WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced positive topline data from RSVHR, a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of zelicapavir in outpatient adults with acute RSV infection who are at high risk of complications including the elderly and/or those with. ...

Core Insights - Merus NV's shares increased by 38.2% to $95.21 following Genmab's announcement of an $8 billion all-cash acquisition deal, which includes the addition of the breakthrough therapy Petosemtamab to Genmab's late-stage pipeline [1] Gainers - Steakholder Foods Ltd rose 92% to $8.32 after announcing an agreement to acquire Twine Solutions [4] - JFB Construction Holdings surged 77.4% to $12.15 following a $44 million private placement announcement [4] - Plus Therapeutics gained 24.3% to $0.77 after securing a national coverage agreement with UnitedHealthcare for its CNSide assay [4] - Avalo Therapeutics rose 24.1% to $13.40 after a previous decline of 6% [4] - Enanta Pharmaceuticals gained 22.7% to $9.69 ahead of presenting topline results from its Phase 2b study of Zelicapavir for RSV [4] - Canopy Growth Corp jumped 19.4% to $1.60 [4] - Zura Bio Ltd gained 18.3% to $2.85 after a 15% increase on Friday [4] - Tilray Brands surged 17.4% to $1.35, with first-quarter financial results to be announced on October 9 [4] - Larimar Therapeutics jumped 16.4% to $5.93, with an update on the Nomlabofusp program scheduled for September 2 [4] Losers - MoonLake Immunotherapeutics dipped 86.3% to $8.50 despite achieving statistically significant results in its Phase 3 VELA trials [4] - Maris Tech fell 37.3% to $2.62 after reporting a H1 loss of 30 cents per share [4] - Sunrise New Energy Co Ltd shares dipped 28.1% to $0.88 after a previous 10% gain [4] - Cycurion Inc declined 15.5% to $0.28 after a significant drop of over 30% on Friday [4] - bioAffinity Technologies dipped 14.4% to $4.53 after a 55% increase on Friday [4] - Youxin Technology Ltd fell 13.9% to $0.058 following a 1-for-80 reverse split announcement [4] - Top KingWin Ltd declined 12.8% to $4.07 after a previous 48% increase [4] - Cellectis SA fell 10.4% to $3.01 [4] - Quantum-Si Inc decreased 10.1% to $1.34 after filing for a mixed shelf of up to $300 million [4] - Penguin Solutions Inc fell 8.4% to $24.00 [4]

Several small- and mid-cap biotech and medical stocks saw notable after-hours price action on Friday, September 26, following a mix of clinical updates, investor presentations, and strategic announcements.Enanta Pharmaceuticals Inc. (ENTA) surged sharply in after-hours trading on Friday, September 26, following a modest gain during the regular session. The stock closed the day at $7.90, up 1.94%, before vaulting another 20% after hours to reach $9.48. This dramatic post-close rally was driven by investor r ...

Enanta Pharmaceuticals Inc. (ENTA) will hold a conference call and webcast on Monday, September 29, 2025, at 8:30 a.m. ET to share topline results from its RSVHR study.RSVHR is a phase 2b trial evaluating its lead drug candidate Zelicapavir for the treatment of respiratory syncytial virus (RSV) in high-risk adults.Respiratory syncytial virus (RSV) causes severe lung infections, including bronchiolitis and pneumonia. High-risk populations include premature babies, young infants, and children. In the U.S. al ...

WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced the company will hold a conference call and webcast on Monday, September 29 at 8:30 a.m. ET to share topline results from RSVHR, a Phase 2b study evaluating zelicapavir for the treatment of respiratory syncytial virus (RSV) in high-risk adults. Conference Call and Webcast. ...

Financial Data and Key Metrics Changes - Enanta Pharmaceuticals has evolved from a virology-focused company to include immunology in its pipeline, indicating a strategic shift in its business model [4][9] - The company reported positive Phase II data for its protease inhibitor EDP-235, which is aimed at treating SARS-CoV-2, and anticipates a clearer regulatory pathway for its development [8][9] Business Line Data and Key Metrics Changes - The company has two main programs targeting respiratory syncytial virus (RSV), focusing on N protein and L protein inhibitors, which aim to address the unmet need for active RSV infection treatments [6][7] - Enanta is also expanding into immunology with programs targeting KIT and STAT6, with the first program aimed at chronic spontaneous urticaria and the second aiming for an oral alternative to Dupixent [9][24] Market Data and Key Metrics Changes - The company is considering partnerships for its RSV assets, learning from its experience in hepatitis C, to maximize the potential of being the first to market in a new category [25] - The uptake of existing RSV vaccines has been low, with only about 20% of the target population vaccinated, indicating a significant market opportunity for effective antiviral treatments [40] Company Strategy and Development Direction - Enanta aims to leverage its expertise in virology and immunology to develop innovative treatments, with a focus on high-risk patient populations for RSV and mast cell-driven diseases [9][21] - The company plans to announce a third program in immunology later this year, further diversifying its pipeline [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data from the Phase II study for zelicapavir, which targets high-risk adults for RSV, and expects to report results soon [20][26] - The management highlighted the importance of early treatment in viral infections and the need for effective antiviral therapies, especially in high-risk populations [15][30] Other Important Information - Enanta is currently involved in litigation regarding its intellectual property related to SARS-CoV-2 treatments, with cases filed in both the US and EU [53][54] - The company is focused on developing potent and selective drug candidates, with ongoing IND enabling activities for its immunology programs [22][24] Q&A Session Summary Question: What is the expected duration of symptoms for placebo in a high-risk RSV study? - Management indicated that while specific data is not available, symptoms in high-risk populations are generally more prolonged compared to younger groups [28][30] Question: How important is virology in the context of secondary endpoints? - Management emphasized that while symptoms are crucial for registration, virology is also important as quicker viral knockdown correlates with faster symptom resolution [33][35] Question: Can you provide an update on the litigation with Pfizer regarding COVID therapeutics? - Management stated that there is limited information available but confirmed ongoing legal proceedings in both the US and EU regarding intellectual property related to SARS-CoV-2 [53][54]

Enanta Pharmaceuticals (NasdaqGS:ENTA) FY Conference September 09, 2025 02:00 PM ET Company ParticipantsTara L. Kieffer - Chief Product Strategy OfficerDr. Jay R. Luly - President and CEOOperatorThank you. All right. Good afternoon, everyone. Thank you very much for joining us here for this afternoon session with Enanta Pharmaceuticals, Inc. and a fireside chat with President and Chief Executive Officer Jay R. Luly and Chief Product Strategy Officer Tara L. Kieffer. Jay, Tara, thanks very much for joining u ...

Summary of Enanta Pharmaceuticals (ENTA) Conference Call Company Overview - Enanta Pharmaceuticals, Inc. is focused on developing drugs in viral antivirals and immunology indications, with a strong historical emphasis on virology [6][5][1]. Key Points and Arguments Virology Focus - Enanta has a 20-year history in virology, initially working on hepatitis C, leading to the development of two marketed drugs: Viekira Pak and MAVYRET, with MAVYRET being the only eight-week cure for chronic and acute HCV [6][17]. - Recent efforts have shifted towards respiratory viruses, particularly respiratory syncytial virus (RSV), with two drug candidates, zilicapivir and EDP-323, currently in phase 2 development [6][7]. RSV High-Risk Adult Study - The high-risk adult study for zilicapivir is set to report results later this month, focusing on patients over 65 or those with conditions like COPD, asthma, or CHF [8][10]. - The study aims to enroll patients within 72 hours of symptom onset, with a primary endpoint based on symptom resolution using a patient-reported outcome tool [10][11]. Comparison with Other Treatments - The company is looking to demonstrate a clinically meaningful reduction in symptom duration, aiming for a one-day improvement, which aligns with historical benchmarks for approval in similar respiratory virus treatments [11][39]. - Previous studies for influenza and SARS-CoV-2 have shown that a one-day reduction in symptom duration is considered clinically meaningful [11][39]. Immunology Programs - Enanta is advancing its KIP program targeting mast cell-driven diseases and a STAT-6 program aimed at developing an oral alternative to Dupixent [14][15]. - The KIP program is expected to enter clinical trials early next year, with a candidate selection for the STAT-6 program anticipated in the second half of the year [15][16]. Acute HCV Treatment - The recent approval of MAVYRET for acute HCV treatment is significant as it allows for earlier intervention, potentially reducing the spread of the virus [17][18]. - The impact of this approval on Enanta's revenue is still being assessed, with expectations for a clearer picture emerging over the next few quarters [22]. RSV Treatment Landscape - The RSV treatment landscape is evolving, with a need for small molecule antivirals alongside existing prophylactic measures like monoclonal antibodies and vaccines [24][25]. - Current vaccine uptake is low, with only about 20% of the eligible population vaccinated, indicating a significant unmet need for effective treatments [25][26]. Pediatric Study Insights - A pediatric study involving 90 patients showed a 1.2 log drop in viral load, outperforming a benchmark study [34][35]. - The company is developing a new caregiver-reported outcome tool, Resolve-P, to better assess symptoms in future studies [38]. Future Expectations - Enanta aims to establish itself as a leader in RSV treatment, with the potential to be the first to market with a therapeutic option [40]. - The company is also exploring opportunities in the immunology space, which is seen as a growing area compared to virology [41]. Additional Important Information - The company has faced challenges in recruiting high-risk populations during the pandemic, impacting some of its studies [32]. - The potential for combination therapies with EDP-323 and zilicapivir is being explored, particularly for immunocompromised patients [31]. This summary encapsulates the key discussions and insights from the Enanta Pharmaceuticals conference call, highlighting the company's strategic focus and future directions in both virology and immunology.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-35839 ENANTA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) DELAWARE 04-3205099 (State or other jurisdiction of incorporation or organization) 4 ...

Company Performance - Enanta Pharmaceuticals reported a quarterly loss of $0.85 per share, which was better than the Zacks Consensus Estimate of a loss of $1.25, representing an earnings surprise of +32.00% [1] - The company posted revenues of $18.31 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 21.29% and showing an increase from $17.97 million in the same quarter last year [2] - Over the last four quarters, Enanta has surpassed consensus EPS estimates two times and topped revenue estimates twice [2] Stock Movement and Outlook - Enanta Pharmaceuticals shares have increased by approximately 20% since the beginning of the year, outperforming the S&P 500's gain of 8.6% [3] - The future performance of the stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$1.21 on revenues of $15.35 million, and for the current fiscal year, it is -$4.33 on revenues of $62.35 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Enanta belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - The performance of Enanta's stock may also be influenced by the overall outlook for the industry, as research shows that the top 50% of Zacks-ranked industries outperform the bottom 50% by more than 2 to 1 [8]