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Innocoll (INNL) Down on FDA's Refusal to File Xaracoll NDA
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Innocoll Holdings plc announced that it has received a Refusal to File letter from the FDA in connection with the New Drug Application (NDA) for its pipeline candidate, Xaracoll, (bupivacaine HCl collagen-matrix implants) for the treatment of postsurgical pain.
Following the announcement, the company’s shares were down almost 50% in after-market trading session on Dec 29.
Year-to-date, Innocoll’s stock has plunged almost 78.7%, underperforming the Zacks classified Medical Drugs industry which has witnessed a declined of 25.4% in the same time frame.
Notably, Innocoll had submitted the NDA in Oct 2016, based on positive results from the phase III MATRIX studies that demonstrated statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.
However, the FDA deemed the application insufficient after a preliminary review and consequently, the regulatory body now requires additional supporting information to review the application.
In the letter, the FDA stated that the candidate should be characterized as a drug/device combination and that the company should submit additional information.
Notably, Innocoll mentioned that it will request the FDA for a Type A meeting in a bid to resolve the issues. The company expects to disclose additional details on Xaracoll after discussions with the FDA.
The FDA’s refusal for Xaracoll’s NDA is a major setback for the company. Moreover, since the FDA requires additional information, the company might have to conduct more studies involving extra cost and time outlay.
Going forward, we expect investors to remain focused on further updates on this development surrounding Xaracoll.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 in the last 60 days. For 2017, its loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.52 for 2017 in the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
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Innocoll (INNL) Down on FDA's Refusal to File Xaracoll NDA
Innocoll Holdings plc announced that it has received a Refusal to File letter from the FDA in connection with the New Drug Application (NDA) for its pipeline candidate, Xaracoll, (bupivacaine HCl collagen-matrix implants) for the treatment of postsurgical pain.
Following the announcement, the company’s shares were down almost 50% in after-market trading session on Dec 29.
Year-to-date, Innocoll’s stock has plunged almost 78.7%, underperforming the Zacks classified Medical Drugs industry which has witnessed a declined of 25.4% in the same time frame.
Notably, Innocoll had submitted the NDA in Oct 2016, based on positive results from the phase III MATRIX studies that demonstrated statistically significant differences in the primary endpoint, the sum of pain intensity in both studies, as well as statistically significant reductions in opioid use and other secondary endpoints.
However, the FDA deemed the application insufficient after a preliminary review and consequently, the regulatory body now requires additional supporting information to review the application.
In the letter, the FDA stated that the candidate should be characterized as a drug/device combination and that the company should submit additional information.
Notably, Innocoll mentioned that it will request the FDA for a Type A meeting in a bid to resolve the issues. The company expects to disclose additional details on Xaracoll after discussions with the FDA.
The FDA’s refusal for Xaracoll’s NDA is a major setback for the company. Moreover, since the FDA requires additional information, the company might have to conduct more studies involving extra cost and time outlay.
Going forward, we expect investors to remain focused on further updates on this development surrounding Xaracoll.
INNOCOLL HLDGS Price and Consensus
INNOCOLL HLDGS Price and Consensus | INNOCOLL HLDGS Quote
Innocoll currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Vanda Pharmaceuticals Inc. (VNDA - Free Report) , MannKind Corporation (MNKD - Free Report) and Arbutus Biopharma Corporation (ABUS - Free Report) . All of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 in the last 60 days. For 2017, its loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.52 for 2017 in the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>