SOMERSET, N.J., July 26, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced preliminary, unaudited financial results for the six-months ended June 30, 2024. For the six-months ended June 30, 2024, Legend Biotech expects to record an adjusted net loss for the period of approximately $94.7 million to $109.7 million. See “Use of Non-IFRS Financial Measures”...Read more
RYTELO, for both RS+ and RS- patients, has a Category 1 recommendation for second-line treatment and a Category 2A recommendation for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL) FOSTER CITY, Calif. / Jul 26, 2024 / Business Wire / Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the...Read more
STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STOCKHOLM: CALTX) ("Calliditas") today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver...Read more
Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found,...Read more
HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an...Read more
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology...Read more
$30.3 million financing upfront with up to an additional $92.4 million tied to exercise of warrants, with certain of the warrants subject to shareholder approval Fundraise supports development of novel antibody PMN310 for Alzheimer’s Disease patients Proceeds expected to support Company beyond 6 month and 12 month data from the PMN310 Phase Ib study in Alzheimer’s patients TORONTO, Ontario and CAMBRIDGE, Massachusetts, July 26,...Read more
Presentation to feature Silo’s novel therapeutics for the underserved SARASOTA, FL, July 26, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that CEO Eric Weisblum will present at the H.C. Wainwright 25th Annual...Read more
VANCOUVER, British Columbia, July 26, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (the “Company”), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, announces that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private...Read more
$478 million in second quarter global net product sales First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) Regulated Information – Inside Information July 25, 2024 7:00 AM CET - Amsterdam, the Netherlands – argenx SE...Read more
Five Year Collaboration Intended to Advance PD-1 / VEGF Bispecific in Several Solid Tumors across Multiple Clinical Trials MIAMI & HOUSTON / Jul 25, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) and The University of Texas MD Anderson Cancer Center (MD Anderson) today announced a strategic five-year collaboration agreement for the purpose of accelerating the development of...Read more
Ms. Hamill brings extensive experience and proven leadership focused on commercial growth and shareholder value DUBLIN, July 25, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the election of a new independent director, Laura Hamill, to its Board of Directors. Ms. Hamill, a 35-year veteran of the pharmaceutical industry brings broad executive leadership and global commercial...Read more
FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as the higher...Read more
THRIVE-2 exceeded its enrollment target due to patient demand; 188 patients enrolled with approximately 40% from US sites THRIVE topline readout in patients with active TED on track for September 2024 THRIVE-2 topline readout on track for year-end 2024 WALTHAM, Mass. / Jul 25, 2024 / Business Wire / Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential...Read more
BOTHELL, Wash. / Jul 25, 2024 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today provided an update on recent business development activity, including three recently closed transactions that are expected to enhance the company’s antibody-drug conjugate (ADC) capabilities. Immunome acquired worldwide, exclusive rights to: A panel...Read more
Weekly subcutaneous doses of pemvidutide resulted in up to 68.5% relative reduction in liver fat content (LFC), with up to 55.6% of subjects achieving LFC normalization after 12 weeks of treatment LFC changes were accompanied by significant improvements in body weight and non-invasive markers of liver inflammation Pemvidutide is currently being evaluated in the Phase 2b IMPACT trial in subjects with metabolic dysfunction-associated...Read more
Initiated Phase 2 clinical trial MALVERN, Pa., July 25, 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 dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being...Read more
Treatment of first randomized person with preclinical AD expected this quarter Phase 2b ReTain trial is fully funded and conducted by development partner Lausanne, Switzerland, July 25, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the...Read more
Treatment with INZ-701 shown to prevent intimal proliferation in both ENPP1-deficient and wild-type mice, supporting its potential therapeutic application beyond traditional ERT BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases that affect bone health and blood vessel function,...Read more
Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs) Final supportive study, the Oral Allergy Syndrome (OAS) challenge study, currently enrolling Continues to anticipate requesting a pre-New Drug Application (NDA) meeting before the end of the third quarter WARREN, N.J., July 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc....Read more
Data reviewed complies with standards that would be used to evaluate an EU Marketing Authorization Application PLYMOUTH MEETING, Pa., July 25, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Medicines Agency's Committee...Read more
Presentation to highlight positive outcomes of Iomab-B led bone marrow transplant in difficult to treat TP53 patients and the mutation-agnostic mechanism of Actimab-A for patients with relapsed or refractory acute myeloid leukemia Iomab-B and Actimab-A represent the only clinical stage antibody radiation conjugates in development for patients with acute myeloid leukemia NEW YORK, July 25, 2024 /PRNewswire/ -- Actinium...Read more
Sickle cell disease affects approximately 100,000 patients in the U.S. annually and is a debilitating and life-threatening condition with high unmet need Current conditioning with non-targeted chemotherapies provides limited access to potentially curative bone marrow transplant and recently approved gene therapies for sickle cell disease patients Initial trial focused on conditioning for bone marrow transplant intended to...Read more
ALL represents 10% of all leukemia cases in the United States, progresses rapidly, and is typically fatal within weeks or months if left untreated1 There is an urgent need to develop new therapies for ALL for patients who are not candidates for hematopoietic stem cell transplantation (HSCT) or relapse after FDA ODD and RPDD designations for UCART22 marks an important step towards developing allogeneic CAR T products that would be...Read more
BURLINGTON, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Supplemental New Drug Application...Read more
Data demonstrated in vitro and in vivo ITK inhibition with soquelitinib induced switching of proinflammatory Th17 cells into anti-inflammatory Treg cells Publication confirms and extends understanding of ITK inhibition mechanism of action and its potential in inflammatory autoimmune and allergic diseases Data published by leading researchers from Cornell University in peer-reviewed journal Science Signaling BURLINGAME, Calif., July...Read more
Potential best-in-class therapeutic index for lead candidate anti-CTLA-4 SAFEbody® ADG126 (muzastotug) with higher, more frequent and repeat dosing in combination with Merck’s anti-PD-1 therapy KEYTRUDA* (pembrolizumab) to unleash potential efficacy, while maintaining safety comparable to pembrolizumab alone Poster planned at European Society of Medical Oncology (ESMO) Congress 2024 in September for ADG126 in combination...Read more
WALTHAM, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review Checkpoint’s resubmission of its Biologics License Application (“BLA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for...Read more
NEW YORK, July 25, 2024 (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 an abstract related to IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress...Read more
Clinical benefit observed among non-small cell lung cancer (NSCLC) patients harboring mutant KRAS (mKRAS) variants in the Phase 2 mecbotamab vedotin (CAB-AXL-ADC) study; AXL tumoral expression highly associated with multiple mKRAS variants Evalstotug (CAB-CTLA-4 antibody) as a monotherapy and in combination with PD-1 continues to provide promising anti-tumor activity with a differentiated safety profile associated with a low...Read more
LOS ANGELES, CA, July 25, 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 disease, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded Immix Biopharma cell therapy division Nexcella an $8 million CLIN2 grant award to support clinical...Read more
MISSISSAUGA, Canada, July 25, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of a novel Quality Assessment Product (“QAP™”) for supporting Point-of-Care-Tests (“POCTs”) for infection with the Hepatitis C Virus (“HCV”) at the American Diagnostic and Laboratory Medicine (“ADLM”) conference taking place in...Read more
Prioritizing autoimmune programs aims to focus upon near-term and intermediate value creation potential, while retaining oncology programs as promising clinical data continues to mature Company anticipates annualized capital and workforce requirements to be reduced by approximately 25 percent BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a...Read more
First-in-Class CCL24 Neutralizing Antibody CM-101 Demonstrated a Favorable Safety Profile and Was Generally Well-Tolerated Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC), Establishing Clinical Proof-of-Concept for the Disease-Modifying Potential of CM-101 Treatment with CM-101 Led to Statistically Significant Improvements in Liver...Read more
TEL AVIV, Israel, July 25, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (“Chemomab” or the “Company”), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") that is expected to result in gross proceeds of...Read more
NESS ZIONA, Israel, July 25, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® for the treatment of acne vulgaris and EPSOLAY® for the treatment of inflammatory lesions of rosacea,...Read more
AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases...Read more
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United...Read more
Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults NDA submission on track for second half 2024 Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 25, 2024 (GLOBE...Read more
WARRINGTON, Pa., July 25, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced an update of istaroxime in both clinical and business development. Istaroxime is a novel first-in-class therapy that is designed to improve systolic contraction and diastolic...Read more
Confirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug (IND) filing and first patient dosed expected in 2025 CAMBRIDGE, Mass. / Jul 25, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders,...Read more
WESTON, Fla., July 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100. “Obesity, a well-established risk factor for an array of...Read more
60 Degrees Pharmaceuticals has been awarded a contract with the United States Army Medical Materiel Development Activity to facilitate commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s FDA-approved product indicated for malaria prevention Anticipating increasing ARAKODA sales volume in 2024, the Company increased the commercial batch size of ARAKODA in Q1 2024 Q1 2024...Read more
HOUSTON, TX / ACCESSWIRE / July 25, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that its abstract has been selected for poster presentation at the 2024 SNO/ASCO CNS Cancer Conference being held August 8-10, 2024 in Denver, CO. Details of...Read more
BRANFORD, Conn. / Jul 25, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR) (the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the closing of its previously announced public offering of 16,667,000 shares of common stock, at a public offering price of $0.30 per share. Total gross proceeds from the offering, before deducting underwriting...Read more
Now Approved for Children of All Ages with CLN2 Batten Disease, Regardless of Whether They Yet Show Symptoms SAN RAFAEL, Calif., July 24, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for BRINEURA® (cerliponase alfa) to slow the loss of ambulation in children of all ages with...Read more
Conference call scheduled for 4:30 p.m. ET today VK2735 to Advance to Phase 3 for Obesity; End-of-Phase 2 Meeting Planned for 2H24 Oral VK2735 Phase 2 Study in Obesity Expected to Begin 4Q24 Positive Biopsy Results From VK2809 Reported in June; End-of-Phase 2 Meeting in NASH/MASH Planned for 4Q24 Enrollment Completed in Phase 1b Study of VK0214 for X-ALD; Data Expected 2H24 In Vivo Data From Novel Amylin Agonist Program Reported at...Read more
Second Quarter Revenues of $399.1 Million Net Sales of Proprietary Products Increased Approximately 16% Year-Over-Year GAAP Net Income from Continuing Operations of $94.7 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.55 Company Reiterates 2024 Financial Expectations DUBLIN, July 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the...Read more
NOVATO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the company will share the latest clinical data, regulatory progress and program next steps for GTX-102, its investigational antisense oligonucleotide for Angelman syndrome, on Wednesday, July 24, at the 2024 Angelman Syndrome Foundation (ASF) Family Conference and Research Symposium in Sandusky, Ohio. “Since our positive...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
CORAL GABLES, Fla., July 24, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it has entered into a License, Supply, and Commercialization Agreement with Kye Pharmaceuticals Inc., ("Kye"...Read more
SAGE-324 (BIIB124) did not demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with essential tremor No statistically significant differences were demonstrated between any dose of SAGE-324 and placebo in the change from baseline for the primary endpoint CAMBRIDGE, Mass. / Jul 24, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB) announced...Read more
SOUTH SAN FRANCISCO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced that researchers at Columbia University Irving Medical Center (CUIMC) have initiated an investigator-sponsored trial (“IST”) of NKX019, Nkarta’s allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy in patients with systemic...Read more
Safety, tolerability, pharmacokinetic and pharmacodynamic profile of VG-3927 supports continued development as potential once-daily oral therapy for Alzheimer’s disease (AD) VG-3927 achieved robust decrease of sTREM2 in CSF demonstrating clinical proof-of-target engagement New preclinical and clinical data from SAD cohorts to be presented at upcoming 2024 Alzheimer’s Association International Conference (AAIC) Company...Read more
SAN DIEGO, July 24, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biopharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, is hosting a virtual KOL event titled “Metabolic Rewiring with CB1 Inhibition” today at 9:00 AM ET. During this event the company and members of its clinical advisory board will discuss the scientific rationale for its Nimacimab peripheral...Read more
BOSTON and SAN DIEGO, July 24, 2024 (GLOBE NEWSWIRE) -- Beacon Biosignals, a leader in at-home sleep monitoring and computational neurodiagnostics, today announced a strategic collaboration with Skye Bioscience, Inc. (Nasdaq: SKYE), a pharmaceutical company focused on unlocking new therapeutic pathways for metabolic health, to enhance its upcoming CBEYOND™ Phase 2 clinical trial of Nimacimab. This partnership will incorporate sleep...Read more
NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a...Read more
Event will feature Dr. Randolph Hecht (Professor, UCLA GI Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) EMERYVILLE, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced it will host a virtual key opinion leader (KOL) event on Friday, August 2 at 9:00 AM ET featuring J....Read more
Vancouver, British Columbia--(Newsfile Corp. - July 24, 2024) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, is pleased to announce that its Canadian Nuclear Research Initiative Health ("CNRI-H") Program application was retained and approved by the Canadian Nuclear Laboratories...Read more
Proposed merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for serious, rare genetic skin diseases for which there are no FDA-approved therapies Combined company is expected to have approximately $80.5 million of cash and cash equivalents at closing, including approximately $78.9 million from an oversubscribed private financing with participation from a...Read more
OCALA, Fla., July 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor...Read more
MELBOURNE, Australia and SAN FRANCISCO, July 24, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, will be presenting a webinar to investors and shareholders hosted by MST Financial on Thursday, 25 July 2024 at 8:30am AEST. CEO David Stamler will present the Company’s recent...Read more
FOSTER CITY, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”, “Notable Labs” or the “Company”), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Medicine Platform (PMP), today announced progress for the Phase 2 volasertib program following receipt of “Clearance to Proceed” from the FDA and agreement on the dosing plan for its Phase 2 clinical...Read more
CHATHAM, NJ / ACCESSWIRE / July 24, 2024 / From anthrax to the plague, biological warfare is a real threat to U.S. forces and civilians, so much so the Pentagon budgeted about $2 billion for the country's biological defense for the coming fiscal year. It's also why the U.S. Department of Defense is seeking broad-spectrum antiviral drugs and teaming up with the biotech companies developing them. That's the case with Tonix...Read more
Calgary, Alberta--(Newsfile Corp. - July 24, 2024) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF), and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), today is pleased to announce the extension of its collaboration with Drs. Julie Le Merrer and Jerome Becker, lead investigators at the iBraiN Institute in Tours France. Building upon the promising results using MB204 in an autism...Read more
JACKSON CENTER, Pa., July 24, 2024 (GLOBE NEWSWIRE) -- Halberd Corporation (OTC-PINK: "HALB”) has announced encouraging preliminary outcomes from its Phase II testing at Mississippi State University (MSU) of its Tri-Ax™ nasal spray, aimed at mitigating the effects of traumatic brain injury (TBI) following head trauma. Dr. Russell Carr, the project's Principal Investigator, commented: “In the early stages of our Phase II studies, we...Read more
Treatment of pre-clinical subjects showed cognitive benefits that suggest HT-ALZ's mode of action may involve a reduction in brain inflammation, thereby improving cognitive outcomes for Alzheimer's patients. HT-ALZ's pre-clinical significance lies in its ability to demonstrate marked cognitive improvement and quality of life for subjects suffering from Alzheimer's disease The pre-clinical research shows compelling evidence of HT-ALZ's...Read more
Data indicates that SON-080 was well-tolerated at both doses, with no evidence of a pro-inflammatory cytokine response Pain and quality of life survey results suggest the potential for rapid improvement of peripheral neuropathy symptoms and post-dosing durability with both doses, compared to placebo controls Sonnet intends to seek a partnership to support initiation of a Phase 2 clinical trial of SON-080 in Diabetic Peripheral...Read more
BOSTON, July 24, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ) (“TransCode” or the “Company”), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced the closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.30 per share, for gross proceeds of $3,000,000, before deducting...Read more
10 of 12 patients treated in HER2 expressing solid tumor Phase 1b trial were breast cancer patients Dose selected for ongoing Phase 2b clinical trial in Osteosarcoma was shown to be well tolerated in breast cancer patients Preclinical breast cancer efficacy models showed positive data to prevent breast cancer metastases to the brain, reduce tumor growth by over 90% in combination with HER2-targeted antibodies, and prevent the formation...Read more
Co-Founder and Co-Chairman of The Carlyle Group brings multi-industry investor experience and global policy expertise, replacing retiring director Stephen Berenson Co-founder and director Robert Langer also to retire from the Moderna Board; recruitment efforts ongoing for his replacement CAMBRIDGE, MA / ACCESSWIRE / July 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that David M. Rubenstein, Co-Founder and Co-Chairman of...Read more
$800 million investment in New Jersey supports global growth and expansion with technologically advanced manufacturing capacity and clinical development capabilities for novel cancer medicines HOPEWELL, N.J. / Jul 23, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the opening of its flagship U.S. facility in Hopewell, N.J., at the Princeton West Innovation...Read more
PALO ALTO, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases, announced that Thomas Trimarchi, Ph.D., has been appointed President and Chief Operating Officer (COO) of the company. Dr. Trimarchi will assume his new responsibilities effective immediately and will continue to report directly to CEO and...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
Approximately 40% of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalp Once-daily ZORYVE foam significantly improved both scalp and body psoriasis in a Phase 2b and a pivotal Phase 3 trial Data also show rapid reduction in scalp itch as soon as 24 hours after first application ZORYVE foam demonstrated a favorable safety and tolerability profile WESTLAKE VILLAGE, Calif., July...Read more
Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s New Drug Application (NDA) in the United States Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung Cancer (WCLC) Taletrectinib granted Orphan Drug Designation by the U.S. Food and Drug...Read more
NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that the United States Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) resubmission for Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). FDA considers the...Read more
SOUTH SAN FRANCISCO, Calif., July 23, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced presentations related to the Company’s TREM2 and progranulin programs at the upcoming Alzheimer's Association International Conference® 2024 (AAIC®) being held online and in Philadelphia, Pennsylvania from July 28 – August 1, 2024. Poster presentations will...Read more
Results from the at-home test kit are available to HCPs and their patients through 1health LOS ANGELES / Jul 23, 2024 / Business Wire / ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research with a focus on healthy aging, launches the Niagen+ NAD+ Test Kit*, now available exclusively through the company’s healthcare practitioner (HCP) channel. This innovative test kit provides...Read more
Publication of detailed analysis on INKmune biology compared to cytokine stimulated cells demonstrates important anti-tumor memory like NK cell characteristics BOCA RATON, Fla., July 23, 2024 (GLOBE NEWSWIRE) -- -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company developing treatments that harness the patient’s innate immune system to fight disease, announced the...Read more
IND follows encouraging findings of necrosis, inflammation and T cell infiltration in tumor biopsy of patient in lowest dose cohort SAN JOSE, Calif., July 23, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Moffitt Cancer Center (Moffitt), has received approval by the U.S. Food and...Read more
Collaboration to focus on the development of a formulation of Senju’s SJP-0035 for use with Eyenovia’s Optejet® dispensing technology, following consultation with FDA Chronic dry eye estimated to be a $5 billion global addressable market NEW YORK, July 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive...Read more
56.4% major response rate exceeded 20% primary endpoint 98.2% disease control rate achieved in heavily pretreated patients Responses shown in difficult-to-treat, high-needs patient populations with approximately 27% of patients refractory to all available therapies and 40% dual-class refractory (BTKi and rituximab) FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage...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
Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising clinical activity with a manageable safety profile in treatment-refractory patients with squamous cell carcinoma of the head and neck (SCCHN) in its Phase 2 clinical trial The Company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024 SAN DIEGO, July 23,...Read more
BOSTON / Jul 23, 2024 / Business Wire / Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of common stock, as well as pre-funded warrants to purchase common stock in lieu of common stock for certain investors and accompanying warrants to purchase...Read more
THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing CHICAGO / Jul 23, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies...Read more
First study of AllocetraTM in psoriatic arthritis, a chronic inflammatory condition that causes joint pain, swelling and stiffness, affects as many as 30% of people with psoriasis1, and has limited treatment options Nes-Ziona, Israel, July 23, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of...Read more
DENVER, July 23, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports treatment of the first patient in a commercial setting with QUELIMMUNE™, its U.S. Food and Drug Administration (FDA)-approved, patented cell-directed extracorporeal therapy to treat acute kidney injury (AKI) in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney...Read more
WINNIPEG, Manitoba, July 23, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech”, “Kane” or the “Company”) announces that the US Food and Drug Administration (FDA) has eliminated its usage limitation on the Company’s 510(k) cleared revyve™ Antimicrobial Wound Gel (“revyve™”). Prior to the removal of this restriction, there was a 90 grams/month limit to the amount of revyve™ product that could be...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 14.44 1.36 | $1,078.63 |
| argenx | 8.13 1.67 | $494.46 |
| ZIVO Bioscience | 7.25 659.09 | $8.35 |
| SIGA Technologies | 5.08 93.38 | $10.52 |
| Windtree Therapeutics | 5.00 151.98 | $8.29 |
| Avidity Biosciences | 3.42 7.65 | $48.14 |
| Vertex Pharmaceuticals | 3.00 0.61 | $495.26 |
| Krystal Biotech | 2.97 1.41 | $213.66 |
| Mirum Pharmaceuticals | 2.96 7.33 | $43.33 |
| Corbus Pharmaceuticals | 2.61 4.71 | $58.06 |
| Enliven Therapeutics | 2.29 9.15 | $27.31 |
| Cassava Sciences | 2.17 17.02 | $14.92 |
| Neurogene | 2.13 4.99 | $44.83 |
| Jazz Pharmaceuticals | 2.03 1.85 | $111.57 |
| Keros Therapeutics | 2.03 4.04 | $52.32 |
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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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
CLICK TO LEARN MORE