Sales most recent quarter with YoY comparison. Both EGHT and RNG increased their growth rate in Q2.
RNG: $52.8M, +40%
EGHT: $37.9M, +30%
VBS coming up Thursday. I read recently that the big carriers (T, VZ) are having problems cracking the business market.
Movantik IS a drop in the bucket for AZN. It barely received mention when AZN was fending off PFE. Approval in the US and EU is a big deal for NKTR. The upfront cash relieves a lot of the financing pressure for NKTR's expensive development programs.
Telecoms now allowed to put assets in REIT and lease them back. Capital to be freed up. It's a big deal.
Very good FOLFIRI news. This is the largest use of irinotecan. NKTR should have pursued this from day one instead of single agent against colorectal and ovarian cancer.
So he's likely using today as an opportunity to dump his holdings of CUV. Penny stock pump and dump manipulation tactics. That sounds like Shkreli.
Clinuvel Pharmaceuticals Limited (“Clinuvel”; ASX: CUV) received an unsolicited proposal from Retrophin, Inc. (“Retrophin” NASDAQ: RTRX) on July 17, 2014 to acquire all of the shares in Clinuvel for either 0.175 Retrophin shares per Clinuvel share (valued at $2.14 per share based on the one month VWAP of Retrophin shares on 16 July 2014) or $2.17 in cash per share via a scheme of arrangement. The Retrophin bid values Clinuvel at approximately A$95 million2.
The proposal is subject to numerous conditions. Retrophin has acquired a stake of approximately 4.88% in Clinuvel.
The Board of Directors of Clinuvel is evaluating all aspects of the proposal with a focus on optimising shareholder value. Greenhill is acting as financial adviser and Arnold Bloch Leibler as legal adviser to Clinuvel.
Clinuvel shareholders are advised to take NO ACTION with respect to their Clinuvel shares.
Look for "Less Toxic Transplant Treatment for Sickle Cell" from the WebMD site.
Mixing donor cells with patient cells reduces the need for transplant rejection medication in many patients. Technique can be used on adult patients. High reversal rate in cases where transplant isn't rejected.
Look for "Long-term results of related myeloablative stem-cell transplantation to cure sickle cell disease".
Transplant of cells from closely matching donor essentially results in cure... except in case of transplant rejection. Patients must be heavily treated with rejection medications, which can create their own problems. Patients must also be treated at a young age.
mm, demonstrating your top notch investigative skills. Does this help?
WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., July 25, 2014 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary (AMGN), today announced that an investigational Phase 3 trial of NEXAVAR® (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).
The RESILIENCE (Phase 3 TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2–Negative Breast CancEr) trial was a randomized, double-blind, placebo-controlled Phase III study which enrolled 537 patients in more than 20 countries, including the United States, Europe, Japan and Australia. The study evaluated sorafenib in combination with capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer who are resistant to or failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline is not indicated.
The primary endpoint of the study was progression-free survival. Secondary endpoints included overall survival, time to progression, overall response rate, disease control rate, duration of response, patient reported quality of life and safety. Patients were randomized to receive either 600 mg of oral sorafenib or matching placebo daily on a continuous schedule, in addition to 1,000 mg/m2 of capecitabine twice daily for 14 days of a 21 day cycle.
Given all the breathless headlines in the earnings release. Facts are that wireless margins are falling and the Leap acquisition looks like a major failure.
In an adjuvant setting. Stock triples AH. This is what will happen to NKTR in the unlikely event that NKTR-102 MBC extends life two months plus compared to TPC. Equivalent OS with reduced AE's are all NKTR really needs for approval.
More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of two years after randomization in the trial.
The primary endpoint of the trial was disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.
If the FDA requires data that APPY doesn't have, you could be looking at years and $M's to run further studies. Need clarification from the company.
APPY got a CRL. This is from the FDA web site.
"A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA)."
What you people seem to ignore is that the FDA asked for more data. In other words, the data APPY supplied is insufficient for approval. It is very likely data that APPY doesn't even have, otherwise it would have been submitted in the NDA.
"Venaxis is compiling responses to the FDA's questions and their requests for additional data and information"
Even though the company deftly avoided using the term in the PR.