Dyne Therapeutics Files Routine 8-K, Confirms Nasdaq Listing
Ticker: DYN · Form: 8-K · Filed: Jan 3, 2024 · CIK: 1818794
| Field | Detail |
|---|---|
| Company | Dyne Therapeutics, INC. (DYN) |
| Form Type | 8-K |
| Filed Date | Jan 3, 2024 |
| Risk Level | low |
| Pages | 7 |
| Reading Time | 9 min |
| Key Dollar Amounts | $0.0001 |
| Sentiment | neutral |
Complexity: simple
Sentiment: neutral
Topics: compliance, regulatory-filing, administrative
TL;DR
**Dyne Therapeutics filed a routine 8-K, no new news, just confirming their Nasdaq listing.**
AI Summary
Dyne Therapeutics, Inc. filed an 8-K on January 3, 2024, to report a routine administrative update, specifically regarding its common stock, which trades under the symbol DYN on the Nasdaq Global Select Market. This filing indicates no new material events or financial changes, but rather confirms the company's current registration details. For investors, this means there's no immediate news impacting the stock's value, but it serves as a confirmation of the company's ongoing compliance with SEC reporting requirements.
Why It Matters
This filing is a standard compliance update, confirming Dyne Therapeutics' listing on the Nasdaq Global Select Market. It signals business as usual, with no new material financial or operational news for investors.
Risk Assessment
Risk Level: low — This 8-K filing is purely administrative and does not contain any information that would introduce new risks or change the company's operational or financial standing.
Analyst Insight
A smart investor would recognize this as a routine compliance filing with no immediate impact on Dyne Therapeutics' stock price or fundamental outlook. No specific action is warranted based solely on this filing.
Key Numbers
- $0.0001 — par value per share (the stated par value of Dyne Therapeutics' common stock)
Key Players & Entities
- Dyne Therapeutics, Inc. (company) — the registrant filing the 8-K
- Nasdaq Global Select Market (company) — the exchange where Dyne Therapeutics' common stock is registered
- DYN (company) — the trading symbol for Dyne Therapeutics' common stock
- January 3, 2024 (date) — date of earliest event reported and filing date
- $0.0001 (dollar_amount) — par value per share of common stock
FAQ
What is the purpose of this 8-K filing by Dyne Therapeutics, Inc.?
This 8-K filing, dated January 3, 2024, is a current report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, primarily serving as a Regulation FD Disclosure and Other Events filing. It confirms the company's registration details, including its common stock trading on the Nasdaq Global Select Market under the symbol DYN.
On what stock exchange is Dyne Therapeutics, Inc.'s common stock registered?
Dyne Therapeutics, Inc.'s common stock, with a par value of $0.0001 per share, is registered on the Nasdaq Global Select Market, as stated in the filing.
What is the trading symbol for Dyne Therapeutics, Inc.'s common stock?
The trading symbol for Dyne Therapeutics, Inc.'s common stock is DYN.
What is the date of the earliest event reported in this 8-K filing?
The date of the earliest event reported in this 8-K filing is January 3, 2024.
Does this 8-K filing indicate any significant new financial or operational news for Dyne Therapeutics, Inc.?
No, this 8-K filing is a routine administrative update and does not indicate any significant new financial or operational news. It primarily confirms existing registration details and compliance.
Filing Stats: 2,180 words · 9 min read · ~7 pages · Grade level 11.7 · Accepted 2024-01-03 06:37:51
Key Financial Figures
- $0.0001 — ange on which registered Common stock, $0.0001 par value per share DYN Nasdaq Glob
Filing Documents
- d586587d8k.htm (8-K) — 45KB
- d586587dex991.htm (EX-99.1) — 38KB
- g586587g0103081534782.jpg (GRAPHIC) — 1KB
- g586587g0103082505228.jpg (GRAPHIC) — 3KB
- 0001193125-24-000991.txt ( ) — 224KB
- dyn-20240103.xsd (EX-101.SCH) — 3KB
- dyn-20240103_lab.xml (EX-101.LAB) — 18KB
- dyn-20240103_pre.xml (EX-101.PRE) — 11KB
- d586587d8k_htm.xml (XML) — 3KB
01
Item 7.01. Regulation FD Disclosure. On January 3, 2024, Dyne Therapeutics, Inc. (the "Company") issued a press release announcing positive initial clinical data from its ACHIEVE clinical trial of DYNE-101 in patients with myotonic dystrophy type 1 ("DM1") and its DELIVER clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy ("DMD") who are amenable to exon 51 skipping. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference. On January 3, 2024, the Company also made available a presentation to be used to discuss the initial clinical data from the ACHIEVE and DELIVER clinical trials. A copy of the presentation will be available by 8:00 a.m. ET on the Events & Presentations page of the Investors & Media section of the Company's website (https://www.dyne-tx.com/). The information contained in, or that can be accessed through, the Company's website is not a part of this filing. The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
01
Item 8.01. Other Events. On January 3, 2024, the Company announced positive initial clinical data from its ACHIEVE clinical trial of DYNE-101 in patients with DM1 and its DELIVER clinical trial of DYNE-251 in patients with DMD who are amenable to exon 51 skipping. Phase 1/2 ACHIEVE Trial of DYNE-101 in DM1 The initial efficacy assessment of the DYNE-101 ACHIEVE trial is based on data from 32 adult DM1 patients enrolled in the randomized, placebo-controlled multiple ascending dose ("MAD") portion of the trial, including 6-month data from the 1.8 mg/kg (approximate antisense oligonucleotide ("ASO") dose) cohort (n=16) and 3-month data from the 3.4 mg/kg Q4W cohort (n=16). In each of these cohorts, participants were randomized to receive either DYNE-101 (n=6) or placebo (n=4) once every four weeks or participants in the recovery arm (n=6) received two doses of DYNE-101 followed by placebo for the remainder of the MAD portion of the trial. In the ACHIEVE trial, DYNE-101 demonstrated a dose dependent splicing correction and increase in muscle delivery and DMPK knockdown while also showing functional improvement in myotonia. Key initial findings from ACHIEVE include: Muscle Delivery : Administration of 3.4 mg/kg of DYNE-101 Q4W demonstrated a mean ASO muscle concentration of 21.5 ng/g at 3 months while administration of 1.8 mg/kg Q4W showed a mean ASO muscle concentration of 10.0 ng/g at 3 months and 12.7 ng/g at 6 months. DMPK Knockdown : Evaluable patients in the 3.4 mg/kg Q4W group had a 40% mean DMPK knockdown from baseline compared to 25% in patients in the 1.8 mg/kg Q4W group at 3 months and 16% in patients in the 1.8 mg/kg Q4W group at 6 months. Splicing : Evaluable patients treated with 3.4 mg/kg Q4W of DYNE-101 had a 19% mean splicing correction from baseline across a broad, 22-gene panel at 3 months, with all evaluable participants experiencing an improvement. Patients in the 1.8 mg/kg Q4W group at 3 months had a 13% mean splicing correction and a
Financial Statements and Exhibits
Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated January 3, 2024. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DYNE THERAPEUTICS, INC. Date: January 3, 2024 By: /s/ Joshua Brumm Name: Joshua Brumm Title: President and Chief Executive Officer