Latest news with #MDD
Business Wire
11 hours ago
- Business
- Business Wire
ANRO Investors Have Opportunity to Lead Alto Neuroscience, Inc. Securities Fraud Lawsuit with the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)-- The Schall Law Firm, a national shareholder rights litigation firm, announces the firm has filed a class action lawsuit against Alto Neuroscience, Inc. ('Alto Neuroscience' or 'the Company') (NYSE: ANRO) for violations of the federal securities laws. Investors who purchased the Company's securities pursuant and/or traceable to the Company's initial public offering ('IPO') conducted on or about February 2, 2024 and/or between February 2, 2024 and October 22, 2024, both dates inclusive (the "Class Period"), are encouraged to contact the firm before September 19, 2025. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The class, in this case, has not yet been certified, and until certification occurs, you are not represented by an attorney. If you choose to take no action, you can remain an absent class member. According to the Complaint, the Company made false and misleading statements to the market. Alto Neuroscience led investors to believe that ALTO-100 was more effective in treating major depressive disorder ("MDD") than it actually was. The Company overstated its business and financial prospects. Based on these facts, the Company's public statements were false and materially misleading throughout the offering period. When the market learned the truth about Alto Neuroscience, investors suffered damages. Join the case to recover your losses. The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
Business Wire
16 hours ago
- Business
- Business Wire
Rosen Law Firm Urges Alto Neuroscience, Inc. (NYSE: ANRO) Stockholders with Losses in Excess of $100K to Contact the Firm for Information About Their Rights
NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces that a shareholder filed a class action on behalf of purchasers of common stock of Alto Neuroscience, Inc. (NYSE: ANRO): (i) pursuant and/or traceable to Alto's initial public offering conducted on or about February 2, 2024 (the 'IPO'); and/or (ii) securities between February 2, 2024 and October 22, 2024. Alto describes itself as a 'clinical-stage biopharmaceutical company in the U.S.' For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigating the Allegations that Alto Neuroscience, Inc. (NYSE: ANRO) Misled Investors Regarding its Business Operations. According to the lawsuit, throughout the Class Period, defendants made materially false and misleading statements regarding Alto's business, operations, and prospects. Specifically, the offering documents and defendants made false and/or misleading statements and/or failed to disclose that: (1) ALTO-100 was less effective in treating major depressive disorder ('MDD') than defendants had led investors to believe; (2) accordingly, ALTO-100's clinical, regulatory, and commercial prospects were overstated; (3) as a result, Alto's business and/or financial prospects were overstated; and (4) as a result, Alto's public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. What Now: You may be eligible to participate in the class action against Alto Neuroscience, Inc. Shareholders who want to serve as lead plaintiff for the class must file their motions with the court by September 19, 2025. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here. All representation is on a contingency fee basis. Shareholders pay no fees or expenses. About Rosen Law Firm: Some law firms issuing releases about this matter do not actually litigate securities class actions. Rosen Law Firm does. Rosen Law Firm is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses, improving corporate governance structures, and holding company executives accountable for their wrongdoing. Since its inception, Rosen Law Firm has obtained over $1 billion for shareholders. Follow us for updates on LinkedIn: on Twitter: or on Facebook: Attorney Advertising. Prior results do not guarantee a similar outcome.
Express Tribune
3 days ago
- Health
- Express Tribune
The hidden lives of autistic women
This was it. This was where years of research and self-doubt had brought me; years of switching from pill to pill and doctor to doctor. It had been almost a decade of collecting diagnoses like BPD, PTSD, MDD, GAD, OCD, ADHD, Anorexia Nervosa. Here I finally was, my eyes glued to a long list of my symptoms I had compiled on the note app on my phone, bouncing my leg as I waited to see my new psychologist. I had decided against adding subheadings and printing the list at the last moment so I could add to it if I remembered more symptoms. And simply because I enjoy making lists. (Imagine sharing that with a classroom when your teacher asks what your hobbies are on the first day of school. Spoiler: you don't. You lie, and because you're bad at lying you end up saying something stupid like, 'I like sleeping.') The list was as long as the years of wondering why I felt more alone in rooms full of people, screaming at myself in the mirror to 'just be normal,' carving neat parallel lines into my flesh until 'the right amount' of blood had trickled down my forearm. After what felt like hours (it was 20 minutes), the doctor opened the door to her office, and I was ushered in. She nodded at me and handed me a stack of forms to fill. Not off to the best start, but I sped through them hoping we'd get to talk once I did my assigned work (I've always been a diligent student). Then she collected them from me and ushered me right back out the door – well she tried to. I took this as my cue to finally speak. 'I'd like to get tested for autism --' She cut me off, laughing. 'You can't be autistic, you're normal.' Normal? What was that supposed to mean? 'But I have a whole list of symptoms on my phone if you want to take a look--' Apparently, this was funny, too. 'There's no need for that,' she laughed, waving a hand in dismissal while the other opened the door for me. I felt myself flare up with anger, but I knew there was no point in arguing as I drifted out of her office on autopilot. This wasn't the first time I'd been told this. But this was the first time a licensed medical professional had laughed in my face while saying it. I really thought this time would be different. I thought if I prepared enough and tried to unmask, someone other than my roommate would finally believe me. I couldn't shake the feeling that if I had been a little white boy rambling about trains, this encounter would have taken a completely different turn. This is not an isolated occurrence, and not just for me, but for most autistic women all over the world. Only eight per cent of girls with autism are diagnosed before the age of six, while 25 per cent of boys with autism are diagnosed before this age. Eighty per cent of women remain undiagnosed at age 18. These statistics do not convey the true intensity of the situation as they only consider autistic women who are eventually officially diagnosed, while most autistic women go their whole lives not receiving a diagnosis from a doctor. Many of us self-diagnose while others are still searching for answers for why they feel different from others. Understanding autism According to Dr Victoria Milner, a trainee clinical psychologist from King's College London who investigates barriers to diagnosis and support for autistic women and girls, 'Autism is a neurodevelopmental condition that is characterised by differences and challenges with social interaction and communication, in addition to restricted and/or repetitive behaviours and interests.' It can affect nonverbal communication, like reading and enacting 'appropriate' body language. 'Your face might seem expressionless even though you're feeling things. And a lot of autistic people find it hard to predict what other people, particularly non-autistic people, might say, think or feel and what the consequences might be,' said Robyn Steward, an autistic person, researcher and author of The Experiences of Late-diagnosed Women with Autism Spectrum Conditions: An Investigation of the Female Autism Phenotype. Autistic people also tend to take things literally, sometimes including idioms and figures of speech, because we have a very direct, straightforward communication style that may be interpreted as blunt or rude by allistics (non-autistic people) who are not as prone to just saying exactly what they mean. For instance, when she was a child, Steward's mother asked her to put the bread in the toaster. 'Five minutes later,' Steward recounted, 'she asked me if the toast was done and I was like, 'No, because you didn't tell me to press the button.'' Steward had followed her mother's instruction but didn't understand what she meant (to toast the bread). Many autistic people experience sensory differences, which could be taking in too much or not enough sensory information from one or all their senses. This can result in under-stimulation or overstimulation. We may engage in stimming, repetitive routines or try to find or create silence to cope with this. A majority (75 to 90 per cent) of autistic people have special interests, usually on narrow topics, that they intensely focus on. Since autism is a spectrum, not everyone displays it in the same way or to the same extent. Different autistic people may have different struggles and different strengths. Female autism phenotype Women often present their autism in a way that differs from their male counterparts. This is often referred to as the female autism phenotype. There is no biological reasoning for this, but more so a social one, as Steward explained, 'I would be more inclined to say that perhaps there's more of a feminine presentation of autism and a masculine one because I don't think your gender or biological sex necessarily determine how autism presents.' According to Dori Zener, director of a mental health and peer support agency that works with neurotypical and autistic helpers to help individuals with their mental health, 'Some people say there's no such thing as a female autism phenotype. It's more like internalised autism versus externalised autism.' Due to the way society conditions women to be obedient, get along with others, and suffer in silence, women tend to internalise their autistic traits more and more often than cis men. This tends to make their autism invisible to those around them and sometimes even to themselves. In fact, autistic women camouflage and mask three to four times more than men. 'Masking is, unconsciously or consciously, hiding autistic traits to fit society's expectations. On measures of self-report for autistic traits, women have scored themselves higher than when an external assessor is rating them,' said Sarah Murphy, a trainee clinical psychologist and one of the authors of a recent publication about seeking autism diagnosis for women in Australia. 'Girls being quiet and keeping to themselves is often associated with being a good girl and might not be picked up on as different to what's typically expected, compared to a boy growing up with similar traits,' she added. Why we fail to see autistic women Mariam's* ability to mask was one of the fundamental reasons obtaining a diagnosis was difficult. 'Being a woman, that too from a religious minority, would make me be a people pleaser in most social settings,' said the 29-year-old from Karachi who was diagnosed with autism last year. This internalising of emotions often leads to the development of mental illnesses and unhealthy coping mechanisms, such as depression, anxiety, eating disorders, and self-harm. In comparison to the externalised hyperactivity, agitation, and breakdowns that autistic men are more likely to portray, these internalised manifestations of autism in women allows them to fly under the radar. Autistic women don't tend to see themselves in the media, and neither do the people around them. This includes parents, teachers, pediatricians, and general physicians: the people we rely on to refer a child to a psychiatric expert for said diagnosis. 'There is evidence that shows when presented with a vignette of an autistic character, teachers are more likely to suggest the character is autistic if they are told the character is male, compared to when they are told the character is female,' said Dr Milner. 'An autistic girl may be considered 'shy' when she experiences difficulty making friends, whereas an autistic boy is more likely to be recognised as having social difficulties and subsequently be offered support,' she adds. This leads to many autistic women, myself and Mariam included, straight-up being told that we 'can't be autistic.' This gender bias is present in the world of research and health care itself. According to Murphy, our conceptualisation of autism historically has been around male dominated samples, researchers, and doctors and it is based on these populations that our diagnostic assessment tools have formed. 'In the past, there was a theory that autism was like this extreme version of the male brain which doesn't necessarily hold water. But I think that says a lot about how we think about autism and gender,' she said. One of my favourite parts of being autistic is my special interests. I love how I can focus my undivided attention on them for hours at a time on a regular basis (despite my ADHD) and be able to derive pure joy just from learning more about the topic or even just hearing someone mention it in passing. My special interests, however, are also part of the reason my autism manages to remain undiagnosed. The special interests experienced by autistic women are more commonly relational in nature, compared to more physical or mechanical interests experienced by autistic boys and men (sorry to bring up trains again). Similarly, there is some evidence to show that autistic girls' interests are more often similar in topic to their non-autistic peers, but their intensity and duration may be what sets them apart from 'neurotypical' interests. 'I always kept socially acceptable special interests like food, cinema/filmmaking, makeup,' shared Mariam. 'So, an autistic girl might be really interested in Barbies, but the way that they engage with them is different. They might line them up around their bathtub as opposed to playing with them and interacting with them,' said Zener. Autistic women may also have a person such as a celebrity like Taylor Swift as their special interest but because women who are interested in such things are often dismissed and stereotyped as 'crazy fangirls,' it makes it hard to pick up on the difference between being a fan and having a special interest. ' Nearly 80 per cent of women with autism are misdiagnosed – often with conditions such as borderline personality disorder, eating disorders, bipolar disorder and anxiety. Some of these labels are helpful because they help shed light on a part of the picture. But other labels can be harmful and can dissuade women from seeking the services and support that we really need. Doctor's lack of knowledge about autism in women and even autism in general in Pakistan can also manifest in other ways. 'The misconception that my therapist had about autistic people that they don't have empathy delayed my diagnosis. When actually I'm hyper empathetic because of autism,' said Mariam. Her stimming has often gone under the radar and not qualified as such because it is subtle, such as skin picking or knuckle cracking. Most doctors recognise the more obvious stimming displayed by men. Importance of early diagnosis A lot of the dangers that come with getting a late diagnosis stem from psychiatric professionals being unable to provide their patients with the proper care because they don't know they're autistic. Even if autistic women are not misdiagnosed with other conditions, not receiving an autism diagnosis increases their chances of developing depression and anxiety disorders, due to the isolation and negative self-perception that comes with not being understood and going through life thinking there is something fundamentally 'wrong' with us. 'When you know you have autism and you can be part of the autism community, that can really help, because (autistic) people older or more experienced than you can point you towards resources and information,' said Steward. Being diagnosed and learning about autism has allowed her to heal old wounds. 'All my lifelong struggles finally make sense now,' she says. Stigma hurts, misdiagnosis may be fatal Autistic people are six times more likely to commit suicide than non-autistic people, and autistic women are twice as likely to die by suicide than autistic men, but the population with the greatest risk of suicide are women who mask and camouflage more. 'Imagine all day long you're acting in a way that is not yourself. It's very invalidating and it takes a huge amount of effort and energy,' said Mariam. The sources and the language around autism awareness in the past have been hugely stigmatising, misleading, and negative. Receiving an early diagnosis is not always helpful unless you can positively frame the diagnosis. 'I met younger girls, between the ages of nine to 18, who say they hate their diagnosis, and they reject it outright because they think that being autistic means that there's something wrong with them. A lot of them will say, that means my brain is broken. That means that no one's going to love me. There are so many horrible stereotypes about autism that create a stigma,' said Zener. 'I think what needs to change is the people who are giving diagnoses need to get rid of the word disorder at the end of the autism spectrum. Call it a condition.' This positive, inclusive, diverse, and more accurate awareness is being seen on social media. 'You can go on TikTok now and understand what autism is just by watching a ten-second video,' Zener said. 'There are great books now that are written by autistic women. So, I often say, if you want to learn about autism, go to the source. Really listen to autistic women's stories,' she added. Most schools, universities and governments do not accept an autism diagnosis if it is not from a doctor, and so self-diagnosed autistic women (who make up the majority) are not eligible for the support they need. If any progress is to be made, the diagnostic tools for autistic assessment need to be made more gender inclusive, receiving a diagnosis needs to be made accessible and most of all, autistic women need to be listened to and believed – even if we don't like trains. *Names have been changed to ensure privacy
Business Wire
6 days ago
- Business
- Business Wire
PureTech Founded Entity Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo™ (SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress
BOSTON--(BUSINESS WIRE)-- PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Seaport Therapeutics, ('Seaport') a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. The full text of the announcement from Seaport is as follows: Seaport Therapeutics Announces First Patient Dosed in Phase 2b BUOY-1 Study of GlyphAllo ™ (SPT-300) in Major Depressive Disorder (MDD), With or Without Anxious Distress BUOY-1 builds on successful Phase 1 and Phase 2a data with GlyphAllo – a novel oral prodrug of allopregnanolone and a potential first-in-class treatment for MDD Allopregnanolone has demonstrated rapid antidepressant and anxiolytic activity in clinical settings, but its clinical scope was previously constrained by limitations that Glyph™ is specifically designed to solve Boston, MA – July 17, 2025 – Seaport Therapeutics ('Seaport' or the 'Company'), a clinical-stage biopharmaceutical company that is advancing novel neuropsychiatric medicines with a proven strategy and team, today announced that the first patient has been dosed in the Phase 2b BUOY-1 study of GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) in major depressive disorder (MDD) with or without anxious distress. GlyphAllo is a novel, 'Glyphed' oral prodrug of allopregnanolone, an endogenous molecule that has been shown to dampen stress. Allopregnanolone has been clinically validated in third-party trials as a rapidly acting antidepressant with anxiolytic effects, but its scope of clinical use was previously constrained by limitations that the Glyph™ platform is specifically designed to solve. GlyphAllo has the potential to be a first-in-class treatment for patients with MDD, including those with or without anxious distress. 'The initiation of BUOY-1 marks a significant milestone for Seaport's pipeline, bringing us closer to a potential new treatment for major depression, which impacts around 280 million people globally – nearly 60 percent of whom also experience anxious distress,' said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. 'This is an important step on our journey to deliver new treatments for patients living with depression, anxiety, and other neuropsychiatric conditions.' BUOY-1 is a global, randomized, double-blind, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of GlyphAllo in adults with MDD, with or without anxious distress, a subtype of depression characterized by significant anxiety. The study is expected to enroll up to approximately 360 patients, randomized 1:1 to receive either GlyphAllo or placebo once-daily over a six-week treatment period. The primary endpoint of the study is the change from baseline at six weeks in the Hamilton Depression Rating Scale-17 (HAM-D-17), a gold-standard depression severity rating scale. Following the initial treatment period, eligible patients may enter an open-label extension phase, during which all participants will receive GlyphAllo for up to an additional six weeks. 'CNS clinical trials are inherently complex, and we are applying our team's extensive expertise to implement a high-quality study,' said Antony Loebel, M.D., Chief Medical Officer, President of Clinical Development at Seaport Therapeutics. 'We are confident that our rigorous clinical trial execution, including an emphasis on the quality of patient enrollment, will build on a proven mechanism and established clinical efficacy, to increase our likelihood of success in developing an effective treatment for patients with depression." The BUOY-1 study builds on a foundation of positive clinical data from Phase 1 and Phase 2a studies of GlyphAllo in healthy volunteers. In Phase 1, GlyphAllo demonstrated approximately nine times greater allopregnanolone exposure than that previously reported following oral dosing of allopregnanolone and reached similar exposures to the efficacious doses of IV-infused allopregnanolone. The two key measures used to determine allopregnanolone-associated brain activity, EEG beta frequency power and reduction in saccadic eye velocity, confirmed that GlyphAllo engaged with its target in a dose-dependent manner. The overall safety data, pharmacokinetics, and pharmacodynamic findings, along with non-clinical studies, support six-week dosing of GlyphAllo in BUOY-1. In a Phase 2a proof-of-concept study in healthy volunteers using the Trier Social Stress Test (TSST), a validated clinical model of anxiety, GlyphAllo significantly reduced the stress hormone salivary cortisol at all post-TSST timepoints compared to placebo, meeting the primary endpoint with a p-value of 0.0001 and demonstrating that GlyphAllo regulates hypothalamic-pituitary-adrenal axis reactivity to acute stress. GlyphAllo was generally well-tolerated, with adverse events that were mostly mild and transient. About the Glyph ™ Platform Glyph is Seaport's proprietary technology platform which uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. The Glyph platform has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism otherwise leading to low bioavailability and/or side effects, including liver enzyme elevations or hepatotoxicity. For each program, Seaport leverages its Glyph platform to create unique sets of prodrugs with differentiated profiles, including lymphatic transport and conversion characteristics, as potential candidates to advance into preclinical and clinical proof-of-concept studies. Seaport exclusively licensed this technology from Monash University based on the pioneering research of the Porter Research Group. Advanced initially at PureTech Health and now at Seaport, Glyph has been applied to create therapeutic candidates for the Company's pipeline resulting in new intellectual property, including composition of matter. The group and its collaborators have published research in Nature Metabolism, Frontiers in Pharmacology, Journal of Controlled Release and Molecular Pharmaceutics supporting the Glyph platform's capabilities. See Glyph in action here. About GlyphAllo™ (SPT-300 or Glyph Allopregnanolone) GlyphAllo (SPT-300 or Glyph Allopregnanolone), an oral prodrug of allopregnanolone, is in clinical stage development for the treatment of major depressive disorder (MDD) with or without anxious distress. Allopregnanolone, an endogenous molecule that has been shown to dampen stress, has antidepressant and anxiolytic activity and sleep-promoting effects but poor oral bioavailability due to substantial first-pass hepatic metabolism. Allopregnanolone was previously only approved as an intravenous infusion, which limited the scope of its clinical use. A synthetic analog of allopregnanolone was previously evaluated in MDD and showed promise but may not retain the activity, potency and the breadth of the natural biological response of endogenous allopregnanolone. In a Phase 1 clinical study, GlyphAllo demonstrated oral bioavailability, tolerability and γ-aminobutyric-acid type A (GABA A) receptor target engagement in healthy volunteers. In a Phase 2a clinical study, GlyphAllo demonstrated initial proof-of-concept in the Trier Social Stress Test, a validated clinical model of anxiety in healthy volunteers. GlyphAllo is currently being evaluated in the Phase 2b BUOY-1 study for MDD, with or without anxious distress. About Seaport Therapeutics Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and is guided by an extensive network of renowned scientists, clinicians, and key opinion leaders. For more information, please visit About PureTech Health PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit or connect with us on X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those related to Seaport's development plans for its pipeline of neuropsychiatric therapeutics based on the Glyph™ Platform, the potential of GlyphAllo™ and the Glyph™ platform, the design and expected safety and efficacy outcomes of the BUOY-1 study, the broader applicability of the platform, the addressable market for Seaport's product candidates, if approved, potential benefits to patients, and Seaport's and our future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Sources: Mental disorders; World Health Organization, 2022 Rosellini, A., et al (2018). Anxious distress in depressed outpatients: Prevalence, comorbidity, and incremental validity.
Business Standard
7 days ago
- Health
- Business Standard
Suven Life Sciences updates on Phase-2b clinical trial of Ropanicant
For treatment of Major Depressive Disorder Suven Life Sciences announced that the first patient has been randomized in its Phase-2b clinical trial evaluating Ropanicant, a novel oral α4β2 nicotinic acetylcholine receptor (nAChR) antagonist, for the treatment of Major Depressive Disorder (MDD). The Phase-2b double blinded, placebo controlled study builds on the positive results of the completed Phase-2a trial, which demonstrated favorable safety, clinically meaningful and significant improvement in depressive symptoms from baseline based on the Montgomery berg Depression Rating Scale (MADRS) score, with indication of rapid onset of action in MDD patients distinguishing Ropanicant from existing standard therapies. Insights from Phase-2a evolved the study design, dose selection, and dosing regimen for the current Phase 2b trial being conducted in exclusively in USA under FDA IND. "Randomizing the first patient in our Phase-2b study of Ropanicant is an important milestone for Suven Life Sciences. It reflects our continued commitment to developing innovative treatments for patients suffering from MDD. said Venkat Jasti, Chairman and MD of Suven Life Sciences.
