|Over a week ago|
Viridian Therapeutics submits IND application for VRDN-001 » 08:0710/1410/14/21
Viridian Therapeutics announced the submission of an investigational new drug application to the United States Food and Drug Administration. The Company is seeking authorization to initiate a Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor-1 receptor monoclonal antibody in development for the treatment of thyroid eye disease, a debilitating disease that can cause proptosis (bulging eyes), double vision, and potential blindness. The Company believes this clinical trial could provide key proof of concept clinical data in TED patients, with the potential to show clinically meaningful improvements in signs and symptoms of TED, including proptosis. The Company expects to announce top line clinical data from the proof of concept portion of the proposed trial in the second quarter of 2022.
Evercore starts Viridian at Outperform on thyroid eye disease opportunity » 06:5610/1210/12/21
Evercore ISI analyst…
Evercore ISI analyst Maneka Mirchandaney initiated coverage of Viridian Therapeutics (VRDN) with an Outperform rating and $40 price target. The rare disease company is currently focused on developing IGF-1R antibodies for thyroid eye disease, or TED, said Mirchandaney. The analyst notes that Horizon Therapeutics' (HZNP) Tepezza acts on the same pathway and "provides strong validation on efficacy and commercial potential" for Viridian's "potentially best-in-class IGF-1R antibodies."
Viridian Therapeutics initiated with an Outperform at Evercore ISI » 06:4310/1210/12/21
Evercore ISI analyst…
Evercore ISI analyst Maneka Mirchandaney initiated coverage of Viridian Therapeutics with an Outperform rating and $40 price target.
|Over a month ago|
Eleven new option listings and one option delisting on September 22nd » 08:3009/2209/22/21
PMCB, SBOW, SELF, USAP, TWKS, VRDN, SRAD, SVBI, SNR
New option listings for…
New option listings for September 22nd include PharmaCyte Biotech Inc (PMCB), ProShares Ultra MSCI Brazil Capped (UBR), Cambria Cannabis ETF (TOKE), SilverBow Resorces (SBOW), First Trust SMID Cap Rising Dividend Achievers (SDVY), Self Storage Group (SELF), Universal Stainless & Alloy (USAP), TWKS Stock (TWKS), Viridian Therapeutics Inc (VRDN), SRAD Stock (SRAD), and Severn Bancorp, Inc. (SVBI). Option delistings effective September 22nd include New Senior Investment (SNR).
Viridian Therapeutics 6.185M share Spot Secondary priced at $11.00 » 06:0509/2109/21/21
Jefferies, SVB Leerink…
Jefferies, SVB Leerink and Evercore ISI acted as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 18:3909/2009/20/21
APRE, VRDN, GMAB, SGEN, SDC, HRI, HLF, LEN, VRCA, ROLL, CFMS, KAR, PGR
Check out this evening's…
Viridian Therapeutics files to sell common stock and preferred stock » 16:0409/2009/20/21
Jefferies, SVB Leerink…
Jefferies, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering.
Viridian Therapeutics provides updates on upcoming milestones » 07:0508/1108/11/21
VRDN-001: The company…
VRDN-001: The company remains on track to file an IND in the fourth quarter of 2021, with initial proof of concept clinical data in TED patients expected in the second quarter of 2022. VRDN-002: IND-enabling activities remain on track with plans to file an IND by the end of 2021. The Company expects to initiate clinical development with a Phase 1 single ascending dose trial to explore safety, tolerability, pharmacokinetics, and target engagement of intravenous VRDN-002 in healthy volunteers. Data from this trial are expected by mid-year 2022, and could demonstrate feasibility of a low-volume and/or low-frequency dosing paradigm. In parallel, formulation development is on track to support initiation of a clinical trial evaluating low-volume subcutaneous injection of VRDN-002 in 2022. Discovery Pipeline: The Company continues to evaluate additional opportunities to expand its product pipeline for rare disease indications and remains focused on opportunities to leverage validated mechanisms and technologies to bring new therapeutic options to patients underserved by current therapies.
Viridian Therapeutics sees cash, cash equivalents fund operations into 2024 » 07:0508/1108/11/21
Cash, cash equivalents…
Cash, cash equivalents and short-term investments were $109.3M as of June 30, 2021, compared to $127.6M as of December 31, 2020. The Company believes that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations into 2024.
Viridian Therapeutics reports Q2 EPS ($2.21), consensus ($1.52) » 07:0508/1108/11/21
Reports Q2 revenue…
Reports Q2 revenue $1.090M. "We continue to make rapid progress with our lead TED program, VRDN-001," said Jonathan Violin, Ph.D., President and Chief Executive Officer of Viridian. "Following a highly collaborative pre-IND dialogue with the FDA for VRDN-001, we remain on track to submit IND filings for both VRDN-001 and VRDN-002 to the FDA in the fourth quarter of 2021. This would put us on track to report key Phase 1/ 2 proof of concept clinical data in TED patients in the second quarter of 2022 for VRDN-001, quickly followed by Phase 1 first-in-human data in mid-year 2022 for VRDN-002. We are also progressing our discovery programs as we expand our pipeline beyond IGF-1R and TED, advancing our strategy to discover and develop novel and differentiated monoclonal antibodies."