FridayApr 12, 2024 12:55 pm

BioMedNewsBreaks — Longeveron Inc. (NASDAQ: LGVN) Closes on Public Offering Valued at Estimated $5.2M

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, has closed on its previously announced public offering. The offering was comprised of up to 2,234,043 shares of Class A LGVN common stock (or prefunded warrants in lieu thereof) and warrants to purchase up to 2,234,043 shares of Class A common stock, both offered at $2.35 per share and associated warrant. The announcement noted that the warrants are exercisable upon issuance for up to five years. The public offering resulted in gross…

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FridayApr 12, 2024 11:42 am

BioMedNewsBreaks — PaxMedica Inc. (NASDAQ: PXMD) Announces ‘Milestone Achievement’ on Journey to Developing PAX-101

  PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, has completed the execution of three pivotal registration/validation batches of PAX-101, which is an IV formulation of suramin. According to the announcement, this is an important milestone achievement as the company works toward enabling a New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”). Currently, the company anticipates submitting the NDA in Q4 2024; this will mark another key milestone as the company works toward the potential commercial availability in the United States of the first and only form of suramin for…

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ThursdayApr 11, 2024 3:03 pm

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Looking to Advance Discussions for Accelerated Approval, New NDA for CNM-Au8(R) in 2024

Clene (NASDAQ: CLNN), alongside 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. These include amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “Clene’s lead candidate, CNM-Au8(R), is a gold nanocrystal suspension that has emerged as a promising candidate for the treatment of both ALS and MS… Despite the FDA’s decision in late 2023 against allowing Clene to move forward with an accelerated approval pathway based on initial biomarker data, Clene is diligently preparing supplemental data to provide additional supportive biomarker, survival and mechanistic…

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WednesdayApr 10, 2024 2:12 pm

BioMedNewsBreaks — OneMedNet Corporation (NASDAQ: ONMD) Moves to Solidify Cash Position, Accelerate Growth

OneMedNet (NASDAQ: ONMD) is the leading curator of regulatory-grade Real World Data (“iRWD(TM)”) through its proven OneMedNet iRWD(TM) solution. The company recently announced that it has entered into a definitive securities purchase agreement, dated as of March 28, 2024, with an institutional investor providing up to $4.54 million in funding through a private placement for the issuance of senior convertible notes. OneMedNet intends to use the net proceeds from the offering for working capital purposes. “This securities purchase agreement demonstrates confidence in our comprehensive iRWD(TM) platform, marking an important milestone for OneMedNet as we have the investment needed to expedite…

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WednesdayApr 10, 2024 12:44 pm

BioMedNewsBreaks — Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Chief Science Officer to Present at This Month’s Europe Dermatology Drug Development Summit

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on the development of inflammation and immunology (“I&I”) biological products and on providing contract development and manufacturing organization (“CDMO”) services through its Scinai Bioservices business unit, will be featured at this month’s annual Dermatology Drug Development Summit Europe. During the three-day gathering, SCNI chief science officer Dr. Tamar Ben-Yedidia will discuss the company’s NanoAbs as a local treatment for plaque psoriasis; Ben-Yedidia will be joined by Professor Michael Schön, director of the University Medical Center Göttingen's Department of Dermatology, Venereology & Allergology. The summit is scheduled for April 16–18, 2024, in Berlin; SCNI’s presentation is slated…

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WednesdayApr 10, 2024 9:15 am

BioMedNewsBreaks — Telo Genomics Corp. (TSX.V: TELO) (OTCQB: TDSGF) Notes Key Milestone with Award of College of American Pathologists Accreditation

Telo Genomics (TSX.V: TELO) (OTCQB: TDSGF),a biotech company developing the industry's leading telomere technology platform with diagnostic and prognostic applications measuring genomic instability in oncology, has received accreditation for its Toronto-based laboratory at the MaRS Center from the Accreditation Committee of the College of American Pathologists (“CAP”). The accreditation followed more than a year of preparation and an on-site inspection by the CAP Accreditation Programs. CAP is the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, and its accreditation recognizes rigorous and robust standards. “The CAP accreditation highlights Telo Genomics' commitment and…

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TuesdayApr 09, 2024 4:12 pm

BioMedNewsBreaks — IGC Pharma Inc. (NYSE American: IGC) Adds AI Expert to Support Development of Phase 2 Clinical Trial

IGC Pharma (NYSE American: IGC), a company focused on developing innovative solutions to address Alzheimer’s disease, has announced the addition of Pablo Arbelaez, Ph.D., an expert in artificial intelligence (“AI”) and one of the world’s top researchers. Dr. Arbelaez will support the development of the Phase 2 clinical trial of IGC Pharma’s lead therapeutic candidate IGC-AD1, targeting agitation in Alzheimer’s. “We welcome Dr. Pablo Arbelaez to our team of senior advisors. His expertise in AI will aid in enhancing early detection methods for Alzheimer’s disease and subsequently aiding faster diagnoses, which is essential for effective treatment,” said Ram Mukunda, CEO…

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TuesdayApr 09, 2024 3:36 pm

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Presents Key Data in First-Ever Scientific Presentation of Proprietary HeartBeam AI

HeartBeam(NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, is presenting new data at the European Heart Rhythm Association (“EHRA”) Conference. According to the announcement, this is the first scientific presentation on the company’s deep learning algorithm: HeartBeam AI. The data demonstrates that applying the company’s artificial intelligence (“AI”) algorithms to vectorcardiography (“VCG”) showed considerably improved performance in the detection of atrial flutter over single-lead electrocardiograms (“ECGs”) and similar performance to 12-lead ECGs, the standard for diagnosing atrial flutter. The company noted that the data indicates an opportunity for a VCG-based algorithm…

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MondayApr 08, 2024 2:43 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), Scinai Bioservices Enter MSA with Ayana Pharma

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on the development of inflammation and immunology (“I&I”) biological products, through its contract development and manufacturing organization (“CDMO”) business unit, Scinai Bioservices, has signed a five-year Master Service Agreement (“MSA”) with Ayana Pharma Ltd. As outlined by the MSA, Scinai will provide drug-development and cGMP manufacturing services to Ayana; the agreement is forecast to bring in at least $1.8 million in revenues for Scinai over the next five years. Ayana officials noted that the company had done an extensive search looking for a CDMO and was “attracted” to Scinai’s experience in biopharmaceutical drug development and manufacturing for…

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FridayApr 05, 2024 12:23 pm

BioMedNewsBreaks — PaxMedica Inc. (NASDAQ: PXMD) Developing Robust Product Lineup to Address ASD, Associated Neurodevelopmental Conditions

PaxMedica (NASDAQ: PXMD) is a clinical-stage biopharmaceutical company focused on the development of novel anti-purinergic therapies (“APTs”) for the treatment of autism spectrum disorder (“ASD”) and other serious conditions with intractable neurologic symptoms. The company is on a promising path to address the unmet medical needs of ASD, bringing hope to millions. “ASD is a developmental disorder affecting how individuals interact with other people, behavior, communication, and learning. This disorder can be diagnosed at any age, but symptoms often appear in the first two years of life. There is currently no approved pharmacologic treatment targeting the cause and symptoms. Current…

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