Event in Progress:
Discover the latest content that has just been published on Research Tree
Edison Investment Research is terminating coverage on Genkyotex (GKTX). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.
Companies: GENTICEL
Edison
Genkyotex has initiated a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease (DKD). Separately, it has announced the positive outcome of a safety review of its Phase II trial with GKT831 in patients with primary biliary cholangitis (PBC) with no adverse events or patient dropouts. Interim data have been pushed back slightly to autumn 2018 from mid-2018 and full data to H119 from end-2018 due to a slow rate of activation of a number of research centres
Premium
As expected, Genkyotex has initiated enrolment in the Phase II trial of GKT831 in patients with primary biliary cholangitis (PBC) in the first clinical trial site in the US. The trial plans to test GKT831 in 102 patients over 24 weeks. Interim data are expected in H118 and full data in H218. Moreover, the company has announced a Phase II investigator-sponsored trial in patients with Type 1 diabetes (T1D) and kidney disease. The trial will start in Australia in H217 and will be entirely funded an
Genkyotex is a Euronext-listed company formed by the merger of Genticel and Genkyotex focused on NOX science and its application in fibrosis and other indications. The lead asset, GKT831, will start a Phase II trial in primary biliary cholangitis (PBC) in Q217, with data expected in 2018. Positive results could justify future development in other large fibrotic diseases including non-alcoholic steatohepatitis (NASH). GKT771 will be Phase I ready in late 2017 and will focus on inflammation and an
Genticel has received a milestone payment of $1.2m from the Serum Institute of India (SIIL). This is the last milestone Genticel will receive associated with the preclinical development of GTL003 in new multivalent vaccines that contain pertussis (whooping cough). SIIL can now finish formal preclinical development before moving to clinical development, which could unlock further milestone payments. Under the collaboration with SIIL, Genticel is entitled to up to $57m development and sales milest
And then worst of all, you never get approval when you say you will. There is nothing that causes investor whiplash more than a sudden announcement of an unsuccessful clinical trial. Whether you are the onedrug wonder on AIM or the multi-drug portfolio NASDAQ darling, the market never takes too kindly to unsavoury news from the FDA on clinical results. But should investors lambast these two scenarios similarly based on poor trial results? The variables are endless but in this example the clear a
Companies: 0QFK 600258 GTCL SHRS GSK AZN ETX NIOX INDV VER
Hybridan
Genticel has announced 18-month data from the Phase II trial of the GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 infections (HPV16/18). In this update, GTL001 showed no statistically significant difference in any subgroup. Safety remains positive. Genticel will present 24-month data in Q117, which will include the full data set and inform next steps. The company continues leveraging its Vaxiclase platform in collaboration with the Serum Institute of India (SIIL) and plans t
Genticel has announced further analysis of its Phase II results on the GTL001 vaccine to treat early-stage human papillomavirus (HPV) 16 and 18 infections. The pre-specified group of patients with normal cytology had a significantly higher viral clearance than those taking placebo (p=0.018). Post-hoc analysis of the combined group of normal and ASCUS patients also shows a statistically significant difference (p=0.0029) between groups. In our view, this indicates that GTL001 could be effective in
Genticel has announced the Phase II results of its GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 (HPV 16 and 18) infections. The primary 12-month endpoint, focused on women with early cervical cellular abnormalities, was not achieved. Positively, in the subgroup of women with normal cytology, a significant clearance rate was seen. Further clearance data after 18 months are expected by Q316 and management expects this to enable Phase III preparations and partnering.
Genticel develops gentle therapeutic vaccines to treat early-stage human papilloma virus infections. The lead vaccine, GTL001, targets high-risk HPV 16 and 18 infections causing c 75% of cervical cancers in North America and the EU. There is no therapeutic vaccine to treat up to 12m women (in these markets). Phase II data, due in H116, could enable a major partnering deal to fund Phase III. A second product, GTL002, based on an improved proprietary platform (Vaxiclase), could enter trials in 201
Research Tree provides access to ongoing research coverage, media content and regulatory news on GENTICEL. We currently have 10 research reports from 2 professional analysts.
Companies: BILN IGP RBN SBTX
Cavendish
Verici’s $8.2m gross raise means the company can now focus on scaling Tutivia and invest further into the development of existing and new products. With a uniquely well balanced Tutivia test, a growing sales team and LCD coverage expected later this year, we forecast Tutivia revenues of $2.6m/$4.5m in FY24E/FY25E. The Thermo Fisher deal was a huge validation of Clarava and Verici’s technology and in addition to licensing/milestone payments, we forecast double digit royalties on net Clarava sales
Companies: Verici Dx Plc
Singer Capital Markets
26th March 2024 @HybridanLLP Status of this Note and Disclaimer This document has been issued to you by Hybridan LLP for information purposes only and should not be construed in any circumstances as an offer to sell or solicitation of any offer to buy any security or other financial instrument, nor shall it, or the fact of its distribution, form the basis of, or be relied upon in connection with, any contract relating to such action. This document has no regard for the specific investment object
Companies: BIRD MBH CHRT INSE KMK FNTL HDD JNEO CCS
Companies: Aptamer Group Plc
Turner Pope Investments
SkinBioTherapeutics has reported on the 6-months to December 2023, noting steady revenue growth from lead product AxisBiotix-Ps, progress on the development of SkinBiotix with partner Croda (Sederma) and post-period end, the acquisition of Dermatonics. The company has updated on several positive developments through the start of 2024, including AxisBiotix Acne positive interim results, initiation of research on the MediBiotix Pillar and progress with the oral and inflammation programmes. The com
Companies: SkinBioTherapeutics Plc
The Hardman & Co Healthcare Index (HHI) has been running since 2009. Its main function is to highlight the attractions of life sciences investments over the long term. For the second year running, apart from global economic influences affecting world markets, performance in 2023 was dented by the capital-intensive nature of the sector. The HHI fell 3.7%, to 483.8, underperforming the main London markets – FTSE 100 (+3.8%) and FTSE All-Share (3.8%) but outperforming the FTSE AIM All-Share Index (
Companies: TXG NDVA TSVT BCOW Z29 TXG NCYT GNS SUN AMS OMG APH EKF EAH IMM AGL DEMG AGY TSTL IPO GDR ETX TRX HVO CTEC AVO OXB DEST VLG IXI VAL INDV AGR AVCT BAI 123F IMCR BCOW
Hardman & Co
Companies: CLBS GHH NANO TRX SAVE TMT GELN
On 18th December 2023 Incanthera announced a deal with Marionnaud in Switzerland to distribute ‘Skin+CELL’, its advanced dermatological solution for the delivery of vitamin B3 for skin protection and cosmetic rejuvenation. This gives Incanthera access to a high-end cosmetics distribution presence in Europe, and in addition, ownership of Marionnaud by AS Watson, the largest cosmetics distributor in Asia, offers significant new market opportunities further afield.
Companies: Incanthera Plc
Stanford Capital Partners
FY EBITDA and EBIT came in materially above consensus FY EBITDA came in at EUR98.8m, down 4% yoy and 12% above consensus. The EBITDA margin was 12.6%. Restated for one-off costs, it was 13.1%, more than 2 percentage points above the guidance. It was fully explained by price increases, notably on X-ray, mix and control of fixed costs. FY EBITA came in at EUR38m, 46% above consensus. 2024 guidance looks conservative Guerbet is aiming for organic growth above 8% (8.8%e). With markets growing at
Companies: Guerbet (GBT:EPA)Guerbet SA (GBT:PAR)
BNP Paribas Exane - Sponsored Research
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now
Companies: Irlab Therapeutics Ab
Tissue Regenix has reported on strong performance through 2023, noting record revenues driven by product adoption and expanded distribution, positive adjusted EBITDA for the first time and an increased cash position versus H1/23. FY23 revenues grew 20% to $29.5m supported by 25% growth from BioRinse products and 17% growth from dCELL products. Significantly, Tissue Regenix reported its first adjusted EBITDA profit for the year, +$0.9m, supported by revenue growth and cost management. We expect t
Companies: Tissue Regenix Group plc
Creo Medical has published a trading update for the 12 months to December 2023, during which the company focused on commercialising its core technology. Revenue for the period increased 13% YoY to £30.8m, while the underlying operating loss improved to £16.4m. Operationally, during the period, the number of confirmed users of Creo’s Speedboat range more than doubled over the year, the first procedures with MicroBlate Flex to ablate lung tumours were performed and Creo expects to receive regulato
Companies: Creo Medical Group Plc
Companies: NTQ KMK JNEO DCTA
LungLife AI is a medical diagnostics company focused on the development of AI-supported blood-based tests for the early detection of lung cancer. It has identified a significant medical need for non-invasive, sensitive and specific tests in early-stage lung cancer. The company’s core technology, the LungLB test, seeks to detect circulating tumour cells (CTCs) to identify malignant lung nodules. It aims to apply machine learning/AI (ML/AI) to derive algorithms to increase test accuracy. Following
Companies: LungLife AI, Inc.
This month's feature article is entitled 'Gold and a Chinese Credit Event'. A Western phenomenon? If you own, or are considering owning, gold or gold equities, it’s likely that you’re concerned about protecting your wealth, or the performance of your fund, in the expectation of some kind of financial instability. Maybe your confidence in policymakers is ebbing, or you’ve researched debt bubbles in history and concluded that physical gold and silver have been the safest places to be invested whe
Companies: NBPE ICGT ARBB CSN RECI CLIG HAT AVO STX VTA APAX
Share: