Global study in approximately 180 adults with hidradenitis suppurativa to assess the efficacy and safety of two dose regimens of AVTX-009 compared to placebo Topline data expected in 2026 WAYNE, Pa. and ROCKVILLE, Md., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS)....Read more
Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company...Read more
Anticipated advantages of UGN-103 include a shorter manufacturing process and a simpler reconstitution procedure PRINCETON, N.J. / Oct 02, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103...Read more
LYON, France, October 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company’s proprietary Focal One® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH). “We’ve been offering targeted HIFU ablation to prostate cancer patients for more...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5,...Read more
CAMBRIDGE, MA / ACCESSWIRE / September 30, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. Global recruitment for the Nova 301 trial has also begun. "Norovirus is a significant public health concern that affects...Read more
SAN DIEGO, Sept. 23, 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 the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure...Read more
The first healthy volunteer has been dosed in the first component of the Phase 1 study Initial safety and pharmacokinetic data expected in Q4 2024 Initiation of the second component of the Phase 1 study, in adult DMD patients, expected in Q1 2025 TORONTO / Sep 18, 2024 / Business Wire / Satellos Bioscience Inc. (“Satellos” or the “Company”) (TSX: MSCL) (OTCQB: MSCLF), a public biotech company developing new small molecule therapeutic...Read more
BASKING RIDGE, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the second-line cholangiocarcinoma (“CCA”) cohort of the BOLSTER trial. This follows the recently announced successful...Read more
Two patients dosed; several additional patients screened for enrollment Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior...Read more
WAYNE, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the...Read more
No TCB008-related Adverse Events seen in any of the re-start patients 6 Patients received second dose, 3 Patients received third dose, 1 Patient received fourth dose EDINBURGH, Scotland, Sept. 12, 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...Read more
Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the...Read more
Phase 2/3 of the DRAGON II trial will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and Japan Phase 1b of DRAGON II trial to evaluate pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese subjects was recently completed Tinlarebant granted Orphan Drug and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1 Pivotal...Read more
Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin Funding for study provided by NIH and BrainUp® Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON, Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced that the first patient has been dosed with CX-801 monotherapy in a Phase 1 study (NCT06462794) in patients with solid tumors. CX-801 is a dually-masked interferon alpha-2b PROBODY® cytokine with potential broad applicability in both...Read more
Outcomes is the third study in the Phase 3 SYNCHRONY clinical trial program SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study...Read more
SAN DIEGO, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Ventyx Biosciences, Inc. (Nasdaq: VTYX) (“Ventyx”), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced that the first patient has been dosed in a Phase 2a trial of VTX3232 in patients with early Parkinson’s disease. “We are excited to initiate this trial...Read more
ROCKVILLE, Md. & EDMONTON, Alberta / Sep 05, 2024 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) announced today that the first participant has been dosed in a Phase 1a single ascending dose (SAD) study of AUR200, a differentiated, potential best-in-class therapy for autoimmune diseases that targets both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand). The SAD study...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA®...Read more
WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against...Read more
Descartes-15 observed to achieve an approximately ten-fold increase relative to Descartes-08 in CAR expression and selective target-specific killing in preclinical studies GAITHERSBURG, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in...Read more
BRANFORD, Conn. / Aug 28, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a precision dermatology company, announced that it has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary...Read more
PASADENA, Calif., Aug. 26, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. (“Roche”) for treatment of unresponsive (MSI Low) metastatic colorectal cancer. As part of the clinical trial (NCT06012734,...Read more
Complete enrollment currently expected in 3Q 2024 Topline results expected in 1Q calendar year 2025 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J., Aug. 22, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced that...Read more
SEATTLE, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ (QLHC), today announced the first patient has been dosed in their clinical trial evaluating Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, as a neoadjuvant treatment in...Read more
Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases SAN FRANCISCO and WALTHAM, Mass., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology...Read more
MRT-6160, a potent and highly selective VAV1-directed molecular glue degrader, represents a potential novel therapeutic approach for systemic and neurological autoimmune and inflammatory diseases Initial Phase 1 clinical results, including biomarker data to demonstrate pharmacodynamic effects, anticipated in Q1 2025 BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology...Read more
LEXINGTON, Mass. and AMSTERDAM, Aug. 15, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first patient has been dosed in a Phase I/IIa clinical trial of AMT-191 for the treatment of Fabry disease, a rare, inherited genetic disease. The Phase I/IIa study is a multi-center, open-label trial being conducted...Read more
Media Release 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 Safety data from this first-in-human study anticipated by year-end and pharmacokinetics and pharmacodynamics data in first half CY2025 SYDNEY, AUSTRALIA, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the...Read more
WOBURN, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced...Read more
PITTSBURGH, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us,” “we” or the “Company”), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, today announces the dosing of the first two patients with LP-310 in its Phase 2a clinical trial in Oral Lichen Planus (OLP) patients. Lipella’s Phase 2a trial is a multicenter, dose-ranging study involving...Read more
DUBLIN, July 31, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). "IH is a debilitating sleep disorder characterized by profound sleep inertia, or difficulty waking up and...Read more
NEWTON, Mass., July 29, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) in the brain for the treatment of Alzheimer’s disease (AD), today announced that the first subject has been dosed with a subcutaneous formulation of sabirnetug (ACU193) in a Phase 1 pharmacokinetic (PK) comparison...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 24, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5,...Read more
KB-0742 cleared 80mg four-days-on, three-days-off dosing schedule in dose escalation Company expects to provide an efficacy update on this expansion cohort in 1H 2025 SAN MATEO, Calif. and CAMBRIDGE, Mass., July 23, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to developing small molecule therapeutics that address cancers and other diseases driven by deregulated transcription, today...Read more
LB54640 has shown targeted effect on MC4R without hyperpigmentation BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an...Read more
CAMBRIDGE, Mass., July 22, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the initiation of HEROEX-1, its Phase 1a/1b clinical trial evaluating its novel HER2-selective inhibitor, NVL-330, for pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). "HER2...Read more
Pure Biologics’ exploratory Phase 0 study to evaluate pharmacodynamic activity of PBA-0405 in solid tumors SOUTH SAN FRANCISCO, Calif. / Jul 18, 2024 / Business Wire / Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study...Read more
GenFleet’s IND in China was cleared in June 2024; this is the first discovery program from the collaboration Verastem announced in 2023 to advance into human clinical trials Verastem plans to initiate development studies outside of China after evaluating initial dose escalation data from the Phase 1 study in China BOSTON / Jul 12, 2024 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to...Read more
Testing the efficacy and safety of our lead product candidate, INT230-6, as Monotherapy Compared with Systemic U.S. Standard-of-Care Chemotherapy SHELTON, Conn., July 9, 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...Read more
Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Timing of milestone in-line with mid-2024 guidance Data from ex-US clinical trial reported at ASGCT 2024 showed a 92% overall response rate LOS ANGELES, July 08, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L)...Read more
WATERTOWN, Mass. and GOSSELIES, Belgium, July 08, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the dosing of the first patient in GALAXIES Lung-301, a global, randomized, double-blind Phase 3 registrational clinical trial of belrestotug +...Read more
GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in its Phase 2 open-label clinical trial evaluating Descartes-08 in patients with systematic lupus erythematosus (SLE). Descartes-08, Cartesian’s lead mRNA cell therapy candidate...Read more
Novel arenaviral therapeutic vaccine, developed in collaboration with Gilead Sciences, Inc. (Gilead), to be evaluated as a potential component of a curative regimen for human immunodeficiency virus (HIV) HOOKIPA achieves a $5 million non-dilutive milestone payment under its collaboration and license agreement with Gilead Under the collaboration agreement, HOOKIPA is responsible for advancing the HIV program through the completion...Read more
EMERYVILLE, Calif., June 27, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of...Read more
Top-Line Data Readout From the Single Ascending Dose Part 1 Expected in the Third Quarter of 2024, and From the Multiple Ascending Dose Part 2 in the First Quarter of 2025 Planned Part 3 Will Assess Total Weight Loss at 24 Weeks, Exploring Maximum Titratable Dose and Dietary Changes; Interim Data Readout Expected Mid-2026 with Top-Line Data in the Second Half of 2026 Recent Financing of up to $70 million Will Fund the Ongoing...Read more
NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access...Read more
CAMBRIDGE, Mass., June 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the first patient was treated with BEAM-302, an investigational in vivo base editing medicine designed to precisely correct the underlying cause of severe alpha-1 antitrypsin deficiency (AATD), that is currently being evaluated in a Phase 1/2...Read more
SOUTH SAN FRANCISCO, Calif. / Jun 25, 2024 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today announced that the first patient has been dosed in the company’s Phase 3 NEAT (Neurologic Effects of EryDex on Subjects with A-T) clinical trial to evaluate the...Read more
First-Patient-In (FPI) for Phase 1 combination treatment with IDE397, IDEAYA's MAT2A inhibitor, and Trodelvy®, Gilead's Trop-2 directed antibody-drug conjugate (ADC) The global Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of IDE397 in combination with Trodelvy MTAP-deletion is found in approximately 26% of patients with bladder cancer SOUTH SAN FRANCISCO, Calif.,...Read more
First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced...Read more
SRK-439, a myostatin inhibitor, is part of Scholar Rock’s industry-leading anti-myostatin portfolio Obesity program continues to progress, with first participants dosed in Phase 2 EMBRAZE trial of apitegromab in obesity CAMBRIDGE, Mass. / Jun 24, 2024 / Business Wire / Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic...Read more
Reminder: Management “CEO Chat” with Zacks Small-Cap Research Analyst Begins Today at 11 a.m. Eastern Time BURLINGTON, Mass. / Jun 20, 2024 / Business Wire / Bone Biologics Corporation (“Bone Biologics” or the “Company”) (Nasdaq: BBLG, BBLGW), a developer of orthobiologic products for spine fusion markets, announces that the first two patients have been treated in the multicenter, prospective, randomized pilot clinical study of the...Read more
Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit Funding for the study comes from the US$5 million Therapeutic Accelerator Award from PanCAN SAN DIEGO, and CALGARY, AB, June 20, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology,...Read more
MALVERN, Pa., June 20, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the first patient has been dosed in its Phase 3 liMeliGhT clinical trial for OCU400—a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP). “Each clinical...Read more
High-dose NGN-401 has been well-tolerated, and low-dose NGN-401 continues to show a favorable safety profile Interim safety data presented at the International Rett Syndrome Foundation (IRSF) ASCEND Summit NEW YORK / Jun 18, 2024 / Business Wire / Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced...Read more
SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection. Chronic...Read more
Preclinical data for SPY001 demonstrate the potential for improved dosing over standard of care, including the potential for dosing every eight or twelve weeks compared to dosing every two weeks for subcutaneous vedolizumab Interim subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated by year-end 2024 SPY002, an extended half-life anti-TL1A antibody designed for enhanced potency to both TL1A monomers and...Read more
APR-1051 is a highly selective and potentially best-in-class oral WEE1 inhibitor Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need Dosing of the first patient in the ACESOT-1051 study represents a key advancement in Aprea’s clinical pipeline DOYLESTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”,...Read more
SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to...Read more
Top-line data forthcoming SAN DIEGO / Jun 13, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02). The study, which was conducted...Read more
VYN202 has been designed to achieve class-leading potency and BD2-selectivity Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24 BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and...Read more
Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024 Phase 1b study portion of multiple ascending weekly doses in participants with recurrent genital herpes on track to initiate by end of year with interim data expected in 1H 2025 SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more
CAMBRIDGE, Mass. & MONTREAL / Jun 10, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s camonsertib monotherapy non-small cell lung cancer (NSCLC) expansion of the TRESR clinical trial. “Camonsertib has demonstrated a promising signal of prolonged progression free survival in...Read more
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety,...Read more
Topline Readout Expected in Q4 2024 NASHVILLE, Tenn. / Jun 06, 2024 / Business Wire / Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced that the first patient has been dosed in its Phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam...Read more
DNA vaccine proof-of-concept study expected to demonstrate an “mRNA better” platform LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial....Read more
Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo Top-line data from the 24-week double-blind portion of the trial expected in mid-2025 BRIDGEWATER, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment...Read more
SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1 Anticipate potential proof-of-concept data available in the first half of 2025 SOUTH SAN FRANSCISO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today...Read more
NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that patient dosing has commenced in the Company’s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep...Read more
BHV-1510 is a novel trophoblast cell surface antigen-2 (Trop-2) directed antibody drug conjugate (ADC) that has demonstrated a highly differentiated preclinical monotherapy efficacy profile, the potential for broader therapeutic margin than other Trop-2 ADCs currently in development, and synergistic affects when combined with anti-PD1 therapy Biohaven also entered into a clinical supply agreement with Regeneron to study the combination...Read more
Phase 2 study to assess updated formulations for improved immune responses of multivalent vaccine candidate against influenza B strain Study initiated following previously reported interim data from Phase 2 Part of combined Phase 1/2 study in seasonal influenza Composition of vaccine candidate changed to match all three WHO-recommended flu strains, following recommendation to exclude B/Yamagata lineage TÜBINGEN, GERMANY AND BOSTON,...Read more
Top-line Phase 1 CSU results expected at year end 2024 SAN CARLOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced that the first patient with chronic spontaneous urticaria (CSU) has been dosed in a randomized, double-blind, placebo-controlled Phase 1 trial of AK006. The Phase 1 trial is designed to...Read more
CT-0525 is the first CAR-Monocyte to be evaluated in humans in the solid tumor setting Initial data expected by year-end 2024 PHILADELPHIA, May 16, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the first patient was dosed in its Phase 1 clinical...Read more
LEXINGTON, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the first participants were dosed in a Phase 1a single ascending dose (SAD) trial of VY-TAU01, an investigational anti-tau antibody developed to inhibit the spread of pathological tau in Alzheimer’s disease. The objective of the randomized, double-blind,...Read more
First patient dosed in trial to evaluate the safety, pharmacokinetics and pharmacodynamics of TOUR006 in patients with inflammatory risk and chronic kidney disease Topline data anticipated in the first half of 2025 with potential to advance TOUR006 toward Phase 3 readiness for atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases TRANQUILITY trial intended to provide evidence of TOUR006’s...Read more
Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile 16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025 Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion SAN FRANCISCO and WALTHAM,...Read more
PH-762 is Phio’s lead product candidate Screening on the next cohort is on-going MARLBOROUGH, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced progress on its Phase 1b clinical study for their lead compound...Read more
HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival...Read more
Expects to Initiate the Phase 2 Expansion Study in the Second Half of 2024 Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, May 14, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the first patient has been enrolled and...Read more
Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV Clinical trial funded by a NIAID grant to a multi-center university consortium Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- Fortress...Read more
SENTI-202 is a potential first-in-class Logic Gated off-the-shelf CAR-NK cell therapy Initial clinical efficacy data expected by year-end 2024 and durability data expected in 2025 SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today...Read more
Pre-treatment Sample of Patient’s Blood Showed Rapid and Potent Depletion of CD19+ B Cells in Ex Vivo Cytotoxicity Assay with FT819 Translational Data from FT819 Phase 1 B Cell Malignancies Study Support Key Therapeutic Mechanisms of Activity for B Cell-mediated Autoimmune Diseases Initial Clinical Observations of FT522 CAR NK Cell Program in Phase 1 B Cell Lymphoma Study Show Rapid, Deep, and Sustained B Cell Depletion and Enhanced...Read more
Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME On-track to report initial data from the solid tumor clinical trial in 2024 WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that...Read more
CHARLOTTESVILLE, Va., May 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical...Read more
VERVE-102 is an investigational in vivo base editing medicine designed to permanently inactivate the PCSK9 gene in the liver to durably reduce blood low-density lipoprotein cholesterol Heart-2 enrolling patients with heterozygous familial hypercholesterolemia or premature coronary artery disease BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care...Read more
BOULDER, Colo. / May 06, 2024 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the dosing of the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of...Read more
BOSTON, May 01, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that the first patient has been enrolled in an investigator-initiated Phase 2 trial to evaluate GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, at the Earle A. Chiles Research Institute (EACRI), a division...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...
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