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Robbins LLP Reminds Sarepta Therapeutics, Inc. Investors with Large Losses to Contact the Firm for Information About the SRPT Class Action Lawsuit
GlobeNewswire News Room· 2025-07-07 21:24
Core Viewpoint - A class action has been filed against Sarepta Therapeutics, Inc. for allegedly misleading investors regarding the safety of its gene therapy drug, ELEVIDYS, during the period from June 22, 2023, to June 24, 2025 [1][2]. Allegations - The complaint alleges that Sarepta failed to disclose significant safety risks associated with ELEVIDYS, including the inability of trial protocols to detect severe side effects and the potential for adverse events to halt recruitment and dosing in clinical trials [2]. - Specific incidents include a patient death reported on March 18, 2025, leading to a stock price drop of $27.81 per share (27.44%) to close at $73.54 [3]. - A second patient death due to acute liver failure was disclosed on June 15, 2025, resulting in a further stock price decline of $15.24 per share (42.12%) to close at $20.91 [3]. - Following an FDA investigation announcement regarding acute liver failure risks on June 24, 2025, Sarepta's stock fell by $1.52 per share (8.01%) to close at $17.46 [4]. Class Action Participation - Shareholders interested in participating as lead plaintiffs must file a motion by August 25, 2025, but can remain absent class members without taking action [5].
Ascendis to Share Its Latest Endocrinology Rare Disease Data at ENDO 2025
Globenewswire· 2025-07-07 20:01
Core Insights - Ascendis Pharma A/S announced two oral presentations at ENDO 2025, showcasing data on the safety and efficacy of its treatments for hypoparathyroidism and achondroplasia [1][2] Group 1: Hypoparathyroidism - Dr. Aliya Khan will present data from Week 156 of the Phase 3 PaTHway Trial, highlighting the long-term safety and efficacy of TransCon PTH (palopegteriparatide) in adults with hypoparathyroidism [1][2] - The presentation will cover maintenance of serum and urine biochemistries within normal levels and sustained improvement in renal function [1] Group 2: Achondroplasia - Dr. Carlos Bacino will present safety and tolerability data from Week 52 of the pivotal ApproaCH Trial of once-weekly TransCon CNP (navepegritide) in children with achondroplasia [1][2] - The data is expected to support the transformative potential of the investigational therapy for this rare genetic condition [2] Group 3: Company Overview - Ascendis Pharma is focused on applying its innovative TransCon technology platform to develop therapies that address unmet medical needs [5] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [5]
Inventiva receives $10 million milestone payment from CTTQ
Globenewswire· 2025-07-07 20:00
Daix (France), New York City (New York, United States), July 7, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the receipt of a $10 million milestone payment from Chia Tai-Tianqing Pharmaceutical Group Co., Ltd (“CTTQ”), a subsidiary of Sino Biopharm. This milestone payment follows the succes ...
The Play On Aurinia Pharmaceuticals: Rising Cash Flow Provides Opportunity
Seeking Alpha· 2025-07-07 16:49
Group 1 - The article highlights Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) as a focus for investment discussions in 2025, particularly in the context of covered call opportunities in the biotech sector [1] - The Biotech Forum, led by Bret, offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions and weekly research updates [1] - The forum provides market commentary and portfolio updates every weekend, indicating an active engagement with current market trends [1] Group 2 - The article does not provide specific financial metrics or performance data for Aurinia Pharmaceuticals Inc. or the broader biotech industry [2][3]
Ipsen - Half year statement - 2025 06 30
Globenewswire· 2025-07-07 16:00
Core Insights - Ipsen has announced its half-year statement regarding the liquidity agreement with NATIXIS ODDO BHF, detailing the resources allocated to the dedicated liquidity account as of June 30, 2025 [1] - The company operates as a global biopharmaceutical entity focusing on transformative medicines in oncology, rare diseases, and neuroscience, leveraging nearly 100 years of development experience [2] - Ipsen is publicly listed on Euronext in Paris and has a Sponsored Level I American Depositary Receipt program in the U.S. [3] Financial Summary - As of June 30, 2025, the liquidity account included 38,030 shares valued at €1,320,416.64 and 12,751 shares valued at €3,137,934.80 [6] - The trading volume during the period from January 1, 2025, to June 30, 2025, included 2,468 purchase transactions and 2,393 sell transactions, with a total of 339,729 shares purchased for €36,644,907.65 and 326,400 shares sold for €35,329,344.25 [6]
Immix Biopharma Announces Accelerated NEXICART-2 Clinical Trial Progress in relapsed/refractory AL Amyloidosis
Globenewswire· 2025-07-07 13:35
Core Insights - Immix Biopharma is advancing its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, expanding to 18 sites in the U.S. [1][2] - The company is on track for the first Biologics License Application (BLA) for a cell therapy targeting an unaddressed orphan indication [1][2] - Interim results from the NEXICART-2 trial were presented at ASCO 2025, showcasing the progress of the therapy [1][2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The lead candidate is NXC-201, a BCMA-targeted CAR-T cell therapy, currently evaluated in a multi-center study [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3] Market Context - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [5] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [5]
SELLAS Life Sciences Appoints Linghua Wang, MD, PhD, to Scientific Advisory Board
Globenewswire· 2025-07-07 12:45
Core Insights - SELLAS Life Sciences Group, Inc. has appointed Dr. Linghua Wang to its Scientific Advisory Board, enhancing its expertise in cancer research and translational science [1][2] - The company aims to leverage Dr. Wang's experience in cancer immunogenomics and computational biology to advance its scientific and clinical strategy during a critical growth phase [2][3] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications [4] - The lead product candidate, GPS, targets the WT1 protein found in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [4] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [4]
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
Globenewswire· 2025-07-07 12:30
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable disease or better with two partial responses and two complete responses lasting 7.5 and 66+ months, respectively Preclinical data support a novel combination of MB-101 (IL13Rα2‐targeted CAR-T cell therapy) and MB-108 (HSV-1 oncolytic virus) to optimize clinical results FDA previously granted Orphan Drug Designation to Mustang for MB-108 for the treatment of malignant glioma WORCESTER, Mas ...
Silo Pharma Advances PTSD Drug SPC-15 Toward Planned 2025 IND Submission with Pre-Clinical Study Data Expected in Q3 2025
Globenewswire· 2025-07-07 12:15
Core Insights - Silo Pharma, Inc. is developing SPC-15, an intranasal prophylactic targeting Post-Traumatic Stress Disorder (PTSD), with plans to submit an Investigational New Drug (IND) application by the end of 2025 [1][4] - The company anticipates receiving preclinical study data for SPC-15 within 30 to 90 days, which will inform the IND application process [1][4] - SPC-15 aims to address a significant unmet need in the PTSD treatment market, as there have been no new drug approvals for PTSD in nearly 25 years, despite the condition affecting approximately 3.9% of the global population [6] Company Overview - Silo Pharma is a developmental stage biopharmaceutical company focused on novel therapeutics for underserved conditions, including stress-induced psychiatric disorders and chronic pain [8] - The company collaborates with Columbia University for preclinical studies and holds exclusive global rights for the development and commercialization of SPC-15 [7][8] - Silo Pharma's portfolio includes other programs targeting fibromyalgia, chronic pain, Alzheimer's disease, and multiple sclerosis [8] Drug Development Process - The final studies for SPC-15 include a Good Laboratory Practice-compliant toxicology study and a large animal safety study requested by the FDA [2] - The company plans to utilize the FDA's 505(b)(2) regulatory pathway for SPC-15, which could expedite the approval process and reduce development costs [5] - If the IND application is approved, Silo Pharma could initiate a Phase 1 clinical trial for SPC-15 by the end of 2026 [4]
GSK's Specialty Medicines Surge - Still Looks Undervalued In 2025
Seeking Alpha· 2025-07-07 11:45
Core Insights - GSK plc is a prominent biopharmaceutical company focused on developing specialty and general drugs, as well as vaccines [1] Financial Performance - GSK's Q1 2025 results demonstrated strong momentum, particularly in the specialty medicines segment [1] - The oncology performance of GSK was noted as excellent, indicating a robust growth area for the company [1]