On October 28, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it has commenced an underwritten public offering of up to $400,000,000 of shares of its common stock (Press release, Ultragenyx Pharmaceutical, OCT 28, 2020, View Source [SID1234569209]). In addition, the company is expected to grant the underwriters of the offering an option for a period of 30 days to purchase up to an additional $60,000,000 of shares of common stock at the public offering price, less the underwriting discount.

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The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed. J.P. Morgan, Goldman Sachs & Co. LLC, BofA Securities and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became automatically effective on February 21, 2018. This offering is being made solely by means of prospectus supplement and accompanying prospectus. When available, copies of the preliminary prospectus supplement and the accompanying prospectus related to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at prospectus- [email protected]; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; and Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, United States, Attn.: Prospectus Department or by telephone 1-631-274-2806.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 28, 2020 GSK reported that resilient performance, strong commercial execution and further strategic progress in Q3 (Press release, GlaxoSmithKline, OCT 28, 2020, View Source [SID1234569208]).

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Financial and product highlights
Reported Group sales £8.6 billion, -8% AER, -3% CER (Pro-forma -5% CER*, -3% CER excluding divestments/brands under review). Pharmaceuticals £4.2 billion, -7% AER, -3% CER; Vaccines £2.0 billion, -12% AER, -9% CER; Consumer Healthcare £2.4 billion, -4% AER, +2% CER (Pro-forma -6% CER*). Strong performance from key growth drivers in respiratory, HIV, oncology and Consumer Healthcare partly offset by expected disruption from COVID-19
Sales of new and specialty pharmaceuticals (excluding established products) £2.5 billion, +8% AER, +12% CER
Respiratory sales £978 million, +21% AER, +26% CER. Trelegy sales £194 million +40% AER, +45% CER. Nucala sales £251 million, +24% AER, +29% CER
HIV sales £1.2 billion, -4% AER, flat at CER; two-drug regimen sales £222 million, +87% AER, +94% CER
Oncology sales £99 million, +55% AER, +58% CER
Shingrix sales £374 million, -30% AER, -25% CER. US prescriptions rates returned to 2019 levels by quarter-end
Total Group operating margin 21.5%. Adjusted Group operating margin 30.8%. SG&A decline reflecting ongoing and active focus on cost management. R&D costs down in quarter; expect 2020 full year R&D costs to rise mid-to-high single digits as we continue to invest in late-stage pipeline
Total EPS 25.0p, -20% AER, -9% CER reflecting adverse changes on contingent consideration liabilities offset by asset disposals and improved operating performance
Adjusted EPS 35.6p, -8% AER, +1% CER reflecting operating profit growth partly offset by higher effective tax rate and non-controlling interest allocation of Consumer Healthcare profits
Q3 net cash flow from operations £0.9 billion. Free cash flow £(0.2) billion
19p dividend declared for the quarter
Guidance
On track to deliver full year 2020 Adjusted EPS at the lower end of the -1% to -4% range at CER
Pipeline highlights
Continued progress in biopharma pipeline with 3 approvals since Q2 results: FDA and EC approval of Blenrep as first anti-BCMA therapy for multiple myeloma; FDA approval of Trelegy for asthma; FDA approval of Nucala as first biologic treatment for Hypereosinophilic Syndrome (HES)
Positive European CHMP opinions in HIV for cabotegravir and rilpivirine as long-acting regimen for HIV treatment and for Zejula as first-line monotherapy maintenance treatment in ovarian cancer
Phase III trials to start in Q4 and Q1 2021 for RSV vaccines in maternal and older adults following positive Phase I/II data
First participant vaccinated in Phase III clinical trial of 5-in-1 meningitis ABCWY vaccine candidate
COVID-19 Solutions update
Phase I/II study of Sanofi-GSK adjuvanted recombinant protein-based vaccine candidate initiated. Phase III trial expected to start December 2020
Supply agreements reached with US, EU, UK, Canada for Sanofi-GSK vaccine. Statement of Intent signed with COVAX facility to support successful and equitable access to COVID-19 vaccines worldwide
Phase III study underway for Vir-GSK antibody (VIR-7831) for high-risk outpatients with COVID-19, with initial results potentially available by the end of 2020
GSK Q3 2020 results
Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has responded well to a challenging operating environment this year with disciplined cost control and strong commercial momentum in key growth products including Nucala, Trelegy, Benlysta, 2 drug-HIV regimens, Zejula, Shingrix and our priority Consumer Healthcare brands. This, combined with improving vaccination rates this quarter, means we are on track to deliver within our earnings guidance range for 2020. In addition, we continue to make good progress on our preparations to separate the Group and create two new companies – in Biopharma and Consumer Health – which we believe will deliver options for sustainable growth and returns to shareholders.

"R&D delivery has continued with three product approvals since Q2 results and presentation of new clinical data to support the start of Phase III development for our very promising RSV vaccines. We are also urgently advancing possible COVID-19 Solutions with our partners, including clinical trials for antibody therapy VIR-7831 and three different adjuvanted vaccines. We expect to see data on all of these before the end of the year."

On October 28, 2020 Data presented by Invitae (NYSE: NVTA), a leading medical genetics company, reported at the American Society of Human Genetics (ASHG) Virtual Meeting found one in ten men with prostate cancer harbor genetic changes linked to hereditary cancer syndromes and three-quarters of those patients met criteria for changes in cancer management or treatment based on their genetic findings (Press release, Invitae, OCT 28, 2020, View Source [SID1234569207]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The study of more than 4,000 men with prostate cancer also found no statistical difference in the rate of cancer-causing genetic changes based on stage of disease, suggesting common criteria used to restrict testing would miss clinically important changes for many patients and their families.

"These new findings provide further evidence of the strong genetic associations with prostate cancer. It’s clear that we must continue to explore how we can make genetic testing more available and accessible for men with prostate cancer, which will support treatment decisions through targeted therapies, clinical trial eligibility and additional management recommendations," said Sarah Nielsen, M.S., L.C.G.C., the lead author on the study. "Not only does increased genetic testing benefit the patient, but it also lends insight into family health risks, and particularly for female relatives, who might face an unknown higher risk of breast and ovarian cancers."

The study also looked at the rate of genetic changes based on reported ethnicity. Study participants included greater representation of patients reporting African-American and Hispanic ethnicity than most studies that have examined the inherited genetics of prostate cancer patients. Researchers found lower positivity rates among men reporting African-American (6.2%) and Asian (6.7%) ethnicity, while the rates of genetic variants of uncertain significance were highest in these two populations (58.9% and 66.7%, respectively), highlighting the need to expand testing in these populations to better understand and normalize unique genetic variations.

Participants in the study received testing through Invitae’s sponsored hereditary prostate cancer testing program which provides no-charge testing for men with prostate cancer.

On October 28, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI) a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the third quarter 2020 financial results and provide a corporate update on Wednesday, November 4, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, OCT 28, 2020, View Source [SID1234569205]).

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Conference Call and Webcast:

Wednesday, November 4, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic:

(877) 837-3910, Conference ID# 1281757

International:

(973) 796-5077, Conference ID# 1281757

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

On October 28, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported that it will report its third quarter 2020 financial results on Thursday, November 5, 2020 (Press release, Deciphera Pharmaceuticals, OCT 28, 2020, View Source [SID1234569204]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Thursday, November 5, 2020, to discuss the Company’s financial results and provide a corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 6048987. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.