Bagsværd, Denmark, 17 January 2025 – Novo Nordisk today announced headline results from STEP UP, a phase 3b trial in the global STEP programme. STEP UP is a 72-week efficacy and safety trial investigating subcutaneous semaglutide 7.2 mg compared to semaglutide 2.4 mg and placebo, all administered once weekly. The trial included 1,407 randomised adults with obesity. All treatment arms were in conjunction with lifestyle...Read more
ADDIS ABABA, Ethiopia and KINSHASA, Democratic Republic of the Congo and WASHINGTON and PARIS, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Africa CDC’s support for the MOSA, a pan-African randomized platform adaptive trial for the MpOx Study, adding to the initial EU funding, has enabled the enrollment of the first patients at Mbandaka Hospital in Equateur Province, Democratic Republic of Congo (DRC). These patients have been randomized in this...Read more
Company on track to report topline data in first half of 2025 Positive preliminary data from all five single ascending dose (SAD) cohorts ranging from 15mg to 450mg support safety and tolerability of PALI-2108 Continued progress toward Phase 1b/2a of PALI-2108 trial for the treatment of UC Carlsbad, CA, Jan. 16, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc, (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a...Read more
MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). “OCU200 has the potential to change the treatment landscape for DME,...Read more
ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeks BLA resubmission on track for calendar Q1 2025 Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the...Read more
Set to begin larger Phase 2b study in sarcopenia and new trial in GLP-1-induced sarcopenia and frailty Transformative potential for novel TNF-alpha inhibitor drug: Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market BALTIMORE / Jan 15, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral...Read more
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
Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population The safety profile of TIVDAK among the China subpopulation was manageable and consistent with that observed in the global population Zai Lab intends to submit a New Drug Application (NDA) to China’s...Read more
New pancreatic cancer cohort moves forward with full enrollment of 30 patients in Stage 1 SAN DIEGO and CALGARY, AB, Jan. 15, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced that Germany's medical regulatory body, the Paul-Ehrlich-Institute (PEI), has approved the continuation of patient enrollment into Cohort 5 of the...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
CTIM-76 Phase 1 trial focused on CLDN6-positive gynecologic and testicular cancers Trial marks key milestone in driving pipeline progress PHILADELPHIA, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating...Read more
ALISO VIEJO, Calif. / Jan 14, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced several positive clinical updates for its iDose® sustained-release procedural pharmaceutical platform, including: In a new 36-month follow-up analysis of its two Phase 3 pivotal...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
CAMBRIDGE, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, today announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system's response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated...Read more
Interim data from Cohort 4 expected Q1 2025 MIAMI, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...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
311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025 Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with...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
The first selective Fatty Acid Binding Protein 5 inhibitor safely administered to human subjects Initial safety and pharmacokinetic data expected during the first half 2025 SOLANA BEACH, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, or dermatologic and...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
Single Pivotal Trial Designed to Demonstrate Efficacy and Safety of Every 3- and Every 6-Month Administration in a 6-Month Treatment Period Pioneering Patient-Centric Dosing Flexibility in HAE with Potential Market-Leading First-Choice Profile Phase 3 Initiation On-Track, Expected in Q1 2025 Strong Financial Position, Funded Through Expected Top-Line Phase 3 Results BOSTON / Jan 13, 2025 / Business Wire / Astria...Read more
Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Expects to report seven data readouts...Read more
KRRO-110 is the first product candidate from Korro’s proprietary RNA editing OPERATM platform Interim readout from REWRITE expected in the second half of 2025 Korro to advance additional pipeline programs towards clinical development CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on...Read more
Pathologic Complete Response reported for 2 patients with cutaneous Squamous Cell Carcinoma Marlborough, Massachusetts--(Newsfile Corp. - January 13, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced pathologic...Read more
The Company's natural psilocybin extract powers a culturally transformative study to address methamphetamine addiction through indigenous frameworks. Vancouver, British Columbia--(Newsfile Corp. - January 13, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is proud to...Read more
Topline ATTENTION-AD trial: Patients showed improved cognition and function over three years Delayed-start analysis of treatment with oral blarcamesine was significant reflecting importance of early treatment initiation Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more
BURLINGAME, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data, which include previously reported results from cohort 1 of the trial and new data covering...Read more
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer NECTIN4 gene amplification development strategy underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in 2025 Emerging...Read more
601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 Data from SYNCHRONY Real-World study anticipated in the first half of 2026 SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked...Read more
Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern...Read more
100% (9/9) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years 100% (9/9) of treated evaluable subjects demonstrated improvement or stabilization in mobility testing, which was only performed up to one year Improvement in visual function was statistically significant (p=0.01, treated vs untreated eyes), regardless of mutation at two...Read more
Primary endpoint of DFS met at first prespecified interim analysis, showing a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to placebo Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting; a recent Phase 3 trial with Keytruda® failed in the same setting1 Libtayo is...Read more
CB-010 GALLOP Phase 1 trial initiated in lupus CB-012 AMpLify Phase 1 trial in r/r AML completes dose level 3 with no DLTs; enrolling patients at dose level 4 CB-010 ANTLER 2L LBCL and CB-011 CaMMouflage r/r MM Phase 1 clinical data expected in H1 2025 Sri Ryali appointed chief financial officer Caribou to present at 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, at 10:30 am PST BERKELEY, Calif., Jan. 12,...Read more
Orbit Phase 3 study of setrusumab in osteogenesis imperfecta continuing to planned second interim analysis, expected in mid-2025 Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, receives positive EMA opinion on European Orphan Designation Application; European Commission expected to issue final decision in first quarter 2025 LONDON, Jan. 12, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO)...Read more
Clinically meaningful and statistically significant results are the first pivotal Phase 3 data for sasanlimab, a subcutaneously administered PD-1 inhibitor If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population Treatment naïve high-risk NMIBC is an area of significant unmet need, where therapeutic options have largely remained unchanged...Read more
LAVA-1266 is a potent and selective bispecific anti-CD123 Gammabody® First-in-human study enrolling adult patients with CD123-expressing AML or MDS Initial Phase 1 data read-out expected by year-end 2025 UTRECHT, The Netherlands and PHILADELPHIA, Jan. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody®...Read more
LUNAR-H5N1 becomes the third STARR® mRNA vaccine candidate to enter clinic First Phase 1 participant injected December 2024 Interim Phase 1 data expected H2 2025 SAN DIEGO / Jan 10, 2025 / 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
BELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers. “Dosing the first patient in...Read more
Across all DME patients dosed to date, 4D-150 continues to be well tolerated with no intraocular inflammation observed at any timepoint or dose level 3E10 vg/eye demonstrated strong signals of clinical activity with sustained gain of BCVA of +8.4 letters and reduction of CST of -194 µm from baseline through Week 32 3E10 vg/eye achieved an 86% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W and dose response...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
PBFT02 demonstrated durable, elevated CSF PGRN levels and early evidence of reduction in plasma NfL levels, a disease progression biomarker, compared to published natural history data Evaluating Dose 2, 50% lower than Dose 1, in subsequent FTD-GRN and FTD-C9orf72 patients to allow for dose exploration and support regulatory strategy Expect to report 12-month data from Dose 1 and interim safety and biomarker data from Dose 2 in 2H...Read more
CAMBRIDGE, Massachusetts, Jan. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on developing precision therapies for neurodegenerative diseases, today announced the initiation of its Phase 1b clinical trial (PRECISE-AD) evaluating its lead therapeutic candidate, PMN310, in Alzheimer’s disease (AD). PMN310, a humanized IgG1 antibody, is engineered to selectively target...Read more
DYNE-101 in DM1: Dyne plans to initiate global Registrational Expansion Cohort of ACHIEVE trial with registrational dose of 6.8 mg/kg Q8W following study data showing splicing correction and robust and sustained functional improvements; potential to support H1 2026 submission for U.S. Accelerated Approval DYNE-251 in Exon 51 DMD: Based on recent FDA feedback, pursuing U.S. Accelerated Approval with dystrophin as surrogate endpoint;...Read more
Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types First expansion cohort initiated in patients with TNBC previously treated with at least one topo-1 ADC; dose...Read more
SAN DIEGO and TORONTO, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company, today announced dosing the first set of patients in the TUSCANY Phase 1/2 study with tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) as a frontline triple drug combination (triplet) therapy for patients newly diagnosed with acute...Read more
Phase 3 ABTECT Trial evaluating obefazimod for moderately to severely active ulcerative colitis (“UC”) reaches 1,003 of 1,224 participants, representing 82% of target enrollment. Enrollment completion expected in Q2 2025. Top-line results for the 8-week induction trial anticipated in Q3 2025, with 44-week maintenance data on track for Q2 2026 and, if successful, NDA submission planned for H2 2026. Blinded baseline characteristics...Read more
First in vivo gene insertion clinical trial dosing infants reports complete clinical response in the first participant at the lowest dose level (1.3 x 1013 GC/kg) of ECUR-506 from three months post exposure to the end of study (six months post exposure) as demonstrated by the removal of standard of care ammonia scavenging medicines, followed by absence of hyperammonemic crises and normalization of protein intake The OTC-HOPE Phase 1/2...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
New SER-155 Phase 1b study biomarker data in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients demonstrate that SER-155 promoted epithelial barrier integrity and decreased systemic inflammatory biomarkers compared to placebo; data support the broader potential of Seres’ live biotherapeutics to target inflammatory and immune diseases SER-155 clinical results accepted for 2025 TANDEM Meeting oral presentation in...Read more
In the PET trial, RAP-219 achieved and exceeded target receptor occupancy, increasing support for the dosing regimen utilized in the ongoing Phase 2a trial in focal epilepsy; restricted neuroanatomical expression of TARP8 was confirmed In the MAD-2 trial, RAP-219 was observed to be generally well tolerated with faster titration and higher exposures than in the initial MAD trial Data underscore the potential broad therapeutic index of...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
EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12 No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE...Read more
Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024. Data from follow-up will be included in FDA submission, expected in Q3 2025. Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024. BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year1. WOBURN, Mass., Jan. 08,...Read more
Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged leading contract research organization (CRO); On track to begin dosing of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 Expected timelines for recruitment updates and preliminary readouts of MIRACLE trial accelerated to 2H 2025 (n=45); 1H 2026 (n=~75-90) with potential...Read more
Case reports published in medical literature suggest that tafenoquine combined with standard-of-care treatment exhibits a high cure rate in immunosuppressed patients who have relapsing babesiosis and for whom prior treatment has failed. Babesiosis, a tick-borne disease, is potentially life-threatening if not treated early. The incidence of babesiosis has been increasing in the Northeast U.S. and elsewhere. Total cumulative accessible...Read more
Data show favorable safety and tolerability with dosing up to 800 mg for 10 days Plans to initiate human challenge study in 2025 in norovirus-infected subjects BOTHELL, Wash., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces favorable safety and tolerability results at dosing up to 800 mg per day for 10 consecutive days from the multiple-ascending dose (MAD) portion of...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
WOBURN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the first patients have been enrolled in studies evaluating RP2 in two different settings: checkpoint naïve metastatic uveal melanoma; and second-line recurrent or metastatic hepatocellular carcinoma (HCC). “On the heels of our BLA...Read more
Compelling early clinical response signals for VIR-5818 and VIR-5500 in heavily pretreated patients with various solid tumors VIR-5818: In patients receiving doses ≥400 µg/kg, tumor shrinkage observed in 50% (10/20) of participants with various HER2-expressing cancers; confirmed partial responses in 33% (2/6) of participants with HER2-positive CRC VIR-5500: PSA declines in 100% (12/12) and PSA50 response confirmed in 58% (7/12)...Read more
Rapid onset of deep and durable clinical responses observed across multiple dosing cohorts with a favorable safety profile Mean change in UAS7 from baseline of -26.6 observed in the 240mg single dose cohort at 8 weeks, multiple dosing regimens ≥120mg demonstrated UAS7 change of more than -25 points 100% (N=3) Complete Responses (UAS7 = 0) observed in the 240mg single dose cohort at 8 weeks and 66% maintained Well Controlled disease at...Read more
AUSTIN, Texas, January 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors. “The initiation of the PULS Trial represents a major milestone in efforts to...Read more
New trials in three new indications have been initiated with the Nanobody® sonelokimab: Phase 3 VELA-TEEN trial in adolescent hidradenitis suppurativa (HS), Phase 2 LEDA trial in palmoplantar pustulosis (PPP) and Phase 2 S-OLARIS trial in axial spondyloarthritis (axSpA) MoonLake now independently running seven trials in 2025 across large dermatology and rheumatology indications: adult HS, adolescent HS, psoriatic arthritis (PsA), PPP...Read more
Successfully dosed 6 patients in safety run-in segment, now accelerating enrollment Positive data from first four patients announced December 2024 NXC-201 is the only one-time CAR-T therapy in development for AL Amyloidosis Next program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix...Read more
New in vivo preclinical data announced today, demonstrate that icovamenib, in combination with semaglutide showed additional 11.5% body weight reduction and 43% increase in lean muscle mass compared to semaglutide alone Icovamenib, in combination with semaglutide, approximately doubled C-peptide production per unit of glucose compared to semaglutide alone leading to a 60% improved reduction of fasting blood glucose Ex vivo human islet...Read more
Over 300 Participants Have Completed Cumulative Six Months of Cytisinicline Treatment in the ORCA-OL Trial, Completing the Long-Term Exposure Requirement for NDA Submission ORCA-OL Long-Term Exposure Timelines Remain on Track with No Safety Concerns Identified Planned Cytisinicline NDA Submission on Target for Q2 2025 SEATTLE and VANCOUVER, British Columbia, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq:...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
Epstein-Barr virus (EBV) causes infectious mononucleosis and is associated with several types of cancer and multiple sclerosis There are no current treatments or vaccines for EBV First participant dosed with novel investigational EBV vaccine targeting multiple viral proteins in Phase I study WESTON, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), announces dosing of the first...Read more
Median overall survival improvement expected to exceed one year First and only regimen with a survival benefit over current standard of care in first-line treatment of EGFR-mutated lung cancer RARITAN, N.J., Jan. 7, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating...Read more
Alignment achieved with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for EMPEROR One-year study of zorevunersen will evaluate reductions in major motor seizure frequency as well as improvements in behavior and cognition in children and adolescents ages 2 to <18 years old FDA Breakthrough Therapy designation positions zorevunersen on...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
Phase 1 results support proceeding to Phase 2 in patients with post-bariatric hypoglycemia (PBH), which is expected to begin in 2H 2025 Phase 1 trial in healthy volunteers showed MBX 1416 was generally well-tolerated with a favorable safety profile Pharmacokinetic results demonstrated sustained dose-dependent exposure and support once-weekly dosing Company to host conference call to discuss results today at 8:30 am ET CARMEL,...Read more
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeks Overall, DNL343 was found to be safe and well tolerated Additional analyses, including neurofilament light (NfL) and other fluid biomarkers, prespecified sub-group analyses and analyses from the active treatment extension period are expected later in 2025 SOUTH SAN...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
Highly Positive Clinical Data on Completion of Testing for First Subject Dosed Twice Daily with QRX003 in Open-Label Study Demonstrated Clinical Benefits from QRX003 Observed Across All Measured Endpoints Before and After Dosing with QRX003 Photographs Available for Review On Website No Product Safety Concerns Identified in Any Quoin Netherton Study to Date ASHBURN, Va., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd....Read more
Topline data from the chronic cohort is expected in Q2 2025 Institutional Review Board (IRB) protocol amendment changes approved, and screening has been initiated for subacute cohort Vancouver, British Columbia--(Newsfile Corp. - January 2, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced that it has enrolled the 20th and...Read more
Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo Navacaprant showed an efficacy signal in female participants; Company plans to further analyze results Navacaprant generally well-tolerated with safety profile comparable to placebo Neumora expects to share additional updates on navacaprant development program at...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
LAUSANNE, Switzerland, Dec. 30, 2024 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced the completion of enrollment in LOTIS-5, the Phase 3 confirmatory trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma...Read more
ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer’s disease agitation) AXS-05 reduced worsening of Alzheimer’s disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer’s disease overall clinical...Read more
TEL AVIV, Israel, Dec. 27, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy. PainReform previously disclosed initial topline data from its...Read more
ABI-4334 was well-tolerated with a favorable safety profile and half-life supporting once-daily oral dosing observed In the first 150 mg dose cohort, ABI-4334 showed strong antiviral activity with a mean reduction of 2.9 log IU/mL in plasma HBV DNA over 28 days of treatment Enrollment in final cohort of 400 mg ongoing with data anticipated in 1H 2025 SOUTH SAN FRANCISCO, Calif., Dec. 26, 2024 (GLOBE NEWSWIRE) -- Assembly...Read more
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
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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