Funded by the U.S. Department of Defense, a new study will be conducted to examine why individuals, especially veterans, who suffer from a certain sleep disorder often end up developing Parkinson’s disease . The DoD awarded $4 million to researchers at Oregon Health and Science University (OSHU), the VA Healthcare System at Portland, the VA Sound Healthcare System at Puget, and the University of Washington to conduct this study.

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Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). The company recently secured a new $10 million debt facility, which enables the payoff of another higher interest rate loan and the finance of operations to generate additional data to support the new drug application of lead drug candidate CNM-Au8 for ALS.

As an individual grows older, they experience continued loss of strength and skeletal muscle mass. Once an adult reaches 40, they start losing roughly 8% of their muscle mass every 10 years. By age 70, this often rises to 15% loss in muscle mass every 10 years.

Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS. “The FDA guidance on a potential path to meet the regulatory standard for substantial evidence of effectiveness supporting accelerated approval came following an in-person Nov. 1 Type C meeting with the DN1 where the company presented additional clinical trial data and analyses. The FDA recommended that Clene leverage additional Neurofilament Light (‘NfL’) data from its three Expanded Access Programs (‘EAPs’) to support earlier findings,” reads an article discussing the guidance.

A new study has determined that a medication normally prescribed for multiple sclerosis can help persons with poor working memory. Working memory is an important component of cognitive function. Sadly, it is often impaired in patients with conditions like schizophrenia.

New research has found that a toxic protein may affect the skeletal muscle tissues, spinal cord, and brain, aiding the development and progression of amyotrophic lateral sclerosis .

Parkinson’s disease is a neurodegenerative condition that affects an individual’s brain, causing issues with their movement, sleep and mental health. Common symptoms include tremors, slowed movements and issues with balance.

Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). The company has now secured a new $10 million debt facility, enabling the pay-off of another loan at higher interest rates to significantly improve its cash position as well as finance operations to generate of additional data to support the new drug application of lead drug candidate CNM-Au8 for ALS ( https://ibn.fm/Maor9 ).

Clene (NASDAQCLNN) has announced a $10 million debt facility with three affiliated entities, set to close by December 20, 2024. The 18-month secured, partially convertible note carries a 12% fixed interest rate, with an interest-only period for the first year. Sixty-five percent of the note is convertible into common stock at $5.67 per share, a 130% premium over the stock’s signing day closing price. Proceeds will support Clene’s development of its CNM-Au8 treatment for ALS and neurodegenerative diseases, addressing FDA data requirements for regulatory approval. The company also aims to repay its prior $7.9 million Loan Agreement with Avenue Venture Opportunities Fund.

Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), has received additional written guidance and a roadmap from the U.S. Food and Drug Administration’s (“FDA”) Division of Neurology 1 regarding a potential accelerated approval pathway for lead drug candidate CNM-Au8 in ALS ( https://ibn.fm/8VQGo ).

Glioblastoma multiforme is an aggressive type of cancer that usually affects an individual’s spinal cord or brain. Brain cancers, which are among the most difficult cancers to treat, are the primary cause of cancer deaths in kids.

Clene (NASDAQCLNN) received FDA guidance on leveraging data from its ongoing expanded access programs (“EAPs”) to support an accelerated approval application for CNM-Au8, its treatment for ALS. The FDA recommended using neurofilament light chain (“NfL”) biomarker analyses to substantiate the drug’s efficacy. Clene plans to submit additional data in mid-2025, alongside commencing the Phase 3 RESTORE-ALS trial. Clinical findings presented at an FDA meeting highlighted CNM-Au8’s significant survival benefits and benign safety profile, underscoring its potential as a transformative ALS therapy. Clene remains committed to addressing the urgent unmet needs of ALS patients.

Clene (NASDAQCLNN) reported its Q3 2024 financial results and provided updates on its CNM-Au8 programs. Key operational highlights included a recent FDA meeting to discuss the potential for accelerated approval of CNM-Au8 for ALS, a 1-for-20 reverse stock split to meet Nasdaq requirements, an amended debt facility extending funding into Q2 2025, and a $7.3 million funding round. Clene’s Phase 3 RESTORE-ALS trial was presented in October, showcasing the company’s commitment to ALS treatment innovation. Financially, Clene ended Q3 with $14.6 million in cash and reported an $8.0 million net loss, reflecting decreased R&D and G&A expenses, but lower gains on warrant liability adjustments compared to 2023.

Last week, the European Commission announced that it had imposed a half-a-billion dollar fine on Teva, a multinational pharmaceutical firm based in Israel. The company, which specializes in generic drugs, is said to have artificially extended patent protection for its multiple sclerosis drug known as Copaxone. The drug has glatiramer acetate as its active ingredient.

Clene (NASDAQCLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), recently announced an upcoming meeting with U.S. Food and Drug Administration (“FDA”) leadership. The focus is to discuss Clene’s CNM-Au8® biomarker and related clinical and survival data for ALS. “FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 (‘DN1’) review team, as well as recognized key opinion leaders in ALS, biostatistics and biomarkers,” will attend the meeting according to a recent article.

Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) multiple sclerosis (“MS”) and Parkinson’s Disease (“PD”), is participating in two top investor conferences this month to present its latest achievements and key updates on its lead drug candidate, CNM-Au8 ( https://ibn.fm/BDqtM ).

Clene (NASDAQCLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) multiple sclerosis (“MS”) and Parkinson’s Disease (“PD”), announced the successful closing of a $7.3 million registered direct offering and concurrent private placements, designed to boost its capital position during a crucial phase in its on-going operations.

Clene (NASDAQCLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., is a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). Clene announced Wednesday morning that it will participate in two investor conferences this month.

Clene (NASDAQCLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, and its wholly owned subsidiary, Clene Nanomedicine Inc., has closed on a registered direct offering and concurrent private placements. According to the announcement, the transactions consist of common stock and warrants and were with a healthcare-focused institutional investor and existing shareholders, including insiders. Gross proceeds of the offerings and placements totaled an estimated $7.3 million with the potential for additional capital through the future exercise of warrants. Clene also announced the amendment of its existing debt facility with Avenue Venture Opportunities Fund, L.P.

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Clene (NASDAQCLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, has entered into a securities purchase agreement. The company entered the agreement, which calls for the issue and sale of 742,626 shares of common stock (or prefunded warrants in lieu thereof) with a healthcare-focused institutional investor. The company also noted it had entered into additional agreement and placements with current investors as well as directors and officers of Clene. Gross proceeds from the transactions will total an estimated $7.3 million, before standard deductions and fees. Canaccord Genuity is acting as sole placement agent for the offerings, which are expected to close on or about Oct. 1, 2024.

Search for the latest press releases from publicly traded companies, private corporations, non-profits and other public sector organizations.

Clene (NASDAQCLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), announced an upcoming meeting with the U.S. Food and Drug Administration (“FDA”) leadership to discuss lead candidate CNM-Au8 ® .

Clene (NASDAQCLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, will be meeting in-person with the U.S. Food and Drug Administration (“FDA”) before the end of November 2024. The company announced that the meeting, which will focus on discussions about the development of the company’s proprietary CNM-Au8 for the treatment of amyotrophic lateral sclerosis (“ALS”), will include key FDA representatives, including the organization’s director of the Office on New Drugs and director of the Office of Neuroscience, as well as the Division of Neurology 1 (“DN1”) review team and key opinion leaders in the ALS, biostatistics and biomarkers space.