logo
Plus   Neg
Share
Email

CMTA Fast Tracks NDA Filing, USNA In Good Health, DERM To Report Data In Apr.

pharma-020117_24oct18-lt.jpg

Today's Daily Dose brings you news about Clementia's Palovarotene NDA submission; Dermira's near-term catalyst; promising results of Pfizer and Eli Lilly's phase III study of investigational Tanezumab in patients with osteoarthritis pain, and better-than-expected Q3 financial results of USANA Health.

Read on...

Shares of Clementia Pharmaceuticals Inc. (CMTA) surged nearly 36% in extended trading on Tuesday, following the Company's plan to submit a New Drug Application for Palovarotene to the FDA in the second half of 2019.

Palovarotene is being developed for the prevention of heterotopic ossification (HO) associated with flare up symptoms in patients with fibrodysplasia ossificans progressiva (FOP).

The FDA has agreed that the phase II clinical program of Palovarotene, which showed a statistically significant reduction in mean new heterotopic ossification volume, or bone volume, associated with flare-ups of FOP at 12 weeks compared to placebo or untreated flare-ups, would support filing of an NDA.

To know more about CMTA, please visit our "This Day That Year" column.

CMTA closed Tuesday's trading at $10.34, up 6.27%. In after-hours, the stock was up 35.88% to $14.05.

Dermira Inc. (DERM) has completed patient enrollment of 280 subjects in its phase 2b dose-ranging study of Lebrikizumab in patients with moderate-to-severe atopic dermatitis.

The primary endpoint of the study is the percent change in the Eczema Area Severity Index (EASI) from baseline to week 16. The topline efficacy and safety results from the study are expected by early April 2019.

DERM closed Tuesday's trading at $12.45, down 1.50%.

Neurocrine Biosciences Inc. (NBIX) will be presenting new data analyses on the long-term effects of INGREZZA capsules in adults with tardive dyskinesia and from RE-KINECT, the largest real-world screening study of patients with possible tardive dyskinesia on October 26.

Approved in April 2017, INGREZZA is the first FDA-approved treatment for adults with tardive dyskinesia, a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face.

The net product sales for INGREZZA were $116.6 million for the year ended December 31, 2017, and $168.0 million for the first half of 2018.

NBIX closed Tuesday's trading at $108.56, down 0.56%.

Pfizer Inc. (PFE) and Eli Lilly and Co.'s (LLY) phase III study evaluating the efficacy and safety of investigational subcutaneous Tanezumab in patients with osteoarthritis pain has met all three co-primary efficacy endpoints.

According to the study results, patients with moderate-to-severe osteoarthritis (OA) pain of the knee or hip, when treated with Tanezumab for 16 weeks had a statistically significant improvement in pain, physical function and patient's global assessment of their OA, compared to placebo.

More than half of the patients treated with Tanezumab reported a 50% or greater reduction in osteoarthritis pain of the knee or hip.

PFE closed Tuesday's trading at $44.10, down 0.61%.

Psychemedics Corp. (PMD), a provider of hair testing for the detection of drugs of abuse, has reported 10% revenue growth and 7% decline in net income for the third quarter ended September 30, 2018.

The Company's revenue for the recent third quarter was $11.0 million, up from $10.0 million for the comparable period in 2017.

Net income for the quarter ended September 30, 2018 declined to $1.3 million or $0.23 per share from $1.4 million or $0.25 per share, for the comparable period last year due to unfavorable impact from foreign currency exchange rates.

The Company has also declared a quarterly dividend $0.18 per share, which represents its 89th consecutive quarterly dividend.

PMD closed Tuesday's trading at $17.88, up 1.44%.

USANA Health Sciences Inc. (USNA) has reported better-than-expected earnings and net sales for its fiscal third quarter ended September 29, 2018, and boosted its yearly outlook.

Net earnings for the third quarter of 2018 were $31.0 million or $1.24 per share on net sales of $296.8 million. Analysts polled by Thomson Reuters were expecting EPS of $1.12 and net sales of $291.73 million.

In the third quarter of 2017, the Company reported net earnings of $23.8 million or $0.97 per share and net sales of $261.7 million.

Looking ahead, the Company now expects consolidated net sales for 2018 to be between $1.185 and $1.20 billion, up from its prior forecast of between $1.17 and $1.20 billion. Similarly, EPS for the year is now expected to be between $5.00 and $5.15, compared to its previous guidance range of between $4.75 and $5.05.

USNA closed Tuesday's trading at $105.42, down 0.28%.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT
>