Orphazyme (DK) aktie

Orphazyme: Updates in NPC and on Corporate Level

Redeye summarizes where we stand after the press releases by Orphazymer earlier this week.

Orphazymes arimoklomol är säker även efter 36 månaders behandlingsperiod

Danska bioteknikbolaget Orphazymes läkemedelskandidat arimoklomol kom att uppvisa en konsekvent säkerhetsprofil under den 36-månader långa b...

Orphazyme kapar sin globala personalstyrka rejält, upprepar målen för 2021

Danska bioteknikbolaget Orphazyme ska säga upp cirka två tredjedelar av sin globala personal under en omstrukturering.

Långvarig ägare i Orphazyme flaggar under 5 procent

Aescap Venture Management flaggar under 5 procent i den danska "meme-aktien" Orphazyme, som rasade kraftigt nyligen i samband med ett negati...

Orphazyme: Follow-up Note to CRL

Redeye provides a follow-up comment to the transformative negative news in NPC.

Orphazyme: Worst Possible Scenario

Redeye provides a first comment to the hugely disappointing and surprising regulatory update from the FDA, which issued a complete response ...

Orphazyme: Speculation-driven Trading

Redeye provides a comment due to the insane trading in the Orphazyme stock.

Orphazyme: Follow-up Note to Failure in ALS

Redeye provides a follow-up note after listening to the presentation of the top-line results with arimoclomol in ALS.

Orphazyme: Unsuccessful results in Neuromuscular Disorders Again

Redeye provides a first comment on the disappointing top-line results in ALS.

Orphazyme: Follow-up note after sIBM top-line results

Redeye provides a follow-up note to the top-line results in sporadic Inclusion Body Myositis (sIBM) and after having spoken to the managemen...

Orphazyme: Discouraging Results in sIBM

Redeye provides the first comment to the top-line results presented with arimoclomol in sIBM.

Orphazyme: Comment on Financials

Redeye gives its reflections on Orphazyme’s financials for the full year 2020 and the corresponding conference call.

Orphazyme: Biotech Veteran to Assume the CEO Seat

Redeye provides a first reflection on the appointment of Christophe Bourdon as Chief Executive Officer.

Orphazyme: Our View to the Regulatory Update in NPC

Redeye reiterates its probability rate for arimoclomol in NPC.

Orphazyme: Bull story below Bear price

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

Orphazyme: First Comment to CEO Resignation

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

Orphazyme: MAA Submission According to Timeline

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

Orphazyme: Short Comment on Revised Financial Outlook

Redeye updates its estimates for 2020 following corporate communication.

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.

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.

Orphazyme: The US IPO Process Has Started

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

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...

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

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

Orphazyme: Takeaways After Conf Call

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

Orphazyme: Our First Comment

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

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...

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.

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.

Orphazyme: NDA Submission According to Plan

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

Inflationen “äter upp” dina sparpengar – Så förbättrar du avkastningen

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.

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.

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...

Orphazyme: Further NPC data provides further answers

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

Orphazyme: Regulatory progress

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

Orphazyme: H2 19 outlook

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

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).

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...

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.

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 ...

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.

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...

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 ...

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...

Orphazyme: Videointervju med vd Anders Hinsby

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

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...

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

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

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...

Orphazyme: H1 report shows progress

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