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12 stories mentioning RGNXUpdated 28d ago

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Sectors

Sector Update: Healthcare Stocks Softer Late Afternoon

Healthcare stocks decreased late Monday afternoon, with the NYSE Healthcare Index and the State Street Health Care Select Sector SPDR ETF (XLV) each fractionally lower.The iShares Biotechnology ETF (IBB) shed 0.4%.In corporate news, Personalis (PSNL) shares fell past 7% after Craig-Hallum downgraded the stock to hold from buy.Biomea Fusion (BMEA) shares surged past 18% after the company said it has completed enrollment in a phase 2 trial of icovamenib in insulin-deficient Type 2 diabetes patients.Eli Lilly (LLY) has launched its Foundayo weight-loss pill in the UK, making Britain the first European country where the oral treatment is available, news outlets reported Monday, citing a company statement. Lilly shares were down 0.5%.Capricor Therapeutics (CAPR) said Monday the US Food and Drug Administration has extended the target action date for its biologics license application for deramiocel as a treatment for Duchenne muscular dystrophy to Nov. 22 from Aug. 22. Capricor shares jumped past 8%.Regenxbio (RGNX) shares fell more than 23% after the company said it does not plan to resubmit the biologics license application for its investigational gene therapy RGX-121 for Hunter syndrome in the near term following a US Food and Drug Administration clinical hold.

$BMEA$CAPR$LLY$PSNL$RGNX
Wire

Top Midday Decliners

Regenxbio (RGNX) plans not to resubmit the biologics license application for its investigational gene therapy RGX-121 for Hunter syndrome in the near term following a US Food and Drug Administration clinical hold, the company said Monday.Shares slumped 23% as intraday trading volume jumped to over 4.5 million from a daily average of about 1.9 million.Real Brokerage (REAX) said late Friday that the Supreme Court of British Columbia granted a final order approving its proposed combination with RE/MAX.Shares of Real Brokerage sank 16%, with intraday trading volume rising to over 8.2 million from the stock's daily average of roughly 4.4 million.Azenta's (AZTA) board member Martin Madaus has been named interim president and chief executive officer, following John Marotta's resignation as an executive officer and a director, the company said Monday.Shares declined 11%, with intraday trading volume rising to over 1.2 million from a daily average of about 767,000.Price: $8.25, Change: $-2.47, Percent Change: -23.04%

$AZTA$REAX$RGNX
Sectors

Sector Update: Healthcare Stocks Decline in Afternoon Trading

Healthcare stocks were decreasing Monday afternoon, with the NYSE Healthcare Index and the State Street Health Care Select Sector SPDR ETF (XLV) each down 0.1%.The iShares Biotechnology ETF (IBB) shed 0.6%.In corporate news, Eli Lilly (LLY) has launched its Foundayo weight-loss pill in the UK, making Britain the first European country where the oral treatment is available, news outlets reported Monday, citing a company statement. Lilly shares were down 0.8%.Capricor Therapeutics (CAPR) said Monday the US Food and Drug Administration has extended the target action date for its biologics license application for deramiocel as a treatment for Duchenne muscular dystrophy to Nov. 22 from Aug. 22. Capricor shares jumped past 6%.Regenxbio (RGNX) shares fell more than 23% after the company said it does not plan to resubmit the biologics license application for its investigational gene therapy RGX-121 for Hunter syndrome in the near term following a US Food and Drug Administration clinical hold.

$CAPR$LLY$RGNX
Sectors

Sector Update: Healthcare Stocks Rise Pre-Bell Monday

Healthcare stocks were rising pre-bell Monday, with the State Street Health Care Select Sector SPDR ETF (XLV) up 0.4% and the iShares Biotechnology ETF (IBB) gaining 0.2%.Guardant Health (GH) lost a $245.2 million patent infringement lawsuit filed by TwinStrand Biosciences and the University of Washington, TwinStrand said. Guardant Health stock was down more than 2% premarket.United Therapeutics (UTHR) shares were up more than 1% after the company said the US Food and Drug Administration accepted its new drug application for ralinepag to treat pulmonary arterial hypertension.Regenxbio (RGNX) stock was down more than 21% after the company said it does not plan to resubmit the biologics license application for its investigational gene therapy RGX-121 for Hunter syndrome in the near term following a US Food and Drug Administration clinical hold.

$GH$IBB$RGNX$UTHR$XLV
Wire

Regenxbio Seen on Track for Duchenne Approval as Data Strengthens, RBC Says

Regenxbio's (RGNX) Duchenne muscular dystrophy gene therapy appears approvable, with efficacy comparable to Sarepta Therapeutics (SRPT) and a more favorable safety profile, as the company moves toward submitting its rolling biologics license application, RBC Capital Markets said Thursday in a report.Regenxbio is on track to file the first module of the BLA this quarter and expects to complete the submission in Q1 2027, RBC said. By that time, the company anticipates having functional data from roughly half of the 30 patients in its fully enrolled pivotal trial, the report said.RBC said the confirmatory study is also fully enrolled and designed to compare two-year functional outcomes against established benchmarks for disease progression, while a larger placebo-controlled trial recommended by European regulators is planned for 2027 to support global filings.RBC reiterated its outperform rating on Regenxbio stock and $19 price target.Price: $10.47, Change: $-0.81, Percent Change: -7.18%

$RGNX
Research

Barclays Downgrades REGENXBIO to Equalweight From Overweight, $12 Price Target

REGENXBIO (RGNX) has an average rating of overweight and mean price target of $26.25, according to analysts polled by FactSet.

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Insider Trading

Regenxbio Insider Sold Shares Worth $688,756, According to a Recent SEC Filing

Steve Pakola, Chief Medical Officer, on June 29, 2026, sold 56,333 shares in Regenxbio (RGNX) for $688,756. Following the Form 4 filing with the SEC, Pakola has control over a total of 213,009 common shares of the company, with 213,009 shares held directly.SEC Filing:https://www.sec.gov/Archives/edgar/data/1590877/000170065926000012/xslF345X05/primarydocument.xml

$RGNX
Sectors

Sector Update: Healthcare Stocks Rise Late Afternoon

Healthcare stocks were higher late Monday afternoon, with the NYSE Healthcare Index rising 0.9% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 0.8%.The iShares Biotechnology ETF (IBB) climbed 1.7%.In corporate news, AbbVie (ABBV) has agreed to acquire Apogee Therapeutics (APGE) in an all-cash deal worth about $10.9 billion, as the drugmaker looks to boost its immunology portfolio and accelerate its clinical presence in the respiratory segment. AbbVie shares jumped past 6%, and Apogee surged 46%.Regenxbio (RGNX) shares jumped 18% after it said the US Food and Drug Administration has agreed on the next steps for a potential accelerated approval of Navsunli, its experimental gene therapy for Mucopolysaccharidosis II, following discussions related to its appeal of a complete response letter issued in February.Jaguar Health (JAGX) shares climbed 16% after the firm said Monday its board has started a process to explore strategic alternatives to maximize shareholder value.Vivos Therapeutics (VVOS) shares fell 14% after it said Monday it has extended its strategic financing agreement with Streeterville Capital through Aug. 31, giving it additional time to complete planned capital-raising efforts.

$ABBV$APGE$JAGX$RGNX$VVOS
Sectors

Sector Update: Healthcare

Healthcare stocks were higher late Monday afternoon, with the NYSE Healthcare Index rising 1.2% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 0.8%.The iShares Biotechnology ETF (IBB) climbed 1.7%.In corporate news, Regenxbio (RGNX) shares jumped 19% after it said the US Food and Drug Administration has agreed on the next steps for a potential accelerated approval of Navsunli, its experimental gene therapy for Mucopolysaccharidosis II, following discussions related to its appeal of a complete response letter issued in February.

$RGNX
Wire

Update: Regenxbio Shares Rise After FDA Aligns on Accelerated Approval Path for Hunter Syndrome Gene Therapy

(Updates with the company's latest stock move in the headline and the first paragraph.)Regenxbio (RGNX) shares were up 19% in Monday afternoon trading after the company said the US Food and Drug Administration has agreed on the next steps for a potential accelerated approval of Navsunli, its experimental gene therapy for Mucopolysaccharidosis II, following discussions related to its appeal of a complete response letter issued in February.The company said the US FDA agreed that existing clinical data for Navsunli may support the accelerated approval pathway and that Regenxbio does not need to enroll additional patients or conduct new studies, including a previously requested untreated control arm.The agency asked the company to request a type A meeting to review longer-term biomarker and clinical data before resubmitting its marketing application, the company said.Regenxbio said it expects the meeting to occur in July and plans to resubmit the application in Q3.Price: $9.29, Change: $+1.49, Percent Change: +19.04%

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Wire

Sarepta's Elevidys Faces 'Little' Pressure After Regenxbio Data, Wedbush Says

Sarepta Therapeutics' (SRPT) Elevidys is put under a "little" pressure on Regenxbio's (RGNX) positive trial data in Duchenne muscular dystrophy, Wedbush Securities said in a note Friday.The note pointed to statistically significant correlation between microdystrophin expression and functional improvement in the trial of RGX-202, and should benefit all microdystrophin gene therapy programs/products."We see no other big impact on Elevidys," it said. "We do not believe that the relatively small patient number in RGNX's study allows for a fair comparison of microdystrophin expression."The report also said the regulatory pathway for RGX-202 remains to be defined.Wedbush kept its outperform rating and a $35 price target.Price: $18.12, Change: $-0.56, Percent Change: -3.00%

$RGNX$SRPT
Wire

Update: Regenxbio Shares Fall After Q1 Swings to Loss, Revenue Declines; Phase 3 Study of RGX-202 Meets Primary Endpoint

(Updates with latest stock price movement in the headline and first paragraph, Q1 earnings in the second through sixth paragraphs.)Regenxbio's (RGNX) shares were down about 36% in Thursday afternoon trading after its Q1 swung to a loss and revenue declined.The company reported a Q1 net loss Thursday of $1.72 per diluted share, swinging from earnings of $0.12 a year earlier.Analysts polled by FactSet expected a loss of $1.34.Revenue for the quarter ended March 31 fell to $6.4 million from $89.0 million a year earlier.Analysts surveyed by FactSet expected $25.8 million.The company expects its cash, cash equivalents and marketable securities of $150.5 million as of March 31 to fund its operations into early 2027.Separately, the company said Thursday its investigational gene therapy RGX-202 met the primary endpoint in the pivotal phase III portion of the Affinity Duchenne trial for Duchenne Muscular Dystrophy.The company said 93% of patients achieved over 10% microdystrophin expression at week 12.Regenxbio said it is preparing to pursue accelerated approval based on the data and is targeting a potential commercial launch in 2027.Price: $6.47, Change: $-3.57, Percent Change: -35.56%

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