking procedures and delay in recruitment of patients that has pushed the demand for the virtual clinical trial market.
  • In fact, virtual clinical trials are expected to rise from high revenue to the highest revenue in the upcoming years.