From seeking alpha:With the rapidly evolving HCV treatment landscape, we know the bar for safety is high. And based on a different
I’m pleased to report important progress with our HCV programs. First, we’re happy to tell you today that a novel next-generation uridine nucleotide prodrug inhibitor IDX21437 has received approval to enter clinical trials in both Canada and Belgium. Based on its promising early profile IDX21437 was selected as one of our lead drug candidates resulting from our comprehensive nucleotide discovery effort that we have been discussing over the past few years.
Extensive preclinical testing demonstrated a clean safety profile including no cardiac or genotoxicity signals. This along with favorable antiviral activity across genotypes 1 through 6 supported the advanced of this compound into the clinic. We have initiated enrollment for the healthy volunteer portion of a Phase I/II study, which will evaluate the safety and pharmacokinetics of single doses of IDX21437 and we anticipate dosing to begin next week.
In parallel sequential single doses of IDX21437 will be administered to HCV infected patients. The single dose safety PK and antiviral activity will come from the selected doses for the seven-day proof-of-concept portion of the study which will evaluate patients in fact through genotypes 1 through 6 and cirrhotic HCV genotype 1 infected patients.
For IDX2963 an additional uridine nucleotide prodrug candidate we are conducting further preclinical work in response to the FDA’s request related to the positive in vitro Ames test result observed in our IND enabling studies, prior to the initiation of clinical trials. A key objective for our development teams has been to commence a clinical trial for our nucleotide prodrug program this year.
contd: On the target side, obviously, you will see was great to see them launch 16-gig support. That, I think, will help the overall transition to 16-gig because we'll see this end-to-end connectivity now. It won't just be switches, but you'll have not only the arrays and also the servers that can deploy 16-gig and get the performance benefits of that. We do have a number of other target design wins that we're in-flight on. They have varying launch timelines. And obviously before our customers announced, it's pretty confidential. So we can't share a lot of detail there. Suffice to say, I think we put a dagger in the comments from our competition saying they're closing the space and they own all of it and they've got all of these design wins. So I think we just put -- we put on ice on that one. But I do think that we certainly got tens -- multiple tens of design wins that we're working on and we see -- when you look at the opportunity, I think we used to call it incremental opportunity because one of the chief competitors stepped out of the space. We still see it as a kind of $60 million to $80 million opportunity. But that's once everyone's launched, and we will get all of that because we know our chief competitor in Fibre Channel will get some of those wins as well. But it's a nice lift, and it's great to see EMC participate and one of the guys that owns 30% of the market in this space.
contd: And if you're familiar with this kind of a business, it takes multiple quarters to close on those opportunities because there's qualifications and budget as to get approved by customers and the way that rolls out. But as we look at it, we're pleased with the traction in this space. We kind of talked about 3 key initiatives around growing sales and marketing, but growing it, kind of self-funding it with synergies. We've talked about expansion of the partners and the alliances in that space, and we announced a couple of big ones this quarter, Splunk was one that kind of comes to mind, making it easy to connect our appliance to their analytics. And then the third element is growing the channel and getting help from great partners like WWT and Arrow, which are incrementally new relationships, help us there as well. So, so far, I'm pleased with the new leadership has brought to Mike Riley's team. Mike and the team are hitting on the cylinders. We're getting some leverage out of the combined businesses and feeling generally pretty good about the opportunity. That's -- one thing that helps this year is the market they're participating in, while -- it's a few hundred million today, but it's kind of growing at 25% CAGR according to Frost & Sullivan, who spends time on this market. So we're always hitting about 16% of that market. So there's a lot of opportunity for us to gain some share and to grow faster, so that's where we're pretty focused on. So that's kind of the Endace piece. Now switching to 16-gig, we saw about 6% of the business in the quarter on Fibre Channel 16-gig. We think that, that will kind of continue to grow the Endace kind of say in 10% by the end of the year. And we think we're really well positioned, being at #1 share position there. You also were asking about targets specifically. The target wins do come later, right? So we've got all these server OEMs qualified and we're in every single server OEM on the planet.
from seeking alpha:
Jeffrey W. Benck - Chief Executive Officer, President and Director
Thanks, Mike. As you can see from our results, Q1 was the solid quarter where we delivered both top line revenue and EPS that exceeded the high end of our guidance. The team is executing well under challenging macro environment, but we can continue to improve from here. There's a lot of opportunity to be distracted by forces outside of the company right now, but we're staying focused on the opportunities in front of us.
Emulex continues to lead the market in the 16-gig Fibre Channel transition and has achieved 3 straight years of market share gains in the Fibre Channel market, gaining nearly 5 points of market share over the last year, according to the Dell'Oro Group.
We have 2 revenue growth engines. One is network visibility and monitoring from our Endace acquisition, and the other is Ethernet connectivity with our OneConnect 10-gig and new 40-gig solutions.
The industry's speed transition from 1 to 10-gig at the server level and 10 to 40-gig in the backbone of the data center is the natural driver for these opportunities. And we're not even halfway through these speed transitions.
Our operating model is already showing the benefit from the increased focus on operational efficiency, and we are committed to finding incremental opportunities to improve our near-term profitability and increase
On Endace, we're on track to become 10%, which obviously we're 9%, right, already. So we're moving in that direction. It -- we do expect it to be a bit lumpy as we grow of the pipeline of opportunities. It's not a big -- not a huge business yet, but we see strength in the pipeline as we go.
From Streetinsider: Emulex Corp. (ELX) Tops Q1 EPS by 3c; Issues Solid Outlook for Q2.
Emulex Corp. (NYSE: ELX) reported Q1 EPS of $0.13, $0.03 better than the analyst estimate of $0.10. Revenue for the quarter came in at $114.8 million versus the consensus estimate of $111.6 million.
Sees Q2 revenues of $118 - $124 million, versus the consensus of $119.84 million. Sees Q2 EPS of $0.15 - $0.17 versus the consensus of $0.15.
-- Enrollment initiated for a phase I/II clinical trial for IDX21437, a next- generation uridine nucleotide prodrug inhibitor for the treatment of hepatitis C virus infection (HCV)
-- Initiation planned for HELIX-2 combination study in collaboration with Janssen Pharmaceuticals, Inc. including pan-genotypic HCV NS5A inhibitor, samatasvir
IRWD' growth thesis intact, Linzess sales ramping up, other lucrative indications on tap, stock a steal at these levels!!!!
Sentiment: Strong Buy
Hovering around the 52 week low, heavy put buying today ahead of earnings, a little whiff of good news about Linzess will set IRWD soaring!!
Sentiment: Strong Buy
Ironwood Pharmaceuticals Receives Outperform Rating from Zacks (IRWD)
Posted by John Perry on Oct 18th, 2013 // No Comments
Ironwood Pharmaceuticals Inc. logoZacks reiterated their outperform rating on shares of Ironwood Pharmaceuticals (NASDAQ:IRWD) in a research report sent to investors on Wednesday morning, American Banking & Market News reports. The firm currently has a $13.00 price target on the stock.
Zacks’ analyst wrote, “We are initiating coverage on Ironwood with an Outperform recommendation and a target price of $13.00. Linzess’ approval for irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) was a major milestone for the company. We are encouraged by Ironwood’s efforts to expand Linzess’ label to include other indications such as opioid-induced constipation. We are also positive on Ironwood’s partnerships with big pharma companies for the development and commercialization of Linzess in different territories. We believe that the company is well positioned to gain share in the IBS-C market. Based on these factors, we believe the current price represents an attractive entry point for long term investors. “