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PolyPid Unveils a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Diabetes and Weight Loss Market
Globenewswire· 2025-07-15 12:00
PolyPid's proprietary and clinically validated, prolonged-release drug delivery technology aims to subcutaneously deliver GLP-1 for approximately 60 days, compared to current standard of care of weekly injections. The GLP-1 delivery platform expands PolyPid's product portfolio beyond the recently successful Phase 3 D- PLEX100 , demonstrating versatility of the Company's proprietary drug delivery platforms in multiple major therapeutic areas. PETACH TIKVA, Israel, July 15, 2025 (GLOBE NEWSWIRE) -- PolyPid Lt ...
Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.
Prnewswire· 2025-07-15 12:00
Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11 Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy NCT04554914 also o ...
Lisata Therapeutics Expands Intellectual Property Portfolio with New Composition of Matter Patent for Certepetide
Globenewswire· 2025-07-15 12:00
About Lisata Therapeutics Newly issued U.S. patent extends certepetide IP protection to 2040, with subsequent opportunity for patent term extension This patent covers novel cyclic peptides and their use in treating solid tumors BASKING RIDGE, N.J, July 15, 2025 (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 t ...
SELLAS Meets All Primary Endpoints in Phase 2 Trial of SLS009 in r/r AML and Receives FDA Guidance to Advance into First-Line Therapy Study
Globenewswire· 2025-07-15 11:45
Core Insights - SELLAS Life Sciences Group has successfully met all primary endpoints in its Phase 2 trial of SLS009 (tambiciclib) for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3][4] Trial Design and Objectives - The Phase 2 trial was an open-label, single-arm, multi-center study assessing the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels: 45 mg and 60 mg [2] - The trial aimed for a target overall response rate (ORR) of at least 20% and a median survival of at least 3 months [2] Efficacy Results - The trial exceeded the target ORR of 20%, achieving an ORR of 44% among AML MR patients at the optimal 30 mg twice a week (BIW) dose and 50% in ASXL1-mutated AML MR patients [6][12] - Median overall survival (mOS) was reported at 8.9 months for AML MR patients and 8.8 months for those refractory to venetoclax-based regimens, significantly surpassing historical benchmarks of 2.4 months [6][12] Safety Profile - SLS009 was well tolerated, with no dose-limiting toxicities observed across all treatment arms, validating its safety profile [9][12] Future Development Plans - Based on the positive Phase 2 results, the company plans to advance SLS009 into a randomized trial targeting newly diagnosed AML populations, with enrollment expected to begin by Q1 2026 [3][10][13] - The upcoming trial will include two cohorts: one for patients unlikely to benefit from standard therapy based on molecular profiling and another for patients showing early resistance to treatment [13][14] Industry Context - The results from the trial highlight a significant advancement in treatment options for patients with r/r AML, addressing a critical unmet medical need in this patient population [11][12]
Palatin Announces Positive Preclinical Efficacy Data for Oral MC4R Agonist PL7737 in Animal Model of Obesity
Prnewswire· 2025-07-15 11:30
Oral PL7737 monotherapy produced rapid and significant weight loss after just 4 days of treatment Combination of oral PL7737 and tirzepatide resulted in additive weight loss effects IND-enabling toxicology program ongoing IND submission planned for 4Q2025; Clinical data expected in 1H2026PRINCETON, N.J., July 15, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (OTCQB: PTNT), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin rec ...
ZEVASKYN™ Gene Therapy Now Available at New Qualified Treatment Center in San Francisco Bay Area
Globenewswire· 2025-07-15 11:30
Core Insights - Abeona Therapeutics has activated a Qualified Treatment Center for ZEVASKYN, the first FDA-approved therapy for treating RDEB wounds with a single application [1][2] - ZEVASKYN is a gene-modified cellular therapy developed through a collaboration between Abeona Therapeutics and Stanford Medicine, receiving FDA approval in April 2025 [1][2] - The treatment is now available at Lucile Packard Children's Hospital Stanford and Lurie Children's Hospital of Chicago, marking a significant milestone in its commercial launch [2] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product for RDEB [7] - The company operates a fully integrated cGMP cell and gene therapy manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [7] Product Details - ZEVASKYN (prademagene zamikeracel) is the first autologous cell sheet-based gene therapy for RDEB, addressing a severe skin disease caused by defects in the COL7A1 gene [3][4] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, leading to clinically meaningful wound healing and pain reduction [3][4] Patient Support Initiatives - Abeona has established a comprehensive patient support program, Abeona Assist™, to help eligible patients access ZEVASKYN, including assistance with insurance benefits and logistical support [2]
Plus Therapeutics Presents ReSPECT-LM Clinical Trial Results for REYOBIQ™ in Patients with Leptomeningeal Metastases
Globenewswire· 2025-07-15 11:30
Presentation by trial principal investigator at the 2025 SNO/ASCO CNS Metastases Conference Plus will also host an educational symposium with leading experts titled, “Reimagining Your Approach to Leptomeningeal Metastases” HOUSTON, July 15, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces the oral presentat ...
60 Degrees Pharmaceuticals Defines Potential Human Babesiosis Market Size for ARAKODA® (tafenoquine): Annual Max TAM, Sales of $245 Million; Cumulative through Patent Expiration, $1.1 Billion
Globenewswire· 2025-07-15 11:01
New Drug Application intended for 2026, subject to generation of positive data from three U.S. clinical trials planned or in progressTotal addressable market (TAM) for ARAKODA for Human Babesiosis is informed by results of a 6,000 nationwide patient survey and a quantitative research study involving 300 healthcare professionals WASHINGTON, July 15, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing n ...
Perspective Therapeutics to Provide Business Highlights and Report Second Quarter 2025 Financial Results
Globenewswire· 2025-07-15 11:00
Company Overview - Perspective Therapeutics, Inc. is a radiopharmaceutical company focused on advanced cancer treatments using proprietary technology that employs the alpha-emitting isotope Pb to target cancer cells specifically [2][3] - The company is also developing complementary imaging diagnostics that utilize the same targeting moieties, allowing for personalized treatment and optimized patient outcomes through a "theranostic" approach [2] Clinical Development - The company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are currently in Phase 1/2a imaging and therapy trials in the U.S. [3] - Perspective Therapeutics is expanding its regional network of drug product finishing facilities, supported by its proprietary Pb generator, to provide patient-ready products for clinical trials and commercial operations [3] Upcoming Financial Reporting - The company will report its second quarter 2025 financial results and provide a business update on August 13, 2025, before the market opens [1]
New Strong Buy Stocks for July 15th
ZACKS· 2025-07-15 10:56
Group 1 - Futu Holdings Limited (FUTU) has seen a 7.4% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Pan American Silver Corp. (PAAS) has experienced a 9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - RAPT Therapeutics, Inc. (RAPT) has seen a significant increase of 72.1% in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Hamilton Insurance Group, Ltd. (HG) has experienced an 18.4% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Invesco Ltd. (IVZ) has seen a 7.1% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [3]