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ANRO DEADLINE ALERT: Bragar Eagel & Squire, P.C. Reminds Investors in Alto Neuroscience, Inc. (ANRO) of the September 19th Deadline
Globenewswire· 2025-09-17 21:46
Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Alto (ANRO) To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Alto between February 2, 2024 and October 22, 2024 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. Click here to participate in the action. NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- What’s Happening: Brag ...
Barclays Initiates Xencor At Underweight, Sees Limited Upside From Pipeline
Financial Modeling Prep· 2025-09-17 21:22
Core Viewpoint - Barclays has initiated coverage of Xencor Inc. with an Underweight rating and a price target of $6.00, reflecting concerns over the company's internal pipeline despite its history of innovation in antibody technology and successful partnerships [1][2] Company Overview - Xencor Inc. is recognized for its innovative contributions to antibody technology and has established royalty-generating partnerships with companies like AstraZeneca and Incyte, which have provided a steady revenue stream and a robust balance sheet [1] Pipeline and Future Prospects - Analysts have expressed disappointment regarding Xencor's internal pipeline, indicating it has not produced sufficient valuation upside beyond its existing royalty base [2] - The company is expected to release early dose-escalation data for its lead oncology program, XmAb819, later this year, but these results are anticipated to be too preliminary to significantly impact the stock [2]
Arvinas Provides Update on Collaboration with Pfizer and Announces Further Actions to Support Value Creation
Globenewswire· 2025-09-17 20:30
Arvinas and Pfizer plan to jointly select third party for the out-licensing and commercialization of vepdegestrant Additional cost optimization measures expected to realize total annual savings of more than $100 million compared to FY 2024 Board authorizes stock repurchase program of up to $100 million Reaffirms cash runway guidance through the second half of 2028 NEW HAVEN, Conn., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today provided an update on its collaboration with Pfizer Inc. ...
Biogen Receives European Commission Approval for ZURZUVAE® (zuranolone), the First and Only Treatment Approved for Women with Postpartum Depression in Europe
Globenewswire· 2025-09-17 20:30
Postpartum depression is a leading cause of maternal mortality in Europe1-2, and is one of the most common medical conditions associated with pregnancy3-5; up to 20% of women experience postpartum depressive symptoms6-11The approval of this new therapeutic approach introduces an oral, 14-day treatment specifically indicated for PPDThe EC approval of ZURZUVAE is based on the SKYLARK study, which demonstrated rapid relief from depressive symptoms as early as day 3 and sustained through day 45 compared to plac ...
NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1
Globenewswire· 2025-09-17 20:15
Data show a favorable safety profile and early efficacy signals in a heavily pre-treated population whose cancer progressed after multiple prior lines of therapy including anti-PD-1Recommended phase 2 dose (RP2D) established at 33% of gross tumor volume (GTV)47.4% (9/19) best observed objective response rate (ORR) in all lesions per RECIST 1.178.9% (15/19) best observed disease control rate (DCR) in all lesions per RECIST 1.114.6 months median Overall Survival (mOS) in all patients treated (n=21)Investigato ...
Neurocrine Biosciences, Inc. (NBIX) Presents at TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit Transcript
Seeking Alpha· 2025-09-17 20:13
Question-and-Answer SessionGuys, first, I thought we'd start with maybe a brief overview of Neurocrine's strategy for developing and commercializing drugs for neuropsychiatric conditions. In particular, maybe which indications is Neurocrine most interested in? And what types of targets will Neurocrine prioritize?Kyle GanoCEO & Director Thanks, Phil. I'll take that question, and thanks for having us here this morning. Always a pleasure to get together. Your question is actually timely, it's timely for a coup ...
Supernus Pharmaceuticals: Heading In The Right Direction (NASDAQ:SUPN)
Seeking Alpha· 2025-09-17 20:05
Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .Bret leads the investing group The Biotech Forum , in which he and his team offer a model portfolio with their favorite 12-20 high upside biotech stocks, live chat to discuss trade ideas, and weekly research and option trades. The group ...
Supernus Pharmaceuticals: Heading In The Right Direction
Seeking Alpha· 2025-09-17 20:05
Live Chat on The Biotech Forum sees frequent discussion of specific covered call trades. To see what covered call trades I am currently executing along with a model portfolio of attractive biotech stocks, just initiate your free trial into The Biotech Forum by clicking HERE .Bret leads the investing group The Biotech Forum , in which he and his team offer a model portfolio with their favorite 12-20 high upside biotech stocks, live chat to discuss trade ideas, and weekly research and option trades. The group ...
Alto Neuroscience (NYSE:ANRO) FY Conference Transcript
2025-09-17 18:22
Summary of Alto Neuroscience FY Conference Call Company Overview - **Company**: Alto Neuroscience (NYSE: ANRO) - **Focus**: Precision psychiatry and biomarkers in neuropsychiatry, particularly in cognitive impairment and treatment-resistant depression [1][2] Key Points and Arguments Biomarker Selection and Research Approach - Alto emphasizes a dual approach to biomarker selection: understanding the biology of disorders and utilizing machine learning for predictive analysis [2][3] - The company prioritizes prospective replication of findings to ensure confidence in advancing drug development [3] FDA Guidelines and Regulatory Framework - Alto follows FDA's 2019 enrichment guidelines, which allow for the inclusion of biomarkers in clinical trials to enhance predictive value and reliability [6][7] - The Chief Medical Officer's experience with the FDA supports Alto's strategic alignment with regulatory expectations [7] Pipeline Overview - **ALTO-101**: A PDE4 inhibitor targeting cognitive impairment associated with schizophrenia (CIAS). Expected to read out results in the coming months [9][42] - **ALTO-207**: A combination of pramipexole and ondansetron for treatment-resistant depression (TRD). The mechanism targets dopamine receptors, particularly the D3 subtype, to enhance efficacy while mitigating side effects [10][13][15] - **ALTO-300**: An adjunctive treatment for major depressive disorder (MDD) using agomelatine, with a focus on improving tolerability and efficacy [11][49] Clinical Efficacy and Data Insights - ALTO-207 has shown promising effect sizes in previous studies, with a Cohen's D of 0.9 indicating significant efficacy in TRD populations [14][24] - The EEG biomarker linked to ALTO-207 correlates with motivational deficits and anhedonia, providing insights into treatment response [19][20] Safety and Tolerability - The combination therapy of pramipexole and ondansetron aims to reduce nausea and vomiting, common side effects of pramipexole alone [15][29] - Monitoring for impulse control disorders is crucial, especially given pramipexole's history in Parkinson's patients [30][31] Study Design and Future Plans - Phase IIB trials for ALTO-207 are set to begin in the first half of the next year, with a robust design aimed at regulatory submission [35][36] - The ALTO-300 study is being upsized based on interim analysis findings, with a focus on rigorous patient screening and data integrity [49][50] Additional Important Insights - The need for effective treatments in neuropsychiatry is emphasized, particularly for populations with limited options [47] - Alto's commitment to high standards in clinical trial execution reflects a broader trend in the industry towards increased rigor and reliability [50] This summary encapsulates the critical aspects of Alto Neuroscience's conference call, highlighting the company's strategic focus, pipeline developments, and commitment to advancing neuropsychiatric treatments through innovative biomarker-driven approaches.
Rapport Therapeutics, Inc. (RAPP) Presents at TD Cowen's 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit Transcript
Seeking Alpha· 2025-09-17 18:03
Question-and-Answer SessionMaybe just to kick things off, obviously, impressive Phase II data readout last week that investors were looking for. Maybe at a topline, can you just briefly summarize, I guess, first, how this trial was conducted? And if you want to try and touch on the novel trial design and then maybe hit the high points of the efficacy that you saw and then you can kind of drill down into the details.Abraham CeesayCEO, President, Treasurer & Director Sure. Happy to, Joe, and I really apprecia ...