Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended Phase 2 dose (RP2D) Initial PK, PD and safety data expected in...Read more
Rezatapopt is a first-in-class precision oncology investigational therapy for patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type (WT) First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS WT advanced solid tumors PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a...Read more
Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY, March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic...Read more
Three-part study to evaluate safety, tolerability and pharmacokinetics now underway RM-718 showed potential to reduce body weight and hyperphagia, no hyperpigmentation observed in preclinical studies BOSTON, March 25, 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...Read more
Preclinical data with APG808 demonstrate the potential for improved dosing over other treatment options in development, including the potential for dosing every six- or eight- weeks compared to dosing every two weeks for other biologics in development Second product candidate to enter the clinic following positive interim results from Phase 1 Healthy Volunteer Trial for APG777, which exceeded all of its trial objectives Interim...Read more
FLORHAM PARK, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been dosed in a Phase 2 investigator-initiated trial (IIT) with Pembrolizumab, Plinabulin, BeyondSpring’s lead asset, plus Etoposide/Platinum (EP) for first-line (1L)...Read more
REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of...Read more
CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient dosed in the global pivotal, Phase 3 MAGNITUDE trial of NTLA-2001. NTLA-2001 is an investigational in vivo CRISPR-based therapy designed as a single-dose treatment to inactivate the TTR gene and...Read more
LP-284 is in a Phase 1 clinical trial, having been developed with guidance from Lantern’s AI platform, RADR®, as a potential therapy for relapsed or refractory non-Hodgkin’s lymphoma and other solid tumors. LP-284 is the second of Lantern’s synthetic-lethal franchise of molecules that have been shown to be synthetically lethal in DNA damage repair deficient cancers and has entered into first-in-human clinical trials. LP-284 is the third...Read more
NUV-1511 is the Company’s first drug-drug conjugate (DDC) to enter the clinic NEW YORK / Mar 14, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic. “Dosing...Read more
First patient has been dosed in the randomized, controlled, double blind clinical trial for Autism Spectrum Disorder in pediatric patients TEL AVIV, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that it has...Read more
TANDEM is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (“FDC”) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with HeFH, ASCVD or ASCVD risk equivalents requiring additional lowering of low-density lipoprotein cholesterol (“LDL-C”) Company expects to report topline data in the first quarter of 2025 TANDEM is being conducted in parallel with BROOKLYN, BROADWAY and...Read more
Study will inform on long-term safety profile and tissue frataxin levels OLE initiated with 25 mg daily subcutaneous injections of nomlabofusp Frataxin data and safety data from the OLE study are intended to help support a potential Biologics License Application (“BLA”) submission for accelerated approval targeted for H2 2025 Initial data expected in Q4 2024 BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar...Read more
First patient dosed with IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel for first-line treatment of pancreatic ductal adenocarcinoma (PDAC) Phase 2a portion of Phase 1/2a clinical trial will evaluate IMM-1-104 as monotherapy in PDAC, non-small cell lung cancer (NSCLC) and melanoma, and as combination therapy in PDAC Topline data from the Phase 1 portion of Phase 1/2a trial of IMM-1-104 expected in...Read more
TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury...Read more
Company anticipates dosing of KO-2806 in combination with adagrasib in KRASG12C-mutant NSCLC next quarter Dose escalation of KO-2806 as a monotherapy continues in parallel SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced dosing of the first patient...Read more
Phase 1/2 study is evaluating IPH6501, a first-in-class CD20-targeting tetraspecific natural killer cell engager, from ANKET® platform, for the treatment of CD20-expressing B-cell Non-Hodgkin's Lymphomas. MARSEILLE, France / Mar 06, 2024 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1/2 multicenter trial...Read more
The Phase 1b trial of VLS-01 investigates the pharmacokinetics, pharmacodynamics, safety and tolerability of atai’s proprietary, optimized oral transmucosal formulation of DMT VLS-01 is being developed as a rapid-acting and durable antidepressant for treatment resistant depression, which affects approximately 100 million people globally VLS-01 is designed to induce a short psychedelic experience, allowing for a total in-clinic...Read more
Phase 2 trial in patients with RAS-mutated mCRC will evaluate onvansertib plus SoC versus SoC alone in the first-line setting Pfizer Ignite is responsible for the clinical execution of the trial Initial topline results expected in mid-2024 Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT SAN DIEGO, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a...Read more
Conducted in Collaboration with Columbia University, the CheMo4METPANC Phase 2 trial is the first large, multi-center, randomized study evaluating motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies compared to chemo alone Gulam Manji, MD, PhD, of Columbia University to present encore pilot phase data at the Immuno-Oncology (IO) 360° Summit on February 29 TEL AVIV, Israel, Feb. 28, 2024...Read more
PIVOT-006 Phase 3 open-label trial of adjuvant cretostimogene is CG Oncology’s earliest disease stage clinical trial for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Primary endpoint of PIVOT-006 Phase 3 clinical trial is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival (PFS) IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- CG...Read more
AeriSeal System Shows Promise in Limiting Collateral Ventilation, Potentially Enabling a Greater Number of Severe COPD/Emphysema Patients to Benefit from Treatment with Zephyr® Valves, a Minimally Invasive Treatment Option REDWOOD CITY, Calif. / Feb 26, 2024 / Business Wire / Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx” or the “Company”), a global leader in minimally invasive treatments for chronic obstructive pulmonary disease...Read more
KOMET-008 is evaluating ziftomenib in combination with gilteritinib, FLAG-IDA or LDAC in patients with relapsed/refractory NPM1-mutant or KMT2A-rearranged AML SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that the first patient has been dosed in...Read more
MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer...Read more
SEATTLE, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in oncology with a focus on breast cancer, today announced that the first patient has been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in the Re-Evaluating Conditions for Active...Read more
On track to provide update from ongoing Phase 1 clinical trial in mid-2024; additional data expected in 1H 2025 BOSTON, Feb. 22, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that it has expanded its ongoing...Read more
ARV-102 is a novel oral PROTAC® protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2 (LRRK2) The Phase 1 trial of ARV-102 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers NEW HAVEN, Conn., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on...Read more
RP-1664 is a Potential First-in-Class, Selective, PLK4 Inhibitor CAMBRIDGE, Mass. & MONTREAL / Feb 15, 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 Phase 1 LIONS (PLK4 Inhibitor in Advanced Solid Tumors) clinical trial evaluating RP-1664, a potential first-in-class,...Read more
OCALA, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”). The...Read more
BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC®...Read more
Dr. Yelena Janjigian, Chief of GI Cancers, Leads Investigator Sponsored Study at Memorial Sloan Kettering Cancer Center Trial is Supported by Stand Up To Cancer as Part of an Initiative to Find Treatments for the ~70% of Gastroesophageal Cancer (GEC) Patients for Whom Current Treatments Don't Work Randomized Phase 2 Represents First Novel Combination of Allogeneic Cell Therapy with BOT/BAL Through Collaboration of Agenus and...Read more
BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib intravitreal implant,...Read more
The ABILITY-1 Study is evaluating MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the monotherapy dose escalation portion of the ABILITY-1 Study Company expects to report results from both the monotherapy expansion and combination escalation and expansion arms...Read more
SOUTH SAN FRANCISCO, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC) and GSK plc (LSE/NYSE: GSK) today announced that the first patient has been dosed in PROGRESS-AD, the global Phase 2 clinical trial of AL101/GSK4527226 in patients with early Alzheimer’s disease (AD), including mild cognitive impairment and mild dementia due to AD. AL101 is an investigational human monoclonal antibody designed to block and...Read more
Phase 1 clinical trial dosing of first patient complete; primary objective to assess safety/tolerability and absolute bioavailability of TH104 Phase 1 study expected to be completed in 1Q24 with topline readout in 2Q24 Company fully funded into 2025 with full readouts of Phase 1 and 2 in moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25 BRIDGEWATER, NJ / ACCESSWIRE / February 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR)...Read more
Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024 Acclaim-1 Study Has FDA Fast Track Designation AUSTIN, Texas, Feb. 5, 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 in January 2024, the first patient was enrolled and dosed...Read more
NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment...Read more
PASADENA, CA, Jan. 29, 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 Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma...Read more
First patient dosed in company’s second clinical program with initial data expected in second half of 2024 Cash runway extended into second half of 2025 with clinical trials on track CAMBRIDGE, Mass., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, announced today it has dosed the first patient in VBP301, its Phase 1/2, multicenter, open-label, first-in-human study of...Read more
BASKING RIDGE, N.J., Jan. 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 a Phase 2a trial evaluating LSTA1 in patients with newly diagnosed glioblastoma multiforme (“GBM”). The trial is an...Read more
The 7-peptide formulation of ELI-002 is designed to stimulate an immune response against seven KRAS mutations that drive 25% of all solid tumors, potentially defeating resistance mechanisms Elicio will present a Trial in Progress poster on the design of the AMPLIFY-7P trial at the ASCO Gastrointestinal Cancers Symposium taking place January 18-20, 2024 BOSTON, Jan. 11, 2024 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq:...Read more
Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S. REVEAL pediatric trial into the U.K. TSHA-102 clinical program now includes broad evaluation across pediatric, adolescent and adult patients in three countries...Read more
WATERTOWN, Mass., Jan. 10, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic macular edema (DME). EYP-1901 is an investigational sustained delivery therapy containing...Read more
The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada. Eligible patients include those who have been diagnosed with type 1 diabetes for up to 15 years. Data from the Phase II study are expected in 2024. REDWOOD CITY, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to...Read more
Preliminary data from the 5 mg/kg PGN-EDO51 dose level in the CONNECT1-EDO51 Phase 2 trial are expected mid-2024: including initial safety, exon 51 skipping and dystrophin protein production data Phase 1 results following a single dose of 10 mg/kg of PGN-EDO51 in healthy volunteers demonstrated peak exon 51 skipping of 3.8% with 100% of subjects demonstrating exon skipping BOSTON, Jan. 08, 2024 (GLOBE NEWSWIRE) -- PepGen...Read more
Company Doses First Participants in Phase 2 Portion of Ongoing VAX-31 Phase 1/2 Study in Adults Following Independent Review of Phase 1 Safety and Tolerability Data; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024 Following Successful End-of-Phase 2 Meeting with FDA, Company Planning for Initiation of VAX-24 Adult Phase 3 Pivotal, Non-Inferiority Study in Second Half of 2024; Topline...Read more
SYDNEY, AUSTRALIA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will...Read more
KELOWNA, BC / ACCESSWIRE / January 4, 2024 / Tryp Therapeutics Inc. ("Tryp" or the "Company") (CSE:TRYP), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs,is pleased to announce that the first patient has been dosed in a Phase 2a clinical trial being conducted by the University of Michigan in a collaboration with Tryp...Read more
STOCKHOLM, Jan. 4, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir's licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has dosed the first patient with TNG348, a novel USP1 inhibitor. Tango received U.S. Food and Drug Administration clearance on its Investigational New Drug...Read more
BOSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ (homologous...Read more
CAMBRIDGE, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, announced today the first patient, first visit for PIVOT-PO, a global pivotal Phase 3 clinical trial of tebipenem HBr in...Read more
Boca Raton, Florida, Jan. 02, 2024 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023. INKmune™ is a biologic therapy given as...Read more
NKGen Biotech’s autologous clinical program product candidate, SNK01, demonstrated improvement in neuroinflammation and cognitive function in patients with Alzheimer’s Disease (“AD”) in its Phase 1 dose-escalation safety trial. SNK01 consists of a non-genetically modified NK cell product with enhanced cytotoxicity and activating receptor expression for the treatment of moderate AD. Initial patient in this Phase 1/2a trial received 6...Read more
Largest ever PSP clinical trial will evaluate the efficacy and safety of AMX0035 in adults with PSP compared to placebo Trial to enroll approximately 600 participants across the U.S., Canada, Europe, and Japan CAMBRIDGE, Mass. / Dec 22, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in ORION, a randomized, double-blind,...Read more
Initiated SURF201 Phase 1 Study; dosed first patient with TYRA-200 Cleared multiple dose cohorts in SURF301 and continues to dose escalate with TYRA-300 Received FDA feedback on TYRA-300 Phase 2 ACH study: IND submission planned for 2H 2024 CARLSBAD, Calif., Dec. 22, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that...Read more
Topline data from confirmatory Launch-HTN trial expected in 2H 2025 Topline data from ongoing Advance-HTN pivotal trial expected in 2H 2024 RADNOR, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today...Read more
NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune modulating therapeutic cancer vaccines based on its T-win® platform, announced today that the first patient has been dosed in its Phase 2 trial (NCT05280314) studying treatment with IO102-IO103 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in neoadjuvant and adjuvant patients...Read more
Proof-of-concept study is initial step toward goal of identifying more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease choosing gene therapy TEL AVIV, Israel, Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been...Read more
Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2 topline readout expected before end of 2024 to support NDA submission OCS-01 is also being evaluated as potentially the first topical eye drop treatment for Diabetic Macular Edema (DME) in the DIAMOND program and for the treatment of Cystoid Macular Edema (CME) in the LEOPARD...Read more
Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from...Read more
SUNNYVALE, Calif., Dec. 19, 2023 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease, today announced that the first patient was enrolled and treated in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial for the treatment of patients with New York Heart Association Class II and III ischemic heart failure...Read more
NEW YORK, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough neuro-immunomodulation therapies, today announced “first patient dosed” in its Phase 2a study comparing two doses of intranasal foralumab and placebo in patients with non-active secondary-progressive multiple sclerosis (na-SPMS). Six investigational centers...Read more
Safety, transcript splicing correction and clinical outcome measures data at 5 mg/kg PGN-EDODM1 dose level in patients from FREEDOM-DM1 clinical trial expected in 2024 Clearance of Clinical Trial Application (CTA) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) extends enrollment in FREEDOM-DM1 Phase 1 clinical trial to third country BOSTON, Dec. 18, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a...Read more
SEISMiC Extension Study results are anticipated in mid-2024 and expected to provide dose optimization for Phase 3 The Company is also progressing a parallel SCAI Stage C Phase 2 study with istaroxime in cardiogenic shock targeting data in a similar timeframe WARRINGTON, Pa., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing...Read more
Week 96 Phase 2b HARMONY Results for Treatment of Patients with Pre-Cirrhotic NASH/MASH (F2-F3) to be Reported in March 2024 End-of-Phase 2 FDA Meeting Scheduled for the first quarter of 2024 to Review Phase 3 Study and Regulatory Path for Treatment of NASH/MASH Patients with Compensated Cirrhosis (F4) SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a...Read more
DIAMOND-1 Phase 3 trial, assessing the efficacy and safety of OCS-01 eye drops following 52 weeks of treatment in Diabetic Macular Edema (DME) patients, was initiated as planned Stage 1 results showed superiority of OCS-01 eye drops vs. vehicle with robust statistical significance with no unexpected adverse events observed Second 52 weeks Phase 3 trial of OCS-01 in DME, DIAMOND-2, is anticipated to start in Q1 2024 If approved,...Read more
FORWARD-53 is fully enrolled with potentially registrational dystrophin expression data expected in 2024 Previous clinical proof-of-concept data demonstrated highest level of exon skipping ever observed in the clinic and that WVE-N531 was present in myogenic stem cells, which are important for potential muscle regeneration CAMBRIDGE, Mass., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage RNA...Read more
CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial. This is a first-in-human, multi-center, open label study designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy...Read more
Initial Tolerability and Safety Data from First Patient Expected by Year-End, with Preliminary Efficacy Results by End of January 2024 HOUSTON / Dec 14, 2023 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on...Read more
Study being led by Dr. Jean-Claude Tardif at the Montreal Heart Institute No adverse reactions observed, and study can continue as planned EDMONTON, Alberta, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced the...Read more
BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) shared positive feedback that the PROPEL 3 trial design would be acceptable as a registrational study to support a marketing application...Read more
MALVERN, Pa., Dec. 13, 2023 (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 ArMaDa Phase 1/2 clinical trial of OCU410 (AAV-RORA), a modifier gene therapy product candidate being developed for dry AMD...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [Nasdaq: UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today announced that the first patients have been dosed in the Phase 2 ASPIRE study of UBX1325 (foselutoclax), a Bcl-xL inhibitor being evaluated head-to-head against standard of care anti-VEGF in patients with diabetic macular edema...Read more
BOSTON / Dec 07, 2023 / Business Wire / Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the first patient has been dosed in the global Phase 3 CoMpass trial evaluating the safety and efficacy of bel-sar for the first-line treatment of adult patients with early-stage choroidal...Read more
First U.S. patient with refractory or relapsed SSTR2-positive neuroendocrine tumors treated with [212Pb]VMT-α-NET Preliminary data readout expected in second half of 2024 SEATTLE, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that the first patient was dosed at the University of Iowa in an investigator-initiated Phase 1 trial...Read more
Atopic Dermatitis (AD) trial is the second KT-474 Phase 2 clinical trial to begin enrolling patients this quarter following trial in Hidradenitis Suppurativa (HS) Topline Phase 2 data from both the AD and HS trials expected in the first half of 2025 WATERTOWN, Mass., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule...Read more
Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential transformative impact on the treatment of inflammatory eye diseases RELIEF Phase 2b trial will evaluate the efficacy and safety of licaminlimab in moderate-to-severe Dry Eye Disease, and further explore the potential of a genetic biomarker Trial was initiated as planned with topline...Read more
BOTHELL, Wash., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, viral and...Read more
Commences initial Phase 3 study with first orally delivered epinephrine prodrug candidate Reaffirms topline data anticipated in first quarter 2024 WARREN, N.J., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced...Read more
REDWOOD CITY, Calif., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell-driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant...Read more
SGT-610 has “Orphan Drug” designation status in the U.S. and E.U. and “Breakthrough Therapy” designation status in the U.S., as potentially the first and only therapy aimed at preventing new BCCs in Gorlin syndrome Sol-Gel to host a virtual Key Opinion Leader event to discuss the Gorlin syndrome patient experience and treatment needs, as well as the SGT-610 Phase 3 trial on Wednesday, December 6th at 12 pm ET NESS ZIONA, Israel,...Read more
HAYWARD, Calif., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or the “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference ("ddRNAi") platform, today announced the first subject has been dosed in the BB-301 Phase 1b/2a Clinical Treatment Study. BB-301 is the Company’s...Read more
SBI-100 Ophthalmic Emulsion, a CB1 agonist/activator delivered as a topical eye drop, was developed to treat patients with elevated intraocular pressure Phase 2 study evaluating efficacy and safety using two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days Analysis of IOP data from 50% of patients enrolled in Phase 2 study to be performed in Q1 2024 SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Skye...Read more
TORONTO, Ontario and CAMBRIDGE, Massachusetts, Nov. 20, 2023 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced that the Company dosed the first subjects...Read more
MALVERN, Pa., Nov. 10, 2023 (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 its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease, a...Read more
VAX-31, a 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate, is the Broadest-Spectrum PCV to Enter the Clinic Topline Safety, Tolerability and Immunogenicity Data Expected in Second Half of 2024 VAX-31 is Designed to Provide Coverage for Approximately 95% of Invasive Pneumococcal Disease Circulating in the U.S. Adult Population SAN CARLOS, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine...Read more
SEATTLE, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), announced today that the first patient was dosed at Washington University in St Louis in the Company’s Phase 1/2a trial evaluating the safety and efficacy of [212Pb]VMT-α-NET, a targeted alpha-particle therapy (TAT), in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2)...Read more
CARLSBAD, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, announces today that the first patient in the Phase 1a clinical trial has been dosed with QN-302, a potential first-in-class, investigational G-Quadruplex (G4)-selective transcription inhibitor...Read more
Multi-national, randomized, controlled adaptive Phase III study in ulcerative pyoderma gangrenosum (PG) initiated and first patient dosed in the U.S. PG is a rare and debilitating autoimmune skin disease characterized by painful ulcers that can rapidly progress JENA, Germany, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement...Read more
Phase 1 trial underway for Terns’ first oral GLP-1R agonist candidate for obesity, with 28-day proof of concept data anticipated in 2H24 Oral GLP-1R agonist offers potential for weight loss and improved convenience compared to currently marketed injectables FOSTER CITY, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company...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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