When is the next data read‑out or regulatory filing for divesiran in polycythemia vera expected? | SLN (Aug 07, 2025) | Candlesense
SLN

When is the next data read‑out or regulatory filing for divesiran in polycythemia vera expected?

Answer

Based on the information contained in the press release you provided, the company does not disclose a specific date for the next data read‑out (e.g., a conference presentation, a clinical‑data update) or for a regulatory filing (e.g., an IND amendment, a meeting with the FDA/EMA) for divesiran in polycythemia vera (PV).

What the release tells us

Item Details from the release
Therapeutic candidate divesiran – a first‑in‑class siRNA for polycythemia vera
Recent activity Updated data were presented at the EHA (European Hematology Association) conference in the quarter preceding the Q2‑2025 results. The data were described as “highly encouraging and supportive of the therapeutic potential of divesiran.”
Company’s statement Craig Tooman, President, highlighted the EHA data but did not announce a forthcoming read‑out or filing date.
Financial context The Q2‑2025 results focus on the company’s overall financial performance; no timeline for subsequent clinical‑development milestones is included.

Why a concrete date isn’t available

  • Press‑release scope – The release is primarily an earnings announcement. Companies often bundle clinical‑development updates into earnings calls only when a milestone is imminent (e.g., a data read‑out, a filing, or a trial initiation). In this case, the only clinical update mentioned is the EHA presentation that already occurred.
  • Regulatory‑filing cadence – For a novel siRNA program in a rare disease such as PV, regulatory filings (e.g., IND amendments, meeting requests with the FDA’s Oncology Division, or EMA’s Scientific Advice) are typically announced separately from earnings updates, unless the filing is imminent (within a few weeks). No such announcement appears in the Q2‑2025 release.
  • Future‑milestone planning – Companies often outline a “next‑data‑readout” in the “Upcoming Milestones” section of an earnings release. This release does not contain that section, indicating that the next read‑out has not yet been scheduled or publicly disclosed.

How to stay informed about the next read‑out or filing

Source What to monitor Frequency
Company’s investor‑relations website (silence‑therapeutics.com) Press releases, “Events & Presentations” archive, SEC filings (e.g., 8‑K, 10‑Q) Check weekly; especially after each quarterly earnings call
SEC EDGAR database Form 8‑K filings for “Regulation FD Disclosure” or “Clinical‑Trial Update” Real‑time; alerts can be set for ticker SLN
Conference calendars (EHA, ASH, AACR, etc.) Abstract submissions, oral/poster presentations for divesiran Review quarterly (Q1, Q2, Q3, Q4)
Regulatory agency portals (FDA’s “Drugs@FDA”, EMA’s “European public assessment reports”) New IND amendments, meeting minutes, or “Orphan Drug Designation” updates Check monthly
Third‑party news aggregators (Business Wire, GlobeNewswire, Reuters) “Silence Therapeutics” + “divesiran” keyword alerts Set up real‑time alerts

Reasonable expectation (based on typical development timelines)

While the exact date is unknown, a reasonable industry‑standard window can be inferred:

Milestone Typical timing window (if no date announced)
Data read‑out (e.g., conference presentation) Usually 3–6 months after a positive data set is shown at a conference. Since the EHA data were presented in Q1 2025, a follow‑up read‑out could be expected late Q3 2025 or early Q4 2025 (e.g., at ASH 2025 in December or at a Q4 investor‑day).
Regulatory filing (e.g., IND amendment, meeting request with FDA/EMA) Companies often file within 6–9 months of a positive early‑phase read‑out to keep the development timeline on track for a 2026‑2027 pivotal‑trial start. That would place the filing mid‑2025 to early 2026.

Caveat: These are general industry expectations and should not be taken as official dates for Silence Therapeutics. The only definitive way to know the exact timing is when the company publicly announces it.

Bottom line

  • No specific date for the next divesiran data read‑out or regulatory filing is provided in the Q2‑2025 earnings release.
  • The most recent data were shown at EHA 2025 (Q1 2025). A subsequent read‑out is likely later in 2025 (Q3/Q4) but has not been formally scheduled.
  • Regulatory filing expectations are also unspecified; a filing could occur mid‑2025 to early 2026 based on typical development timelines.
  • Action: Keep monitoring Silence Therapeutics’ investor‑relations page, SEC filings, and major hematology/oncology conference schedules for any future announcements. Setting up real‑time alerts for “SLN” and “divesiran” will ensure you capture the next official update as soon as it is released.

Other Questions About This News

How does the company’s R&D spend as a percentage of revenue compare to other siRNA peers such as Alnylam or Dicerna? Are there any upcoming catalysts (e.g., conference presentations, data releases) that could drive the stock price in the near term? Did the company update its guidance for Q3 or full‑year 2025 earnings and cash flow? What are the implications of the recent EHA data on the probability of success for divesiran’s development program? What is the estimated market size for siRNA therapies in PV and related hematologic indications? How did the second‑quarter revenue and net loss compare to analyst consensus estimates? What is the current cash balance and projected cash‑burn rate, and how many months of runway does the company have? Are there any new partnership, licensing, or co‑development agreements that could impact future revenue streams? What regulatory hurdles or FDA/EMA milestones could affect the timeline to approval for divesiran? How might the Q2 results influence valuation multiples (e.g., EV/EBITDA, price‑to‑sales) for SLN compared to its peers?