Trial remains on track for completion and data readout in the second half of 2025 COPENHAGEN, Denmark, January 15, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a...Read more
The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (33.3%) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20%) Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical control 100% of...Read more
LEXINGTON, Mass., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has voluntarily halted all dosing...Read more
Vancouver, British Columbia – TheNewswire - 15 January, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a clinical stage biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines to treat depressive disorders. The Company is delighted to provide an update on clinical trial progress and technology developments. MindBio is currently...Read more
PH284 nasal spray demonstrated improvements to subjective feelings of hunger in cancer patients PH284 is the fifth pherine product candidate in Vistagen’s neuroscience pipeline with a positive efficacy signal SOUTH SAN FRANCISCO, Calif. / Jan 14, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from...Read more
Study Supported by $2.6 Million FDA Orphan Products Development Grant PRINCETON, N.J., Jan. 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™...Read more
Highlights: Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Immunology Results Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Microbiome Responses Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects MELBOURNE, Australia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX:...Read more
Two new partial responses (PRs) reported in Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer Overall Response Rate (ORR) of 50%; historic benchmark of 32% for FOLFIRINOX alone Nearly $14M in net proceeds raised in January 2025 through utilization of Company’s ATM CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX),...Read more
Substantial, Rapid and Sustained Statistically Significant Reductions of Key Biomarkers Achieved Across Doses, Including up to 80% Mean Reduction of Androstenedione Meaningful Improvements Demonstrated in Multiple Clinical Signs and Symptoms of CAH Affecting Patient Health Safety and Efficacy Data Support Initiation of Phase 3 Clinical Trial Management to Host Investor Conference Call Today at 8:30 AM ET SAN DIEGO, Jan. 10, 2025...Read more
Primary endpoint met in phase 2a POC trial in postpartum depression with a MADRS reduction from baseline of –35.4 points (p<0.0001, n=10) and 100% of patients in remission at Day 8 Primary endpoint met in phase 2a POC trial in bipolar II disorder with a current major depressive episode with a MADRS reduction from baseline of –16.8 points (p=0.0099, n=6) and 33% of patients in remission at Day 8 In both trials, GH001 was...Read more
SAN FRANCISCO, Jan. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the company has completed target enrollment in its REZOLVE-AD Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. Rezpegaldesleukin is a first-in-class interleukin-2 receptor (IL-2R) agonist that proliferates and activates regulatory T cells (Tregs) with promising dose-dependent clinical activity in...Read more
Enrollment Completed Ahead of Schedule Initial Data Expected in 2025 NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, completed enrollment in its neoadjuvant/adjuvant Phase 2 basket trial (IOB-032/PN-E40). The trial is studying IO102-IO103, the company’s lead investigational...Read more
13-Week Study to Evaluate the Safety and Efficacy of Oral VK2735 Dosed Once Daily SAN DIEGO, Jan. 8, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of a Phase 2 clinical trial of the oral tablet formulation of VK2735, the company's dual agonist of the...Read more
Targeted enrollment of 168 RRMS patients achieved in December 2024 The last patient is expected to complete the trial in the third quarter of 2025 SAN DIEGO--(BUSINESS WIRE)-- Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that it...Read more
Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30-50% of adults with hypertension, both conditions associated with excess morbidity and mortality Obstructive sleep apnea represents Mineralys’ third precision, targeted indication for lorundrostat, further expanding its market potential in aldosterone-driven diseases Initiation of the trial anticipated in the first quarter of...Read more
Highlights: 100% of Patients in Cohort 1 Achieve Primary Efficacy Endpoint No Treatment-Related Adverse Effects Observed Preserves Cancer Treatment Efficacy with Zero Dose Reductions NEW YORK, Jan. 7, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a leading biopharmaceutical company focused on patient-centric solutions, today shared encouraging interim safety and efficacy results from its Phase 2a clinical trial...Read more
Updated data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients show favorable overall response rate (ORR = 43%) and disease control rate (DCR = 86%); planning for pivotal trial underway Favorable initial data for IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer patients show target lesion shrinkage in all evaluable...Read more
First participants initiated Phase 2 dosing for both CF and OTC deficiency in December 2024 Phase 2 interim data for both mRNA therapeutic programs on track for first half of 2025 SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory...Read more
Totality of data observed with subcutaneous lonigutamab in Thyroid Eye Disease (TED) patients demonstrate potential for efficacy in line with standard of care and a more favorable safety profile Conducted positive end of Phase 2 FDA meeting; Phase 3 program expected to be initiated in Q1 2025 Topline Phase 3 data expected in second half of 2026; cash runway expected through mid-2027 Conference call to review unmet need in TED, new...Read more
Data support favorable safety and tolerability profile with no serious adverse events (SAEs) or study-related drug discontinuations Enrollment to be extended due to low influenza infection among challenged participants; virology results are uninterpretable BOTHELL, Wash., Dec. 31, 2024 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces plans to extend enrollment in the Phase 2a human...Read more
TibuSURE is the first clinical trial designed to investigate anti-BAFF and IL-17 pathways in systemic sclerosis. TibuSURE launches with the initiation of its first clinical site. HENDERSON, Nev. / Dec 23, 2024 / Business Wire / Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced the launch of...Read more
EDINBURGH, Scotland, Dec. 20, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced 3 patients have now completed the full-dose regimen in the ACHIEVE Phase 2b trial in the UK with no drug-related Adverse Events seen in any of the...Read more
JENA, Germany, Dec. 20, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the first patient has been dosed in its Phase 2a basket study in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), investigating the Company’s oral C5aR inhibitor, INF904. Camilla Chong, MD, Chief...Read more
HAMPTON, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the Company has initiated a Phase 2 study of barzolvolimab in atopic dermatitis (AD) and that the study is actively enrolling patients. AD is one of the most common chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of life1. Mast cells are strongly...Read more
Open label study designed to evaluate the safety, tolerability, and efficacy of bremelanotide in patients with Type 2 diabetic nephropathy Demonstrated efficacy at 6 months 71% percent of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr) 71% of patients achieved improved or stabilized estimated glomerular filtration rate (eGFR) Bremelanotide therapy increased urinary VEGF levels...Read more
Results demonstrate that inhaled AP-PA02 provides a durable reduction of Pseudomonas aeruginosa in the lung, with a favorable safety and tolerability profile LOS ANGELES, Dec. 19, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for chronic pulmonary diseases and...Read more
Investigational REGN7508 (catalytic domain) and REGN9933 (A2 domain) are being evaluated for their potential to control thrombosis while minimizing bleeding risk in a variety of patient populations and clinical settings Evaluated against current standards of care, single doses of REGN7508 and REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects Phase 3 program to be initiated in...Read more
Treatment with the highly selective NaV1.8 pain signal inhibitor suzetrigine met the primary endpoint with a statistically significant and clinically meaningful 2.02 point within-group reduction from baseline in the Numeric Pain Rating Scale (NPRS) Placebo arm showed similar within-group reduction in NPRS Suzetrigine was generally well tolerated Advancement to Phase 3 in painful lumbosacral radiculopathy planned,...Read more
PADOVA study showed numerical delay in motor progression and positive trends on multiple secondary and exploratory endpoints Prasinezumab continues to be well tolerated and no new safety signals were observed Genentech is further evaluating the data and will work together with health authorities to determine next steps SOUTH SAN FRANCISCO, Calif. / Dec 19, 2024 / Business Wire / Genentech, a member of the Roche...Read more
The study is one of five clinical efforts - three proof-of-concept investigator-initiated trials (IIT) and two Phase 2 studies - of crofelemer for the rare disease indications of MVID and/or short bowel syndrome with intestinal failure (SBS-IF) in the US, EU, and/or Middle East/North Africa regions; availability of first IIT proof-of-concept results potentially in Q1 2025 Crofelemer, Jaguar's novel plant-based prescription drug, has...Read more
Improvements Across Measures of Behavior, Function, Cognition and Movement Expediting Plans to Advance CT1812 into Late-Stage Trials Full Results to be Presented at International Lewy Body Dementia Conference (ILBDC) Cognition Therapeutics and Dr. Galvin, a Principal Investigator, Will Host a Conference Call at 8am ET on December 18 to Review the Topline Data PURCHASE, N.Y., Dec. 18, 2024 (GLOBE NEWSWIRE)...Read more
Icovamenib met the primary endpoint, displaying a meaningful statistically significant placebo-corrected mean reduction in HbA1c in the prespecified per protocol patient population Best response achieved in target, beta-cell deficient patients on one or more antidiabetic agents at baseline, showing a placebo-adjusted mean reduction of 1.47% in HbA1c at Week 26 with statistical significance, after only 12 weeks of dosing icovamenib with...Read more
Statistical Significance Met on Primary Endpoints of 1 Year Survival Rate and Median Overall Survival Doubling of 1 Year Survival Rate and 37% Reduction in Risk of Death Two Month (29%) Increase in Median Overall Survival Multiple Patients with Complete Responses (CRs) and/or Partial Response (PR) with 100% Reduction in Target Lesions Elraglusib in Combination with GnP Demonstrated a Favorable Risk-Benefit Profile Trial Continues...Read more
Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibody Sanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions PARSIPPANY, N.J. and PARIS, Dec. 17, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S....Read more
Independent Data Monitoring Committee (IDMC) recommends move-forward dose in Part 2a of potential registration-enabling trial in 1L HLA-A2-Negative MUM, based on clinical efficacy and safety observed Over 185 patients enrolled in potential registration-enabling trial in 1L HLA-A2-Negative MUM, and the darovasertib and crizotinib combination has received U.S. Food and Drug Administration (FDA) Fast Track designation in MUM SAN...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) metastatic colorectal cancer (mCRC). Petosemtamab...Read more
Results for all three TransCon hGH starting dose cohorts, in first clinical trial of an indication outside of growth hormone deficiency, showed a safety and tolerability profile comparable to daily somatropin Annualized height velocity was similar at Week 26 in once-weekly TransCon hGH-treated and daily somatropin-treated children COPENHAGEN, Denmark, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today...Read more
Company continues to advance PGN-EDO51 in CONNECT1-EDO51, with the 10 mg/kg cohort now fully enrolled BOSTON / Dec 16, 2024 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the...Read more
Trial met primary endpoint of reduction in circulating levels of creatine kinase (CK), a biomarker associated with skeletal muscle damage, in the largest Becker interventional trial to date On the key secondary endpoint, sevasemten-treated patients showed stabilization of North Star Ambulatory Assessment (NSAA) with a trend towards improvement at 12 months compared to placebo Sevasemten was well-tolerated and no new safety...Read more
Dose-ranging trial evaluated deupirfenidone 550 mg three times a day (TID) (approximately equivalent exposure to pirfenidone 801 mg TID1) and deupirfenidone 825 mg TID and successfully demonstrated dose-dependent response Decline in lung function seen with deupirfenidone 825 mg TID as a monotherapy was -21.5 mL; natural lung function decline expected in healthy adults >60 years is ~-15 to ~-25 mL2; decline in lung function with...Read more
Enrollment is ongoing and seven sites in Switzerland have been activated SHELTON, Conn. and BERN, Switzerland, Dec. 12, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune...Read more
Independent Data Monitoring Statistician reaffirmed current sample size to remain at N=160 The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the...Read more
Keros will host an update call and webcast today, December 12, 2024, at 8:00 a.m. ET LEXINGTON, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth...Read more
REDWOOD CITY, Calif. / Dec 11, 2024 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced results from the DAZALS study, a randomized, double-blind, placebo-controlled, Phase 2 trial evaluating two...Read more
The trial (NCT06207370) evaluates tafenoquine combined with standard treatment for babesiosis, addressing a critical unmet medical need. The clinical site is led by Brigham and Women’s Hospital researchers Ann Woolley, M.D., and David Leaf, M.D. The double-blind, placebo-controlled trial will examine outcomes for hospitalized patients with severe babesiosis, a tick-borne illness often found as a co-infection of Lyme...Read more
1 MG Dose (Z)-Endoxifen Shows Potential as a Well-Tolerated, Preventative Therapy for Premenopausal Women at Risk of Developing Breast Cancer Data to be Presented in a Poster Spotlight Session During the 2024 San Antonio Breast Cancer Symposium SEATTLE, Dec. 11, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”), today announced full results from its Phase 2 KARISMA-Endoxifen trial...Read more
The ongoing obesity Phase 2 trial is a randomized, double-blind, placebo-controlled, dose finding, clinical trial to evaluate the safety and efficacy of KDS2010 in approximately 75 overweight or obese patients currently enrolling in South Korea with a cohort in U.S. to be added in 2025. KDS2010 has shown promising preclinical results with a novel mechanism of blocking MAO-B-dependent aberrant GABA (gamma-aminobutyric acid) production...Read more
New interim data show 11.4-month median PFS in 2L patients with PI3Kα-mutated, HR+/HER2- metastatic breast cancer at RP2D 39% confirmed ORR across all patients & 67% in patients with kinase mutations at RP2D Data support planned initiation of 2L pivotal study in 2025 Next-generation triplet combination with atirmociclib (CDK4-selective) initiated & ribociclib triplet combination ongoing Relay Therapeutics to host a...Read more
SIGNAL-AA demonstrated encouraging clinical activity of bempikibart in patients with alopecia areata (AA), including improvement from baseline on SALT score and meaningful achievement of SALT-20 response SIGNAL-AD Phase 2a clinical trial in atopic dermatitis demonstrated promising findings in Part A but did not meet primary endpoint in Part B Across both trials, bempikibart was observed to be safe and well...Read more
CAHmelia-204 Study of 200mg Once-Daily (QD) Tildacerfont in Adult Congenital Adrenal Hyperplasia (CAH) Did Not Achieve Primary Endpoint of Glucocorticoid (GC) Reduction Dose-Ranging Data from CAHptain-205 Study of Tildacerfont in Adult and Pediatric CAH Suggests Higher Doses and Twice-Daily (BID) Dosing May Be Necessary for Efficacy in CAH Evaluation of Strategic Opportunities and Cost-Reduction Activities Underway SOUTH SAN...Read more
Analyses pooling data from IMerge Phase 2, Phase 3 and the QTc substudy suggest patients who were ESA ineligible or who had prior treatment with luspatercept or lenalidomide experienced clinical benefit from imetelstat similar to prior results from the IMerge pivotal trial Data from the QTc substudy reinforce imetelstat as a second-line treatment option for LR-MDS patients with transfusion-dependent anemia regardless of prior therapies,...Read more
Based on more than six months of additional monitoring, data show continued improvement in overall survival (OS) in intent-to-treat (ITT) population of women newly diagnosed with advanced ovarian cancer Median OS increased from 11 to 13 months in IMNN-001 treatment group based on latest data analysis No change in IMNN-001 favorable safety profile including no reports of serious immune-related adverse events IMUNON remains on track to...Read more
Neflamapimod did not demonstrate statistically significant effects versus placebo on primary and secondary endpoints at 16 weeks Favorable safety and tolerability results with no new safety signal identified Target plasma drug concentrations not achieved during 16-week double-blind phase of the trial Trial participants continue to receive neflamapimod during open-label extension BOSTON, Dec. 10, 2024 (GLOBE NEWSWIRE) -- CervoMed...Read more
Initial results from randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care in RAS-mut mCRC demonstrated 64% ORR in the 30mg onvansertib dose arm versus 33% ORR in the control arm In the experimental arms, 30mg dose of onvansertib demonstrated a higher ORR compared to 20mg dose of onvansertib (64% vs. 50%) with deeper tumor regression in the 30mg arm Onvansertib was well tolerated at both...Read more
Long-term data confirm fixed-duration Columvi and Lunsumio achieve durable remissions beyond the end of treatment, with real-world data suggesting reduced treatment-related travel burden due to less frequent dosing First presentation of Lunsumio given subcutaneously showed non-inferiority to intravenous treatment with a consistent safety profile, potentially providing an additional outpatient option with a shorter administration...Read more
Elritercept demonstrated a durable transfusion independence in lower-risk myelodysplastic syndromes, including in patients with high transfusion burden, with a median duration of response of 134.1 weeks Durable clinical responses were associated with improvements in patient-reported measures of fatigue in MDS patients early, and with continued improvement over time Data from ongoing Phase 2 clinical trial in myelofibrosis continue to...Read more
ZUMA-5 Analysis Shows Median Progression-Free Survival of 62.2 Months and Median Duration of Response of 60.4 Months After Median Follow-Up of More Than Five Years Over Half of Patients Alive at Time of Analysis, with No Need for Subsequent Therapy and Rare Instances of Late Disease Progression, Indicating Curative Potential SANTA MONICA, Calif. / Dec 09, 2024 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced...Read more
54% of patients experience more than 2.5 years of durable hematocrit (Hct) control (<45%), decreased phlebotomy use, long-term tolerability, and improvements in patient-reported outcomes in patients with polycythemia vera NEWARK, CA / ACCESSWIRE / December 9, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced details from a poster presentation with final data from the rusfertide Phase 2 REVIVE study....Read more
Based on successful Phase 2a data, Company set to initiate Phase 2b sarcopenia study in early 2025; currently securing centers of excellence to begin enrollment First oral TNF-α inhibitor, if approved, would offer potential patient benefit in an approximate $40 billion TNF inhibitor market BALTIMORE / Dec 09, 2024 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical...Read more
- Median Overall Survival (mOS) Not Yet Reached, Now Exceeds 7.7. Months at Latest Follow-Up in the 30 mg BIW Cohort in Patients Relapsed or Refractory to Venetoclax-Based Regimens - - Overall Response Rate (ORR) of 56% Achieved to Date in Patient with Acute Myeloid Leukemia with Myelodysplasia Related Changes (AML MRC) Prospectively Enrolled in Two Expansion Cohorts; Exceeding Prespecified Target Response Rate of 33% - NEW YORK,...Read more
Multiple clinical trial sites across Taiwan are actively screening patients, following successful site initiation visits. Expansion into Taiwan is particularly significant as over 50% of lung cancer cases in Taiwan occur in never-smokers. DALLAS / Dec 09, 2024 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today...Read more
Subgroup analyses from Ph 2 protocol-defined R/R mNPM1 AML efficacy population (N=64) show responses across all major subgroups, including heavily pretreated patients 26% CR+CRh (20/77) and 48% ORR (37/77) in all enrolled patients who met the efficacy evaluable criteria in Ph 2 R/R mNPM1 AML cohort 100% ORR (37/37) and 95% CRc (35/37) in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in...Read more
Observed an antiviral effect for the primary and secondary virology endpoints in the overall population, with a viral load decline of 1.4 log at the end of treatment in Part 2 Demonstrated a viral load decline of 1.2 log compared to placebo at the end of treatment in prespecified analysis of patients randomized within 3 days of symptom onset Zelicapavir was well-tolerated with a favorable safety profile Conference call and webcast to...Read more
Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) at the 66th Annual Meeting and Exposition of...Read more
Preliminary results from 86 patients enrolled in the Phase 2 pivotal iMMagine-1 study of anito-cel demonstrated 97% ORR and 62% CR/sCR at a median follow-up of 9.5 months No delayed neurotoxicities have been observed to date with anito-cel, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome in more than 150 patients dosed across the Phase 1 and iMMagine-1 studies 30.2-month median...Read more
Based on data, 1.75 mg/kg dose established as recommended dose for Phase 3 trial of this investigational antibody-drug conjugate RAHWAY, N.J. / Dec 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate (ADC) that targets receptor...Read more
52% ORR per mIWG criteria, including 83% ORR for patients receiving 100 mg BID 88% ORR per PPR criteria, including 100% ORR for patients receiving 100 mg BID Median time to response 2.2 months with median duration of response and median PFS not yet reached Top-line data from APEX Part 2 on-track for mid-2025 Cogent to host investor webcast on Monday, December 9 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., Dec. 08, 2024...Read more
73% of the NKTR-255 treatment group compared to 50% of the placebo group achieved a complete response at 6 months NKTR-255 enhanced CAR T-cell kinetics with improved CD8+ CAR-T area under the curve (AUC) 0-15 days post-administration being 5.8-fold greater than placebo-controls SAN FRANCISCO, Dec. 7, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced results of its Phase 2 proof-of-concept study evaluating...Read more
Decision follows observations of liver transaminitis without clinically significant symptoms in some subjects on azelaprag Company will evaluate data from patients enrolled to date and share updated plans for azelaprag in Q1 2025 In parallel to evaluating azelaprag, Company will continue to advance earlier platform-derived programs, including IND submission for CNS penetrant NLRP3 inhibitor anticipated in the second half of...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson’s...Read more
St. Joseph's Healthcare Hamilton is the latest Canadian clinical study site for clinical investigation of Theralase®'s Anti-Cancer Therapy for the treatment of bladder cancer TORONTO, ON / ACCESSWIRE / December 5, 2024 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or...Read more
TARA-002 demonstrates 72% six-month landmark complete response rate and 70% complete response rate at any time across BCG exposures 100% six-month landmark complete response rate and 80% complete response rate at any time observed in BCG-Unresponsive patients 64% six-month landmark complete response rate and 67% complete response rate at any time observed in BCG-Naïve patients 80% reinduction salvage rate and compelling durability...Read more
SAN DIEGO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US...Read more
ATH434 is a Disease Modifying Drug Candidate Targeting Alpha-Synuclein and Iron in Parkinsonian Disorders Topline Data Expected in Early 2025 MELBOURNE, Australia and SAN FRANCISCO, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today...Read more
Primary Endpoint Achieved with 98% Sustained Virologic Response at 12 Weeks Post-Treatment (SVR12) after Short Eight Week Treatment Duration Regimen Was Generally Safe and Well-Tolerated Global Phase 3 Program Initiation Expected Early in 2025 BOSTON, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea” or “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and...Read more
NEW YORK, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the expansion of its Phase 2 clinical trial evaluating intranasal foralumab for non-active secondary progressive multiple...Read more
Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93% of Acute Otitis Media in U.S. Children Under Five VAX-31 Offers Potential to Protect Vulnerable...Read more
BOSTON, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced the completion of enrollment in the Phase 2 AMPLIFY-7P study (NCT05726864). The randomized Phase 2 study is evaluating a 7-peptide formulation of ELI-002 (ELI-002 7P) in patients with...Read more
Namilumab failed to show treatment benefit in patients with pulmonary sarcoidosis Further development of namilumab for the treatment of sarcoidosis will be discontinued BASEL, Switzerland and LONDON and NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show...Read more
Phase 3 AURORA trial on track to commence in 1H2025; Primary endpoint to assess proportion of Descartes-08-treated participants with myasthenia gravis demonstrating an MG-ADL improvement of ≥3 points at Month 4 relative to placebo Deepening responses observed over time in Phase 2b trial, with Descartes-08-treated participants observed to have a 5.5-point reduction in MG-ADL at Month 4 Durable responses observed through Month 12 in...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine...Read more
Final data demonstrate CM24 in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy clear and consistent improvement across all efficacy endpoints A biomarker enriched patient population analysis based on pretreatment ranges of serum CEACAM1 demonstrated significant improvement in the treatment arm over the control of 79% reduction in risk of death (HR 0.21, P = 0.04) with median OS improvement of 5.1 months and over 90%...Read more
Study failed to meet primary and secondary efficacy endpoints WARREN, N.J., Nov. 26, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the global Phase 2 placebo-controlled CardinALS study did not meet its primary endpoint of slowing disease progression on the composite ALSFRS-R and mortality analysis. While there was modest numerical benefit recorded on the primary endpoint and correlation of favorable...Read more
MariTide Demonstrated up to ~20% Average Weight Loss at 52 Weeks Without a Weight Loss Plateau in People Living With Obesity or Overweight MariTide is the First Obesity Treatment With Monthly or Less Frequent Dosing to Demonstrate Safe and Effective Weight Loss in a Phase 2 Study In People With Type 2 Diabetes Living With Obesity or Overweight MariTide Demonstrated up to ~17% Average Weight Loss Without a Weight Loss Plateau and...Read more
GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with...Read more
Strong Interest in Trial Participation Resulted in Enrollment Exceeding Target by 20 Percent and Completion Ahead of Schedule Top-line Data Expected in Q1 2025 THE WOODLANDS, Texas, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup,...Read more
Topline results in second dementia indication expected to be reported in December 2024 PURCHASE, N.Y., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering novel, genetically validated therapies for the treatment of neurodegenerative diseases, today announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Treatment with...Read more
Interim results indicate cognitive improvement in the active treatment group compared to placebo No serious adverse events or deaths reported in the trial POTOMAC, Md. / Nov 25, 2024 / Business Wire / IGC Pharma, Inc. (NYSE American: IGC) ("IGC Pharma" or the "Company") today announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1. The trial focuses on agitation in Alzheimer's as its primary...Read more
Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation Data expected 1Q calendar year 2025 CRANBURY, N.J., Nov. 25, 2024...Read more
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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