Breaks Categories: News

FridayMay 10, 2024 10:36 am

BioMedNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Releases Q1 2024 Financial, Operational Report

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, is reporting on its financial and operational results for first quarter 2024, for the period ended March 31, 2024. Highlights of the report include the 510(k) submission for BEAT’s AIMIGo(TM) system for review by the U.S. Food and Drug Administration (“FDA”); presubmission meetings being held with the FDA in preparation to submit a second 510(k) for BEAT’s 12-lead synthesis software; beginning patient enrollment for a study designed to demonstrate the similarity between the synthesized 12-lead ECG and a standard 12-lead ECG; the presentation…

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WednesdayMay 08, 2024 1:27 pm

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Releases Q1 2024 Financial Numbers, Operation Highlights

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., are reporting on first-quarter 2024 financial results and operating highlights for its CNM-Au8 clinical program for amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). Clene Nanomedicine is a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases. Highlights of the report include the news that data from the long-term extension of Clene’s phase 2 VISIONARY-MS clinical trial of CNM-Au8® exhibits significant evidence of repair and remyelination across multiple paraclinical endpoints; the publication of an article in the “ACS Pharmacology & Translational Science,” a journal that publishes…

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WednesdayMay 08, 2024 8:30 am

BioMedNewsBreaks — NanoViricides Inc. (NYSE American: NNVC) Lead Drug Candidate Indicates Strong Orthopoxvirus Activity

NanoViricides (NYSE American: NNVC), a global leader in broad-spectrum antiviral nanomedicines, is reporting that, in a lethal animal model, its lead drug candidate, NV-387, showed ultra-broad antiviral activity, including activity against the orthopoxvirus family, including smallpox and mpox. According to the announcement, in the model of lung infection by Ectromelia virus, oral dosing with NV-387 showed an increase in lifespan of mice comparable to oral treatment with tecovirimat (TPOXX[R], SIGA), which is currently the approved drug against smallpox. “We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly,” stated the company in…

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TuesdayMay 07, 2024 2:39 pm

BioMedNewsBreaks — FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) Marks Important Step in Advancing Lucid-21-302

FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, today announces the submission to ethics of a trial. Entitled “A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of Lucid-21-302 in Healthy Adult Participants,” the clinical trial application is submitted for review by a human ethics review committee (“HREC”) in Australia. The step is necessary to obtain permission to initiate the multiple ascending dose (“MAD”) trial, which follows the Phase-1 single ascending dose (“SAD”)…

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TuesdayMay 07, 2024 2:12 pm

BioMedNewsBreaks – Sigyn Therapeutics Inc. (SIGY) Announces Publication of Article on Emerging Candidate – Sigyn Therapy(TM)

Sigyn Therapeutics (OTCQB: SIGY), a development-stage medical technology company, today announced that it has published an article entitled: “Sigyn Therapy(TM), an Emerging Candidate to Address Endotoxemia, Sepsis and Drug-Resistant Viral & Bacterial Infections.” “When we designed Sigyn Therapy, we envisioned a medical device that could overcome the limitations of previous blood purification technologies to treat life-threatening conditions that are beyond the reach of drugs. Along with the efforts of our dedicated team, contributions from science advisors, collaborators and shareholders have helped to advance our vision toward reality,” said Jim Joyce, co-founder and CEO of Sigyn Therapeutics. “Consider that in the…

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TuesdayMay 07, 2024 1:17 pm

BioMedNewsBreaks — PaxMedica Inc. (PXMD) Continues Advancement of PAX-101 Regulatory Strategy

PaxMedica (OTC: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, has issued a corporate update in light of its transition off the NASDAQ stock market, emphasizing this change will not affect the company’s commitment to advancing treatments for neurological disorders. “Our determination to progress with the NDA submission for PAX-101 remains unaffected, as does our commitment to our clinical program to further explore the potential for anti-purinergic therapies to address the core symptoms of autism spectrum disorder (‘ASD’),” said Howard Weisman, CEO of PaxMedica, further emphasizing the company’s efforts to advance healthcare solutions globally. “We are not…

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MondayMay 06, 2024 3:20 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Announces Nasdaq Delisting Notification and Appeal, ADS Ratio Change

Scinai Immunotherapeutics (NASDAQ: SCNI) is a biopharmaceutical company focused on developing inflammation and immunology (“I&I”) biological products and providing CDMO services through its Scinai Bioservices business unit. The company today announced that it has received a staff determination letter on April 30, 2024, from the Listing Qualifications Department of the Nasdaq Stock Market LLC. In the letter, Nasdaq notified the company that, due to its non-compliance with the minimum $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), the company's American Depositary Shares (“ADSs”) would be scheduled for delisting from the Nasdaq Capital Market and would be suspended…

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MondayMay 06, 2024 3:05 pm

BioMedNewsBreaks — Aileron Therapeutics Inc. (NASDAQ: ALRN) Closes Underwritten Registered Direct Offering

Aileron Therapeutics (NASDAQ: ALRN) is a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. The company has announced the closing of its underwritten registered direct offering priced at-the-market under Nasdaq rules of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of common stock. Aileron secured aggregate gross proceeds of approximately $20 million, before deducting underwriting discounts and commissions and other offering expenses and excluding any proceeds that may be received from exercise of the warrants. Titan Partners Group, a…

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MondayMay 06, 2024 8:30 am

BioMedNewsBreaks — NanoViricides Inc. (NYSE American: NNVC) Reports that NV-387 Shows Strong Activity Against Influenza A

NanoViricides (NYSE American: NNVC), a global leader in broad-spectrum antiviral nanomedicines, is reporting that the ultra-broad antiviral activity spectrum of NV-387 includes influenza A viruses, possibly including bird flu H5N1 virus as well. According to the announcement, the company performed a lethal animal model of lung infection by influenza A/H3N2 virus that indicated NV-387 showed superior antiviral effects compared to three approved anti-influenza drugs: Oseltamivir (Tamiflu[R], Roche), Peramivir (Rapivab[R], Biocryst), and Baloxivir (Xofluza[R], Shionogi, Roche). “We are pleasantly surprised by this extremely broad and strong antiviral activity of NV-387,” said NanoViricides president and executive chair Anil R. Diwan, PhD, in…

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ThursdayMay 02, 2024 2:36 pm

BioMedNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) Schedules Release of Q1 2024 Financial Results, Earnings Conference Call/Webcast

Longeveron (NASDAQ: LGVN), a clinical-stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (“HLHS”), Alzheimer’s disease and Aging-Related Frailty, will be releasing its first-quarter 2024 financial results this month. The company announced that it will release the report, along with a business update, on May 14, 2024, after the U.S. markets close. The company has also scheduled a conference call and webcast to discuss the release; the call will begin at 5 p.m. ET, also on May 14. Those wishing to access the call can dial 877-407-0789 and use the conference…

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