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Odonate On The Move With CONTESSA, FDA Snubs CLSD, It's A Yes For AZN, VRTX

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Today's Daily Dose brings you news about Seattle Genetics' pivotal breast cancer trial results; early FDA approval of Vertex Pharma's cystic fibrosis drug; Clearside Biomedical confirming the rejection of XIPERE; double whammy of Aradigm; HealthStream's third-quarter financial results; an update on Odonate Therapeutics' phase III breast cancer trial and label expansion of AstraZeneca's oral diabetes medicine FARXIGA.

Read on...

Shares of Aerpio Pharmaceuticals Inc. (ARPO) jumped nearly 15% on Monday, following the Company's exploration of strategic alternatives and its plan to streamline operations in order to preserve its capital and cash resources.

The Board is exploring the potential for an acquisition, company sale, merger, business combination, asset sale, in-license, out-license or other strategic transaction, the Company noted.

As part of streamlining the operations, Aerpio revealed that the management team will be led by Joseph Gardner, the Company's current President with Gina Marek, the company's Vice President of Finance, continuing in her position. Stephen Hoffman, and Michael Rogers, the company's Chief Executive Officer, and Chief Financial Officer, respectively, have transitioned from their roles, and Hoffman has resigned from his position on the Board, the Company added.

ARPO closed Monday's trading at $0.53, up 14.74%.

The European Medicines Agency's Committee for Medicinal Products for Human Use is expected to issue a negative opinion for Aradigm Corp.'s (ARDM.OB) marketing authorization application for Linhaliq as a treatment for non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

Linhaliq was also turned down by the FDA in January 2018.

In February of this year, Aradigm filed a petition for bankruptcy protection under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Northern District of California.

The FDA has expanded the label of AstraZeneca's (AZN) FARXIGA to reduce the risk of hospitalization for heart failure (hHF) in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

FARXIGA received its initial approval in January 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The drug recorded annual sales of $1.39 billion in 2018, up 30% over 2017.

AZN closed Monday's trading at $43.72, down 0.34%.

Clearside Biomedical Inc. (CLSD), in a SEC filing, has confirmed that its New Drug Application for XIPERE for the treatment of macular edema associated with uveitis has been turned down by the FDA.

Xipere is a proprietary suprachoroidal injectable suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye using a specially-designed SCS microinjector.

The FDA has requested additional stability data and reinspection of the drug product manufacturer, and additional data on the clinical use of the final to-be-marketed SCS Microinjector delivery system.

The writing was already on the wall for XIPERE because on August 22, 2019, the FDA's Office of Pharmaceutical Quality (OPQ) requested that Clearside provide stability data for the triamcinolone acetonide (TA) suspension produced utilizing an enhanced manufacturing process implemented by the Company.

The Company currently believes that the recommendations cited in the CRL can be addressed in a timely manner that will enable the Company to resubmit the NDA in the first quarter of 2020.

CLSD closed Monday's trading at $0.81, down 0.16%.

HealthStream Inc. (HSTM) has reported improved earnings and revenue for the third quarter ended September 30, 2019, in addition to updating its revenue outlook for the year.

Income from continuing operations for the third quarter of 2019 was $3.5 million or $0.11 per share on revenue of $62.5 million. This compared with income from continuing operations of $3.04 million or $0.09 per share and revenue of $59.9 million in the third quarter of 2018.

Looking ahead to full-year 2019, the Company now expects revenue to be in the range of $252 million to $256 million compared to its previous forecast range of $251 million to $258 million. Revenue in 2018 was $231.6 million.

HSTM closed Monday's trading at $26.35, up 0.73%.

Odonate Therapeutics Inc. (ODT), a pharmaceutical company developing drugs that improve and extend the lives of patients with cancer, has completed enrollment in CONTESSA, a multinational, multicenter, randomized, phase III study evaluating its drug candidate Tesetaxel as a potential treatment for patients with HER2 negative, hormone receptor-positive metastatic breast cancer.

The Company expects to report top-line results from CONTESSA in the third quarter of 2020.

ODT closed Monday's trading at $28.95, up 7.42%. During its heydays, the stock was trading as high as $43.

Shares of Seattle Genetics Inc. (SGEN) closed at an all-time high of $100.89 on Monday, following positive topline results from the HER2CLIMB trial.

HER2CLIMB is a pivotal trial evaluating the Company's investigational drug Tucatinib in combination with approved chemotherapy drugs Herceptin and Xeloda against Herceptin and Xeloda alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

The trial met the primary endpoint of progression-free survival, showing that the addition of Tucatinib to the regimen of Herceptin and Xeloda demonstrated a 46 percent reduction in the risk of disease progression or death.

The Tucatinib arm demonstrated an improvement in overall survival, with a 34 percent reduction in the risk of death compared to Herceptin and Xeloda alone. For patients with brain metastases at baseline, the Tucatinib arm also demonstrated superior progression-free survival, with a 52 percent reduction in the risk of disease progression or death compared to those who received Herceptin and Xeloda alone.

The Company is planning to submit the Tucatinib New Drug Application to the FDA in the first quarter of 2020.

SGEN touched a high of $102.84 in intraday trading on Monday, before closing the day's trading at $100.89.

The FDA has approved Vertex Pharmaceuticals Inc.'s (VRTX) Trikafta for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population. The approval comes well ahead of the decision date of March 19, 2020.

Trikafta, which is a combination of elexacaftor/ivacaftor/tezacaftor, is the first triple combination therapy to be approved for patients with the most common cystic fibrosis mutation.

The triple therapy to treat cystic fibrosis also under review by the European Medicines Agency.

VRTX closed Monday's trading at $183.98, up 4.40%.

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