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First Device For Congenital Heart Defect, AIMT & US Shutdown, ASLN On Watch

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Today's Daily Dose brings you news about the approval of the world's first device for treatment of premature babies and newborns with an opening in their hearts; the impact of the U.S. government shutdown on Aimmune Therapeutics; Array's BEACON CRC trial results; and Exelixis' expanded FDA approval for Cabometyx tablets.

Read on…

Amplatzer Piccolo Occluder, the world's first device for treatment of premature babies and newborns with an opening in their hearts, a common congenital defect, has just won the FDA approval.

Developed by Abbott (ABT), Amplatzer Piccolo, which is even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

ABT closed Monday's trading at $68.27, down 1.07%.

The FDA will commence the review of Aimmune Therapeutics Inc.'s (AIMT) Biologics License Application for AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4-17, only when the U.S. government shutdown and lapse in appropriations has ended.

The partial government shutdown which began on December 22, 2018, and is still continuing, is the longest in the country's history.

The Company submitted the Biologics License Application for AR101 on December 21, 2018.

The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy in ages 4-17 in June 2015.

Last month, DBV Technologies S.A. (DBVT) withdrew its Biologics License Application for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age. The decision to withdraw the application was based on feedback from the FDA, which concluded that BLA, submitted on October 18, 2018, lacked sufficient detail regarding data on manufacturing procedures and quality controls.

AIMT closed Monday's trading at $24.30, down 5.19%. DBVT closed the day's trading at $7.92, down 0.63%.

Array BioPharma Inc. (ARRY) has reported encouraging updated results from the safety lead-in of its BEACON CRC trial.

BEACON CRC trial is evaluating the triplet combination of BRAFTOVI, MEKTOVI, and ERBITUX in patients with BRAFV600E-mutant metastatic colorectal cancer.

The results showed that mature median overall survival was 15.3 months for patients treated with the triplet. The updated confirmed overall response rate remains 48% and updated median progression-free survival remains 8.0 months, added the Company.

Commenting on the study results, Victor Sandor, Chief Medical Officer, Array BioPharma, said, "We are delighted with the updated results from the BEACON CRC safety lead-in. Following consultations with the FDA and European Medicines Agency, we initiated an amendment to the BEACON CRC protocol to allow for an interim analysis based primarily on confirmed ORR and durability of response endpoints, which we believe could support an accelerated approval with positive results. We anticipate top-line results from this interim analysis in the first half of this year".

ARRY closed Monday's trading at $17.07, down 3.61%. In after-hours, the stock was up 8.38% to $18.50.

ASLAN Pharmaceuticals' (ASLN) phase 1b/2 clinical trial of Varlitinib plus gemcitabine and cisplatin in first-line biliary tract cancer has demonstrated an objective response rate of 60% and disease control rate of 100% n 300mg dose cohort.

Patients in the study received oral Varlitinib twice daily (BID) at a dose of either 200mg or 300mg plus gemcitabine (1000mg/m2) and cisplatin (25mg/m2) on days one and eight of a three-week cycle.

The data will be presented during a poster presentation at the upcoming American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco on 18 January 2019, the Company noted.

ASLN closed Monday's trading at $3.41, down 3.94%.

Shares of Bio-Path Holdings Inc. (BPTH) plunged over 15% in after-hours trading on Monday, after the Company priced an underwritten public offering of 8.59 million shares of its common stock at $0.13 each.

The aggregate gross proceeds from the offering are expected to be about $1.1 million, and the offering is expected to close on or about January 17, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

BPTH closed Monday's trading at $0.20, down 12.96%. In after-hours, the stock plunged 15.08% to $0.17.

The FDA has approved Exelixis Inc.'s (EXEL) Cabometyx tablets for patients with hepatocellular carcinoma who have been previously treated with Bayer/Onyx's Nexavar (sorafenib).

Cabometyx, available in 3 strengths of 20mg, 40mg, and 60mg, is already approved in the United States for the treatment of patients with advanced renal cell carcinoma.

The drug is also approved in the European Union, Norway, Iceland, Australia, Switzerland, South Korea, Brazil and Taiwan for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC.

Cabometyx generated $324.0 million in net product revenue in full-year 2017 and $428.3 million in the first nine months of 2018.

EXEL closed Monday's trading at $22.86, down 3.79%. In after-hours, the stock was up 5.29% to $24.07.

Pfizer Inc.'s (PFE) New Drug Applications for Tafamidis for the treatment of transthyretin amyloid cardiomyopathy have been accepted for priority review by the FDA - with a decision expected in November 2019.

The two NDAs are based on two forms of Tafamidis - meglumine salt and free acid.

PFE closed Monday's trading at $42.37, down 1.19%.

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