Bullish option flow detected in GSK Pharma with 7,587 calls trading, 4x expected, and implied vol increasing over 1 point to 22.80%. Apr-23 38 calls and Jun-23 36 calls are the most active options, with total volume in those strikes near 5,800 contracts. The Put/Call Ratio is 0.18. Earnings are expected on April 26th.
Deutsche Bank analyst Emmanuel Papadakis upgraded GSK to Buy from Hold with a price target of 1,700 GBp, up from 1,500 GBp. The shares are "too cheap if there is any semblance of sustainability" through fiscal 2027, which is probable given the company's long acting injectables in HIV and RSV, with potential upside from bepirovirsen in hepatitis B, the analyst tells investors in a research note.
Bullish option flow detected in GSK Pharma with 7,128 calls trading, 1.6x expected, and implied vol increasing over 2 points to 24.16%. 3/31 weekly 35 calls and Jun-23 32 calls are the most active options, with total volume in those strikes near 5,000 contracts. The Put/Call Ratio is 0.42. Earnings are expected on April 26th.
GSK plc announced "positive headline results" from the phase III trial evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. "GSK's MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo. Invasive meningococcal disease, a major cause of meningitis and septicaemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents. Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. One-in-five survivors suffers long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems. Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases in most of the world. As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine. Currently, in the US, two separate vaccines needing four injections are required to protect against all five serogroups. This immunisation regimen, coupled with low awareness of the disease, can lead to sub-optimal immunisation coverage rates, particularly for MenB, with an estimated coverage of only approximately 31% of adolescents in the US," the company stated. Tony Wood, Chief Scientific Officer at GSK, said: "These statistically significant phase III data are a very encouraging step toward reducing the incidence of meningococcal disease. In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease's incidence peak, could drive significant public health impact. In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation."
GSK plc announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala as an add-on maintenance treatment for severe eosinophilic asthma, or SEA. "If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition. The application is based on positive data from a phase III trial among Chinese patients and the global SEA development programme, which included three key clinical trials - DREAM, MENSA and SIRIUS - that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients. The 52-week phase III trial in Chinese patients studied the effect of mepolizumab as adjunctive therapy in patients with SEA with a primary endpoint of reduction, relative to placebo, in the annual rate of clinically significant exacerbations. The efficacy and safety of mepolizumab in the Chinese population were shown to be consistent with that in a non-Chinese population with SEA," the company stated.
Reports Q4 revenue $55.2M, consensus $47.4M. Cash and cash equivalents as of December 31, 2022 were $90.5 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan for at least the next twelve months. "We ended our year delivering on our strategic focus, which included a commitment to maximize Auryxia revenue, support vadadustat globally and thoughtfully invest in our pipeline," said CEO John Butler. "We believe the work our team executed through the fourth quarter and more broadly in 2022 has put us in a strong position as we prepare for several meaningful upcoming milestones. Building on our positive CHMP opinion for vadadustat in Europe, we anticipate potential Marketing Authorization of Vafseo by the European Commission in May 2023, and we are active in our process to select a partner in Europe to deliver Vafseo to patients with chronic kidney disease on dialysis, if approved." "Auryxia revenue continues to fund our business, and we entered 2023 with a robust operating plan, including funding for several compelling pipeline opportunities," said CFO David Spellman. "Regarding revenue, we reported nearly 25% net product revenue growth for Auryxia over 2021, which exceeded guidance. 4Q22 included an inventory build of approximately $3M year over year. We have set 2023 net product revenue guidance at $175M-$180M as we remain cautious about a phosphate binder market recovery; the market continues to contract modestly due to COVID-19 and dialysis staffing issues. We will continue to be mindful of non-essential spend and work to reduce costs overall."
GSK plc announced that the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee, or VRBPAC, voted that the available data support the safety and effectiveness of GSK's respiratory syncytial virus, or RSV, older adult vaccine candidate for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older. The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety. Phil Dormitzer, Global Head of Vaccines R&D, GSK said: "Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems. Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications. We're delighted that the Advisory Committee recognized the strength of our vaccine's data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine."