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FDA Thumbs-Down Makes EOLS Frown, IMMU Up On Breast Cancer Data, MGEN On Watch

pharma daily 051618 lt

Today's Daily Dose brings you news about Agios Pharma's upcoming catalysts; Evolus' disappointment over FDA rejection of DWP-450 for treatment of moderate to-severe glabellar lines; promising data of Immunomedics' investigational Sacituzumab govitecan in heavily pre-treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC), and Insmed's regulatory catalyst in May.

Read on…

Agios Pharmaceuticals Inc. (AGIO) has a couple of catalysts coming its way next month.

The updated data from Phase 1 expansion trial of Ivosidenib in mutant IDH1 Relapsed/Refractory AML, and the first data from a phase I study of AG-881 in IDH-mutant glioma are scheduled for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 1-5, 2018 in Chicago.

AGIO closed Wednesday's trading at $86.20, up 0.89%.

Endocyte Inc. (ECYT) will be presenting updated data from the phase II study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC), including data from an additional 20 patient expansion cohort, at the 2018 ASCO Annual Meeting on Saturday, June 2, 2018.

The Company recently reported median overall survival of 13.5 months for the first cohort of 30 patients enrolled.

According to the Company, in the 50 patients receiving 177Lu-PSMA-617, 62% had a greater than 50% reduction in their PSA levels. Further, 44% of patients had a PSA reduction of 80% or greater.

The PSA response rates in additional 20 mCRPC patients enrolled at Peter MacCallum Cancer Centre are higher than previously reported for first group of 30 patients, noted the Company.

ECYT closed Wednesday's trading at $12.56, up 3.72%.

Shares of Evolus Inc. (EOLS) slumped 26% on Wednesday, following the FDA's decision to reject the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters.

Evolus expects to respond with a complete submission to FDA within 90 days.

The good news is that the FDA has issued a favorable Establishment Inspection Report ("EIR") to Daewoong Pharmaceutical Co. Ltd., confirming the favorable completion of its pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

Last November, the FDA had issued an FDA Form 483 with ten inspectional observations to Daewoong to take corrective actions.

EOLS closed Wednesday's trading at $10.70, down 26.96%. In after-hours, the stock was up 1.87% to $10.90.

You can read more about EOLS in our "In the Spotlight" column.

Shares of Immunomedics Inc. (IMMU) are up over 4% in extended trading on Wednesday, after the Company announced that Sacituzumab govitecan, its lead investigational ADC, induced promising objective responses as a single agent in heavily pre-treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).

Sacituzumab govitecan generated a confirmed overall response rate (ORR) of 31 percent in heavily pre-treated ER+/HER2- metastatic breast cancer patients, based on local assessment. The six-month clinical benefit rate was 48 percent.

"For women with HR+ metastatic breast cancer relapsing after endocrine treatment, there are currently limited treatment options. I am very encouraged with the results of sacituzumab govitecan in this subgroup of patients with metastatic breast cancer, "said Aditya Bardia, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA.

IMMU closed Wednesday's trading at $19.51, up 3.89%.

Insmed Inc.'s (INSM) New Drug Application for ALIS (Amikacin Liposome Inhalation Suspension) for adult patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex (MAC) has been considered for priority review by the FDA.

The regulatory agency's decision on ALIS is expected on September 28, 2018.

Before the final decision, an advisory committee meeting could be convened by the FDA to discuss the NDA for ALIS.

INSM closed Wednesday's trading at $27.89, up 2.54%.

miRagen Therapeutics Inc. (MGEN) will be presenting new interim data from its ongoing Phase 1 clinical trial of cobomarsen (also known as MRG-106) in patients with the mycosis fungoides form of cutaneous T-cell lymphoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2018.

The Company plans to initiate a phase II clinical trial for Cobomarsen in patients with cutaneous T-cell lymphoma in the second half of 2018.

MGEN closed Wednesday's trading at $7.51, up 0.13%.

Nektar Therapeutics (NKTR) will be presenting preliminary clinical data from the ongoing PIVOT Phase 1/2 study on June 2, 2018.

The Phase 1/2 PIVOT clinical trials, known as PIVOT-02 and PIVOT-04, are evaluating the potential for the combination of NKTR-214 and Opdivo to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, triple-negative breast cancer, bladder and non-small cell lung cancer patients.

NKTR closed Wednesday's trading at $85.80, up 2.88%.

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