Tablet PK exposure increases proportionally with an increase in dose
More favorable PK properties in tablets enable a lower dose to achieve the same exposure as the capsule formulation, with improved predictability and reduced variability
Tablet steady state showing Cmax/Cmin ratio <2 MIAMI, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology... Read more
TORONTO, Nov. 21, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures, announced today an update on its ongoing research study evaluating Bucillamine as a potential treatment for nerve agent exposure. The study is being conducted in collaboration with Defence... Read more
Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries
Posters for Phase 2 and Phase 3 clinical trials available CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025,... Read more
Leading edge artificial intelligence and machine learning platform supports enhanced salesforce targeting and engagement for cutaneous T-cell lymphoma immunotherapy launch CRANFORD, N.J., Nov. 21, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical... Read more
RICHMOND, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo’s request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.
This acceptance follows Sangamo’s meeting... Read more
90-day trial will measure change in general fatigue in patients with chronic babesiosis following tafenoquine treatment
Study will run approximately 12 months and enroll up to 100 patients
Internal estimates of the unmet medical need are between 4,400 and 190,000 cases annually, with no existing FDA-approved treatment for babesiosis WASHINGTON, Nov. 21, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma”... Read more
EMERYVILLE, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (“XOMA Royalty”) (Nasdaq: XOMA) today announced it has successfully completed its previously announced acquisition of all the outstanding common shares of LAVA Therapeutics N.V. (“LAVA”) (NASDAQ: LVTX) with a nominal value of €0.12 per share (“Shares”). LAVA shareholders received $1.04 in cash per Share and a non-transferrable contingent value right (“CVR”) per Share... Read more
Findings expand Telomir-1's oncology profile into cancers of the blood, adding to previously reported activity in triple-negative breast, pancreatic, and aggressive prostate cancer models. MIAMI, FL / ACCESS Newswire / November 21, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing small-molecule therapies targeting the epigenetic and metabolic roots of cancer, aging, and age-related... Read more
These agreements are designed to be a flexible financing solution to support operations while finalizing a strategic partnership
Company is in advanced stages to finalize a strategic transaction with a potential partner, and it remains on track to complete the transaction by year end
These agreements ensure BioAtla can maintain operational momentum while completing that process SAN DIEGO, Nov. 21, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global c... Read more
Cadmus C. Rich, MD, MBA, as Chief Medical Officer, and Carlos Quezada-Ruiz, MD, FASRS, as Chair of the Scientific Advisory Board, bring invaluable clinical development expertise to VIS-101 Program
The ability to attract seasoned ophthalmology leaders highlights the compelling opportunity for VIS-101, and underscores our commitment to assembling a world-class team
VIS-101, a novel bifunctional biologic targeting VEGF-A/ANG2, has the potential to become the current standard... Read more
NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that given the high rate of non-responsiveness to therapies in adults with severe acute graft versus host disease (aGvHD) who fail corticosteroids, and the high mortality in these patients, Mesoblast and the United States National Institutes of Health (NIH)-funded Blood and Marrow Transplant Clinical... Read more
PIPE-307 demonstrated an acceptable safety and tolerability profile
PIPE-307 treatment did not result in a significant change in binocular 2.5% low contrast letter acuity (LCLA) SAN DIEGO / Nov 20, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today reported... Read more
CAREFNDR underscores the potential clinical value of paltusotine beyond acromegaly, and demonstrates progress in Crinetics’ commitment to addressing unmet needs in the neuroendocrine tumor community SAN DIEGO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been randomized in the pivotal Phase 3 CAREFNDR trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating... Read more
Alpha DaRT pancreatic cancer patient treatments underway in U.S. multi-center pilot study
Newly received radioactive material license for New Hampshire facility positions the Company for continued advancement towards commercial readiness
Multiple meaningful milestones targeted in the coming months, including completion of patient recruitment in the U.S. pivotal ReSTART trial
Cash, cash equivalents & deposits balance of $75.9 million provides runway... Read more
Evidence of Monotherapy Activity: Partial response observed in a MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation who remains on trial for more than 11 months
A second MEK-rechallenge 3rd-line melanoma patient with BRAF V600E mutation has achieved stable disease and remains on trial for more than 6 months
Initial Disease Control Rate in efficacy evaluable patients of 71.4% with BRAF-mutated tumors: 5 of 7 patients achieved stable disea... Read more
Phase 3 Study initiating in First Quarter of 2026
Single Pivotal Study Accelerates Potential FDA Approval
Timeline by Approximately 3 Years BOSTON and ATLANTA, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today announced that it expects... Read more
SAN FRANCISCO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced the closing of its previously announced underwritten public offering of 11,500,000 shares of its common stock, which includes the full exercise of the underwriters’ option... Read more
BETHESDA, Md., Nov. 20, 2025 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that it has engaged a construction firm to carry out the construction of the first Grade C manufacturing suite in the Company's Sawston, UK facility, the construction firm is onsite and the construction activities have begun. The Company anticipates... Read more
MiNK-215, an IL-15 armoured FAP-targeting CAR-iNKT, targets and clears tumor-protective FAP+ fibroblasts to allow immune cells to infiltrate and kills cancer cells
Activates multiple immune pathways to generate potent, lasting anti-tumor activity in lung and MSS colorectal cancer models NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT)... Read more
DUBLIN, Nov. 20, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that it will host a virtual key opinion leader (KOL) investor event on Monday, December 8, 2025 at 10:30 AM ET. To register, click here.
The event will feature Horacio Kaufmann, MD (Dysautonomia Center, NYU Langone Health), who will join company management to discuss the unmet medical need for symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system... Read more
Crofelemer can potentially extend lives of MVID patients - infants and children who face the lethal natural history of the disease
Parenteral support reduction of up to 37% is groundbreaking; No approved treatments exist for MVID in any region SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 20, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that, in support of a possible expedited approval pathway... Read more
SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company that is focused on rebalancing inflammation, today announced successful submission and acceptance of the end-of-phase 1 meeting package to FDA and that the company is on track to hold the meeting later this year. The primary purpose of this meeting is to establish agency feedback and input into the clinical... Read more
Calgary, Alberta--(Newsfile Corp. - November 20, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to no-option patients suffering from pain, angina, peripheral arterial disease, chronic limb threatening ischemia, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, is pleased to announce Dr. William R. Shankle,... Read more
Company starts enrollment in Romania for Phase 2 THIO-101 Part C study of ateganosine as a treatment for advanced non-small cell lung cancer patients CHICAGO, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced a presentation by CEO Vlad Vitoc, M.D. at Smart Diaspora 2025, a conference dedicated... Read more
Published, peer-reviewed narrative review in CNS Spectrums compiles pharmacologic, pharmacokinetic and clinical data of VMAT2 inhibitors to highlight important differences between treatments
Review presents distinctive profile of INGREZZA, including selective VMAT2 targeting, simplified dosing without required titration and robust clinical data across diverse patient populations and concludes that VMAT2 inhibitors are not clinically interchangeable
Publication provides... Read more
NEW YORK, Nov. 20, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics today announced that it has been officially accepted into the NVIDIA Connect Program, a global initiative supporting innovative software and technology companies working with advanced computing and AI platforms.
Acceptance into the NVIDIA Connect Program provides Hoth Therapeutics with access to... Read more
FDA Response Streamlines Path to Commercial Production of PF614 SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.
Ensysce... Read more
Evaxion’s AI-Immunology™ platform has discovered novel CMV antigens that significantly reduce viral infection in preclinical models
EVX-V1 is a next-generation, multi-component vaccine program combining these novel AI-discovered antigens with AI-optimized versions of established CMV vaccine antigens
Evaxion’s proprietary AI-optimized pre-fusion glycoprotein B (gB) antigen demonstrates superior performance compared to the traditional gB antigen, including... Read more
HOUSTON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial... Read more
BELTSVILLE, Md., Nov. 20, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced that it will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on Wednesday, December 3rd, at 11:00 am ET.
A live audio webcast will be available through the Investors section... Read more
Post-implantation analysis of ATEVs demonstrates progressive recellularization with host cells, transforming the ATEV into a multi-layered living tissue similar to that of native blood vessels
Positive outcomes for dialysis patients suffering from Steal syndrome who were treated with the ATEV
Additional presentations report durable two-year outcomes for patients treated in Ukraine conflict, superior two-year outcomes for female dialysis patients,... Read more
Successful preliminary discussion with NYSE representatives and potential investors
OS Therapies shareholders to receive direct equity participation in new listing
'Shelter Me: Cancer Pioneers' film featuring canine and human patients treated with OST-HER2 receives Anthem Award in the 'Documentary or Film under Awareness Categories, Health' category
Company congratulates Disney (NYSE: DIS) for winning the 2025 Daytime Emmy 'Outstanding Daytime Special' category and... Read more
Collaboration uses Receptor AI's platform to design highly selective anti-cancer kinase inhibitor products for BriaPro, a BriaCell subsidiary
Partnership expected to expand BriaPro's small-molecule pipeline
Aims to accelerate the development of next generation therapeutics with improved efficacy and safety PHILADELPHIA and VANCOUVER, British Columbia and BOSTON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT)... Read more
Sol-Gel intends to pursue high-frequency BCC as an additional indication for its lead drug candidate SGT-610, which, if approved, could at least double the drug’s commercial potential
In September 2025, Sol-Gel announced Health Canada approval of EPSOLAY
Sol-Gel signed an additional agreement with Viatris covering Australia and New Zealand for both EPSOLAY and TWYNEO NESS ZIONA, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ:... Read more
HOUSTON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), announced today that it has signed a national agreement with Humana, Inc. (NYSE: HUM), effective October 29, 2025, covering approximately 16 million people throughout the United States, to provide the CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) laboratory developed... Read more
PRINCETON, N.J. and TOKYO and CAMBRIDGE, Mass., Nov. 20, 2025 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the treatment of patients... Read more
Announces three-year business strategy and commercial growth drivers, targeting up to 10% revenue growth in 2026
Expects to expand seasonal vaccine franchise from three to up to six approved products by 2028
Targets readouts from nine ongoing Phase 2 and Phase 3 clinical studies in its oncology pipeline, including three Phase 3 programs for intismeran autogene
Further improves 2026 and 2027 expected GAAP operating expenses by approximately $0.5 billion each year on... Read more
NEW YORK, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced it had established a sustainable supply of high-potency iboga bark from trusted sourcing channels with deep experience in the iboga trade and treatment field through its strategic partner, PsyLabs. This is a significant... Read more
Non-dilutive financing from premier lender bolsters strong balance sheet and provides increased flexibility
Company reiterates 2025 financial guidance provided on 3Q25 earnings call and targets cash breakeven by 2028 CAMBRIDGE, MA / ACCESS Newswire / November 20, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced it has closed a five-year term loan facility for up to $1.5 billion of capital from Ares Management Credit Funds (Ares), a leading global alternative investment... Read more
GT-02287 reduces mitochondrial stress and enhances neuronal survival in MPP+ treated rat dopaminergic neurons
GT-02287 decreases staining for MIRO1, suggesting improved mitochondrial health in α-synuclein-induced mouse PD model
GT-02287 improves mitochondrial function by facilitating GCase trafficking to the mitochondria in patient-derived fibroblasts harboring GBA1 mutation BETHESDA, Md., Nov. 20, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX)... Read more
Ongoing Enrollment Continues in VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers
Commissioning Completed for Expanded NexoBrid® Facility; Full Operational Capacity Expected by Year-End 2025
Balance Sheet Strengthened with $30 Million Equity Financing
Third Quarter 2025 Revenue of $5.4 Million, Up 23% Year-over-Year
Conference Call Today, November 20, 2025, at 8:30 a.m. Eastern Time YAVNE, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq:... Read more
~35% of erectile dysfunction patients in a $3.2 billion market are non-responders to brands including Viagra and Cialis, and these drugs can be contraindicated for an estimated 16 million men living with diabetes
CF602’s unique mechanism of action enables potential treatment of diabetic patients RAMAT GAN, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline... Read more
TEL AVIV, Israel, Nov. 20, 2025 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), today announced that NeuroThera Labs Inc. (TSXV: NTLX) ("NeuroThera"), a clinical-stage pharmaceutical company focused on developing novel treatments for central nervous system (CNS) disorders, in which SciSparc holds a controlling interest of approximately 75%, has advanced its collaboration with Clearmind Medicine Inc. by filing an Israeli patent application... Read more
Prestigious Hadassah Medical Center Joins Yale, Johns Hopkins, Tel Aviv Sourasky and IMCA, in Evaluating the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate Vancouver, Canada, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health... Read more
REYKJAVIK, Iceland and LONDON, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing a... Read more
BOSTON and ATLANTA, Nov. 20, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (NASDAQ: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of pulmonary arterial hypertension (“PAH”), today announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of... Read more
BOULDER, Colo., Nov. 20, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the appointment of biotechnology veteran Christopher Martin to its Board of Directors. Mr. Martin brings proven success across all key commercial functions, including marketing, sales, commercial operations, market access, trade and business development.
"We are thrilled to welcome Chris to our Board of Directors,"... Read more
Nebokitug PSC Phase 3 Design Near Completion Following Positive FDA Feedback
Regulatory Alignment Advances, with EMA Guidance Supporting a Single Nebokitug Phase 3 Registration Trial Using a
Clinical Event Composite Endpoint
Phase 2 SPRING Trial OLE Data Showing Favorable Safety and Consistent Improvements in Key Biomarkers in PSC Patients Treated with Nebokitug for Up to 48 Weeks Presented at AASLD 2025
New Clinical Data Presented at AASLD 2025 Provides Insights... Read more
HOUSTON, Nov. 19, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced the closing of its previously announced issuance and sale to an existing shareholder of 3,540,000 shares of its common... Read more
NDA based on data from global ARROS-1 Phase 1/2 clinical trial
FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for... Read more
