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Morgan Stanley Names Rocket Pharmaceuticals (RCKT) as Key Beneficiary of 2026 Biotech Sector Recovery

https://finviz.com/news/315164/morgan-stanley-names-rocket-pharmaceuticals-rckt-as-key-beneficiary-of-2026-biotech-sector-recovery
Morgan Stanley has identified Rocket Pharmaceuticals (RCKT) as a key beneficiary of the anticipated 2026 biotech sector recovery. Despite a recent price target reduction, the firm expects small-to-mid-cap biotech companies like RCKT to outperform as they transition from capital consumption to production. Rocket Pharmaceuticals recently achieved significant milestones, including the FDA lifting a clinical hold on a pivotal trial and setting a PDUFA action date for its KRESLADI gene therapy.

Rocket Pharmaceuticals (NASDAQ:RCKT) General Counsel Martin Wilson Sells 12,253 Shares

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-general-counsel-martin-wilson-sells-12253-shares-2026-02-18/
Rocket Pharmaceuticals General Counsel Martin Wilson sold 12,253 shares of RCKT stock for $40,557 on February 13th, reducing his ownership by 1.76%. The stock traded up 4.2% to $3.45 on February 18th, with analysts holding a consensus "Hold" rating and a price target of $14.36. Institutional investors own 98.39% of the company which focuses on gene therapies for rare pediatric diseases.

Rocket Pharmaceuticals (NASDAQ:RCKT) CEO Sells $40,643.49 in Stock

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-ceo-sells-4064349-in-stock-2026-02-18/
Rocket Pharmaceuticals (NASDAQ:RCKT) CEO Gaurav Shah sold 12,279 shares of the company's stock for a total of $40,643.49 on February 13th, reducing his ownership by 1.15%. Following the sale, Shah still owns 1,052,045 shares valued at approximately $3.48 million. The stock traded up during midday, and institutional investors own a significant portion of the company, while analyst ratings are mixed with a consensus "Hold" and an average target price of $14.36.

Rocket Pharmaceuticals (NASDAQ:RCKT) Insider John Militello Sells 3,726 Shares

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-insider-john-militello-sells-3726-shares-2026-02-18/
Rocket Pharmaceuticals insider John Militello sold 3,726 shares of the company's stock on February 13th at an average price of $3.31, reducing his stake by 3.89%. Following the sale, Militello directly owns 92,176 shares. Despite the insider selling, Rocket Pharmaceuticals saw its stock trade up 4.2% on heavy volume, while analysts maintain a "Hold" consensus rating with a wide range of price targets.

Morgan Stanley Names Rocket Pharmaceuticals (RCKT) as Key Beneficiary of 2026 Biotech Sector Recovery

https://www.insidermonkey.com/blog/morgan-stanley-names-rocket-pharmaceuticals-rckt-as-key-beneficiary-of-2026-biotech-sector-recovery-1698331/
Morgan Stanley identifies Rocket Pharmaceuticals (RCKT) as a key beneficiary of an anticipated biotech sector recovery in 2026, predicting outperformance for US small-to-mid cap biotech companies. The company achieved significant regulatory milestones including FDA lifting a clinical hold on a Phase 2 trial and setting a PDUFA date for KRESLADI, marking progress towards its first commercial launch. Despite lowering its price target, Morgan Stanley maintains an Equal Weight rating, noting RCKT's focus on gene therapies for rare diseases and its advancements in both cardiovascular and hematology programs.
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Analysts Recommend Rocket Pharmaceuticals as a Top Buy

https://intellectia.ai/news/stock/analysts-recommend-rocket-pharmaceuticals-as-a-top-buy
Analysts are highlighting Rocket Pharmaceuticals as a potential top buy, despite Morgan Stanley lowering its price target due to ongoing optimism for small-to-mid cap biotech companies. The company has made significant clinical progress, including the FDA lifting a clinical hold on RP-A501 and setting a PDUFA action date for KRESLADI, a gene therapy vital for its commercial launch. Rocket Pharmaceuticals is strategically focusing on hematology programs and advancing cardiovascular products, positioning itself for future revenue growth and market competitiveness.

Rocket Pharmaceuticals (NASDAQ:RCKT) Stock Passes Below 50-Day Moving Average - Here's What Happened

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-stock-passes-below-50-day-moving-average-heres-what-happened-2026-02-10/
Rocket Pharmaceuticals (NASDAQ:RCKT) stock recently fell below its 50-day moving average, trading as low as $3.07 and closing at $3.20. The company currently holds a "Hold" consensus rating from analysts, with an average price target of $14.36, and exhibits strong institutional ownership at 98.39%. Despite mixed analyst ratings and a negative P/E ratio, Rocket Pharmaceuticals maintains strong liquidity with a current and quick ratio of 7.30.

Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) Receives Average Recommendation of "Hold" from Brokerages

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-inc-nasdaqrckt-receives-average-recommendation-of-hold-from-brokerages-2026-02-02/
Seventeen brokerage analysts have given Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) a consensus "Hold" rating, with an average 12-month price target of $14.36. Institutional investors hold a significant 98.39% of the stock, though recent filings show only minor adjustments to positions. The company, which focuses on gene therapies for rare pediatric diseases, reported slightly better-than-expected earnings in its last quarter.

Rocket Pharmaceuticals Stock Craters After Gene Therapy Patient Dies

https://www.msn.com/en-us/health/other/rocket-pharmaceuticals-stock-craters-after-gene-therapy-patient-dies/ar-AA1FA2St?apiversion=v2&domshim=1&noservercache=1&noservertelemetry=1&batchservertelemetry=1&renderwebcomponents=1&wcseo=1
Rocket Pharmaceuticals (RCKT) stock fell sharply after the company reported the death of a patient in its Phase 1 clinical trial for RP-A501, an investigational gene therapy for Danon Disease. The company stated the death was due to a severe cardiac adverse event, possibly related to the therapy, and has paused enrollment for the higher dose cohort while continuing to monitor patients. This news impacted investor confidence, leading to a significant drop in share value despite the company's intention to engage with regulatory bodies regarding the ongoing trial.

Rocket Pharmaceuticals (NASDAQ:RCKT) Stock Price Crosses Above Fifty Day Moving Average - Here's Why

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-stock-price-crosses-above-fifty-day-moving-average-heres-why-2026-01-24/
Rocket Pharmaceuticals (NASDAQ:RCKT) stock price recently crossed above its 50-day moving average, trading at $3.72 on high volume, indicating potential upward momentum. The company, a clinical-stage gene therapy developer for rare pediatric diseases, holds an average analyst rating of "Hold" with a consensus target price of $14.36, despite recent downgrades from some firms. Institutional investors have significantly increased their holdings, with 98.39% of the stock owned by hedge funds and other institutional investors.
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Will The FDA's Decision On KRESLADI Propel Rocket Pharmaceuticals?

https://www.rttnews.com/amp/3610695/will-the-fda-s-decision-on-kresladi-propel-rocket-pharmaceuticals.aspx
Rocket Pharmaceuticals (RCKT) shares are down significantly from their 52-week high as the company awaits an FDA decision on KRESLADI, a gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I). The FDA previously declined approval but accepted a resubmitted Biologics License Application, with a decision date set for March 28, 2026. An approval could lead to a valuable Rare Pediatric Disease Priority Review Voucher and potential peak sales of $294 million for KRESLADI by 2031, according to an analyst.

Will The FDA's Decision On KRESLADI Propel Rocket Pharmaceuticals?

https://www.rttnews.com/3610695/will-the-fda-s-decision-on-kresladi-propel-rocket-pharmaceuticals.aspx
Rocket Pharmaceuticals (RCKT) is nearing a significant regulatory decision for its gene therapy KRESLADI, targeting severe Leukocyte Adhesion Deficiency-I (LAD-I), with the FDA's decision date set for March 28, 2026. The therapy previously met all primary and secondary endpoints in a global Phase 1/2 study, demonstrating 100% overall survival at 12 months. An approval could lead to a Rare Pediatric Disease Priority Review Voucher, which is transferable and could generate substantial non-dilutive cash for the company, whose shares are currently down 65% from their 52-week high.

RCKT: 2026 will see key clinical milestones and a potential first commercial launch in gene therapy

https://www.tradingview.com/news/urn:summary_document_transcript:quartr.com:2599880:0-rckt-2026-will-see-key-clinical-milestones-and-a-potential-first-commercial-launch-in-gene-therapy/
Rocket Pharmaceuticals (RCKT) is focusing on three cardiovascular gene therapy programs, with Danon disease as the primary near-term value driver. The company anticipates approval for Kresladi in March 2026, which is expected to extend its cash runway and support future product launches. Multiple clinical milestones are also anticipated throughout 2026 for its pipeline.

Rocket Pharmaceuticals to Participate in the 44th Annual J.P. Morgan Healthcare Conference

https://www.businesswire.com/news/home/20260105175291/en/Rocket-Pharmaceuticals-to-Participate-in-the-44th-Annual-J.P.-Morgan-Healthcare-Conference
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) announced its participation in the 44th Annual J.P. Morgan Healthcare Conference. CEO Gaurav Shah, M.D., is scheduled to present on Wednesday, January 14, at 11:15 a.m. PT and will be available for investor meetings. A webcast of the presentation will be accessible on the Investors section of the Company’s website.

Rocket Pharmaceuticals to Participate in the 44th Annual J.P. Morgan Healthcare Conference

https://finance.yahoo.com/news/rocket-pharmaceuticals-participate-44th-annual-120000360.html
Rocket Pharmaceuticals, a late-stage biotechnology company, announced its participation in the 44th Annual J.P. Morgan Healthcare Conference. CEO Gaurav Shah, M.D., is scheduled to present on January 14 at 11:15 a.m. PT. The company is advancing genetic therapies for rare disorders including Danon Disease, PKP2-arrhythmogenic cardiomyopathy, LAD-I, Fanconi Anemia, and Pyruvate Kinase Deficiency.
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Rocket Pharmaceuticals to Participate in the 44th Annual J.P. Morgan Healthcare Conference

https://www.biospace.com/press-releases/rocket-pharmaceuticals-to-participate-in-the-44th-annual-j-p-morgan-healthcare-conference
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) announced its participation in the 44th Annual J.P. Morgan Healthcare Conference. CEO Gaurav Shah, M.D., is scheduled to present on January 14 at 11:15 a.m. PT. The company, a late-stage biotechnology firm, focuses on developing genetic therapies for rare disorders, with a pipeline including treatments for Danon Disease, PKP2-arrhythmogenic cardiomyopathy, LAD-I, Fanconi Anemia, and Pyruvate Kinase Deficiency.

The Truth About Rocket Pharmaceuticals: Is RCKT About To Explode Or Crash?

https://www.ad-hoc-news.de/boerse/ueberblick/the-truth-about-rocket-pharmaceuticals-is-rckt-about-to-explode-or-crash/68445542
Rocket Pharmaceuticals (RCKT) is generating significant buzz in biotech and finance circles due to its focus on gene therapy for rare diseases. The article explores the hype, the company's business fundamentals including its pipeline and cash position, and its volatility, advising potential investors that it's a high-risk, high-reward speculative stock. It concludes that RCKT is a "game-changer candidate" for risk-takers, but not a guaranteed winner.

Rocket Pharmaceuticals: Upside On LAD-I Approval And Amended Danon Program

https://seekingalpha.com/article/4855875-rocket-pharmaceuticals-upside-on-lad-i-approval-amended-danon-program
Rocket Pharmaceuticals (RCKT) is rated Buy with a $17 price target, significantly higher than its current price. The bullish outlook is driven by a high-probability LAD-1 approval in March 2026 and the resumption of the Danon's disease trial with an improved protocol. Risk-adjusted DCF analysis values its key programs at approximately $700M, far surpassing the current $151M enterprise value, and near-term catalysts include the LAD-1 PDUFA date and a potential $150M Priority Review Voucher.

Rocket Pharmaceuticals (NASDAQ:RCKT) Raised to Hold at TD Cowen

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-nasdaqrckt-raised-to-hold-at-td-cowen-2025-12-20/
TD Cowen upgraded Rocket Pharmaceuticals (NASDAQ:RCKT) to a "hold" rating, contributing to a consensus "Hold" rating for the stock with an average price target of $14.50. The company recently reported better-than-expected quarterly EPS of ($0.45) but is anticipated to post a full-year loss of approximately $2.83 per share. Insider activity shows a significant sale of shares by John Militello in October, and institutional investors hold a substantial stake in the company.

RCKT Class Action Alert: Shareholder Rights Law Firm Robbins LLP Reminds Investors of the Lead Plaintiff Deadline in the Rocket Pharmaceuticals, Inc. Class Action Lawsuit

https://www.keloland.com/business/press-releases/accesswire/1040153/rckt-class-action-alert-shareholder-rights-law-firm-robbins-llp-reminds-investors-of-the-lead-plaintiff-deadline-in-the-rocket-pharmaceuticals-inc-class-action-lawsuit/
Robbins LLP has filed a class action lawsuit against Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) on behalf of investors who purchased securities between February 7 and May 26, 2025. The lawsuit alleges that Rocket Pharmaceuticals misled investors regarding the viability and efficacy of their drug RP-A501 for Danon disease, after a patient in the Phase 2 trial experienced a serious adverse event and died, causing the stock to drop significantly. The firm is reminding investors of the lead plaintiff deadline.
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Rocket Pharmaceuticals Leads Our Trio Of Penny Stock Contenders

https://simplywall.st/stocks/us/software/otc-raas.y/cloopen-group-holding/news/rocket-pharmaceuticals-leads-our-trio-of-penny-stock-contend/amp
This article highlights three penny stock contenders for investors to consider as the year ends, amid market volatility. It delves into the financial health, operations, and recent developments of Rocket Pharmaceuticals (RCKT), a biotechnology company, and Cloopen Group Holding (RAAS.Y), a cloud-based communication provider, noting their potentials despite current unprofitability. The piece emphasizes the importance of strong financials and growth potential for penny stocks.

Rocket Pharmaceuticals Leads Our Trio Of Penny Stock Contenders

https://simplywall.st/stocks/us/software/otc-raas.y/cloopen-group-holding/news/rocket-pharmaceuticals-leads-our-trio-of-penny-stock-contend
Amidst U.S. market volatility at year-end, this article explores penny stock opportunities, focusing on three companies: Rocket Pharmaceuticals, Cloopen Group Holding, and another unidentified one. Rocket Pharmaceuticals, a pre-revenue biotechnology company, is highlighted for its progress in gene therapy and a promising BLA submission despite being unprofitable. Cloopen Group Holding, a Chinese cloud communication company, is also examined for its revenue segments and financial health, noting its volatility and management experience.

Rocket Pharmaceuticals (RCKT) Stock Target Reduced Following Q3 2025 Update on Cash Position

https://finviz.com/news/254776/rocket-pharmaceuticals-rckt-stock-target-reduced-following-q3-2025-update-on-cash-position
BofA reduced its price target for Rocket Pharmaceuticals (RCKT) to $8 from $10, maintaining a Buy rating, following the company's Q3 2025 update on its cash position. Rocket Pharmaceuticals reported a strong financial foundation with ~$222.8 million in cash, cash equivalents, and investments, projected to fund operations into Q2 2027. The company also made significant progress in its AAV cardiovascular gene therapy portfolio and has a BLA resubmission for KRESLADI accepted by the FDA with a PDUFA target action date of March 28, 2026.

Rocket Pharmaceuticals (RCKT) Stock Target Reduced Following Q3 2025 Update on Cash Position

https://www.insidermonkey.com/blog/rocket-pharmaceuticals-rckt-stock-target-reduced-following-q3-2025-update-on-cash-position-1660422/?amp=1
BofA reduced Rocket Pharmaceuticals' (RCKT) price target to $8 from $10, maintaining a Buy rating after the company updated its cash position following its Q3 2025 earnings. Rocket Pharmaceuticals reported approximately $222.8 million in cash, cash equivalents, and investments, providing an operational runway into Q2 2027, and significantly reduced its net loss compared to the previous year. The company also made progress in its gene therapy pipeline, with the FDA lifting a clinical hold on its RP-A501 trial and accepting the BLA resubmission for KRESLADI.

Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) Receives Consensus Rating of "Hold" from Brokerages

https://www.marketbeat.com/instant-alerts/rocket-pharmaceuticals-inc-nasdaqrckt-receives-consensus-rating-of-hold-from-brokerages-2025-12-14/
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) has received a consensus "Hold" rating from eighteen brokerages, with an average 12-month target price of $15.47, significantly higher than its current share price of $3.39. This rating results from three sell, seven hold, and eight buy recommendations. Despite the "Hold" consensus, analysts expect a full-year EPS of -2.83, while the company reported a quarterly EPS of -$0.45, beating estimates. Insider John Militello recently sold 28,918 shares, reducing his ownership by over 30%.
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Maverick Capital Ltd. Has $20.49 Million Stock Position in Rocket Pharmaceuticals, Inc. $RCKT

https://www.marketbeat.com/instant-alerts/filing-maverick-capital-ltd-has-2049-million-stock-position-in-rocket-pharmaceuticals-inc-rckt-2025-12-12/
Maverick Capital Ltd. has significantly increased its stake in Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) by 60.9%, now owning 7.75% of the company, valued at $20.49 million. Institutional ownership of Rocket Pharmaceuticals is high at 98.39%, while insiders hold 24.76%, despite a recent insider sale. The company's stock is trading around $3.45 with an average analyst rating of "Hold" and a consensus price target of $15.47.

We're Keeping An Eye On Rocket Pharmaceuticals' (NASDAQ:RCKT) Cash Burn Rate

https://www.sahmcapital.com/news/content/were-keeping-an-eye-on-rocket-pharmaceuticals-nasdaqrckt-cash-burn-rate-2025-12-09
Rocket Pharmaceuticals (NASDAQ:RCKT) is an unprofitable company whose cash burn rate is being scrutinized. With US$223m cash and a burn rate of US$203m last year, the company has an estimated cash runway of 13 months, prompting concerns about its long-term financial sustainability without significant changes or new funding. The company's cash burn is 56% of its market capitalization, meaning that raising more capital through share issuance could substantially dilute existing shareholders.

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Rocket Pharmaceuticals, Inc. - RCKT

https://www.wjtv.com/business/press-releases/globenewswire/9461848/investor-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-rocket-pharmaceuticals-inc-rckt/
Pomerantz LLP is investigating Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) following a significant stock price drop. This investigation follows the announcement of a serious adverse event, including a patient death, in a Phase 2 trial for RP-A501, an investigational gene therapy. The FDA has placed a clinical hold on the trial, leading to a 62.84% fall in Rocket's stock price.

Rocket Pharmaceuticals to Participate in the 8th Annual Evercore Healthcare Conference

https://www.businesswire.com/news/home/20251125498119/en/Rocket-Pharmaceuticals-to-Participate-in-the-8th-Annual-Evercore-Healthcare-Conference
Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) announced its participation in the 8th Annual Evercore Healthcare Conference in Miami. Gaurav Shah, M.D., Chief Executive Officer, will engage in a fireside chat on Tuesday, December 2, at 7:55 a.m. ET and host investor meetings. A webcast of the presentation will be accessible on the Investors section of the Company’s website.

Rocket Pharmaceuticals Trims Losses And Stays On Track For Gene Therapy

https://finimize.com/content/rocket-pharmaceuticals-trims-losses-and-stays-on-track-for-gene-therapy
Rocket Pharmaceuticals (RCKT) has reduced its net loss to $50.3 million in Q3 2025 and implemented cost controls, extending its cash reserves until Q2 2027. The gene therapy firm is progressing with its clinical pipeline, including a Phase 2 trial for Danon disease and a regulatory decision for KRESLADI expected by March 2026. Wall Street analysts maintain a 'buy' consensus with an $8 price target, indicating a 58.5% upside.
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Rocket Pharmaceuticals Reports Third Quarter 2025 Financial Results and Highlights Recent Progress

https://www.businesswire.com/news/home/20251106225105/en/Rocket-Pharmaceuticals-Reports-Third-Quarter-2025-Financial-Results-and-Highlights-Recent-Progress
Rocket Pharmaceuticals (NASDAQ: RCKT) released its Q3 2025 financial results, highlighting significant progress in its genetic therapy pipeline for rare disorders. Key achievements include the planned resumption of the pivotal Phase 2 trial for RP-A501 for Danon disease in H1 2026 and the upcoming PDUFA date for KRESLADI™ for severe LAD-I on March 28, 2026. The company also announced key leadership appointments and reported a cash position of $222.8 million, providing an operational runway into Q2 2027.

Rocket Pharmaceuticals, Inc. Q3 Loss Decreases, Beats Estimates

https://www.nasdaq.com/articles/rocket-pharmaceuticals-inc-q3-loss-decreases-beats-estimates
Rocket Pharmaceuticals (RCKT) reported a Q3 loss of -$50.33 million, or -$0.45 per share, which is a decrease from -$66.72 million, or -$0.71 per share, in the prior year. This financial outcome surpassed analysts' average expectation of a -$0.52 per share loss. The company's Q3 performance indicates improved financial results compared to the same period last year and exceeded Street estimates.

What is Leerink Partnrs’ Estimate for RCKT FY2026 Earnings? - Defense World

https://www.defenseworld.net/2025/10/18/what-is-leerink-partnrs-estimate-for-rckt-fy2026-earnings.html
This article discusses Leerink Partners' FY2026 earnings estimate for Rocket Pharmaceuticals (RCKT), alongside other analyst opinions. It also covers recent insider transactions, institutional investor activity, and provides an overview of Rocket Pharmaceuticals' business focusing on gene therapies for rare diseases.

RCKT Stock Up as FDA Accepts Resubmitted BLA for Gene Therapy - TradingView

https://www.tradingview.com/news/zacks:74408084d094b:0-rckt-stock-up-as-fda-accepts-resubmitted-bla-for-gene-therapy/
Rocket Pharmaceuticals announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for gene therapy Kresladi (marnetegragene autotemcel; marne-cel) to treat severe LAD-I, with a decision expected by March 28, 2026. The BLA acceptance led to a 23.1% surge in RCKT's stock, following positive data from a global phase I/II study. The company previously received a Complete Response Letter for the BLA and would be eligible for a Rare Pediatric Disease Priority Review Voucher upon approval.

FDA Acceptance Of Rocket Pharmaceuticals' Lead Gene Therapy Application Reestablishes Momentum For Stock - Benzinga

https://www.benzinga.com/news/fda/25/10/48208865/fda-acceptance-of-rocket-pharmaceuticals-lead-gene-therapy-application-reestablishes-momentum-for-stock
The FDA accepted Rocket Pharmaceuticals' Biologics License Application resubmission for Kresladi, its lead gene therapy for severe Leukocyte Adhesion Deficiency-I (LAD-I), setting a PDUFA date of March 28, 2026. This acceptance is seen positively by analysts, re-establishing momentum for the stock given the therapy's compelling durability and positive clinical data, which include 100% overall survival at 12 months post-infusion. Analysts anticipate potential peak sales of $294 million by 2031, despite the company's planned focus on its late-stage AAV pipeline.
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Rocket Pharmaceuticals Shares Surge after FDA Accepts Drug Application Resubmission - MarketScreener

https://www.marketscreener.com/news/rocket-pharmaceuticals-shares-surge-after-fda-accepts-drug-application-resubmission-ce7d5aded981f32d
Rocket Pharmaceuticals' shares surged by over 17% after the FDA accepted the resubmission of its application for Kresladi, a drug to treat severe Leukocyte Adhesion Deficiency-I. The FDA has set a target action date of March 28, 2026, for its decision. An approval could also make the company eligible for a Rare Pediatric Disease Priority Review Voucher.

Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission of KRESLADI™ for the Treatment o - PharmiWeb.com

https://www.pharmiweb.com/press-release/2025-10-14/rocket-pharmaceuticals-announces-fda-acceptance-of-bla-resubmission-of-kresladi-for-the-treatment-o
Rocket Pharmaceuticals announced that the FDA has accepted the Biologics License Application (BLA) resubmission for KRESLADI™ (marnetegragene autotemcel) to treat severe Leukocyte Adhesion Deficiency-I (LAD-I), setting a PDUFA target action date of March 28, 2026. The BLA is supported by positive Phase 1/2 study data, showing 100% overall survival at 12 months, satisfaction of all primary and secondary endpoints, and a well-tolerated safety profile for the gene therapy. If approved, Rocket is eligible for a Rare Pediatric Disease Priority Review Voucher.

Rocket Pharmaceuticals (RCKT) Resubmitted Gene Therapy Application Accepted by FDA

https://www.gurufocus.com/news/3142256/rocket-pharmaceuticals-rckt-resubmitted-gene-therapy-application-accepted-by-fda
Rocket Pharmaceuticals (RCKT) shares surged 11% after the FDA accepted its resubmitted application for Kresladi, a gene therapy for LAD-I, setting a target action date of March 28, 2026. The therapy previously showed 100% survival rate in a Phase 1/2 study, highlighting its potential despite the company's current status as a clinical-stage entity with no revenue but strong liquidity. The resubmission follows an initial rejection, marking a significant regulatory step forward for the biopharmaceutical company.

Rocket Pharma says gene therapy gets FDA review (RCKT:NASDAQ) - Seeking Alpha

https://seekingalpha.com/news/4503852-rocket-pharma-says-gene-therapy-gets-fda-review
Rocket Pharmaceuticals' gene therapy candidate Kresladi is undergoing FDA review again after the company's resubmitted marketing application was accepted. This news led to an ~11% jump in RCKT's premarket trading. The FDA had previously rejected the initial biologics license application in June 2024.

FDA Accepts Rocket Pharmaceuticals' Resubmission for Kresladi Gene Therapy

https://www.gurufocus.com/news/3141739/fda-accepts-rocket-pharmaceuticals-resubmission-for-kresladi-gene-therapy
Rocket Pharmaceuticals (RCKT) has announced that the FDA accepted its resubmitted biologics license application for Kresladi, a gene therapy for severe Leukocyte Adhesion Deficiency-I, with a PDUFA target date of March 28, 2026. The clinical-stage biotechnology company, despite having no revenue and negative earnings, shows strong liquidity and low leverage through its financial ratios but faces high stock volatility and a "Distressed" stock categorization based on its Piotroski F-Score. Institutional ownership is high, reflecting investor confidence, balanced by mixed insider activity.
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Rocket Pharmaceuticals’ FDA Resubmission for KRESLADI™ Accepted - TipRanks

https://www.tipranks.com/news/company-announcements/rocket-pharmaceuticals-fda-resubmission-for-kresladi-accepted
Rocket Pharmaceuticals announced that the FDA has accepted the resubmission of its Biologics License Application for KRESLADI™, a gene therapy for severe LAD-I, with a PDUFA date set for March 28, 2026. The therapy has shown 100% survival in clinical trials, and if approved, the company may receive a Rare Pediatric Disease Priority Review Voucher. Despite a current "Underperform" rating from Spark AI Analyst due to developmental-phase risks and lack of revenue, the company's strong equity position is noted as a positive.

FDA accepts Rocket Pharmaceuticals’ gene therapy BLA for rare disease - Investing.com

https://www.investing.com/news/company-news/fda-accepts-rocket-pharmaceuticals-gene-therapy-bla-for-rare-disease-93CH-4285541
This article indicates that there was an application error preventing the content from loading. Therefore, no information about the FDA's acceptance of Rocket Pharmaceuticals' gene therapy BLA for a rare disease is available. The article content is limited to navigation and error messages.

FDA accepts Rocket Pharmaceuticals' resubmitted gene therapy application - StreetInsider

https://www.streetinsider.com/Corporate+News/FDA+accepts+Rocket+Pharmaceuticals+resubmitted+gene+therapy+application/25449948.html
The FDA has accepted Rocket Pharmaceuticals' resubmitted Biologics License Application for KRESLADI, an investigational gene therapy for severe Leukocyte Adhesion Deficiency-I, setting a PDUFA target action date of March 28, 2026. This application is supported by positive Phase 1/2 study data showing 100% overall survival and significant improvements in patients with LAD-I, a rare and often fatal genetic immune disorder. The therapy has various FDA and EU designations, and Rocket Pharmaceuticals expects a Rare Pediatric Disease Priority Review Voucher upon approval.

100% overall survival at 12 months — Rocket Pharma's KRESLADI BLA accepted; PDUFA Mar 28, 2026 - Stock Titan

https://www.stocktitan.net/news/RCKT/rocket-pharmaceuticals-announces-fda-acceptance-of-bla-resubmission-xffvx05191jz.html
Rocket Pharmaceuticals announced that the FDA has accepted the resubmission of its Biologics License Application (BLA) for KRESLADI™ (marnetegragene autotemcel; marne-cel) for severe Leukocyte Adhesion Deficiency-I (LAD-I). The Prescription Drug User Fee Act (PDUFA) target action date is March 28, 2026. The BLA is supported by positive Phase 1/2 clinical data showing 100% overall survival at 12 months post-infusion, with all primary and secondary endpoints met and the therapy being well tolerated.

Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission of KRESLADI™ for the Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I) - Yahoo Finance

https://finance.yahoo.com/news/rocket-pharmaceuticals-announces-fda-acceptance-110000620.html
Rocket Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) resubmission for KRESLADI™ (marnetegragene autotemcel) to treat severe Leukocyte Adhesion Deficiency-I (LAD-I), setting a PDUFA target action date of March 28, 2026. The BLA is supported by positive Phase 1/2 study data showing 100% overall survival and significant reductions in infections, with KRESLADI™ being well-tolerated. Rocket Pharmaceuticals is also eligible for a Rare Pediatric Disease Priority Review Voucher upon approval.
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Rocket Pharmaceuticals Announces FDA Acceptance of BLA Resubmission of KRESLADI™ for the Treatment of Severe Leukocyte Adhesion Deficiency-I (LAD-I) - The Joplin Globe

https://www.joplinglobe.com/region/national_business/rocket-pharmaceuticals-announces-fda-acceptance-of-bla-resubmission-of-kresladi-for-the-treatment-of-severe/article_71b63a6c-c07c-5e7c-b3e5-04b9177d9fa8.html
Rocket Pharmaceuticals announced the FDA's acceptance of the Biologics License Application (BLA) resubmission for KRESLADI™ (marnetegragene autotemcel) for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I). The BLA is supported by strong clinical efficacy and safety data from a global Phase 1/2 study, which demonstrated 100% overall survival at 12 months post-infusion. This gene therapy aims to provide a potential cure for patients with severe LAD-I, who currently face limited treatment options and poor survival rates beyond childhood.

Rocket Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635c4 - MarketScreener

https://www.marketscreener.com/news/rocket-pharmaceuticals-announces-inducement-grants-under-nasdaq-listing-rule-5635c4-ce7d5ad8d189f427
Rocket Pharmaceuticals, Inc. announced inducement equity awards for its new Chief Medical Officer, Dr. Syed Rizvi. These awards, approved by the Compensation Committee, include stock options and restricted stock units with various vesting schedules. The grants were made as a material inducement for Dr. Rizvi's employment, aligning with Nasdaq Listing Rule 5635(c)(4).

Rocket Pharmaceuticals Announces Inducement Grants under Nasdaq Listing Rule 5635(4) - MarketScreener

https://www.marketscreener.com/news/rocket-pharmaceuticals-announces-inducement-grants-under-nasdaq-listing-rule-5635-4-ce7d5ad8de80fe23
Rocket Pharmaceuticals, Inc. announced inducement equity incentive awards granted to its new Chief Medical Officer, Dr. Syed Rizvi, on October 6, 2025. These awards, approved by the Compensation Committee and made under Nasdaq Listing Rule 5635(4), include stock options and restricted stock units with specific vesting schedules, serving as a material inducement for his employment. The company continues to advance its pipeline of genetic therapies for rare disorders.

Rocket Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - October 10, 2025

https://www.biospace.com/press-releases/rocket-pharmaceuticals-announces-inducement-grants-under-nasdaq-listing-rule-5635c4-october-10-2025
Rocket Pharmaceuticals announced inducement grants to Dr. Rizvi under Nasdaq Listing Rule 5635(c)(4), consisting of stock options and restricted stock units. These awards are a material inducement for Dr. Rizvi's employment and are subject to multi-year vesting schedules. The company, a late-stage biotechnology firm, specializes in genetic therapies for complex and rare disorders.

Bronstein, Gewirtz & Grossman, LLC Encourages Rocket Pharmaceuticals, Inc. (RCKT) Investors to Inquire about Securities Investigation - ACCESS Newswire

https://www.accessnewswire.com/newsroom/en/business-and-professional-services/bronstein-gewirtz-and-grossman-llc-encourages-rocket-pharmaceuti-1080106
Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT). The investigation focuses on whether Rocket and its officers/directors engaged in corporate wrongdoing, targeting investors who bought Rocket securities before September 17, 2024, and still hold them. The firm encourages affected investors to contact them for more information, noting that their representation is on a contingency fee basis.
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