GlaxoSmithKline, Vir Biotechnology announce rolling EMA review of sotrovimab » 05:5805/0705/07/21
GlaxoSmithKline (GSK) and…
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GlaxoSmithKline reports European Commission approves expanded use of Benlysta » 07:0905/0505/05/21
GlaxoSmithKline announced the European Commission has approved the expanded use of intravenous and subcutaneous Benlysta in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis in Europe, in addition to systemic lupus erythematosus. The EU marketing authorization follows the recent approval for the similar expanded LN indication in the U.S., the company noted.
ViiV Healthcare initiates rolling submission of NDA for cabotegravir for PrEP » 07:2305/0405/04/21
ViiV Healthcare, the…
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline (GSK), with Pfizer (PFE) and Shionogi Limited as shareholders, announced the initiation of a rolling submission of a new drug application, or NDA, with the US Food and Drug Administration for investigational, long-acting, injectable cabotegravir for the prevention of HIV, also called pre-exposure prophylaxis, or PrEP. The rolling submission allows ViiV Healthcare to submit portions of the regulatory application to the FDA as they are completed, rather than waiting until every section of the NDA is complete to submit the entire application for review. The complete submission will be based on results from two phase IIb/III studies, HPTN 083 and HPTN 084. HPTN 083 evaluated the safety and efficacy of long-acting cabotegravir for HIV prevention in men who have sex with men and transgender women.1 HPTN 084 evaluated cabotegravir for HIV prevention in women who are at increased risk of HIV acquisition.2 The Data Safety Monitoring Board stopped the blinded, randomized portion of both studies early after cabotegravir was shown to be superior to daily emtricitabine/tenofovir disoproxil fumarate tablets, ViiV noted.
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GlaxoSmithKline price target raised to 1,200 GBp at Deutsche Bank » 12:1004/3004/30/21
Deutsche Bank analyst…
Deutsche Bank analyst Emmanuel Papadakis raised the firm's price target on GlaxoSmithKline to 1,200 GBp from 1,150 GBp and keeps a Sell rating on the shares.
GlaxoSmithKline reconfirms guidance range for 2021 » 07:1004/2804/28/21
GlaxoSmithKline said: "We reconfirm our guidance range for 2021 for a decline of mid to high-single digit percent Adjusted EPS at CER. In 2021, as planned we will continue to increase investment in our pipeline, build on our top-line momentum for key growth drivers and largely complete readiness for separation. Assuming healthcare systems and consumer trends approach normality in the second half of the year, we continue to expect Pharmaceutical revenue to grow flat to low-single digits at CER and Consumer Healthcare revenue to grow low to mid-single digits at CER excluding brands divested/under review with above market growth. For our Vaccines business, as noted at the time of announcing full-year 2020 results, we anticipated disruption during the first half of the year, given governments' prioritisation of COVID-19 vaccination programmes and ongoing measures to contain the pandemic. This was expected to impact adult and adolescent immunisations, including Shingrix, notably in the US and this is reflected in our first-quarter 2021 Vaccines performance. We are encouraged by the rate at which COVID-19 vaccinations are being deployed in many countries, particularly the US and UK, which provides support for healthcare systems returning to normal. As a consequence we remain confident in the underlying demand for our Vaccine products, and we expect strong recovery and contribution to growth, notably from Shingrix, in the second half of the year. We continue to expect Vaccines revenue for 2021 to grow flat to low-single digits at CER." A dividend of 19p was declared for Q1 and GSK said it continues to expect 80p/share for 2021.
GlaxoSmithKline reports Q1 adjusted EPS 22.9p vs. 37.7p a year ago » 07:0904/2804/28/21
Group turnover was EUR…
Group turnover was EUR 7.42B in the quarter, down 18% AER, 15% CER. Excluding the impact of brands divested or under review in Consumer Healthcare, Group turnover was down 13% at CER. Emma Walmsley, CEO of GSK, said: "Our first quarter results are in line with our expectations and reflect the anticipated impacts of COVID-19. We continue to expect a significant improvement in performance over the remainder of the year and reconfirm our guidance for 2021 and 2022 outlook. The launch of Cabenuva for HIV and Phase III starts for our RSV vaccine and a new long-acting treatment for severe asthma are key milestones as we continue to strengthen our growth prospects. Separation plans are also well underway and we look forward to sharing our strategy and growth outlook for New GSK with investors in June."
GlaxoSmithKline call volume above normal and directionally bullish » 12:0504/2704/27/21
Bullish option flow…
Bullish option flow detected in GlaxoSmithKline with 3,806 calls trading, 1.9x expected, and implied vol increasing over 7 points to 28.45%. 4/30 weekly 37.5 calls and May-21 35 puts are the most active options, with total volume in those strikes near 3,400 contracts. The Put/Call Ratio is 0.35. Earnings are expected on April 28th.
AnaptysBio granted conditional marketing authorization for JEMPERLI » 10:3604/2304/23/21
AnaptysBio (ANAB) announced that the European Commission has granted conditional marketing authorization for JEMPERLI for use in women with mismatch repair deficient/microsatellite instability-high recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe. JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation antibody platform and subsequently developed by TESARO, Inc., now a part of GSK (GSK), under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date, and JEMPERLI is the first AnaptysBio-generated antibody to obtain regulatory approval. JEMPERLI is indicated as a monotherapy for treatment of adult patients with recurrent or advanced dMMR/MSI-H endometrial cancer, who have progressed on, or are being dosed following, prior treatment with a platinum-containing regimen, and is the first indication approved by the European Commission for JEMPERLI. AnaptysBio has earned a $10M milestone payment as a result of this approval.
GlaxoSmithKline reports European Commission approves Jemperli » 10:2204/2304/23/21
GlaxoSmithKline announced the European Commission has granted conditional marketing authorization for Jemperli, a programmed death receptor-1-blocking antibody, for use in women with mismatch repair-deficient/microsatellite instability-high recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. "The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe," the company stated.
Roche announces FDA approval of VENTANA MMR RxDx panel » 06:4104/2304/23/21
Roche (RHHBY) announced…
Roche (RHHBY) announced U.S. Food and Drug Administration approval of the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with Jemperli monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA on April 22, 2021.