We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Proteon Slips to 52-Week Low on Kidney Disease Study Data
Read MoreHide Full Article
Proteon Therapeutics, Inc. announced disappointing top-line data from the first phase III study (PATENCY-1) on its lead candidate, vonapanitase (formerly known as PRT-201), in patients with chronic kidney disease (CKD). Shares of the company tumbled approximately 75% on the news to a 52-week low of $2.50 on Dec 13.
Proteon’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, the stock has tumbled 36.2% so far this year, while the industry registered a decline of 26.3%.
What Led to the Share Price Decline?
The multi-center, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of a single dose of vonapanitase in patients with CKD, receiving or expecting to receive hemodialysis, who underwent surgical creation of a radiocephalic arteriovenous fistula. Thus, the study enrolled 313 patients, who were followed for up to one year.
Data showed the study failed to meet the primary endpoint of improved primary unassisted patency, defined as the length of time from fistula surgical creation to the first occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency (blood flow) in comparison to placebo. In the study, patients receiving vonapanitase experienced a reduction of 17% in the risk of primary unassisted patency loss over one year when compared to placebo. In addition, 42% of patients on the vonapanitase arm retained primary unassisted patency, in comparison to 31% in the placebo arm at the end of one year.
However, data indicated that vonapanitase may improve secondary patency (secondary endpoint – length of time from surgical creation until fistula abandonment (final failure)) compared to placebo. In fact, patients treated with vonapanitase witnessed a reduction of 34% in the risk of secondary patency loss over one year compared with placebo.
Further, data on one of the study’s three tertiary endpoints demonstrated that vonapanitase may improve unassisted fistula use for hemodialysis and any use of the fistula (unassisted or assisted) for hemodialysis. On the safety front, adverse events reported for vonapanitase were similar to placebo.
Although the study results are far from impressive as the candidate has missed the primary endpoint, its performance with respect to the secondary measure raises optimism.
Proteon intends to review the full data set from the PATENCY-1 study and further evaluate these results in the ongoing second phase III study, PATENCY-2.
Owing to the clinical importance of fistula abandonment and fistula use for hemodialysis for both patients and physicians, the company plans to increase the enrollment of patients in the PATENCY-2 study. Enrollment is expected to be complete in the first quarter of 2017. Top-line data from this study should be out in the second quarter of 2018.
As per the company’s press release, there is no FDA-approved preventative treatment for the improvement of fistula patency, representing significant unmet medical need. Vonapanitase has the potential to become an important treatment option for the eligible patient population, if developed successfully.
We note that vonapanitase enjoys Fast Track and Orphan Drug status in the U.S., and Orphan Medicinal Product status in the EU for hemodialysis vascular access indications.
Meanwhile, Proteon is currently conducting a couple of phase I studies on the candidate for the treatment of peripheral artery disease.
In the press release, Proteon reported cash, cash equivalents and available-for-sale investments of $43.3 million, as of Nov 30, 2016. The company anticipates these financial resources to be sufficient to fund its operations into the third quarter of 2018, based upon changes it intends to implement in the operating plan.
Proteon currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include MannKind Corporation (MNKD - Free Report) , Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over 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%. Its share price has surged almost 73% year to date.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, 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%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Proteon Slips to 52-Week Low on Kidney Disease Study Data
Proteon Therapeutics, Inc. announced disappointing top-line data from the first phase III study (PATENCY-1) on its lead candidate, vonapanitase (formerly known as PRT-201), in patients with chronic kidney disease (CKD). Shares of the company tumbled approximately 75% on the news to a 52-week low of $2.50 on Dec 13.
Proteon’s year-to-date share price movement shows that the stock has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, the stock has tumbled 36.2% so far this year, while the industry registered a decline of 26.3%.
What Led to the Share Price Decline?
The multi-center, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of a single dose of vonapanitase in patients with CKD, receiving or expecting to receive hemodialysis, who underwent surgical creation of a radiocephalic arteriovenous fistula. Thus, the study enrolled 313 patients, who were followed for up to one year.
Data showed the study failed to meet the primary endpoint of improved primary unassisted patency, defined as the length of time from fistula surgical creation to the first occurrence of a fistula thrombosis or corrective procedure to restore or maintain patency (blood flow) in comparison to placebo. In the study, patients receiving vonapanitase experienced a reduction of 17% in the risk of primary unassisted patency loss over one year when compared to placebo. In addition, 42% of patients on the vonapanitase arm retained primary unassisted patency, in comparison to 31% in the placebo arm at the end of one year.
However, data indicated that vonapanitase may improve secondary patency (secondary endpoint – length of time from surgical creation until fistula abandonment (final failure)) compared to placebo. In fact, patients treated with vonapanitase witnessed a reduction of 34% in the risk of secondary patency loss over one year compared with placebo.
Further, data on one of the study’s three tertiary endpoints demonstrated that vonapanitase may improve unassisted fistula use for hemodialysis and any use of the fistula (unassisted or assisted) for hemodialysis. On the safety front, adverse events reported for vonapanitase were similar to placebo.
Although the study results are far from impressive as the candidate has missed the primary endpoint, its performance with respect to the secondary measure raises optimism.
Proteon intends to review the full data set from the PATENCY-1 study and further evaluate these results in the ongoing second phase III study, PATENCY-2.
Owing to the clinical importance of fistula abandonment and fistula use for hemodialysis for both patients and physicians, the company plans to increase the enrollment of patients in the PATENCY-2 study. Enrollment is expected to be complete in the first quarter of 2017. Top-line data from this study should be out in the second quarter of 2018.
As per the company’s press release, there is no FDA-approved preventative treatment for the improvement of fistula patency, representing significant unmet medical need. Vonapanitase has the potential to become an important treatment option for the eligible patient population, if developed successfully.
We note that vonapanitase enjoys Fast Track and Orphan Drug status in the U.S., and Orphan Medicinal Product status in the EU for hemodialysis vascular access indications.
Meanwhile, Proteon is currently conducting a couple of phase I studies on the candidate for the treatment of peripheral artery disease.
In the press release, Proteon reported cash, cash equivalents and available-for-sale investments of $43.3 million, as of Nov 30, 2016. The company anticipates these financial resources to be sufficient to fund its operations into the third quarter of 2018, based upon changes it intends to implement in the operating plan.
PROTEON THERAPT Price and Consensus
PROTEON THERAPT Price and Consensus | PROTEON THERAPT Quote
Zacks Rank & Key Picks
Proteon currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include MannKind Corporation (MNKD - Free Report) , Sucampo Pharmaceuticals, Inc. and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.69 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
Vanda’s loss estimates narrowed from 62 cents to 52 cents for 2016, while its earnings estimates increased from 13 cents to 22 cents for 2017 over 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%. Its share price has surged almost 73% year to date.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, 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%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>