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Septerna:健康志愿者1期数据,2027年第一季度HP-And;模型更新
研报英文原文证据摘录
J P M O R G A N
North America Equity Research
18 August 2026
Septerna
Phase 1 Data in Healthy Volunteers HP-And-Coming in
1Q27; Model Update
Overweight
SEPN, SEPN US
Price (18 Aug 26):$43.80
▲Price Target (Dec-27):$48.00
Prior (Dec-26):$38.00
We are updating our model post 2Q26 results and establishing a Dec 2027 price target
of $48. Overall, while we acknowledge SEPN’s strong performance YTD (~+57% vs
NBI +~22%), we see several opportunities for further upside for SEPN from current
levels as the potency/versatility of the platform is validated over time across its novel
product candidates and see the phase 1 data for SEP-479 (an oral, small molecule
PTH1R agonist for hypoparathyroidism; HP) in healthy volunteers that is on the
horizon as representing a key milestone to potentially continue to validate the
platform. Reiterate Overweight.
Phase 1 trial for SEP-479 ongoing… Septerna expects to report phase 1 data
for SEP-479 from both the SAD and MAD cohorts (including serum calcium
and endogenous serum PTH) in healthy volunteers in 1Q27 (from prior late
2026 or early 2027). As context, Septerna indicated that based on
pharmacokinetic (PK) data from the ongoing phase 1 clinical trial, the
observed elimination half-life of SEP-479 is ~3-4 days (“at the longer end” of
its preclinical estimates), which it anticipates will support once-daily dosing;
to fully characterize steady-state PK, dosing for the MAD cohorts will be
extended to 14 days. We see this approach as interesting based on the target of
PTH1R, which has been validated by Ascendis Pharma’s Yorvipath1 .
On SEP-631 next steps… Further, for SEP-631 (an oral, small molecule
MRGPRX2 NAM), the company noted it is evaluating development strategies
for “capital-efficient” and “signal-finding” clinical studies in mast cell-driven
diseases with high unmet need to provide derisking before initiating larger
studies, a decision that was made on the heels of competitor data.
On other efforts... Finally, Septerna continues to progress toward
development candidate selection for its TSHR NAM program, with the goal of
delivering a potential disease-modifying oral treatment for Graves’ disease and
…
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