Outside Biostatisticians with Specific Expertise in Alzheimer’s Disease Will Conduct an Independent Statistical Analysis on The Clinical Dataset.
Clinical Dataset May Be Announced Approximately Year-End 2022, Pending Completion of Study Report by Outside Biostatisticians.
AUSTIN, Texas, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology... Read more
Vancouver, British Columbia--(Newsfile Corp. - December 6, 2022) - Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTC Pink: DTCFF) ("Defence" or the "Company"), a Canadian biopharmaceutical company specialized in the development of immune-oncology vaccines and drug delivery technologies, is pleased to announce the successful completion of all GLP studies related to its anti-cancer AccuTOXTM molecule.... Read more
ROCKVILLE, Md., Dec. 6, 2022 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), today announced the publication of a manuscript discussing prostate cancer cell lines derived from African American men for precision medicine.... Read more
TEL AVIV, Israel and RALEIGH, N.C., Dec. 6, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of an underwritten public offering with gross proceeds to the Company of approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. The offering... Read more
BOSTON, Dec. 05, 2022 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today reported results from a prespecified immunogenicity analysis of the 203 subjects enrolled in the run-in cohort of NEST-IN1 (Norovirus Efficacy and Safety Trial for INfants), the company’s ongoing Phase 2b trial for HIL-214,... Read more
Completion of Trial Represents Continuing Progress Towards Development of the Industry's First Overdose Protection Pain Product
SAN DIEGO, CA / ACCESSWIRE / December 5, 2022 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC),(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety to reduce abuse and overdose,... Read more
LP352 exhibited a strong correlation between plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) concentration, which increased in a dose-dependent and consistent manner
LP352 demonstrated early quantitative electroencephalogram (qEEG) changes, and sustained effects on qEEG activity after continuous dosing in a dose-dependent manner indicating receptor engagement
Favorable safety... Read more
7 of 10 patients treated with NKX019 monotherapy at 1 billion and 1.5 billion CAR NK cells per dose achieved complete response (70% CR rate)
5 CRs achieved across all dose levels after a single cycle (3 weekly doses) of NKX019 monotherapy; 3 partial responses deepened to CR with additional cycles
Patients with CR observed across multiple NHL histologies, including LBCL
Consolidation dosing... Read more
Hematopoietic Stem Cell Transplantation (HCT) from Unrelated Donors is a Component of the Treatment Protocol for Several Hematologic Malignancies
GvHD Complicates Treatment and Limits the Success of Engraftment after HCT
In addition to GvHD, Tonix is Developing TNX-1500 for Prophylaxis of Organ Transplant Rejection and Treatment of Autoimmune Disorders
Phase 1 Study of TNX-1500 is Expected to... Read more
VANCOUVER, British Columbia, Dec. 05, 2022 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian clinical stage pharmaceutical development company, is pleased to announce that the United States Food and Drug Administration (“U.S. FDA”) has granted Orphan Drug Designation (ODD) to Ifenprodil as a treatment... Read more
Submission is EQRx’s first to European Medicines Agency
Application is based on data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib as first-line treatment of patients with EGFR-mutated non-small cell lung cancer
CAMBRIDGE, Mass., Dec. 02, 2022 (GLOBE NEWSWIRE) -- EQRx, Inc. (Nasdaq: EQRX), a new type of pharmaceutical company committed to developing and expanding access to... Read more
BOSTON, Dec. 2, 2022 /PRNewswire/ -- Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), which is building the leading platform for cell programming and biosecurity, today announced that in connection with its transaction with Bayer CropScience LP ("Bayer") on October 17, 2022, Ginkgo granted 9,868,143 restricted stock units to 139 new employees, and in connection with its acquisition of Zymergen... Read more
The world of biotech is having what some are calling a golden age. Many companies are presenting new and innovative drugs to the FDA for approval and later the public for consumption. Smart Beta EFTs like SPDR S&P Biotech (NYSEARCA: XBI) (“XBI”) and iShares Biotechnology (NASDAQ: IBB) (“IBB”) are bringing a lot of awareness and attention to the field for investors to get excited about.
BriaCell... Read more
Calgary, Alberta--(Newsfile Corp. - December 2, 2022) - Voyageur Pharmaceuticals Ltd. (TSXV: VM) (OTC Pink: VYYRF) (the "Company" or "Voyageur") announces that it has issued 125,322 Deferred Share Units ("DSUs") to directors pursuant to its fixed 10% equity incentive compensation plan adopted by the Company following receipt of shareholder approval on June 28, 2021 (the "Plan"). Each DSU represents... Read more
TEL AVIV, Israel, and RALEIGH, N.C., Dec. 2, 2022 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $8.0 million, before deducting underwriting discounts and other expenses payable by the Company. The... Read more
Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL
Key Secondary Endpoint CDR-SB Also Met, Demonstrating Statistically Significant Results
Plan to Meet with Regulatory Authorities to Determine Next Steps
NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”)... Read more
Roivant to develop PF-06480605 (now RVT-3101), a potential first in class, fully human monoclonal antibody that blocks tumor necrosis factor-like ligand 1A (TL1A), a cytokine believed to play a key role in inflammation and fibrosis
RVT-3101 is currently being evaluated in a large global Phase 2b study (TUSCANY-2) with final results expected in 1H 2023
BASEL, Switzerland and LONDON... Read more
Presentations include initial results for an investigational combination of fianlimab (LAG-3 inhibitor) and Libtayo (PD-1 inhibitor) in advanced non-small cell lung cancer
TARRYTOWN, N.Y., Dec. 1, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology... Read more
AbCellera (Nasdaq: ABCL) and Rallybio Corporation (Nasdaq: RLYB) announced today that they have entered into a strategic alliance to discover, develop, and commercialize novel antibody-based therapeutics for rare diseases. This multi-year, multi-target collaboration will combine AbCellera’s antibody discovery engine with Rallybio’s clinical and commercial expertise in rare diseases to identify... Read more
Fort Lee, NJ, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to... Read more
If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL cholesterol caused by homozygous familial hypercholesterolemia
TARRYTOWN, N.Y., Nov. 30, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for... Read more
The companies enter a multi-target research collaboration to develop multiple small molecule programs targeting immune modulation in cancer and potentially other disease areas based on targets selected by BioNTech
In addition to these programs, BioNTech will receive a global, exclusive license to develop and commercialize Ryvu’s STING agonist portfolio as standalone small molecules
Ryvu will... Read more
IPA (IMMUNOPRECISE ANTIBODIES LTD.) ( “IPA”) (NASDAQ: IPA), an advanced biotherapeutic research and technology company, today announced that BioStrand BV (“BioStrand”), an AI in silico discovery subsidiary of IPA, has entered into a research collaboration and license agreement (the “Agreement”) with BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell”), a clinical-stage... Read more
Adzenys XR-ODT Total Prescription (TRx) Unit Growth Driven by a Combination of Continued Sales Force Execution, Leveraging of the Aytu RxConnect Patient Support Program, and a Positive Response to the Adderall® XR Supply Disruption
Adzenys XR-ODT is the Only FDA-Approved, Extended-Release, Orally Disintegrating Tablet Formulation of Amphetamine
Adzenys XR-ODT Continues to be Available as an... Read more
BOSTON, Nov. 30, 2022 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today that it has submitted an exploratory Investigational New Drug (eIND) application to the U.S. Food and Drug Administration (FDA) for a planned First-in-Human Phase 0 clinical trial. The planned clinical... Read more
ISFIYA, Israel, Nov. 30, 2022 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today announced financial results and provided... Read more
Vancouver, British Columbia--(Newsfile Corp. - November 30, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced an update for its clinical development plans for its proprietary Psilocin based compound L-130.
Philip... Read more
Microdose Psilocybin Safety and Efficacy Clinical Study in Fragile X Syndrome
Vancouver, British Columbia--(Newsfile Corp. - November 30, 2022) - Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) ("NOVA" or the "Company"), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is... Read more
LOS ANGELES, Nov. 30, 2022 (GLOBE NEWSWIRE) -- Irwin Naturals Inc. (CSE: IWIN) (OTC: IWINF) (FRA: 97X) (“Irwin” or the “Company”) announced today it reached a binding, arms-length, agreement to acquire Serenity Health, LLC in Louisville, Kentucky, on November 25, 2022. The move continues Irwin’s national ketamine clinic rollup strategy that has seen the Company move quickly toward... Read more
TORONTO, Nov. 30, 2022 (GLOBE NEWSWIRE) -- REVIVE THERAPEUTICS LTD. (CSE: RVV; OTCQB: RVVTF) (“Revive” or the “Company”) is pleased to announce that it is arranging a private placement of a minimum of $3 million and up to $5 million of units (each, a “Unit”), at a price of $0.15 per Unit; (the “Offering”). The Offering is being led by EMD Financial Inc.
Each Unit shall be comprised... Read more
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Founded in 2012, Zinc8 Energy Solutions has assembled an experienced team of professional engineers, scientists and business managers to execute the development and commercialization of a dependable low-cost zinc-air battery...
