AZN's POSEIDON Has Poise, MRTX On The Move, MOR Drops Atopic Dermatitis Trial

(RTTNews) - Today's Daily Dose brings you news about Mirati's phase I/II trial results of MRTX849 in patients with solid tumors; MorphoSys' decision to discontinue the clinical development program of MOR106 in atopic dermatitis. Medpace's Q3 results; Orthofix Medical trimming its 2019 outlook; AstraZeneca's POSEIDON trial results; and Omeros' update on Narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

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AstraZeneca plc's (AZN) phase III trial evaluating IMFINZI, tremelimumab, and chemotherapy vs. chemotherapy alone in the 1st-line treatment of patients with metastatic Stage IV non-small cell lung cancer patients, dubbed POSEIDON, has met the primary endpoint by showing a statistically significant and clinically meaningful improvement in the final progression-free survival.

IMFINZI received FDA approval in the curative-intent setting of unresectable, Stage III non-small cell lung cancer that has not progressed after chemoradiation therapy in February 2018. The drug received its initial approval in 2017 for the treatment of patients with metastatic urothelial carcinoma.

The sales of IMFINZI in the first half of 2019 were $633 million, representing growth of 244%.

AZN closed Monday's trading at $47.75, up 0.17%.

Dassault Systèmes has completed the acquisition of Medidata Solutions Inc., whose clinical expertise and cloud-based solutions power the smarter development and commercialization of treatments.

All of the issued and outstanding common shares of Medidata were acquired by Dassault for $92.25 per share in cash, representing a total enterprise value of approximately $5.8 billion.

Medpace Holdings Inc. (MEDP), a clinical contract research organization, has reported improved earnings and revenue for the third quarter ended September 30, 2019.

On an adjusted basis, non-GAAP net income for the third quarter of 2019 was $26.96 million, or $0.71 per share, compared to $24.96 million or $0.67 per share for the third quarter of 2018. Revenue for the recent third quarter increased 20.6% to $216.2 million from $179.3 million for the comparable prior-year period.

Looking ahead to full-year 2019, adjusted net income is forecasted in the range of $107.2 million to $112.0 million, compared to an adjusted net income of $95.5 million for 2018. Furthermore, Adjusted Net Income per share for 2019 is expected in the range of $2.85 to $2.97 per share.

Revenue for 2019 is expected to be in the range of $840.0 million to $860.0 million, representing growth of 19.2% to 22.1% over 2018 revenue of $704.6 million.

MEDP closed Monday's trading at $77.01, up 2.18%.

Shares of Mirati Therapeutics Inc. (MRTX) were up over 14% in after-hours on Monday, following the release of the first clinical results from its phase I/II trial evaluating MRTX849, an investigational KRAS G12C inhibitor, in patients with solid tumors expressing KRAS G12C mutations.

The ongoing phase I/II trial of MRTX849 has enrolled 17 patients, including 10 patients with non-small cell lung cancer, 4 patients with colorectal cancer, and 3 patients with other tumor types. Five dose cohorts have been evaluated: 150 mg, 300 mg, 600 mg, and 1200 mg, taken orally once daily, and 600 mg, taken orally twice daily.

The data released on Monday covered 12 patients across all dose levels, and according to the Company, MRTX849 demonstrated clinical activity, including objective responses, in patients with non-small cell lung cancer and colorectal cancer.

MRTX closed Monday's trading at $81.47, up 0.78%. In after-hours, the stock was up 14.15% to $93.00.

MorphoSys AG (MOR), Galapagos NV (GLPG) and Novartis (NVS) have decided to discontinue the clinical development program of MOR106 in atopic dermatitis.

The clinical development program of MOR106 in atopic dermatitis included two Phase 2 studies IGUANA and GECKO, as well as a Phase 1 bridging study for subcutaneous formulation and a Japanese ethno-bridging study. All studies in atopic dermatitis will be ended.

The decision to end the atopic dermatitis program was based on an interim analysis for futility that was performed in the Phase 2 IGUANA trial. The analysis detected a low probability to meet the primary endpoint of the study, defined as the percentage change in the eczema area and severity index (EASI) score. The decision was based on a lack of efficacy and not on safety concerns.

MOR106 was jointly discovered by Galapagos and MorphoSys. In July 2018, Galapagos and MorphoSys entered into an exclusive worldwide development and commercialization collaboration with Novartis with respect to MOR106.

MOR closed Monday's trading at $26.91, down 4.27%.

Omeros Corporation (OMER) has submitted the first sections of the rolling submission of its Biologics License Application to the FDA for Narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

Hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA, is a far-too-often deadly complication of stem-cell transplantation. There currently is no approved product for the treatment or prevention of HSCT-TMA, and Narsoplimab is the only drug in development for the treatment of HSCT-TMA with FDA's breakthrough therapy designation.

OMER closed Monday's trading at $16.91, up 6.15%.

Orthofix Medical Inc. (OFIX) has lowered its top line and bottom line outlook for the year ending December 31, 2019, while reporting a wider net loss and 1.6% increase in sales for the third quarter of 2019.

Net loss for the third quarter of 2019 widened to $40.5 million or $2.14 per share from $1.2 million or $0.07 per share in the prior year period. Adjusted net income from continuing operations was $7.9 million, or $0.41 per share, compared to adjusted net income of $8.3 million, or $0.44 per share in the prior year period.

Net sales for the third quarter of 2019 were $113.5 million compared to $111.7 million in the third quarter of 2018.

Looking ahead to the full year 2019, the Company has trimmed its adjusted EPS outlook to $1.55 to $1.60 per share from its prior forecast range of $1.75 to $1.82. Net sales for the year are now expected to range between $460 and $463 million, down from the earlier guidance of $472 to $477 million.

OFIX closed Monday's trading at $49.02, down 1.96%.