$RGNX

5 stories mentioning RGNXUpdated just now

Every FINWIRES story that references RGNX, newest first.

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

Sectors3h ago

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

Wire3h ago

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%

$RGNX

Wire38d ago

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

Wire39d ago

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%

$RGNX

Track with the FINWIRES app suite

FolioX

Track RGNX in your portfolio

WheelAI

Analyze RGNX options with the wheel strategy

StockInsider

See market sentiment on RGNX