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AstraZeneca's NEPTUNE Fails, Xtandi Gets Priority Review, SENS Makes Sense

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Today's Daily Dose brings you news about AstraZeneca's Imfinzi setback; Astellas Pharma's upcoming regulatory catalyst; Cresco Labs' better-than-expected revenue and real-world data of Senseonics' using Eversense CGM.

Read on…

AstraZeneca PLC (AZN) has announced disappointing results from its phase III trial evaluating Imfinzi in combination with Tremelimumab against standard-of-care platinum-based chemotherapy in patients with previously untreated stage IV non-small cell lung cancer.

Imfinzi is approved for the treatment of patients with metastatic urothelial carcinoma and for the treatment of patients with unresectable non-small cell lung cancer that has not progressed after chemoradiation. Tremelimumab is an investigational drug that is being tested in a clinical trial programmed in combination with Imfinzi in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.

In the trial, dubbed NEPTUNE, the combination of Imfinzi and Tremelimumab did not meet the primary endpoint of improving overall survival compared to the standard-of-care chemotherapy.

NEPTUNE is the second late-stage trial of Imfinzi to disappoint in the first-line treatment of non-small cell lung cancer.

In July 2017, the Company's MYSTIC study, a phase III trial evaluating Imfinzi both as monotherapy and in combination with Tremelimumab in patients with previously untreated metastatic (Stage IV) first-line non-small-cell lung cancer failed to meet an initial primary progression-free survival (PFS) endpoint.

The other ongoing Imfinzi trials are:

-- PEARL - a phase III study testing Imfinzi as a monotherapy compared to standard-of-care chemotherapy in Stage IV, first-line non-small cell lung cancer.
-- POSEIDON - a phase III study testing Imfinzi in combination with chemotherapy with or without Tremelimumab compared to standard-of-care chemotherapy in Stage IV, first-line non-small cell lung cancer.

AZN closed Wednesday's trading at $45.42, up 1.79%.

Astellas Pharma Inc.'s (ALPMY.OB) supplemental New Drug Application for XTANDI to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer has been accepted by the FDA and granted priority review.

A decision on the application is expected in the fourth quarter of 2019.

XTANDI was approved in August 2012 to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

Last July, the FDA broadened the indication of the blockbuster drug XTANDI to men with non-metastatic castration-resistant prostate cancer.

XTANDI is jointly developed and manufactured by Medivation, now a part of Pfizer, and Astellas Pharma.

ALMPY.OB closed Wednesday's trading at $13.77, up 1.81%.

Cresco Labs Inc. (CRLBF.OB) (CL.CN), one of the largest vertically integrated multistate cannabis operators in the United States, has reported better-than-expected revenue for the second quarter ended June 30, 2019.

The revenue for the second quarter of 2019, was $29.9 million, an increase of 253% compared to revenue of $8.5 million for the second quarter of 2018. Analysts polled by Thomson Reuters were expecting revenue of $27.91 million.

The Company incurred a net loss of $3.9 million in the recent second quarter, compared to net income of $1.6 million in the prior-year period.

CRLBF.OB closed Wednesday's trading at $8.35, down 0.54%.

Senseonics Holdings Inc. (SENS) has published the real-world data from the first 205 U.S. patients using Eversense CGM in Diabetes Technology and Therapeutics, a peer-reviewed journal.

Eversense CGM is a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, developed and marketed by the Company.

According to the published data, the Eversense CGM System showed strong performance and safety over a 90-day sensor wear period, especially in the low glucose ranges.
In the second quarter of 2019, the Company's revenue was $4.6 million compared to $3.6 million for the second quarter of 2018. Looking ahead, the revenue for the full year 2019 is expected to be in the range of $25 to $30 million. Revenue for full-year 2018 was $18.9 million.

SENS closed Wednesday's trading at $1.08, up 2.86%. In after-hours, the stock was up 2.78% to $1.11.

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