Septerna Inc (SEPN)

No one watching but LONG here!

Septerna tops Q4 loss expectations as collaboration revenue lifts resultsMarch 10, 2026 7:03 AM
IH Market News
Septerna Inc. (NASDAQ:SEPN) reported a smaller-than-expected loss for the fourth quarter on Monday, posting a deficit of -$0.24 per share compared with analyst forecasts of -$0.72 per share. The clinical-stage biotech company generated $24.1 million in quarterly revenue, largely supported by its partnership with Novo Nordisk.Despite the stronger results, Septerna shares slipped 0.89% in after-hours trading following the announcement.Fourth-quarter revenue included $14.0 million in amortized income related to the $195.0 million upfront payment Septerna received from Novo Nordisk in July 2025. An additional $10.1 million came from research services performed under the collaboration agreement.This marked a sharp increase from the $0.2 million in revenue reported in the same quarter of 2024. For the full year 2025, Septerna posted revenue of $46.0 million, compared with $1.1 million in 2024.The company also highlighted encouraging Phase 1 data for SEP-631, its oral small-molecule MRGPRX2 negative allosteric modulator. According to Septerna, the treatment displayed a safety profile similar to placebo while delivering strong suppression of wheal formation across tested dose levels. The company intends to launch a Phase 2b study of SEP-631 for chronic spontaneous urticaria in the second half of 2026.“These results demonstrate clinical proof-of-mechanism and validate the ability of our Native Complex Platform to uncover novel mechanisms of action and rapidly generate differentiated oral small molecules for historically challenging GPCRs,” said Jeffrey Finer, chief executive officer and co-founder of Septerna.Operating expenses rose during the quarter as the company expanded its research programs. Research and development spending increased to $31.9 million from $19.3 million a year earlier, while general and administrative costs rose to $8.3 million from $5.6 million.Net loss for the quarter narrowed to $10.7 million, compared with $20.7 million in the fourth quarter of 2024.As of December 31, 2025, Septerna reported $548.7 million in cash, cash equivalents and marketable securities, which the company believes will support operations through at least 2029. The company is also advancing SEP-479, its oral PTH1R agonist, with plans to begin a Phase 1 trial in the first half of 2026.Septerna stock price

Original: Septerna tops Q4 loss expectations as collaboration revenue lifts results

Going to claw back green today and through the conference go higher. investor meetings to follow... should have been a new high.

Septerna Reports Positive Phase 1 Data For SEP-631; Plans Phase 2 In CS Urticaria

https://www.nasdaq.com/articles/septerna-reports-positive-phase-1-data-sep-631-plans-phase-2-cs-urticaria

(RTTNews) - Septerna, Inc. (SEPN), a clinical-stage biotechnology company pioneering small-molecule therapies targeting G protein-coupled receptors (GPCRs), announced positive results from its Phase 1 clinical trial of SEP-631 for the treatment of Mast Cell-Driven Diseases. SEP-631, developed by Septerna, is a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) for the treatment of patients with chronic spontaneous urticaria (CSU) and other mast-cell driven diseases. The Phase 1 study is a randomised, double-blind, placebo-controlled trial in healthy volunteers, assessing SEP-631's safety, tolerability, pharmacokinetics, and pharmacodynamics across single-ascending-dose, multiple-ascending-dose, and food-effect cohorts.

SEP-631 was well tolerated, showed a pharmacokinetic profile supportive of once-daily dosing, and provide clear evidence of MRGPRX2 pathway inhibition. SEP-631 demonstrated a pharmacokinetic profile supportive of convenient once-daily oral dosing, including a half-life of approximately 24 hours and no clinically meaningful effect of food on exposure, according to Septerna. Pharmacodynamic activity was assessed using Icatibant-induced skin wheal formation, an established skin test that measures mast cell activation and target engagement. Short-wave infrared imaging technology was used to measure wheal formation, providing precise assessment for mast cell activity. Also, SEP-631 produced robust suppression of wheal formation across evaluated dose levels, with complete inhibition observed at doses as low as 10 mg once daily following the 10 µg/mL icatibant challenge. Following the 100 µg/mL icatibant challenge, inhibition was dose-dependent, with progressively greater suppression observed at increasing SEP-631 doses, with near-complete inhibition achieved at 90 and 200 mg once daily. Septerna noted that SEP-631 was well-tolerated across all doses, with an adverse event profile comparable to placebo, no severe adverse events, and no clinically meaningful laboratory or ECG abnormalities. These results also validate Septerna's Native Complex Platform, which enables new approached to GPCR drug discovery by reconstructing functional GPCR complexed outside of cells.

Based on these results, Septerna plans to initiate a Phase 2b clinical trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of this year and to continue evaluating additional mast cell-driven indications. The planned Phase 2b study will be a randomized, double-blind, placebo-controlled, global trial evaluating once-daily oral SEP-631 in adult patients with moderate-to-severe CSU who remain symptomatic despite treatment with second-generation antihistamines. Following the expansion to CSU, the firm also plans to pursue an open-label study in chronic inducible urticaria (CIndU), specifically in patients with symptomatic dermatographism.Septerna is also evaluating SEP-631 in other mast cell-driven diseases, including atopic dermatitis, interstitial cystitis, migraine and asthma. Septerna is scheduled to host a conference call and webcast on Monday, March 2, 2026, at 8:00 a.m. ET to discuss the Phase 1 results and initial Phase 2 development strategy for SEP-631. "Overall, we believe the strength and consistency of these results position SEP-631 as a potentially differentiated oral treatment for patients living with mast cell-driven diseases," said Jae Kim, M.D., chief medical officer of Septerna. SEPN has traded between $4.66 and $32.63 in the last one year. The stock closed Friday's trade at $29.02, down 4.16%

New 52 week high...Nice!

Another nice green day so far. Approaching 52 week high, 28.99...

$SEPN

Green [again] on a red day. Go SEPN, release some early data soon to boom!

I'm loaded on this one long. Hopefully good data news is coming.

Back on track, SEPN let's have some news.

SEPN keeps on chugging. 2025 high hit, not far off all time high. Novo partnership news coming before eoy?

Don't call it a comeback...but nice climb after February bad news. Looking forward to some positive update on Phase 1 data and/or Novo partnership progress.

Huge long-term news with novo for sure which is good after dropping their lead pipeline candidate. Should have more news coming later this year on accelerated progress on others (MRGPRX2 Program) as a result.

Definitely back on the swing up!

Oh Boys and Girls 20$ coming💵💵💵🚀🚀🚀⏰⏰⏰

sorry if this was already posted but could be another push for this
https://www.stockconsultant.com/consultnow/basicplus.cgi?symbol=SEPN

$SEPN $7.85 close AH! 
Nice!
Breakout confirmed! 
Chart is primed for some BIG MOVES! 
Have a great weekend folks.
$CRMD $ARBE $ARVN $CVAC $ECX $BCRX $MOS $KIDZ $DRUG $NUKK $ZAPP

Very interesting...
https://www.stockconsultant.com/consultnow/basicplus.cgi?symbol=SEPN

After spending 2 months in the markdown phase and another 2 months in the consolidation phase, this is looking to break out again and enter a new markup phase. Institutional buyers are returning. Could have some nice price action going forward.

SEPN,Daily.