What is the expected timeline for the PK/PD study results and subsequent regulatory milestones?
Based on the excerpt you provided, the press release does not contain a specific timeline for when the results of the confirmatory PK/PD study for RLYB116 will be available, nor does it spell out the subsequent regulatory milestones (such as an IND filing, a potential PhaseâŻII/III start, or any FDA/EMA interactions).
The portion of the release you shared ends abruptly after noting that the PK/PD study âis an important âŠâ, and no further details about expected dates or next steps are included in the text you posted.
What this means
| Item | Information in the excerpt | Interpretation |
|---|---|---|
| PK/PD study completion | Mentioned only that the study has been launched. | No indication of when the study will finish. |
| PK/PD study readâout | Not stated. | No expected month/quarter provided. |
| Regulatory milestones (e.g., IND filing, BLA/MAA submission, meetings with FDA/EMA) | Not mentioned. | No timeline disclosed. |
How to obtain the timeline
- Read the full press release â The complete Business Wire article will typically include a forwardâlooking statement that outlines when the company expects data readâouts (e.g., âWe anticipate PK/PD results in Q4âŻ2025â) and any planned regulatory filings (e.g., âWe plan to submit an IND in early 2026â).
- Check the âInvestor Relationsâ section of Rallybioâs website â Companies often post the full earnings release, slide decks, and presentations that contain detailed timelines.
- Listen to or review the earnings call transcript â Management usually discusses expected data readâouts and regulatory plans during the Q2 earnings call, and those details are often posted as a transcript or webcast replay.
Bottom line
From the information you provided, Rallybio has started a confirmatory PK/PD study for its lead program RLYB116, but the expected date for receiving those study results and any downstream regulatory milestones has not been disclosed in the snippet. To get the precise timeline, youâll need to consult the full press release or accompanying investorârelation materials.