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News

Urovant Sciences Reports 2019 Third Fiscal Quarter Financial Results

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Urovant Sciences (Nasdaq: UROV) today reported financial results for the 2019 third fiscal quarter ended December 31, 2019.

Recent Business Highlights

  • Submitted a New Drug Application for vibegron for the treatment of patients with overactive bladder to the U.S. Food and Drug Administration (FDA) in December 2019.
  • Initiated a Phase 2a study of URO-902, a novel gene therapy product for patients with overactive bladder that have failed oral pharmacologic therapy.
  • Entered into a $300 million low interest, interest-only, five-year term loan facility with Sumitomo Dainippon Pharma.

This has been an exciting and transformational quarter for our company, marked by key milestones across all aspects of our business, said Keith A. Katkin, chief executive officer of Urovant Sciences. We submitted our New Drug Application for vibegron for the treatment of patients with overactive bladder to the FDA ahead of schedule, initiated a Phase 2a study of our novel gene therapy product, URO-902 and entered into a transformative relationship with Sumitomo Dainippon Pharma. We now look forward to our interactions with the FDA as we prepare to bring to market a potentially best in class therapeutic option for the treatment of patients suffering from overactive bladder.

Third Fiscal Quarter 2019 Financial Summary

For the quarter ended December 31, 2019, total operating expenses were $39.8 million, comprised of research and development expenses of $23.1 million and general and administrative expenses of $16.7 million. Total operating expenses for the quarter include a $10.3 million non-cash, stock-based compensation charge due to the accelerated vesting of certain options and restricted stock units upon the change in control triggered by the closing of the Sumitomo Dainippon Pharma transaction with Roivant Sciences. Net loss for the quarter ended December 31, 2019 was $41.3 million, or $1.36 per share. Cash used in operations was $23.6 million. As of December 31, 2019, total cash and cash equivalents was $131.9 million.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss 2019 third fiscal quarter ended December 31, 2019 financial results today, February 13, 2020, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing (866) 470-1049 for domestic callers or (409) 217-8245 for international callers and entering conference ID 9699592. A replay of the call will be available approximately four hours after the call and accessible for 7 days at (855) 859-2056, conference ID 9699592. A webcast will be archived on the Investor Relations page of the Urovant Sciences website immediately after the call and available for at least 30 days.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. The Companys lead product candidate, vibegron, is an oral, once-daily small molecule beta-3 agonist that is being evaluated for overactive bladder (OAB). Urovant Sciences reported positive data from the vibegron 12-week, Phase 3 pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study. The Company submitted a New Drug Application to the FDA seeking approval of vibegron for the treatment of patients with OAB in December 2019. Vibegron is also being evaluated for treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH) and for abdominal pain associated with irritable bowel syndrome (IBS). Urovants second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy. Urovant Sciences, a subsidiary of Sumitovant Biopharma Ltd., which is a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Sumitovant Biopharma Ltd.

Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant’s promising pipeline is comprised of early-through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Companys intent, belief or expectations and can be identified by words such as anticipate, believe, can, continue, could, estimate, expect, intend, likely, may, might, objective, ongoing, plan, potential, predict, project, should, strive, to be, will, would, or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding the Companys plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; Urovants plans to advance the clinical development of vibegron in patients with OAB and obtain FDA approval; the Companys plans to advance the clinical development of URO-902 in patients with OAB; the clinical development of vibegron in patients with OAB+BPH and IBS-pain; and continued commitments of Sumitomo Dainippon Pharma with respect to financing and support for commercialization efforts. The Companys forward-looking statements are based on managements current expectations and beliefs and are subject to a number of risks and uncertainties that could lead to actual results differing materially from those projected, forecasted or expected. Although the Company believes that the assumptions underlying these forward-looking statements are reasonable, they are not guarantees and the Company can give no assurance that its expectations will be attained. Factors that could materially affect the Companys operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to: the Companys limited operating history and the fact that it has never generated any product revenue; the Companys ability to achieve or maintain profitability in the future; the Companys dependence on the success of its lead product candidate, vibegron; the Companys reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Companys clinical trials for vibegron and URO-902 and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Companys dependence on Merck Sharp & Dohme Corp. and Ion Channel Innovations, LLC to have accurately reported results and collected and interpreted data related to vibegron and URO-902 prior to the Companys acquisition of the rights related to these product candidates; reliance on third parties to conduct, supervise and monitor the Companys clinical trials; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain and enforce intellectual property protection for the Companys technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; the failure to achieve the market acceptance necessary for commercial success for a product candidate; the Companys ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; and other risks and uncertainties listed in the Companys filings with the United States Securities and Exchange Commission (SEC), including under the heading Risk Factors in the Companys most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, the Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

UROVANT SCIENCES LTD.

Condensed Consolidated Statements of Operations

(unaudited; in thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

Nine Months Ended December 31,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

23,099

 

 

$

21,299

 

 

$

62,909

 

 

$

69,308

 

 

General and administrative(2)

 

 

16,687

 

 

 

4,862

 

 

 

29,587

 

 

 

12,650

 

 

Total operating expenses

 

 

39,786

 

 

 

26,161

 

 

 

92,496

 

 

 

81,958

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(1,401

)

 

 

 

 

 

(2,495

)

 

 

 

 

Loss on disposal of furniture and equipment

 

 

 

 

 

 

 

 

(236

)

 

 

 

 

Other income (expense)

 

 

(34

)

 

 

(219

)

 

 

(145

)

 

 

(299

)

 

Loss before provision for income taxes

 

 

(41,221

)

 

 

(26,380

)

 

 

(95,372

)

 

 

(82,257

)

 

Provision for income taxes

 

 

38

 

 

 

61

 

 

 

113

 

 

 

121

 

 

Net loss

 

$

(41,259

)

 

$

(26,441

)

 

$

(95,485

)

 

$

(82,378

)

 

Net loss per common sharebasic and diluted

 

$

(1.36

)

 

$

(0.87

)

 

$

(3.14

)

 

$

(3.51

)

 

Weighted average common shares outstandingbasic and diluted

 

 

30,413,946

 

 

 

30,264,643

 

 

 

30,365,142

 

 

 

23,450,692

 

 

 
(1)

Includes $2,844 and $322 of share-based compensation expense during the three months ended December 31, 2019 and 2018, respectively, and $3,366 and $887 of share-based compensation during the nine months ended December 31, 2019 and 2018.

(2)

Includes $9,685 and $511 of share-based compensation expense during the three months ended December 31, 2019 and 2018, respectively, and $11,431 and $1,741 of share-based compensation during the nine months ended December 31, 2019 and 2018.

Condensed Consolidated Balance Sheets

(unaudited; in thousands)

 

 

 

 

 

 

 

 

 

December 31, 2019

 

 

March 31, 2019

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

131,921

 

 

$

85,353

 

Restricted cash

 

 

243

 

 

 

243

 

Due from Sumitovant Pharma Ltd.

 

 

111

 

 

 

 

Prepaid expenses and other current assets

 

 

10,182

 

 

 

12,914

 

Total current assets

 

 

142,457

 

 

 

98,510

 

Furniture and equipment, net

 

 

1,241

 

 

 

923

 

Operating lease right-of-use assets

 

 

3,219

 

 

 

 

Restricted cash, net of current portion

 

 

623

 

 

 

600

 

Other assets

 

 

11

 

 

 

88

 

Total assets

 

$

147,551

 

 

$

100,121

 

 

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,388

 

 

$

1,925

 

Accrued expenses

 

 

14,701

 

 

 

9,877

 

Due to Roivant Sciences Ltd.

 

 

7

 

 

 

15

 

Interest payable

 

 

343

 

 

 

 

Current portion of long-term debt

 

 

43,760

 

 

 

 

Current portion of operating lease liabilities.

 

 

335

 

 

 

 

Total current liabilities

 

 

61,534

 

 

 

11,817

 

Long-term debt, net of current portion

 

 

87,287

 

 

 

13,534

 

Operating lease liabilities, net of current portion

 

 

3,179

 

 

 

 

Total liabilities

 

 

152,000

 

 

 

25,351

 

Total shareholders’ equity (deficit)

 

 

(4,449

)

 

 

74,770

 

Total liabilities and shareholders’ equity (deficit)

 

$

147,551

 

 

$

100,121

 

 

Investor inquiries:

Ryan Kubota

949.769.2706

[email protected]

Media inquiries:

[email protected]

News

Suncity Group Named Title Sponsor for Local Arts Events

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Fully Supports Macau’s Cultural Industry and the Recovery of Macau

 

MACAU, CHINA – Media OutReach – 20 September 2020 – To revitalize the development of Macau’s cultural industry, Suncity Group fully supports the local arts event, rooting for Macau citizens and local artists through series of astonishing and diversified music entertaining events. ‘Suncity Group Rooting for Macau – SIM! Music Festival 2020’ is the first musical performance of series events title sponsored by Suncity Group, ended perfectly at the Cotai Arena, Venetian Macau on September 19.

[View Image]

Maria Helena de Senna Fernandes, Director of Macau Government Tourist Office, Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd. attended the event 

‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau

[View Image]

Local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival

 

With the purpose of ‘reigniting the local performing arts power’, a group of outstanding local singers, artists, dancers and more than 200 people from the industry were assembled to organise this music festival. A total of 12 units did their utmost to compete in the same stage with singing and dancing. There was no cessation to the excitement and the symphony of applause and cheers in the whole night.

 

The organisers have specially invited Mr. Kevin Ho, Macau Deputy to the National People’s Congress of PRC, Dr. Wilfred Wong, President and Executive Director of Sands China Ltd., Mr. Alvin Chau, Chief Executive Officer and Director of Suncity Group and President of Macau Artistes Association to serve as adjudicators and presenters, witnessing and supporting this diversified music festival that belongs to Macau with the other officiating guests. It shot in the arm of Macau’s cultural industry which has been gradually recovering after the pandemic. After a series of stiff competitions and wonderful performances by the participating units, the ‘Best Styling Award’ went to Walk with Scamper, the ‘Best Teamwork Award’ was awarded to Girls Rock, the ‘Best Positive Energy’ was given to Bacalhau Talkshow & Band, and finally the ‘Best Performance Award’ was awarded to Classic heritage- The Final Trigger by Mr. Alvin Chau.

 

Mr. Chau said, ‘2020 is the year full of difficulties. With the impact of the pandemic, performing arts and cultural industries in mainland China and Macau have been hard hit. Most of the large-scale musical performances have also been suspended. “Suncity Group Rooting for Macau – SIM! Music Festival 2020” as the first music festival of this year, it undoubtedly brings more positive energy to Macau society as well as the cultural industry, pro-actively supporting the development of Macau’s industrial diversification.’

 

As the first extraordinary music feast of series events ended, ‘Suncity Group Rooting for Macau – SIM! Full Band festival 2020’, also title sponsored by Suncity Group, comes immediately thereafter and will be held on September 26. 13 teams of local rock bands will spare no effort to inspire local Macau citizens and awaken their rocking soul. There are also DJ performances, cold beer and snacks at that night, creating a diversified and dynamic rock music festival with hyper performances and mouth-watering delicacies. It once again roots for the recovery of Macau’s economy.

 

As an enterprise rooted in Macau, Suncity Group is committed to the motherland and Macau. With actively fulfilling its social responsibilities, the Group strives to support the recovery of cultural industry in mainland China and Macau as well as the diversified development of Macau in cooperating to national policies and long-term development of China. Through the title sponsorship of the series arts events, Suncity Group hopes to bring more positive energy and get the uptick of confidence to the Macau society.

 

High-resolution images can be downloaded in the gallery:

https://dropbox.suncity-group.com/url/0919sim

About Suncity Group

Suncity Group was founded in 2007. Since establishment, Suncity Group has been striving to provide the extraordinary VIP entertainment service for our guests, and we then opened a number of VIP Clubs in various 6-star hotels and resorts throughout Macau with the rapid growth of our business. Meanwhile, we successively set up exclusive VIP Clubs in Manila, Seoul, Incheon, Phnom Penh and Da Nang, etc.

 

Adhering to the spirit of “Innovating With Diversity, Striving For Success”, Suncity Group spared no effort to develop high-end entertainment services and products as well as roll out global VIP loyalty program for the selected members to enjoy entertainment, travel, catering services, luxury shopping and motion picture. Today, the scope of our business covers most sectors, especially in the fields of global travel, film production, concert and event planning, catering and luxury goods.

 

As a Macau born and bred enterprise, Suncity Group is not only devoted to develop the Asian market, but also oriented to expand the global network. In the future, we will surely continue to diversify our VIP entertainment services, attract more exclusive members and make every effort to promote our business in every corner of the world.

 

Official Website | www.suncitygroup.com.mo/en

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CNOOC Limited Announces Commencement of Production at Liuhua 16-2 Oilfield / 20-2 Oilfield Joint Development Project

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HONG KONG, Sept. 20, 2020 /PRNewswire/ — CNOOC Limited (the "Company", SEHK: 00883, NYSE: CEO, TSX: CNU) announced today that Liuhua 16-2 oilfield/ 20-2 oilfield joint development project has commenced production.

Liuhua 16-2 oilfield / 20-2 oilfield joint development project is located in Eastern South China Sea. The average water depth of the joint development project is approximately 410 meters.  One 150,000 DWT FPSO and three underwater production systems are newly built. A total of 26 development wells are planned to be put into production and development. The project is expected to reach its peak production of approximately 72,800 barrels of crude oil per day in 2022.

CNOOC Limited holds 100% interest of Liuhua 16-2 oilfield/ 20-2 oilfield joint development project.

– End –

Notes to Editors:

More information about the Company is available at http://www.cnoocltd.com.

*** *** *** ***

This press release includes "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements regarding expected future events, business prospectus or financial results. The words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends" and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors the Company believes are appropriate under the circumstances. However, whether actual results and developments will meet the expectations and predictions of the Company depends on a number of risks and uncertainties which could cause the actual results, performance and financial condition to differ materially from the Company’s expectations, including but not limited to those associated with fluctuations in crude oil and natural gas prices, macro-political and economic factors, changes in the tax and fiscal regimes of the host countries in which we operate, the highly competitive nature of the oil and natural gas industry, the exploration and development activities, mergers, acquisitions and divestments activities, environmental responsibility and compliance requirements, foreign operations and cyber system attacks.  For a description of these and other risks and uncertainties, please see the documents the Company files from time to time with the United States Securities and Exchange Commission, including the Annual Report on Form 20-F filed in April of the latest fiscal year.

Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements. The Company cannot assure that the results or developments anticipated will be realised or, even if substantially realised, that they will have the expected effect on the Company, its business or operations.

*** *** *** ***

For further enquiries, please contact:

Ms. Jing Liu
Manager, Media & Public Relations
CNOOC Limited
Tel: +86-10-8452-3404
Fax: +86-10-8452-1441
E-mail: [email protected]

Ms. Ada Leung 
Hill+Knowlton Strategies Asia
Tel: +852-2894-6225
Fax: +852-2576-1990
E-mail: [email protected]

Photo – https://photos.prnasia.com/prnh/20200911/2914374-1LOGO?lang=0

 

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SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Odonate Therapeutics, Inc. of Class Action Lawsuit and Upcoming Deadline – ODT

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NEW YORK, Sept. 19, 2020 — Pomerantz LLP announces that a class action lawsuit has been filed against Odonate Therapeutics, Inc.  (“Odonate” or the “Company”) (NASDAQ: ODT) and certain of its officers.   The class action, filed in United States District Court for the Southern District of California, and docketed under 20-cv-01828, is on behalf of a class consisting of all persons other than Defendants who purchased or otherwise, acquired Odonate securities between December 7, 2017, and August 21, 2020, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are a shareholder who purchased Odonate securities during the class period, you have until November 16, 2020, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. 

[Click here for information about joining the class action]

Odonate was founded in 2013 and is based in San Diego, California.  Odonate is a pharmaceutical company that develops therapeutics for the treatment of cancer.  The Company is focused on developing tesetaxel, an orally administered chemotherapy agent. 

Tesetaxel is in Phase 3 clinical study for patients with locally advanced or metastatic breast cancer (“MBC”), called the CONTESSA trial, which is evaluating tesetaxel in combination with capecitabine in patients with MBC.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational, and compliance policies.  Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) tesetaxel was not as safe or well-tolerated as the Company had led investors to believe; (ii) consequently, tesetaxel’s commercial viability as a cancer treatment was overstated; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

On August 24, 2020, during pre-market hours, Odonate issued a press release announcing top-line results from the CONTESSA trial.  Although the study met its primary endpoint, tesetaxel plus capecitabine was associated with Grade 3 or higher neutropenia (low levels of white blood cells), which occurred in 71.2% of patients with the combination treatment versus 8.3% for capecitabine alone.  Various other Grade 3 or higher treatment-emergent adverse events (“AEs”) were also associated with tesetaxel plus capecitabine versus capecitabine alone.  Further, discontinuation rates were 4.2% from neutropenia and 3.6% from neuropathy, and the overall discontinuation rate was 23.1% in the treatment group compared to 11.9% in the capecitabine alone group.

On this news, Odonate’s stock price fell $15.21 per share, or 45.35%, to close at $18.33 per share on August 24, 2020.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.

CONTACT: Robert S. Willoughby Pomerantz LLP [email protected]

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