FDA Nod For NVO's Hemophilia A Drug, ICPT's NASH Trial Hits Goal, NVTA Abuzz

(RTTNews) - Today's Daily Dose brings you news about Bausch Health's acquisition of the U.S. rights to Eton Pharma's EM-100 eye drop; Cellular Biomedicine's business highlights and financial results for Q4, 2018; CE Mark approval for Edwards Lifesciences' PASCAL transcatheter valve repair system; Invitae's better-than-expected Q4 financial results; positive results of Intec Pharma's (NTEC) pharmacokinetic study of Accordion Pill in Parkinson's disease patients; Intercept Pharma's NASH trial data; and FDA approval of Merck's Keytruda and Novo Nordisk's ESPEROCT.

Read on...

AbbVie's (ABBV) New Drug Application for Upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis has been accepted for priority review by the FDA.

The regulatory agency's decision on Upadacitinib is expected in Q3 2019.

Upadacitinib is also under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis.

ABBV closed Tuesday's trading at $80.52, down 0.41%.

Bausch Health Companies Inc. (BHC) has acquired the U.S. rights to Eton Pharmaceuticals' (ETON) EM-100, an investigational eye drop for the treatment of ocular itching associated with allergic conjunctivitis.

EM-100 has been submitted to the FDA for review.

The FDA decision on Bausch Health's New Drug Application for DUOBRII Lotion, 0.01%/0.045%, for the topical treatment of plaque psoriasis in adults is expected to be announced shortly. The original decision date was February 15, 2019.

BHC closed Tuesday's trading at $25.19, down 1.02%.

Cellular Biomedicine Group Inc. (CBMG) has reported business highlights and financial results for the fourth quarter and full year ended December 31, 2018.

Net loss widened to $38.9 million or $2.20 per share for 2018 on net sales & revenue of $224 thousand. This compared with a net loss of $25.5 million or $1.78 per share and net sales & revenue of $336 thousand for 2017.

The Company has a couple of key milestones lined up for this year namely:

-- Initiation of an investigator-led Phase I clinical study of CD22 targeting relapsed CD19 ALL patients. -- Initiation of an investigator-led Phase I clinical study of CD20 targeting relapsed CD19 Non-Hodgkin lymphoma (NHL) patients. -- Initiation of an investigator-led Phase I clinical study of NKG2D targeting acute myeloid leukemia (AML) patients. -- Initiation of Phase I clinical study of AFP-TCR for Hepatocellular carcinoma (HCC) in the U.S. and in China. -- Initiation of Phase I clinical study of TIL in Non-small-cell lung carcinoma (NSCLC) in the U.S. and in China. -- Presentation of B-cell maturation antigen (BCMA) clinical data from the ongoing BCMA clinical study in patients with MM by end of 2019.

CBMG closed Tuesday's trading at $19.81, up 1.28%.

Edwards Lifesciences Corporation (EW) has received CE Mark for its PASCAL transcatheter valve repair system for the treatment of patients with mitral regurgitation.

The PASCAL system is not approved in the United States and is under a pivotal trial, which is currently enrolling patients with symptomatic primary mitral regurgitation.

EW touched an all-time high of $178.68 in intraday trading on Tuesday before closing at $177.03, down 0.42%.

Shares of Invitae Corporation (NVTA) rose more than 6% in extended trading on Tuesday, following better-than-expected financial results for the fourth quarter and full year ended December 31, 2018.

Net loss for the fourth quarter of 2018 narrowed to $29.84 million or $0.40 per share on total revenue of $45.35 million. Analysts polled by Thomson Reuters were expecting a loss of $0.45 per share and total revenue of $40.78 million. Net loss was $40.49 million or $0.78 per share and total revenue was $25.39 million in the fourth quarter of 2017.

The Company ended December 31, 2018, with cash, cash equivalents, restricted cash, and marketable securities of $131.9 million.

NVTA closed Tuesday's trading at $16.51, up 2.80%. In after-hours, the stock was up 6.90% to $17.65.

Intec Pharma Ltd.'s (NTEC) pharmacokinetic study, which compared its Accordion Pill against Sinemet in Parkinson's disease patients, has met the primary endpoint.

In the study, Accordion Pill dosed three times daily reduced plasma levodopa variability compared to standard oral Sinemet dosed five times per day with statistical significance.

A phase III trial of Accordion Pill for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, dubbed ACCORDANCE, is underway - with results expected in mid-2019.

NTEC closed Tuesday's trading at $8.54, up 4.27%.

Intercept Pharmaceuticals Inc.'s (ICPT) pivotal phase III study of obeticholic acid in patients with liver fibrosis due to nonalcoholic steatohepatitis, dubbed REGENERATE, has yielded positive results.

The trial involved NASH patients with stage 2 and 3 fibrosis across 339 qualified centers worldwide, and a smaller exploratory cohort of 287 patients with high-risk early fibrosis.

In the primary efficacy analysis, once-daily obeticholic acid 25 mg met the primary endpoint of fibrosis improvement with no worsening of NASH at the planned 18-month interim analysis.

Although a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, this did not reach statistical significance.

The study was required to meet one of the two primary endpoints, and REGENERATE has achieved it.

Intercept intends to file for approval of obeticholic acid for NASH in the U.S. and Europe in the second half of 2019.

ICPT closed Tuesday's trading at $117.57, up 6.09%.

Merck's (MRK) blockbuster drug KEYTRUDA has received FDA approval for yet another indication - this time, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Keytruda, co-developed and co-commercialized with AstraZeneca, is already approved for the treatment of melanoma, non-small cell lung cancer, head, and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, and Merkel cell carcinoma.

The drug fetched annual revenue of $7.17 billion in 2018, and $3.81 billion in 2017.

MRK closed Tuesday's trading at $79.24, down 0.71%.

Mirati Therapeutics Inc. (MRTX) announced the appointment of Faheem Hasnain as Chairman of the Board, effective February 15, 2019.

Hasnain replaces Dr. Rodney Lappe who is retiring from the board and is giving up his role as Chairman.

Hasnain is the Executive Chairman of Gossamer Bio, Inc., a public company focused on the discovery and development of novel and differentiated therapeutic products, to address high unmet needs amongst the various targeted patient population.

Clinical Trials & Near-term Catalyst:

The Company lead programs include Sitravatinib and MRTX849.

-- Last month, the Company dosed the first patient in a Phase 1/2 clinical trial of MRTX849 for patients with advanced solid tumors that harbor KRAS G12C mutations. -- The Company plans to begin a phase III randomized trial with Sitravatinib in combination with a checkpoint inhibitor in the first half of 2019.

MRTX closed Tuesday's trading at $71.78, down 1.16%.

Natera Inc.'s (NTRA) Panorama SNP-based non-invasive prenatal test (NIPT) has demonstrated high positive predictive values in detecting common chromosomal aneuploidies in all women, including women under 35 years of age.

The Panorama test, which reveals a baby's risk for severe genetic disorders as early as nine weeks into pregnancy, is yet to be approved by the FDA.

Commenting on the study results, Kimberly A. Martin, Natera Vice President, Global Women's Health, said, "We believe this study continues to reaffirm NIPT as the most accurate screening option for pregnant women of all ages."

NTRA closed Tuesday's trading at $16.45, down 0.60%.

The FDA has approved Novo Nordisk's (NVO) ESPEROCT for the treatment of adults and children with haemophilia A.

ESPEROCT is indicated for use in adults and children with haemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment, and control of bleeding episodes and perioperative management of bleeding.

Due to third-party IP agreements, Novo Nordisk will not be able to launch ESPEROCT before 2020 in the U.S.

NVO closed Tuesday's trading at $50.32, down 0.06%.

Trovagene Inc. (TROV) has implemented a reverse split of its common stock, $0.0001 par value, at a ratio of 1 for 6, and the shares will begin trading on a split-adjusted basis on February 20, 2019.

The reverse stock split intended to bring the company into compliance with minimum bid price requirement for maintaining listing on Nasdaq Capital Market.

As a result of the reverse split, the number of outstanding common shares will be reduced from approximately 24.1 million shares to approximately 4.0 million shares.

TROV closed Tuesday's trading at $0.48, down 14.27%.