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Hot Stocks
Amryt Pharma announces new patents for Oleogel-S10 » 07:22
01/18/22
01/18
07:22
01/18/22
07:22
AMYT

Amryt Pharma

$10.50 /

+0.51 (+5.11%)

Amryt announces an update…

Amryt announces an update regarding the patents for its lead development candidate, Oleogel-S10. Oleogel-S10: The United States Patent and Trademark Office, USPTO, has issued to Amryt a notice of allowance for US Patent Application No. 17/393,171 'Betulin-Containing Birch Bark Extracts and their Formulation' with claims covering the Oleogel-S10 formulation. If Oleogel-S10 is approved by the FDA, the resulting patent will be listable in the Approved Drug Products with Therapeutic Equivalence Evaluations, published by the United States Food and Drug Administration and this patent will expire in January 2039. Together with four previously granted patents, if Oleogel-S10 is approved, Amryt will have 5 Orange Book-listed patents for Oleogel-S10 with patent protection through January 2039, without patent term extension. Dr Joe Wiley, CEO of Amryt Pharma, commented: "We are always working to develop and extend our IP portfolio and today's news further illustrates the robust IP protection enjoyed by our lead development asset, Oleogel-S10. Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment ."

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AMYT Amryt Pharma
$10.50 /

+0.51 (+5.11%)

AMYT Amryt Pharma
$10.50 /

+0.51 (+5.11%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$10.50 /

+0.51 (+5.11%)

Hot Stocks
Amryt Pharma announces safety, efficacy data for Mycapssa » 07:13
01/11/22
01/11
07:13
01/11/22
07:13
AMYT

Amryt Pharma

$10.08 /

-0.575 (-5.40%)

Amryt presents long-term…

Amryt presents long-term safety and efficacy data from the open-label extension of its global Phase 3 MPOWERED non-inferiority clinical trial that compared Mycapssa to long-acting iSRLs for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support the marketing authorization application for Mycapssa by the EMA which is currently under evaluation. Mycapssa is approved in the United States for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide. MPOWERED Phase 3 Trial - Open-Label Long-Term Safety & Efficacy Data: 60 patients that completed the 15 months core treatment phase elected to continue treatment with Mycapssa in the MPOWERED open label extension study. During the RCT 19 patients were treated with iSRLs and 35 were treated with Mycapssa. In addition, 6 patients were treated with a combination of Mycapssa and cabergoline. Key study outcomes included: 93%, 91% and 92% of patients completed year 1, 2 and 3 of the OLE, respectively, out of those that entered each year; The average IGF-1 levels of enrolled patients were stably maintained within the normal limits at the end of the OLE period; 86%, 81% and 87% of all patients maintained their biochemical response at year 1, 2 and 3 of the OLE respectively, while utilizing a non-response imputation; 94%, 90% and 93% of patients maintained their biochemical response at year 1, 2 and 3 of the OLE respectively, while utilizing the last observed carried forward imputation in patients treated with Mycapssa monotherapy; Of patients switching from iSRLs to Mycapssa during the OLE, 47% reported excellent or very good symptomatic control at the end of the Randomized Control Treatment, increasing to 79% at the end of the OLE; 58% had at least 3 active acromegaly symptoms on iSRLs at the end of the RTC decreasing to 37% at the end of the OLE after switching to Mycapssa; In addition, patients treated with iSRLs during the RCT improved when treated with Mycapssa in the OLE on the Emotional, GI interference, Treatment convenience and Treatment satisfaction domain scores of the Acromegaly treatment satisfaction questionnaire; Acromegaly patients were exposed to Mycapssa during the OLE for a median treatment duration of 2.2 years and a maximal exposure of 3.5 years. Including the 15 months core treatment phase, 10 patients were treated for more than 4 years and 22 patients for more than 3 years; Patients in the OLE demonstrated a median compliance rate of 99% over this period of time; The long-term safety profile of Mycapssa during the OLE, was consistent with the safety profile observed during the core study with no new safety signals with long- term exposure.

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AMYT Amryt Pharma
$10.08 /

-0.575 (-5.40%)

AMYT Amryt Pharma
$10.08 /

-0.575 (-5.40%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$10.08 /

-0.575 (-5.40%)

Hot Stocks
Amryt Pharma announces publication of results for MPOWERED Phase 3 trial » 07:16
01/04/22
01/04
07:16
01/04/22
07:16
AMYT

Amryt Pharma

$10.75 /

+0.07 (+0.66%)

Amryt announces that The…

Amryt announces that The Lancet Diabetes & Endocrinology has published the full results of the global Phase 3 MPOWERED clinical trial that compared Mycapssa to long-acting injectable Somatostatin Receptor Ligands for maintenance of biochemical response in patients with acromegaly. The MPOWERED trial was designed to support the marketing authorization application for Mycapssa to the EMA which is currently under evaluation. The MPOWERED trial adds to the evidence base built with two previous Phase 3 trials, CH-ACM-01 and CHIASMA OPTIMAL, both of which supported the US FDA approval of Mycapssa for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide. Key outcomes of the MPOWERED Phase 3 Trial are listed below: Mycapssa was non-inferior to long-acting injectable octreotide or lanreotide in maintenance of biochemical control, in patients previously responding to both treatments. On the primary endpoint of the proportion of patients maintaining biochemical response throughout the 9-month Randomized Control Treatment phase, 91% of patients on Mycapssa maintained response compared to 100% on iSRLs. Response was defined as the time-weighted average of IGF-1 less than1.3 x upper limit of normal throughout the phase. Mean IGF-1 was the same at the start and end of the RCT phase in both groups and was maintained within normal limits. All sensitivity analyses supported the results of the primary endpoint using both time-weighted average and more traditional landmark methods of analyzing IGF-1 data. Oral octreotide results for breakthrough and active acromegaly symptoms. At the end of the RCT phase, 15% of patients in the oral octreotide group reported breakthrough symptoms of acromegaly, compared with 31% in the iSRL group. The overall number of individual active acromegaly symptoms was similar between treatment groups. A significant reduction in the number of certain active acromegaly symptoms was reported in patients responding to Mycapssa at the end of the run-in phase. Specifically, significant reductions were shown in the proportions of participants with swelling of extremities and fatigue. Patient reported outcomes with oral octreotide capsules. A significant improvement was reported from baseline while treated with iSRLs to the end of the run-in phase in patients responding to Mycapssa in three of the five Acromegaly Treatment Satisfaction Questionnaire scales, with improving trends in the other two scales. Change from start of the RCT phase for each of the five Acro-TSQ scales was generally similar between treatment groups. Oral octreotide capsules showed comparable safety profile to iSRLs. The incidence of adverse events during the RCT was similar between groups with 39 of 55 participants in the oral octreotide group and 26 of 37 participants in the iSRL group reporting at least one AE. In both treatment groups, most treatment-related AEs were gastrointestinal. 17 of 36 participants randomly assigned to iSRL reported injection site reactions via the Acro-TSQ scales at the end of the RCT, and 13 of 16 reported that injection site reactions interfered with daily activities.

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AMYT Amryt Pharma
$10.75 /

+0.07 (+0.66%)

AMYT Amryt Pharma
$10.75 /

+0.07 (+0.66%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$10.75 /

+0.07 (+0.66%)

Over a month ago
Hot Stocks
Amryt says FDA PDUFA date for Oleogel-S10 NDA extended to Feb. 28, 2022 » 07:09
11/23/21
11/23
07:09
11/23/21
07:09
AMYT

Amryt Pharma

$11.30 /

-0.19 (-1.65%)

Amryt announces that the…

Amryt announces that the US Food and Drug Administration has extended the review period for the New Drug Application for Oleogel-S10 for the treatment of the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. The FDA extended the Prescription Drug User Fee Act goal date to allow time to review additional analyses of data previously submitted by Amryt. The submission of this additional information has been determined by the FDA to constitute a Major Amendment to the NDA, resulting in an extension of the PDUFA goal date by three months to February 28, 2022. This is a standard review extension period to allow the FDA additional time to review information already submitted by Amryt. At the same time, the FDA also issued a new Information Request regarding existing study data in order to continue the FDA's evaluation of Amryt's NDA. In June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The PDUFA goal date extension has no impact on the priority review status of Oleogel-S10. The European Medicines Agency review process for Oleogel-S10 in EB is ongoing and Amryt is in the process of responding to the remaining Major Objections in the List of Outstanding Issues sent by the EMA. The Committee for Medicinal Products for Human Use opinion is now expected in January 2022. Amryt's previously issued revenue guidance for FY 2021 in the range of $220M - $225M which represents growth of 20% to 23% on FY 2020 is unaffected by the new regulatory timelines.

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AMYT Amryt Pharma
$11.30 /

-0.19 (-1.65%)

AMYT Amryt Pharma
$11.30 /

-0.19 (-1.65%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$11.30 /

-0.19 (-1.65%)

Hot Stocks
Amryt Pharma announces intention to delist from AIM » 05:29
11/22/21
11/22
05:29
11/22/21
05:29
AMYT

Amryt Pharma

$11.49 /

+0.16 (+1.41%)

Amryt Pharma announced…

Amryt Pharma announced its intention to cancel the admission of its ordinary shares to trading on AIM with effect from 7:00 a.m. on January 11. The company's last day of trading on AIM will be January 10. Amryt will retain its listing on Nasdaq, each representing five ordinary shares, under its existing ticker symbol.

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AMYT Amryt Pharma
$11.49 /

+0.16 (+1.41%)

AMYT Amryt Pharma
$11.49 /

+0.16 (+1.41%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$11.49 /

+0.16 (+1.41%)

Over a quarter ago
Conference/Events
Amryt Pharma management to meet virtually with Maxim » 04:55
10/13/21
10/13
04:55
10/13/21
04:55
AMYT

Amryt Pharma

$11.89 /

-0.12 (-1.00%)

Virtual Meeting to be…

Virtual Meeting to be held on October 13 hosted by Maxim.

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AMYT Amryt Pharma
$11.89 /

-0.12 (-1.00%)

AMYT Amryt Pharma
$11.89 /

-0.12 (-1.00%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$11.89 /

-0.12 (-1.00%)

AMYT Amryt Pharma
$11.89 /

-0.12 (-1.00%)

Conference/Events
Amryt Pharma management to meet virtually with Maxim » 15:50
10/04/21
10/04
15:50
10/04/21
15:50
AMYT

Amryt Pharma

$12.13 /

+0.03 (+0.25%)

Virtual Meeting to be…

Virtual Meeting to be held on October 13 hosted by Maxim.

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AMYT Amryt Pharma
$12.13 /

+0.03 (+0.25%)

AMYT Amryt Pharma
$12.13 /

+0.03 (+0.25%)

10/04/21 JonesTrading
Amryt Pharma initiated with a Buy at JonesTrading
08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
AMYT Amryt Pharma
$12.13 /

+0.03 (+0.25%)

AMYT Amryt Pharma
$12.13 /

+0.03 (+0.25%)

Initiation
Amryt Pharma initiated with a Buy at JonesTrading » 10:19
10/04/21
10/04
10:19
10/04/21
10:19
AMYT

Amryt Pharma

$12.20 /

+0.1 (+0.83%)

JonesTrading analyst…

JonesTrading analyst Catherine Novack initiated coverage of Amryt Pharma with a Buy rating and $45 price target. Mycapassa, brought in via the recent deal for Chiasma, is the only FDA-approved oral therapy for acromegaly while positive data for lead candidate Oleogel-S10 in epidermolysis bullosa could support FDA approval, which would make it the only available therapy in another rare disease, Novack tells investors. She also sees an opportunity for the company to continue to expand its pipeline.

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AMYT Amryt Pharma
$12.20 /

+0.1 (+0.83%)

AMYT Amryt Pharma
$12.20 /

+0.1 (+0.83%)

08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
05/05/21 Piper Sandler
Chiasma downgraded to Neutral from Overweight at Piper Sandler
AMYT Amryt Pharma
$12.20 /

+0.1 (+0.83%)

AMYT Amryt Pharma
$12.20 /

+0.1 (+0.83%)

Conference/Events
Amryt Pharma to hold a virtual capital markets event » 09:55
09/13/21
09/13
09:55
09/13/21
09:55
AMYT

Amryt Pharma

$10.80 /

+0.05 (+0.47%)

Virtual Capital Markets…

Virtual Capital Markets Event will be held on September 13 at 10 am. Webcast Link

ShowHide Related Items >><<
AMYT Amryt Pharma
$10.80 /

+0.05 (+0.47%)

AMYT Amryt Pharma
$10.80 /

+0.05 (+0.47%)

08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
05/05/21 Piper Sandler
Chiasma downgraded to Neutral from Overweight at Piper Sandler
AMYT Amryt Pharma
$10.80 /

+0.05 (+0.47%)

AMYT Amryt Pharma
$10.80 /

+0.05 (+0.47%)

Conference/Events
Amryt Pharma to hold a virtual capital markets event » 04:55
09/13/21
09/13
04:55
09/13/21
04:55
AMYT

Amryt Pharma

$10.69 /

-0.04 (-0.37%)

Virtual Capital Markets…

Virtual Capital Markets Event will be held on September 13 at 10 am. Webcast Link

ShowHide Related Items >><<
AMYT Amryt Pharma
$10.69 /

-0.04 (-0.37%)

AMYT Amryt Pharma
$10.69 /

-0.04 (-0.37%)

08/19/21 SVB Leerink
Amryt Pharma initiated with an Outperform at SVB Leerink
07/27/21 H.C. Wainwright
Amryt Pharma initiated with a Buy at H.C. Wainwright
06/07/21 Canaccord
Amryt Pharma Filsuvez review represents meaningful milestone, says Canaccord
05/05/21 Piper Sandler
Chiasma downgraded to Neutral from Overweight at Piper Sandler
AMYT Amryt Pharma
$10.69 /

-0.04 (-0.37%)

AMYT Amryt Pharma
$10.69 /

-0.04 (-0.37%)

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