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FDA Nod For JNJ, CORI Awaits Results In Q2, MDGL's HeFH Data Fails To Impress

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Today's Daily Dose brings you news about Corium's upcoming catalysts; appointment of Bill Lundberg as Head of CRISPR's Scientific Advisory Board; Immunomedics' quarterly financial results; FDA approval of JNJ's prostate cancer drug ZYTIGA for an additional indication; positive results from Madrigal's phase II trial of MGL-3196 in patients with heterozygous familial hypercholesterolemia and possible delay in the FDA decision on two biosimilar candidates.

Read on...

Corium International Inc. (CORI) has a couple of catalysts to watch out for this year.

A pivotal bioequivalence study comparing the Company's once-weekly transdermal patch Corplex Donepezil to daily oral Aricept is underway - with top-line results expected in the second quarter of calendar 2018.

Ancillary studies that are required in the New Drug Application data package for Corplex Donepezil, including standard skin tolerability and alternative patch application site studies are underway, and a heat effects study is expected to commence this month.

Corium is targeting submission of a Section 505(b)(2) NDA in the fourth quarter of calendar 2018.

CORI closed Thursday's trading at $12.01, down 1.56%.

CRISPR Therapeutics' (CRSP) Chief Scientific Officer Bill Lundberg is relinquishing his post, and will take over as Head of the Company's Scientific Advisory Board, besides serving as a Senior Advisor to the Company.

Recent events:

-- On December 7, 2017, the Company submitted its first Clinical Trial Application for a CRISPR gene-edited therapy, CTX001 in ß-thalassemia, in Europe.
-- On December 12, 2017, the Company entered into an agreement with Vertex Pharmaceuticals Inc. (VRTX) to co-develop and co-commercialize CTX001.

CRSP closed Thursday's trading at $38.64, down 7.27%.

Immunomedics Inc. (IMMU) has reported a narrower loss and higher revenue for the second quarter ended December 31, 2017.

Net loss attributable to stockholders in the recent second quarter narrowed to $2.5 million or $0.02 per share from $24.4 million or $0.23 per share, for the same quarter last fiscal year. The narrower loss is due primarily to the $34.0 million decrease in non-cash cost from the decrease in the fair value of warrant liabilities, offset partially by the $14.3 million increase in costs and expenses, noted the Company.

Total revenues for the quarter ended December 31, 2017, were $0.6 million, compared to $0.4 million for the same quarter last fiscal year.

The Company is planning to submit its Biologics License Application for approval of Sacituzumab Govitecan as 3rd line treatment for metastatic triple-negative breast cancer in May of this year.

A confirmatory phase III study of Sacituzumab Govitecan in metastatic triple-negative breast cancer patients with two or more prior therapies, dubbed ASCENT, will continue to be executed.

IMMU closed Thursday's trading at $15.70, down 4.96%.

Fluidigm Corp. (FLDM) has reported better-than-expected results for the fourth quarter and full year ended December 31, 2017.

On a non-GAAP basis, net loss for the fourth quarter of 2017 shrunk to $3.0 million or $0.08 per share from $9.3 million or $0.32 per share for the fourth quarter of 2016. Total revenue for the fourth quarter of 2017 was $27.7 million, an increase of 11% from $25.1 million in the fourth quarter of 2016.

Analysts polled by Thomson Reuters were expecting the Company to incur a loss of $0.39 per share on revenue of $27.14 million.

For the first quarter of 2018, the Company has forecast total revenue in the range of $24 million to $27 million. Wall Street analysts expect total revenue of $26.71 million for the quarter.

FLDM closed Thursday's trading at $5.78, down 0.34%.

The FDA has approved a new indication for Johnson & Johnson's (JNJ) ZYTIGA in combination with corticosteroid prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer. This combination was approved for the similar indication in Europe last November.

ZYTIGA in combination with prednisone is already indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

The drug generated sales of $2.51 billion for Johnson & Johnson in 2017 compared to $2.3 billion in 2016.

JNJ closed Thursday's trading at $126.36, down 3.85%.

Despite Madrigal Pharmaceuticals Inc. (MDGL) announcing positive results from its phase II trial of MGL-3196 in patients with heterozygous familial hypercholesterolemia, the stock was down nearly 10% on Thursday.

The 12-week phase II study met the primary endpoint of statistically significant improvement in the reduction of LDL cholesterol (LDL-C) in HeFH patients on maximal statin therapy with MGL-3196 compared to placebo.

Statistically significant results were also achieved for MGL-3196 compared to placebo for multiple secondary endpoints including reduction of triglycerides, apolipoprotein B (ApoB), and lipoprotein(a) (Lp(a)), a highly atherogenic lipid particle commonly elevated in HeFH patients and not adequately controlled by existing therapies.

The Company will be presenting 12-week results from an ongoing MGL-3196 Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) on April 13, 2018 during a main plenary session at the Annual Meeting of the European Association for the Study of the Liver (EASL).

The 12-week results were reported on December 6, 2017, which sent the stock soaring over 118% that day.

The 36 weeks results from the phase II NASH trial of MGL-3196 are expected in the second quarter of 2018.

MDGL closed Thursday's trading at $131.53, down 9.90%.

REGENXBIO Inc. (RGNX) has completed dosing of the third cohort of six patients in its phase I clinical trial evaluating RGX-314 for the treatment of patients suffering from wet age-related macular degeneration.

The Company plans to share top line results from the phase I trial in late 2018.

RGNX closed Thursday's trading at $25.50, down 2.86%.

Tandem Diabetes Care Inc. (TNDM) gained 11.45% to close Thursday's trading at $2.92.

On January 9, 2018, the Company announced preliminary results for the year and quarter ended December 31, 2017, and provided 2018 guidance.

On a non-GAAP basis, the Company expects fourth quarter sales of about $39 million to $40 million. Non GAAP sales in the fourth quarter of 2016 were $24.8 million.

For full year 2017, non-GAAP sales are anticipated to be roughly $101 million to $102 million. The Company had reported non GAAP sales of $88.5 million in 2016.

For the year ending December 31, 2018, GAAP sales are estimated to be in the range of $132 million to $140 million.

The Company intends to report its fourth quarter and full year 2017 financial and operating results on Thursday, March 1, 2018 after the markets close.

Teva Pharmaceutical Industries Ltd. (TEVA) may have to wait longer to know the FDA decision on two biosimilar candidates, and migraine drug candidate Fremanezumab.

The Biologics License Application for Fremanezumab was accepted for priority review by the FDA last December, with a regulatory action anticipated by mid-2018.

CT-P10, a biosimilar candidate to Rituxan, and CT-P6, a biosimilar candidate to Herceptin, are also under FDA review, with a decision expected during the first half of 2018.

Teva and Celltrion have an exclusive partnership to commercialize Celltrion's mAb biosimilar candidates CT-P10 and CT-P6 in the U.S. and Canada.

In a press release issued Thursday, Teva said that Celltrion, its only source for API production for Fremanezumab, and also for the biosimilar candidates, was issued a warning letter for its facility in Incheon, South Korea, by the FDA last month.

Teva noted that it is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA. That said, Teva added that it in active dialogue with the FDA in an effort to maintain the priority date for the approval of Fremanezumab.

TEVA closed Thursday's trading at $18.64, down 10.60%.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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