WednesdayNov 22, 2023 9:45 am

Genprex Inc. (NASDAQ: GNPX) Granted Orphan Drug Designation in Small Cell Lung Cancer by FDA, Presented Data at Two October Events Focused on Lung Cancer

Genprex was granted orphan drug designation by the FDA earlier this year for development of REQORSA combined with Tecentriq in small cell lung cancer Use of REQORSA combined with Tecentriq is the subject of Genprex’s upcoming Acclaim-3 clinical trial Genprex took part in two events in October – the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; and Genprex’s own hosted event, a Virtual Key Opinion Leaders on Bringing Gene Therapy to the Fight Against Lung Cancers Genprex (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes, was…

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WednesdayNov 22, 2023 9:00 am

Clene Inc. (NASDAQ: CLNN) Capitalizing on the Promising Chemical and Therapeutic Properties of Nanocrystals to Address High Unmet Medical Needs

Clene is focused on developing and commercializing novel clean-surfaced nanotechnology (“CSN(R)”) therapeutics The company utilizes an electro-crystallization nanotherapeutics platform, which results in nanocrystals that exhibit catalytic activities multiple times higher than numerous other commercially available nanoparticles that the company has comparatively evaluated Clene is focusing on central nervous system (“CNS”) disorders like amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”) Its lead investigational product, CNM-Au8(R), has so far demonstrated a good safety and tolerability profile, with Phase 2 trials suggesting efficacy in ALS patients Nanotechnology has attracted a great deal of the scientific community’s attention thanks to…

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TuesdayNov 21, 2023 9:45 am

Longeveron Inc. (NASDAQ: LGVN) Encouraged by Positive Results from Phase 2a Trial in Patients with Mild AD; Explores Paths Forward for the Development of Lomecel-B(TM)

Longeveron recently released topline results from its Phase 2a trial evaluating Lomecel-B(TM) as a potential treatment for mild AD The study met its primary safety endpoint across all four study groups and showed positive and statistically significant results in secondary endpoint involving the Composite Alzheimer’s Disease Score (“CADS”) for Lomecel-B(TM) and components of the CADS The positive results are expected to form the basis for further development of Lomecel-B(TM) as a potential treatment for mild AD Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions for which there is an unmet medical need, announced…

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ThursdayNov 16, 2023 9:45 am

Clene Inc. (NASDAQ: CLNN) Reports Q3 2023 Financial Results, Recent Operating Highlights for Its ALS Clinical Program

Clene recently released its financial results for the third quarter ended September 30, 2023, and provided recent operating highlights for its ALS clinical program The ALS clinical program includes two independent studies evaluating the safety and efficacy of the company’s lead investigational product CNM-Au8(R) The 24-month long-term data cut from the open-label extension of the RESCUE-ALS study showed a significant median survival benefit of 19.3 months, a significant 52% decreased risk of ALS clinical worsening events, and a 75% decreased risk of long-term all-cause mortality Clene also summarized long-term follow-up data from the HEALEY ALS platform trial, which demonstrated significantly…

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TuesdayNov 14, 2023 9:30 am

PaxMedica Inc. (NASDAQ: PXMD) Is Hoping to Boost Patient Independence with Potential ASD Treatment Amid Growing Prevalence Rates

PaxMedica is developing PAX-101, which utilizes the company’s proprietary source of suramin sodium, for the treatment of ASD (Autism Spectrum Disorder) There is no FDA-approved treatment for the core symptoms of autism, even though the rates of autism spectrum disorder have jumped significantly from 2000 to 2020 ASD is characterized by deficits in social communication, restricted and repetitive patterns of behavior, and significant impairment in functioning, three core aspects of the disease that PaxMedica aims to address The company announced positive topline results from a Phase 2 study evaluating PAX-101 as a potential treatment for ASD and hopes to replicate…

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FridayNov 10, 2023 9:45 am

Clene Inc. (NASDAQ: CLNN) Among Grant Awardees Selected to Advance Scientific Research on ALS

Clene, a company targeting the treatment of neurodegenerative diseases that severely impact people’s lives, is currently focusing on amyotrophic lateral sclerosis (“ALS”) alongside other neurodegenerative diseases The company’s wholly owned subsidiary, Clene Nanomedicine, and two collaborators, Columbia University and Synapticure, are the recipients of a four-year grant totaling $45.1 million The grant will support an Expanded Access Protocol (“EAP”) study for Clene’s investigational product, CNM-Au8(R) CNM-Au8 is an orally administered gold nanocrystal suspension that is thought to improve mitochondrial health and protect neuronal function to treat neurodegenerative diseases, including ALS The EAP study will give patients who did not initially…

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FridayNov 10, 2023 9:00 am

Renovaro Biosciences Inc. (NASDAQ: RENB) CEO Provides Update on Combination with AI Expert GEDiCube Intl Ltd. in Letter to Shareholders

The agreement with GEDiCube rebrands the company as a wholly-owned subsidiary under the name Renovaro.AI The combined company brings together two innovative platforms in AI and biotherapeutics to offer comprehensive solutions spanning early detection, diagnostic insights, and targeted immunotherapies, for cancer and other diseases The AI division intends to launch commercial products for early cancer detection and improved therapy selection in 2024 – rapidly expanding the largely untapped precision medicine market In September, Renovaro Biosciences (NASDAQ: RENB), an advanced, preclinical biotechnology company focused on cell, gene, and immunotherapy, and GEDiCube Intl Ltd., an AI medical technology company, announced a definitive agreement…

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MondayNov 06, 2023 9:00 am

Renovaro Biosciences Inc. (NASDAQ: RENB) Announces Three New Members to Board of Directors as Definitive Agreement with GEDiCube Announced

Renovaro added Avram Miller, Leni Boeren, Ruud Hendriks, to the company's board of directors The three additions bring extensive financial backgrounds that will help as the company ventures into the new agreement with GEDiCube and Renovaro AI branding Avram Miller believes that Renovaro Bioscience, combined with GEDiCube, has the key elements to play a significant role in transforming AI's impact on medicine Renovaro Biosciences (NASDAQ: RENB), an advanced, pre-clinical biotechnology firm in cell, gene, and immunotherapy focused on solid tumors with short life expectancy, recently announced a definitive agreement to combine with the advanced AI Company GEDiCube Intl Ltd., rebranding…

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FridayNov 03, 2023 9:00 am

PaxMedica Inc. (NASDAQ: PXMD) PRV Sale Prospects Strengthened by Recent Industry Developments

PaxMedica, with the help of financial services firm Bourne Partners, is actively exploring presale of its Priority Review Voucher (“PRV”), highly valuable in the pharmaceutical marketplace once it gets formal approval from the FDA The move is the next step in PaxMedica's ongoing commitment to advancing innovative healthcare solutions for autism patients worldwide Similar successful endeavors in the pharmaceutical landscape have demonstrated lucrative potential PaxMedica (NASDAQ: PXMD), a pioneering biopharmaceutical company focused on advancing treatments for neurologic disorders, has set its sights on an exciting potential opportunity. With the engagement of Bourne Partners, a prominent financial services firm specializing in…

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MondayOct 30, 2023 9:45 am

Clene Inc. (NASDAQ: CLNN) Reports Improved Survival Status in ALS Patients Treated with CNM-Au8(R) on Follow-Up Analysis; Announces Peer-Reviewed Study

Clene is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases like ALS In 2019, Clene’s drug candidate, CNM-Au8(R), was selected for the HEALEY ALS Platform Trial, with enrollment commencing in the summer of 2020 Over the years since, Clene has consistently released additional data from the Trial, most recently reporting significant long-term survival improvement among patients treated with CNM-Au8 compared to PRO-ACT historical controls The company also announced the publication of a peer-reviewed study in the nanotechnology-focused journal Small; the study describes CNM-Au8’s mechanism of action Clene received a $45.1…

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