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ADMA Braces For Busy Year, AMPH Gets FDA Nod, CHRS Faces Litmus Test In Nov.

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Today's Daily Dose brings you news about ProPhase Labs' first quarter financial results; Soleno's progress in Prader-Willi Syndrome program; ADMA's upcoming milestones; Dicerna's near-term catalyst, and Coherus' regulatory catalyst in November.

Read on…

ADMA Biologics Inc. (ADMA) has a couple of events to watch out for in the coming months.

The Company expects to submit Prior Approval Supplement for an optimized manufacturing process for Bivigam, an intravenous Immune Globulin (Human), approved for the treatment of patients with Primary Humoral Immunodeficiency, this year.

ADMA is also expected to respond to the FDA's Complete Response Letter for RI-002, an intravenous immune globulin, for the treatment of patients with Primary Humoral Immunodeficiency Disease, this year. RI-002 was turned down by the FDA in July 2016.

The Company's consolidated net loss for the first quarter ended March 31, 2018 was $17.8 million or $0.39 per share compared to a net loss of $6.5 million or $0.51 per share for the first quarter ended March 31, 2017.

Total revenues in the recent first quarter were $4.0 million, up from $2.6 million in the year-ago quarter.

ADMA closed Monday's trading at $5.26, up 5.41%.

Amphastar Pharmaceuticals Inc.'s (AMPH) abbreviated new drug application for Calcium Chloride injection 10% in the 10 mL Luer-Jet Prefilled Syringe System has received FDA approval.

For the past 40 years, the Company has sold and marketed the product under the "grandfather" exception (now termed "unapproved") to the FDA's "Prescription Drug Wrap-Up" program. Net revenues for the company's Calcium Chloride injection for the year ended December 31, 2017 were $13.5 million.

AMPH closed Monday's trading at $16.12, up 8.12%.

Coherus BioSciences Inc.'s (CHRS) re-submitted biologics license application for CHS-1701, a biosimilar candidate for Amgen Inc.'s (AMGN) blockbuster treatment, Neulasta, has been accepted for review by the FDA - with a decision expected on November 3, 2018.

CHS-1701 was turned down by the FDA last June.

CHRS closed Monday's trading $16.75, up 1.52%.

Dicerna Pharmaceuticals Inc. (DRNA) expects to have clinical proof-of-concept data from its Phase 1 clinical trial of DCR-PHXC in healthy volunteers and patients with Primary Hyperoxaluria in the second half of 2018.

Dicerna expects to initiate a multi-dose Phase 2/3 study of DCR-PHXC in the first quarter of 2019, pending positive POC data and regulatory feedback.

DRNA closed Monday's trading at $14.44, down 0.14%.

Having obtained advice and guidance from the FDA, Galectin Therapeutics Inc. (GALT) is proceeding with plans for a phase III trial program with GR-MD-02 in NASH cirrhosis.

The target population of the phase III clinical trial will be patients with NASH cirrhosis without esophageal varices.

On December 5, 2017, the Company announced that its phase IIb clinical trial of GR-MD-02 in NASH cirrhosis patients, dubbed NASH-CX trial, showed statistically significant and clinically meaningful results in reducing the primary endpoint measurement of HVPG (hepatic venous pressure gradient) in comparison to placebo in NASH cirrhosis patients without esophageal varices, which represented 50 percent of the patients enrolled in the clinical trial.

GALT closed Monday's trading at $4.00, up 19.05%.

ProPhase Labs Inc. (PRPH) has reported solid sales figures for the first quarter ended March 31, 2018.

Net sales from continuing operations for the recent first quarter were $3.4 million compared to $771,000 in the year-ago quarter.

The Company's net income from continuing operations for the first quarter of 2018 is $43,000 or $0.00 per share, down from $16.9 million or $0.99 per share in the year-ago quarter.

The first quarter 2017 result benefited primarily due to a $18.1 million income tax benefit arising from the sale of the Company's Cold-EEZE brand and product line to a wholly-owned subsidiary of Mylan N.V. in March 2017.

The Company also noted that it continues to explore a wide range of acquisition opportunities in the consumer products space, as well as investments and acquisitions in other sectors and industries, particularly related to technology.

PRPH closed Monday's trading at $5.21, up 26.76%.

Soleno Therapeutics Inc. (SLNO) has initiated its multi-center Phase III clinical trial of Diazoxide Choline Controlled-Release for the treatment of Prader-Willi Syndrome (PWS).

The trial, which is designed to enroll approximately 100 PWS patients at 10-15 sites in the U.S., is anticipated to take approximately 9-12 months to complete.

Diazoxide Choline Controlled-Release has orphan designation for the treatment of PWS in the US and in the EU.

It is estimated that one in 12,000 to 15,000 people in the US have PWS. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families.

SLNO closed Monday's trading at $1.90, up 20.25%.

by RTTNews Staff Writer

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