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Share Name Share Symbol Market Type Share ISIN Share Description
Genincode Plc LSE:GENI London Ordinary Share GB00BL97B504 ORD 1P
  Price Change % Change Share Price Shares Traded Last Trade
  0.00 0.0% 36.00 0.00 07:38:52
Bid Price Offer Price High Price Low Price Open Price
35.00 39.00
Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m)
Health Care Equipment & Services 34
Last Trade Time Trade Type Trade Size Trade Price Currency
- O 0 36.00 GBX

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Date Time Title Posts
06/12/202109:28GENinCode32

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DateSubject
07/12/2021
08:20
Genincode Daily Update: Genincode Plc is listed in the Health Care Equipment & Services sector of the London Stock Exchange with ticker GENI. The last closing price for Genincode was 36p.
Genincode Plc has a 4 week average price of 36p and a 12 week average price of 36p.
The 1 year high share price is 48.50p while the 1 year low share price is currently 34.30p.
There are currently 95,816,866 shares in issue and the average daily traded volume is 10,134 shares. The market capitalisation of Genincode Plc is £34,494,071.76.
06/12/2021
09:28
hedgehog 100: 29/11/2021 07:00 UK Regulatory (RNS & others) GENinCode PLC Directorate Change LSE:GENI Genincode Plc "GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces that David Evans, Non-Executive Director, has notified the Board of his intention to stand down from his role with immediate effect. Bill Rhodes, Non-Executive Chairman of GENinCode Plc said: " We would like to thank David for his invaluable contribution to GENinCode during his tenure. David has worked with members of the GENinCode management team for many years, and he has always provided instrumental strategic advice and counsel from his wealth of experience in the sector. On behalf of the Board, I would like to wish him the very best for the future."" https://uk.advfn.com/stock-market/london/genincode-GENI/share-news/GENinCode-PLC-Directorate-Change/86669484 No I don't think he'll be selling any time soon. Like most people here I imagine, I think he'll be intending to wait until GENI progresses its business plan, and hopefully multibags, before selling any. It could be that he always intended stepping down at some point relatively soon after GENI floated, having helped the company achieve this important milestone, and being very busy. GENI still has five directors, and the board looks very strong. But the opportunity acquire more cheap GENI shares, with fewer restrictions, could have been an additional inducement. Either for his own account, and/or for his Intuitive Investments (IIG) life sciences fund. And investment in GENI from IIG would make perfect sense, and stepping down as a GENI director could simplify this.
30/11/2021
17:05
hedgehog 100: I don't think it's likely that he would try to sell an institutional-sized stake on the market: more likely he would place it, especially with his contacts. But he's a specialist investor in this sector, so he will know how good GENI is: HTTP://www.sharesmagazine.co.uk/article/life-sciences-industry-veteran-david-evans-launches-new-investment-company He's also extremely wealthy. So I think it's far more likely that he's become aware of a periodic seller of GENI shares, and wishes to take advantage of that.
30/11/2021
14:15
hedgehog 100: 29/11/2021 07:00 UKREG GENinCode PLC Directorate Change "GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease, announces that David Evans, Non-Executive Director, has notified the Board of his intention to stand down from his role with immediate effect. Bill Rhodes, Non-Executive Chairman of GENinCode Plc said: " We would like to thank David for his invaluable contribution to GENinCode during his tenure. David has worked with members of the GENinCode management team for many years, and he has always provided instrumental strategic advice and counsel from his wealth of experience in the sector. On behalf of the Board, I would like to wish him the very best for the future."" https://uk.advfn.com/stock-market/london/genincode-GENI/share-news/GENinCode-PLC-Directorate-Change/86669484 David Evans has already been removed from the board of directors page on GENI's website: HTTP://investors.genincode.com/investors/board-of-directors He owns 3.46% of GENI's shares: HTTP://investors.genincode.com/investors/shareholder-information Now he's resigned he will have more leeway to add to his holding, to take advantage of the depressed GENI s.p.
25/11/2021
11:09
hedgehog 100: "The FDA's Breakthrough Devices Program ... Requirements for participation For a manufacturer to be able to obtain approval for their devices through the Breakthrough Devices Program, it must meet several requirements. ▪ The medical device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. Examples would include strokes, heart attacks, cancer, severe trauma and ALS. ▪ At least one of the following criteria must be met: ▪ The device is a technological breakthrough (breakthrough technology). For example, a new genetic test that would allow the treatment options to be evaluated better. ▪ There are no approved alternatives. According to the FDA, there is currently no device that can diagnose Parkinson's disease directly. ▪ It offers a significant improvement compared to approved alternatives. The device is in the best interest of patients. This would be the case if the alternatives have major side effects or if the new device significantly improves the diagnostic options and their use. ..." HTTP://www.johner-institute.com/articles/regulatory-affairs/fda/breakthrough-devices/ 25/11/2021 06:59 UK Regulatory (RNS & others) GENinCode PLC Trading update LSE:GENI Genincode Plc " ... -- Cardio inCode(R) de-novo submission for US regulatory approval with the FDA - The Company continues to have constructive and ongoing discussions with the FDA and is finalising its de-novo application. The de-novo submission is expected to be filed by the end of this year. -- Breakthrough Device Designation (FDA) for Cardio inCode(R) - Discussions continue to progress with the FDA to advance Cardio inCode(R) as a 'Breakthrough device'. Discussions have been extended partly due to FDA workload, but also resulting from a detailed assessment of GENinCode's CVD prognostic device which, in turn, has given the Company confidence to file its de-novo submission earlier than it might otherwise have planned. The Company remains well placed to complete this process over the coming months. ..." https://uk.advfn.com/stock-market/london/genincode-GENI/share-news/GENinCode-PLC-Trading-update/86652844 The FDA seem to be very seriously considering Cardio inCode(R) for Breakthrough Device Designation. Which is not surprising, as it appears to meet the qualifying criteria well. If it gets it, the pathway to approval and sales in the US would clearly be accelerated. But it would also provide a real boost in terms of kudos and distinction.
08/11/2021
17:18
hedgehog 100: A good recent example of spin-out outperformance is BYIT, which IPOed in December at 270p, since when it has doubled. Current share price 558.5p, market cap. £1.33 billion. GENI looks to have even more potential though, starting from a much lower market cap., and with such huge business growth prospects. 17/12/2020 08:01 UK Regulatory (RNS & others) Bytes Technology Group PLC Completion of Demerger and Admission to Trading LSE:BYIT Bytes Technology Group Plc "Following the announcement by Bytes Technology Group on 11 December 2020 of the Offer Price of its IPO, the Company announces the completion of the Demerger of the Bytes Group from the Altron Group, which took effect at 8.00 a.m. (UK time) today. In addition, the Company announces its entire ordinary share capital consisting of 239,482,333 Ordinary Shares of GBP0.01 each has today been admitted to the premium listing segment of the Official List of the FCA and to trading on the LSE's Main Market for listed securities under the ticker "BYIT" and the Main Board of the JSE by way of a secondary inward listing under the symbol "BYI"." https://uk.advfn.com/stock-market/london/bytes-technology-BYIT/share-news/Bytes-Technology-Group-PLC-Completion-of-Demerger/83927665 Bytes Technology (BYIT):
06/11/2021
17:12
hedgehog 100: Well Toffeeman, you seem to have a good eye for a quality health sector growth stock, so hopefully RMD's success is a good sign for GENI ... RMD's rise looks like pure GENIus!
06/11/2021
12:35
hedgehog 100: The last health sector share thread Toffeeman started was nearly four years ago, on US-Oz listed stock ResMed, a leader in CPAP (continuous positive airway pressure) tech. https://uk.advfn.com/cmn/fbb/thread.php3?id=42141486 Current share price: US$260.55, up from about US$5 in January 2000. Industry Sector Turnover (m) Profit (m) EPS - Basic PE Ratio Market Cap (m) Healthcare 3,196.83 479.52 3.24 77.0 37,968 https://uk.advfn.com/stock-market/NYSE/RMD/share-price ResMed (RMD): https://uk.advfn.com/cmn/chrt/chrt_wrap.php?epic=NYSE%3ARMD&name=&type=1&size=2&period=12&ind_type1=0&ind_type2=1&ind_type3=0
31/10/2021
12:09
hedgehog 100: 22/07/2021 07:00 UK Regulatory (RNS & others) GENinCode PLC Admission to trading on AIM & First Day of Dealing LSE:GENI Genincode Plc "... On 28 April 2021, the Company announced a partnership to provide genetic testing from labs based at Royal Brompton and Harefield Hospitals. Following this, it was announced on 14 June 2021 that a product commercialisation agreement had been entered into with EVERSANA in the US. The Directors believe that the partnership with EVERSANA, a leading provider of global commercial services to the life science industry, will provide a significant opportunity for the Group to progress its commercialisation plans for the US. ..." https://uk.advfn.com/stock-market/london/genincode-GENI/share-news/GENinCode-PLC-Admission-to-trading-on-AIM-First/85642649 "GENinCode announces major US commercialisation partnership with EVERSANA Posted on June 14, 2021 Oxford, UK. — 14, June 2021 — GENinCode UK Limited, the cardiovascular disease company focused on predictive genetics for the prevention of cardiovascular disease, announces its partnership with EVERSANA Life Sciences LLC (“EVERSANA”) as its launch and commercialisation partner to access the United States market for the GENinCode portfolio of polygenic cardiovascular disease (“CVD”) products focused on genetic risk. EVERSANA is a leading provider of global commercial services to the life sciences industry. In the United States, GENinCode will utilise EVERSANA’s COMPLETE Commercialisation model fully integrating services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, health economics and outcomes research and compliance, with each service optimised by data and predictive analytics. The suite of expertise will underpin and accelerate the launch of GENinCode’s first product Cardio inCode for the risk assessment of CVD in primary prevention. The EVERSANA group comprises over 4,000 employees. GENinCode specialises in polygenic risk assessment for the onset of cardiovascular disease with the Company’s technology providing clinicians with genetic risk assessment and AI bioinformatics to inform, predict and prevent cardiovascular events. CVD is the leading cause of death and disability worldwide accounting for one in every four deaths in the United States. In 2010, the global cost of CVD was approximately US $863 billion. By 2030, this figure is set to rise to US $1,044 billion and is both a major health issue and global economic burden. CVD is a broad disease classification which encompasses conditions such as coronary artery disease (causing angina, heart attacks, heart failure), cerebrovascular disease (causing stroke, and some dementia), peripheral vascular disease (causing limb ischaemia, and some chronic kidney disease) and venous thromboembolism. GENinCode will deliver its portfolio of polygenic CVD products through its partnership with EVERSANA. GENinCode and EVERSANA have a vision to inform patients about their cardiovascular risk and to improve public health by using the predictive capability of genomics to assist in making lifestyle choices and targeting treatment to improve patient outcomes. Over the past 15 years GENinCode has amassed significant investment in its research, data, bioinformatics technology and product development to assess disease risk to prevent the onset of CVD. Matthew Walls, CEO, GENinCode said: “We have worked closely with the EVERSANA team over the past 12 months and are delighted to announce our US partnership. EVERSANA provide proven launch and commercialisation expertise to support our market access and will help accelerate our speed to market.” Jim Lang, CEO of EVERSANA said: “GEN inCode’s approach to understanding and addressing genetic risk is revolutionary and as such, these products demand a commercialisation model that bypasses traditionally strategies to acceleration launch, access and impact. EVERSANA is eager to put the full power of our platform to work.” For more information visit www.genincode.com Enquiries: GENinCode UK Limited Tamsin Jeffs Tel +44 (0)7800 903435 EVERSANA Sarah Zwicky Tel +1 (414) 434-4691 About GENinCode GENinCode is a UK based company specializing in cardiovascular disease risk. Cardiovascular disease is the leading cause of death and disability worldwide. GENinCode UK Limited operates business units in Europe and Latin America through GENinCode S.L.U, and in the United States through GENinCode U.S. Inc. GENinCode’s predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. Our CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict disease onset. To learn more about GENinCode, visit www.genincode.com or connect through LinkedIn and Twitter. About EVERSANA EVERSANA™ is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter." HTTP://www.eversana.com/2021/06/14/genincode-announces-major-us-commercialisation-partnership-with-eversana/
30/10/2021
12:35
hedgehog 100: 22/07/2021 07:00 UK Regulatory (RNS & others) GENinCode PLC Admission to trading on AIM & First Day of Dealing LSE:GENI Genincode Plc "... The Company's commercialisation strategy in the US is a significant part of GENinCode's long-term growth and commercial strategy. The Directors expect Cardio inCode to be reviewed by the FDA as a De Novo device. The Company submitted an initial application to the FDA in February 2021 for Breakthrough Device designation for its Cardio inCode product. The FDA review is ongoing with a decision expected in Q3 2021. ..." https://uk.advfn.com/stock-market/london/genincode-GENI/share-news/GENinCode-PLC-Admission-to-trading-on-AIM-First/85642649 "HOW TO USE THE DE NOVO PATHWAY FOR YOUR MEDICAL DEVICE By Tom Rish, January 12, 2021 , in Regulatory Compliance and Regulatory Affairs and Medical Device Product and Medical Device Industry and Process / Planning ... How is De Novo different from the 510(k) route? While devices using the 510(k) pathway rely on predicate devices for proving substantial equivalence to a previously marketed device, De Novo begins with a completely clean slate. With no equivalence criteria required, De Novo uses a risk-based approach to assessing medical devices. ..." HTTP://www.greenlight.guru/blog/how-to-use-de-novo-pathway "The FDA's Breakthrough Devices Program The FDA is trying to facilitate quicker access for critically ill patients to novel medical devices through a new program for breakthrough devices. In December 2018, it published a guidance document on the program. In this article, we will explain how the Breakthrough Devices Program works and what requirements manufacturers must meet in order to be able to participate in it. ... Requirements for participation For a manufacturer to be able to obtain approval for their devices through the Breakthrough Devices Program, it must meet several requirements. ▪ The medical device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions. Examples would include strokes, heart attacks, cancer, severe trauma and ALS. ▪ At least one of the following criteria must be met: ▪ The device is a technological breakthrough (breakthrough technology). For example, a new genetic test that would allow the treatment options to be evaluated better. ▪ There are no approved alternatives. According to the FDA, there is currently no device that can diagnose Parkinson's disease directly. ▪ It offers a significant improvement compared to approved alternatives. The device is in the best interest of patients. This would be the case if the alternatives have major side effects or if the new device significantly improves the diagnostic options and their use. ..." HTTP://www.johner-institute.com/articles/regulatory-affairs/fda/breakthrough-devices/
10/9/2021
16:52
diversification: '@Stifel initiate coverage for @GenIncode with a BUY rating - "With US launch planned for 2022 and potential for sales to reach $225m by 2028E, we see significant upside to the shares." Target price 175p #GENI
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