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Iovance Biotherapeutics: Tough Decisions Being Made But Catalysts In H2'25
Seeking Alpha· 2025-08-21 20:56
Group 1 - Iovance Biotherapeutics has taken initial steps to rebuild confidence in the launch of Amtagvi (lifileucel) [1] - The company's financial situation regarding cash resources compared to cash burn remains questionable [1] - A previous analysis rated Iovance Biotherapeutics as a hold, indicating cautious optimism [1]
Celldex: Despite Dropping Eosinophilic Esophagitis Program, Barzolvolimab On Track
Seeking Alpha· 2025-08-21 19:45
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
S&P 500 Moves Lower; Walmart Shares Fall After Q2 Results
Benzinga· 2025-08-21 17:27
U.S. stocks traded lower midway through trading, with the Dow Jones index falling around 50 points on Thursday.The Dow traded down 0.62% to 44,660.91 while the NASDAQ fell 0.74% to 21,016.48. The S&P 500 also fell, dropping, 0.66% to 6,353.29.Check This Out: How To Earn $500 A Month From Intuit Stock Ahead Of Q4 EarningsLeading and Lagging SectorsHealth care shares jumped by 0.7% on Thursday.In trading on Thursday, consumer staples stocks fell by 0.9%.Top HeadlineShares of Walmart Inc. WMT fell 4% on Thursd ...
Krystal Biotech Announces Update on Development Plans for Oncology Program KB707 and Prioritization of Inhaled KB707 for the Treatment of Non-Small Cell Lung Cancer
Globenewswire· 2025-08-21 16:11
Core Viewpoint - Krystal Biotech, Inc. is advancing the development of KB707, a redosable immunotherapy targeting non-small cell lung cancer (NSCLC), with promising early efficacy data leading to an End of Phase 2 meeting with the FDA to discuss registration pathways [1][2][3] Group 1: Development Plans and Efficacy - The company has observed a 36% objective response rate in heavily pre-treated NSCLC patients as of April 15, 2025, with no Grade 4 or 5 adverse events reported, indicating a favorable safety profile [3] - Enrollment is ongoing in the KYANITE-1 study, a Phase 1/2 trial evaluating inhaled KB707 in patients with locally advanced or metastatic lung tumors [4] - The company has paused enrollment in the OPAL-1 study, which evaluates intratumoral KB707, to prioritize inhaled KB707, while continuing to monitor patients in OPAL-1 [5] Group 2: Company Overview - Krystal Biotech is a commercial-stage biotechnology company focused on genetic medicines for diseases with high unmet medical needs, with its first product, VYJUVEK, being the first redosable gene therapy approved in multiple regions [6]
Shattuck Labs Announces IND for SL-325 Is in Effect for the Treatment of Inflammatory Bowel Disease
Globenewswire· 2025-08-21 14:17
Core Insights - Shattuck Labs, Inc. is developing SL-325, a potentially first-in-class DR3 antagonist antibody aimed at treating Inflammatory Bowel Disease (IBD) and other inflammatory and immune-mediated diseases [1][5] - The company plans to dose the first participant in its Phase 1 clinical trial in healthy volunteers in Q3 2025, with enrollment expected to be completed by Q2 2026 [2][4] - Current cash and cash equivalents, along with anticipated proceeds of up to $103 million from a recent private placement, are expected to fund operations into 2029 [1] Company Overview - Shattuck Labs, Inc. specializes in developing treatments for autoimmune and inflammatory diseases, focusing on novel therapeutics targeting TNF superfamily receptors [5] - The company has offices in Austin, Texas, and Durham, North Carolina [5] Clinical Development - SL-325 is designed to achieve a complete and durable blockade of the DR3/TL1A pathway, with preclinical studies showing high-affinity binding and superior activity compared to TL1A antibodies [4] - The Phase 1 clinical trial will evaluate safety, tolerability, and pharmacokinetics through a randomized, double-blind, placebo-controlled design [2]
Apollo Biowellness, Inc., Launches New Product Brand
Newsfile· 2025-08-21 13:30
Core Insights - Apollo Biowellness, Inc. has announced the launch of a new self-stable biologic cosmetic line named Cielo Skin Care, which utilizes self-stabilized exosome and placental-based products derived from human tissue to enhance skin cell regeneration and anti-aging effects [1][3][4] Product Launch Details - The Cielo Skin Care line is set to launch in late Q3 and will be available in Q4 through major retail, e-commerce, direct-to-consumer marketing, social media influencers, and TV shopping outlets [4] - The company claims this is the first shelf-stable biologic skin care cosmetic, which is expected to significantly contribute to the growth of its business model alongside its existing Doctor and Med Spa brand, Evolutionary Biologics [4] Company Overview - Apollo Biowellness, Inc. and its subsidiary, Evolutionary Biologics, focus on the discovery, development, and marketing of products aimed at improving human health, positioning themselves as leaders in the field of Regenerative Medicine [5] - The company is currently working on marketing licensed patent-pending natural stem cell mobilizing agents and a dual acting all-natural diet aid designed to help control hunger [5]
Contact The Gross Law Firm by October 6, 2025 Deadline to Join Class Action Against Altimmune, Inc.(ALT)
Prnewswire· 2025-08-21 12:45
ALLEGATIONS: According to the complaint, on June 26, 2025, Altimmune published a press release announcing topline results from the IMPACT Phase 2b MASH trial of Pemvidutide in the Treatment of MASH. While defendants had continuously provided inflated expectations ahead of these results, the analysis showed a pointed failure by the Company to achieve statistical significance in its analysis of the fibrosis reduction primary endpoint in its IMPACT Phase 2b MASH trial. In particular, while a positive trend in ...
Tyra Biosciences Announces First Child Dosed in BEACH301, its Phase 2 Study for Dabogratinib (TYRA-300) in Pediatric Achondroplasia
Prnewswire· 2025-08-21 12:00
-Dabogratinib is the only oral FGFR3-selective inhibitor in clinical development for achondroplasia- -Initial results from safety sentinel cohort expected in 2H 2026- CARLSBAD, Calif., Aug. 21, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that the first child has been dosed in BEACH301, a Phase 2 c ...
iSpecimen Announces Completion of Milestone 1 in Digital Transformation Journey with Salestack Platform
Newsfile· 2025-08-21 12:00
The completion of Milestone 1 is expected to provide several immediate and long-term benefits significant to the Company: This accomplishment positions iSpecimen to advance to Milestone 2 (Integration), which will focus on connecting all parts of the Company's business to the Salestack platform to create end-to-end efficiency across operations, customer engagement, and data management. "With Milestone 1 complete, we have implemented a robust and scalable platform that sets the stage for innovation," continu ...
Septerna Announces Dosing of the First Participants in Phase 1 Clinical Trial of SEP-631, an Oral Small Molecule MRGPRX2 Negative Allosteric Modulator for the Treatment of Mast Cell-Driven Diseases
GlobeNewswire News Room· 2025-08-21 12:00
"Mast cell-driven diseases represent significant unmet medical needs worldwide, affecting millions of patients who often struggle with inadequate symptom relief with current therapies," said Jae Kim, M.D., chief medical officer of Septerna. "We are excited to initiate the first-in-human trial for SEP-631, a small molecule NAM that aims to inhibit mast cell activation by selectively blocking MRGPRX2, a GPCR that plays a critical role in mast cell activation and degranulation. SEP-631 has the potential to pro ...