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Vad är Orphazyme (DK)?

Orphazyme (DK)

Orphazyme är ett biokemibolag. Bolaget är specialiserade mot ovanliga sjukdomar där det finns en brist i funktionen hos värmekokproteiner. Tekniken baseras på arimoklomol, som stimulerar produktionen av värmekokproteiner i celler som upplever en ökad grad av stress och toxicitet. Sjukdomar som ämnar behandlas med bolagets produkter innefattar exempelvis Gauchers sjukdom och amyotrofisk lateral skleros (ALS). Bolaget etablerades under 2009 och har sitt huvudkontor i Köpenhamn.

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Pressmeddelanden

Orphazyme: Our View to the Regulatory Update in NPC

Redeye reiterates its probability rate for arimoclomol in NPC.

28 Dec 2020 12:20

Orphazyme: Bull story below Bear price

Redeye revisits the Orphazyme case in light of exceptional news flow in the first half of 2021.

17 Dec 2020 06:25

Orphazyme: First Comment to CEO Resignation

Redeye gives a first impression, following the news of CEO Stratton’s resignation.

11 Dec 2020 10:03

Orphazyme: MAA Submission According to Timeline

Redeye sees positive that arimoclomol in NPC now enters the filing stage in Europe as well.

09 Nov 2020 09:15

Orphazyme: Short Comment on Revised Financial Outlook

Redeye updates its estimates for 2020 following corporate communication.

26 Oct 2020 07:00

Orphazyme: Now a Listed Company in the US

Redeye recognizes the first day of trading in the US, with a global offering carried out in conjunction.

30 Sep 2020 06:00

Orphazyme: Our View on the Latest News

Redeye gives a view on Friday’s news, where Orphazyme gave an update on the global offering process.

28 Sep 2020 05:30

Orphazyme: The US IPO Process Has Started

Redeye gives a first comment on the news that Orphazyme commences a global offering.

22 Sep 2020 06:00

Orphazyme: The Stage is Set for Approval

Redeye acknowledges another critical step towards approval for arimoclomol, as the FDA has accepted, with priority review, Orphazyme’s New D...

16 Sep 2020 07:22

Orphazyme: Another Step Towards IPO in the U.S.

Redeye is encouraged by the progress towards a potential dual listing in the U.

07 Sep 2020 06:00

Orphazyme: Takeaways After Conf Call

Redeye provides a second note, following the conference call in conjunction with the H1’20 report.

28 Aug 2020 12:59

Orphazyme: Our First Comment

Redeye gives its first reflections on Orphazyme’s H1’20 report published this morning.

28 Aug 2020 07:25

Orphazyme: Comment on Latest News

Redeye acknowledges that Orphazyme has built further value in its pipeline during the latest days, following increasing commitments in PD, a...

20 Jul 2020 10:46

Orphazyme: Eyeing a Secondary Listing in the US

Earlier today, we learned that Orphazyme had submitted a draft registration statement for a potential public offering in the United States.

01 Jul 2020 11:32

Orphazyme: Data Supports Further Development

Redeye reckons phase II results far from perfect, possibly due to the small sample size and an overall tricky population group.

25 Jun 2020 06:52

Orphazyme: NDA Submission According to Plan

Redeye acknowledges a significant milestone for Orphazyme, following the initiation of a rolling NDA submission to the FDA.

29 May 2020 07:29

Orphazyme: Another regulatory milestone

Redeye gives a brief view of the news that Orphazyme has received its third US Fast Track Designation with its lead compound, arimoclomol.

22 May 2020 08:28

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Orphazyme: Takeaways after Publishing of Annual Report 2019 and Conference Call

Last week, Orphazyme announced the full-year results for 2019 and published its annual report for 2019.

02 Mar 2020 06:42

Orphazyme: Home run moves nearer (and with funding in place)

The case for Orphazyme continues to strengthen as arimoclomol’s US early access program reinforces a raft of positive data and regulatory pr...

13 Feb 2020 06:30

Orphazyme: Further NPC data provides further answers

Orphazyme has reported long-awaited results from the open-label phase 2/3 extension study (OLE).

03 Jan 2020 14:44

Orphazyme: Regulatory progress

During November and December, Orphazyme has received both breakthrough therapy designation and Fast Track designation by FDA in two separate...

19 Dec 2019 07:43

Orphazyme: H2 19 outlook

Last week, Orphazyme announced the results for their first half a year.

03 Sep 2019 06:45

Orphazyme: Preparation in progress for filing also in the US (NPC)

We here provide a short note to the news that Orphazyme prepares for filing in the US with arimoclomol in Niemann-Pick disease Type C (NPC).

22 Jul 2019 08:39

Orphazyme: Milestone reached in ALS

Earlier today, Orphazyme announced that they have completed enrollment in the phase III program with arimoclomol in Amyotrophic Lateral Scle...

18 Jul 2019 10:19

Orphazyme: Short reflection on the transition of CEO

Earlier today, Orphazyme announced that they have appointed Kim Stratton as the new CEO for the company, succeeding Anders Hinsby.

15 Jul 2019 11:21

Orphazyme: Preparation in progress for filing in 2020

Orphazyme today announced, based on feedback from the European Medical Agency (EMA), that they are preparing for filing with arimoclomol in ...

07 Jun 2019 09:28

Orphazyme: Update in phase II/III trial (sIBM) confirms the timeline

Orphazyme today announced that the ongoing phase II/III trial in patients with sporadic Inclusion Body Myositis (sIBM) is fully enrolled.

23 Apr 2019 13:29

Orphazyme: Summary of 2018, important year ahead

Arimoclomol in the NPC indication will drive the story in the near-term but Orphazyme has a broad pipeline with multiple potential value dri...

04 Mar 2019 06:30

Orphazyme: Detailed data shines more light on NPC project

Additional details from the 12-month NPC trial gives a better understanding of arimoclomol in NPC, but there's still uncertainty around the ...

01 Feb 2019 06:30

Orphazyme: Detailed NPC data reported

Orphazyme today reported the detailed follow-up data from their NPC Phase II/III clinical trial, from which preliminary top-line data was re...

30 Jan 2019 08:02

Orphazyme: Videointervju med vd Anders Hinsby

Anders Hinsby, vd på Orphazyme, ger oss en kort beskrivning av bolaget och vad som ligger i pipeline.

26 Nov 2018 09:46

Orphazyme: Competitor fails in NPC

Mallinckrodt has announced that their VTS-270 project, a competitor to Orphazyme's arimoclomol for the treatment of NPC, failed to show stat...

07 Nov 2018 15:39

Orphazyme: Top-line data in the NPC Phase II/III shows promise

Top-line data with arimoclomol showed a promising efficacy at 12 months.

02 Oct 2018 05:56

Orphazyme: Top-line data in NPC looks promising

Orphazyme has reported top-line results for the NPC Phase II/III trial, showing a treatment benefit of arimoclomol over placebo at 12 months...

28 Sep 2018 06:51

Orphazyme: H1 report shows progress

The first half of 2018 has been filled with operational progress.

28 Aug 2018 12:17

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