On October 27, 2021 GSK reported that strong Q3 sales of £9.1 billion +5% AER, +10% CER Total EPS 23.3p -7% AER, +3% CER; Adjusted EPS 36.6p +3% AER, +10% CER 2021 full year EPS guidance improved (Press release, GlaxoSmithKline, OCT 27, 2021, View Source [SID1234592009])

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Pharmaceuticals £4.4 billion +5% AER, +10% CER with growth in New and Specialty medicines
+24% CER; Respiratory +33% CER; Immuno-inflammation +32% CER ex-COVID-19 solutions; Oncology +34% CER; total HIV +8% CER
Vaccines £2.2 billion +7% AER, +13% CER with Shingrix £502 million +41% CER
COVID-19 solutions sales £209 million; Xevudy £114 million and pandemic adjuvant £94 million
Consumer Healthcare £2.5 billion +3% AER, +8% CER (+10% excluding divestments/brands under review)
Cost discipline supports delivery of EPS growth
Total Group operating margin 21.4%. Total EPS 23.3p -7% AER, +3% CER
Adjusted Group operating margin 31.7%. Adjusted EPS 36.6p +3% AER, +10% CER. This included a contribution to growth from COVID-19 solutions of approximately +5% AER, +5% CER in Q3 (+6% AER,+6% CER in the nine months)
Q3 net cash flow from operations £2.6 billion. Free cash flow £1.2 billion
Continued momentum in R&D delivery and strengthening of pipeline
Additional regulatory indications approved for Nucala in respiratory and Jemperli in cancer
HIV progress with FDA priority review of cabotegravir for prevention of HIV (PDUFA action date 23 Jan 2022) and new collaboration on ultra long-acting integrase inhibitor
Positive Phase III data on daprodustat in anaemia due to chronic kidney disease to be presented at the American Society of Nephrology meeting in Nov 2021
COVID-19 solutions: approval in Japan for Xevudy and ongoing discussions with several governments Phase III start with SK Bioscience for adjuvanted COVID-19 vaccine
World Health Organization recommendation for broad roll-out of RTS,S malaria vaccine for children living in sub-Saharan Africa
Progress on demerger to create new world-leading Consumer Healthcare company in 2022
New UK Corporate Headquarters announced
Announcement expected of Chair Designate in Q4 2021
2021 EPS guidance improved and reconfirm 2022 outlook
Now expect 2021 Adjusted EPS to decline between -2% to -4% at CER excluding COVID-19 solutions, previously mid-to-high single digit decline
Now expect 2021 Adjusted EPS contribution from COVID-19 solutions of 7% to 9% at CER
Expectation for meaningful improvement in revenues and margins in 2022 reconfirmed
2022 outlook excludes any contribution from COVID-19 solutions
Dividend of 19p declared for Q3 2021. Continue to expect 80p/share for 2021

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has delivered another quarter of strong business performance, with double-digit sales growth in Pharmaceuticals and Vaccines, increased momentum in Consumer Healthcare, and continued discipline on costs. This has allowed us to improve our full-year guidance and, alongside the progress in strengthening our R&D pipeline, reinforces our confidence in the outlook for a step-change in growth and performance in 2022 and beyond. We also continue to make excellent progress towards unlocking the value of Consumer Healthcare through a successful demerger in mid-2022."

On October 27, 2021, Acceleron Pharma reported that Bristol Myers Squibb ("BMS") announced the net sales of REBLOZYL (luspatercept-aamt) were approximately $160 million for the quarter ended September 30, 2021, which include approximately $20 million to $25 million of sales from an inventory build due to the transition to wholesaler distribution and approximately $13.5 million of net sales outside of the United States (Press release, Acceleron Pharma, OCT 27, 2021, View Source [SID1234592008]).

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As previously disclosed, under the collaboration agreement between Acceleron Pharma Inc. (the "Company") and BMS for REBLOZYL, the Company is eligible to receive tiered royalty payments from BMS on net sales of REBLOZYL in the low-to-mid 20% range. The Company expects to report royalty revenue of approximately $32.0 million from net sales of REBLOZYL in the quarter ended September 30, 2021.

This preliminary unaudited revenue estimate is the responsibility of management and is subject to the completion of the Company’s customary quarter-end financial closing procedures, including management’s review and finalization, as well as review procedures by the Company’s independent registered public accounting firm, which have not yet been completed. During the course of the Company’s review process, items may be identified that would require it to make adjustments, which could result in material changes to the Company’s preliminary unaudited estimated financial results. Consequently, this revenue estimate should not be viewed as a substitute for the Company’s earnings release and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.

The information contained in this Item is being furnished and shall not be deemed "filed" for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.

On October 27, 2021 Race Oncology Limited ("Race") reported it has entered into a research collaboration with Dr Dan Dominissini of the Chaim Sheba Medical Center, Israel to analyse clinical patient samples from the ongoing Zantrene Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML) for FTO and FTO-related biomarkers (ASX Announcement: 9 August 2021) (Press release, Race Oncology, OCT 27, 2021, View Source [SID1234592003]).

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The biomarker testing will include FTO gene sequencing, FTO protein levels (intracellular staining and flow cytometry), FTO mRNA levels, and analysis of the m6A/A ratio in mRNA from patient tumour samples before, during and after treatment with Zantrene.

Dr Dominissini is a world-renowned expert in RNA methylation and m6A RNA methylation and has authored more than 32 publications in high impact peer-reviewed journals including Nature, Science and Cell.

This research collaboration has strategic importance for Race as the data will advance Race’s ‘Three Pillar’ strategy announced at the 2020 AGM (ASX Announcement: 30 November 2020).

"We are delighted to be extending our successful collaboration with the team at Chaim Sheba to generate important data on the effects of Zantrene on FTO and related molecules. These data will give us the first insights into the effect of Zantrene in patients on FTO and m6A RNA methylation and continues to advance our Three Pillar Strategy."

Race CSO Dr Daniel Tillett
"Conceptual and technological breakthroughs since 2011, by our group and others, have introduced the novel notion that internal chemical modifications of mRNA and long non-coding RNA are abundant, dynamic and sometimes reversible events, which constitute essential regulatory elements in RNA metabolism. Dedicated cellular machineries that install (‘writers’), remove (‘erasers’) and recognize (‘readers’) the various RNA modifications have been discovered, revealing essential roles for mRNA and lncRNA modification in various cellular, developmental and disease processes, and providing avenues for therapeutic intervention. N6-methyladenosine (m6A) is the most prevalent internal mRNA modification, removed by the enzyme FTO, with established key roles in carcinogenesis. We are excited to see these basic discoveries translated into the clinic by the Zantrene study of Race Oncology for relapsed or refractory AML. We hope that our scientific collaboration will advance the understanding of the correlation between FTO and m6A status in AML and response to treatment."

Dr Dominissini from Chaim Sheba
Relapsed or Refractory Acute Myeloid Leukemia
Primary refractory or relapsed acute myeloid leukemia is associated with poor prognosis and remains a major therapeutic challenge. Primary refractory AML is defined by the absence of complete remission (CR), manifested by blast count of ≥5% in bone marrow after one or two cycles of intense induction chemotherapy.

Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses of intensive chemotherapy.

Even when CR is achieved through intense chemotherapy, approximately half of the younger and 80% of the older patient’s relapse. In both clinical situations, refractory and/or relapsed AML, active disease remains a major therapeutic challenge despite recent advances.

Study Design
Samples will be taken from patients participating in the existing study, "An open-label, Phase 1b/2 study of intravenous FluCloZan (fludarabine, clofarabine, Zantrene (bisantrene dihydrochloride)" in cohorts of adult patients with R/R AML using a Simon’s 2-stage design: a Phase 1b lead-in dose escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of FluCloZan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D in up to 17 subjects.

On October 27, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will report its third quarter 2021 financial and operating results after the close of U.S. financial markets on Wednesday, November 3, 2021 (Press release, Tracon Pharmaceuticals, OCT 27, 2021, View Source [SID1234592002]). In addition, management will host a conference call to provide an update on corporate activities and discuss the financial results.

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On October 27, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that it will host a conference call and live webcast on Tuesday, November 2, 2021 at 8:30 a.m. EDT to report financial results for the third quarter 2021 and provide business updates (Press release, ADC Therapeutics, OCT 27, 2021, View Source [SID1234592001]).

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To access the live call, please dial 833-303-1198 (domestic) or +1 914-987-7415 (international) and provide conference ID 4035885. A live webcast of the presentation will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.