AbbVie BV

Almost one-third of oncologists surveyed by ZoomRx view Teliso-V as a game changer. AbbVie could have the hottest cancer drug launch of 2025 on its hands. That is one takeaway from a recent ZoomRx survey, which found oncologists are more aware of and excited about AbbVie’s telisotuzumab-vedotin (Teliso-V) than any other investigational cancer candidate.AbbVie shared phase 2 data on Teliso-V, a c-Met-directed antibody-drug conjugate (ADC), in non-small cell lung cancer (NSCLC) late last year. Based on the results, the drugmaker plans to file for accelerated approval in the third quarter with a view to bringing the ADC to market in 2025. Excitement is already building in the oncology community.ZoomRx found 55% of oncologists are aware of Teliso-V. Almost one-quarter of oncologists named the candidate as one of the three most exciting cancer prospects in development, making it the most widely anticipated program in the survey.Almost one-third of the oncologists view Teliso-V as a game changer and almost one-quarter said they will prescribe the ADC. Those figures are lower than for some of the other drug candidates, but ZoomRx recommended a cautious reading of those aspects of the survey because of the low base sizes. Overall awareness of the candidates that scored higher on those rankings is relatively low. ZoomRx surveyed the oncologists from June 6-17. As such, the survey reflects what the physicians learned at the American Society of Clinical Oncology annual meeting but not Roche’s bombshell July 4 disclosure about the failure of its anti-TIGIT antibody tiragolumab in NSCLC. Roche subsequently stopped two other studies of the antibody and said it continued the remaining trials because enrollment was at or nearing completion.The results may have looked different if ZoomRx had polled physicians after July 4. Tiragolumab took second spot on the ranking of the investigational assets with the highest perception scores, reflecting the level of awareness and excitement.Almost half of respondents were aware of tiragolumab and 20% were excited about the asset, putting it in the top three candidates for both metrics. The belief tiragolumab may have superior efficacy, superior mechanism of action and be a game changer was held by between 43% and 54% of oncologists who were aware of the asset and familiar with its clinical trial data.Jazz Pharmaceuticals’ zanidatamab, AstraZeneca’s camizestrant and Eli Lilly’s imlunestrant completed the top five. Zanidatamab is a HER2 bispecific antibody. Camizestrant and imlunestrant are both selective estrogen receptor degraders. 

FN Media Group Presents GlobalInvestmentDaily.com Market Commentary LONDON , March 19, 2024 /PRNewswire/ -- The U.S. Federal Drug Administration (FDA) has now designated psilocybin, a classical compound found in "magic mushrooms," as a "breakthrough therapy" for the treatment of major depressive disorder three times. And the world's largest clinical trial ever into the use of psilocybin for treating depression at London hospital in what scientists are hailing as a "milestone" in mental health research. Mentioned in today's commentary includes: Johnson & Johnson (NYSE: JNJ), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Atai Life Sciences N.V. (NASDAQ: ATAI), AbbVie Inc. (NYSE: ABBV). This new frontier in treatment has kickstarted a multi-trillion-dollar industry geared at fixing the brain through therapy. Johnson and Johnson has gone all in on its fastest-growing drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market. In its Q4 2023 earnings released in January, JNJ reported a 74.1% increase in sales of SPRAVATO worldwide and views the drug as its next billion-plus product. And some of the core team members behind the development of the SPRAVATO have now joined a small, but emerging NYSEAmerican-listed company, CYBIN (CYBN, CYBN.NE). CYBIN has now been granted "Breakthrough Therapy Designation", and is the first adjunctive psychedelic-based therapy for Major Depressive Disorder (MDD) ever to receive this FDA designation. Oppenheimer initiated coverage on CYBN last year, saying it was encouraged by the results so far and believed the stock would have room to run further with new results. It has a price target of $4. H.C.Wainwright & Co. took it further, with a price target of US $10.00 per share, after the recent Small Pharma acquisition. But with impressive Phase 2 results showing remission after only two doses and a coveted FDA designation, this small company is now poised for much greater attention from investors. Phase 2: Behind the Breakthrough Therapy Designation CYBIN is developing differentiated, next-generation therapeutics that hope to offer fast, sustained therapeutic effects that are safe and tolerable, with efficacy in only 1-2 doses and short in-clinic times. The company is on the leading edge of transformational psychedelic therapeutics, developing novel and proprietary therapeutics to improve clinical outcomes and patients' mental health and well-being. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile at a low dose. And it's been pounding the patent pavement, too. In August, CYBIN agreed to acquire Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies' combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy. The combined portfolio creates the industry's largest, most advanced, well protected DMT program. The combined company has the intellectual property strength of 29 patents granted and 158 patents pending in the psychedelic drug development sector. That is the largest portfolio in the industry. Phase 2 topline efficacy data for the company's CYBOO3 was one of the biggest drivers of value for CYBIN in the near-term, and the results were even better than expected. Now that it's been granted "Breakthrough Therapy Designation", CYBIN is targeting the potential for its CYB003 to achieve "Best-in-Class Status", and it's confident it has a solid shot at this. In targeting depression, CYBIN's CYB003 is hoping to offer a lifeline to a chronic illness that victimizes some 280 million people around the world. They are also targeting what is now recognized as the leading cause of disability in the world, which costs the global economy an estimated $1 trillion in lost productivity annually. Nowhere But Up: The Next Near-Term Catalysts CYBIN plans to initiate its Phase 3 study of CYBOO3 in MDD in the middle of this year, with the Phase 2 study of CYB004 in Generalized Anxiety Disorder (GAD) launched on March 15. For the Phase 2 proof-of-concept study of CYB004, CYBIN is using its proprietary DMT molecule, which was developed for the treatment of GAD, following the FDA's clearance of its new drug application in January. "We are building on foundational investigative work from our Phase 2a trial of intravenous SPL026 (DMT) which showed preliminary evidence of effectiveness treating anxiety with rapid onset of antidepressant effects and reduction in anxiety scores," Drysdale said in a press release. "The molecular structure of psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms,' allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses," according to Johns Hopkins Center for Psychedelic and Consciousness Research. This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending. CYBIN (CYBN, CYBN.NE) is a clear leader in the biotech race for an alternative to the antidepressant empire, and now it has breakthrough therapy status, and is the first adjunctive therapy known to achieve this for massive depressive disorder. Big Pharma is Racing for a Piece of the Pie Johnson & Johnson (JNJ) is a global leader in healthcare, with a diverse portfolio that spans pharmaceuticals, medical devices, and consumer health products. Within this vast array, Janssen, its pharmaceutical branch, has made significant strides in mental health with esketamine, marketed as Spravato. This nasal spray, a derivative of the anesthetic ketamine, represents a significant breakthrough, gaining FDA approval for use in treatment-resistant depression. The approval of Spravato underscores J&J's commitment to addressing complex mental health challenges. AbbVie (ABBV) emerged as a standalone biopharmaceutical entity following its split from Abbott Laboratories in 2013. Focused on discovering treatments for a wide range of diseases, including rheumatoid arthritis and various cancers, AbbVie's acquisition of Allergan expanded its reach into the burgeoning field of psychedelics for mental health. Allergan, known for its pioneering work in this area, has enriched AbbVie's pipeline with potential psychedelic-based therapies. Atai Life Sciences (ATAI) is at the forefront of transforming mental health care, prioritizing the development of treatments for mental health disorders. Atai's innovative strategy encompasses a wide array of compounds, including psychedelics. The company's collaborative approach, partnering with leading firms to accelerate the development of groundbreaking therapies, exemplifies its commitment to pioneering advancements in mental health treatment. Compass Pathways (CMPS) is pioneering the therapeutic use of psilocybin, focusing its research efforts on addressing treatment-resistant depression. The company's clinical trials and research initiatives are part of a larger mission to establish psilocybin therapy as a validated treatment option, highlighting the potential of psychedelics to offer profound therapeutic benefits. Compass's dedication to rigorous scientific inquiry and ethical research practices positions it as a leader in the psychedelic research community, contributing valuable insights that could reshape mental health care. MindMed (MNMD) tands as an innovator in the neuro-pharmaceutical industry, delving into the therapeutic potential of psychedelics for treating a range of mental health conditions. MindMed's exploratory work with substances such as LSD, MDMA, DMT, and psilocybin is driven by a vision to unlock new treatment pathways for conditions like anxiety, depression, and addiction. Recent advancements in MindMed's research highlight the company's role in pioneering the use of psychedelics as therapeutic agents, underscoring the potential of these substances to revolutionize mental health care. ** IMPORTANT NOTICE AND DISCLAIMER -- PLEASE READ CAREFULLY! ** PAID ADVERTISEMENT. This article is a paid advertisement. GlobalInvestmentDaily.com and its owners, managers, employees, and assigns (collectively "the Publisher") is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. ("Cybin" or "Company") to conduct investor awareness advertising and marketing. Cybin paid the Publisher two hundred and fifty thousand US dollars to produce and disseminate one article profiling the Company over a period of one week. This compensation should be viewed as a major conflict with our ability to be unbiased. 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FN Media Group Presents GlobalInvestmentDaily.com Market Commentary LONDON, Sept. 19, 2023 /PRNewswire/ -- Depression is costing the economy $1 trillion in lost production every single year. Yet, a classical compound that even the FDA has twice designated a "breakthrough therapy" is shaping up to potentially be the revolutionary treatment that big pharma has been waiting for. Mentioned in today's commentary includes: Johnson & Johnson (NYSE: JNJ), AbbVie Inc. (NYSE: ABBV), Atai Life Sciences NV (NASDAQ: ATAI), Compass Pathways PLC (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD). Scientists say this "miracle compound" can help reset the brain and has huge implications for the treatment of people with... Depression and anxiety PTSD Addiction And many other disabling diseases… But this is a game of patents, and with multi-billion-dollar IP at stake, Big Pharma certainly isn't wasting any time…In fact, Johnson and Johnson (NYSE: JNJ) recently reported massive sales growth for its up-in-coming blockbuster drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market. As reported on JNJ's most recent earnings call, US & worldwide sales for SPRAVATO were up 93.2% & 98.6% y/y respectively, making it the fastest growing drug in its neuroscience portfolio (by far); and with US $170 million in Q2 2023 sales, J&J CEO, Joaquin Duato, went out of his way on the earnings call to dub SPRAVATO its next $1 billion-plus product… Some of the core team behind the SPRAVATO IP recently joined a small but emerging NYSE American listed company on the leading edge of the next biotech breakthrough… That company expects to report Phase 2 clinical data in just a few months, and it recently announced a game-changing agreement to acquire a key strategic asset . The company? Cybin Cybin (NYSE:CYBN) (NEO:CYBN) is on the leading edge of transformational psychedelic therapeutics , developing novel and proprietary therapeutics to improve clinical outcomes and the mental health and wellbeing of patients. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile, but at a low dose. Cybin's intellectual property portfolio encompasses several granted U.S. patents in support of its lead candidates – CYB003 and CYB004 - and over 50 pending patent applications across 6 patent families. Two of the biggest drivers of value for Cybin in the near-term include Phase 2 topline efficacy data for CYB003, expected to be released in the fourth-quarter of this year, and the Phase 1 data for CYB004, also expected before the end of this year. On August 28, Cybin announced an agreement to acquire Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies' combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy. De-Risking Safety and Efficacy: Near-Term Catalysts Oppenheimer, which has initiated coverage on CYBN, is encouraged by the results so far, and believes the stock will have room to run further with new results expected before the end of the year. The analysts expect the DMT acquisition to provide Cybin with "key synergies" as it "deepens focus on short treatment duration, expecting late 2023 readouts". Likewise, in an August 28, 2023 company update, H.C.Wainwright & Co. reiterated its "buy" rating on CYBN, with a price target of US $10.00 per share, after the recent Small Pharma acquisition, which it sees as strengthening Cybin's position in short-acting psychedelics. The acquisition also gives Cybin access to Small Pharma's SPL026, "which has already demonstrated potential in MDD including rapid antidepressant effects that appear durable for six months based on datasets reported in January and April 2023, H.C.Wainwright noted. The Proprietary Molecules That Are Changing Mental Health "The molecular structure of psilocybin, a naturally occurring psychedelic compound found in 'magic mushrooms,' allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses," according to Johns Hopkins Center for Psychedelic and Consciousness Research. What makes Cybin's pipeline so important to the new world of mental health is that from the start, it has set out to create novel and improved psilocybin molecules, while others in the space have been relying on generic materials that are not proprietary. This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending. That makes it the leader of intellectual property in this space. Cybin has taken two molecules—DMT and psilocybin—and focused on the deuteration, which improves the molecules' efficiency. In other words, it eases the path of the molecule into the brain, making it much faster and much more potent with a lower dose. Lower doses mean more potency, and proprietary materials will have to lead this charge, giving the company with the most IP a huge advantage. "Getting it out of the periphery and into the brain is now becoming much faster, without causing side effects," says Drysdale. "If you get the molecules out of the blood stream and into the brain, you're making it more efficient". There is an enormous need to address Major Depressive Disorder (MDD), the leading cause of disability due to mental illness. Between 2010 and 2018, the cost of this illness in the U.S. alone soared 38%, affecting 17.5 million adults at a cost of a devastating $326 billion. That bill includes the direct medical costs of treating MDD, treating comorbidities, suicide-related costs and workplace productivity impacts. And that was five years ago. The costs continue to mount. Another major unmet need in the mental health space is an effective treatment for anxiety disorders, which affect an estimated 18% of the U.S. population alone, or more than 300 million people around the world. Anxiety disorders are the sixth leading cause of disability in adolescents and young adults. Cybin's CYB004 is hoping to address this need. With the combined power of Cybin and Small Pharma and all the complex and proprietary IP that this merger brings together under a single umbrella, CYBN is positioned for big things in a space that desperately needs to cross the finish line on a new way to treat mental health. With its IP catalogue, acquisition agreement, and near-term catalysts, Cybin's (CYBN) small $75-million market cap appears to be far below its potential for the coming months and years. with its expected stage 2 clinical data reveal, this may set up Cybin for an exciting 2024. A New Era of Healthcare Backed by Big Medicine Johnson & Johnson (JNJ) is a multinational healthcare behemoth, with its fingers in a myriad of sectors ranging from pharmaceuticals to medical devices and consumer health products. Within the vast expanse of J&J's portfolio, its pharmaceutical subsidiary, Janssen, ventured into the realm of mental health with the development of esketamine, marketed under the brand name Spravato. This nasal spray, which is a close relative of the anesthetic ketamine, received FDA approval for its use in treating treatment-resistant depression. AbbVie (ABBV), a global powerhouse in the biopharmaceutical world, came into existence after its split from Abbott Laboratories in 2013. Since its inception, AbbVie has been laser-focused on developing treatments for a range of conditions, from rheumatoid arthritis to various forms of cancer. The acquisition of Allergan by AbbVie brought with it a subtle yet significant pivot towards the psychedelic sector. Allergan, before its acquisition, had shown a keen interest in the potential of psychedelics, investing in research related to their use for mental health conditions. Atai Life Sciences (ATAI), a clinical-stage biopharmaceutical company, emerged with a clear mission: to revolutionize the treatment of mental health disorders. Atai's approach to mental health is both comprehensive and innovative. The company boasts a diverse pipeline of compounds, including a range of psychedelics, and has fostered collaborations with various companies to develop groundbreaking therapies. Compass Pathways (CMPS) stands as a beacon in the realm of mental health care, with its pioneering research in the therapeutic use of psilocybin. Psilocybin, a psychedelic compound found in certain mushrooms, has been the focal point of Compass's research endeavors. The primary thrust of Compass's research has been the potential application of psilocybin therapy for treatment-resistant depression. Through rigorous clinical trials and research initiatives, Compass Pathways seeks to legitimize and standardize the use of this compound in a therapeutic context MindMed (MNMD) is a beacon of innovation in the neuro-pharmaceutical landscape. With its roots firmly planted in the exploration of psychedelic substances, the company seeks to unlock new treatment modalities for a range of mental health conditions. MindMed's research portfolio is as diverse as it is promising. The company is actively exploring the therapeutic applications of substances like LSD, MDMA, DMT, and psilocybin. Each compound, with its unique properties, offers a potential avenue for addressing conditions like anxiety, depression, and addiction. ** IMPORTANT NOTICE AND DISCLAIMER -- PLEASE READ CAREFULLY ** PAID ADVERTISEMENT. This article is a paid advertisement. FTB Capital and its owners, managers, employees, and assigns (collectively "the Publisher") is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. (CYBN) to conduct investor awareness advertising and marketing. CYBN paid the Publisher to produce and disseminate this article and related banner ads for one hundred fifty thousand dollars. This compensation should be viewed as a major conflict with our ability to be unbiased. Readers should beware that third parties, profiled companies, and/or their affiliates may liquidate shares of the profiled companies at any time, including at or near the time you receive this communication, which has the potential to hurt share prices. Frequently companies profiled in our articles experience a large increase in volume and share price during the course of investor awareness marketing, which often ends as soon as the investor awareness marketing ceases. The investor awareness marketing may be as brief as one day, after which a large decrease in volume and share price may likely occur. This communication is not, and should not be construed to be, an offer to sell or a solicitation of an offer to buy any security. Neither this communication nor the Publisher purport to provide a complete analysis of any company or its financial position. The Publisher is not, and does not purport to be, a broker-dealer or registered investment adviser. This communication is not, and should not be construed to be, personalized investment advice directed to or appropriate for any particular investor. Any investment should be made only after consulting a professional investment advisor and only after reviewing the financial statements and other pertinent corporate information about the company. Further, readers are advised to read and carefully consider the Risk Factors identified and discussed in the advertised company's SEC, SEDAR and/or other government filings. Investing in securities, particularly microcap securities, is speculative and carries a high degree of risk. Past performance does not guarantee future results. This communication is based on information generally available to the public, and does not (to the Publisher's knowledge, as confirmed by CYBN) contain any material, non-public information. The information on which it is based is believed to be reliable. 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