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Novan Announces Top-Line Data From Mid-Stage Molluscum Study
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Novan, Inc. announced full top-line data from its phase II study evaluating its topical nitric oxide candidate, SB206, for the treatment of molluscum contagiosum, a skin infection causing lesions. Data included results from the fourth cohort of the study, evaluating SB206 12% once daily. Last month, Novan announced preliminary top-line data from three arms of the study evaluating twice daily dosages of SB206 4%, 8% and 12%.
Data from the study demonstrated that once daily treatment with SB206 12% achieved reductions in molluscum lesions of statistical significance as early as second week of treatment. It also showed that once daily SB206 12% arm achieved the highest rate of complete clearance in patients at week 12.
The phase II study evaluated SB206 in patients aged two years and older with 3 to 70 molluscum lesions. Data from the once daily SB206 12% arm showed that 38% of patients achieved complete clearance rates compared to 18% for the vehicle. Moreover, reduction in lesions from baseline were 29%, 37%, 56% and 55% at week 2, 4, 8 and 12, respectively.
The company is planning to request an end-of-Phase II meeting with the FDA by the end of this year on the back of availability of full data from the study. Novan plans to initiate a phase III study with once daily SB206 12% and will discuss the structure of the study in the meeting. The late-stage study is expected to be initiated in the first half of next year with top-line data anticipated by the end of 2019 or in early 2020.
Novan’s stock has declined 70.1% this year so far compared with a decrease of 11.3% recorded by the industry.
Per the press release, molluscum contagiosum is a contagious skin infection, which affects around 6 million patients in the United States, especially in pediatric patients. There is no FDA- approved treatment available for the disease so far. Meanwhile, over-the-counter products used for treating molluscum have average treatment duration of 13 months. Thus, successful development of SB206 will be a boost for the company as the candidate has better efficacy and a huge patient population.
Some better-ranked stocks from the same sector include BioSpecifics Technologies Corp , Bellicum Pharmaceuticals, Inc. and Galmed Pharmaceuticals Ltd. (GLMD - Free Report) . While BioSpecifics Technologies sports a Zacks Rank #1 (Strong Buy), Bellicum and Galmedcarry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics Technologies’earnings estimates have increased from $2.28 to $2.50 for 2018 and from $2.38 to $2.78 for 2019 over the past 60 days. The company delivered positive earnings surprise in three of the four trailing quarters with the average beat being 17.04%. The stock is up 41.7% so far this year.
Bellicum’s loss estimates have narrowed from $2.37 to $2.30 for 2018 and from $2.22 to $2.01 for 2019 over the past 60 days. The company came up with a positive earnings surprise in three of the four trailing quarters with the average beat being 3.52%.
Galmed’s loss per share estimates have narrowed from 59 cents to 48 cents for 2018 and from $1.06 to $1.00 for 2019 over the past 60 days. The company delivered a positive surprise in two of the four trailing quarters with the average beat being 16.69%.
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Novan Announces Top-Line Data From Mid-Stage Molluscum Study
Novan, Inc. announced full top-line data from its phase II study evaluating its topical nitric oxide candidate, SB206, for the treatment of molluscum contagiosum, a skin infection causing lesions. Data included results from the fourth cohort of the study, evaluating SB206 12% once daily. Last month, Novan announced preliminary top-line data from three arms of the study evaluating twice daily dosages of SB206 4%, 8% and 12%.
Data from the study demonstrated that once daily treatment with SB206 12% achieved reductions in molluscum lesions of statistical significance as early as second week of treatment. It also showed that once daily SB206 12% arm achieved the highest rate of complete clearance in patients at week 12.
The phase II study evaluated SB206 in patients aged two years and older with 3 to 70 molluscum lesions. Data from the once daily SB206 12% arm showed that 38% of patients achieved complete clearance rates compared to 18% for the vehicle. Moreover, reduction in lesions from baseline were 29%, 37%, 56% and 55% at week 2, 4, 8 and 12, respectively.
The company is planning to request an end-of-Phase II meeting with the FDA by the end of this year on the back of availability of full data from the study. Novan plans to initiate a phase III study with once daily SB206 12% and will discuss the structure of the study in the meeting. The late-stage study is expected to be initiated in the first half of next year with top-line data anticipated by the end of 2019 or in early 2020.
Novan’s stock has declined 70.1% this year so far compared with a decrease of 11.3% recorded by the industry.
Per the press release, molluscum contagiosum is a contagious skin infection, which affects around 6 million patients in the United States, especially in pediatric patients. There is no FDA- approved treatment available for the disease so far. Meanwhile, over-the-counter products used for treating molluscum have average treatment duration of 13 months. Thus, successful development of SB206 will be a boost for the company as the candidate has better efficacy and a huge patient population.
Novan Inc. Price
Novan Inc. Price | Novan Inc. Quote
Zacks Rank & Stocks to Consider
Novan currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same sector include BioSpecifics Technologies Corp , Bellicum Pharmaceuticals, Inc. and Galmed Pharmaceuticals Ltd. (GLMD - Free Report) . While BioSpecifics Technologies sports a Zacks Rank #1 (Strong Buy), Bellicum and Galmedcarry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics Technologies’earnings estimates have increased from $2.28 to $2.50 for 2018 and from $2.38 to $2.78 for 2019 over the past 60 days. The company delivered positive earnings surprise in three of the four trailing quarters with the average beat being 17.04%. The stock is up 41.7% so far this year.
Bellicum’s loss estimates have narrowed from $2.37 to $2.30 for 2018 and from $2.22 to $2.01 for 2019 over the past 60 days. The company came up with a positive earnings surprise in three of the four trailing quarters with the average beat being 3.52%.
Galmed’s loss per share estimates have narrowed from 59 cents to 48 cents for 2018 and from $1.06 to $1.00 for 2019 over the past 60 days. The company delivered a positive surprise in two of the four trailing quarters with the average beat being 16.69%.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>