Posts tagged ARIAD
ARIAD completes NDA submission for brigatinib

ARIAD Pharmaceuticals (NASDAQ:ARIA) has completed a rolling NDA submission to the FDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.

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WB ups ARIAD price target to $12

William Blair has raised it price target for ARIAD Pharmaceuticals (NASDAQ:ARIA) to $12 from $10 after an analyst day on Friday where the company discussed the outcome of its strategic review. The stock was quoted at $7.59 on Monday afternoon.

The strategic review included ARIAD’s commitment to financial discipline and its refined focus on rare cancers with precision medicines in Iclusig, brigatinib, and AP32788, as well as discovery work on a suite of oral agents in immuno-oncology.

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ARIAD reports long-term safety, efficacy data for Iclusig

ARIAD Pharmaceuticals (NASDAQ:ARIA) has reported long-term follow-up data from its pivotal Phase 2 PACE clinical trial of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

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ARIAD reports updated data in pivotal ALTA study

ARIAD Pharmaceuticals (NASDAQ:ARIA) has reported updated clinical data for brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, from the pivotal ALTA trial in patients who had experienced disease progression on crizotinib therapy.

The data show that, of patients on the 180 mg regimen (Arm B) with a median follow-up of 8.3 months, 54% achieved a confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival exceeded one year (12.9 months) in this post-crizotinib setting.

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ARIAD Pharma initiates Phase 1/2 trial in NSCLC

ARIAD Pharmaceuticals (NASDAQ:ARIA) has initiated a Phase 1/2 clinical trial of AP32788, an investigational tyrosine kinase inhibitor (TKI) designed as a targeted therapy for patients with non-small cell lung cancer (NSCLC) with specific mutations in EGFR or HER2.

AP32788 targets tumors driven by EGFR or HER2 kinases and was designed to achieve selective inhibition of these kinases with exon 20 mutations. There are currently no approved targeted treatment options available for the approximately 4% to 9% of EGFR-mutated lung tumors with exon 20 insertion mutations in NSCLC patients.

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Incyte to acquire ARIAD’s EU operations, in-license Iclusig

Incyte (NASDAQ:INCY) has agreed to acquire ARIAD Pharmaceuticals’ (NASDAQ:ARIA) European operations. At the expected June 1 closing of the transaction, Incyte will obtain an exclusive license to develop and commercialize Iclusig in Europe and other select countries.

The agreement to divest its European operations and out-license Iclusig in Europe will enable ARIAD to focus its promotion of Iclusig on the highly valuable U.S. market, while strengthening its financial position and maintaining important optionality through a potential buy-back provision for the Iclusig license rights in the event of a change-in-control of ARIAD.

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