Breaks Categories: News

WednesdayDec 27, 2023 3:07 pm

BioMedNewsBreaks – Zevra Therapeutics Inc. (NASDAQ: ZVRA) Resubmits Arimoclomol New Drug Application to the FDA

Zevra Therapeutics (NASDAQ: ZVRA) a rare disease therapeutics company, today announced it resubmitted its New Drug Application (“NDA”) for arimoclomol, an investigational therapeutic candidate for the treatment of Niemann-Pick disease type C (“NPC”) to the U.S. Food and Drug Administration (“FDA”) on Dec. 22, 2023. Based on standard NDA resubmission review timelines, the company anticipates an acknowledgment letter from the FDA that the resubmission is complete and setting the PDUFA date within 30 days. Zevra expects the NDA to be classified as Class II, which would be subject to a review period by the FDA within six months from the…

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WednesdayDec 27, 2023 2:05 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Announces January Analyst, Investor Webinar

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on the development of both inflammation and immunology. During the webinar, SCNI CEO Amir Reichman will present an overview of the company’s performance throughout the year 2023, along with a discussion of the company’s upcoming plans for 2024. Specifically Reichman will discuss the company’s plan to commence clinical trials on its anti-IL-17 VHH antibody (“NanoAb”) innovative psoriasis treatment. The webinar is scheduled for Jan. 9, 2024, at 10 a.m. ET. To register for the webinar, visit https://ibn.fm/BibuA To view the full press release, visit https://ibn.fm/xiKig About Scinai Immunotherapeutics Ltd.  Scinai Immunotherapeutics is a biopharmaceutical…

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ThursdayDec 21, 2023 5:15 pm

BioMedNewsBreaks — Longeveron Inc. (NASDAQ: LGVN) Enters Definitive Agreement for $2.36M Registered Direct Offering

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 announced a $2.36 million registered direct offering. The company entered into a definitive agreement for the issue and sale of 1,355,301 shares of common stock, priced at $1.745 per share. In addition, the company announced a concurrent private placement comprised of the issue and sale of unregistered warrants to purchase up to 1,355,301 additional shares common stock. According to the announcement, the warrants will have an exercise price $1.62 per share…

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ThursdayDec 21, 2023 4:52 pm

BioMedNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Files 8-K Following Nasdaq Compliance Achievement

In a significant corporate update, PaxMedica (NASDAQ: PXMD) today filed an 8-K with the Securities and Exchange Commission, disclosing its successful compliance with Nasdaq’s minimum equity requirements. Journey Towards Compliance PaxMedica's compliance journey began on December 6, 2022, when Nasdaq noted its inability to meet the Minimum Market Value of Listed Securities Requirement of $35 million over 30 days. PaxMedica faced potential delisting in June 2023 but successfully appealed and, after a Nasdaq Hearings Panel review, received an exception to remain listed, subject to meeting specific financial criteria. Achieving and Announcing Compliance With the recent notification from Nasdaq, PaxMedica has…

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ThursdayDec 21, 2023 3:00 pm

BioMedNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces New Data from HEALEY ALS Platform Trial, Provides Update on ALS Clinical Development Meeting with FDA

Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., today announced new data from the 12-month long-term open label extension (“OLE”) of the CNM-Au8(R) treatment arm in the HEALEY ALS Platform Trial. A key biomarker of neurodegeneration, Neurofilament Light Chain (“NfL”) is released from neurons following axonal injury, especially in people living with ALS, where higher levels of NfL have been found to predict more rapid decline in clinical function and increased mortality risk. As detailed in the announcement, CNM-Au8 30mg treatment reduced plasma NfL levels compared to baseline. “As consensus is building…

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WednesdayDec 20, 2023 1:07 pm

BioMedNewsBreaks — Longeveron Inc. (NASDAQ: LGVN) Reports Additional Positive Clinical Data, Imaging Biomarker Results in Phase 2a Lomecel-B(TM) Trial

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, is releasing new clinical and biomarker results from the CLEAR MIND trial of its investigational product Lomecel-B(TM). The phase 2a trial evaluates Lomecel-B for the treatment of mild Alzheimer’s disease. According to the report, the new data indicates that that Lomecel-B improved cognitive function in multiple measures in a dose-response fashion. In addition, caregiver ratings showed improved quality of life in patients receiving Lomecel-B, and MRI Biomarker study data indicates that Lomecel-B countered loss…

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WednesdayDec 20, 2023 10:26 am

BioMedNewsBreaks – InMed Pharmaceuticals Inc. (NASDAQ: INM) Approves Election of Directors During 2023 Annual General Meeting

InMed Pharmaceuticals (NASDAQ: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, is reporting on the results of its 2023 annual general meeting. According to the report, during the meeting, which was held on Dec. 19, 2023, all matters considered by shareholders were approved; agenda items were sent to shareholders in a notice of meeting and management information communication that was released on Oct. 27, 2023. In addition, shareholders approved the election of five directors, including Eric A. Adams, Janet Grove, Andrew Hull, Nicole Lemerond and Bryan Baldasare; directors will hold their…

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MondayDec 18, 2023 1:38 pm

BioMedNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Announces DSMB Recommendation to Continue Pivotal GBM Study without Modification

CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, announced a recommendation from the independent Data Safety Monitoring Board (“DSMB”) regarding Berubicin, the company’s investigational agent. According to the announcement, the DSMB recommends that CNS Pharmaceuticals’ ongoing global, potentially pivotal trial of Berubicin for the treatment of glioblastoma multiforme (“GBM”) continue without modification. The company also noted that it anticipated enrollment for the trial to be complete in the first quarter of 2024. The Berubicin study is a multicenter, open-label, randomized controlled study…

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FridayDec 15, 2023 12:12 pm

BioMedNewsBreaks – Astiva Health Files Statement for Proposed IPO

Astiva Health is a fast-growing Medicare Advantage Prescription Drug (“MAPD”) health plan dedicated to reshaping personalized and comprehensive healthcare. The organization today announced that it has started the process of registering its common shares on the Nasdaq Global Select, marking a crucial step for Astiva Health as it moves toward making a lasting impact in the healthcare industry. According to the announcement, the specifics of the number of shares to be offered and the price range are yet to be determined. The offer is contingent upon market conditions, and there is no assurance regarding the completion, size or terms of…

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ThursdayDec 14, 2023 1:22 pm

BioMedNewsBreaks – Clene Inc. (NASDAQ: CLNN) Lead Drug Candidate Featured in Peer-Reviewed Publication Describing Brain Target Engagement in Neurodegenerative Diseases

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (“ALS”), Parkinson’s disease and multiple sclerosis (“MS”), along with subsidiary Clene Nanomedicine, is announcing the publication of a peer-reviewed article describing brain target engagement by CNM-Au8(R), the company’s lead drug candidate. Coauthored by physician scientists from the University of Texas Southwestern Medical Center and Clene, the paper is titled “Evidence of Brain Target Engagement in Parkinson’s Disease and Multiple Sclerosis by the Investigational Nanomedicine, CNM-Au8, in the REPAIR Phase 2 Clinical Trials” and was published…

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