DevvStream

Latest Biotech News


ZenGUARD(TM) Enhanced Air Filters to Be Added as Class 1 Medical Device Under Zentek's Medical Device Establishment Licence

Last Trade: 1.28 0.12 10.34

GUELPH, ON / ACCESSWIRE / November 27, 2024 / Zentek Ltd. ("Zentek" or the "Company") (Nasdaq:ZTEK)(TSX-V:ZEN), an intellectual property development and commercialization company, announces its decision that its ZenGUARD™ Enhanced Air Filters will be added under the company's existing medical device establishment licence ("MDEL"), similar to ZenGUARD™ Surgical Masks. Initial test work and validation began on... Read more


Rallybio Announces Publication of Target-Mediated Drug Disposition Modeling and Simulations Informing the RLYB212 Dosing Regimen in Pregnant Women

Last Trade: 1.09 0.01 0.93

Dosing Regimen to be Evaluated in Recently Initiated RLYB212 Phase 2 Clinical Trial  NEW HAVEN, Conn. / Nov 27, 2024 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the publication of a manuscript titled, “Informing Pregnancy Dose via... Read more


TransCode Therapeutics Announces $8 Million Private Placement

Last Trade: 0.34 -0.04 -9.81

BOSTON, Nov. 27, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, today announced that it has entered into a securities purchase agreement with certain institutional investors. The aggregate gross cash proceeds are expected to be approximately $8 million before deducting fees to the placement agent... Read more


Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA

Last Trade: 9.20 0.16 1.77

First marketing authorization submission for blarcamesine NEW YORK, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett... Read more


Esperion Therapeutics: Otsuka Submits New Drug Application in Japan for Bempedoic Acid in the Treatment of Hypercholesterolemia

Last Trade: 2.49 -0.09 -3.31

ANN ARBOR, Mich., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale of bempedoic acid in Japan for the treatment of hypercholesterolemia and familial hypercholesterolemia. Bempedoic acid has a novel mechanism of action... Read more


Lexicon Pharmaceuticals Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

Last Trade: 0.80 -0.02 -1.98

Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 THE WOODLANDS, Texas, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind,... Read more


Revolutionizing Healthcare: Lexaria Bioscience Highlights Expanding Therapeutic Benefits of GLP-1 Drugs

Last Trade: 2.08 -0.05 -2.35

Semaglutide being investigated for applications in heart disease, Alzheimer's, liver disease, and more GLP-1 drugs expected to generate multi-hundreds of billions of revenues in the years to come KELOWNA, BC / ACCESSWIRE / November 26, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following... Read more


Ensysce Biosciences Completes Significant Milestone, Dosing First Subjects in Breakthrough Therapy PF614-MPAR Trial

Last Trade: 0.51 -0.04 -6.93

Landmark Overdose Protection Clinical Trial of PF614-MPAR  Expects Early Interim Data in 1Q 2025  SAN DIEGO, CA / ACCESSWIRE / November 26, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has... Read more


Shuttle Pharmaceuticals Expands Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma as UVA Cancer Center...

Last Trade: 0.84 -0.04 -4.02

GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the... Read more


PharmaTher Holdings Announces Update on FDA New Drug Application for Ketamine

Last Trade: 0.18 0.01 5.88

FDA provided preliminary responses to questions contained in the clarification only post-CRL meeting scheduled for December 2, 2024 PharmaTher has decided to cancel the meeting as the FDA preliminary responses were satisfactory and do not require further discussion PharmaTher initiated activities to address the MINOR deficiencies cited in the CRL TORONTO, Nov. 26, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings... Read more


BriaCell Therapeutics 2024 SABCS® Spotlight Poster to Showcase Positive Overall Survival Data Across All Patient Subtypes in Metastatic Breast Cancer

Last Trade: 0.79 0.05 6.28

SABCS® “Spotlight” poster to be presented on Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST highlights positive BriaCell survival and clinical benefit data across all metastatic breast cancer patient subtypes Median overall survival of 13.4 months exceeds historical controls. Phase 2 final median overall survival calculation is pending, as many patients remain alive Potential identification of biomarkers... Read more


Red Light Holland Partners with FDA-compliant and DEA-registered Irvine Labs to Supply Raw Material For Manufacturing Microdosing Psilocybin Capsules

Last Trade: 0.03 0.0002 0.63

Irvine Labs' FDA-compliant and DEA-registered facility enables psilocybin production and psilocybin exports and imports to and from legal jurisdictions worldwide. Manufacturing at Irvine Labs, in California, is expected to lower production costs. All products will meet cGMP standards and include Certificates of Analysis. Toronto, Ontario--(Newsfile Corp. - November 26, 2024) - Red Light Holland... Read more


Portage Biotech Reports Results for Fiscal Quarter Ended September 30, 2024

Last Trade: 4.45 -0.42 -8.62

WESTPORT, Conn., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (“Portage” or the “Company”) (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of novel multi-targeted therapies for use as monotherapy and in combination, today reported its financial results for the fiscal quarter ended September 30, 2024. “We are continuing to explore multiple strategic alternatives to further unlock... Read more


Lexaria Bioscience GLP-1 Human Pilot Study #3 Completes Dosing as Scheduled

Last Trade: 2.08 -0.05 -2.35

DehydraTECH-processed tirzepatide from Zepbound® is being tested in an oral dose format KELOWNA, BC / ACCESSWIRE / November 25, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has been completed for human pilot study #3 (the "Study") investigating a DehydraTECH-processed version of the... Read more


Tenaya Therapeutics Doses First Patient in RIDGE™-1 Phase 1b Clinical Trial of TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy...

Last Trade: 3.20 -0.09 -2.74

TN-401 AAV9-based Gene Therapy Designed to Deliver Fully Functional PKP2 Gene with the Aim of Increasing Protein Levels to Address Underlying Disease RIDGE-1 Currently Enrolling at Six Centers; Observational Natural History and Seroprevalence Study of PKP2-associated ARVC Adults Continues Enrollment at 20 Clinical Sites in the U.S., UK and Europe Initial Clinical Data for RIDGE-1 Anticipated in 2025 SOUTH... Read more


Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal

Last Trade: 9.20 0.16 1.77

NEW YORK, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today... Read more


IMUNON Announces Results from its End-of-Phase 2 Meeting with the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer

Last Trade: 0.84 0.01 1.46

FDA Project Team supports the company’s proposed Phase 3 trial strategy, including overall trial design, target patient population, treatment schedule, and primary endpoint Final Protocol submission on track for December, supporting initiation of Phase 3 registrational trial in Q1 2025 LAWRENCEVILLE, N.J., Nov. 25, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage... Read more


Pluri Evaluates Readiness for Mass Production of PLX-R18 for Acute Radiation Syndrome Amid Rising Nuclear Threat Concerns

Last Trade: 5.34 -0.06 -1.11

HAIFA, Israel, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a biotechnology company leveraging its proprietary platform for cell-based solutions to create a collaborative network of ventures, today announced that it is assessing its readiness to initiate mass production of PLX-R18, a novel potential treatment for hematopoietic complications of the acute... Read more


Enveric Biosciences Preclinical Pharmacokinetic Studies of EB-003 Support Oral Bioavailability, Demonstrate Brain Penetration, and Show No Evidence of...

Last Trade: 0.33 0.002 0.61

Dose-proportional oral bioavailability without clinical signs, including those associated with hallucinogenic compounds, was demonstrated in rat and dog pharmacokinetic (PK) studies while significant brain penetration was observed in rat CAMBRIDGE, Mass. / Nov 25, 2024 / Business Wire / Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of... Read more


BetterLife Pharma Obtains Favourable Cardiac Safety Data for BETR-001

Last Trade: 0.08 0.00 0.00

VANCOUVER, British Columbia, Nov. 25, 2024 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced it has completed one of its IND-enabling cardiac safety studies of BETR-001. These GLP in vitro studies... Read more


BridgeBio Pharma: Attruby™ (acoramidis), a Near Complete TTR Stabilizer (≥90%), approved by FDA to Reduce Cardiovascular Death and Cardiovascular-related...

Last Trade: 27.91 1.47 5.56

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date: In as few as 3 months, the time to first event... Read more


Lexicon Pharmaceuticals to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Last Trade: 0.80 -0.02 -1.98

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity Efforts Expected to Reduce 2025 Operating Costs by $100 Million Conference Call and Webcast at 9:00 am ET THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc.... Read more


Sunshine Biopharma Launches a New Generic Prescription Drug

Last Trade: 2.98 -0.06 -1.94

FORT LAUDERDALE, FL / ACCESSWIRE / November 22, 2024 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched a new generic prescription drug. The newly launched drug is Ursodiol, a... Read more


Humacyte Clinical Results Highlighting Benefit of the ATEV™ in the Repair of Civilian and Military Arterial Injuries Published in JAMA Surgery

Last Trade: 4.47 0.04 0.90

In two studies the acellular tissue engineered vessel (ATEV) provided benefits in terms of patency, limb salvage, and infection resistance compared to current synthetic graft treatment benchmarks  Results were published in a premier peer-reviewed surgical journal sponsored by the American Medical Association  DURHAM, N.C., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a... Read more


Rallybio Announces Initiation of Phase 2 Clinical Trial of RLYB212

Last Trade: 1.09 0.01 0.93

Screening is Now Underway to Identify Pregnant Women at Higher Risk for HPA-1a Alloimmunization and FNAIT  NEW HAVEN, Conn. / Nov 21, 2024 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the initiation of its Phase 2 clinical trial... Read more


BriaCell Therapeutics Announces First Patient Dosed with Bria-OTS™ in Metastatic Breast Cancer Study

Last Trade: 0.79 0.05 6.28

Phase 1/2 dose escalation study to evaluate BriaCell’s personalized next generation immunotherapy treatment in metastatic breast cancer Bria-OTS™ to be studied as monotherapy and in combination with BeiGene’s anti-PD-1 antibody PHILADELPHIA and VANCOUVER, British Columbia, Nov. 21, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that... Read more


Palisade Bio to Present Preclinical Results for PALI-2108 Demonstrating Engagement of Key Fibrotic Pathways of Crohn's Disease and Ulcerative Colitis (UC)

Last Trade: 2.38 -0.04 -1.65

Data to be presented at the 8th Annual Antifibrotic Drug Development (AFDD) Summit PALI-2108 may offer a solution for fibrostenotic Crohn’s disease by enhancing efficacy, safety, and therapeutic potential compared to traditional treatments Carlsbad, CA, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for autoimmune,... Read more


Xenetic Biosciences Presents Positive Preclinical Data Highlighting the Potential of Co-Administration of DNase I with CAR T Cells in a Murine Model of Melanoma...

Last Trade: 4.34 0.23 5.57

Data presented at the AACR Special Conference in Cancer Research: Tumor-body Interactions: The Roles of Micro- and Macroenvironment in Cancer Results bolster Company's rationale for incorporating DNase I as an adjunctive treatment to improve therapeutic responses in patients undergoing CAR T cell therapy FRAMINGHAM, MA / ACCESSWIRE / November 21, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or... Read more


Dyadic International Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV and Malaria Using C1 Platform Technology

Last Trade: 1.77 0.04 2.31

JUPITER, Fla., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Dyadic International, Inc. (NASDAQ: DYAI), a global biotechnology company, announced today that it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies (mAbs) targeting respiratory syncytial virus (RSV) and malaria utilizing the company’s proprietary C1 protein production platform to provide globally... Read more


Bright Minds Biosciences to Present Data at the American Epilepsy Society 2024 Annual Meeting

Last Trade: 38.68 0.57 1.50

Poster presentations on BMB-101 will focus on 5-HT2C functional selectivity and Phase 1 clinical data   NEW YORK, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, is proud to announce two... Read more


Recursion Pharmaceuticals and Exscientia, two leaders in the AI drug discovery space, have officially combined to advance the industrialization of drug discovery...

Last Trade: 6.08 0.19 3.23

Recursion unveils post-combination technology-enabled portfolio with more than 10 clinical and preclinical programs, 10 advanced discovery programs, and more than 10 partnered programs Platform will focus on first and best-in-class drug discovery and development, demonstrating the ability to find novel insights and dramatically reduce the time and cost of discovery Recursion will host an update call today,... Read more


Northwell Health Cancer Institute Launches Patient Enrollment in RenovoRx’s Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial

Last Trade: 1.26 -0.10 -7.35

The Northwell Health Cancer Institute is the Most Recent Clinical Site to Join the TIGeR-PaC Study, and RenovoRx Aims to Reach Full Patient Enrollment in the First Half of 2025 Phase III Clinical Trial is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer LOS ALTOS, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx”... Read more


ALL Study Groups using DehydraTECH Processing Outperform Rybelsus(R) in Body Weight Control in Lexaria Bioscience 12-Week GLP-1, Diabetes Animal Study

Last Trade: 2.08 -0.05 -2.35

DehydraTECH-liraglutide and a select DehydraTECH-CBD formulation were the top performing groups in the Study outperforming the Rybelsus® control group in both body weight-loss, by 11.53% and 10.65% respectively, and in blood sugar, by 11.13% and 3.35% respectively. DehydraTECH-semaglutide compositions with and without SNAC technology outperformed Rybelsus® control in body weight Weight-control... Read more


Pasithea Therapeutics Announces Positive Safety Review Committee (SRC) Recommendation from its ongoing Phase 1 Clinical Trial of PAS-004 in Advanced Cancer

Last Trade: 3.00 -0.01 -0.33

SRC recommended that the trial escalate to the next dose level of 15mg capsule  No dose-limiting toxicities (DLTs) observed to date  No rash observed to date  MIAMI, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment... Read more


Lexicon Pharmaceuticals Appoints Ivan H. Cheung to Board of Directors

Last Trade: 0.80 -0.02 -1.98

THE WOODLANDS, Texas, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Ivan H. Cheung has been elected to its Board of Directors. Mr. Cheung is a biopharmaceutical executive with more than 25 years of experience in the healthcare industry and a proven track record of shareholder value creation. He is currently the chief executive officer and a director of... Read more


Oral Presentation at AASLD The Liver Meeting® 2024 Highlights Broad Clinical Activity of Chemomab Therapeutics CM-101 Across Multiple Biomarkers and Its...

Last Trade: 1.67 0.08 4.72

Clinical Data from Phase 2 SPRING Trial Shows that CM-101 Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis TEL AVIV, Israel, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory... Read more


Telo Genomics Receives Approval from the Intellectual Property Ontario Program (IPON)

Last Trade: 0.07 0.00 0.00

Toronto, Ontario--(Newsfile Corp. - November 19, 2024) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (the "Company" or "Telo") a biotech company developing the industry's leading telomere technology platform with diagnostic and prognostic applications measuring genomic instability in oncology, is pleased to announce that its application to the IPON program (Intellectual Property Ontario) was approved. The IPON... Read more


PharmaTher Holdings Announces Update on FDA New Drug Application for Ketamine

Last Trade: 0.18 0.01 5.88

FDA granted a post-complete letter clarification meeting scheduled for December 2, 2024 Company initiated activities to address the deficiencies cited in the CRL TORONTO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the FDA granted a post-complete letter clarification meeting (the... Read more


BridgeBio Pharma: Open-Label Extension Data Confirms Sustained Benefit of Acoramidis on Cardiovascular Outcomes, Including Statistically Significant Reduction...

Last Trade: 27.91 1.47 5.56

Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at Month 36 within the Open Label Extension The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of... Read more


Esperion Therapeutics Highlights New Exploratory Data from CLEAR Outcomes Trial Highlighting Value of NEXLETOL® (bempedoic acid) in Oral Featured Science...

Last Trade: 2.49 -0.09 -3.31

An Exploratory Analysis Reports Patients with PAD Who Took Bempedoic Acid Were 36% Less Likely to Experience a Major Adverse Limb Event Compared to Placebo  ANN ARBOR, Mich., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the presentation of an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take... Read more

COPYRIGHT ©2022 GREEN STOCK NEWS