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| Share Name | Share Symbol | Market | Stock Type |
|---|---|---|---|
| Allergy Therapeutics Plc | AGY | London | Ordinary Share |
| Price Change | Price Change % | Share Price | Last Trade
|
|
|---|---|---|---|---|
| 0.20 | 2.94% | 7.00 | 16:35:13 |
| Open Price | Low Price | High Price | Close Price | Previous Close |
|---|---|---|---|---|
| 6.50 | 6.50 | 6.98 | 7.00 | 6.80 |
| Industry Sector |
|---|
| PHARMACEUTICALS & BIOTECHNOLOGY |
| Top Posts |
|---|
Posted at 03/1/2025 14:22 by totally banjo Hi cathal, as far as I can tell the 210 days are classed as 'active days' ie week days or even 'days' that the application is worked on which might not be every week day if that makes sense. AGY house broker state an approval decision in 12 to 18 months from submission!If or lets be positive when the Grass MATA MPL approval is granted in Germany this, from what I can gather, opens it up for automatic EU approval, I would assume after a bit of paper work. From the Paul-Ehrlich-Institu Mutual Recognition Procedure The Mutual Recognition Procedure (MRP) allows the pharmaceutical company to obtain a marketing authorisation for a medicinal product that has already been nationally authorised in a Member State of the European Union (EU) / European Economic Area (EEA), known as the Reference Member State (RMS), on the basis of the examination and assessment of the quality, efficacy and safety of that Member State by other participating Member States (Concerned Member States – CMS). Repeat Use Procedure Once an MRP (or a DCP) is performed, it may be followed later by other MRPs for obtaining an authorisation in other member states of the European Union (EU) and the European Economic Area (EEA) (Repeat Use Procedure, RUP). If this procedure is to be used, the Reference Member State shall be notified in advance using a special form (see link below under Further Information). Edit- DCP-- Decentralised Procedure-The procedure for authorising medicines in more than one European Union Member State in parallel. It can be used for medicines that do not need to be authorised via the centralised procedure and have not already been authorised in any Member State. Guidance Documents The Paul-Ehrlich-Institu hxxps://www.pei.de/E |
Posted at 03/1/2025 13:00 by cathal71 MAA via Paul Ehrlich?Hey All. As an intruduction, I have been a long term holder of AGY so have been through all the pains of thinking I had lost it all to subsequent benefits of having gone large (comparatively) in the 1p placings. Anyway, on to the question. Do we know if the MAA submitted on 25th November is only for Germany? I know the EU application takes 210 days but there is a Germany only option via PEI which I assume is the case here given their history with Germany and highest revenue potential.. I still cant work out though when approval could be granted if it is shorter than the 210 days. Interested to hear anyones thoughts. Could it be longer than 210 days even? I know they followed tbe same path for Pollinex Quattro. That seemed to take 2 years but they were still allowed to sell it. A bit confusing. Wondering when the next catalyst is |
Posted at 30/12/2024 20:23 by totally banjo yes, been a great year especially for anyone buying in at start with a 3x profit!A nice rise too at end of day! I was having a look at AGY product (Oralvac)for House Dust Might (HDM)this morning which has flat lined regarding sales for last 2 years at about 6% of total sales. Oralvac is based on the Pollinex Quattro range of vaccines which has been available for about seven years (Edit 14 years). It's also worth noting that the new Grass MATA MPL (awaiting Germany, leading quickly to Europe approvals while USA FDA approval route starting soon) is also based on the Pollinex Quattro platform but greatly improved, so you would think it could be arranged to treat House Dust Might? Another one of those 'papers' (Very expensive to purchase) this time relating to House Dust Might, mainly concentrating on the USA market but also the world in general: House Dust Mite Allergy Market: To Grow at a CAGR of 13.6% from 2024 to 2031 HAL Allergy Group, Allergy Therapeutics 12-24-2024 "According to a new report published by CoherentMI The house dust mite allergy market is estimated to be valued at USD 2.6 Bn in 2024 and is expected to reach USD 5.3 Bn by 2031, growing at a compound annual growth rate (CAGR) of 13.6% from 2024 to 2031." hxxps://www.openpr.c |
Posted at 23/12/2024 21:07 by totally banjo Pollinex Quattro SCIT is AGY original grass/tree pollen therapy with the new GRASS MATA MPL although based on the Pollinex platform is a lot stronger and hence more effective!The new GRASS MATA MPL therapy is currently going through the German regulatory approval stage along with imminent start to FDA approval in the USA! Sorry for waffling on, I've had too many mince pies :-) Edit and I nodded off between the two posts, that's Christmas for you! |
Posted at 20/12/2024 20:10 by totally banjo "The total number of shares issued is 4,766,439,938 Ordinary Shares of 0.1 pence each. 92.62% of the shares are not in public hands, as at 13 December 2023."I brought this up a few weeks/months ago I think with SkyGem Acquisition Limited (ZQ Capital) having 65% and Southern Fox Investments 27.43% leaving only about 7.5% in 'public hands'! Therefore a good part of the 7.5% will be either held by long term holders (like me although I don't have as many anymore) or been bought over the last year (probably for the longer term) hence the rise in SP! Again therefore, with the huge potential of AGY over the next year/years where does the share price go during this time as there will come a point where you can't buy any shares or am I being thick? (I've had a few early pints :-) ) |
Posted at 19/12/2024 14:25 by totally banjo beccasan, to be fair Italy have never been a major market for AGY at 6% of global sales but that's not to say they can't improve!Germany is by far the largest market at 49% of global sales. See Annual Report: hxxps://www.allergyt |
Posted at 19/12/2024 13:51 by totally banjo Exercise of Options and Total Voting Rights19 December 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy immunotherapies, announces that to rectify an administrative oversight in relation to the exercise of options under the Company's block admission facility, the Company has made an application to the London Stock Exchange for 709,638 ordinary shares of 0.1 pence each to be admitted to trading on AIM. It is expected that these shares will be admitted to trading on AIM on or around 27 December 2024. The Group's total issued ordinary share capital remains unchanged at 4,766,439,938 ordinary shares, with no shares held in treasury. This figure may be used by shareholders as the denominator for their calculations regarding disclosure obligations. |
Posted at 06/11/2024 12:54 by totally banjo Well it's steady away with a 2% increase in revenue for H2 2024 with medical trials and approvals still all on track!Not an earth shattering set of results by any means but happy to hold and maybe add for the longer term. A bit from AGY broker —Upcoming catalysts: Potential share-price catalysts for investor attention, which we note could materialise over the next 12 to 18 months include: (i) European approval and launch of Grass MATA MPL; (ii) first-year top-line efficacy and safety data from the long-term G308 study; and (iii) further data from the phase I/II PROTECT potential blockbuster VLP Peanut programme. —Investment thesis: While we continue to envisage growth of AGY’s existing portfolio, the foundation of our enthusiasm and investment thesis remains long-term value creation, as the new products are rolled out globally and further clinical data become available. Both Grass MATA MPL and VPL Peanut could be on course to enter blockbuster (>$1bn) markets, and we believe both are likely to be very attractive to potential commercial partners. |
Posted at 27/10/2024 11:28 by jimmyloser What an exciting time to be a shareholder in AGY. Impo/Dyor etcWith Prelim results imminent and likely to tell us about increased productivity and efficiency resulting in growth in sales as indicated in the recent funding RNS. We also have the much awaited marketing application for Grass Mata (see below) and the update in Q4 of the biomarker data (much awaited and see below) It has been a turbulent ride across several years, but hey ho, it has been interesting and educational. PROTECT – Peanut The preliminary results from the first two cohorts of peanut allergic patients assessing safety and efficacy are expected in Q4 2024. Allergy Therapeutics announces successful meetings with Paul Ehrlich Institut to enable MAA plans for Grass MATA MPL Collaborative meetings held with the Paul Ehrlich Institut (PEI) to discuss proposed Chemistry, Manufacture and Controls (CMC) and clinical packages in support of upcoming Grass MATA MPL Marketing Authorisation Application (MAA), on track for submission in Q4 2024 - By including patients from the US, the G306 and G309 trials were designed as supportive to enable a pathway for Biologics License Application (BLA) in the US 3 June 2024 Allergy Therapeutics (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today announces updates on progression of the Group's MAA preparation for Grass MATA MPL. Developing a comprehensive data package Positive regulatory discussions have been held with the PEI regarding the results of the pivotal G306 Phase III trial, as well as the data in support of CMC requirements and the subsequent regulatory pathway to national registration of Grass MATA MPL, the Group's short-course subcutaneous allergen-specific immunotherapy (SCIT) candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen. During the meetings, key trial data from the pivotal G306 Phase III trial were shared, alongside supporting CMC data that the Group plans to use as the basis for the proposed marketing authorisation application. Feedback was constructive and PEI confirmed that, subject to the usual regulatory approval procedures and detailed data analysis, the Group may proceed with an MAA. As previously announced, the Group intends to submit an MAA in Q4 2024. Supportive of US strategy Completion of the G309 and G306 field studies represents a significant milestone in plans for registration in the US. Following an earlier successful end of phase 2 meeting with FDA, the subsequent studies were designed to support a pathway forward to BLA in the US with both G309 and G306 studies including US subjects and it is also planned to include US subjects in the upcoming paediatric study G308. As previously communicated, a specific requirement for FDA, will involve a further study known as G307 to meet the required total number of US subjects treated using the product intended for registration and the Group are planning for meetings with the FDA to agree a route forward. Immediate focus will be preparing the data package for national MAA in Q4 alongside exploration for potential collaborations for US expansion. Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, commented: "We appreciate the supportive and helpful discussions with the PEI and are very pleased that preparations for the regulatory submission of our Grass MATA MPL immunotherapy candidate remain on track. Bringing Grass MATA MPL to this stage has been a huge undertaking for a company like us. After many years and significant investment, we are extremely encouraged by the possibility of bringing this state-of-the-art vaccine to the market, transforming the lives of millions of patients around the world." |
Posted at 04/9/2024 10:24 by totally banjo The PROTECT trial estimated completion date is a few months into 2025 but this, I believe, is the follow up on subjects after the trial is finished.Therefore it is likely that we will get the results of the trial in Q4 2024 which will, if positive, give AGY exposure on the global stage which should be reflected in the share price I'm very positive for AGY future but it does need highlighting that the various on going trials will take time to become revenue generating. It is also quite possible AGY could be bought out before this time! |
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