Tillkännagivande • Jan 08

Enanta Pharmaceuticals, Inc. Provides Update on Its Research and Development Programs

Enanta Pharmaceuticals, Inc. announced updates on its research and development programs and highlighted upcoming key milestones for 2026. Pipeline Updates Virology Enanta’s virology pipeline includes the leading portfolio in development for RSV treatment, consisting of zelicapavir and EDP-323, both of which received Fast Track designation from the FDA. Enanta most recently evaluated zelicapavir, an oral, once-daily RSV N-protein inhibitor, in RSVHR, a Phase 2b study in a high-risk adult outpatient population, including the elderly and/or those with asthma, chronic obstructive pulmonary disease, or congestive heart failure. In September 2025, the Company announced positive data from the study. A clinically meaningful improvement in time to complete resolution of all 13 RSV symptoms was observed for zelicapavir compared to placebo, with a benefit of 6.7 days for patients with congestive heart failure, chronic obstructive pulmonary disease or age 75 or older, termed the HR3 population. Zelicapavir also showed an improvement in time to complete resolution on the 29-parameter total RiiQ™ symptom scale of 7.2 days for the HR3 population compared to placebo. The study met key secondary endpoints, including a reduction in hospitalization and antiviral effects. Zelicapavir has been dosed in more than 700 people to date and continues to be well-tolerated with a favorable safety profile. Enanta is continuing Phase 3 enabling activities, including aligning with the FDA on an adult Phase 3 trial design and overall registration path. In parallel, the Company is exploring potential business development opportunities related to its RSV program. Enanta’s second RSV candidate, EDP-323, is an oral, once-daily RSV L-protein inhibitor, which can be used alone or in combination with other agents, such as zelicapavir, to potentially broaden the treatment window or addressable patient populations. In October, the Company presented data on a post-exposure prophylaxis analysis performed in subjects who were not infected by Day 5 after RSV exposure in the EDP-323 human challenge study. The data showed the potential for EDP-323 to be effective in preventing RSV infection when initiated up to five days after RSV exposure, building on the previously reported EDP-323 challenge study treatment data. Immunology Enanta’s immunology pipeline is focused on designing and developing highly potent and selective oral inhibitors for the treatment of inflammatory diseases, by targeting key drivers of the type 2 immune response. Enanta today announced its third immunology program targeting MRGPRX2, a non-canonical G-Protein-Coupled-Receptor (GPCR) expressed predominantly on mast cells. Inhibiting MRGPRX2 may have potential to address multiple chronic inflammatory diseases including urticaria, asthma, prurigo nodularis and others. Currently, Enanta is advancing novel, potent and selective oral inhibitors of MRGPRX2. The Company’s prototype MRGPRX2 inhibitors exhibit potent inhibition invitro and in vivo. Specifically, they demonstrate MRGPRX2 inhibition with nanomolar potency (EC50 of 1-2nM) in cellular assays and prevent skin mast cell activation in humanized MRGPRX2 mouse models. Further, the Company’s MRGPRX2 prototype inhibitors show potent activity across multiple MRGPRX2 agonists. These prototypes are highly selective for MRGPRX2 versus other GPCRs. Finally, these prototypes show favorable in vitro and in vivo ADME properties supporting once daily dosing. Enanta continues to evaluate multiple compounds in preclinical studies and expects to select a development candidate in the second half of 2026. Enanta recently selected EDP-978, a novel, potent and selective oral KIT inhibitor, as its clinical candidate for the treatment of chronic spontaneous urticaria and potentially other mast cell driven diseases. EDP-978 demonstrates nanomolar potency in both binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also exhibits favorable in vitro and in vivo ADME properties preclinically. The Company is on track to submit an IND in the first quarter, with topline Phase 1 data expected in the fourth quarter of 2026. In November, Enanta nominated EPS-3903, a novel, potent and selective oral STAT6 inhibitor, as its lead development candidate for the treatment of atopic dermatitis and other diseases currently treated by dupilumab. Preclinical data show EPS-3903 exhibits nanomolar activity in binding and cellular assays and high selectivity for STAT6. Importantly, EPS-3903 shows rapid, continuous and complete (>90%) inhibition of phosphorylated STAT6 (pSTAT6) after oral dosing in mice. Further, EPS-3903 demonstrates efficacy comparable to dupilumab in multiple disease models. Specifically, in a house dust mite asthma model, treatment with EPS-3903 results in complete (>90%) inhibition of lung pSTAT6 and decreased inflammation comparable to dupilumab, including clinically relevant biomarkers of eosinophils and TARC in the lung and serum IgE. Additionally, in an MC903 atopic dermatitis mouse model, EPS-3903 demonstrates efficacy comparable to dupilumab, with complete (>90%) inhibition of pSTAT6 in the skin and spleen, as well as a robust decrease in serum IgE. EPS-3903 has favorable in vitro and in vivo ADME properties with once-daily dosing potential. The Company is currently performing scale-up and IND enabling activities and targeting an IND filing in the second half of 2026. Corporate In August 2025, Enanta filed a patent infringement action in the Unified Patent Court (UPC) of the European Union against Pfizer Inc. and certain of its subsidiaries. The suit seeks a determination of liability for infringement of European Patent No. EP 4 051 265 (the “’265 Patent”) in connection with Pfizer’s manufacture, use, and sale of Paxlovid™ (nirmatrelvir tablets; ritonavir tablets) in the 18 EU member states participating in the UPC. Under UPC procedures, a hearing on the infringement action is expected to occur within the UPC’s published 12-month target, with a decision rendered within weeks thereafter. Enanta expects to provide an update on the UPC litigation in the second half of 2026. The Company expects the following milestones across its pipeline in 2026: Virology Respiratory Syncytial Virus Align with FDA on adult Phase 3 design and registration path in Second Quarter 2026 Prepare for a Phase 3 study of zelicapavir in high-risk adults in 2H 2026 Explore business development opportunities for RSV assets Immunology KIT Program File IND for EDP-978 in First Quarter 2026 Report Phase 1 data for EDP-978 in Fourth Quarter 2026 STAT6 Program File an IND for EPS-3903 in 2H 2026 MRGPRX2 Program Nominate development candidate in 2H 2026.

Tillkännagivande • Oct 21

Enanta Pharmaceuticals, Inc. Presents New Data for Zelicapavir, its N-Protein Inhibitor and EDP-323, L-Protein Inhibitor

Enanta Pharmaceuticals, Inc. announced that new data for zelicapavir, its oral, once-daily, N-protein inhibitor, and EDP-323, its oral, once- daily, N-protein inhibitor, both in development for the treatment of respiratory syncytial virus (RSV), will be presented at IDWeek™? 2025 being held October 19 - 22, 2025, virtually and in Atlanta, Georgia. A post hoc analysis of a Phase 2 study of zelicapavir in children 28 days to 36 months reported in December 2024, demonstrated that treatment with zelicapavir resulted in a shorter time to complete resolution of RSV-related symptoms, as measured by ReSViNET, a parent/guardian clinical scoring system. The randomized, double-blind, placebo-controlled trial was conducted in children 28 days to 36 months of age evaluating the safety, pharmacokinetics, and antiviral activity of zelicapavir given once daily for 5 days. Caregivers reported the severity of RSV-related symptoms daily from baseline through Day 14. In the study, 96 patients were randomized and dosed (n=69 zelicapavir, n=27 placebo). Although resolution of symptom severity to mild showed no difference, a post hoc analysis of time to complete resolution of symptoms (defined as absent and discharged from hospital), showed an estimated Kaplan-Meier median of 6.99 days for zelicapavir versus 8.60 days for placebo. Similarly, an analysis of sustained resolution (defined as absent and remaining absent at all subsequent time points and discharged from hospital) resulted in 6.99 days for zelicapavir versus 10.68 days for placebo. All zelicapavir recipients achieved model-predicted target drug exposures. Adverse events (AEs) were similar between treatment groups, with none leading to treatment discontinuation or study withdrawal. These data demonstrate that treatment with zelicapavir is associated with a shorter time to complete resolution of RSV symptoms in children, thereby supporting further evaluation of zelicapavir in pediatric clinical trials. A randomized, double-blind, placebo-controlled human viral challenge Phase 2a study evaluated the efficacy, antiviral activity, safety and pharmacokinetics of EDP-323. Healthy volunteers were inoculated with RSV-A on Day 0. After confirmed RSV infection or 5 days later, randomized participants received EDP-323 600mg (n=47), 200mg (with 600mg loading dose, n=47), or placebo (n=47) once daily for 5 days and were followed through 28 days. Clinical symptoms were assessed once-daily using the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) and viral loads were assessed by quantitative real-time PCR on nasal washes. Participants showed rapid (within the first 24 hours) and statistically significant improvements in RiiQ™ RSV symptoms and viral load after EDP-323 dosing. Compared to placebo, there were 73% (p=0.0012), 61% (p=0.0010), and 67% (p<0.0001) RiiQ™ total symptom score AUC reductions in the 200mg, 600mg, and EDP-323 pooled recipients, respectively. Lower respiratory tract disease scores AUC were reduced by 95% (p=0.0002), 73% (p=0.0088), and 85% (p=0.0002) respectively, in the 200mg, 600mg, and pooled EDP-323 recipients versus placebo. There were 87% and 85% viral load AUC reductions in 200mg and 600mg recipients, respectively versus placebo (all p<0.0001). EDP-323 dosing groups showed similar efficacies. Frequencies of treatment-emergent adverse events (TEAEs) were similar across EDP-323 and placebo groups. No serious TEAEs, severe AEs, or AEs leading to treatment discontinuation or study withdrawal occurred. These findings support the further development of EDP-323 as a once-daily, oral RSV treatment. A randomized, double-blind, placebo-controlled, human viral challenge Phase 2a study evaluated the efficacy, antiviral activity, safety and pharmacokinetics of EDP-323. Healthy volunteers were inoculated with RSV-A on Day 0. RSV real-time PCR was performed, and nasal washes were collected twice daily on Days 2-12. Study participants were randomized 1:1:1 and received either 600mg of EDP-323 orally for 5 days (high-dose group), 600mg loading dose for 1 day followed by 200mg once daily for 4 days (low-dose group), or placebo. A post exposure prophylaxis (PEP) analysis was performed in subjects who were not infected by Day 5 after RSV exposure. In this population, 68 RSV-exposed, susceptible subjects were randomized to receive EDP-323 (low dose n=24, high dose n=21) or placebo (n=23). Of these subjects, 26% (6/23) of those who received placebo became infected versus 0% (0/45) of EDP-323 recipients (p<0.001). Evaluated separately, the two EDP-323 dosing groups’ PEP effects were statistically significant (low dose p=0.009, high dose p=0.022) versus placebo. There were no serious TEAEs, severe AEs, or AEs leading to treatment discontinuation or study withdrawal occurred. The frequency of TEAEs were similar across EDP-323 and placebo groups. These data suggest that EDP-323 is highly effective in preventing RSV infection when initiated up to 5 days after RSV exposure and further support evaluating the drug for prophylaxis.

Total avkastning till aktieägarna	-19.8%
Framtida utdelningsavkastning	n/a
Utdelningstillväxt	n/a
Nästa utbetalningsdag för utdelning	n/a
Ex utdelningsdag	n/a
Utdelning per aktie	n/a
Utdelningsandel	n/a

Segment	Utdelningsavkastning
Företag (ENTA)	n/a
Marknadens lägsta 25% (US)	1.3%
Marknad Topp 25% (US)	4.0%
Genomsnitt för branschen (Biotechs)	2.1%
Prognosanalytiker (ENTA) (upp till 3 år)	n/a

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/07/31 13:17
Aktiekurs vid dagens slut	2026/07/31 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/09/30

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Brian Skorney	Baird
Geoffrey Meacham	Barclays
Patrick Trucchio	Berenberg

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Recent updates

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