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 disease.
This milestone marks a significant... 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 (GLOBE NEWSWIRE) -- Alpha Tau Medical... 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 Phase 1 Multiple Dose (MD) study... 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 (OS) is 1.4 years1 TAMPA,... 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 of subjects for the first... 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 trial of PF614, its lead product... 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 ADAPTIR™ and ADAPTIR-FLEX™ platform... 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 Annual Meeting (ASH).
The AML triplet... 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, Pharmacological Research and Evaluation through... 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 States Patent and Trademark Office... 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 designed to enhance the number and... 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 study
Initiation of EMBARQ-ColdU... 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 announced that it has received... 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, today announced that the Japan... 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 York, New York--(Newsfile Corp. -... 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 Therapeutics Corp. (Nasdaq: BCTX, BCTXW)... 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 company, today announced the planned... 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 mechanism of action for selectively... 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 the treatment of cancer and autoimmune... 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 “Company”), a clinical-stage... Read more
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 levels
Data highlight the potential... 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 Orphan Drug Designation, is supported... 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 of life science tools, reagents,... 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 underwriters a 30-day option to... 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 single healthcare-focused investor... 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 specific cancer cell v... 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, Israel, Dec. 09, 2025 (GLOBE... 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 Committees and Dr. Murphy will... 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 Pharma Group International (NASDAQ:... 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 International (NASDAQ: AAPG; HKEX: 6855), a... 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, commercial stage, integrated bi... 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 malignancies COPENHAGEN, Denmark... 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 clinical studies show potential direct... 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 myeloma undergoing autologous h... 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 oral dose of ABI-5366
Company... 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 Biologics Inc.
AbCellera (Nasdaq: ABCL)... 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 Meeting.
In this Phase 1 dose escalation... 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 (Nasdaq: AUTL), an early commercial-stage... 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 representing three ordinary shares, or for... 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 addition, Kymera intends to grant... 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 $45,000,000 of shares of its common... 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 option to purchase up to an... 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, pre-funded warrants to purchase... 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 clinical-stage oncology company, today... 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. FDA
Company to host in-person event... 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 cell differentiation
Presented in... 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 combination was well tolerated in... 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 67th American Society of Hematology... 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 Machinery
Highlights Potential of Fusogen... 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 functionality.
During the meeting,... Read more
