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Allergy Therapeutics PLC (AGY)     

banjomick - 01 Feb 2016 13:59

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Mission Statement
To create a sustainable, fast-growing and profitable global speciality pharmaceutical business with a substantial franchise in the allergy sector by developing innovative, patented, registered therapies for both the treatment and prevention of allergy-related conditions.

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NEWS

19th Jul 2018 Proposed placing and subscription to raise up to £10.6 million
13th Jul 2018 Hardman & Co Research
12th Jul 2018 Trading update
25th Jun 2018 Positive data of Pollinex Quattro Grass vaccine
29th May 2018 Positive data with house-dust mite immunotherapy
21st May 2018 Positive top-line results from Grass Ph II study
14th May 2018 Publication of MCT Adjuvant Data
07th Mar 2018 Hardman Research: Clinical development towards submission
07th Mar 2018 Interim Results for the six months ended 31 December 2017


VIDEO/AUDIO
21st May 2018 Allergy Therapeutics on track for phase III grass pollen trial in 2019
September 2017 5 minute pitch
09th May 2016 Allergy Therapeutics boss excited by PQBirch204 Phase II data
08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable
18th Feb 2016 Allergy Therapeutics hopes to launch "exciting" grass pollen allergy vaccine in 2019
14th Jan 2016 Allergy Therapeutics boss says the firm is outperforming its competitors

EVENTS
27 11 2018 AGM (tentative)
03 10 2018 Shares Investor Evening (London)
26 09 2018 Preliminary Annual Results 2018 Announcement (tentative)


WEBSITES

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banjomick - 08 Mar 2016 08:33 - 7 of 159

***PLEASE CLICK LINK AT BOP FOR FULL RESULTS***

08 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")

Interim Results for the six months ended 31 December 2015


Allergy Therapeutics plc (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces unaudited interim results for the six months ended 31 December 2015.

Highlights

Financial highlights

· Revenue increased by 12% at constant currency to £31.5m (H1 2015: £28.2m)* and reported revenue increased by 3% to £29.0m (H1 2015: £28.2m)

· R&D expenditure increased to £6.5m (H1 2015: £1.1m) as the two Phase II studies in Germany and the US were successfully progressed

· Fundraising of £11.5m (gross) successfully completed with placing of 41,005,500 ordinary shares in the Company to invest in new product development, strengthen the balance sheet and accelerate growth

· Cash balance bolstered to £33.2m (H1 2015: £8.0m)



Products and pipeline highlights

· Increasing market share in all major markets

· Spanish Alerpharma acquisition fully integrated

· US Phase II study for GrassMATAMPL (marketed in Europe as Pollinex Quattro Grass product) initiated in December 2015 - on track for data read out in H2 2016

· PQ Birch204 Phase II study patient enrolment completed - results expected in H2 2016

· Acquisition of Virus Like Particles ("VLP") technology licence for the development of a potential new injectable vaccine immunotherapy treatment for allergy sufferers, with peanut as the lead project

· Positive house dust mite study results for Acarovac - July 2015


Post period end highlights


· US Grass MATAMPL study fully recruited according to plan in February 2016



Commenting on the interim results, Manuel Llobet, Chief Executive Officer, said:

"The first half of this year has seen continued momentum with our product sales continuing to outperform the market with further market share gains across Europe. We delivered 12% revenue growth at constant currency. This double-digit growth against a (broadly) flat market has been driven by a combination of our winning proposition of lifestyle enhancing short course aluminium-free vaccines boosted by our successful sales strategy.

"Our business is gaining significant scale and momentum in Europe through both organic and acquisitive growth and we expect this to continue as we further invest in our commercial infrastructure and prepare to take our products over to the US. We eagerly await the data from two ongoing Phase 2 studies for GrassMATAMPL and PQ Birch204 which are both due to report later in 2016.‎"

* Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the effects of foreign exchange movements. See table in financial review for an analysis of revenue.


Joint Statement from the Chairman and Chief Executive Officer

Operating Review

Overview

During the first six months of the year, the Company's revenues grew 12% (at constant currency) compared to 11% at the end of June 2015, and against flat or low growth markets in Europe. Allergy Therapeutics' robust level of double digit top line growth at constant currency is due to the benefits offered to patients of a short course, aluminium-free, therapy which is enabling the Company to outperform its competitors and grow its market share in Europe. Geographically, the major contributing markets to the Company's growth have been Germany and Spain, followed by The Netherlands, the UK and Austria.

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banjomick - 08 Mar 2016 09:43 - 8 of 159

Video supporting today's Interim Results:

https://player.vimeo.com/video/158104723?title=0&byline=0&portrait=0&autoplay=1&wmode=transparent

banjomick - 17 Mar 2016 09:08 - 9 of 159

17 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Board change


Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces that Ian Postlethwaite, Finance Director, has resigned from the Company to pursue a new opportunity. Ian will remain as a Director of the Company and Finance Director for up to six months to allow time for a suitable successor to be appointed and for an orderly handover. The Board has commenced a search for his successor and a further announcement will be made in due course.

Peter Jensen, Chairman of Allergy Therapeutics, said: "Ian has been the Finance Director for 14 years and a significant contributor to the success of the Company. During this time Allergy Therapeutics has listed on AIM, achieved a number of financial goals including two fund raisings in 2015 to support the Company's clinical and other development plans, and has growing revenues from products on sale in Europe. Ian leaves the Company in the strongest position it has ever been in, in terms of sales, cash balance and growth potential. We are very positive about the future of Allergy Therapeutics and wish Ian the best for his ongoing career."


http://www.moneyam.com/action/news/showArticle?id=5241719

banjomick - 23 Mar 2016 09:11 - 10 of 159

23 March 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Issue of equity in respect of the exercise of options


Allergy Therapeutics announces the issue and allotment of 2,305,089 new ordinary shares of 0.1p each in the capital of the Company ("Ordinary Shares") pursuant to the exercise of 2,305,089 share options by certain employees.

Application has been made to the London Stock Exchange for admission to trading of the new Ordinary Shares on AIM ("Admission"). It is expected that Admission will take place and that dealings in the new Ordinary Shares on AIM will commence at 8:00 a.m. on 29 March 2016. The new Ordinary Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing Ordinary Shares in the capital of the Company, including the right to receive all dividends or other distributions made, paid or declared in respect of such shares after the date of issue of the new Ordinary Shares.

Allergy Therapeutics' enlarged issued ordinary share capital immediately following Admission will be 589,158,508 Ordinary Shares with voting rights attached. The Company has no Ordinary Shares in Treasury; therefore the total number of voting rights in Allergy Therapeutics is 589,158,508. This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the share capital of the Company under the FCA's Disclosure and Transparency Rules.


http://www.moneyam.com/InvestorsRoom/posts.php?tid=19493#lastread

banjomick - 30 Mar 2016 21:50 - 11 of 159

Allergy Therapeutics-Edison Report

Fresh finance, fresh product lines

30 March 2016 | Allergy Therapeutics, Pharma & biotech

http://www.edisoninvestmentresearch.com/research/report/allergy-therapeutics21/full

banjomick - 13 Apr 2016 13:08 - 12 of 159

***You need to Register for FREE to finish reading this article"***


Interview - Allergy Therapeutics Sniffs Out Second Chance
Apr. 12, 2016 8:51 AM ET
About: Allergan plc (AGN)

After nearly a decade of delays Allergy Therapeutics (NYSE:AGN) is getting back on track with its short-course allergy vaccines. The company expects results from two phase II studies at the end of June: one in the US with Pollinex Quattro Grass, the other in Europe with Pollinex Quattro Birch.

The UK group hopes that the grass vaccine will be the first seasonal subcutaneous immunotherapy to reach the US, with phase III trials to start later this year and launch in 2020 if all goes well. In Europe, Allergy already sells its Pollinex Quattro products on a named-patient basis, with revenues of £43m ($60m) in 2015, but is also seeking its first formal approval.

The US opportunity is “potentially transformational”, say Edison analysts, who put peak US sales for the Pollinex Quattro range – including the grass vaccine, the tree vaccine and a third product, Pollinex Quattro Ragweed – at $1.1bn.

This would be quite a turnaround from 2007, when Allergy was forced to delay its research program after an adverse event. Although this turned out to be unrelated to the vaccine, the FDA did not lift its clinical hold until 2012 after it had conducted a review of novel vaccine adjuvants.

Subcutaneous vs sublingual

Allergy did not resume US clinical development until last year. In the meantime, the company’s vaccines have been overtaken by sublingual allergy treatments developed by Stallergenes and ALK Abello.

But these oral treatments have not taken off, perhaps owing to a preference for subcutaneous vaccines in the US. Allergy's chief executive, Manuel Llobet, tells EP Vantage that, being subcutaneous, Pollinex Quattro “will have a really fast penetration”.

Somewhat counterintuitively, he believes that compliance with Allergy’s vaccines, which require four to six injections, is better than with sublingual treatments. “You might have to go to the doctor six times, but then that’s it. With the tablet you have to take one every day for at least a year, and patients don’t really follow the treatment.”

page 1 / 3 | Next »

http://seekingalpha.com/article/3964658-interview-allergy-therapeutics-sniffs-second-chance

banjomick - 09 May 2016 09:23 - 13 of 159

9 May 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics announces positive top-line results from the PQBirch204 Phase II study for birch-induced seasonal allergic rhinitis


· Primary endpoint met

· Statistically significant dose-response relationship (p<0.01)

· All dosing regimens were safe and well tolerated

· Adherence was greater than 90%

Allergy Therapeutics, (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, today announces positive top-line results from the Company's PQBirch204 Phase II study, a multi-centre, double-blind, placebo-controlled study designed to explore the safety and response of different cumulative doses of Birch Modified Allergen Tyrosine adsorbed and MPL® (POLLINEX® Quattro Birch) for birch pollen induced seasonal allergic rhinitis.

The study randomised 371 patients into six cumulative dosing regimens plus a placebo, evaluating the change in Total Symptom Score (TSS) following a conjunctival provocation test (CPT) with the objective to achieve a dose recommended for Phase III development.


Results summary of the PQBirch 204 Phase II study programme


· The primary endpoint, to demonstrate a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300 SU, was met. This enables prediction of the dose to enter Phase III development

· The study demonstrated a statistically significant (p<0.01) dose-response for the 5000 standardised units (SU) to 27300SU dose range studied

· The dose-response closely followed and extended the findings of the previous dose-response study (PQBirch203), which studied doses from 600SU to 13600SU

· PQBirch continues to be well-tolerated and no safety concerns were reported in any treatment arm. There was no significant relationship between any adverse drug reaction exhibited and the respective dosage of allergoid

· Overall adherence to the dosing regimens was approximately 94% with no relevant differences between treatment arms.

Manuel Llobet, Chief Executive Officer of Allergy Therapeutics, said: "The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis. Approximately 6% of the population in Europe alone is allergic to birch pollen and there continues to be a need for a safe and well tolerated effective treatment for this significant health issue. Pollinex is the only ultra-short course aluminium-free treatment in the market and its convenience for patients is driving our market penetration in all our European markets.

"This study is a significant milestone in our route to Marketing Authorisation and keeps us on track to commence the Phase III study in early 2017."

http://www.moneyam.com/action/news/showArticle?id=5337115


banjomick - 09 May 2016 10:18 - 14 of 159

I missed this video from 8th March 2016..........

08th Mar 2016 Allergy Therapeutics says double-digit revenue growth is sustainable

banjomick - 09 May 2016 13:23 - 15 of 159

Allergy Therapeutics results not to be sniffed at
12:33 09 May 2016

The phase II trial assessed the response from 371 patients, which revealed a statistically significant dose-response relationship from the groups receiving the medication.

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Allergy Therapeutics plc (LON:AGY) described as “very encouraging” the results from the latest clinical study of its PQBirch204 treatment for hay fever caused by birch pollen.

The phase II trial assessed the response from 371 patients, which revealed a statistically significant dose-response relationship from the groups receiving the medication.

Allergy said the latest clinical data “reaffirmed the potential” of the company’s Pollinex platform to treat the different variants of allergic rhinitis.

Researchers also found that PQBirch204 was safe and well tolerated, while 94% of patients stuck to the dosing guidelines.

It is expected a phase III study will get underway early next year.

"The results of the PQBirch204 trial are very encouraging and they reaffirm the potential of our Pollinex platform to treat the underlying cause of allergic rhinitis,” said chief executive Manuel Llobet.

Is Allergy undervalued?

The shares, up 28% in the last year, were ahead a further 3% in early afternoon trade at 26.37p.

There is further for the stock to go, according to Panmure Gordon’s Dr Mike Mitchell.

He says the market is applying an “unduly onerous” discount to the Allergy shares, which he values at 53p.

“In itself the outcome for the Birch programme paves the way for late-stage development of that programme on track and, on a qualitative basis, the news potentially reflects an important de-risking factor for Allergy Therapeutics’ wider platform,” Mitchell said in a note to clients.

Profitable and growing strongly

Allergy Therapeutics has a profitable core business and, as the name suggests, a number of ground-breaking allergy vaccines that trade under various brand names. Its most commonly prescribed vaccines are used to treat pollen-related allergies, particularly allergies to grasses and trees.

It has has a strong presence in Europe with established operations in Germany, Italy, Spain, Austria, Switzerland, the Netherlands and the United Kingdom, while in other markets it often makes its products available through distribution partners.

Its Pollinex Quattro vaccine for the treatment of seasonal allergic rhinitis from grass, tree or ragweed pollen allergy is already established in Europe, and the board is confident the success can be replicated in the US, where it will enjoy first mover advantage in a market potentially worth $2bn.

----ADDS BROKER COMMENT, SHARE PRICE AND BAKCGROUND---

Ian Lyall

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banjomick - 09 May 2016 18:21 - 16 of 159

Allergy Therapeutics boss excited by PQBirch204 Phase II data
14:25 09 May 2016

Manuel Llobet, chief executive of Allergy Therapeutics plc (LON:AGY) says the latest data from its Phase II trial of its PQBirch204 treatment for hay fever caused by birch pollen is “exciting for our company”.

Allergy released the results from the latest clinical study, which assessed the response from 371 patients.

The phase II trial revealed a statistically significant dose-response relationship from the groups receiving the medication, with Llobet noting the company has received “very strong top –line data”.

It means the company is still on track to start the Phase III study in early 2017, and Llobet says the data is “another step towards our clinical goal to get Polinex Quattro Birch registered in Europe as soon as possible”.


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banjomick - 09 May 2016 18:34 - 17 of 159

Hardman & CoAllergy Therapeutics Plc Progress towards EU reg approval
Allergy Therapeutics Plc (LON:AGY) is a long-established specialist in the prevention, diagnosis and treatment of allergies. It’s lead product, Pollinex Quattro is available in Europe only on a ‘Named Patient’ basis. However, protocols have been agreed with EU and US regulators for a programme of clinical trials to get full regulatory approval of Pollinex Quattro as a biological. AGY has reported positive outcomes from one of the trials required for EU approval. There remains a considerable valuation mis-match between AGY and its peers, which provides scope for considerable upside towards our risk-adjusted DCF valuation of 89p per share.

***Link below for full report***

http://www.directorstalkinterviews.com/wp-content/uploads/2016/05/09-05-16-progress-towards-eu-reg-approval.pdf

banjomick - 10 May 2016 11:04 - 18 of 159

PQBirch204 Phase II Study (May 2016)- Video


http://fmp-tv.co.uk/company/allergy-therapeutics-investors-video-and-news/

banjomick - 14 May 2016 11:56 - 19 of 159

Proactive Investors One2One Investor Forum - London

Clinigen Group PLC | Allergy Therapeutics plc | Sareum Holdings Plc | Abzena plc

May 19th 2016, 6.00 pm - Chesterfield Mayfair Hotel, 35 Charles Street, Mayfair

The presentations will start at 6:00pm and finish at approx 8:00pm. After the presentations are complete the directors will also be available to take questions during a free canapé and wine reception.

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banjomick - 23 May 2016 16:30 - 20 of 159

The presentation from last Friday can be viewed from link below:

http://www.proactiveinvestors.co.uk/archives/documents

banjomick - 26 May 2016 13:57 - 21 of 159

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Conference Overview

SMi proudly announces the return of 3rd annual Allergies conference to London in July 2016!

Aimed at an audience of senior scientists and allergy specialists involved in immunology and drug research, Allergies 2016 will provide the perfect platform to discuss pioneering clinical developments and the next generation of allergy therapeutics.

Created with a top panel of industry thought leaders, this year's event will look to capture expert insight by honing in on new pathways with novel vaccines and adjuvants, immunoassays for molecular diagnostic’s, paediatric allergies, personalised treatment, allergen specific immunotherapies, plus much more.

Through strategic direction and regulatory guidance, the programme will look to strengthen knowledge in topics such as biomarker validation, and arm attendees with the key requirements and tools for successful trials and study outcomes.

************************************************************

Day1

16:00 Defining the most effective dose


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Tim Higenbottam, Research & Development Director, Allergy Therapeutics Ltd

•Development of new allergen subcutaneous specific immunotherapies
•Limiting factors on injection intervals optimal dose of allergen (allergoid)
•Use of provocation testing

Conference programme

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banjomick - 06 Jun 2016 11:37 - 22 of 159

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banjomick - 07 Jun 2016 14:11 - 23 of 159

Major Shareholders

Shareholder Name--------------------------------Amount-----------------% Holding

CFR International SPA & Associated Holding-- 240,584,571---------------40.84
Southern Fox Investments----------------------125,158,783---------------21.59
Odey Asset Management-------------------------42,959,498-----------------7.29
Invesco Asset Management----------------------34,110,209-----------------5.79
Black Rock Investment Management------------19,000,000-----------------3.22

Director Shareholdings (*- Executive Director)

Director Name-------------------------------Amount--------------% Holding

Manuel Llobet*-----------------------------3,175,000---------------0.54
Ian Postlethwaite*-------------------------1,360,000---------------0.23
Stephen Smith-------------------------------776,513----------------0.13
Peter Jensen---------------------------------120,000----------------0.02

Help using this page

As at 23 March 2016

http://www.allergytherapeutics.com/investor-relations/shareholder-information/major-shareholders/

banjomick - 10 Jun 2016 09:05 - 24 of 159

10 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Appointment of Finance Director

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces the appointment of Nick Wykeman to the Board as Finance Director with immediate effect.

Mr Wykeman was most recently at Skyepharma PLC until August 2015 where he was the Group Financial Controller for six years. Prior to that, Mr Wykeman had also worked at Quest International (a part of ICI PLC) as the Group Financial Controller (Special Projects), following six years at Deloitte & Touche. Mr Wykeman has a BSc (Hons) in Economics and is a qualified accountant, being a member of the Institute of Chartered Accountants of England and Wales.

Mr Wykeman replaces Ian Postlethwaite, who, further to the announcement made on 17 March 2016, has now resigned from the Company and the Board with immediate effect.

Peter Jensen, Chairman of Allergy Therapeutics, said: "We welcome Nick to his role as Finance Director and look forward to his contribution to the Company as we continue to grow the business internationally on all fronts. His international experience in life sciences is well suited to the role and we're pleased to have attracted him to Allergy Therapeutics.

"We also thank Ian Postlethwaite for his fourteen, successful years with Allergy Therapeutics and wish him well for his future."

Nicolas Alexander Ulrich Wykeman, age 51, is currently a director of the following company:

Current Directorships

Wykeman Consulting BV

Allergy Therapeutics confirms that there are no further disclosures to be made in relation to Rule 17 of paragraph (g) of Schedule Two of the AIM Rules for Companies.

http://www.moneyam.com/action/news/showArticle?id=5357969

banjomick - 13 Jun 2016 07:49 - 25 of 159

13 June 2016
Allergy Therapeutics plc
("Allergy Therapeutics" or the "Company")

Allergy Therapeutics hosts Satellite Symposium at EAACI

~ World-leading allergists present technological advances and immunotherapy innovations ~

Allergy Therapeutics (AIM:AGY), the fully integrated specialty pharmaceutical company specialising in allergy vaccines, announces today that data was presented in a Satellite Symposium entitled: "Adjuvants in Allergy: elevating efficacy" at the 35th Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI) in Vienna, Austria on 12 June 2016, relating to a number of the Company's products and technologies.

Three world-leading experts in the field of allergen immunotherapy and vaccine delivery, Ralph Mösges, Randolph Brehler and Thomas Kündig, presented information on innovation in immunotherapy including Allergy Therapeutics' key product Pollinex Quattro®. Pollinex Quattro®'s specialist technology was discussed, highlighting the marketed product's ability to reduce irritation and systemic reactions. Furthermore, Dr Brehler discussed how the potent depot adjuvant MCT (Micro Crystalline Tyrosine), initiated by the Company as an alternative to aluminium in subcutaneous immunotherapy and used in Pollinex Quattro® as well as certain other of the Company's subcutaneous injected therapies, has an immunomodulating action that augments a shift in the immune reactions responsible for the symptoms of allergic rhinitis.

Data on the future role of Virus-Like-Particles (VLP) in immunotherapy was also presented as a potential new injectable vaccine immunotherapy technology. Allergy Therapeutics recently acquired an exclusive VLP technology licence and is conducting a research project on VLP-based allergy vaccines. The worldwide food allergy market is worth a potential $8bn and, currently, there is no established and safe immunotherapy treatments available for peanut allergy, the first indication the Company intends to address.


Manuel Llobet, Chief Executive Officer, commented: "As a fully integrated specialty pharmaceutical company, we are delighted to be breaking new ground in allergen immunotherapy. Allergy Therapeutics has the potential to transform allergy treatment with an established range of diagnostics and specific short-course aluminium-free immunotherapy vaccines and we are well-placed to deliver the relief from symptoms of allergy that millions of patients need."

Satellite Symposium: Adjuvants in Allergy: elevating efficacy

1) Ultra-short course immunotherapy, Ralph Mösges MD, PhD, MSEE, University of Cologne (Pulmonology, Allergology and Clinical Immunology)

2) Adjuvants in immunotherapy, Randolf Brehler MD, University of Münster (Allergology)

3) Future immunotherapy: virus like particles, Thomas Kündig, University Hospital Zurich (Immunology, Cell Biology and Pharmacology)

http://www.moneyam.com/action/news/showArticle?id=5358789

banjomick - 13 Jun 2016 12:00 - 26 of 159

Shares Spotlight - Manuel Llobet CEO of Allergy Therapeutics (AGY)
Published on Jun 13, 2016

Mark Dunne interviews Manuel Llobet who discusses his companies allergy products.

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