UBS analyst Daniel Brennan initiated Thermo Fisher with a Buy rating and $295 price target.
Tuesday, October 9, 2018
Express Scripts introduces Medicare Prescription Drug Plan offerings for 2019
Express Scripts introduced its Express Scripts Medicare Prescription Drug Plan, or PDP, offerings for 2019, offering seniors three high-value options for coverage and savings. The company’s popular, low-premium Saver plan, which made its debut in 2018, will continue to provide affordable access to more than 2,800 commonly used medications while offering an expanded preferred pharmacy network that will now include Walmart in addition to CVS Pharmacy and the Kroger Family of Pharmacies.
Arbutus Biopharma provides update on HBV development programs
Arbutus Biopharma provided an update on its key HBV development programs. AB-506, the company’s second generation capsid inhibitor, has progressed through the healthy volunteer portion of a multi-component phase 1a/1b study in which it was demonstrated to be generally safe and well-tolerated after 10 days of dosing. This month, AB-506 will enter the 28-day HBV patient portion of the trial, where it will be evaluated both with and without a nucleoside analog. AB-452 is a novel, orally available RNA-destabilizer that has shown compelling anti-viral effects in multiple preclinical models. AB-452 is a new chemical entity acting via a novel mechanism and the company is taking the time needed to further characterize the compound following emerging nonclinical safety findings before initiating clinical studies. At present, this is expected to delay the initiation of the phase 1 program while the company completes the ongoing nonclinical studies. ARB-1467, an RNAi agent targeting HBV replication and antigen production, is currently in a 30-week study in HBV patients, in combination with tenofovir and PEG-IFN. To date, six HBV patients have enrolled and been treated. Three patients did not meet the predetermined response criteria at week 6 to proceed to PEG-IFN treatment as per protocol. Two patients have not yet progressed to the six-week analysis point to determine if the addition of PEG-IFN is warranted. One patient has responded strongly, with a 3.17 log reduction in HBsAg level at treatment week 14 of under 4 IU/mL having started with a baseline level of greater than 6000 IU/mL, indicating that this regimen may drive HBsAg levels to undetectable in some patients. The study remains open to enrollment and the company will provide periodic updates. AB-729. Arbutus is developing a second-generation RNAi agent, AB-729, a subcutaneously-administered GalNAc conjugate, targeting HBV. In preclinical models AB-729 exhibits potent and durable reductions in HBsAg. This agent is expected to enter clinical studies in Q2 2019 and may be combined with AB-506 in a clinical study in 2H 2019.
Celmatix, Oncotest-Teva announce commercial agreement for Fertilome test
Celmatix has announced a commercial agreement with Oncotest-Teva, a subsidiary of Teva Pharmaceutical Industries, in Israel to bring the Fertilome test, the world’s first multigene panel test for a woman’s reproductive health and fertility, to the Israeli market. This partnership represents the first strategic international collaboration for Celmatix and will make the Fertilome genetic test widely available to women through their doctors in Israel. With the Fertilome test, Celmatix is ushering in a new era of personalized medicine in reproductive health. With this collaboration, the company is taking that movement global. A simple blood test ordered by a doctor, the Fertilome test can empower women to be more proactive about their family building by revealing whether they have genetic markers that have been associated with fertility-affecting conditions such as recurrent pregnancy loss, primary ovarian insufficiency, endometriosis, and polycystic ovary syndrome.
Morgan Stanley keeps Equal Weight rating on Perrigo after CEO change
After Perrigo announced that Murray Kessler will replace Uwe Roehrhoff as President and CEO, Morgan Stanley analyst David Risinger said the “good news” is that Kessler has an “impressive history” and a strong track record of creating shareholder value. However, he will need to learn Perrigo’s businesses and markets and Risinger is concerned that the change raises questions about Perrigo’s prospects given that Roehrhoff was appointed in January of this year. The fact that Perrigo’s press release did not include a reiteration of financial guidance could cause investors to wonder if there is any risk to that outlook, added the analyst, who keeps an Equal Weight rating on Perrigo shares.
Sermonix Pharmaceuticals launches Phase 2 trial to evaluate oral lasofoxifene
Sermonix Pharmaceuticals announced the launch of a Phase 2 trial for the treatment of metastatic breast cancer. The program is an open-label, randomized, multi-center study evaluating the activity of its lead investigational drug, oral lasofoxifene, versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. Linical Accelovance Group, a mid-size global contract research organization, will serve as Sermonix’s research partner for the study, enrolling 100 patients in 27 sites across the U.S. The trial will utilize oral lasofoxifene for advanced breast cancer patients with ESR1 gene mutations. The primary clinical endpoint will be progression-free survival. Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator, which Sermonix licensed from Ligand Pharmaceuticals.
Nymox: Gleason grade progression cut 81% in Phase 2b prostate cancer trial
Nymox Pharmaceutical announced new long-term clinical trial results from the company’s 146 patient Phase IIb NX03-0040 Fexapotide U.S. study for low grade localized prostate cancer. All patients in the 78 month study had greater than or equal to 56 months from the time of enrollment, with a range of 56 to 78 months. After 78 months, the data shows that men who received the high dose Fexapotide 15mg single dosage treatment had a 73% reduction in the need for surgery or radiotherapy associated with much more favorable biopsy Gleason results compared to controls. There were 5% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81%. In the low grade localized prostate cancer trial reported today, Fexapotide triflutate was administered by a single painless injection directly into the prostate in a simple procedure requiring several minutes or less in an office setting without sedation or anesthesia, and guided by routine ultrasound. FT was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040. The patients were then biopsied after 6 weeks and then every 18 months, along with serial PSA measurements and long-term follow-up. After 78 months of study, high dose FT 15mg single treatment resulted in 73% less surgery or radiotherapy associated with Gleason grade progression, and both doses of FT as a group were overall effective. The 15mg dose was more effective than the lower dose. There were 5% patients in the entire FT group who showed increase in their Gleason primary pattern grade in the 78 month study, compared to controls where the incidence of grade 4 or higher primary pattern was 26.3%, a reduction of 81%.
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