Silexion stock falls after receiving German regulatory feedback

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Investing.com -- Silexion Therapeutics Corp (NASDAQ:SLXN) stock fell 4% Tuesday after the company announced it received formal...

Investing.com -- Silexion Therapeutics Corp (NASDAQ:SLXN) stock fell 4% Tuesday after the company announced it received formal written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) regarding its planned Phase 2/3 clinical trial for SIL204.

The clinical-stage biotechnology company, which develops RNA interference therapies for KRAS-driven cancers, described the feedback as "positive" and "an important milestone" supporting the acceptability of its proposed study design. However, investors appeared unimpressed with the timeline, as the company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of the fourth quarter of 2025 and in Germany during the first quarter of 2026.

Silexion remains on track to initiate its Phase 2/3 clinical trial of SIL204, its lead product candidate for locally advanced pancreatic cancer, in the first half of 2026, pending regulatory clearance. The written feedback from BfArM covered clinical design, dosing plans, patient population strategy, nonclinical support, and manufacturing considerations.

"This written Scientific Advice represents a meaningful step in our regulatory path and provides us with the supporting clarity needed to finalize our Phase 2/3 submission packages," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion.

The company continues to advance operational and development activities required for trial launch, including manufacturing readiness, toxicology data integration, and clinical site preparations.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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enGene stock rises after FDA selects bladder cancer therapy for CMC pilot program

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Investing.com -- enGene Holdings Inc (NASDAQ:ENGN) stock rose 2% on Tuesday after the FDA selected its bladder cancer therapy for a specialized manufacturing readiness program.

The clinical-stage genetic medicines company announced that its non-viral gene therapy, detalimogene voraplasmid, has been chosen to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The therapy is being developed for patients with high-risk, non-muscle invasive bladder cancer.

The CDRP Program, which selects only nine companies annually, is designed to support manufacturing development for therapies with compressed clinical development timeframes. It allows for earlier and more structured engagement between companies and the FDA on manufacturing strategies.

"Manufacturing readiness in drug development is often underappreciated. We have already scaled detalimogene manufacturing to commercial-level, and CDRP is expected to help ensure CMC readiness for filing and commercialization," said Ron Cooper, President and Chief Executive Officer of enGene.

The selection comes shortly after enGene reported positive preliminary results from its LEGEND trial’s pivotal cohort. The trial showed an improved complete response rate of 62% at six months in patients with high-risk, BCG-unresponsive bladder cancer with carcinoma in situ. Safety data from 125 patients demonstrated a favorable tolerability profile, with low rates of treatment-related adverse events.

Detalimogene has already received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA. The company plans to submit a Biologics License Application for the therapy in the second half of 2026.

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German Competition Watchdog Reviews Changes to Apple's App Tracking Framework

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By Edith Hancock

Germany's competition regulator said it is reviewing changes Apple made to its app-tracking consent tools in the country after officials warned they could give the tech giant's own software a leg-up over competing apps.

The Federal Cartel Office said Tuesday that it is looking at a series of changes Apple has made to its App Tracking Transparency Framework that allow users to choose whether apps can track their activity across other apps and websites for advertising.

The watchdog said that Apple shows different consent prompts depending on whether an app is Apple's or a third-party's. It warned in February that the wording and design of those windows made it more likely that users would choose to consent to its access requests than to those from other apps.

"In order to keep this important privacy tool available to our users in Germany, we have agreed to make changes to the text and formatting of the ATT prompt at the FCO's request, while maintaining core user benefits," an Apple spokesperson said. The company said it doesn't show the App Tracking Transparency prompt for third-parties because it doesn't track users across other companies' apps and websites.

Under the proposed changes, Apple offered to revise consent windows it displays for third parties' tracking and personalized ads and to simplify the query structure it includes for third-party apps, the FCO said.

The FCO also said that Apple didn't offer to change its advertising success measurement process. It said it will seek feedback from app publishers, media and advertising industry associations, content providers and local data privacy authorities to check if the changes bring Apple's features in line with Germany's digital competition rules.

FCO president Andreas Mundt said Apple's framework is of considerable importance for competition across the digital ecosystem, adding that the case hinges on who determines how apps gain access to user data. "We see a fundamental need for change and are therefore carefully examining whether the currently proposed adjustments are sufficient," he said.

Write to Edith Hancock at edith.hancock@wsj.com

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Investing.com -- Token Cat Limited (NASDAQ:TC) stock rose 4.1% Tuesday after the company announced its board had approved a new Crypto Asset Investment Policy authorizing the allocation of up to $1 billion of cash reserves into selected crypto assets.

The company plans to implement the policy in phases, focusing initially on emerging crypto project tokens with strong growth prospects, including assets related to AI, RAW-to-chain initiatives, and token-equity hybrid models.

Token Cat recently appointed Sav Persico as Chief Operating Officer to lead the implementation of this new strategy. Persico brings thirty years of crypto and blockchain experience to the role.

"The Policy is an important step in strengthening our asset strategy. Sav’s deep expertise in crypto and blockchain will help us execute this long-term plan with strong discipline and effective leadership," said Guangsheng Liu, Chief Executive Officer of Token Cat Limited.

The company has established a Crypto Asset Risk Committee, led by the CFO, to oversee asset allocation and manage risk controls. The committee will report regularly to the board. Token Cat emphasized it will not self-custody acquired crypto assets, instead opting for high-tier custody standards.

Persico stated that the company views crypto assets as "long-term value reserves, not speculative tools," aiming to enhance resilience amid macroeconomic uncertainty.

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