Research, Charts & Company Announcements
Research Tree provides access to ongoing research coverage, media content and regulatory news on PAION AG. We currently have 7 research reports from 1 professional analysts.
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One hand on the prize
21 Nov 16
Paion has reported positive data from the first pivotal US study of its ultra-short-acting sedative remimazolam in procedural sedation. Induction and recovery from sedation was faster for remimazolam than the widely used drug midazolam, showing remimazolam could speed patient throughput in colonoscopy screening. Paion out-licensed US rights to Cosmo Pharmaceuticals for c €20m cash, €42.5m milestones and a 20-25% royalty. A second pivotal study is expected to complete recruitment in Q217. Our valuation moves to €208m (€3.74/share) vs €203m (€3.65/share) as higher US/Canada uptake is partially offset by uncertainty about EU development.
Colonoscopy Phase III success prompts US deal
05 Jul 16
Paion reported positive top-line results from its Phase III colonoscopy trial and promptly out-licensed US rights to Cosmo Pharmaceuticals. The deal brings c €20m of cash (including a €9.6m share purchase), €42.5m potential milestones and a 20-25% royalty. The next goal is end of recruitment in the bronchoscopy Phase III expected in late 2016/early 2017, with results two to three months later. We lift our valuation to €203m (vs €193m); the share issue sees our per-share valuation fall to €3.65/share (vs €3.81/share).
Pivotal colonoscopy results mid-year
17 May 16
Paion is approaching an important catalyst, with results from the US colonoscopy Phase III trial of remimazolam due to report mid-year. Filing for US approval is expected to be end 2017 at the earliest, as recruitment in the confirmatory bronchoscopy trial continues to be moderate. Partnering discussions for Japan are not expected to conclude until H216 at the earliest; we assume Japan filing in H217. We trim our valuation to €193m or €3.81/share (vs €203m or €4.01/share), with a launch date 12 months later in the US and Japan partly offset by lower forecast expenditure.
Extra four years US patent life a welcome boost
17 Feb 16
The patent term of Paion’s new US patent covering the crystalline form of remimazolam besylate has been extended by 4.3 years due to delays in the US patent office. This will extend US market exclusivity for the ultra shortacting anaesthetic to late 2031 vs our previous expectation of 2027, which leads us to increase our valuation to €203m from €182m. We look toward to the outcome of the pre-NDA meeting in Japan (Q116) and results from the US colonoscopy Phase III as potential near-term catalysts.
A setback in Europe, but US on track
10 Feb 16
Paion has discontinued its European Phase III trial of remimazolam for general anaesthesia in patients undergoing cardiac surgery due to slow recruitment. The US Phase III in colonoscopy is still on track to complete recruitment in the current quarter, but completion of the bronchoscopy Phase III may be pushed into 2017. Paion remains on track for a potential US filing in 2017, while a pre-NDA meeting with Japanese regulators in Q116 could clear the way for a filing in Japan, ideally with a partner. We delay our forecast launch date for general anaesthesia in Europe by two years to 2020 and lower our valuation to €182m from €230m.
Looking ahead to a pivotal year
18 Nov 15
Paion is at an advanced stage of developing its ultrashort-acting sedative remimazolam for use in procedural sedation and general anaesthesia. Three Phase III studies are due to report results in 2016, ahead of potential filings in the US and Europe in 2017. A positive outcome from a pre-NDA meeting with Japanese regulators in Q116 could lead to a filing in Japan in H216. We raise our valuation modestly to €230m from €224m as these milestones approach.
N+1 Singer - Morning Song 22-02-2017
22 Feb 17
CORETX (COR LN) Contract wins and new Lifestyle facility | Gooch & Housego (GHH LN) Solid Q1 trading plus earnings enhancing acquisition of StingRay Optics | NCC Group (NCC LN) Further issues in Assurance | PCI-PAL (PCIP LN) Strong H1 underpins positive outlook | UBM (UBM LN) Results | Verona Pharma (VRP LN) Phase IIa RPL554 add-on trial to tiotropium commenced
Panmure Morning Note 15-02-2017
15 Feb 17
With the early January trading update having prompted us to upgrade forecasts, today’s interim results show how the group’s focus on areas such as product development and international sales are translating through to growth in both the top and bottom-line. The consistency of delivery is what impresses us, reflecting the maturity of the management team and the clarity of the longterm vision. We repeat our Buy recommendation.
N+1 Singer - Morning Song 21-02-2017
21 Feb 17
Abzena (ABZA LN) Contract bookings strong; US costs higher than expected | City of London Investment Group (CLIG LN) Earnings and interim dividend in line, some modest growth in FuM | dotdigital Group (DOTD LN) Good H1; broadening avenues of growth | Grafenia (GRA LN) Weak print volumes | Vernalis (VER LN) Interims highlight increasing Tuzistra™ scrip volume
Panmure Morning Note 20-02-2017
20 Feb 17
Chi-Med has announced the initiation of a Phase II study of savolitinib in locally advanced or metastatic pulmonary sarcomatoid carcinoma (PSC) in China. This is a disease where patients are usually diagnosed by normal pathology (i.e. not via molecular diagnostics methods) but given that 20-30% of PSC patient show c-Met gene amplification this potentially represents a very rich patient pool for savolitinib as a highly selective and potent oral c-Met inhibitor. The continued strength of Chi-Med’s clinical momentum is further demonstrated by today’s news and we consider this represents further upside potential against our existing investment case. We repeat our Buy recommendation.
Discovering a sustainable model
21 Feb 17
We expect C4XD to begin to deliver commercially in 2017, following the shift in strategy away from fee for service in 2016. Over the next 12 months we expect C4XD to sign its first pre-clinical out-licensing deal, develop at least one more product line and sign at least one more strategic alliance. We believe this demonstration of the model will translate to a step up in value and we initiate coverage with a BUY recommendation and 129p price target.
AIPAC Phase IIb starts randomised component
15 Feb 17
Prima BioMed maintains its leadership in LAG-3 immunotherapies with the initiation of the randomised Phase IIb component of the AIPAC trial of IMP321 in breast cancer. In addition, the TACTI-Mel study of IMP321 combined with Keytruda in melanoma is expected to complete recruitment and report safety data in mid-2017, while the pipeline now includes a first-in-class Lag-3 agonist antibody. Initial efficacy data on the first 15 patients in AIPAC is also expected mid-year. We have revised development timelines for in-house and partnered LAG-3 programmes, which sees our valuation decrease to A$252m or A$0.12/share (vs A$282m or A$0.14/share).