- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients - - Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older - - Vertex expects to initiate...Read more
Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapyMedian OS with gotistobart has not been reached at almost 15...Read more
New two- and three-year EPCORE® NHL-2 follow-up data evaluating epcoritamab in combination with standard of care regimens demonstrate remission in patients with DLBCL and FL Latest EPCORE DLBCL-3 trial results show encouraging overall response and complete response rates for epcoritamab monotherapy in newly-diagnosed, elderly patients with DLBCL Data presented at the 67th Annual Meeting and Exposition of the American Society of...Read more
Lisaftoclax monotherapy demonstrated significant and durable clinical efficacy and a manageable safety profile in patients with heavily pretreated BTK-refractory R/R CLL/SLL, underscoring its utility as a potential new treatment option Lisaftoclax achieved a 62.5% objective response rate (ORR) in heavily pretreated, BTKi-refractory patients, nearly half with complex karyotypeLisaftoclax monotherapy demonstrated a median progression-free...Read more
-- Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline -- -- Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients -- -- New 48-week data demonstrate a clear,...Read more
Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI® Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journey Eighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment at 30...Read more
-- Anito-cel demonstrated 96% ORR and 74% CR/sCR at a median follow-up of 15.9 months; responses continue to deepen over time -- -- Overall MRD negativity was 95% and sustained MRD negativity for >6 months was 83%, both at 10-5 sensitivity level -- -- 12-month PFS and OS rates were 82.1% and 94.0%; 18-month PFS and OS rates were 67.4% and 88.0%; 24-month PFS and OS rates were 61.7% and 83.0% -- -- To date, no delayed or non-ICANS...Read more
Demonstrated meaningful overall anemia responses across all patient subgroups, regardless of baseline transfusion status Anemia response was seen independent of concomitant JAK inhibitor therapy use WATERTOWN, Mass., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from...Read more
Updated Data from 31 Adult and Adolescent SCD Patients Treated with risto-cel (Formerly BEAM-101) Show Mean Hemoglobin F (HbF) Induction of >60%, Hemoglobin S (HbS) Reduction to <40%, and Resolution of Anemia Durable for up to 20 Months Patients Required a Median of One Cell Collection Cycle and Experienced Rapid Neutrophil and Platelet Engraftment Safety Profile Remained Consistent with Busulfan Conditioning, Autologous...Read more
SEATTLE, Dec. 06, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, announced growing interventional use of its clonoSEQ® test among the 90 abstracts featuring clonoSEQ data at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition,...Read more
Objective response rate (ORR) of 83% including two complete responses in CLL patients in Phase 1a study with median progression free survival (PFS) of 22.1 months across all doses tested Emerging data from randomized Phase 1b cohorts points to higher ORR and longer progression free survival at the 600 mg recommended Phase 2 dose (RP2D) compared to the 200 mg dose Bexobrutideg was well tolerated with a consistent safety profile between the...Read more
Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis Totality of data demonstrates that greater TGF-β inhibition, observed at 1500mg of ficerafusp alfa, drives deeper tumor responses that translate to more durable outcomes for patients Pivotal FORTIFI-HN01 optimal dose...Read more
– Data support initiation of a combination cohort in the ongoing Phase 1 clinical trial to evaluate ARV-393 plus glofitamab as a chemotherapy-free combination approach in diffuse large B-cell lymphoma (DLBCL); initiation expected in 2026 – NEW HAVEN, Conn., Dec. 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today...Read more
― Clear dose-response observed, with a robust and clinically meaningful fetal hemoglobin (HbF) induction at the Week 6 timepoint (n=12): mean absolute HbF in the 20 mg cohort increased by 9.9% at Week 6 (vs. 5.6% at Week 6 in the 12 mg cohort); 7 of 12 patients in the 20 mg cohort (58%) achieved absolute HbF levels ≥20% ― ― >3.75-fold mean induction of HbF at Week 12 in the 20 mg cohort among patients who reached the Week 12 visit as of...Read more
First disclosure of PRT12396, a JAK2V617F-selective JH2 inhibitor demonstrates disease modifying potential in myeloproliferative neoplasms PRT12396 has completed GLP toxicology studies and is on track for IND filing in the first quarter 2026 First disclosure of a mutant calreticulin (mCALR) targeted degrader antibody conjugate (DAC) with a novel CDK9 degrader payload JAK2V617F and mCALR are the two primary driver mutations responsible...Read more
Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52) 3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free vs. 1/4 (25%) in the control arm TSC-101 was well-tolerated with no dose-limiting toxicities observed Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc. on Monday, December 8, at 8:00 a.m. ET WALTHAM,...Read more
Designed with our proprietary AI-Immunology™ platform based on patient sequencing data, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigensEVX-04 induces targeted immune responses and prevents tumor growth in preclinical modelsEVX-04 is an off-the-shelf therapeutic cancer vaccine developed for acute myeloid leukemia (AML), a disease characterized by high mortality rates and massive unmet medical needThe...Read more
New interim results from the EpiCom trial, a prospective evaluation of behavioral outcomes in patients with tuberous sclerosis complex, suggest improvements in non-seizure outcomes Eight abstracts, including four late-breaking abstracts, underscore Jazz's continued commitment to the epilepsy community and advancing the comprehensive treatment for rare forms of epilepsy DUBLIN, Dec. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals...Read more
Company to host video conference call and webcast at 8:00 a.m. ET on Monday, December 8, 2025 WATERTOWN, Mass., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, will announce results from the BroADen Phase 1b clinical trial evaluating KT-621, its oral STAT6 degrader, in...Read more
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC IRVINE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc....Read more
Monthly reductions in seizure frequency of 90.9% among participants treated for ≥48 months in the OLE, with 38% achieving ≥1 year of seizure freedom New X-TOLE OLE data analysis supports the ability to attain and regain extended periods of seizure freedom with long-term use of azetukalner, even in patients with difficult-to-treat disease Four real-world study posters illustrate significant burden of depression and ASM titration on...Read more
Long-term Phase 1/2a and open label extension (OLE) data for zorevunersen on top of standard of care anti-seizure medicines (ASMs) demonstrate durable seizure reductions, including increases in seizure-free days, in addition to improvements in cognition, behavior and quality of life Propensity score weighted analysis comparing the effects of zorevunersen to natural history showed reductions in seizures and improvements in cognition and...Read more
AMX0114 was generally well-tolerated, with no treatment-related serious adverse events Amylyx will proceed with opening enrollment of second cohort Data are being presented at the 36th International Symposium on ALS/MND CAMBRIDGE, Mass. / Dec 05, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the presentation of early safety and tolerability data from its Phase 1 LUMINA...Read more
Post-hoc analysis of RAP-219 Phase 2a data showed early onset of action and consistency of median response over the entire treatment period, along with consistent efficacy data regardless of patients’ disease severity RAP-219 demonstrated meaningful improvements in patient-reported seizure severity among those with moderate or greater baseline impairment BOSTON and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Rapport...Read more
Houston, Texas and Tuebingen, Germany, December 05, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, announced today that it has agreed to sell 12,500,000 ordinary shares at $10.00 per share in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering...Read more
SAN FRANCISCO, Dec. 5, 2025 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) today announced that the Organization and Compensation Committee of Nektar's Board of Directors granted non-qualified stock options to purchase an aggregate of 18,310 shares of its common stock to two newly-hired employees under Nektar's 2025 Inducement Plan. Nektar's 2025 Inducement Plan was adopted by its Board of Directors on...Read more
Systemic activity of 35% ORR in 2L+ patients, including in patients with active brain metastases Manageable safety profile with low discontinuation rate Enrollment completed; no further development planned in this patient population Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc....Read more
Highly differentiated 1L preliminary systemic activity of 67% ORR and 100% intracranial ORR (by BICR-RANO), including in patients with active brain metastases 45% ORR in 2L patients exceeds competitor benchmarks Competitive safety profile, with no significant off-target toxicity and manageable on-target toxicity, resulting in low discontinuation rate Enrollment and follow-up continue in 1L patients at selected dose of 80 mg once daily,...Read more
THE WOODLANDS, Texas, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin will be presented at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025). The conference is being held December 8-10, 2025, at the Mayflower Hotel in Washington, D.C. This data is from SOTA-P-CARDIA, a prospective,...Read more
BOSTON, Dec. 5, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced it has been awarded by the Environmental Molecular Sciences Laboratory (EMSL) at Pacific Northwest National Laboratory (PNNL) a four-year, up to $47M contract to co-design, build, and integrate a High‑Throughput Automated Phenotyping Platform (HTP‑APP) in support of the Microbial Molecular Phenotyping Capability (M2PC). The platform, selected through a...Read more
LYT-200 demonstrated favorable tolerability and strong efficacy in a heavily pretreated population, both in combination with standard of care and as a monotherapy, supporting advancement toward a potentially registrational Phase 2 trial Initial median overall survival of 13.2 months observed in the combination cohort at the proposed Phase 2 dose, exceeding expected late-line relapsed/refractory setting survival of <2.5 months; overall...Read more
EMERYVILLE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (“XOMA Royalty”) (Nasdaq: XOMA), the biotech royalty aggregator, today announced it has successfully completed its previously announced acquisition of the entire issued and to be issued share capital of Mural Oncology plc (“Mural”) (Nasdaq: MURA) (the “Acquisition”) pursuant to an Irish High Court sanctioned scheme of arrangement under Chapter 1 of Part 9 of...Read more
Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data...Read more
U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2 Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025 Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025 New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
Maxim Group LLC is acting as the exclusive Financial Advisor for the transaction PHILADELPHIA, PA / ACCESS Newswire / December 5, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced that it has entered into a warrant inducement agreement for...Read more
Boca Raton, FL, Dec. 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, announces a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune’s CORDStrom™ platform. The article, titled, “Fate and Function of Exogenously Administered MSCs: Current Insights and Future...Read more
ARLINGTON, Mass., Dec. 05, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) (“KALA” or the “Company”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase of an aggregate of 10,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.00 per share (or pre-funded warrant in lieu thereof). H.C....Read more
NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or...Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance from the US Food and Drug Administration (FDA) and the...Read more
IRVING, Texas, Dec. 4, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance ™ (Caris POA), will collectively present 19 studies across a range of breast cancer types at the San...Read more
Successful interim analysis triggered early stop for efficacy Topline study results to be shared at the American Epilepsy Society Annual Meeting on December 6, 2025 Praxis confirms an upcoming meeting with the FDA to discuss the results and NDA path BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the...Read more
Praxis confirms plans to submit the essential tremor NDA for ulixacaltamide in early 2026 BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of its...Read more
SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or...Read more
LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an...Read more
PRAGUE, Czech Republic and DURHAM, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- SCTbio, a leading European CDMO specializing in GMP manufacturing for cell-based products, and Fortrea, a leading global contract research organization (CRO), today announced a strategic collaboration agreement between the two companies. This partnership aims to streamline development, accelerate timelines and bring advanced therapies to patients faster. This...Read more
SAN DIEGO, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics, today announced the commencement of a proposed underwritten public offering of shares of its common stock. In addition, Capricor intends to grant the underwriters a 30-day option to purchase an additional number of shares of common stock equal to 15% of the...Read more
Highly differentiated 1L EGFR PACC preliminary systemic activity of 80% ORR and 100% intracranial ORR, including in patients with active brain metastases 36% ORR in median 3L EGFR PACC patients exceeds competitor benchmarks Competitive safety profile, with no significant off-target toxicity and manageable on-target toxicity, resulting in low discontinuation rate Enrollment and follow-up continue in 1L EGFR PACC patients at selected...Read more
NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced plans to host a virtual event, “A Clinician’s Perspective: Holistic Approach to Managing PKP2-Associated Arrhythmogenic Cardiomyopathy,” at the 22nd Global Cardiovascular Clinical Trialists (CVCT) Forum on Tuesday, December 9th...Read more
Study to evaluate safety and efficacy of novel anti-PRLR antibody; interim data anticipated in the second half of 2026 Trial design leverages operational synergies to enable accelerated registrational trials for androgenetic alopecia (AGA) and Phase 2 for endometriosis KOL seminar scheduled for December 11 to discuss new human ex vivo data, clinical trial design, and market opportunity in AGA VANCOUVER, Wash. and NEW YORK, Dec. 04,...Read more
BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β, a cytokine directly downstream of NLRP3, at Day 14 High brain penetration: BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14 Company is expanding the Phase 1 trial to include MAD cohorts in...Read more
Pancreatic cancer multi-center clinical trial in U.S. is underway; patient recruitment expected to be completed by the end of Q1 2026 JERUSALEM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, announced today that two abstracts have been accepted to the 2026 American Society of Clinical...Read more
WASHINGTON, Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative...Read more
Nes-Ziona, Israel, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, “Enlivex” or “the Company”), today announced that it will host a virtual fireside chat on Thursday, December 11, 2025 at 11:00 am ET. Shai Novik, Executive Chairman of Enlivex, will provide an update on the Company’s plans following its recently closed $212,000,000 private placement. Mr. Novik will discuss the launch of Enlivex’s digital asset...Read more
EMERYVILLE, Calif. / Dec 04, 2025 / Business Wire / OmniAb, Inc. (NASDAQ: OABI) today announced it will hold a virtual investor event to showcase the launch of OmniUltra™ on Monday, December 15, 2025, beginning at 5:00 p.m. Eastern time. The event is expected to last approximately one hour and will include a review of OmniAb’s newest technology offering, OmniUltra, the industry's only transgenic chicken engineered to express ultralong...Read more
APONVIE, an aprepitant product, highlighted as the only FDA-approved IV formulation Neurokinin-1 (“NK-1”) antagonist indicated for the prevention of PONV in adults, with a long half-life and quicker onset than oral aprepitant Aprepitant alone, or added to a multimodal regimen, recognized as significantly reducing the risk of PONV, and aprepitant monotherapies are noted as more effective compared to 5-HT3 receptor antagonists for...Read more
NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA) (“Protara”), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that it has commenced an underwritten public offering of $75 million in aggregate of shares of its common stock or, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its...Read more
Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settings SEATTLE, Dec. 4, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, announced the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November...Read more
Cohort 1 data from multiple dose ReSPECT- Leptomeningeal Metastases (LM) trial showed no dosage limiting toxicity ReSPECT-Glioblastoma (GBM) trial of REYOBIQ as a novel therapeutic for recurrent GBM demonstrated promising safety and efficacy signal, supporting continued Phase 2 enrollment and investigation MRI combined with SPECT imaging biomarkers effectively evaluate overall survival response with REYOBIQ in recurrent GBM treatment...Read more
Phase 2b trial showed significant improvements on primary and key secondary outcomes measures, most prominently in patients without AD co-pathology Significant reduction in key neurodegeneration biomarker correlated with treatment response, suggesting neflamapimod may act on underlying disease CervoMed preparing to initiate Phase 3 registrational trial in patients with DLB in the second half of 2026 BOSTON, Dec. 04, 2025 (GLOBE...Read more
An independent Data Safety Monitoring Board (DSMB) confirms EB103’s favorable safety profile with no treatment-related serious adverse events (SAEs) even in high-risk patients who are ineligible for currently available commercial CD19 products DSMB recommends advancement of STARLIGHT-1 to Phase II at the Recommended Phase II Dose (RP2D) High-dose cohort of Phase I achieved a 100% complete response (CR) rate at Month 1 Data supports...Read more
One complete response and three partial responses observed in heavily pretreated ICI-secondary refractory patients in high dose cohorts Deep and durable ongoing responses with median time on treatment of 15 months Company to accelerate development of PLN-101095 with initiation of a Phase 1b expansion trial in 2026 Strong cash position supports planned operations through 2028 SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced it will host a conference call and webcast to discuss updated clinical results from SENTI-202 being presented at the ASH Annual Meeting on Tuesday, December 9, 2025 at...Read more
AGOURA HILLS, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003, the company’s intravenous Deciparticle™ formulation of everolimus. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) Dec 9-12. This work describes the first...Read more
QUÉBEC, Dec. 4, 2025 /CNW/ - Devonian Health Group Inc. ("Devonian" or the "Corporation") (TSXV: GSD) (OTCQB: DVHGF), a biopharmaceutical corporation specializing in the development of prescription drugs targeting fibroinflammatory diseases, is pleased to announce the publication of a peer-reviewed article in Biomedicines titled "Thykamine™: A New Player in the Field of Anti-Inflammatory Drugs." The study presents notable evidence...Read more
CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada ("Agency"), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS). After...Read more
SHELTON, Conn., Dec. 4, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, today announces two presentations at the upcoming...Read more
Vancouver, British Columbia--(Newsfile Corp. - December 4, 2025) - PreveCeutical Medical Inc. (CSE: PREV) (OTCID: PRVCF) (FSE: 18H0) (the "Company" or "PreveCeutical") is pleased to announce that the Australian Patent Office has granted Australian Patent No. AU2020212659, titled "A Cyclic Peptide", which relates to the Company's pain therapy program. This patent represents a significant milestone in the development and...Read more
Calgary, Alberta--(Newsfile Corp. - December 4, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), a leader in autologous stem cell therapeutics for ischemic diseases, is pleased to announce the appointment of Shaune Harding, OStJ, RN non-practicing, as Director of Patient Care & Clinical Operations. In this senior clinical role, Ms. Harding will oversee: On-boarding of all new patients...Read more
New data showcase the versatility and anti-tumor activity of the CAPTN-3 platform and its unique multi-arm design in treatment-resistant cancers REHOVOT, Israel, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced that it will present...Read more
ARLINGTON, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) (“KALA” or the “Company”), today announced that it has entered into definitive agreements for the purchase of an aggregate of 10,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.00 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. The...Read more
The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042. Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies. Aramchol's excellent safety and tolerability is a perfect drug candidate to be...Read more
Management to meet with investors and potential partners during Biotech Showcase 2026 CAMBRIDGE, Mass. / Dec 04, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced that the company will present and participate in the Sachs Associates 9th Annual...Read more
Extends cash runway into first half of 2028, beyond planned completion of ViraxImmune™ US based regulatory study in post-acute sequelae of COVID-19 ("PASC", or long COVID) and submission to the FDA, completion of UK based regulatory study in post-acute infection syndrome (PAIS) and submission to MHRA along with expansion of our immune-profiling platform and partnerships. LONDON, Dec. 4, 2025 /PRNewswire/ -- Virax Biolabs Group...Read more
Topline results from Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia expected in the second half of 2026 Topline results from Phase 2 VISTA trial of ML-007C-MA for Alzheimer’s disease psychosis expected in the second half of 2027 Raised $296.5 million in gross proceeds from initial public offering and concurrent private placement completed in October 2025 Cash, cash equivalents and short-term investments sufficient to fund...Read more
Partnership expands access to LYMPHIR for patients with cutaneous T-cell lymphoma across Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the UAE LYMPHIR international availability extends to 19 markets outside the U.S. CRANFORD, N.J., Dec. 4, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today...Read more
Mike Bonney and Carolyn Bertozzi to Depart; Company Appoints Stuart Arbuckle as New Independent Director CAMBRIDGE, Mass. / Dec 03, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced changes to its Board of Directors, including the departure of two directors and the appointment of a new independent director. Mike Bonney and Carolyn Bertozzi, Ph.D., who have...Read more
Event to Review R&D Progress and Outline Exelixis’ Strategy for Building Next-generation Oncology Franchises ALAMEDA, Calif. / Dec 03, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced that it will webcast its virtual event, Exelixis 2025 R&D Day: Building Next-generation Oncology Franchises, on Wednesday, December 10, 2025, from 1:00 p.m. to 3:30 p.m. EST. During the event, featured speakers will review...Read more
Initiation of trial marks milestone for Crinetics’ novel nonpeptide drug conjugate platform SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors....Read more
VANCOUVER, British Columbia and BOSTON, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced that the company will host an investor webinar focused on its data presentations at the American Epilepsy Society Annual Meeting (AES...Read more
Robust and clinically meaningful benefits across all three key markers of disease – 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits Consistent results across adolescent and adult patients with C3G and primary IC-MPGN, including patients with C3G recurring after transplant EMPAVELI is the first FDA-approved treatment for C3G and primary IC-MPGN patients 12 and older WALTHAM,...Read more
Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months Findings supported recent favorable interactions with FDA where alignment was reached on modifying the ongoing G203 into a pivotal trial in high-grade gliomas NEW YORK / Dec 03, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer...Read more
Primary endpoint met; median time to onset of symptom relief achieved in 1.28 hours, significantly faster versus placebo (p<0.0001) All secondary efficacy endpoints met (p<0.0001), including End of Progression™1 (median 17.47 minutes) and complete symptom resolution (median 11.95 hours) Well-tolerated safety profile of deucrictibant confirmed Efficacy and safety outcomes consistent across all HAE subtypes represented (HAE...Read more
Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively) Statistical significance was achieved in all type 1 error controlled secondary endpoints Results demonstrate clinically meaningful and statistically significant skeletal and cardiac benefits, supporting...Read more
Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO and SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced two late-breaking oral presentations highlighting data from a Phase 1b trial of enozertinib...Read more
Initial clinical data expected mid-2026 SOUTH SAN FRANCISCO, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing...Read more
Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile The interim results, including immunological data...Read more
CAMBRIDGE, Mass., Dec. 3, 2025 /PRNewswire/ -- STRM.BIO, a start-up biotechnology company pioneering non-viral delivery technologies for in vivo cell and gene therapy, today announced that it has been awarded a contract from the Advanced Research Projects Agency for Health (ARPA-H) through its Engineering of Immune Cells Inside the Body (EMBODY) program. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D. The award includes up...Read more
ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated an 89.8% ORR and 77.6% CR across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up Combination continues to be generally well-tolerated with a manageable safety profile LOTIS-7 trial is on track for complete patient enrollment in 1H 2026; plan to share full data at a medical meeting and submit for publication by end of 2026 Company to host...Read more
Poster highlights 6-month follow-up data from the ongoing Phase 2 trial of NDV-01 in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Relmada plans to advance NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies in two indications in H1 2026 Company is focused on high-risk NMIBC and intermediate-risk NMIBC, representing about 80% of new NMIBC cases...Read more
TARA-002 demonstrates 72% complete response rate at any time in BCG-Naïve patients TARA-002 demonstrates a 69% complete response rate at the 6-month landmark and a 50% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile observed with no Grade 3 or greater treatment-related adverse events reported Company obtained written feedback from FDA on registrational path forward for...Read more
| Company | Change | Last Trade |
|---|---|---|
| Praxis Precision Medicines | 58.02 30.54 | $247.99 |
| Krystal Biotech | 12.17 5.48 | $234.13 |
| Bright Minds Biosciences | 6.47 8.93 | $78.89 |
| United Therapeutics | 5.21 1.08 | $489.31 |
| Bolt Biotherapeutics | 4.86 869.59 | $5.42 |
| Galecto | 4.57 19.97 | $27.46 |
| Abivax | 3.88 3.51 | $114.52 |
| Alumis | 2.86 34.46 | $11.16 |
| Jazz Pharmaceuticals | 2.79 1.67 | $169.70 |
| Nuvalent | 2.74 2.56 | $109.60 |
| Protagonist Therapeutics | 2.32 2.66 | $89.65 |
| Vera Therapeutics | 2.29 5.37 | $44.90 |
| Terns Pharmaceuticals | 2.26 8.33 | $29.39 |
| Oculis | 2.25 11.42 | $21.95 |
| Surrozen | 2.23 12.23 | $20.46 |
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
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