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
Dramatic 95% Reduction of Cognitive Decline in CT1812-treated Patients with Lower Plasma p-tau217 Correlated with Improvements in Key Indicators of Alzheimer’s Disease Biology Findings Support Disease-modifying Potential of CT1812 PURCHASE, N.Y., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (NASDAQ: CGTX), a clinical-stage company developing drugs to treat neurodegenerative disorders, provided an...Read more
AUSTIN, Texas, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that new analyses of data from its Phase 2 OraGrowtH210 and OraGrowtH212 clinical trials were presented orally at the 62nd Annual European Society for Paediatric Endocrinology Meeting, or ESPE 2024, held November 16-18, 2024 in Liverpool, UK. “The new analyses...Read more
Screening is Now Underway to Identify Pregnant Women at Higher Risk for HPA-1a Alloimmunization and FNAIT NEW HAVEN, Conn. / Nov 21, 2024 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced the initiation of its Phase 2 clinical trial investigating RLYB212 in pregnant...Read more
PITTSBURGH, Nov. 21, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on innovative therapies for serious diseases with significant unmet needs, today announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral rinse being developed for the treatment of Oral Lichen...Read more
LOS ANGELES / Nov 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast...Read more
SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver...Read more
DiffuSphere™ is designed to enable precise drug delivery at therapeutic dose levels directly into target tissues, enhancing efficacy while minimizing systemic drug levels to optimize safety In clinical trials, a single administration of DiffuSphere™ successfully delivered fluticasone propionate for at least six months in patients with eosinophilic esophagitis or osteoarthritis DiffuSphere™ has shown its versatility with various...Read more
The Phase 2 DIMENSION Study did not meet its primary endpoint Dalzanemdor was generally well-tolerated; no new safety signals were observed Based on these data, the Company does not plan further development of dalzanemdor CAMBRIDGE, Mass. / Nov 20, 2024 / Business Wire / Sage Therapeutics, Inc. (Nasdaq: SAGE) today announced topline results from the Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) in participants with cognitive...Read more
Oral Late Breaker Presentation Summarizes Positive Results Including Successful Achievement of Study's Primary and Secondary Endpoints Data Support VK2809's Best-in-Class Profile Highlighted by Robust Liver Fat Reductions, Histologic Results Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and Promising Tolerability and Safety SAN DIEGO, Nov. 19, 2024 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a...Read more
GEO-CM04S1 Improved Immune Response vs mRNA Vaccine ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the completion of an interim data review by the Data Safety Monitoring Board (DSMB) for the ongoing Phase 2 clinical trial of GEO-CM04S1, GeoVax’s dual-antigen next-generation COVID-19...Read more
Ten clinical trial sites across Japan and Taiwan are actively screening patients, with additional sites expected to also begin patient enrollment in the coming months U.S. clinical sites continue to actively screen and dose patients in both the LP-300 combination arm and the standard-of-care control arm of the Harmonic trial Non-small cell lung cancer (NSCLC) in never smokers occurs at rates 2 to 3 times higher in East Asian countries...Read more
Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin...Read more
Muvalaplin, an oral, once-daily treatment that inhibits lipoprotein(a) formation via a novel mechanism, achieved positive results in a 12-week Phase 2 study These data were published in the Journal of the American Medical Association (JAMA) and simultaneously presented today at the American Heart Association (AHA) Scientific Sessions 2024 INDIANAPOLIS, Nov. 18, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Marked and rapid reductions in both pericarditis pain and inflammation maintained throughout the 26-week study Episodes of pericarditis per year substantially reduced MAvERIC-Pilot results support advancing CardiolRx™ into the Phase II/III MAVERIC-2 and the Phase III MAVERIC-3 clinical trials Toronto, Ontario--(Newsfile Corp. - November 18, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol"...Read more
Two patients exceed 14 months on treatment in Phase 2 trial of advanced ovarian cancer Allarity maintains a cash balance of $18.5 million, sufficient to advance and accelerate stenoparib’s clinical development toward FDA approval Expansion of Allarity Medical Laboratory into revenue-generating services for external biotech clients Continued focus on advancing stenoparib to address critical unmet needs in ovarian...Read more
100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003 Robust, long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score compared to baseline at 12 months after two 16 mg doses of CYB003 Findings validate dosing regimen and confirm that CYB003’s effects are highly durable and offer sustained...Read more
52-week LUNA data combined with follow-up from OPTIC at 4 years continue to support long-term potential best-in-class product profile of Ixo-vec 6E10 dose in LUNA maintains visual and anatomic endpoints and demonstrates potential best-in-class injection-free rates and reduction in injection burden No LUNA patients who received local steroid prophylaxis had inflammation at week 52 or at any subsequent visit, and 100% of OPTIC 2E11...Read more
WILMINGTON, Del. / Nov 18, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine...Read more
Eight participants achieved HBsAg loss at any time. Two participants met criteria for functional cure. Two participants who discontinued NUC therapy seroconverted to HBsAb positivity. OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), today announced the most significant data so far from the ongoing Phase 2b HBV003 clinical trial. The data will be presented by Dr. Chun-Jen Liu...Read more
Significantly greater mean declines in HBsAg levels (p <0.017) were seen in those receiving imdusiran, VTP-300 and low-dose nivolumab compared to other cohorts assessed previously 23% of participants receiving imdusiran, VTP-300 and low-dose nivolumab reached HBsAg loss by Week 48 WARMINSTER, Pa. and OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the...Read more
Adults with moderately-to-severely active Sjögren's disease who received investigational FcRn blocker nipocalimab had improvements in disease activity scores at 24 weeks with accompanying significant reductions in IgG and autoantibody levels Nipocalimab was granted U.S. FDA Breakthrough Therapy Designation for the treatment of adults living with moderate-to-severe Sjögren's disease based on results from the Phase 2 DAHLIAS...Read more
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...
CLICK TO LEARN MORE