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BMY's Orencia Scores Another FDA Nod, Janssen Ends Deal With CAPR, PBYI On Track


Today's Daily Dose brings you news about termination of the Collaboration Agreement and License Option entered into between Capricor and Janssen Biotech; Puma's progress in NALA trial; FDA clearance of K2M Group's NILE Proximal Fixation Spinal System; Egalet's public offering and label expansion of Bristol-Myers' rheumatoid arthritis drug Orencia.

Read on...

Bristol-Myers Squibb Co.'s (BMY) ORENCIA has received FDA approval for yet another indication - this time, for the treatment of adults with active Psoriatic Arthritis, a chronic, inflammatory disease that can affect both the skin and musculoskeletal system.

Approved and available in both intravenous and subcutaneous injection formulations, ORENCIA is already indicated for adult rheumatoid arthritis and juvenile idiopathic arthritis.

The global sales of ORENCIA in 2016 were $2.26 billion compared to $1.89 billion in 2015.

BMY closed Thursday's trading at $55.28, down 1.90%.

The Collaboration Agreement and License Option entered into between Capricor Therapeutics Inc. (CAPR) and Janssen Biotech Inc related to Capricor's lead candidate CAP-1002 has been terminated. This follows Janssen Biotech's decision of not to exercise option for CAP-1002.

CAP-1002 is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy, myocardial infarction (heart attack), and heart failure.

On May 12, 2017, Capricor announced that its ongoing phase II clinical trial of CAP-1002 in adults with cardiac dysfunction following a large heart attack, dubbed ALLSTAR, is unlikely to achieve its primary endpoint, based on a pre-specified administrative interim analysis of the trial.

CAP-1002 is also under a phase I/II clinical trial in patients with DMD-associated cardiomyopathy, dubbed HOPE.

Now that the Collaboration Agreement and License Option have been terminated, Capricor shall retain all rights to develop and commercialize CAP-1002 for any indication, either independently or in collaboration with third parties.

CAPR closed Thursday's trading at $0.760, down 5.59%.

Celsion Corp. (CLSN) has agreed to sell an aggregate of about 2.435 million shares of common stock, or pre-funded warrants in lieu thereof, at a price of $2.07 per common share or warrant share, respectively to institutional investors in a registered direct offering.

The estimated net proceeds to the Company from the registered direct offering are expected to be approximately $4.3 million. The offering is expected to close on or about July 11, 2017.

CLSN closed Thursday's trading at $1.92, down 20.66%.

Conatus Pharmaceuticals Inc.'s (CNAT) exclusive license with Novartis (NVS) for the global development and commercialization of Emricasan became effective on July 5, 2017.

Conatus is in receipt of a $7 million payment from Novartis under terms of the Option, Collaboration and License Agreement signed in December 2016.

Emricasan is under four phase IIb clinical trials namely:

-- A phase IIb trial of Emricasan, in post-orthotopic liver transplant (POLT) recipients, dubbed POLT-HCV-SVR. Top-line results are expected in the first half of 2018.
-- A phase IIb trial of Emricasan in reducing hepatic venous pressure gradient in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension, dubbed ENCORE-PH. Top-line results from this trial are expected in 2018.
-- 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 2019.

CNAT closed Thursday's trading at $6.18, down 0.32%. In after-hours, the stock was up 3.07% to $6.37.

Shares of Egalet Corp. (EGLT) slumped more than 35% on Thursday, following the pricing of public offering of its common stock and warrants.

The Company has priced its underwritten public offering of 16.66 million shares of its common stock and accompanying warrants to purchase up to 16.66 million shares, at a combined public offering price of $1.80 per share and accompanying warrant. Each warrant will have an exercise price of $2.70 and will expire five years from the date of issuance.

The offering is expected to close on or about on July 11, 2017.

EGLT closed Thursday's trading at $1.63, down 35.83%.

K2M Group Holdings Inc. (KTWO) has received FDA clearance as well as a CE Mark for its NILE Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation.

NILE Proximal Fixation addresses complex spinal deformity cases and consists of bands and connectors that may be used in conjunction with spinal rod constructs for attachment to the posterior vertebral structures at the proximal end of the construct. The CE Mark for NILE Proximal Fixation also includes the use of anchors, which are not cleared for use in the United States, noted the Company.

The Company is slated to release its Q2, 2017 financial results after the market close on August 1st.

Net loss was $10.9 million or $0.26 per share for the three months ended March 31, 2017, compared to a net loss of $10.2 million or $0.25 per share in the year-ago quarter. Total revenue for the first quarter 2017 increased 9.9%, to $61.9 million from $56.3 million for the first quarter of 2016.

KTWO closed Thursday's trading at $22.95, down 3.29%.

Puma Biotechnology Inc. (PBYI) has completed the targeted patient enrollment in its phase III trial of PB272 in patients with HER2-positive metastatic breast cancer who have received two or more prior HER2 directed regimens in the metastatic setting.

The trial, dubbed NALA, is designed to enroll 600 patients. The NALA trial is evaluating PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer.

The co-primary endpoints of the trial are progression free survival (PFS) and overall survival (OS). The Company anticipates that primary analysis of PFS will be available during the first half of 2018.

PBYI closed Thursday's trading at $86.45, down 1.59%.

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