Breaks Categories: News

MondayJan 08, 2024 2:19 pm

BioMedNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Significant Positive Results from LTE VISIONARY-MS Trial

Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including (“ALS”) and multiple sclerosis (“MS”), today reported new CNM-Au8(R) results from the long-term open label extension (“LTE”) of the VISIONARY-MS trial in participants with stable relapsing multiple sclerosis (“RMS”) totaling nearly three years of follow-up. After completion of the double-blind period, study participants were offered to continue on CNM-Au8 30mg for up to an additional 96-weeks in the LTE. Analyses were reported for the modified intent…

Continue Reading

ThursdayJan 04, 2024 2:14 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) CEO Releases Shareholder Letter

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on development of inflammation and immunology (“I&I”) biological products, has released a letter from its CEO, Amir Reichman. In the letter, Reichman summarizes the company’s 2023 accomplishments and looks forward to 2024. According to the letter, company highlights for the year include a recently completed ex-vivo study that indicates the potential of SCNI’s anti-IL-17 VHH antibody (“NanoAb”) to effectively and conveniently treat mild to moderate plaque psoriasis; the launch of Scinai Bioservices, the company’s boutique, end-to-end CDMO (“CDMO”) business unit, which will focus on assisting biotech companies to bring their products to market; capital infusions that…

Continue Reading

ThursdayJan 04, 2024 12:20 pm

BioMedNewsBreaks – Profound Medical Corp. (TSX: PRN) (NASDAQ: PROF) Announces Pricing of US$20M Public Offering

Profound Medical (TSX: PRN) (NASDAQ: PROF) recently announced the pricing of its underwritten public offering of 2,666,667 common shares, each at a price to the public of US$7.50, led by health care-focused institutional investors. Of approximately US$20,000,000 in gross proceeds from the offering, the company intends to use net proceeds to fund the continued commercialization of the TULSA-PRO(R) system in the United States, to fund the continued development and commercialization of the TULSA-PRO system and the Sonalleve(R) system globally, as well as for working capital and general corporate purposes. Titan Partners Group, a division of American Capital Partners, is acting as…

Continue Reading

ThursdayJan 04, 2024 9:42 am

BioMedNewsBreaks – Sigyn Therapeutics Inc. (SIGY) CEO Releases Shareholder Letter Outlining Opportunities, Challenges, Processes

Sigyn Therapeutics (OTCQB: SIGY), a development-stage medical technology company, has released a shareholder letter from chair and CEO Jim Joyce. In the letter, whose objective is to help shareholders better understand SIGY opportunities, challenges and decision-making processes, Joyce reiterates the company’s long-term objective of building an enduring organization whose therapies save lives. The letter included an update on the company’s proposed underwritten financing and then discussed in detail the company’s portfolio of new therapies. “Our endeavors today are comprised of Sigyn Therapy(TM) to address pathogen-associated inflammatory disorders, the ImmunePrep(TM) platform to enhance the performance of immunotherapeutic antibodies, ChemoPrep(TM) to improve the delivery of…

Continue Reading

TuesdayJan 02, 2024 10:05 am

BioMedNewsBreaks – Branded Legacy Inc. (BLEG) Announces Retirement of Additional 442M Common Shares

Branded Legacy (OTC: BLEG), further highlighting its commitment to shareholders and future growth, today announced the final retirement of an additional 442 million common shares, bringing the total shares retired to an extraordinary 2.44 billion. The action surpasses the initial commitment and underscores Branded Legacy’s unwavering dedication to shareholder value. According to the announcement, the retirements have resulted in management now owning zero common stock, aligning the company’s leadership with the best interests of its shareholders. “We are proud to announce the retirement of an additional 442 million common shares, surpassing our initial commitment and reaffirming our dedication to shareholder…

Continue Reading

FridayDec 29, 2023 12:06 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Enters Agreement for Million-Dollar Exercise of Outstanding Warrants

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative inflammation and immunology (“I&I”) biological products and provision of boutique CDMO (“CDMO”) services, has entered a definitive agreement for the immediate exercise of outstanding warrants. The agreement outlines the purchase of up to 2,606,552 American Depositary Shares (“ADSs”), with each ADS representing 400 ordinary shares. According to the announcement, exercise prices for the ADSs range from $1.16 to $5 per ADS and terms range from three years to five and one-half years. The company anticipates closing on the offering, which will be subject to customary conditions, about Jan. 3, 2024. Gross…

Continue Reading

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…

Continue Reading

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…

Continue Reading

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…

Continue Reading

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…

Continue Reading