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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: luckydog88 who wrote (63138)	6/16/2025 7:49:23 AM
From: luckydog88	1 Recommendation Recommended By erippetoe Respond to of 63283

downgrades this morning: HC Wainwright Downgrades Sarepta Therapeutics to Sell From Neutral, Adjusts PT to $10 From $40 Piper Sandler Downgrades Sarepta Therapeutics to Neutral From Overweight, Adjusts PT to $36 From $70 BMO Capital Downgrades Sarepta Therapeutics to Market Perform From Outperform, Adjusts PT to $70 From $120 Sarepta Therapeutics, Inc. (SRPT) stock experienced a steep decline of approximately 40% in premarket trading on Monday following a sobering safety update for its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. What Happened On Sunday, Sarepta provided a safety update regarding Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy, and steps the company is taking to strengthen the safety profile in non-ambulatory patients. These steps follow a second reported case of acute liver failure (ALF), resulting in death. In March, Sarepta Therapeutics (SRPT) reported a patient death following treatment with Elevidys, having suffered acute liver failure. The cases of ALF to date have both occurred in non-ambulatory (patients who cannot walk independently) individuals with Duchenne. Sarepta and Roche Holdings AG (OTC:RHHBY) temporarily halted several clinical studies in April. During its first-quarter earnings release, Sarepta revised its 2025 total net product revenues guidance to $2.3-$2.6 billion from $2.9-$3.1 billion. William Blair writes that the revised guidance primarily concerns delayed Elevidys turnaround times. *Also Read: Ten-Year Data From Roche’s Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%* Key Safety Initiatives As part of a comprehensive review of safety data, Sarepta is taking proactive steps to mitigate the risk of acute liver failure in non-ambulatory patients. A panel will evaluate data and assess the company’s proposed regimen, which includes sirolimus and is supported by preclinical data demonstrating the effectiveness of additional immunosuppression in moderating liver enzyme elevations, a key factor in mitigating potential safety events. Sarepta will share the panel’s recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. In the meantime, Sarepta is temporarily suspending shipments of Elevidys for non-ambulatory patients. For ambulatory patients, no treatment changes are being proposed and the current practice of administering corticosteroids before and after Elevidys infusion and post-treatment monitoring remains the same. Sarepta has voluntarily paused dosing in the ENVISION clinical study (also known as Study SRP-9001-303). ENVISION is a global, randomized, double-blind, placebo-controlled trial evaluating Elevidys in older ambulatory and non-ambulatory Duchenne muscular dystrophy patients. In the U.S., it serves as the confirmatory trial required under the FDA’s accelerated approval pathway for non-ambulatory patients.