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AVITA Turns Heads, SENS' Eversense Is "MRI Safe", SCYX Jumps 100% On FURI Data

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Today's Daily Dose brings you news about wide acceptance of AVITA Medical's RECELL System for burns in the U.S.; FDA's "MRI safe" notice to Senseonics' Eversense; SCYNEXIS' positive phase III results in patients with refractory or intolerant fungal disease; Surmodics' better-than-expected fiscal 2019 first quarter results and revised outlook; and Cardiovascular Systems' stellar results for its fiscal 2019 second quarter.

Read on...

AVITA Medical (AVMXY.OB), a global regenerative medicine company, announced that its RECELL System has generated strong interest from burn centers and greater than expected sales orders in advance of the January 2019 U.S. national market launch.

RECELL Autologous Cell Harvesting Device (RECELL System) received FDA clearance last September for the treatment of acute thermal burns.

The total product sales for the second quarter of fiscal 2019, i.e., three months ended December 31, 2018, were A$1.445 million - with A$1.10 million in U.S. sales and $A343 thousand in international sales. This compared with total product sales of A$343 thousand in the year-ago quarter.

AVMXY.OB closed Wednesday's trading at $1.68, up 2.44%.

Cardiovascular Systems Inc. (CSII) has reported stellar results for its fiscal 2019 second quarter, ended December 31, 2018.

The net income was $0.5 million or $0.01 per share compared to a net loss of $0.4 million or $0.01 per share in the prior-year period. Revenues for the recent quarter were $60.2 million, an increase of $7.6 million, or 14.4%, from the second quarter of fiscal 2018.

Analysts polled by Thomson Reuters were expecting a loss of $0.04 per share on revenue of $59.73 million for fiscal 2019 second quarter.

For fiscal 2019 ending June 30, 2019, the Company anticipates revenue in a range of $243 million to $247 million. Analysts are expecting revenue of $244.95 million for the year. Revenue in fiscal 2018 was $217 million.

CSI closed Wednesday's trading at $30.06, up 3.41%.

Novan Inc. (NOVN) has been granted an end-of-Phase II meeting with the FDA in early March 2019 for the SB206 molluscum program.

SB206 is the Company's lead asset for the treatment of molluscum contagiosum.

Molluscum contagiosum is a common skin disease caused by a virus and is characterized by pink or flesh-colored bumps on the skin (Source: American Academy of Dermatology).
The Company intends to provide a further update after the meeting with respect to a path forward for the asset and indication.

NOVN closed Wednesday's trading at $1.33, down 1.48%.

Pulmatrix Inc. (PULM) has offered to sell 5.32 million shares of its common stock to the public at a price of $0.17 each.

The aggregate gross proceeds from the offering are expected to be approximately $905,000. The offering is expected to close on or about February 4, 2019, subject to customary closing conditions.

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology.
PULM closed Wednesday's trading at $0.17, down 1.05%. In after-hours, the stock fell another 5.15% to $0.16.

In a first for the continuous glucose monitoring category, Senseonics Holdings Inc. (SENS) has received notice from FDA that its Eversense Sensor is no longer contraindicated for MRI scanning.

Eversense is a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes.

Commenting on the FDA's notice, Tim Goodnow, President and CEO of Senseonics, said, "Now patients using Eversense CGM do not need to worry about an emergency MRI or delay getting a scheduled MRI based on their glucose sensor. All other CGMs currently on the market are required to be removed before an MRI scan, according to their FDA indications".

SENS closed Wednesday's trading at $2.44, down 0.81%.

Shares of SCYNEXIS Inc. (SCYX) jumped over 100% in extended trading on Wednesday, following positive results from the first interim efficacy analysis of its ongoing FURI study.

FURI is a phase III study of investigational drug Ibrexafungerp (formerly SCY-078) in patients with refractory or intolerant fungal disease.

According to the interim analysis of the first 20 treated patients, oral Ibrexafungerp showed clinical benefits in 17 out of 20 patients, with 11 patients achieving a complete or partial response and six patients a stable disease response. Only two patients did not respond to Ibrexafungerp treatment and the outcome for one patient was considered indeterminate.

SCYX closed Wednesday's trading at $0.72, down 2.70%. In after-hours, the stock was up 100% to $1.44.

Surmodics Inc. (SRDX), a provider of medical device and in vitro diagnostic technologies to the healthcare industry, has reported better-than-expected financial results for its fiscal 2019 first quarter ended December 31, 2018.

On a non-GAAP basis, net income for fiscal 2019 first quarter was $1.70 million or $012 per share on revenue of $22.24 million. Analysts polled by Thomson Reuters were expecting a breakeven and revenue of $20.18 million.

The non-GAAP net income in the comparable year-ago quarter was $1.38 million or $0.10 per share on revenue of $17 million.

The Company has also boosted its outlook for fiscal 2019. Accordingly, non-GAAP EPS is now expected to be in the range of $0.02 to $0.22 per share compared with previous expectations of a loss of ($0.07) to earnings of $0.23 per share. The lower end of fiscal 2019 revenue outlook has been increased to $94 million from $92 million, and the upper end of the guidance is maintained at $97 million. Analysts are expecting earnings of $0.09 per share and revenue of $93.76 million for the year.

SRDX closed Wednesday's trading at $52.00, up 6.21%.

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