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BMY To Explore Stivarga/Opdivo Combo, MYOK Ahead Of Timeline, UNH On Watch

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Today's Daily Dose brings you news about UnitedHealth's rosy outlook; MyoKardia's upcoming milestone in 2020; Atara's public offering, and collaboration between Bayer, Bristol-Myers Squibb (BMY) and Ono Pharmaceutical.

Read on…

Atara Biotherapeutics Inc. (ATRA) has priced an underwritten public offering of 6.87 million shares of its common stock at a price to the public of $15.28 each.

The aggregate gross proceeds from the offering are expected to be approximately $150.0 million. The offering is expected to close on or about July 23, 2019, subject to customary closing.

Clinical Trials & Near-term Catalyst:

The Company's most advanced compound is Tab-cel, a potential treatment for patients with Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV+PTLD), as well as other EBV associated hematologic and solid tumors.

-- A phase III study of Tab-cel for the treatment of EBV+PTLD following allogeneic hematopoietic cell transplant (HCT) after failure of rituximab, dubbed MATCH study, is underway.
-- Another phase III trial of Tab-cel for the treatment of EBV+PTLD following solid organ transplant (SOT) after failure of rituximab or rituximab and chemotherapy, dubbed ALLELE study, is also ongoing.

The two ongoing MATCH and ALLELE studies have been combined into a single study, dubbed ALLELE.

The Company plans to initiate a Tab-cel biologics license application submission for patients with EBV+ PTLD in the second half of 2020.

Atara plans to conduct an interim analysis prior to initiating the BLA submission. To ensure the integrity of the ongoing, open-label tab-cel studies, Atara does not expect to disclose interim top-line EBV+ PTLD results until after acceptance of the FDA BLA filing.

ATRA closed Thursday's trading at $15.28, up 1.80%.

Bayer, Bristol-Myers Squibb (BMY) and Ono Pharmaceutical Co. Ltd. have entered into a clinical collaboration agreement to investigate Stivarga and Opdivo as combination therapy in patients with micro-satellite stable metastatic colorectal cancer, the most common form of metastatic colorectal cancer.

Stivarga, developed by Bayer, is approved to treat colorectal cancer, gastrointestinal stromal tumors that are no longer responding to previous treatments, and for liver cancer. Opdivo from the stable of Bristol-Myers Squibb is approved for the treatment of advanced melanoma, advanced non-small cell lung cancer, advanced small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H or dMMR metastatic colorectal cancer, and hepatocellular carcinoma.

BMY closed Thursday's trading at $44.05, down 0.18%.

Horizon Therapeutics plc's (HZNP) New Drug Application for PROCYSBI Delayed-Release Oral Granules in Packets has been accepted for review by the FDA - with a decision anticipated in 2020.

PROCYSBI, which is currently available as delayed-release capsules, is FDA-approved for children one year of age and older and adults living with nephropathic cystinosis.

Nephropathic cystinosis is a rare, life-threatening metabolic lysosomal storage disorder that causes toxic accumulation of cystine in all cells, tissues, and organs in the body. If untreated, elevated cystine accumulation leads to progressive, irreversible tissue damage and multi-organ failure, including kidney failure, blindness, muscle wasting and premature death.

If approved by the FDA, the new dosage form of PROCYSBI would provide another option for patients.

HZNP closed Thursday's trading at $24.63, up 1.40%.

MyoKardia Inc. (MYOK) now anticipates reporting topline data from its EXPLORER-HCM trial in the second quarter of 2020, ahead of previous guidance of the second half of 2020.

EXPLORER-HCM is a phase III trial evaluating Mavacamten in treating patients with obstructive hypertrophic cardiomyopathy (oHCM). Enrollment in the pivotal trial is expected to be completed by mid-August.

A near-term catalyst to watch out for is the topline data from the MAVERICK-HCM study, which is expected to be reported in the fourth quarter of 2019.

MAVERICK-HCM is a phase II trial designed to assess the safety and tolerability of a 16-week treatment course of Mavacamten in patients with non-obstructive Hypertrophic Cardiomyopathy.

MYOK closed Thursday's trading at $53.55, up 7.49%.

Privately held Pear Therapeutics has made a filing with the FDA seeking marketing authorization for Somryst, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression.

Somryst is designed to provide tailored neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction driven by learning algorithms to reduce the severity of insomnia and symptoms of depression.

UnitedHealth Group (UNH), which has reported strong second-quarter 2019 results, has also increased its full-year earnings outlook again.

The Company's net earnings attributable to common shareholders in the second quarter of 2019 were $3.29 million or $3.42 per share up from $2.92 million or $2.98 per share in the year-ago quarter. On an adjusted basis, net earnings per share attributable to common shareholders were $3.60 in Q2, 2019 Vs $3.14 in Q2, 2018.

The second quarter of 2019 revenues grew to $60.6 billion from $56.08 billion in the year-ago period.

Looking ahead, the Company has increased its full-year net earnings outlook range to $13.95 to $14.15 per share, and adjusted net earnings forecast range to $14.70 to $14.90 per share. Previously, the Company had forecast net earnings outlook to range between $13.80 and $14.05 per share and adjusted net EPS in the range of $14.50 to $14.75.

UNH closed Thursday's trading at $260.60, down 2.27%.

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