Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S.
Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial
Company to host investor webcast on Dec. 11, 2024
For U.S. media and investors only DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Jazz Ph... Read more
Kura to receive a $330 million upfront payment and up to $1.2 billion in total milestone payments, including $420 million in near-term milestone payments and opt-in right for solid tumors
Companies to jointly develop and commercialize ziftomenib; 50/50 profit share in the U.S.; Kura to lead U.S. development and commercial activities and book sales; Kyowa Kirin has exclusive commercialization rights outside the U.S.
Companies to jointly pursue broad development... Read more
VANCOUVER, British Columbia, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (“Rakovina” or the “Company”), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response targeting technologies, is pleased to announce an upcoming poster presentation highlighting preliminary results of its Deep Docking and generative Artificial Intelligence (AI) drug development program at the Neuro-Oncology Annual... Read more
VANCOUVER, British Columbia, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) is proud to announce the publication of a pivotal research article in the prestigious Journal of Cosmetic Dermatology.
About the Study
The article, titled “TFC-1326 Compound Reduces Clinical Signs of Skin Aging: Evidence From In Vitro Human Adipose and Skin Models and Pilot Clinical Trial,” highlights the groundbreaking efficacy of Sirona’s proprietary compound... Read more
Nemvaleukin was generally well tolerated in ARTISTRY-1, a completed phase 1/2 clinical trial, with durable responses observed in both monotherapy and combination therapy across a range of heavily pretreated advanced solid tumors, including in platinum-resistant ovarian cancer (PROC), which does not typically respond to immunotherapies
Safety profile and anti-tumor activity observed in ARTISTRY-1 supported the company’s two potentially registrational trials, with readouts... Read more
Prof. Robert Sutton to deliver plenary presentation on Phase 2b CARPO trial of Auxora™ in Acute Pancreatitis (AP) at American Pancreatic Association (APA) 2024 Annual Meeting
Poster presentation on Phase 2b CARPO trial at Emergencies in Medicine (EIM) 2024 Meeting LA JOLLA, Calif., Nov. 20, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated... Read more
PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25
Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting ADC
New Clinical Trial Collaboration... Read more
The PRIME initiative provides enhanced support to developers of promising medicines to optimize development plans and accelerate evaluation
Pivotal trials of NX-5948 are planned to initiate in 2025 SAN FRANCISCO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced that the European... Read more
License includes Genprex's Reqorsa® Gene Therapy in Combination with ALK-Inhibitors for the Potential Treatment of ALK-Positive Lung Cancer AUSTIN, Texas, Nov. 20, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced it has entered into an exclusive license agreement with the University of Michigan,... Read more
DALLAS / Nov 20, 2024 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced an oversubscribed $53 million equity financing to support the continuing clinical advancement of FB102.
“We are appreciative of the support from new and existing investors including OrbiMed, Janus Henderson Investors, Tybourne Capital Management, Alger, Ikarian... Read more
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 improvement demonstrated in ALL study groups during the final... Read more
SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD).
The Orphan Drug designation provides... Read more
LOS ANGELES / Nov 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer who have been previously... Read more
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” or the “Company”) (Nasdaq: RNXT), a life sciences... Read more
Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a multi-mechanism strategy for potential improved patient outcomes
Favorable early safety, efficacy, tolerability and durability of remission data informed Aptevo's ongoing RAINIER Phase 1b/2 trial SEATTLE, WA / ACCESSWIRE / November 20, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO), a clinical-stage biotechnology... Read more
SEATTLE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that five abstracts featuring data on (Z)-endoxifen have been accepted for presentation at the San Antonio Breast Cancer Symposium (SABCS), taking place December 10-13, 2024, in... Read more
Celularity is collaborating with its strategic partner, Genting Berhad, to bring Celularity placenta-derived allogeneic stem cell therapeutics to the Asia Pacific region
Genting Berhad announced groundbreaking on a new, state-of-the-art wellness and health center in Bali, Indonesia, that will utilize Celularity products
Strategic partnership positions Celularity to be a key supplier of innovative stem cell and regenerative medicine products for use in the Asia Pacific... Read more
HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation.
“The introduction of... Read more
CARSON CITY, Nev., Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that an abstract on the design of its planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted as a poster presentation at the Demystifying Long COVID International... Read more
IRVINE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that four Trials in Progress Posters highlighting cretostimogene, in addition to the recently announced late breaking abstract on BOND-003, will be presented at the Society of Urologic Oncology (SUO) 25th... Read more
Strokes affect 795,000 people annually in the US. Obesity, a top risk factor for strokes, is associated with around one out of five strokes.
Cardiac complications following a stroke are a leading cause of mortality and morbidity, second only to acute neurological injury.
The pathomechanism underlying cardiac dysfunction following a stroke includes a surge of catecholamines, such as epinephrine, which induces inflammasome activation triggering a systemic inflammatory... Read more
TUSCANY study is open to enroll patients to receive TUS+VEN+AZA triplet at select US sites
Favorable safety and broad clinical activity make tuspetinib an ideal agent to combine with venetoclax and azacitidine to potentially address larger AML populations
Study execution update is expected during ASH 2024 SAN DIEGO and TORONTO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage... Read more
MALVERN, Pa., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod... Read more
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 of neurofibromatosis type 1 (NF1) and other cancer... Read more
DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety
In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis
DiffuSphere™ has shown its versatility with various drug classes, supporting the... Read more
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, November 20, 2024 at 7:30 a.m. ET / 5:30 a.m. MT / 12:30 p.m.... Read more
Candidate VY1706 demonstrates significant reductions of tau at low doses in NHP study; IND and CTA filings anticipated in 2026
VY1706 is the fifth neuro gene therapy development candidate nominated leveraging Voyager’s IV-delivered, CNS-penetrant TRACER capsids LEXINGTON, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that... Read more
Achieved all co-primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies versus each of placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy at day 84 with statistical significance (p<0.001)
Obicetrapib and ezetimibe fixed-dose combination observed to lower LDL-C by approximately 50% at day 84, compared to placebo, with over 70% of patients achieving LDL-C levels below 55 mg/dL
Data supports global... Read more
SINGAPORE, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Further to an announcement on October 7, 2024, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of blood and solid cancers, is pleased to announce that the first patient has been dosed in its first-in-human Phase... Read more
Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases
Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025
Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology... Read more
The Phase 2 DIMENSION Study did not meet its primary endpoint
Dalzanemdor was generally well-tolerated; no new safety signals were observed
Based on these data, the Company does not plan further development of dalzanemdor CAMBRIDGE, Mass. / Nov 20, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive impairment (CI) associated with Hun... Read more
WEST CHESTER, Pa., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and in either case, accompanying warrants to purchase shares of its common stock,... Read more
Hoerter Brings Over Three Decades of Oncology Commercialization and Leadership Experience
Appointment Underscores Continued Transformation of Board to Lead C4T into Next Phase of Pipeline Progress WATERTOWN, Mass., Nov. 20, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today announced the continued evolution of its Board of Directors with... Read more
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 NextPoint Therapeutics, and he has served as senior advisor to TPG... Read more
Lead Independent Director at Microsoft and former Group Worldwide Chair for Johnson & Johnson brings extensive experience in life sciences innovation, governance and operations BOSTON / Nov 20, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, (“Seaport”) a biopharmaceutical company that is advancing novel neuropsychiatric... Read more
Phase 2 data establish proof-of-concept of efgartigimod SC in myositis
Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIA
Potential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment options November 20, 2024, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of... Read more
Sangamo plans to initiate enrollment of patients in the Phase 1/2 study for ST-503 in mid-2025 RICHMOND, Calif. / Nov 19, 2024 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber... Read more
Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary Endpoints
Data Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and Safety SAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical... Read more
Alpha DaRT® accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market access to the Alpha DaRT® for patients with recurrent glioblastoma multiforme (GBM)
First patient treated in Recurrent Lung Cancer study in Israel, which will assess the safety and feasibility of delivering Alpha DaRT® sources into the lung using an endobronchial ultrasound procedure
FDA approval of an Investigational Device Exemption... Read more
SOUTH SAN FRANCISCO, Calif., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease’s (AASLD) The Liver Meeting (TLM) 2024, being held November 15... Read more
HOUSTON, Nov. 19, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) , a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced the filing of a patent application covering methods for treatment of splenomegaly using a cell-based therapeutic approach.
Splenomegaly, or an enlarged spleen, often... Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19 vaccine, as a booster vaccine for... Read more
CORAL GABLES, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, “the Company”), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that Sergio Traversa, Chief Executive Officer (CEO), will present at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024.
Jefferies London Healthcare Conference details: Presentation:
Wednesday, November... Read more
Alzamend is developing AL001, a lithium product designed for enhanced safety and efficacy compared to currently available FDA-approved and marketed lithium therapies
At a low dose, AL001 evidenced consistently higher lithium concentrations than lithium carbonate within critical brain regions comprising target tissue for efficacy, which may provide therapeutic benefits with less risk in multiple neurological disorders
Data will guide upcoming “Lithium in Brain” Phase... Read more
Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months
U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial
Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries versus the US and Europe. DALLAS... Read more
High responder rate associated with a duration of response ranging as long as 54 months in QUILT-3.032 with 100 patients enrolled
Updated data intended to be submitted as part of a European Medicines Agency (EMA) Submission in Q4 2024
Complete response data in 100 patients consistent with CR rate of 71% reported for 82 patients published in NEJM CULVER CITY, Calif. / Nov 19, 2024 / Business Wire / ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today... Read more
BELTSVILLE, Md., Nov. 19, 2024 (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 the presentation of preclinical data demonstrating that treatment with NC605, a novel anti-Siglec-15 (S15) antibody, resulted in enhanced generation of quality bone with better mechanical properties, in an oral presentation... Read more
Protects the use of onvansertib in combination with standard of care in the KRAS mutated mCRC setting through 2043 SAN DIEGO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the United States Patent and Trademark Office (USPTO) has issued to Cardiff Oncology U.S. patent No. 12,144,813 with an expected... Read more
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 “Meeting”) scheduled for December 2, 2024.
As... Read more
OCALA, Fla., Nov. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen® (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC). Results of the study were reported in The Journal for ImmunoTherapy... Read more
