SEC Form SC 13G/A filed by REGENXBIO Inc. (Amendment)
$RGNX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 2/11/2025 | $38.00 → $14.00 | Buy → Neutral | Goldman |
| 2/7/2025 | $27.00 | Outperform | Raymond James |
| 11/15/2024 | $22.00 | Overweight | Morgan Stanley |
| 10/10/2024 | $18.00 | Outperform | Raymond James |
| 6/7/2024 | $38.00 | Buy | Goldman |
| 3/11/2024 | $36.00 | Buy | H.C. Wainwright |
| 3/8/2024 | $20.00 → $35.00 | Sector Perform → Outperform | RBC Capital Mkts |
| 3/6/2024 | $37.00 | Market Perform → Outperform | Leerink Partners |
Goldman downgraded REGENXBIO from Buy to Neutral and set a new price target of $14.00 from $38.00 previously
Raymond James resumed coverage of REGENXBIO with a rating of Outperform and set a new price target of $27.00
Morgan Stanley resumed coverage of REGENXBIO with a rating of Overweight and set a new price target of $22.00
8-K - REGENXBIO Inc. (0001590877) (Filer)
SCHEDULE 13G/A - REGENXBIO Inc. (0001590877) (Subject)
10-Q - REGENXBIO Inc. (0001590877) (Filer)
RGX-121 would be the first and only potential one-time commercially-available therapy designed to directly address the underlying genetic cause of Hunter syndrome, if approvedCommercial launch plans remain on track REGENXBIO plans to present updated pivotal data during the ICIEM meeting in September 2025ROCKVILLE, Md., Aug. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that the U.S. Food and Drug Administration (FDA) extended its review timeline of the Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) goal date has
RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidanceClemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; FDA inspections completed successfullyPre-license inspection (PLI) of in-house manufacturing facility, quality systems and processes completed with no observationsBioresearch monitoring information (BIMO) inspection of laboratory and clinical data practices completed with no observationsSurabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy in chronic retinal dise
A pivotal Phase IIb/III clinical trial using suprachoroidal delivery for treatment of diabetic retinopathy will be initiatedNew Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office injection of surabgene lomparvovec in subjects with non-proliferative diabetic retinopathyREGENXBIO to receive $100 million upon first subject dosed in the Phase IIb/III clinical trial and an additional $100 million upon first subject dosed in a second Phase III clinical trial ROCKVILLE, Md., Aug. 7, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced it will initiate a pivotal Phase IIb/III clinical trial for investigatio
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
RGX-202 in Duchenne muscular dystrophy on track for topline results 1H 2026 and BLA submission mid-2026Pivotal trial enrollment accelerated, expected to complete in October 2025 ahead of previous guidanceClemidsogene lanparvovec (RGX-121) on track to be first gene therapy and one-time treatment for MPS II; FDA inspections completed successfullyPre-license inspection (PLI) of in-house manufacturing facility, quality systems and processes completed with no observationsBioresearch monitoring information (BIMO) inspection of laboratory and clinical data practices completed with no observationsSurabgene lomparvovec (sura-vec, ABBV-RGX-314) on track to be first gene therapy in chronic retinal dise
ROCKVILLE, Md., July 31, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, August 7, at 8:00 a.m. ET to discuss its financial results for the second quarter ended June 30, 2025, and operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should access the live call by dialing (646) 307-1963 (domestic) or (800) 715-9871 (international) and enter the passcode 9571992. A replay of the webcast will be available via the company's investor website approximately two hours after the call's conclusion. Those who plan on participating are advised to
RGX-202 in Duchenne muscular dystrophy on track for BLA submission mid-2026Pivotal trial more than half enrolled, with completion expected in 2025 Additional Phase I/II functional data expected 1H 2025 Initiating commercial supply manufacturing in Q3 2025FDA acceptance of Biologics License Application (BLA) for clemidsogene lanparvovec (RGX-121, partnered with Nippon Shinyaku) expected in May 2025 Pivotal data evaluating the safety and efficacy of the subretinal delivery of surabgene lomparvovec (ABBV-RGX-314, partnered with AbbVie) in patients with wet age-related macular degeneration are expected in 2026 and planning of diabetic retinopathy pivotal study continuesConference call today at 4
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
NEW YORK, Dec. 6, 2024 /PRNewswire/ -- S&P Dow Jones Indices ("S&P DJI") will make the following changes to the S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices effective prior to the open of trading on Monday, December 23, to coincide with the quarterly rebalance. The changes ensure each index is more representative of its market capitalization range. All companies being added to the S&P 500 are more representative of the large-cap market space, all companies being added to the S&P MidCap 400 are more representative of the mid-cap market space, and all companies being added to the S&P SmallCap 600 are more representative of the small-cap market space. The companies being removed from t
Life sciences veteran Mitchell Chan joins the company ahead of multiple catalysts across late-stage gene therapy programsVit Vasista steps down following more than 15 years at the CompanyROCKVILLE, Md., Sept. 17, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Mitchell Chan has been appointed as Executive Vice President and Chief Financial Officer, effective today. A veteran finance executive and operating partner in the biotechnology industry, Mr. Chan has held key roles in raising capital, business development transactions and operations for nearly 20 years. "We are excited to welcome Mitchell at this exciting time for REGENXBIO," said Curran Simpson, President and
Curran Simpson, Chief Operating Officer, Appointed as President and CEOCo-Founder Kenneth T. Mills to Step Down as President and CEO; Named Chairman of the Board ROCKVILLE, Md., June 12, 2024 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that Curran Simpson, Chief Operating Officer, has been appointed as President, Chief Executive Officer and a member of the Board of Directors, effective July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and Chief Executive Officer following 15 years of leadership at the Company, and he is taking on an expanded role on the Board as Chairman. In connection with these changes, Board member Daniel Tassé has been appointed as RE