Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression...Read more
Combines chemiluminescence detection with dual-channel fluorescence in the near-infrared and infrared (NIR and IR) ranges for expanded multiplexing Enables up to 24 targets per sample and supports complex assay configurations Strengthens Bio-Techne's leadership in proteomic analytical instruments and supports 21 CFR Part 11 compliance MINNEAPOLIS, Dec. 9, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider...Read more
Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026 Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026 BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE)...Read more
FOSTER CITY, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that it has commenced a proposed underwritten public offering of $400 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. In addition, Terns expects to grant the...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the underwriters a 30-day option to purchase up to...Read more
No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2...Read more
Royalty term on Ultomiris® sales in the United States anticipated to continue into year-end 2028, extending term by three years Additional $100 million to $120 million in potential royalty revenue estimated to be received by Xencor, based on consensus sales forecasts PASADENA, Calif. / Dec 09, 2025 / Business Wire / Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for...Read more
BOSTON, Dec. 9, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced its partnership with Deep Origin on a 4.5-year project funded by the Advanced Research Projects Agency for Health (ARPA-H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. CATALYST is led by ARPA-H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D. The collaboration,...Read more
First patient in the world treated with Alpha DaRT® in the brain According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months This pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs JERUSALEM, Dec. 09, 2025...Read more
City of Hope to Evaluate PEDMARK® for Reducing Ototoxicity in Adult Men with Stage II-III Metastatic Testicular Germ Cell Tumors Initiation of Study Reflects Growing Clinical Interest in Addressing the Burden of Hearing Loss Among Patients Receiving Cisplatin-Based Chemotherapy RESEARCH TRIANGLE PARK, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical...Read more
Financing includes leading U.S. biotechnology institutional investors and mutual funds LOS ANGELES, CA, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced the closing of its previously announced underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per...Read more
TORONTO and HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines for the treatment of cancer as well as autoimmune and inflammatory diseases is pleased to announce that it will host a live webinar on December 10, 2025 at 08:30 AM Eastern Time. As previously announced,...Read more
Placebo-controlled Phase 2 study will evaluate SAT-3247 treatment over three months among ambulatory children with Duchenne Study endpoints include safety and tolerability, effect on muscle force and function, and impact on muscle quality and regeneration Enrollment of first study participant anticipated by end of 2025 TORONTO / Dec 09, 2025 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the...Read more
The ALSTARS Trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of COYA 302 in patients with amyotrophic lateral sclerosis (ALS) being conducted at clinical sites in the United States and Canada Dosing of ALS patients has commenced in the ALSTARS Trial and signifies a key milestone for the Company. COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, is...Read more
New patent further strengthens global intellectual property estate supporting Atossa's lead program across the breast cancer spectrum and other hormone-driven conditions SEATTLE, Dec. 9, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer, today announced that the United...Read more
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission New...Read more
New Patent Grants Broad Composition Claims for PDS0101 Previously Granted Patent Protections and Anticipated Market Exclusivity Provide Protection for PDS0101 in the United States into the 2040s PRINCETON, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers,...Read more
PHILADELPHIA, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced the appointments of Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., to its Board of Directors. As part of their appointments, Dr. Lee will serve as a member of the Audit and the Compensation...Read more
RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after...Read more
ASH 2025 oral presentation on SENTI-202 in 20 Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients (18 response evaluable) shows high efficacy: 50% ORR and 42% CR/CRh (100% of CRs and 83% of all responses were MRD negative) at RP2D, 7.6 months median duration of composite Complete Remission across all patients, and a favorable safety profile Pharmacodynamic data from these patients validate SENTI-202’s novel OR/NOT Logic Gate...Read more
Weinstein brings a global track record of transforming companies through value unlocking, and participation in over 20 M&A transactions and more than $5 billion in exits across healthcare, biotechnology, and nutrition. Weinstein’s ownership is expected to increase to approximately 30% on an issued and outstanding basis, reflecting his conviction in Pluri’s asset base, its valuation potential, and its long term strategy. HAIFA,...Read more
POTOMAC, MARYLAND / ACCESS Newswire / December 9, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's...Read more
Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC) Enrollment exceeding expectations with strong clinical site and patient interest Topline interim data readout expected in 1H2026 Phase 3 combination regimen continues under FDA Fast Track designation PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell...Read more
100% of patients in Cohorts 1-3 remain free of cytokine release syndrome CRIS-7-derived CD3 design underpins a controlled T-cell response, supporting the differentiated safety profile, combinability with standard of care SEATTLE, WA / ACCESS Newswire / December 9, 2025 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary...Read more
5 of 8 patients (62.5%) achieved Undetectable MRD (uMRD) LEXINGTON, Mass., Dec. 9, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, yesterday provided updated clinical data from the ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104) in a poster presentation at the 67th ASH...Read more
Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number...Read more
Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer Significant unmet need in pancreatic cancer where median overall survival...Read more
Financing from new and existing healthcare focused investors The proceeds are expected to extend the Company’s cash runway into Q1 2027, with potential inflection points anticipated in its clinical programs during that period DOYLESTOWN, Pa., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit...Read more
Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical...Read more
Once issued, this new U.S. Patent will expand the scope of Enveric’s EVM301 patent portfolio of potential neuroplastogenic molecules for treatment of neuropsychiatric conditions. CAMBRIDGE, Mass. / Dec 09, 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...Read more
Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its...Read more
Proceeds strengthen cash position and support commercial launch of LYMPHIR™, a novel cancer immunotherapy for cutaneous T-cell lymphoma (CTCL) CRANFORD, N.J., Dec. 9, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has entered into a definitive agreement with a...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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Company | Change | Last Trade |
|---|---|---|
| Spruce Biosciences | 10.92 13.37 | $92.60 |
| Abivax | 8.11 7.05 | $123.16 |
| Bolt Biotherapeutics | 5.31 948.21 | $5.87 |
| Wave Life Sciences | 2.78 15.00 | $21.31 |
| Terns Pharmaceuticals | 2.34 5.82 | $42.57 |
| Vor Bio | 2.32 27.75 | $10.68 |
| Galecto | 2.06 8.01 | $27.79 |
| Exicure | 1.83 34.33 | $7.16 |
| vTv Therapeutics | 1.75 5.74 | $32.26 |
| Fulcrum Therapeutics | 1.61 12.39 | $14.60 |
| XOMA | 1.59 5.21 | $32.08 |
| Surrozen | 1.51 7.33 | $22.10 |
| Nektar Therapeutics | 1.50 2.62 | $58.78 |
| Apollomics | 1.29 7.72 | $18.00 |
| Cartesian Therapeutics | 1.18 17.56 | $7.90 |
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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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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