GSK price target lowered to 1,550 GBp from 1,975 GBp at Citi » 11:2812/0212/02/22
Citi analyst Andrew Baum…
Citi analyst Andrew Baum lowered the firm's price target on GSK to 1,550 GBp from 1,975 GBp and keeps a Neutral rating on the shares.
AnaptysBio, GSK announces Phase 3 RUBY trial results for JEMPERLI » 09:0212/0212/02/22
AnaptysBio (ANAB) announced that GSK's (GSK) RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial of JEMPERLI plus standard of care chemotherapy compared to chemotherapy plus placebo in patients with primary advanced or recurrent endometrial cancer, met its primary endpoint of investigator-assessed progression-free survival. The JEMPERLI regimen showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient/microsatellite instability-high patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient/microsatellite stable patient subgroup. While the overall survival data were immature at the time of this analysis, a favorable trend was observed in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups. The safety and tolerability profile of dostarlimab plus chemotherapy was consistent with clinical trials of similar regimens. Regulatory submissions based on the trial results are anticipated in the first half of 2023. GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting. "We are encouraged to see AnaptysBio-discovered molecules continue to deliver differentiated outcomes for patients in indications with substantial unmet need. We are grateful to our partners at GSK for enabling broad development of JEMPERLI and to the patients in the RUBY and other JEMPERLI trials for their participation," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We believe that potential first-in-class approvals for JEMPERLI in endometrial cancer and other indications could over time materially contribute to our strong capital position as we focus on the R&D of our immune cell modulator pipeline. This includes our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA agonist, which act directly on cell types mediating disease pathology and have the potential to treat a broad range of autoimmune and inflammatory disorders."
GSK reports EMA accepts marketing authorization application for momelotinib » 07:3812/0212/02/22
GSK plc announced that…
GSK plc announced that the European Medicines Agency, or EMA, validated the marketing authorization application for momelotinib, a potential new oral treatment for myelofibrosis. Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signaling pathways: Janus kinase 1, and JAK2 and activin A receptor type I, which could address the significant medical needs of myelofibrosis patients with anaemia. The MAA is based on results from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary endpoints, the company stated.
GSK's phase 3 trial of Jemperli meets primary endpoint » 06:2412/0212/02/22
The company states: …
The company states: "GSK announced positive headline results from the planned interim analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli plus standard-of-care chemotherapy, carboplatin-paclitaxel, followed by Jemperli compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. The trial met its primary endpoint of investigator-assessed progression-free survival. It showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient microsatellite instability-high patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient microsatellite stable patient subgroup. While the overall survival (OS) data were immature at the time of this analysis, a favourable trend was observed in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups. The safety and tolerability profile of dostarlimab in the RUBY phase III trial was consistent with clinical trials of similar regimens. The most common treatment-emergent adverse events in patients receiving dostarlimab plus chemotherapy were nausea, alopecia, fatigue, peripheral neuropathy, anaemia, arthralgia, constipation and diarrhoea." Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK said: "Patients with primary advanced or recurrent endometrial cancer have limited treatment options. Long-term outcomes remain poor, and new treatment options are urgently needed to evolve the current standard of care, which is platinum-based chemotherapy. Based on these positive headline results from the RUBY phase III trial, GSK intends to seek regulatory approvals for a potential new indication for dostarlimab in the treatment of primary advanced or recurrent endometrial cancer."Reference Link
GSK price target lowered to 1,535 GBp from 1,650 GBp at Morgan Stanley » 15:1911/3011/30/22
Morgan Stanley analyst…
Morgan Stanley analyst Mark Purcell lowered the firm's price target on GSK to 1,535 GBp from 1,650 GBp and keeps an Equal Weight rating on the shares.
|Over a week ago|
GSK initiated process for withdrawal of U.S. marketing authorization for Blenrep » 06:5611/2211/22/22
GSK plc announced it has…
GSK plc announced it has initiated the process for withdrawal of the US marketing authorization for Blenrep, or belantamab mafodotin-blmf, following the request of the U.S. Food and Drug Administration. This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the U.S. FDA Accelerated Approval regulations. Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma, or RRMM, who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. "As part of the company's efforts to ensure physicians and patients are supported during this important time, patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy programme will have the option to enroll in a compassionate use programme to continue to access treatment. Further information on enrolling patients into the compassionate use programme will be provided directly to REMS-enrolled prescribers. Patients currently being treated with Blenrep should consult their healthcare provider," the company stated. Sabine Luik, Chief Medical Officer, said, "We respect the Agency's approach to the accelerated approval regulations and associated process. Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments. We will continue the DREAMM clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma."
CureVac, GSK teamed on 4 Phase 1 studies in COVID-19 and flu vaccines » 07:4511/1611/16/22
"CureVac (CVAC) is…
"CureVac (CVAC) is delivering on its previously announced 2022 clinical development program in prophylactic vaccines and has initiated a total of four Phase 1 studies in COVID-19 and flu in collaboration with GSK (GSK). All clinical candidates are based on CureVac's second-generation mRNA backbone and are being tested as a booster vaccination. In line with the company's development strategy to take an unrestricted technology approach, each program features a candidate applying unmodified mRNA as well as a candidate applying modified mRNA to identify the best-performing candidate for later-stage clinical development. All trials are well on track to deliver clinical data in early Q1 2023. Data are expected to be reported as combined data sets for both candidates per indication," said the company in a statement.
CureVac reports cash equivalents position of EUR 540.9M at September-end » 07:3911/1611/16/22
CureVac (CVAC) reports…
CureVac (CVAC) reports cash and cash equivalents position of EUR 540.9M as of September 30; driven mainly by proceeds related to transfer of production capacity to GSK (GSK)."This has been a highly productive year for CureVac, with a significant expansion of our operational bandwidth and further extension of applications for our mRNA technology," said Franz-Werner Haas, Chief Executive Officer of CureVac. "Looking across our three core competencies, we have expanded our broad technology platform into modified as well as multivalent mRNA approaches by starting four clinical trials in COVID-19 and flu. All trials are on track to deliver important clinical data in the near future. These trials diversify and advance our product development pipeline with promising candidates, as do the new technologies fueling our growing oncology footprint and our innovations in molecular therapies. We have increased integration of our flexible and scalable manufacturing to now serve the early clinical trial stage through to commercial supply based on a unitary framework. This contributes to the speed of our product developments, further supported by our integrated end-to-end solution, The RNA Printer , for which we have successfully filed applications for manufacturing licenses to support our oncology area." "In the third quarter of 2022, we further advanced our corporate transformation from a research-oriented biotech to an integrated and commercial-ready biopharma company by focusing our resources on clear priorities in our technology platform, product pipeline and manufacturing landscape," said Pierre Kemula, Chief Financial Officer of CureVac. "For the first time since the fourth quarter of 2021, the headwind from wind-down costs related to our first-generation vaccine candidate, CVnCoV, has subsided, demonstrating our diligent work to resolve or reallocate prior commitments."
Biogen price target raised to $315 from $300 at Oppenheimer » 06:3811/1411/14/22
BIIB, SNY, GSK
Oppenheimer analyst Jay…
Oppenheimer analyst Jay Olson raised the firm's price target on Biogen (BIIB) to $315 from $300 and keeps an Outperform rating on the shares. The analyst notes shares have outperformed in 2022 driven mostly by positive CLARITY-AD results. More recently, Olson is "encouraged" by the appointment of Chris Viehbacher as CEO based on his accomplishments at Sanofi (SNY) and GSK (GSK). After hitting a low point earlier this year, the analyst expects Biogen's shares to continue on an upward trajectory along with improving investor confidence as details emerge for lecanemab and competitors at CTAD and commercial prospects materialize next year.
GSK says GSK3036656 demonstrated early bactericidal activity in Phase IIa study » 06:3411/1411/14/22
GSK plc announced…
GSK plc announced "positive" results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis. "These results demonstrate the potential for GSK3036656 to be a component of simpler treatment regimens in the future which could help address the TB epidemic," the company stated. A selection of these data was presented in an oral late breaker session at the Union World Conference on Lung Health on November 11. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK, said: "Existing treatments for TB can be complicated, of long duration and have serious side effects which significantly impact the lives of patients with TB around the world. Today's encouraging data provide a good foundation from which to investigate GSK3036656 in different combinations in Phase IIb/c studies, with the aim of contributing to shorter, simpler and better tolerated treatment regimens for patients with TB."