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GILD's KTE-X19 To Face FDA, NTEC Drops As NVS Walks Away, KZIA On Watch

pharma062917 11dec19 lt

Today's Daily Dose brings you news about Puma Biotech's SUMMIT basket trial results; TransEnterix' reverse stock split; Seattle Genetics' pivotal HER2CLIMB study and the latest update on Intec/Novartis deal.

Read on…

Kite, a Gilead Co. (GILD), has submitted a Biologics License Application to the FDA for KTE-X19, an investigational chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The Company plans to submit a Marketing Authorization Application for KTE-X19 in the European Union in early 2020. This product candidate is designated a Breakthrough Therapy by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory mantle cell lymphoma.

GILD closed Wednesday's trading at $67.78, up 1.04%.

Shares of Intec Pharma Ltd. (NTEC) declined 11% on Wednesday, following the termination of the Feasibility and Option agreement with Novartis (NVS) for the development of a custom-designed Accordion Pill (AP) for a proprietary Novartis compound.

Despite the Accordion Pill having met the technical and pharmacokinetic (PK) clinical specifications set forth by Novartis, the agreement has been terminated as the program no longer meets Novartis' mid to long-term strategic goals.

NTEC closed Wednesday's trading at $0.52, down 11.30%.

Kazia Therapeutics Ltd.'s (KZIA) lead program, GDC-0084, has been selected to join GBM AGILE, an international, academic-led, multi-drug adaptive phase II / III study in glioblastoma.

The study is expected to recruit up to 200 patients into the GDC-0084 arm, with recruitment expected to commence in the second or third quarter of the calendar year 2020.

It is expected that data from GBM AGILE will be used to seek marketing approval for GDC-0084 from FDA and other regulatory agencies.

GDC-0084 was licensed from Genentech in late 2016.

KZIA closed Wednesday's trading at $4.42, up 3.51%.

Puma Biotechnology Inc. (PBYI), on Wednesday, announced encouraging updated results from its phase II SUMMIT basket trial, which is evaluating Neratinib in patients who have solid tumors with activating HER2 or HER3 mutations.

According to the Company, Neratinib in combination with Trastuzumab and Fulvestrant showed that for the 17 efficacy evaluable HER2-mutant, HR-positive breast cancer patients, 9 patients (53%) experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients (59%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 24 weeks).

The median duration of response has not been reached and the median progression-free survival was 9.8 months, added the Company.

Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as NERLYNX(r) (neratinib) tablets. The drug was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early-stage breast cancer in August 2018.

PBYI closed Wednesday's trading at $8.69, up 2.36%. In after-hours, the stock gained another 3.80% to $9.02.

Seattle Genetics Inc. (SGEN) plans to seek approval of Tucatinib for the treatment of patients with HER2-positive metastatic breast cancer in the U.S. and Europe by the first quarter of 2020.

The pivotal clinical trial comparing Tucatinib in combination with Trastuzumab and Capecitabine against Trastuzumab and Capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who were previously treated with Trastuzumab, Pertuzumab, and T-DM1 has yielded encouraging results.

In the trial, dubbed HER2CLIMB, the primary endpoint of progression-free survival showed that the addition of Tucatinib was superior to trastuzumab and capecitabine alone, with a 46 percent reduction in the risk of disease progression or death.

Moreover, the addition of Tucatinib to the commonly used combination of Trastuzumab and Capecitabine improved overall survival, reducing the risk of death by 34 percent compared to trastuzumab and capecitabine alone.

SGEN closed Wednesday's trading at $111.34, down 2.32%.

TransEnterix Inc. (TRXC), a medical device company, is all set to effect a reverse stock split of one-for-thirteen, with the common stock beginning to trade on a split-adjusted basis when markets open on December 12, 2019.

No fractional shares are issued in connection with the reverse stock split, the Company added.

TRXC closed Wednesday's trading at $0.165, down 7.15%.

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