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 placement (the “Private Pl... 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 oral, liver selective, glucokinase... 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 company focused on the generation and... 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, 2024 (GLOBE NEWSWIRE) -- ProMIS... 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, supporting confidence in Multikine’s... 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 Global Investment Conference... 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 National Comprehensive Cancer Network... Read more
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” below for a reconciliation of... 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 stiffness.
The TRANSFORM trial is a... 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 development of chimeric... 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 incidence of immune-related adverse e... 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 readily available for all patients NEW... 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 for Advanced Therapies (CAT) has... 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 novel class of therapeutic biologics... 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 2024. The poster will share data... 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 discounts and other offering expenses,... 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 the presentation are as follows:
Title:... 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 ARAKODA sales revenue increased 515%... 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 inform subsequent gene therapy conditioning... 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 concentration formulation of LIVMARLI... 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 25, 2024 (GLOBE NEWSWIRE) -- Corvus... 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, today announced the publication... 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, today announced encouraging EB-003... 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 best-in-class medicines for serious... 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 ivonescimab.
Leveraging MD... 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. (NASDAQ: AQST) (“Aquestive” or the... 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 relaxation of the heart... 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 of antibodies against an undisclosed... 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 NEWSWIRE) -- Tonix Pharmaceuticals... 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 (sNDA) seeking to expand... 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 different metabolic disorders,... 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 Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM)... 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 Conference August 8-10, in Denver,... 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 steatohepatitis (MASH), with data... 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 adults with metastatic... 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 Stiffness, a Well-Validated Biomarker... 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 pathologic form of the Tau protein,... 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 States.
BioCardia previously confirmed... 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, today announced it has entered into... 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 Chicago, Illinois... 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 developed for geographic atrophy... 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 approximately $10 million to the... 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 operations expertise to the company's Bo... 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 (Euronext & Nasdaq: ARGX),... 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 with pembrolizumab in metastatic... 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 neuronal ceroid lipofuscinosis... 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 ADA in June; IND in Obesity Planned... 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 of breast cancer compared with... 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 model earlier this year, we now aim... 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 cell growth and improved... Read more
