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Oryzon Genomics

New data support holistic effects of ORY-2001

Update | Pharmaceutical & healthcare | 14 Dec 2017

Recently, Oryzon has published a flurry of fresh preclinical data backing its products ORY-2001 and ORY-3001. Latest data from ORY-2001 expanded the understanding about its diverse effects on Alzheimer's disease (AD) patients, potentially including a disease modifying effect. At ASH in December 2017 Oryzon revealed first preclinical data with ORY-3001 showing that the drug could be effective in sickle cell disease. The company also introduced its plans to continue the development of ORY-1001, its lead oncology asset, once it gets the rights back in early Q118, after Roche completes a dose-finding study with small cell lung cancer patients. Our valuation is EUR 305m or EUR 8.9/share (vs EUR 8.6/share).

Oryzon Genomics

Ramping up R&D activity; catalysts in 2019

Update | Pharmaceutical & healthcare | 09 Nov 2018

The EUR 13m (gross) private placement announced on 30 October 2018 will support Oryzon’s expanding R&D programme with a total of five clinical trials now underway. Two new Phase IIa trials with iadademstat (formerly ORY-1001) are starting in acute myeloid leukaemia (AML) (ALICE trial) and small cell lung cancer (SCLC) (CLEPSIDRA trial). Results from another two Phase IIa studies with vafidemstat (formerly ORY-2001) in Alzheimer’s disease (AD) patients (ETHERAL) and multiple sclerosis (MS) patients (SATEEN) are due to report results in H219. Before that, interim results from the innovative design ‘basket trial’ with vafidemstat in aggression control in various neuropsychiatric conditions are due in H119. Our valuation is EUR 342m or EUR 8.7 per share (vs EUR 328m or EUR 9.6 per share).

Oryzon Genomics

Awaiting for eventful 2019

Outlook | Pharmaceutical & healthcare | 18 Jul 2018

The next year is shaping up to be transformative for Oryzon with two data readouts from Phase IIa trials with ORY-2001 in Alzheimer’s disease (AD) and multiple sclerosis (MS). In addition, an innovative design basket trial with ORY-2001 in several neuropsychiatric disorders may also deliver first results next year. Oryzon is resuming the development of ORY-1001 in acute myeloid leukaemia (AML) and small-cell lung cancer (SCLC). While Roche’s departure was a setback in 2017, the stars started to align again after the Biogen Abeta antibody data provided a much-needed boost for AD research industry and indirectly for Oryzon’s ORY-2001. Furthermore, a fundamental study published in Cell described the potential of LSD1 inhibition in immunooncology setting adding a new dimension to ORY-1001’s potential. We value Oryzon at EUR 328m or EUR 9.6/share (vs EUR 9.4/share).

Oryzon Genomics

Phase IIa trial in Alzheimer's disease initiated

Update | Pharmaceutical & healthcare | 22 May 2018

According to the latest news from Oryzon, the first Alzheimer’s disease (AD) patients (3/90) were recruited into the Phase IIa ETHERAL clinical trial testing ORY-2001, a dual LSD1/MAOB inhibitor for CNS indications. The trial is expected to be finalised in Q419, but Oryzon plans to report preliminary data in early 2019, which is one of the main catalysts in the near term. The second Phase IIa trial with ORY-2001 SATEEN in multiple sclerosis (MS) continues to enrol patients, with the preliminary readout planned in early 2019, another key catalyst for the share price. Our valuation is marginally higher at EUR 322m or EUR 9.4/share (vs EUR 315m or EUR 9.2/share previously).

Oryzon Genomics

Multiple data readouts in 2019 within cash reach

Update | Pharmaceutical & healthcare | 08 Mar 2018

Oryzon is ramping up its R&D programme and plans to conduct a total of four mid-stage clinical trials with lead assets ORY-1001 (a specific LSD1 inhibitor for cancers) and ORY-2001 (a dual LSD1/MAOB inhibitor for CNS indications). If all goes according to plan, data readouts are expected from all four trials in 2019 and these key catalysts are reachable with current cash, as per our calculations. The most advanced studies are the two Phase IIa trials with ORY-2001 in multiple sclerosis (MS) and Alzheimer’s disease with the MS study, SATEEN, enrolling patients since January 2018. Our valuation is marginally higher at EUR 315m or EUR 9.2/share.

Oryzon Genomics

ORY-1001 rights back to Oryzon

Update | Pharmaceutical & healthcare | 22 Aug 2017

Roche’s decision to discontinue the development of ORY-1001 and return the rights to Oryzon was major recent news. Roche cited portfolio reprioritisation as the reason and that the decision was not driven by data. While this is a setback in business development for Oryzon, in our view, ORY-1001’s potential has not been compromised and the company indicated that it will continue developing ORY-1001 for both current indications, acute leukaemia and SCLC, before seeking a new partner for late-stage development. On a more positive note, Oryzon reported positive final Phase I data for ORY-2001, which is now ready for further development in several neurological indications. Our valuation is EUR 295m (vs EUR 312m previously) or EUR 8.6/share.

Oryzon Genomics

Roche returns rights on ORY-1001

Flash note | Pharmaceutical & healthcare | 21 Jul 2017

As reported yesterday, Roche has decided to discontinue the development of ORY-1001 (a selective LSD1 inhibitor) and return the rights to Oryzon, according to which the decision was due to Roche reprioritising its portfolio and not driven by data. The process may take several months and during this period Roche will also finalise a dose-finding Phase I study in small cell lung cancer (SCLC) and hand the data over to Oryzon. The company is now free to initiate planning for further clinical activities, although it will likely take some time to present updated ORY-1001 development plans. Oryzon also mentioned that around the time when ORY-1001 was out-licensed to Roche in April 2014, it was contacted by several other companies interested in epigenetic programmes in oncology. In our view, this suggests that the company could potentially replace Roche with another partner interested in epigenetics and LSD1 inhibition.

Oryzon Genomics

ORY-2001 and ORY-3001 next in focus

Update | Pharmaceutical & healthcare | 22 May 2017

Oryzon's Q117 financial results were broadly in line with our expectations. The company's partner, Roche is now solely responsible for ORY-1001's development; it is conducting a Phase I trial in small cell lung cancer (SCLC) and can expand into other indications. Meanwhile, Oryzon is now focusing its internal R&D efforts on ORY-2001 for neurodegenerative diseases and ORY-3001 for as yet undisclosed non-cancer indications. Our valuation is slightly higher at €312m.

Oryzon Genomics

Maturing epigenetics portfolio

Outlook | Pharmaceutical & healthcare | 02 May 2017

Oryzon has been making steady progress with its epigenetics R&D pipeline. Following positive Phase I/IIa trial results in December 2016, ORY-1001, an LSD1 inhibitor, is now in Roche's hands and the company is focusing on its newer programmes: clinical-stage ORY-2001, a dual LSD1/MAOB inhibitor for neurodegenerative diseases and ORY-3001, a selective LSD1 inhibitor, in advanced preclinical studies in non-cancer areas. We have incorporated the recent €18m equity raise into our valuation, which has increased to €308m.

Oryzon Genomics

New data further back MS indication

Update | Pharmaceutical & healthcare | 13 Mar 2017

Oryzon has two assets, ORY-1001 and ORY-2001, in the clinical stage of development, with ORY-3001 being investigated for oncology indications in the preclinical stage. While the most advanced, ORY-1001, is now in Roche's hands, Oryzon has been making progress with the newer programmes. Data from the Phase I trial with ORY-2001 for Alzheimer's disease (AD) will be announced by end March 2017 and fresh preclinical data from ORY-2001 studies support its potential in a second indication, multiple sclerosis (MS). We make minor adjustments to our valuation, increasing it slightly to €266m.

Oryzon Genomics

Expanding clinical R&D pipeline

Update | Pharmaceutical & healthcare | 09 Dec 2016

Oryzon presented more granular data from Phase I/IIa in acute leukaemia at the American Society of Hematology (ASH) meeting after the positive headline results had been announced earlier. ORY-1001’s further development is now in Roche’s hands, which also initiated a Phase I trial in a new indication small cell lung cancer (SCLC). Recently Oryzon released preclinical data supporting ORY-2001’s potential in multiple sclerosis (MS), which we now include in our valuation. All these developments led to an increase in our Oryzon’s valuation to EUR 250m.

Oryzon Genomics

First look at ORY-1001 Phase I/IIa data

Update | Pharmaceutical & healthcare | 16 Nov 2016

Oryzon's share price soared more than 30% this morning after the abstracts were made available online ahead of the American Society of Hematology (ASH) meeting on 3-6 December. During the poster session at ASH, Oryzon will be presenting the preliminary data from the Phase I/IIa trial with its lead product ORY-1001. In our view, the combination of no negative surprises in the safety profile and the first ever clinical data indicating potential efficacy in a subgroup acute leukemia patients is behind the share price rally today. We expect management to provide comprehensive data at the upcoming ASH meeting on 5 December, when Oryzon will also host an investor meeting. The company has also revealed that multiple sclerosis is now officially included in the development plan of its second product ORY-2001. Our valuation is under review.