Entheon Biomedical Corp.

With continued “spottiness” in the supply chain in mind, for the year ahead, Stryker has mapped out a relatively conservative forecast, with organic net sales growing between 7% and 8.5% throughout 2023. After the third quarter of 2022, even as supply chain issues continued to hinder Stryker’s ability to meet demand for its devices in a timely manner, CEO Kevin Lobo told investors that organic net sales for the full year were likely to clock in at the high end of the company’s previous estimates, with growth between 8.5% and 9%. In fact, Stryker ended up flouting that forecast. According to its full-year earnings report, which came out Tuesday, the devicemaker saw its organic net sales jump by 9.7% compared to 2021. Overall, with the effects of changing foreign exchange rates and Stryker’s acquisitions and divestitures factored back in, the company registered a total net sales increase of 7.8%, to reach $18.45 billion. Stryker’s net earnings also got a boost. After raking in just below $2 billion in 2021, profits increased by more than 18% a year later, coming out to nearly $2.4 billion in 2022. Those fiscal wins came even as the “all-time high” order backlog that Lobo reported the previous quarter grew even larger in the final months of the year. On another call with investors on Tuesday, the CEO highlighted the “giant growth” of Stryker’s medical segment, which spent the fourth quarter “really digging out of some of the backlog that they had of orders,” and was able to rack up a 32% year-over-year increase in global sales for the period. Even so, Lobo noted, “If you look at the backlog entering 2023, it’s actually higher than what we had at the end of [2021].” The company is therefore expecting to spend 2023 continuing to chip away at that demand and move past the supply chain stranglehold—resulting in what CFO Glenn Boehnlein said should be visible improvements by the second half of the year. “We actually feel pretty good about our access to supply. We are seeing a reduced volume of spot buys—which are those really high-cost items—and we are also beginning to work with our original set of vendors, and also going up the food chain and actually working with chip suppliers,” Boehnlein told investors. “We feel like we have a good handle on what’s going to happen with the supply chain.” As Lobo noted in his concluding remarks on Tuesday’s call, “We obviously are going to continue to have some challenges around spottiness in the supply chain, but it certainly feels like the worst is behind us.” With that “spottiness” in mind, for the year ahead, Stryker has mapped out a relatively conservative forecast, with organic net sales growing between 7% and 8.5% throughout 2023. Chugging away at that rate—essentially, the standard market growth rate—will allow the company to focus much of its energy toward upcoming additions to its Mako robotic surgery system, Lobo said on the call, after which the company will be able “to start to grow above market.” Mako is already available for use in performing joint replacement procedures, and Stryker is now planning on adding indications for use in spine and shoulder surgeries, with initial rollouts set for the latter half of 2024, according to Jason Beach, the company’s VP of investor relations.

PALM BEACH, FL, Nov. 14, 2022 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - Anti-anxiety drugs are medications that are used to treat anxiety disorders that are mainly used to relieve anxiety and tension, work by reducing the symptoms of anxiety, such as fear, stress, and panic attacks. A report from PS Market Research projected that the global market for anxiety and depression treatment products is projected to progress at a CAGR of 3.3% through 2030. It said the major factors responsible for the growth of the market include growing geriatric population, rising awareness about mental diseases and their treatment, and increasing number of product approvals. The report said: "With the growing age, individuals go through a number of stress conditions. Some of which are common to all age groups, while some are old-age specific such as loss in capabilities to function properly. In addition, the elder people experience reduced socioeconomic status with retirement, which worsen the situation as it leads to isolation and loneliness. Thus, the older people are more vulnerable toward mental disorders, such as anxiety and depression. Thus, the rising cases of anxiety and depression in elderly population, across the world, would help the anxiety and depression treatment market growth. The awareness about mental diseases has increased across the world, owing to the increased initiatives taken by private and public healthcare institutions… In recent years, the players in the anxiety and depression treatment industry have indulged themselves in more product launches to offer a better product portfolio than other competitors." Active biotech and pharma companies in the markets this week include Marvel Biosciences Corp. (TSX-V: MRVL), Sage Therapeutics, Inc. (NASDAQ: SAGE), Minerva Neurosciences, Inc. (NASDAQ: NERV), atai Life Sciences N.V. (NASDAQ: ATAI), Cybin Inc. (NYSE: CYBN) (NEO: CYBN). The article added: "Mergers and acquisitions allow pharmaceutical companies to increase their portfolios, expand their reach, and enhance their workflow, in the anxiety and depression treatment market. Also, several key players are involved in mergers and acquisitions to accelerate the pace of drug discovery and development, in order to gain a competitive edge… Thus, these development strategies will create a diverse portfolio of depression and anxiety drugs in the market, leading to more demand for such drugs. Geographically, North America generated the largest share in the anxiety and depression treatment market… and is expected to maintain its position in coming years. This is majorly ascribed to the rise in number of cases of pain, coupled with the greater prevalence of anxiety and major depressive disorders, growth in awareness regarding mental health, high-disposable income, and increase in number of prescriptions for antidepressants, in the region." Marvel Biosciences Corp. (TSXV: MRVL) BREAKING NEWS: Marvel Biosciences Lead Drug Candidate MB-204 Demonstrated Superior Anti-Anxiety Activity Over FDA-Approved Istradefylline in Head-to-Head Pre-clinical Studies - Marvel Biosciences Corp. and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the " Company" or " Marvel"), is pleased to announce that in a pre-clinical test for anxiety, its lead drug candidate MB-204, a fluorinated derivative of Istradefylline, out-performed Istradefylline in a head-to-head pre-clinical and in depressive and anti-anxiety studies. Istradefylline is the only US FDA approved A2a receptor antagonist currently approved to treat Parkinson's disease. "This head-to-head study suggests MB-204 has a superior anti-anxiety activity compared to its parental molecule Istradefylline," said Dr Mark Williams, Chief Science Officer of Marvel Biosciences. "What was particularly interesting is that the mice treated with MB-204 had more social interactions than mice treated with Istradefylline. Social isolation can compound depression and anxiety, so this is an intriguing finding for MB-204." "Depression and anxiety can be debilitating and it continues to be a growing problem among many age groups," said Rod Matheson CEO of Marvel Biosciences. "With rates of up to one in eight adults taking an anti-depressive, and the recent revisiting of the serotonin hypothesis of depression, the need for novel anti-depressants and anti-anxiety medications is greater than ever. We are on track to enter Phase I FDA human trials as early as the first quarter of next year and hope to advance our unique lead candidate MB-204 through the FDA approval process as quickly as possible to help alleviate patients' suffering from these conditions with a new mechanism of action." Using the well-established elevated plus maze pre-clinical model for anxiety, and the same doses of MB-204 as compared to Istradefylline (7.5 mg/kg) resulted in: Longer times spent in the open arms, especially in the first minute, which indicates a larger anti-anxiety effect Engaged in more risky behaviour than Istradefylline, as measured by head dipping behaviours again suggesting less anxiety Did not trigger excessive locomotive activity whereas Istradefylline did promote excessive locomotive activity Promoted ultrasonic vocalizations (USVs), whereas Istradefylline did not evoke any USVs which is indicative of social communication CONTINUED… R ead this full press release and more news for Marvel Biosciences at: Other recent developments in the biotech industry of note include: Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, recently reported business highlights and financial results for the third quarter ended September 30, 2022. "This has been an important year for Sage, marked by the execution of significant milestones across our franchises. Looking ahead, we remain focused on the completion of the NDA submission for zuranolone in MDD and PPD, and are well into commercialization preparations to support a potential launch. Patients with depression are desperate to find new medicines that are safe, rapid-acting, short course, and have a sustained effect. We believe zuranolone, if approved, has the potential to deliver a new treatment option for patients," said Barry Greene, Chief Executive Officer at Sage Therapeutics. "In parallel, our team is advancing multiple clinical studies across our pipeline that span our neuropsychiatry and neurology franchises. I am proud of the tremendous progress our team has made on behalf of patients this year and am energized by the momentum we have going into 2023 and beyond." Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, recently reported key business updates and financial results for the quarter ended September 30, 2022. Roluperidone Update As announced on August 17, 2022, the company submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for roluperidone to treat negative symptoms in schizophrenia. The submission included data from two clinical trials, the company's phase 2b and phase 3 studies, in patients diagnosed with schizophrenia with negative symptoms. atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently reported financial results for the quarter ended September 30, 2022 and provided a business update. "In addition to multiple study initiations this quarter, we have announced two positive clinical trial results, with more on the way," said Florian Brand, Co-Founder and Chief Executive Officer of atai. "We're excited about the upcoming Phase 2a topline results of PCN-101 that could represent a meaningful shift in the current treatment paradigm for patients." "The third quarter of 2022 demonstrated our strong capability to execute. Not only did we have first patient dosed of a Phase 1 trial of VLS-01 and initiation of a Phase 1 trial of EMP-01, we also began collecting data on our digital therapeutic app supporting '(mind)set-and-setting' prior to dosing," said Srinivas Rao, Co-Founder and Chief Scientific Officer. "Moreover, positive safety, tolerability, and pharmacodynamic results from both KUR-101 and GRX-917 Phase 1 trials reinforce our belief in our unique approach to drug selection, which emphasizes prior evidence in humans. Finally, we continue to strengthen our enabling technology capabilities through initiation of a proof-of-concept Phase 1 clinical trial of a sol-gel based technology which could enable direct-to-brain delivery of various compounds in development across atai's pipeline." Cybin Inc. (NYSE AMERICAN: CYBN) (NEO: CYBN) recently announced that its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine (" DMT") has completed dosing for four out of five participant cohorts and The Safety Review Committee has confirmed no clinically significant safety or tolerability issues. The CYB004-E Phase 1 trial was acquired from Entheon Biomedical Corp. (" Entheon") in July 2022. The CYB004-E trial marks one of a number of strategic transactions that Cybin has completed in recent months to support its research and development pipeline of active psychedelic-based programs and potential future novel drug candidates. The acquisition of the CYB004-E Phase 1 trial replaced Cybin's planned pilot study that was expected to commence in the third quarter of 2022, and as such, has served to potentially accelerate the clinical development path of CYB004, the Company's proprietary deuterated DMT molecule for the potential treatment of anxiety disorders. DISCLAIMER: FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. 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TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NEO:CYBN) (NYSE AMERICAN:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics®, is pleased to announce that its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine (“DMT”) has completed dosing for four out of five participant cohorts and The Safety Review Committee has confirmed no clinically significant safety or tolerability issues. The CYB004-E Phase 1 trial was acquired from Entheon Biomedical Corp. (“Entheon”) in July 2022. The CYB004-E trial marks one of a number of strategic transactions that Cybin has completed in recent months to support its research and development pipeline of active psychedelic-based programs and potential future novel drug candidates. The acquisition of the CYB004-E Phase 1 trial replaced Cybin’s planned pilot study that was expected to commence in the third quarter of 2022, and as such, has served to potentially accelerate the clinical development path of CYB004, the Company’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders. “The acquisition of the Phase 1 DMT study was done with an eye toward informing and accelerating the clinical path forward for CYB004 and we are very pleased with the progress so far. With strong intellectual property in place for this program, the CYB004-E trial is a critical next step towards better understanding the therapeutic potential of DMT and will better inform the future development of CYB004,” said Doug Drysdale, Chief Executive Officer of Cybin. The CYB004-E trial is ongoing at the Centre for Human Drug Research in the Netherlands and is the Company’s largest Phase 1 DMT trial conducted to date. The study is assessing the pharmacokinetics and pharmacodynamics of DMT and is anticipated to provide safety and dosing data to inform the clinical development plan for CYB004. Cybin expects the Phase 1 trial to be completed in the first half of 2023i. About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders; the Company’s expectation that the CYB004-E Phase 1 trial will accelerate the CYB004 timeline; the Company’s expected timeline to complete the Phase 1 trial; and the Company’s expectations and objectives regarding the results of the CYB004-E study. These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the three months ended June 30, 2022 and the Company's annual information form for the year ended March 31, 2022, which are available under the Company's pro and with the U.S. Securities and Exchange Commission on EDGAR at . Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations. Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved nor disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein. i There is no assurance that these timelines will be met. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company.