Biotechnology

Monday Jul 15, 2024 - 11:22 am

InvestorNewsBreaks – Safety Shot Inc. (NASDAQ: SHOT), KeHE Join Forces to ‘Bring Safety Shot to the Masses’

Safety Shot (NASDAQ: SHOT) today announced its strategic partnership with KeHE Distributors, a leading natural and organic, specialty and fresh food distributor in North America. The collaboration expands Safety Shot’s presence to a broader audience and enhances consumer accessibility nationwide. Under the partnership, KeHE Distributors, renowned as one of the nation’s largest and most respected pure-play grocery and natural distributors, will play a pivotal role…

Friday Jul 12, 2024 - 1:15 pm

InvestorNewsBreaks – Astiva Health Providing Tailored Approach to Healthcare

Astiva Health, a leading healthcare provider that specializes in delivering personalized and comprehensive healthcare solutions to diverse communities, recognizes that successful treatment outcomes are largely dependent on the patient, with 90% of treatment success attributed to patient involvement. Patient engagement can lead to reduced hospitalizations as well as improve effectiveness, efficiency, quality of health services, quality of life, and responsiveness. “Astiva Health is leading the…

Friday Jul 12, 2024 - 12:27 pm

InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Management Slated to Participate in Upcoming Emerging Growth Conference

Clene (NASDAQ: CLNN) 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 amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), will be participating in next week’s Emerging Growth Conference. According to the announcement, members of Clene’s management team will be presenting at the one-day conference, which is scheduled…

Thursday Jul 11, 2024 - 2:00 pm

InvestorNewsBreaks – InMed Pharmaceuticals Inc. (NASDAQ: INM) Reports Significant Improvements from INM-089 in AMD, Validates INM-901 as Potential AD Treatment

InMed (NASDAQ: INM) is a clinical stage pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates targeting the CB1/CB2 receptors. The company recently released several critical updates regarding its INM-089 therapy treating dry Age-related Macular Degeneration (“AMD”) and its INM-901 small molecule drug candidate targeting Alzheimer’s disease (“AD”). “Recent preclinical data for INM-089 demonstrated significant functional and pathological improvements in an…

Thursday Jul 11, 2024 - 1:05 pm

InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Prepares to Submit Briefing Book to FDA, Looks to Obtain Key Feedback Regarding NDA for CNM-Au8 in ALS

Clene (NASDAQ: CLNN) 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 amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), is in the process of submitting a briefing book to the U.S. Food and Drug Administration (“FDA”). The company anticipates submitting the book by July 13, 2024, in…

Wednesday Jul 10, 2024 - 12:30 pm

InvestorNewsBreaks – Astrotech Corporation (NASDAQ: ASTC) Sets New Standard for Accuracy, Reliability in Narcotics Detection

Astrotech (NASDAQ: ASTC), through its subsidiary 1st Detect, is revolutionizing narcotics and explosives trace detection. “With recent approval as a U.S. General Services Administration (‘GSA’) authorized vendor, 1st Detect is poised to expand its impact across government agencies. TRACER 1000 is a cutting-edge detector utilizing ruggedized mass spectrometry technology for superior detection at critical security points. 1st Detect’s commitment to excellence is underscored by its…

Tuesday Jul 09, 2024 - 2:26 pm

InvestorNewsBreaks – IGC Pharma Inc.’s (NYSE American: IGC) TGR-63 Demonstrates Blood-Brain Barrier Permeability in Preliminary Findings

IGC Pharma (NYSE American: IGC) today announced preclinical data demonstrating TGR-63’s potential as an effective treatment for Alzheimer’s disease. Analysis of the partition coefficient and mass spectrometry of brain tissue in Alzheimer’s murine models indicates that TGR-63 has the potential to cross the blood-brain barrier in humans. The findings build on earlier results demonstrating TGR-63’s efficacy in reducing amyloid plaque in Alzheimer’s mouse models. “These…

Tuesday Jul 09, 2024 - 1:40 pm

InvestorNewsBreaks — Longeveron Inc. (NASDAQ: LGVN) Elected New Board Member at Annual Stockholder Meeting

Longeveron (NASDAQ: LGVN), a clinical-stage, regenerative-medicine biotechnology company developing cellular therapies for rare, life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (“HLHS”) and Alzheimer’s disease, is announcing an addition to its board of directors. According to the announcement, senior healthcare investment banker Neha Motwani was elected to the board during the company’s recent Annual Meeting of Stockholders. Motwani brings more than two decades of experience to…

Tuesday Jul 09, 2024 - 1:23 pm

InvestorNewsBreaks – VolitionRx Limited (NYSE American: VNRX) appoints PharmaVentures for Capture PCR(TM) and Oncology Portfolio Licensing

VolitionRx Limited (NYSE American: VNRX), a multi-national epigenetics company focused on saving lives and improving outcomes for people and animals with life-altering diseases, announced the engagement of PharmaVentures Ltd (“PharmaVentures”) to act as an advisor. PharmaVentures will provide strategic advice and transactional support as Volition works towards securing licensing deals with industry leaders for both Nu.Q(R) Cancer – a range of simple blood-based assays to…

Tuesday Jul 09, 2024 - 10:44 am

InvestorNewsBreaks — Annovis Bio Inc. (NYSE: ANVS) Names Four New Members to Executive Team

Annovis Bio (NYSE: ANVS), a late-stage, clinical-drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), has announced that four new executives will be joining the company’s management team. The four new leaders include Mark White as chief business officer; Alexander Morris, PhD, as director of strategic communications; Hilda Maibach as senior vice president of statistics; and Blake…

Monday Jul 08, 2024 - 1:33 pm

InvestorNewsBreaks – Cybin Inc. (NYSE American: CYBN) (Cboe CA: CYBN) Sees “Swell” of Insider Investments, Upgrade in Ranking after Positive Year-End Report

Cybin (NYSE American: CYBN) (Cboe CA: CYBN), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options for mental-health disorders, is reporting “a swell” of insider purchases following the company’s year-end update; the report highlighted significant advancements that strengthened Cybin’s position in the development of next-generation psychedelic-based therapeutics. In the announcement, Cybin noted that “fast-moving sectors need equally…

Monday Jul 08, 2024 - 10:29 am

InvestorNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Receives Updated LoI from the European Investment Bank

Scinai Immunotherapeutics (NASDAQ: SCNI), a biotechnology company focused on developing inflammation and immunology (“I&I”) biological products and on providing CDMO services through its Scinai Bioservices business unit, today announced its receipt of an updated non-binding letter of intent (“LoI”) from the European Investment Bank (“EIB”). The updated LoI outlines specific terms for converting the majority of the EIB’s loan into equity in the form of…

Friday Jul 05, 2024 - 9:45 am

InvestorNewsBreaks – FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) Amends Original Material Change Report, Files Amended and Restated MCR

FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, has filed an amended and restated material change report. According to the announcement, the report amended the disclosure in Section 5.1 of the original MCR. “The amended and restated material change report is being filed to provide additional disclosure with respect of the…

Tuesday Jul 02, 2024 - 9:47 am

InvestorNewsBreaks — Annovis Bio Inc. (NYSE: ANVS) Releases Significant Findings from Phase 3 Parkinson’s Study, Schedules Webcast

Annovis Bio (NYSE: ANVS), a late-stage, clinical-drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), is reporting new data from its phase 3 PD study. According to the report, study findings indicate that buntanetap, the company’s proprietary drug candidate, is safe and effective in improving motor and nonmotor activities and improving cognitive functions in patients with early…

Monday Jul 01, 2024 - 12:37 pm

InvestorNewsBreaks – PaxMedica Inc. (PXMD) Intensifying Efforts to Achieve Significant Program Milestones

PaxMedica (OTC: PXMD), a biopharmaceutical company specializing in neurological disorders, is preparing to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for using suramin to treat Human African Trypanosomiasis (“HAT”), a well-established treatment in East Africa for nearly a century. A recent article discussed PaxMedica gearing up for a significant Type C meeting it had with the FDA, which…

Monday Jul 01, 2024 - 10:05 am

InvestorNewsBreaks – FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) Retains Digital Marketing Platform to Increase Market Awareness

FSD Pharma (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, announced that it has partnered with Totaligent Inc. (OTC: TGNT) to assist the company in its efforts to enhance its market awareness. According to the announcement, FSD Pharma retained the services of Totaligent with an objective to “foster productive, continuing dialogues with shareholders…

Monday Jul 01, 2024 - 9:53 am

InvestorNewsBreaks — HeartBeam Inc. (NASDAQ: BEAT) Now Listed on Russell Microcap Index

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has been added to the Russell Microcap(R) Index. The move was effective after market close on June 28, 2024, and is part of FTSE Russell’s annual reconstitution. According to the announcement, the annual Russell U.S. Indexes represent the 4,000 largest U.S. stocks as of April 30, 2024;…

Friday Jun 28, 2024 - 9:08 am

InvestorNewsBreaks – VolitionRx Limited (NYSE American: VNRX) Highlights Latest Achievements in Mid-Year Review

VolitionRx Limited (NYSE American: VNRX) (“Volition”), a multi-national epigenetics company focused on saving lives and improving outcomes for people and animals with life-altering diseases, has released a mid-year review that highlights significant milestones, such as the expansion of the Nu.Q(R) Vet Cancer Test, which is now available for purchase in 15 countries. Additionally, Volition is engaged in active commercial discussions with significant players in the…

Thursday Jun 27, 2024 - 1:55 pm

InvestorNewsBreaks – FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) Notes ‘Important Step’ as Phase 1 Lucid-21-302 Trial Receives HREC Approval

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, has received a key approval for its planned Lucid-21-302 trial. According to the announcement, the human ethics review committee (“HREC”) in Australia approved the trial, which is titled “A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose…

Thursday Jun 27, 2024 - 1:35 pm

InvestorNewsBreaks – Aditxt Inc. (NASDAQ: ADTX), Evofem Biosciences (EVFM) Announce Market Partnership with Hello Alpha

Aditxt (NASDAQ: ADTX), a company dedicated to discovering, developing and deploying promising health innovations, and Evofem Biosciences Inc. (OTCQB: EVFM) are announcing a new market partnership with Hello Alpha, a telemedicine company with a medical team specifically trained for a woman's unique needs. Last year, Aditxt entered into a merger agreement with Evofem outlining Aditxt’s plans to acquire Evofem. Evofem’s market partnership with Hello Alpha involves the widespread…

Thursday Jun 27, 2024 - 12:48 pm

InvestorNewsBreaks – Safety Shot Inc. (NASDAQ: SHOT) Welcomes Druski as Its Newest Brand Ambassador

Safety Shot (NASDAQ: SHOT), a wellness and dietary supplement company, has partnered with American comedian and actor Drew “Druski” Desbordes. Druski, most well known for his sketch-style comedy, joins Safety Short as a brand ambassador. He entertains and embraces his 7.7 million followers on Instagram and 6.8 million on TikTok. The company notes that Druski’s loyal fanbase and aptitude for creating shareable content make him…

Thursday Jun 27, 2024 - 12:04 pm

InvestorNewsBreaks – Vivos Therapeutics Inc. (NASDAQ: VVOS) Reports Results of Seven-Month Provider-Based Marketing and Distribution Model Pilot

Vivos Therapeutics (NASDAQ: VVOS), a leading medical-device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep-related breathing disorders, is reporting on the positive results from seven-month pilot test. The multisite marketing initiative tested the core assumptions behind Vivos’ new affiliation and medical sleep specialist marketing and distribution model. Earlier this month, the company unveiled the new marketing and…

Wednesday Jun 26, 2024 - 1:55 pm

InvestorNewsBreaks – HealthLynked Corp. (HLYK) Announces New COO, Appoints Seasoned Veteran to Enhance Operations and Drive Initiatives

HealthLynked (OTCQB: HLYK), a leading provider of healthcare technology solutions, has announced a new chief operating officer. According to the announcement, the company has promoted Bill Crupi to the position, effective immediately. Crupi joined the company last year and has been instrumental in optimizing operational efficiencies and supporting the company's growth trajectory. Crupi has more than 20 years’ experience working in the healthcare industry and…

Wednesday Jun 26, 2024 - 10:58 am

InvestorNewsBreaks – CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Announces Pricing of Registered Direct, Concurrent Private Placement

CNS Pharmaceuticals (NASDAQ: CNSP) is a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system. The company today announced its entry into securities purchase agreements with health-care focused institutional investors for the purchase and sale of 568,000 shares of common stock in a registered direct offering and warrants to purchase up to 568,000…

Wednesday Jun 26, 2024 - 10:08 am

InvestorNewsBreaks – Annovis Bio Inc. (NYSE: ANVS) Submits Patent Application for New Composition of Buntanetap Matter

Annovis Bio (NYSE: ANVS), a late-stage, clinical-drug platform company pioneering transformative therapies for neurodegenerative disorders such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”), has filed a patent with the U.S. Patent and Trademark Office. The patent covers novel solid forms of buntanetap, selecting the best crystal and building upon the provisional patent the company filed in June 2023. Formerly known as posiphen or ANVS401, buntanetap…

Wednesday Jun 26, 2024 - 9:38 am

InvestorNewsBreaks – IGC Pharma Inc. (NYSE American: IGC) Releases Positive Data from TGR-63 Preclinical Studies

IGC Pharma (NYSE American: IGC), a clinical-stage pharmaceutical company, is reporting on preclinical results in an Alzheimer’s mouse model. According to the announcement, the model demonstrates the potential of IGC Pharma’s therapeutic candidate, TGR-63, to combat Alzheimer's disease. Specifically, the students show a “significant reduction” in amyloid plaque, totaling 78% in the cortex and 85% in the hippocampus. These findings suggest that TGR-63 has potential to…

Tuesday Jun 25, 2024 - 11:11 am

InvestorNewsBreaks – DarioHealth Corp. (NASDAQ: DRIO) Unveils Data Supporting Highly Personalized Approach to Behavior Change

DarioHealth (NASDAQ: DRIO), a leader in the global digital health market, today announced two new studies presented this past weekend at the 84th Annual American Diabetes Association (“ADA”) Scientific Sessions in Orlando. According to the announcement, the first study provides an analysis of member data for those tracking a GLP-1 medication in Dario’s cardiometabolic solution. “This new research shows there is tremendous value in giving…

Tuesday Jun 25, 2024 - 10:19 am

InvestorNewsBreaks – Annovis Bio Inc. (NYSE: ANVS) Announces Upcoming Investor Webcast Focused on PD, Lead Drug Candidate

Annovis Bio (NYSE: ANVS), a late-stage, drug-platform company developing novel therapies for neurodegenerative diseases such as Alzheimer’s (“AD”) and Parkinson’s disease (“PD”), is hosting an investor webcast. During the webcast, Annovis Bio officials will discuss recent developments and future plans for its lead drug candidate, Buntanetap, which targets neurodegeneration by inhibiting the formation of multiple neurotoxic proteins, including amyloid beta, tau, alpha-synuclein and TDP43. Management will…

Monday Jun 24, 2024 - 1:58 pm

InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Upcoming H.C. Wainwright Neuro Perspectives Virtual Conference

Clene (NASDAQ: CLNN) 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 amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”), will be featured at this week’s H.C. Wainwright’s Fifth Annual Neuro Perspectives Virtual Conference. According to the announcement, Clene management will be presenting a fireside chat and will host…

Monday Jun 24, 2024 - 10:17 am

InvestorNewsBreaks – Safety Shot Inc. (NASDAQ: SHOT) Welcomes Ryan Garcia as Brand Ambassador

Safety Shot (NASDAQ: SHOT) today announced a partnership with professional boxer, Ryan Garcia, as a brand ambassador. Garcia began his professional career at 17-years-old and holds a 25-1 victory record, 20 of those wins resulting in knockouts. Garcia’s dedicated followers are integrated with all components of his career, and having the support and loyalty of these fans will largely bolster brand awareness and recognition for…

Friday Jun 21, 2024 - 3:13 pm

InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Presents New Preliminary Data Demonstrating Potential of CNM-Au8(R) as Treatment for Rett Syndrome

Clene (NASDAQ: CLNN) (along with its subsidiaries, “Clene”) and 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, including amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). Clene today announced that Karen Ho, Ph.D., the company’s vice president of translational medicine, presented new, preliminary data demonstrating the potential of…

Thursday Jun 20, 2024 - 12:09 pm

InvestorNewsBreaks – Astrotech Corporation’s (NASDAQ: ASTC) TRACER 1000(TM) Receives ‘Approved’ Status on Air Cargo Security Technology List

Astrotech (NASDAQ: ASTC) and its wholly owned subsidiary, 1st Detect Corporation, today announced that the U.S. Transportation Security Administration (“TSA”) has approved the TRACER 1000(TM) for the Air Cargo Security Technology List (“ACSTL”) following thorough assessment by the TSA QG2 Technical Review Panel (“TRP”). Following the approval, regulated parties in the U.S., such as the air cargo market, which are required to use the ACSTL,…

Thursday Jun 20, 2024 - 10:03 am

InvestorNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Shares Update on Its AVERSA(TM) Fentanyl Product Development Program

Nutriband (NASDAQ: NTRB), a pharmaceutical company with a special focus on transdermal technologies, today provided an update on its AVERSA(TM) Fentanyl product development program. This comes as the company plans to complete scale-up of the commercial manufacturing process and move towards the single Phase 1 human abuse potential study prior to a New Drug Application (“NDA”) filing. According to the update, Nutriband is currently working…

Thursday Jun 20, 2024 - 9:15 am

InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Presents Extended Survival Data to Support CNM-Au8® as Potential Treatment for ALS at 2024 ENCALS Meeting

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, presented new long-term CNM-Au8 treatment results for survival and neurofilament light (“NfL”) levels from the HEALEY ALS Platform Trial open label extension (“OLE”) at the European Network for the Cure of ALS…

Tuesday Jun 18, 2024 - 12:09 pm

InvestorNewsBreaks – Pressure BioSciences Inc. (PBIO) to Host Business and Financial Update Teleconference

Pressure BioSciences (OTCQB: PBIO), a pioneer in the development and distribution of broadly enabling pressure-based instruments, consumables and specialty process development and testing services across global industries, today announced that it will host a teleconference to update investors and other stakeholders on various business and financial topics. The teleconference , scheduled to take place starting at 4:30 p.m. ET on Thursday, June 20, 2024, will…

Tuesday Jun 18, 2024 - 11:50 am

InvestorNewsBreaks – IGC Pharma Inc. (NYSE American: IGC) Execs Slated to Present at Upcoming Ascendiant Capital Markets Event

IGC Pharma (NYSE American: IGC), a clinical-stage pharmaceutical company, will be featured during an upcoming fireside chat hosted by Ascendiant Capital Markets. According to the announcement, IGC Pharma CEO Ram Mukunda and CCO Claudia Grimaldi will be presenting during the event, which is slated to begin at 12 p.m. ET on June 27, 2024. During the presentation, the IGC Pharma management team members are expected to…

Monday Jun 17, 2024 - 9:05 am

InvestorNewsBreaks – CNS Pharmaceuticals Inc.(NASDAQ: CNSP) Enters in Purchase Agreements, Announces Pricing

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, has entered into securities purchase agreements with health-care focused institutional investors. The agreements are for the purchase and sale of 366,000 shares of common stock, or common stock equivalents in lieu thereof, as part of registered direct offering and…

Thursday Jun 13, 2024 - 1:49 pm

InvestorNewsBreaks – Pressure BioSciences Inc. (PBIO) Schedules Business, Financial Update

Pressure BioSciences (OTCQB: PBIO) is a pioneer in the development and distribution of broadly enabling pressure-based instruments, consumables and specialty process development and testing services across global industries. The company today announced that it will host a teleconference on Wednesday, June 19, 2024, at 4:30 p.m. ET to update investors and other stakeholders on various business and financial topics. The company will discuss FY 2023…

Thursday Jun 13, 2024 - 1:13 pm

InvestorNewsBreaks – Astrotech Corp. (NASDAQ: ASTC) Subsidiary Partners with Multistate Testing Lab to Market Proprietary AgLAB Solutions

Astrotech (NASDAQ: ASTC), an innovative science and technology company, and its subsidiary, AgLAB, have entered into a master lease agreement with SC Labs; the companies are working together to jointly market the AgLAB 1000-D2(TM) mass spectrometer and the AgLAB Maximum Value Process testing method to SC Labs customers. AgLAB has pioneered applications featuring the Astrotech Mass Spectrometer Technology that specifically target the hemp and cannabis markets while SC…

Thursday Jun 13, 2024 - 12:09 pm

InvestorNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Marks Major Milestone in Preparations for NDA Submission, Global Suramin Supply

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently completed its three registration/validation batches of PAX-101, an IV formulation of suramin. “This accomplishment marks a significant step toward submitting a New Drug Application (‘NDA’) to the U.S. Food and Drug Administration (‘FDA’) in the fourth quarter of 2024. This step paves the way for potential commercial availability in the U.S.…

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