| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | April 14, 2025 |
| Accession Number: | 0001193125-25-053998 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
Save time and jump to the most important pieces.
| 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
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
4 - REGENXBIO Inc. (0001590877) (Issuer)
$150 million secured at closing extends cash runway into early 2027REGENXBIO retains additional potential non-dilutive funding opportunities, including monetization of Priority Review Voucher (PRV) and milestones from AbbVie ROCKVILLE, Md., May 19, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to $250 million with Healthcare Royalty (HCRx). This agreement monetizes select anticipated royalties and milestones, and provides both immediate and expected future, non-dilutive capital. REGENXBIO received $150 million at closing, extending the Company's expected cash runway into early 2027. "This strate
PARAMUS, N.J., May 14, 2025 /PRNewswire/ -- NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO, Headquarters: Rockville, Maryland, USA, CEO: Curran M. Simpson, (REGENXBIO; Headquarters: Rockville, Maryland, USA; CEO: Curran M. Simpson, NASDAQ:RGNX) for RGX-121 (clemidsogene lanparvovec), a potential first-in-class, investigational gene therapy for the treatment of Mucopolysaccharidosis II (MPS II). The FDA granted REGENXBIO's BLA Priority Review with a Prescription Drug User Fee Act ("PDUFA") t
FDA assigns PDUFA target action date of November 9, 2025 RGX-121 on track to be the first gene therapy and one-time treatment for MPS IIPartner Nippon Shinyaku to lead commercialization upon potential approval REGENXBIO to lead commercial manufacturing and supply chainROCKVILLE, Md., May 13, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome. The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act
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
ROCKVILLE, Md., April 30, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Monday, May 12, at 4:30 p.m. ET to discuss its financial results for the first quarter ended March 31, 2025, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. 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 join 15 minutes prior to the start time. ABOUT REGENXBIO Inc.REGENXBIO is a biotechnology company on a mi
ROCKVILLE, Md., Feb. 26, 2025 /PRNewswire/ -- REGENXBIO Inc. (NASDAQ:RGNX) today announced that it will host a conference call on Thursday, March 13, at 4:30 p.m. ET to discuss its financial results for the fourth quarter and full year ended December 31, 2024, and recent operational highlights. Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. 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 join 15 minutes prior to the start time. ABOUT REGENXBIO Inc.REGENXBIO is a leading
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
SC 13G/A - REGENXBIO Inc. (0001590877) (Subject)
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
8-K - REGENXBIO Inc. (0001590877) (Filer)
144 - REGENXBIO Inc. (0001590877) (Subject)
10-Q - REGENXBIO Inc. (0001590877) (Filer)