Amryt Pharma PLC

Amryt Pharma Plc operates as a holding company with interests in the development and delivery of treatments to help improve the lives of patients with rare and orphan diseases. The company was founded on July 17, 2019 and is headquartered in Dublin, Ireland.

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Amryt Pharma Plc operates as a holding company with interests in the development and delivery of treatments to help improve the lives of patients with rare and orphan diseases. The company was founded in August 2015 and is headquartered in Dublin, Ireland.

DUBLIN, Ireland, and Boston MA, July 28, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce that all resolutions presented to shareholders at both of today's General Meetings were duly passed.

Result of General Meetings

Amryt to Report Q2 2021 Results and Host Conference Call & Webcast on August 6

Publication of Circular to Amryt S hareholders in relation to the acquisition of Chiasma, Inc . , and p osting of Annual Report and Notice s of General Meeting s

Publication of Circular to Amryt Shareholders in relation to the acquisition of Chiasma, Inc., and posting of Annual Report and Notices of General Meetings

Amryt Pharma Announces Filing of Preliminary Registration Statement on Form F-4 in Connection with Its Proposed Acquisition of Chiasma, Inc.

Amryt Pharma PLC (NASDAQ:AMYT LON:AMYT) said the US Food and Drug Administration had confirmed its New Drug Application (NDA) for Oleogel-S10 does not require an Advisory Committee meeting.   Oleogel-S10 was developed to treat junctional and dystrophic epidermolysis bullosa (EB), where the skin is fragile to even the lightest touch.

Amryt Pharma Oleogel-S10 appllcation won't go through advisory committee

FDA confirms NDA for Oleogel-S10 will not require an Advisory Committee Meeting

Amryt (AMYT) is seeking approval for Oleogel-S10 as a potential treatment for patients with rare and distressing genetic skin disorder, epidermolysis bullosa.

Amryt (AMYT) NDA for Skin Disorder Drug Gets Priority Review

The FDA has granted priority review status to Amryt Pharma's (NASDAQ: AMYT) marketing application seeking approval for Oleogel-S10 to treat Epidermolysis Bullosa (EB). Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder characterized by blistering lesions on the skin and mucous membranes.

Amryt Pharma's Oleogel-S10 Application Gets FDA Priority Review Tag for Skin Blistering Disorder

Amryt Pharma PLC (NASDAQ:AMYT; AIM:AMYT) has been granted a priority review of its new drug application for Oleogel-S10 by the US drugs watchdog with a decision expected on or before November 30. The US Food & Drug Administration fast-track has shortened the regulatory timeline from 10 months to six.

Amryt Pharma new drug application for rare skin condition fast-tracked by the US Food & Drug Administration

FDA Grants Priority Review for New Drug Application for Oleogel-S10 for the Treatment of Epidermolysis Bullosa

Amryt Pharma PLC's (NASDAQ:AMYT, LON:AMYT) new drug application for its potential treatment for epidermolysis bullosa (EB) has been approved by the US regulator. The Food and Drug Administration (FDA) accepted Amrty's application for Oleogel-S10 to be approved as a treatment for cutaneous manifestations of junctional and dystrophic EB, which affects adults and young children and for which there is no currently approved treatment.

Amryt Pharma gets FDA approval for new drug application

Chiasma

Amryt Pharma plc (AMYT) Amryt Pharma Acquisition of Chiasma Inc. and Q1 2021 Earnings Conference (Transcript)

NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Chiasma, Inc. (NasdaqGS: CHMA) to Amryt (NasdaqGS: AMYT). Under the terms of the proposed transaction, shareholders of Chiasma will receive 0.396 American Depositary Shares of Amryt for each share of Chiasma that they own. KSF is seeking to determine whether this consideration and the process that led to it ar

CHIASMA INVESTOR ALERT By the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Chiasma, Inc. - CHMA

NEW YORK, May 5, 2021 /PRNewswire/ -- Rowley Law PLLC is investigating potential securities law violations by Chiasma, Inc. (NASDAQ: CHMA) and its board of directors concerning the proposed acquisition of the company by Amryt (NASDAQ: AMYT). Stockholders will receive 0.396 Amryt American Depository Shares for each share of Chiasma stock that they hold.

ALERT: Rowley Law PLLC is Investigating Proposed Acquisition of Chiasma, Inc.

NEW YORK, May 5, 2021 /PRNewswire/ -- WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Chiasma, Inc. ("Chiasma" or the "Company") (NASDAQ: CHMA) in connection with the proposed acquisition of the Company by Amryt Pharma plc ("Amryt") (NASDAQ: AMYT). Under the terms of the merger agreement, Chiasma stockholders will receive 0.396 Amryt American Depositary Shares ("ADSs"), each representing five Amryt ordinary shares, for each Chiasma share that they own, representing implied consideration of $5.13 based upon Amryt's ADS's May 4, 2021 closing price of $12.95.

SHAREHOLDER ALERT: WeissLaw LLP Investigates Chiasma, Inc.

Amryt Pharma PLC (LON:AMYT NASDAQ:AMYT)  is to merge with fellow Nasdaq-listed biotech Chiasma Inc (NASDAQ:CHMA) through an all-share deal that will create a leading specialist in rare and orphan diseases. Chiasma's lead product is Mycapssa, the only orally-taken treatment approved in the US for the growth hormone imbalance condition acromegaly.

Amryt Pharma to merge with Chiasma and create rare diseases powerhouse

A mryt R e ports Record Q1 2021 Financial and Operating Results

Amryt Reports Record Q1 2021 Financial and Operating Results

- Combined business will have three approved commercial products, lomitapide (Lojuxta®/Juxtapid®), metreleptin (Myalept®/ Myalepta®), octreotide (MYCAPSSA®) and a robust clinical pipeline

Amryt Pharma to Acquire Chiasma, Inc. to Further Strengthen Global Leadership in Rare and Orphan Diseases

DUBLIN, Ireland, and Boston MA, April 15, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces that its unaudited financial results for the first quarter 2021 will be released on Wednesday, May  5, 2021 at 0700 EDT/1200 BST.

Amryt to Report Q1 2021 Results and Host Conference Call & Webcast on May 5

DUBLIN, Ireland, and Boston MA, April 6, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, is pleased to announce the appointment of Sheila Frame as President Americas. Sheila will lead all aspects of product commercialization for Amryt in the Americas.  Sheila has held senior leadership roles across several specialty areas with Novartis, Bristol-Myers Squibb, UCB, and AstraZeneca and has worked and lived in North America and in Europe.  Sheila holds an MBA from Concordia University.

Amryt Announces the Appointment of Sheila Frame as President Americas

Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said has completed the rolling submission process that it hopes will end with the fast-track sign-off by the US Food & Drug Administration for its gel to treat a rare and distressing skin disease. Its new drug application (NDA) for Oleogel-S10 could be reviewed in just six months under an expedited protocol that aims to bring through new products for rare ailments such as junctional and dystrophic epidermolysis bullosa (EB).

Amryt Pharma completes FDA submission process for breakthrough skin gel; applies for expedited approval

DUBLIN, Ireland, and Boston MA, March 31, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today announces the completion of the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drugs Administration (“FDA”) for Oleogel-S10 for the potential treatment of cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”).  EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

Amryt Submits a New Drug Application to the US Food and Drug Administration for Oleogel-S10* (Filsuvez®)

Amryt Pharma PLC (NASDAQ:AMYT, LON:AMYT) said it was ‘encouraged' by data from an investigator-sponsored study of lomitapide in Familial Chylomicronaemia Syndrome (FCS). Expert lipidologists in Italy administered the drug, also known as Juxtapid, or Lojuxta, to 18 people with the genetic disease, which results in elevated triglyceride levels, and brings with it “significant risk and disease burden”.

Amryt Pharma encouraged by data from investigator-sponsored study assessment of lomitapide in Familial Chylomicronaemia Syndrome

Amryt Pharma PLC (LON:AMYT, NASDAQ:AMYT) said the European Union regulator will now begin the formal review process for its potential treatment for a rare genetic skin disorder with no currently approved treatment. The European Medicines Agency (EMA) has validated the marketing authorization application for the company's Oleogel-S10 for the potential treatment of cutaneous manifestations of junctional and dystrophic epidermolysis bullosa in young children and adults.

Amryt Pharma's skin disorder treatment approved for EU regulatory review process

DUBLIN, Ireland, and Boston MA, March 29, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company focussed on acquiring, developing and commercializing novel treatments for rare diseases, today announces the validation of the Company's Marketing Authorization Application (“MAA”) for Oleogel-S10 by the European Medicines Agency (“EMA”) for the potential treatment of cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”). EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.

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