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INGN Soars On Revised Outlook, MRK Faces FDA In Sep., KPTI Taken By STORM

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Today's Daily Dose brings you news about Apellis Pharma's upcoming clinical trial catalysts; Conatus' progress in ENCORE-PH study; CE Mark approval of Edwards Cardioband Tricuspid Valve Reconstruction System; Inogen's rosy outlook; Karyopharm's STORM data, and Q1 results of MEDNAX and Orthofix International.

Read on…

Apellis Pharmaceuticals Inc. (APLS) has a couple to catalysts to watch out for this year.

The Company is all set to begin a phase III trial of APL-2 in Geographic Atrophy and a phase III trial of APL-2 in Paroxysmal Nocturnal Hemoglobinuria in the second half of 2018.

Data from a phase II proof-of-concept (POC) monotherapy trial of APL-2 in Autoimmune Hemolytic Anemia (AIHA) remains on track for the first half of 2018.

The phase II POC monotherapy data for APL-2 in four types of complement-dependent nephropathies, including IgA nephropathy, C3 glomerulonephropathy, primary membranous nephropathy, and lupus nephritis, are expected in the second half of 2018.

APLS closed Monday's trading at $24.11, down 3.94%.

Conatus Pharmaceuticals Inc. (CNAT) has completed enrollment in its phase IIb clinical trial of Emricasan in patients with NASH Cirrhosis and severe portal hypertension, dubbed ENCORE-PH.

Top-line results from the ENCORE-PH clinical trial are expected in the fourth quarter of 2018.

The other ongoing clinical trials with Emricasan are:

-- A phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF. Top line results are expected in the first half of 2019.
-- A phase IIb clinical trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF. Top-line results are expected in the second half of 2019.

CNAT closed Monday's trading at $3.41, down 0.87%.

Edwards Lifesciences Corp. (EW) has received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System for the treatment of tricuspid regurgitation.

The Cardioband Tricuspid System is the first commercially available transcatheter therapy for the treatment of tricuspid heart valve disease. It is not approved for commercial sale in the United States.

Cardioband System came under Edwards' fold, following the acquisition of Valtech Cardio in January 2017.

The CE Mark for the Cardioband Tricuspid System prompts a distribution of cash and stock totaling approximately $50 million to the former investors of Valtech Cardio.

EW closed Monday's trading at $127.36, down 1.49%.

Inogen Inc. (INGN) has reported record revenue for the first quarter of 2018, and has boosted its full year 2018 total revenue guidance.

In the first quarter of 2018, the Company's net income surged to $10.8 million or $0.48 per share from $5.9 million or $0.27 per share in the year-ago quarter. Total revenue in the recent first quarter rose 50.6% to $79.1 million from $52.5 million in the same period in 2017.

Looking ahead to full year 2018, Inogen now expects total revenue to range between $310 million and $320 million, up from its prior guidance of $298 million to $308 million, representing growth of 24.3% to 28.3% versus 2017 full year results.

INGN closed Monday's trading at $140.58, down 1.77%. In after-hours, the stock was up 25.20% to $176.

Shares of Karyopharm Therapeutics Inc. (KPTI) were up nearly 24% in after-hours trading on Monday, following positive top-line data from Part 2 of its phase IIb trial of Selinexor in patients with Penta-Refractory Multiple Myeloma, dubbed STORM.

According to the trial results, oral Selinexor achieved a 25.4% overall response rate (ORR), which included two complete responses (CRs) and 29 partial (PRs) or very good partial responses (VGPRs) in the patients with penta-refractory myeloma. The median duration of response (DOR), a key secondary objective, was 4.4 months.

Karyopharm plans to submit a New Drug Application to the FDA during the second half of 2018, with a request for accelerated approval for oral Selinexor as a new treatment for patients with penta-refractory multiple myeloma.

The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency in early 2019 with a request for conditional approval.

A phase III study evaluating Selinexor in combination with Velcade and dexamethasone (SVd) for the treatment of patients with multiple myeloma who have had one to three prior lines of therapy, dubbed BOSTON, is ongoing - with top-line data anticipated in 2019.

KPTI closed Monday's trading at $13.08, down 13.66%. In after-hours, the stock was up 23.39% to $16.14.

Keryx Biopharmaceuticals Inc.'s (KERX) president and chief executive officer Gregory Madison has resigned effective immediately. He has also relinquished his seat on the Company's board of directors.

Jodie Morrison, a member of the company's board of directors, has been named interim chief executive officer of Keryx.

Additionally, the Company has also announced preliminary Q1, 2018 revenue.

The total revenue for the first quarter of 2018 is expected to be between $21.0 million and $22.5 million.

KERX closed Monday's trading at $4.43, down 7.32%.

MEDNAX Inc. (MD) has reported solid results for the first quarter ended March 31, 2018.

On an adjusted basis, net income for the recent first quarter was $83.15 million or $0.89 per share, up from $69.99 million or $0.75 per share in the year-ago quarter. The Company's net revenue for the first quarter of 2018 was $901.9 million, up from $835.6 million in the prior-year period.

For the 2018 second quarter, MEDNAX expects adjusted EPS to be in a range of $1.04 to $1.09.

MD closed Monday's trading at $45.91, down 2.13%.

Merck & Co. Inc.'s (MRK) supplemental Biologics License Application for KEYTRUDA has been accepted for priority review by the FDA - with a decision expected on September 23, 2018.

The Company is seeking approval of its blockbuster drug KEYTRUDA in combination with ALIMTA and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer.

MRK CLOSED Monday's trading at $58.87, down 1.01%.

Orthofix International NV (OFIX) has reported solid financial results for the first quarter ended March 31, 2018.

Adjusted net income from continuing operations for the recent first quarter rose to $7.3 million or $0.39 per share from $4.9 million or $0.27 per share in the prior year period.

Net sales for the first quarter of 2018 were $108.7 million, an increase of 5.8% compared to prior year or 3.3% on a constant currency basis.

For the second quarter of 2018, the Company expects adjusted EPS from continuing operations in the range of $0.35 to $0.37, and net sales to range between $113.0 million and $115.0 million.

Looking ahead to full year 2018, the Company has forecast adjusted EPS from continuing operations to range between $1.58 and $1.68, and net sales in the range of $458.0 million to $464.0 million.

OFIX closed Monday's trading at $61.02, down 0.57%.

Sanofi's (SNY) Biologics License Application for Cemiplimab has been accepted for priority review by the FDA, with a decision expected on October 28, 2018.

The Company is seeking approval of Cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.

Cemiplimab is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (REGN) under a global collaboration agreement.

SNY closed Monday's trading at $39.32, down 0.79%.

Tandem Diabetes Care Inc. (TNDM) has received the CE mark approval for its t:slim X2 Insulin Pump with Dexcom G5 Mobile continuous glucose monitoring (CGM) integration.

The Company plans to begin commercial sales of the pump in select international markets beginning in the second half of 2018.

The Company has been commercializing its touchscreen insulin pumps in the United States since 2012, and received FDA approval of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM integration last August.

TNDM closed Monday's trading at $7.63, down 2.18%.

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