RGLS Disappointed, NOVN Loses Face Over Acne Trial Data, AMGN Abuzz

(RTTNews) - Amgen Inc.'s (AMGN) ABP 501, a biosimilar candidate to AbbVie's (ABBV) blockbuster arthritis drug Humira, has been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP.

ABP 501 has been recommended for approval by the CHMP for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

The CHMP opinion also recommends approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).

The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.

ABP 501 was approved by the FDA last September under the brand name AMJEVITA.

AMGN closed Friday's trading at $157.16, up 2.73%.

Shares of Novan Inc. (NOVN) plunged more than 74% on Friday after reporting encouraging results in one of its phase III trials of SB204 in the treatment of acne vulgaris while reporting mixed results in another replicate trial.

In one of the trials, dubbed NI-AC302, SB204 demonstrated statistical significance compared to vehicle on all three co-primary endpoints, but in another trial, named NI-AC301, the topical acne product candidate demonstrated statistical significance on only one of three co-primary endpoints.

The company had its IPO as recently as September 21, 2016, offering its shares at a price of $11.00 each.

NOVN closed Friday's trading at $4.86, down 74.01%.

Regulus Therapeutics Inc. (RGLS) is disappointed as the FDA has turned down its request to lift the clinical hold on RG-101, an investigational treatment of chronic hepatitis C virus infection, requesting more data to be submitted.

The clinical hold was imposed last July after Regulus reported a second serious adverse event of jaundice in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going phase I US study - 117 days after receiving a single dose of RG-101.

The additional data sought by the FDA from on-going RG-101 clinical and pre-clinical studies for reconsidering the clinical hold are anticipated to be available only in the fourth quarter.

RGLS closed Friday's trading at $2.25, unchanged from the previous day's close.