64% MMR achievement by 24 weeks across all efficacy evaluable patients 75% MMR achievement by 24 weeks in efficacy evaluable patients at doses >320mg QD Encouraging safety/tolerability profile maintained with longer duration of treatment Company to host investor update call today at 4:30pm ET FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a...Read more
REC-4881 (4 mg QD) achieved rapid clinical activity, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment (n=12) After 12 weeks off therapy (week 25 of the study), 82% of evaluable patients (9 of 11) maintained a durable reduction in total polyp burden, with a 53% median reduction observed from baseline Natural history analysis showed that 87% of untreated FAP...Read more
Two-year epcoritamab monotherapy data demonstrate high complete response and encouraging survival rates in patients with Richter transformation (RT), highlighting its potential as a treatment option for those unsuitable for chemotherapy Additional early data show promising efficacy of epcoritamab combination regimens in patients with RT Results underscore the potential of epcoritamab as a versatile therapy for a broad range of B-cell...Read more
Nearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3% achieving a complete HR Molecular responses were frequent, rapid, durable and correlated with hematologic responses; a reduction in mutCALR variant allele frequency (VAF) from baseline occurred in 96.2% of patients with ≥1 post-baseline VAF measurement Exploratory analyses from the...Read more
76.7% complete cytogenetic response rate achieved in patients who failed second-generation TKI first-line therapy Molecular responses continue to deepen with extended treatment duration, reaching 60% major molecular response at 21 cycles Strong efficacy data support potential advancement to earlier treatment lines for a broader patient population ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage...Read more
Dramatically improved disease control with 21.2 months vs. 2.9 months median event-free survival (EFS) Favorable safety profile with 7% vascular occlusion rate Broad patient benefit with proven effectiveness even in patients without T315I mutation (11.9 vs. 3.1 months event-free survival) ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global,...Read more
By the end of 3 induction cycles, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively High-risk IKZF1plus patients showed 90% molecular response rate Low-intensity chemotherapy combination achieved deep responses with favorable safety profile ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group...Read more
ARO-MAPT utilizes the Targeted RNAi Molecule (TRiM™) platform designed for subcutaneous administration and systemic delivery to the CNS by crossing the blood-brain-barrier Study initiation further highlights Arrowhead’s innovation and leadership in the delivery of siRNA PASADENA, Calif. / Dec 08, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a...Read more
SAN DIEGO, Dec. 8, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the election of Jim Lang to its Board of Directors. Mr. Lang brings more than 30 years of executive leadership experience in healthcare, life sciences, business services and data analytics. "Jim brings extensive experience in building and scaling innovative healthcare businesses, and we are delighted to welcome him to...Read more
KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy volunteers to atopic dermatitis (AD) patients KT-621 achieved strong reductions in disease-relevant Type 2 biomarkers in blood, including TARC (median reduction of 74% in patients with baseline TARC levels comparable to dupilumab...Read more
WATERTOWN, Mass., Dec. 08, 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, today announced that it has commenced an underwritten public offering of $500.0 million of shares of its common stock. All of the shares of common stock to be sold in this offering are being offered by Kymera. In...Read more
Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose...Read more
Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase...Read more
SAN FRANCISCO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced the commencement of a proposed underwritten public offering, subject to market and other conditions, to issue and sell $500 million of American depositary shares (ADSs), each...Read more
Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and...Read more
WESTLAKE VILLAGE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Amit Munshi has been appointed to the Arcutis Board of Directors effective December 4, 2025, and announced the retirement of founder and long-serving Board member Bhaskar Chaudhuri, PhD. Dr. Chaudhuri...Read more
Planned acquisition of brelovitug for chronic hepatitis delta virus (HDV) with Breakthrough Therapy and PRIME designations Anticipated to be highly synergistic with Mirum’s liver expertise and proven global commercial capabilities HDV: Large, high unmet-need rare liver disease with no FDA-approved therapies Top-line Phase 3 results expected in 2H 2026 Conference call today, December 8, 2025 at 8:30 am ET/5:30 am PT FOSTER CITY,...Read more
Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and...Read more
WALTHAM, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it has commenced an underwritten public offering of $300,000,000 of shares of its common stock. Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional...Read more
Registrational Expansion Cohort (REC) met primary endpoint, demonstrating statistically significant increase in dystrophin to 5.46% at 6 months (muscle content-adjusted; p<0.0001), replicating the same 7-fold change from baseline previously observed at the registrational dose Functional improvement was observed across multiple clinical endpoints at 6 months in REC; lung function was preserved at 6 months New positive...Read more
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health (“Wave” or “Wave Life Sciences”), announced today that it has commenced an underwritten public offering of $250 million in aggregate of its ordinary shares, and, to certain investors that so choose in lieu of ordinary shares,...Read more
Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01), with no statistically significant changes in the placebo group Sustained and robust suppression of serum Activin E supports expectations for...Read more
BRISBANE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera Therapeutics”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced its plans to commence a public offering, subject to market and other conditions, to issue and sell $200.0 million of shares of its Class A common stock. All of the...Read more
Data presented at the 2025 American Epilepsy Society Annual Meeting PLYMOUTH MEETING, Pa. / Dec 08, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in...Read more
Objective response rate (ORR) of 75.0% including three very good partial responses (VGPR) in heavily pre-treated Waldenström macroglobulinemia patients With a median follow up of 8.1 months, median duration of response (DOR) and median progression-free survival (PFS) have not been reached Encouraging efficacy and favorable tolerability support continued development of bexobrutideg in Waldenström macroglobulinemia Nurix will host a...Read more
ZL-1503, a promising treatment for moderate-to-severe atopic dermatitis and other Type 2 helper T-cell (Th2)-driven diseases, strengthens Zai Lab’s growing global pipeline ZL-1503 originated from Zai Lab’s in-house discovery and development engine SHANGHAI & CAMBRIDGE, Mass. / Dec 08, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the dosing of the first participant in a global Phase 1/1b...Read more
First real-world evidence for a menin inhibitor shows 77% ORR (10/13), 31% (4/13) CR/CRh, 75% (9/12) MRD negativity, and favorable tolerability among primarily R/R NPM1m, KMT2Ar, and NUP98r acute leukemia pts Retrospective review shows revumenib was well tolerated as post-HSCT maintenance in children with KMT2Ar and NUP98r; all pts were alive and 90% (9/10) were relapse free at median follow-up of 19 months Ph 2 SAVE...Read more
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the supplemental New Drug Application (sNDA) for mitapivat for the treatment of adult patients with...Read more
Data Demonstrate Potent in vivo Gene Editing of Hematopoietic Stem Cells (HSCs) in the Bone Marrow with Systemic Delivery in Preclinical Murine Models Using Fusogen Technology Broadens Application of Fusogen Technology Beyond T Cells to Second Cell Type, HSCs, Showing Potent and Specific in vivo Delivery Underscores Ability of Fusogen Technology to Deliver Diverse Payloads, including CRISPR Gene-Editing and Base-Editing...Read more
VANCOUVER, British Columbia / Dec 08, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) today announced that the Company will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. A live audio webcast of the presentation may be accessed through a link that will be posted on AbCellera's Investor Relations website. A replay will be available through the same link following the presentation. About AbCellera...Read more
86% (32/37) CRc and 73% (27/37) CR in newly diagnosed NPM1-m AML, with 68% (17/25) of CRc responders achieving molecular MRD negativity by central NGS Median duration of complete response and overall survival not yet reached in newly diagnosed NPM1-m patients as of data cutoff 65% (31/48) ORR in R/R NPM1-m AML, 83% (19/23) ORR in venetoclax-naïve 41% (13/32) ORR in R/R KMT2A-r AML, 70% (7/10) ORR in venetoclax-naïve Triplet...Read more
Oral presentation from pooled analyses of the IMerge population suggests that treatment-emergent cytopenias may reflect on-target effects associated with meaningful clinical outcomes, including hemoglobin increases and transfusion independence in lower-risk MDS Long-term follow-up analysis from IMerge supports favorable survival trends and durable clinical benefit in LR-MDS Additional analyses in myelofibrosis and advanced MDS/AML...Read more
CLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML 31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed CLN-049 recently granted Fast Track designation by the U.S....Read more
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (“Fulcrum”) (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that it has commenced an underwritten public offering of $150.0 million of shares of its common stock. Fulcrum also intends to grant the underwriters a 30-day...Read more
Patients in 200 mg BID cohort had median progression free survival of 6.2 months and median overall survival of 28.1 months, comparing favorably to results with other therapies Data supports ongoing registration Phase 3 trial in r/r PTCL, Phase 1 trial in atopic dermatitis and potential expansion into other immune and inflammatory diseases Highlights ITK inhibition novel mechanism of action affecting T cell receptor signaling and T...Read more
EMERYVILLE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the Company will present at the 44th Annual J.P. Morgan Healthcare Conference. Members of the management team...Read more
98% reduction in HSV-2 shedding rate, >99% reduction in high viral load shedding rate and 91% reduction in virologically confirmed genital lesion rate observed in 50 mg weekly oral dose of ABI-1179, exceeding expectations for the study 76% reduction in HSV-2 shedding rate, 81% reduction in high viral load shedding rate and 88% reduction in virologically confirmed genital lesion rate observed in proof-of-concept test of monthly...Read more
CHARLESTOWN, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it will present data from its next-generation, proprietary capsid AAV-SLB101 and its cardiac gene therapy pipeline at the Global CardioVascular Clinical Trialists (CVCT) Forum taking place December...Read more
Obe-cel demonstrates high remission rates in pediatric patients with high-risk r/r B-ALL with overall response rate (ORR) of 95.5%; low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) observed, consistent with obe-cel’s adult safety profile FELIX study data analyses highlight product cell phenotype and level of CAR T persistence at three months as potential...Read more
Data show deep, durable responses in the 50 million cell dose level cohort; initial data suggest substantial early improvement in three patients dosed with 100 million cells All patients show deep B-cell depletion after infusion, suggesting an immune reset Nine patients were evaluable for safety, no ICANS or high-grade CRS were observed LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc...Read more
Feedback from U.S. Food and Drug Administration (FDA) supports advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway Phase 3 SURPASS-IPF trial remains on track to be initiated by PureTech’s Founded Entity, Celea Therapeutics, in the first half of 2026 BOSTON / Dec 08, 2025 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company...Read more
Investigator-Initiated Preclinical studies at CIC biomaGUNE aimed at combatting Glioblastoma Multiforme Research will evaluate effects of intra-arterial delivery of Annamycin HOUSTON, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today...Read more
Eti-cel showed an 88% ORR and 63% CR (n=8) at current dose level in r/r NHL after ≥2 prior lines of therapy In vivo data suggest IL-2 may further enhance response rates and optimize eti-cel expansion and persistence IL-2 cohort enrollment to start in Q1 2026; full Phase 1 dataset expected in 2026 NEW YORK, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage...Read more
Dr. Reddy’s receives exclusive rights to develop and commercialise Eftilagimod Alfa in all countries outside North America, Europe, Japan, and Greater China Under the terms, Immutep to receive upfront payment of USD 20 million (~AUD 30.2 million) and is also eligible to receive potential regulatory development and commercial milestone payments of up to USD 349.5 million (~AUD 528.4 million), plus double-digit royalties on commercial...Read more
CLEVELAND, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the first commercial patient treatment with FDA-approved ZEVASKYN (prademagene zamikeracel), a first-of-its-kind, autologous gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN was administered at Lucile Packard Children’s Hospital Stanford in Palo Alto,...Read more
Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients indicated for a pacemaker NEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact...Read more
NEW YORK, Dec. 08, 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 the closing of its underwritten public offering of 13,043,479 shares of its common stock at a public offering price of $5.75 per share. In addition, Protara has granted the underwriters a 30-day option to purchase up to...Read more
SAN DIEGO, Dec. 08, 2025 (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 that clinical data from an investigator-sponsored trial with onvansertib in chronic myelomonocytic leukemia (CMML) will be presented in a poster presentation at the 67th American Society of Hematology (ASH) Annual...Read more
6 Years Long-term survival data reinforce potential benefit to patient survival in treating recurrent or metastatic nasopharyngeal carcinoma with LOQTORZI in combination with chemotherapy REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Coherus Oncology, Inc. (NASDAQ: CHRS) today announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi)...Read more
STAFFORD, Texas, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01. In the double-blinded arms of the Phase III trial,...Read more
FT819 continues to demonstrate meaningful decrease in disease and favorable safety profile with twelve systemic lupus erythematosus (SLE) patients now treated; first systemic sclerosis (SSc) patient treated First ex-U.S. SLE patient treated with FT819 expands enrollment capacity and supports unique ability of FT819 for broad, on-demand patient accessibility Preclinical studies show FT836 chimeric antigen receptor (CAR) T cells...Read more
LA JOLLA, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company listed on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code: 4875), today announced an update and the patients’ basic characteristics data from its Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS), known as the COMBAT-ALS study. These results were presented...Read more
REDWOOD CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today announced positive results from its completed Phase 2 trial evaluating burixafor (GPC-100) in combination with propranolol and granulocyte colony-stimulating factor (G-CSF) for the mobilization of hematopoietic progenitor cells (HPCs) in patients with multiple...Read more
SINGAPORE, Dec. 08, 2025 (GLOBE NEWSWIRE) -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or the “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumors, today announced that it has entered into a Memorandum of...Read more
SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced data presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the...Read more
Ra’anana, Israel, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announces that it has successfully completed a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its PL-14 Allergy Blocker product, a novel nasal spray designed to provide protective intranasal barrier...Read more
Positive results of ERNA-101 in ovarian cancer models demonstrated promising survival benefit and immune activation, underscoring the potential for broad oncology applications, including hematologic malignancies CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the...Read more
Late Breaking Abstract titled "Targeting SCD1 enhances activity of standard of care regorafenib in hepatocellular carcinoma: translational rationale for a phase 1/2 study of the combination of Aramchol and regorafenib" to be presented with a poster on December 9 at 3pm (HST). RAMAT-GAN, Israel, Dec. 8, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical...Read more
All three dose groups (50 mg, 100 mg and 200 mg) showed impressive monotherapy efficacy, with VGPR+ (very good partial response or better) of ≥70% despite limited follow-up; evidence shows that these responses are expected to deepen over time Across all dose groups, 95% (19 of 20 patients) of all evaluable VGPR+ patients achieved minimal residual disease negative status Data featured in an ASH oral presentation; LINKER-MM4 is the...Read more
Trial demonstrated treatment with fixed duration EPKINLY plus rituximab and lenalidomide (EPKINLY+ R2) resulted in statistically significant and clinically meaningful reduction in the risk of disease progression or death and overall response compared to R2 alone EPKINLY + R2 was recently approved by the U.S. Food and Drug Administration as the first and only bispecific-based therapy for follicular lymphoma in the second-line...Read more
The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators Updated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del. / Dec 07, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that...Read more
Rapid and robust reductions in spleen volume and symptoms, and improvements in anemia were observed with INCA033989 as monotherapy and in combination with ruxolitinib (Jakafi®) in patients with myelofibrosis (MF) harboring a CALR mutation (mutCALR) Results demonstrate a favorable safety profile for INCA033989 as a monotherapy and in combination with ruxolitinib – no dose limiting toxicities were reported and a maximum tolerated dose was...Read more
Preliminary clinical evidence of Lisaftoclax overcoming venetoclax resistance in myeloid malignancies with a 31.8% overall response rate(ORR) in this subgroup of patients 80% ORR achieved in newly diagnosed high-risk MDS/CMML Strong safety profile with no dose-limiting toxicities across all patient cohorts in 103-patient study ROCKVILLE, Md. and SUZHOU, China, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International...Read more
SAN FRANCISCO, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced plans to release topline data from its ACCESS clinical program of aleniglipron, the company’s once-daily oral small molecule GLP-1 receptor agonist for the treatment of obesity, before...Read more
WALTHAM, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it plans to announce topline clinical results from the Registrational Expansion Cohort (REC) of the Phase 1/2 DELIVER trial...Read more
CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, will announce interim data from the ongoing Phase 1 INLIGHT clinical trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave’s proprietary SpiNA design, for the treatment of obesity on Monday, December 8,...Read more
SHANGHAI & CAMBRIDGE, Mass. / Dec 07, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the following medicines and indications have been renewed in the 2025 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA): VYVGART® (efgartigimod alfa injection) is renewed for the treatment of adult patients with generalized myasthenia gravis (gMG) who...Read more
R289 continues to be generally well tolerated and at doses of ≥500 mg QD preliminary efficacy was observed in elderly, heavily pre-treated lower-risk MDS patients RBC-TI was achieved by 33% (6/18) of evaluable transfusion dependent patients receiving R289 doses ≥500 mg QD, including 40% (2/5) in the 500 mg BID dose group SOUTH SAN FRANCISCO, Calif., Dec. 7, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a...Read more
CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product for p47phox chronic granulomatous disease (CGD) in the New England Journal of Medicine (NEJM)....Read more
93% overall response and 76% complete response rates with median progression-free survival of 18 months in patients with large B-cell lymphoma in the 3L+ setting 83% overall response and 61% complete response rates in cohort comprised predominantly of patients with primary refractory large B-cell lymphoma in the 2L setting Manageable safety profile appropriate for outpatient administration; no high-grade CRS and ≤ 5% of patients with...Read more
SLS009 in combination with AZA/VEN achieved a 46% overall response rate across all cohorts, a 58% overall response rate in patients with one prior line of therapy, and encouraging survival outcomes in heavily-pretreated AML-MR following prior VEN-based treatment Median overall survival (mOS) of 8.9 months in the least pretreated patient cohort; across all cohorts, mOS was not yet reached in patients with one prior line of therapy vs...Read more
NXC-201 demonstrated a complete response (CR) rate of 75% (15/20) (at s/u IFE(-) level) by independent review committee In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95% NEXICART-2 final readout and BLA submission planned in 2026 LOS ANGELES, CA, Dec. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”,...Read more
Poster outlines clinical benefit with acceptable safety profile across 9 tested dosing regimens Accelerated step-up dosing and higher dosing frequency is feasible and results in increased exposure Six of eight responders presented with low bone marrow blast counts at baseline, supporting further investigation in this patient population most likely to benefit from MP0533 ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Dec. 07,...Read more
Combination of evorpacept plus rituximab and lenalidomide (R2) generated complete responses (CR) in 92% of patients with untreated indolent non-Hodgkin lymphoma (iNHL) comparing favorably to an approximate 50% historical CR rate for R2 alone Data indicates combination of evorpacept plus R2 was well-tolerated and provides impressive anti-tumor activity in frontline treatment setting While longer follow up matures, minimal residual...Read more
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 global...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 chemotherapy Median OS with gotistobart has not been reached at almost...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 karyotype Lisaftoclax monotherapy demonstrated a median...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...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 neurotoxicities,...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...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...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...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....Read more
| Company | Change | Last Trade |
|---|---|---|
| Structure Therapeutics | 35.24 101.97 | $69.80 |
| Kymera Therapeutics | 27.68 41.55 | $94.30 |
| Praxis Precision Medicines | 22.99 9.27 | $270.98 |
| Wave Life Sciences | 11.05 147.53 | $18.54 |
| Terns Pharmaceuticals | 10.40 35.42 | $39.76 |
| Arrowhead Pharmaceuticals | 7.16 11.65 | $68.60 |
| Bolt Biotherapeutics | 4.81 860.64 | $5.37 |
| Arcellx | 4.52 6.50 | $74.08 |
| Fulcrum Therapeutics | 4.10 46.07 | $13.00 |
| Inhibrx | 4.01 4.48 | $93.51 |
| Ocular Therapeutix | 3.53 28.06 | $16.11 |
| Biodexa Pharmaceuticals | 3.41 68.75 | $8.37 |
| Nurix Therapeutics | 3.38 18.68 | $21.47 |
| vTv Therapeutics | 3.16 11.55 | $30.51 |
| DBV Technologies | 3.08 22.16 | $16.98 |
Recursion 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 proprietary biological and chemical datasets...
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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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