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Rocket Pharmaceuticals’ FDA Resubmission for KRESLADI™ Accepted

Story Highlights
  • Rocket Pharmaceuticals’ FDA resubmission for KRESLADI™ was accepted on October 14, 2025.
  • KRESLADI™ shows 100% survival in trials, with a PDUFA date set for March 28, 2026.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Rocket Pharmaceuticals’ FDA Resubmission for KRESLADI™ Accepted

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Rocket Pharmaceuticals ( (RCKT) ) has shared an announcement.

On October 14, 2025, Rocket Pharmaceuticals announced that the FDA accepted the resubmission of the Biologics License Application for KRESLADI™, a gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA set a PDUFA date of March 28, 2026, for this investigational therapy, which has shown promising results in clinical trials, including 100% overall survival at 12 months post-infusion. If approved, Rocket Pharmaceuticals may receive a Rare Pediatric Disease Priority Review Voucher, potentially enhancing their market positioning and offering a new treatment option for patients with this life-threatening condition.

The most recent analyst rating on (RCKT) stock is a Hold with a $7.00 price target. To see the full list of analyst forecasts on Rocket Pharmaceuticals stock, see the RCKT Stock Forecast page.

Spark’s Take on RCKT Stock

According to Spark, TipRanks’ AI Analyst, RCKT is a Underperform.

Rocket Pharmaceuticals’ overall score reflects its position as a biotechnology firm in the development phase, with significant financial risks due to its lack of revenue and reliance on external financing. Technical indicators suggest potential volatility, while the negative P/E ratio highlights current valuation challenges. The company’s strong equity position is a positive factor, but ongoing cash burn remains a critical concern.

To see Spark’s full report on RCKT stock, click here.

More about Rocket Pharmaceuticals

Rocket Pharmaceuticals, Inc. is a fully integrated, late-stage biotechnology company focused on developing genetic therapies for rare disorders with high unmet needs. The company employs a multi-platform approach to design gene therapies for various indications, including a lentiviral vector-based hematology portfolio for conditions such as Leukocyte Adhesion Deficiency-I (LAD-I), Fanconi Anemia, and Pyruvate Kinase Deficiency, as well as an adeno-associated viral vector-based cardiovascular portfolio for diseases like Danon Disease and PKP2-arrhythmogenic cardiomyopathy.

Average Trading Volume: 3,738,408

Technical Sentiment Signal: Sell

Current Market Cap: $369M

For detailed information about RCKT stock, go to TipRanks’ Stock Analysis page.

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