630 Patients Enrolled To Date; Enrollment Completion Now Expected in Q1 2025 with Top-line Results Anticipated in Q2 2025; Upon Potential Positive Phase 3 Data the Company Expects to Submit a New Drug Application (“NDA”) for D-PLEX100 under Fast Track and Breakthrough Therapy Designations, Previously Granted to D-PLEX100 by the FDA; Proceeds from this Financing and Exercise of Data-Triggered Warrant Expected to Extend Cash...Read more
Richland, WA, Dec. 23, 2024 (GLOBE NEWSWIRE) -- – Vivos Inc. (OTCQB: RDGL) proudly announces the initiation of its first human clinical trial for RadioGel® Precision Radionuclide Therapy™ in India. This milestone trial, which has commenced with the successful treatment of five patients with cancerous lymph nodes, represents a transformative step in advancing innovative cancer therapies. This initial trial in India closely aligns...Read more
ARO-INHBE targets a known pathway that signals the body to store fat in adipose tissue In preclinical studies ARO-INHBE reduced body weight and fat mass with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies PASADENA, Calif. / Dec 23, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase...Read more
Promising results support VYN202’s potential as a novel, once-daily oral treatment for a broad range of immune-mediated disorders Consistent with Phase 1a SAD results, VYN202 demonstrated a favorable safety and tolerability profile with no drug-related adverse events historically associated with earlier generation, less selective BET inhibitors VYN202 demonstrated robust pharmacodynamic activity including evidence of target engagement...Read more
The Company has received approval to begin enrollment of the Phase 1b clinical trial in Australia Phase 1b clinical trial will assess safety and tolerability along with biomarkers during three months of dosing with GT-02287 in people diagnosed with Parkinson’s disease Phase 1b clinical trial follows successful Phase 1 study in which GT-02287 was safe and well tolerated while demonstrating GCase target engagement BETHESDA, Md.,...Read more
Investigational agent in development for treatment or prevention of H5N1 Bird Flu Phase 1 dosing completed in healthy volunteers Potent inhibition of drug-resistant and bird flu viruses in vitro In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs Phase 2 study expected to begin in H1 2025 Traws Pharma is expanding its...Read more
IMC-P115C (PRAME-HLE-A02) targets the same peptide and has the same CD3 effector and TCR specificity as brenetafusp, and is designed with extended half-life The Phase 1 trial will assess the safety and clinical activity of IMC-P115C in HLA-A*02:01-positive patients with advanced solid tumors that express PRAME (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 23 December 2024) Immunocore...Read more
POETYK PsA-1 and POETYK PsA-2 trials met primary endpoint, with significantly greater proportion of Sotyktu-treated patients achieving ACR20 response compared with placebo at Week 16 Sotyktu was well-tolerated and demonstrated safety consistent with established profile PRINCETON, N.J. / Dec 23, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055),...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
Bagsværd, Denmark, 20 December 2024 – Novo Nordisk today announced headline results from REDEFINE 1, a phase 3 trial in the global REDEFINE programme. REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg and placebo, all administered once-weekly. The...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
FOSTER CITY, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced today the results from its Phase 3 bridging trial of uproleselan in China in patients with relapsed or refractory acute myeloid leukemia. The trial did not...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
NOVATO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), today announced that the first patient has been dosed in the pivotal Phase 3 Aspire study (NCT06617429) evaluating the efficacy and safety of GTX-102, its investigational antisense oligonucleotide (ASO) for Angelman syndrome. "Initiation of patient dosing in our Phase 3 Aspire study represents an important step forward in the development of...Read more
All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024 Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as CRs in the coming weeks and...Read more
Registered Phase-1b 12-week study will investigate safety, diabetes control, and weight loss KELOWNA, BC / ACCESSWIRE / December 19, 2024 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces it has begun dosing in the Company's Phase 1b, 12-week chronic study GLP-1-H24-4, (the "Study"). The Study is designed mainly to determine whether Lexaria's...Read more
NPM-115 clinical program utilizes a miniature, GLP-1 (exenatide) implant designed to provide comparable efficacy to semaglutide, with twice-yearly administration Study represents the first clinical application of NanoPortal™, the Company’s proprietary drug implant platform technology ALAMEDA, Calif. / Dec 19, 2024 / Business Wire / Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company...Read more
APOLLO study investigating MT-601 in patients with relapsed lymphoma: 78% of patients achieved objective response rates, with 44.4% demonstrating complete response (CR) MT-601 was observed to be well tolerated in all study participants with no observation of immune-effector cell associated neurotoxicity syndrome (ICANS) HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage...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
A-005 was well tolerated and demonstrated ability to cross blood-brain barrier Maximal TYK2 inhibition achieved with favorable pharmacokinetic profile in CNS and periphery Data support advancement to Phase 2 clinical trial in multiple sclerosis, anticipated in 2H 2025 SOUTH SAN FRANCISCO, Calif., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical stage biopharmaceutical company developing...Read more
Phio's Lead Compound PH-762 demonstrates encouraging safety profile in 2nd cohort with recommendation to escalate to next dose concentration Marlborough, Massachusetts--(Newsfile Corp. - December 19, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer...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
Enrollment underway for patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) Company expects to share preliminary Phase 1 clinical data in the first half of 2025 REDWOOD CITY, Calif. & BOSTON / Dec 19, 2024 / Business Wire / Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today...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
HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today reported that results from preclinical studies of BP1001-A for obesity demonstrated enhanced insulin sensitivity, confirming BP1001-A as a potential treatment for obesity and related...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
Trials met efficacy success criteria for non-inferiority of DOR/ISL to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 Safety profiles were generally comparable between DOR/ISL and other therapies in these trials RAHWAY, N.J. / Dec 19, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced topline results from two pivotal Phase 3 trials of the...Read more
OCU410 has a very favorable safety and tolerability profile No serious adverse events related to the study drug have been reported, such as exudation, infectious endophthalmitis, intraocular Inflammation, anterior ischemic optic neuropathy, or vasculitis MALVERN, Pa., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing...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
Regulatory Approval Showcases Clinical Advancement of Linea DNA™ as a Rapid and Effective Means of Producing CAR-T cell Therapies STONY BROOK, NY / ACCESSWIRE / December 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, announced that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial...Read more
Sarepta anticipates filing for accelerated approval of SRP-9003 in 2025 CAMBRIDGE, Mass. / Dec 18, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that enrollment and dosing is complete in EMERGENE (Study SRP-9003-301), a Phase 3 clinical trial of SRP-9003 (bidridistrogene xeboparvovec). SRP-9003 is an investigational gene therapy for the...Read more
Clinical Data from First Subject Dosed Twice Daily with QRX003 in Open Label Study Is Positive at Mid-point of Testing Significant Improvement in Skin Appearance Observed in Pediatric Study after Only 12 Days of Dosing with QRX003 ASHBURN, Va., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases,...Read more
This open-label Phase 1 study measures safety, peripheral and central inflammation, effects on Treg cell populations, and FTD progression; Five of the 8 planned FTD subjects have been enrolled to date; Results of study will inform Coya’s randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD HOUSTON / Dec 18, 2024 / Business Wire / Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage...Read more
Approval given after Safety Review Committee (SRC) review of safety data from the three patients comprising Cohort 2 No significant safety or dose limiting toxicities reported in Cohort 2 New patients currently being evaluated for eligibility in Cohort 3 PK and PD data from Cohort 1 patients consistent with preclinical and Phase 0 trial results BOSTON, Dec. 18, 2024 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the...Read more
Preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trial Monotherapy activity with inhaled KB707 provides further evidence of successful repeat administration of HSV-1 based inhaled lung gene delivery and builds on recent clinical data update for CF and AAT deficiency respiratory disease programs PITTSBURGH, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the...Read more
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company’s second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal...Read more
No dose-limiting toxicities were observed in the RAMP 203 first triplet combination cohort of avutometinib and LUMAKRAS™ (sotorasib) plus defactinib in patients previously treated with a G12C inhibitor BOSTON / Dec 18, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced preliminary clinical data for the triplet combination of...Read more
Data from lowest dose level cohorts demonstrate a favorable safety and efficacy profile Data includes complete results from cohort 1 and initial results from cohort 2 Early exercise of common stock warrants from stockholder generates cash proceeds of approximately $12.7 million Company to host conference call and webcast today at 8:00 a.m. ET / 5:00 a.m. PT BURLINGAME, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) --...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
Approval in Hong Kong marks the first clinical trial application clearance of an in vivo gene editing approach for chronic hepatitis B in Hong Kong and the second CTA approval for PBGENE-HBV in 2024 ELIMINATE-B is a global, multi-site study now actively recruiting patients; expected to report clinical data as it matures throughout 2025 U.S. investigational new drug (IND) anticipated in 2025 DURHAM, N.C. / Dec 18, 2024 / Business Wire...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
Favourable safety profile for world’s first LAG-3 agonist, IMP761, with no treatment related adverse events to date Additional safety data and assessment of PK/PD relationships to follow in first half of CY2025 IMP761 is designed to enhance the “brake” function of LAG-3 on T cells to restore balance to the immune system and address the underlying cause of many autoimmune diseases SYDNEY, AUSTRALIA, Dec. 17, 2024 (GLOBE NEWSWIRE) --...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
The Phase 1/2 trial will assess the safety and clinical activity of IMC-R117C, as a monotherapy and in combination with standards of care, in patients with advanced cancers expressing PIWIL1 First immunotherapy program to target PIWIL1, a cancer-testis antigen overexpressed in a range of cancers, including colorectal cancer (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 17 December 2024) Immunocore...Read more
EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks Safety data remains consistent with the known EYLEA HD and EYLEA safety profiles Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 TARRYTOWN, N.Y., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Regeneron...Read more
TN-201 Well Tolerated at 3E13 vg/kg Dose AAV9 Capsid Demonstrated Robust Delivery of TN-201 Transgene to Heart Muscle Cells Resulting in Increasing RNA Expression and an Increase in Protein Levels Observed at One Year Circulating Biomarkers and Other Clinical Measures Mostly Remained Stable or Improved from Baseline Tenaya Management to Host a Webcast Conference Call Today at 8:00 a.m. ET SOUTH SAN FRANCISCO, Calif., Dec. 17, 2024...Read more
DEER PARK, Ill., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases announced the full readout and compelling results from the clinical trial evaluating PKU GOLIKE as a protein substitute for the treatment of phenylketonuria (PKU) in patients during prolonged fasting periods. The...Read more
In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of 76%; tumor shrinkage was observed in 48% of patients; preliminary median progression free survival (PFS) is 5.6 months and 36% of patients remain on treatment In 17 heavily pretreated NSCLC...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
Phase 1b trial will evaluate receptor occupancy of PIPE-791 in the brain and lungs of patients in multiple cohorts using a PET tracer of the LPA1 receptor Topline data readout planned for the second quarter of 2025 SAN DIEGO / Dec 16, 2024 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical stage biopharmaceutical company focused on discovering and developing novel, oral small molecule...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
Results from Phase 3 long-term extension study of relacorilant to treat patients with hypercortisolism were presented at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) 116 patients with hypercortisolism were enrolled with treatment duration of up to six years Results provide further evidence of relacorilant’s potential benefit as a treatment for patients with hypercortisolism REDWOOD CITY,...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
Once daily brilaroxazine demonstrated favorable long-term safety and robust broad-spectrum efficacy sustained over 1-year Generally well-tolerated with low rates of adverse events and discontinuation Full data set from open-label extension (OLE) of RECOVER expected in Q1 2025 CUPERTINO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a...Read more
Dose-finding clinical trial in China designed to evaluate safety and preliminary anti-tumor activity of SN301A (SENTI-301A manufactured in China) in hepatocellular carcinoma (“HCC”) SOUTH SAN FRANCISCO, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit...Read more
BHV-1300 achieved deep lowering of targeted IgG, with reductions > 60% in the lowest subcutaneous dose tested in the MAD. Subcutaneous BHV-1300 achieved rapid and progressive lowering of IgG within hours of each weekly dose administration, and pharmacodynamic effects were sustained relative to baseline over the four-week period. The optimized subcutaneous formulation also showed substantially less inter-patient variability in...Read more
FLASH2 Study opens patient enrollment PRINCETON, N.J., Dec. 16, 2024 /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 today that it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte™ (synthetic hypericin) in the...Read more
Veligrotug met all primary and secondary endpoints with high statistical significance in THRIVE-2, achieving a week 15 proptosis responder rate (PRR) of 56% (placebo-adjusted PRR of 48%, p < 0.0001) THRIVE-2 is the first global phase 3 study in patients with chronic TED to demonstrate a statistically significant and clinically meaningful 56% diplopia responder rate (placebo-adjusted rate of 31%, p = 0.0006) and 32% rate of...Read more
Voyage is the first-ever Phase 3 study of lysergide D-tartrate (LSD) with the primary endpoint measuring the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) score at week 12 for MM120 Orally Disintegrating Tablet (ODT) 100 µg vs placebo Study builds on positive Phase 2b study results presented at the American Psychiatric Association’s Annual Meeting in May 2024 Topline data from the 12-week double-blind...Read more
Daily subcutaneous injections of 25 mg nomlabofusp in 14 participants were generally well tolerated for up to 260 days in the ongoing open label extension (OLE) study Tissue frataxin (FXN) levels showed mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90 Tissue FXN levels increased and were maintained over time, with mean levels increasing from 15% of healthy volunteers (HV) at baseline to...Read more
Company plans to meet with FDA regarding potential sNDA submission in 1H 2025 Call planned today at 8:30 a.m. (ET) to discuss company’s diabetes program progression DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung...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
Clinical Trial Demonstrates Superior Metabolic Control During Prolonged Fasting in PKU Patients Results Expected to Promote Awareness and Adoption of PKU GOLIKE ® GENEVA, SWITZERLAND / ACCESSWIRE / December 16, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF ) (OTCQB:RLFTF ) (OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare...Read more
Single-agent MDNA11 was more effective than a combination of immune checkpoint inhibitors (anti-mPD1 and anti-mCTLA4) in preventing metastasis and achieving long-term survival in an aggressive mouse model of triple negative breast cancer (TNBC) Mice treated with MDNA11 prior to surgery were able to mount powerful immune and memory response to subsequent tumor rechallenges, demonstrating potential to prevent new tumor...Read more
Heavily-pretreated patients on lunresertib and camonsertib combination achieved 25.9% overall response rate (ORR) in endometrial cancer and 37.5% in platinum-resistant ovarian cancer Nearly half of patients with gynecologic cancers maintained progression-free survival at 24 weeks, comparing favorably to current standard of care Company plans to initiate a registrational Phase 3 trial of lunresertib in combination with camonsertib in...Read more
REDWOOD CITY, Calif. / Dec 12, 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 that the primary endpoint was met in the treatment phase of CATALYST, a randomized, double-blind,...Read more
Two of three patients achieved both complete remission and MRD-negative status High response rates observed in earlier studies continue in ongoing mipletamig trial Cohort 2 enrollment commencing SEATTLE, WA / ACCESSWIRE / December 12, 2024 / Aptevo Therapeutics ("Aptevo") (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel bispecific immune-oncology therapeutics based on its proprietary ADAPTIR® and...Read more
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy NEW YORK / Dec 12, 2024 / Business Wire / Pfizer Inc. (NYSE:PFE) and Alliance Foundation Trials, LLC (AFT) today announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line...Read more
HOUSTON / Dec 12, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable ongoing efficacy results from the eight-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial, and provides additional updates on the first and seventh patients. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT)...Read more
SAGITTARIUS is Natera's first interventional trial using SignateraTM to select patients for targeted therapy in early-stage colon cancer Approximately 700-900 patients expected to be enrolled across more than 20 sites AUSTIN, Texas / Dec 12, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the enrollment of the first patients in the SAGITTARIUS clinical trial....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
Clear evidence of SERPINA1 gene delivery and AAT expression following KB408 administration in AATD patients Both KB408 for AATD patients and KB407 for patients with cystic fibrosis were safe and well tolerated at all dosing regimens evaluated to date Conditional sanctioning of the KB407 Phase 1 CF Study CORAL-1 protocol by CFF TDN Investor call and webcast to be held December 12 at 8:30 am ET to discuss data update PITTSBURGH,...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
87.5% of patients treated with LYNPARZA were alive at six years vs. 83.2% in the comparator arm First and only PARP inhibitor to improve survival in early breast cancer WILMINGTON, Del. / Dec 11, 2024 / Business Wire / Updated results from the OlympiA Phase III trial showed AstraZeneca and Merck & Co., Inc’s, known as MSD outside of the US and Canada, LYNPARZA® (olaparib) demonstrated sustained, clinically meaningful improvements...Read more
Halifax, Nova Scotia--(Newsfile Corp. - December 11, 2024) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") announces results from its most recent preclinical study of its Targeted Hyperthermia Therapy ("THT") which uses the Company's patented, biocompatible gold nanorods ("GNRs") to treat certain solid cancer tumors, shrinking them and acting as an immune stimulator. Building on its success in melanoma and breast...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
VANCOUVER, British Columbia & DALLAS / Dec 11, 2024 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (CSE: ACOG) (“Alpha Cognition” [ACI], or the “Company”), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced interim preclinical data that supports the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The interim data...Read more
Twice daily (BID) dosing regimen expected to maximize clinical benefit for patients by optimizing the activity of Aprea’s experimental drug, ATRN-119, over a 24-hour daily cycle New regimen potentially optimizes clinical outcomes and strengthens the clinical path forward ATRN-119 is the first macrocyclic ATR inhibitor to enter clinical trials DOYLESTOWN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq:...Read more
As monotherapy, imlunestrant significantly reduced the risk of progression or death by 38% compared to standard endocrine therapy (ET) in patients with ESR1 mutations As combination therapy, imlunestrant plus Verzenio significantly reduced the risk of progression or death by 43%, compared to imlunestrant alone, in all patients, regardless of ESR1 mutation status These data were published simultaneously in the New...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
Navenibart Demonstrated 6 Months of HAE Attack Prevention with 1 or 2 Doses 90-95% Mean Monthly Attack Rate Reduction Supporting Chronic Dosing 2 or 4 Times Per Year 67% Attack-Free Rate Over 6 Months in Cohorts 2 and 3 Favorable Safety and Well-Tolerated Profile Phase 3 Initiation on Track for Q1 2025 BOSTON / Dec 11, 2024 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical...Read more
TIGeR-PaC is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer Dr. Meredith Pelster, Associate Director for GI Research Across Sarah Cannon Research Institute (SCRI), Appointed Principal Investigator for TIGeR-PaC Study LOS ALTOS, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company...Read more
ZYNLONTA in combination with glofitamab demonstrated clinically meaningful benefit with 94% best ORR and 72% CR rate Safety data show no dose-limiting toxicities (DLTs), no high-grade cytokine release syndrome (CRS) or high-grade immune effector cell-associated neurotoxicity syndrome (ICANS) across all patients Company to host conference call today at 8:30 a.m. EST LAUSANNE, Switzerland, Dec. 11, 2024 /PRNewswire/ -- ADC...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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