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Needham Hikes Centessa (CNTA) PT to $38 on High Potential for ORX-750 Trial Success and M&A Appeal
Yahoo Finance· 2026-01-08 14:41
Centessa Pharmaceuticals (NASDAQ:CNTA) is one of the best up and coming stocks to buy according to Wall Street. On January 5, Needham raised the firm’s price target on Centessa to $38 from $35 with a Buy rating on the shares. Needham suggested that Centessa’s stock momentum is poised to persist through 2026 due to the forthcoming data from the dose-escalation cohorts of the ongoing ORX-750 Phase 2a study. Consequently, the firm identified the company as one of the most compelling acquisition targets within ...
Centessa Pharmaceuticals Announces CEO Transition as Company Advances Strategy to Extend Orexin Leadership into Multiple Neuroscience Indications
Globenewswire· 2025-12-11 12:00
BOSTON and LONDON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that its Board of Directors has appointed Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, as Chief Executive Officer (CEO) and member of the Board, effective January 1, 2026. Dr. Accardi will succeed Saurabh Saha MD PhD, who will step down from his position as CEO and a member of the Board, effective January 1, 2026. Dr. Sah ...
Centessa Pharmaceuticals (NasdaqGS:CNTA) FY Conference Transcript
2025-12-03 15:37
Centessa Pharmaceuticals (NasdaqGS:CNTA) FY Conference December 03, 2025 09:35 AM ET Company ParticipantsMario Accardi - CEOUmer Raffat - Senior Managing DirectorUmer RaffatExcited to have Centessa Management with us. I think this is a very exciting time for the company. I think you're also one of the most sought-after guys right now across buy-side as well as on the pharma side. So I'll let you kick things off, Mario.Mario AccardiThank you. Great to be here today. Thank you for the invitation. Super exciti ...
Centessa Pharmaceuticals (NasdaqGS:CNTA) FY Conference Transcript
2025-12-02 21:02
Summary of Centessa Pharmaceuticals FY Conference Call Company Overview - Centessa Pharmaceuticals is a clinical-stage biotech company focused on orexin biology and orexin agonism, particularly in the treatment of sleep disorders such as narcolepsy and idiopathic hypersomnia [2][3] Key Developments - The company recently updated its Phase 2 study results involving approximately 50-55 patients across Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) [2][3] - Centessa is the first company to present a robust dataset demonstrating statistically significant efficacy across all three indications [2][3] Pipeline and Future Studies - The lead asset, ORX750, is currently in Phase 2, with additional molecules ORX142 and ORX489 entering Phase 1 studies in Q1 2026 [3][4] - The company aims to expand beyond rare hypersomnias into neurodegenerative and psychiatric conditions [4] Efficacy Data - In NT1, a second dose of 1.5 mg showed a greater than 20-minute change from baseline in the Maintenance of Wakefulness Test (MWT), with half of the patients showing over 30 minutes improvement [6][7] - For NT2, a 4 mg dose resulted in a greater than 10-minute change from baseline, with the Epworth Sleepiness Scale (ESS) improving from 15-16 to 8 [7][8] - In IH, the initial 2 mg dose demonstrated clinically significant improvements in MWT and other efficacy measures [8] Safety and Tolerability - The drug has shown a favorable safety profile, with no significant adverse events reported, and only one dropout due to a pre-existing condition [31][32] Registration Program - The registration program is set to commence in Q1 2026, with flexibility to initiate across all three indications or staggered based on data from the next 50 patients [27][28] Competitive Landscape - The company believes it has a best-in-class profile based on the totality of evidence, including MWT, ESS, and tolerability metrics [34] - The orexin agonist class is viewed as having significant potential, akin to GLP-1 in the field of neurosciences [37] Intellectual Property - Centessa has developed a strong IP portfolio, with protections extending past 2040, based on unique structural biology technology [40] Conclusion - Centessa Pharmaceuticals is positioned to make significant advancements in the treatment of sleep disorders and potentially other neuropsychiatric conditions, with promising data from its lead asset and a robust pipeline [42]
Centessa Pharmaceuticals (NasdaqGS:CNTA) 2025 Conference Transcript
2025-11-18 15:02
Summary of Centessa Pharmaceuticals Conference Call Company Overview - Centessa Pharmaceuticals is a clinical-stage biotech company focused on developing orexin agonists for treating excessive daytime sleepiness disorders, particularly narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [3][4][5] Core Insights and Arguments - **Orexin Agonists**: The company is developing a novel class of drugs targeting the orexin system, which is crucial for regulating sleep and wakefulness. The loss of orexin leads to debilitating symptoms in narcolepsy patients [3][4] - **Clinical Data**: Recent phase two study results showed significant efficacy of their lead drug, ORX750, across all three indications. The data indicated a potential best-in-class profile, particularly in NT1 and NT2 [4][6][10] - **Efficacy Metrics**: In NT1, 50% of patients achieved a mean wakefulness time (MWT) of over 30 minutes at a low dose of 1.5 mg. The Epworth Sleepiness Scale (ESS) showed a reduction of 13 points, indicating substantial improvement in patient-reported outcomes [12][13] - **Safety Profile**: The drug demonstrated a clean safety profile with no serious adverse events reported. Visual disturbances were mild and transient, not affecting the therapeutic index [20][30] - **Pharmacokinetics**: ORX750 has a flat pharmacokinetic (PK) curve, allowing for once-daily (QD) dosing, which is advantageous for patient compliance and efficacy [21][22] Market Opportunity - The combined market for NT1, NT2, and IH is estimated at $18 billion, with a prevalence of approximately 620,000 patients. There is significant unmet clinical need, as current treatments do not adequately address the symptoms for many patients [34][38] Future Plans - Centessa plans to continue its phase two studies and initiate a registration program in Q1 2026. The company has raised $270 million to support these efforts [5][33] - The company is also developing additional candidates, ORX142 and ORX489, which are expected to enter patient studies in Q1 2026 [34][37] Additional Considerations - **Dosing Flexibility**: The potential for split dosing is being evaluated to enhance symptom control for patients with varying schedules [23][24] - **Competitive Landscape**: Centessa aims to differentiate itself from competitors by focusing on the unique efficacy and tolerability of its orexin agonists [27][28] - **Long-term Vision**: The company sees orexin agonists as having broader applications beyond narcolepsy, potentially impacting various neurodegenerative disorders and cognitive functions [35] Financial Position - Centessa's balance sheet shows a proforma cash position of $620 million, providing a solid runway for ongoing and future clinical programs [39]
Centessa Pharmaceuticals Reports Financial Results for the Third Quarter of 2025 and Provides Update on Potential Best-in-Class Orexin Receptor 2 (OX2R) Agonist Program
Globenewswire· 2025-11-05 12:00
Core Insights - Centessa Pharmaceuticals reported significant progress in its OX2R agonist program, particularly with ORX750, which shows potential as a best-in-class treatment for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) [2][5][9] - The company plans to initiate a registrational program for ORX750 in Q1 2026, supported by promising Phase 2a data demonstrating statistically significant improvements in key efficacy measures [2][5][14] OX2R Agonist Program Updates - ORX750 achieved statistically significant, clinically meaningful, and dose-dependent results in the Maintenance of Wakefulness Test (MWT), Epworth Sleepiness Scale (ESS), and Weekly Cataplexy Rate (WCR) across initial cohorts [2][6][9] - The Phase 2a study included 55 participants, with ORX750 showing a favorable safety profile and transient mild to moderate treatment-emergent adverse events [4][9] - ORX142, another candidate in the program, demonstrated a highly differentiated profile in Phase 1 studies, with plans for patient studies to begin in Q1 2026 [2][10][14] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $349.0 million, expected to fund operations into mid-2027 [19] - Research and development expenses for Q3 2025 were $41.6 million, an increase from $33.9 million in Q3 2024, while general and administrative expenses were relatively stable at $12.2 million [19][23] - The net loss for Q3 2025 was $54.9 million, compared to a net loss of $42.6 million in the same period of the previous year [19][23]
LifeSci Capital Reaffirms Buy Rating on Centessa Pharmaceuticals (CNTA) with a $39 PT, Anticipates Key Orexin Pipeline Data
Yahoo Finance· 2025-09-15 13:09
Group 1 - Centessa Pharmaceuticals (NASDAQ:CNTA) is recognized as a promising stock with significant upside potential, with a Buy rating and a price target of $39.00 set by LifeSci Capital analyst Francois Brisebois [1][3] - In Q2 2025, Centessa reported cash and investments totaling $404.1 million, which is expected to sustain operations until mid-2027. R&D expenses rose to $42.7 million from $32.8 million in Q2 2024, resulting in a net loss of $50.3 million compared to a net loss of $43.8 million in the previous year [2] - The company is advancing its orexin receptor 2 (OX2R) agonist pipeline, with its lead candidate ORX750 in a Phase 2a study for narcolepsy and idiopathic hypersomnia, and data from this study is expected within the year [3] Group 2 - Centessa Pharmaceuticals is a clinical-stage pharmaceutical company focused on discovering, developing, and delivering medicines [4]
Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the Second Quarter of 2025
GlobeNewswire News Room· 2025-08-12 11:00
Core Insights - Centessa Pharmaceuticals is advancing a potential best-in-class orexin receptor 2 (OX2R) agonist pipeline, with key data readouts expected in 2025 [2][3] - The company aims to redefine the standard of care for sleep-wake disorders and related comorbidities through its innovative drug candidates [2][3] Pipeline and Milestones - ORX750 is in an adaptive Phase 2a study for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH), with data expected this year [6][7] - ORX142 has initiated a Phase 1 clinical trial, with results from acutely sleep-deprived healthy volunteers anticipated in 2025 [6][7] - ORX489 is currently in IND-enabling studies targeting neuropsychiatric disorders [6][7] Financial Performance - As of June 30, 2025, the company reported cash, cash equivalents, and investments totaling $404.1 million, expected to fund operations into mid-2027 [12] - Research and Development (R&D) expenses for Q2 2025 were $42.7 million, up from $32.8 million in Q2 2024 [12] - The net loss for Q2 2025 was $50.3 million, compared to a net loss of $43.8 million in Q2 2024 [12][14]
Nxera Pharma Operational Highlights and Consolidated Results for the Second Quarter and First Half 2025
Globenewswire· 2025-08-08 06:45
Core Insights - Nxera Pharma reported strong progress in the first half of 2025, with increasing revenues from its marketed products PIVLAZ® and QUVIVIQ®, and advancements in partnered programs [2][3][6] Operational Highlights - PIVLAZ® revenue increased by 7.6% from JPY 5,393 million to JPY 5,805 million compared to the prior corresponding period [6] - QUVIVIQ® generated JPY 1,586 million in revenue for the first half of 2025, with no sales in the prior corresponding period due to its launch in Q4 2024 [6] - Neurocrine Biosciences initiated Phase 3 trials for NBI-'568, resulting in a US$15 million payment to Nxera [6] - Nxera achieved a US$4.8 million milestone payment from Centessa Pharmaceuticals for the initiation of clinical development of ORX142 [6] Financial Highlights - Total revenue for the first half of 2025 was JPY 15,094 million (US$101.6 million), an increase of JPY 2,374 million (US$18.0 million) compared to the prior corresponding period [11] - R&D expenses rose to JPY 7,474 million (US$50.3 million), reflecting increased investment in R&D and currency impact [11] - SG&A expenses decreased to JPY 7,566 million (US$51.0 million), primarily due to targeted cost savings [11] - Operating loss improved to JPY 2,756 million (US$18.5 million) from JPY 3,654 million (US$24.0 million) in the prior corresponding period [11] - Net loss decreased to JPY 3,137 million (US$21.1 million) from JPY 4,703 million (US$30.9 million) in the prior corresponding period [11] - Cash and cash equivalents as of 30 June 2025 were JPY 32,997 million (US$228.1 million), an increase of JPY 729 million (US$22.3 million) from the beginning of the year [11] Pipeline and Future Outlook - Nxera is advancing a proprietary pipeline targeting obesity and chronic weight management, with over 30 active programs [5][10] - The company is well-positioned for significant value delivery for patients and shareholders with multiple key data readouts and new studies expected in the second half of 2025 [3][10]
Nxera Pharma to Receive US$4.8 Million in Milestone Payments Following Centessa’s Initiation of Clinical Development of ORX142, a Novel Orexin Receptor 2 (OX2R) Agonist
Globenewswire· 2025-07-04 07:00
Core Insights - Nxera Pharma will receive US$4.8 million in milestone payments from Centessa Pharmaceuticals due to the initiation of clinical development of ORX142, a novel orexin receptor 2 (OX2R) agonist [1][2] - The milestone payments include US$1.8 million recognized as revenue in Q2 2025 and US$3.0 million in Q3 2025 [2] Company Overview - Nxera Pharma is a technology-driven biopharma company focused on developing specialty medicines for unmet medical needs in Japan and globally [3] - The company has established a commercial business in Japan to develop and market innovative medicines, addressing a growing market in the APAC region [3] Pipeline and Development - Nxera Pharma has an extensive pipeline of over 30 active programs, utilizing its NxWave™ discovery platform, targeting major unmet needs in neurology, metabolic diseases, and immunology [4] - The pipeline includes potentially first- and best-in-class candidates, advancing from discovery to late clinical stages in collaboration with leading pharmaceutical and biotech companies [4] Workforce and Locations - Nxera employs approximately 400 people across key locations including Tokyo, Osaka, London, Cambridge, Basel, and Seoul [5]