ACRS On Watch, Avita, Exicure For The Long Haul, VCYT, NUVA Lift Outlook

pharma 041717 31jul19

Today's Daily Dose brings you news about Aclaris' alopecia areata trial results; CryoLife's better-than-expected financial results; NuVasive's updated earnings outlook; Avita Medical's next move; Veracyte's strong quarterly financial results and Exicure's uplisting to NASDAQ.

Aclaris Therapeutics Inc.'s (ACRS) phase II clinical trial of ATI-501 (AUAT-201 Oral), an investigational oral Janus Kinase (JAK) 1/3 inhibitor, in subjects with alopecia areata has met the primary endpoint.

Alopecia Areata (AA) is an autoimmune dermatologic condition typically characterized by patchy nonscarring hair loss on the scalp and body.

In the trial, subjects with 30% to 100% total scalp hair loss were randomized in a 1:1:1:1 ratio and received 24 weeks of treatment, twice daily, with either 400 mg, 600 mg or 800 mg of ATI-501 or a placebo. The primary endpoint of the trial was the change in SALT (Severity of Alopecia Tool) score at Week 24.

According to the Company, subjects treated with ATI-501 achieved statistically significant improvement over placebo in several measures of hair growth, including the primary endpoint and certain secondary endpoints of the trial.

The percentage change from baseline in SALT score for placebo was 6%; for 400 mg of ATI-501 was 26%; 600 mg was 30%, and for 800 mg also it was 26%.

Pfizer Inc.'s (PFE) phase 2a study of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841, a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in patients with moderate to severe alopecia areata, the results of which were reported last year, showed a Severity of Alopecia Tool (SALT) score of 33.6 points and 49.5 points, respectively.

ACRS closed Tuesday's trading at $1.74, up 0.58%.

Avita Medical Limited (AVMXY.OB) a regenerative medicine company, has seen a surge in the total product sales of its RECELL System for the fourth quarter and fiscal year ended June 30, 2019.

The RECELL System, which was approved by the FDA in September 2018, is indicated for use in the treatment of acute thermal burns in patients 18 years and older.

The total product sales in the fourth quarter of 2019, was A$3.45 million compared to A$354 thousand in the year-ago period.

The Company intends to apply for listing on the NASDAQ, and a confidential draft registration statement related to this was submitted to the SEC on July 19, 2019.

In fiscal 2020, AVITA anticipates pivotal trials commencing to establish the safety and effectiveness of the RECELL System for early intervention treatment of pediatric scald wounds and for trauma/soft tissue repair.

In fiscal 2021, the Company expects to commence a pivotal study of the RECELL System for the treatment of vitiligo and anticipates, in collaboration with COSMOTEC, an M3 Group company, securing marketing approval and reimbursement of the RECELL System in Japan.

AVMXY.OB closed Tuesday's trading at $5.93, up 6.46%.

CryoLife Inc. (CRY), a cardiac and vascular surgery company focused on aortic disease, has reported better-than-expected revenue and earnings for the second quarter of 2019.

Total revenues for the second quarter of 2019 were $71.1 million, which came in above consensus analysts' estimate of $70.79 million. Total revenue in the second quarter of 2018 was $68.5 million.

On a non-GAAP basis, net income for the second quarter of 2019 was $4.1 million or $0.11 per share compared to $3.9 million or $0.10 per share for the second quarter of 2018, and consensus analysts' estimate of $0.07 per share.

Looking ahead to full-year 2019, CryoLife continues to expect revenue in the range of $280 million to $284 million and non-GAAP earnings per share to be between $0.28 and $0.32. Analysts polled by Thomson Reuters have a consensus earnings estimate of $0.30 per share and revenue estimate of $282.2 million for the year.

CRY closed Tuesday's trading at $30.49, up 0.89%.

Exicure Inc.'s (XCUR.OB) common stock has been approved for listing on the Nasdaq Capital Market, subject to certain conditions.

The Company is a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs. The lead product candidate is AST-008, which is under a phase 1b/2 study in patients with advanced solid tumors, and under preclinical development for various neurological conditions.

The Company also intends to offer and sell shares of its common stock in an underwritten public offering, and grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of its common stock offered in the public offering.

XCUR.OB closed Tuesday's trading at $1.85, unchanged from the previous day's close.

NuVasive Inc. (NUVA), focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, has reported better-than-expected earnings for the second quarter of 2019, and has lifted its earnings outlook for the year.

On a non-GAAP basis, the Company's net income was $32.8 million or $0.63 per share for the second quarter 2019 compared to net income of $30.3 million or $0.58 per share for the second quarter 2018. Analysts polled by Thomson Reuters were expecting earnings of $0.56 per share.

Revenue for the second quarter of 2019 was $292.1 million, a 3.7% increase compared to $281.6 million for the second quarter of 2018. Analysts were also expecting revenue of $292.11 million.

Looking ahead to full-year 2019, the Company now expects non-GAAP earnings per share in a range of $2.25 to $2.35, compared with prior guidance of $2.20 to $2.30 per share. The consensus earnings estimate of analysts polled by Thomson Reuters is $2.29 per share for the year. The non-GAAP earnings per share were $2.23 in full-year 2018.

NUVA closed Tuesday's trading at $60.02, up 3.20%.

Veracyte Inc. (VCYT), a commercial-stage genomic diagnostics company, has reported a narrower loss and 32% increase in revenue for the second quarter ended June 30, 2019, besides boosting its full-year 2019 revenue outlook.

Net loss and comprehensive loss for the second quarter of 2019, narrowed to $2.49 million or $0.05 per share from $6.25 million or $0.18 per share in the year-ago quarter. Revenue for the recent second quarter rose to $30.13 million from $22.75 million in the comparable year-earlier quarter.

Looking ahead, the Company now expects 2019 annual revenue guidance to be in the range of $119 million to $122 million, up from its previous guidance range of $117 million to $121 million. The consensus revenue estimate of analysts polled by Thomson Reuters is $119.33 million for the year.

VCYT closed Tuesday's trading at $29.61, up 1.47%.

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