On August 1, 2019 Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo(nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma (Press release, Bristol-Myers Squibb, AUG 1, 2019, View Source [SID1234538005]). The Breakthrough Therapy Designation is based on clinical data which were recently reported at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase 1/2 clinical study.

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FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint.

Bempegaldesleukin, Nektar’s lead immuno-oncology candidate, is an investigational CD122-preferential IL-2 pathway agonist designed to provide activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells. A Phase 3 clinical trial evaluating bempegaldesleukin in combination with nivolumab versus nivolumab in first-line advanced melanoma patients is currently recruiting patients (NCT03635983).

"In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients," said Dr. Stephen Doberstein, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics. "Our teams are encouraged by the deepening of responses we observed in patients with previously untreated advanced melanoma who received the doublet therapy in our PIVOT-02 study. We look forward to continuing to provide updated results at a future medical meeting as the data mature further in this ongoing cohort of melanoma patients."

In February 2018, Bristol-Myers Squibb and Nektar executed a global strategic development and commercialization collaboration for bempegaldesleukin.

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3

On August 1, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on commercializing novel tetracyclines to treat serious and life-threatening conditions, reported that company management will host a conference call at 4:30 p.m. ET on Thursday, August 8, 2019 to discuss the Company’s second quarter 2019 financial results and provide a general corporate update (Press release, Tetraphase, AUG 1, 2019, View Source [SID1234538021]).

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The conference call may be accessed by dialing 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 2336585. A live audio webcast of the conference call will be available online from the "Investors – Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, August 8, 2019, through 7:30 p.m. ET on Thursday, August 15, 2019 by dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 2336585. A replay of the webcast will be available by visiting Tetraphase’s website.

On August 1, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported its operating and financial results for the three months ended June 30, 2019, as well as provide guidance on expected revenues and operating expenses for the third quarter 2019, after the close of the U.S. financial markets on Wednesday, August 7, 2019 (Press release, Opko Health, AUG 1, 2019, View Source [SID1234538037]).

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OPKO’s senior management will provide a business update and discuss its financial results in a live conference call and audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, August 7, 2019.

CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time on Wednesday, August 7, 2019. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 7984069
WEBCAST: OPKO 2Q19 Results Conference Call
For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 7984069. The replay can be accessed for a period of time on OPKO’s website at OPKO 2Q19 Results Conference Call.

About OPKO Health, Inc.
OPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is the nation’s third largest clinical laboratory

On August 1, 2019 DaVita Inc. (NYSE: DVA) reported results for the quarter ended June 30, 2019 (Press release, DaVita, AUG 1, 2019, View Source [SID1234538053]).

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Second quarter 2019 financial highlights:

Completed the sale of our DMG division to Optum.
Consolidated revenues of $2,843 million.
Operating income of $462 million.
Cash flows from continuing operations of $574 million.

DaVita Medical Group sale: As previously disclosed, on June 19, 2019, we completed the sale of our DaVita Medical Group (DMG) division to Collaborative Care Holdings, LLC (Optum), a subsidiary of UnitedHealth Group Inc., for an aggregate purchase price of $4.34 billion, prior to certain adjustments specified in the related purchase agreement, as amended. We recorded a preliminary pre-tax net loss of approximately $23 million related to this divestiture.

Upon the completion of the DMG sale we were required to make mandatory prepayments on debt outstanding under our senior secured credit facility, and we subsequently used the full $4.47 billion in preliminary net proceeds received at closing to prepay term debt outstanding. As a result of these prepayments we recognized a charge of $12 million to write off debt discount and deferred financing costs.

Volume: Total U.S. dialysis treatments for the second quarter of 2019 were 7,520,587, or an average of 96,418 treatments per day, representing a per day increase of 2.6% over the second quarter of 2018. Normalized non-acquired treatment growth in the second quarter of 2019 as compared to the second quarter of 2018 was 2.1%.

Effective income tax rate: Our effective income tax rate on income from continuing operations was 23.5% and 24.6% for the three and six months ended June 30, 2019, respectively. This effective income tax rate is impacted by the amount of third party owners’ income attributable to non-tax paying entities. The effective income tax rate on income from continuing operations attributable to DaVita Inc. was 28.0% and 29.6% for the three and six months ended June 30, 2019, respectively.

Our effective income tax rate on income from continuing operations attributable to DaVita Inc. for the three and six months ended June 30, 2019 was further impacted by the write-off of deferred financing costs and other debt costs and the six months ended June 30, 2019 was also impacted by the goodwill impairment charge recognized in the first quarter of 2019. Excluding these items from the three and six months ended June 30, 2019, our effective income tax rate on adjusted income from continuing operations attributable to DaVita Inc. would have been 27.9% and 28.9% for the three and six months ended June 30, 2019, respectively.

Center activity: As of June 30, 2019, we provided dialysis services to a total of approximately 231,700 patients at 2,971 outpatient dialysis centers, of which 2,723 centers were located in the United States and 248 centers were located in nine countries outside of the United States. During the second quarter of 2019, we opened a total of 33 new dialysis centers, acquired three dialysis centers and closed two dialysis centers in the United States. In addition, we acquired five dialysis centers outside of the United States during the second quarter of 2019.

Share repurchases: During the quarter ended June 30, 2019, we repurchased a total of 2,059,976 shares of our common stock for approximately $112 million at an average price of $54.46 per share. We have also repurchased 4,214,205 shares of our common stock for $238 million at an average price of $56.43 per share from July 1, 2019 through July 17, 2019. On July 17, 2019, our Board of Directors terminated all remaining prior share repurchase authorizations available to the Company and approved a new share repurchase authorization in the amount of $2.0 billion.

On July 22, 2019, we commenced a modified "Dutch auction" tender offer for up to $1.2 billion of our common stock at a price per share not less than $53.50 and not more than $61.50. The tender offer will expire at 12:00 midnight Eastern time at the end of the day on August 16, 2019, unless extended or terminated. The tender offer is contingent on successful execution of the bank financing described below on terms reasonably acceptable to the Company.

Debt Transactions: As previously announced, we plan to enter into a new bank financing consisting of a $1.0 billion secured revolving loan facility, a $1.75 billion secured term loan A facility with a delayed draw feature and a $2.5 billion secured term loan B facility. We expect to use the proceeds from the bank financing to pay off the remaining balances outstanding under our Term Loan B and revolving line of credit under our existing senior secured credit facility, to call the Company’s outstanding 5.75% Senior Notes due 2022 (Senior Notes), to fund the tender offer described above, and to add cash to the balance sheet for potential future share repurchases, acquisitions, and other general corporate purposes. This press release does not constitute a call notice. The Company expects the call notice for the Senior Notes to be issued following completion of the bank financing.

As of July 31, 2019, $502 million and $650 million remained outstanding on our Term Loan B and revolving line of credit, respectively, under our existing senior secured credit facility.

Outlook:

As previously announced on July 22, 2019, the Company updated its adjusted operating income (a non-GAAP financial measure) guidance for fiscal year 2019 to a range of $1.64 billion to $1.70 billion. The Company’s prior guidance at the time for adjusted operating income for fiscal year 2019 was $1.54 billion to $1.64 billion.

On August 1, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported that Xynomic has received approval from China’s National Medical Products Administration ("NMPA") to start two pivotal clinical trials in China (Press release, Xynomic Pharmaceuticals, AUG 1, 2019, View Source [SID1234537980]). In these two trials, Xynomic will test its lead drug candidate abexinostat (as a single agent) as a third-line treatment of diffuse large B-cell lymphoma ("DLBCL") and as a third-line treatment of follicular lymphoma ("FL"), respectively.

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According to China’s National Cancer Center and China’s National Health Commission, DLBCL is the most common aggressive non-Hodgkin’s lymphoma (NHL) subtype with an estimated 50,000 new cases per year in China and FL is the most common indolent NHL subtype with an estimated 10,000 new cases per year in China. DLBCL and FL combined represent approximately 45-60% of China’s NHL market.

According to China’s Center for Drug Evaluation’s database, Xynomic’s abexinostat is the only drug candidate currently under clinical development as third-line treatment of DLBCL in China. Xynomic plans to complete patient enrollment for these two trials in 12 months or sooner. These trials will be conducted in about 24 leading hematological cancer hospitals across China.

"We are truly excited to receive the approval from NMPA of China, world’s second largest market for oncology drugs. Currently in China there are virtually no approved treatment options for DLBCL and FL patients once the patients’ disease progress after R-CHOP treatment. Our abexinostat has demonstrated both safety and efficacy in these settings in prior Phase 1/2 trials. We look forward to completing these trials expeditiously and have also started preparation for commercial launch," said Y. Mark Xu, Xynomic’s Chairman and CEO.