Stifel analyst Jonathan Block raised his price target on IntriCon (IIN) to $70 from $65 by assigning what he called “relatively conservative sales multiples” to his forecasts for the company’s Medical and Hearing businesses, but he also contends that margin expansion will play an important part to IntriCon’s story in the coming years, giving the stock a path toward $100 per share. Block, who believes IntriCon’s traction with Medtronic (MDT) gives it a long runway for growth, keeps a Buy rating on the shares.
Saturday, September 22, 2018
Protalix reports ‘positive’ preliminary data from Fabry Disease study
Protalix reports ‘positive’ preliminary data from Fabry Disease study Protalix announced “positive” preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry disease, stating that additional data will be released at the 1st Canadian Symposium on Lysosomal Diseases 2018. Preliminary data from the first sixteen patients enrolled in the trial demonstrated an improvement in kidney function when switched from agalsidase alfa to pegunigalsidase alfa, the company said. Based on available historical serum creatinine and study 3 month screening period values for approximately 2 years while treated with agalsidase alfa before switching to pegunigalsidase alfa treatment, the annualized estimated glomerular filtration rate slope for patients on Replagal was -6.8ml/min/1.73m. The mean eGFR slope for the same patients following six months of treatment with pegunigalsidase alfa was changed to be +3.7ml/min/1.73m , these results were statistically significant. Baseline characteristic of these patients were: mean estimated glomerular filtration rate 75.40 and 86.03 mL/min/1.73m2 for males and females, with annualized eGFR slope of -8.0 and -5.1 mL/min/1.73m2/year, respectively.
Sarepta negative CHMP re-exam opinion widely anticipated, says H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay said the CHMP confirming its negative opinion for a Conditional Marketing Application for Sarepta’s eteplirsen was widely anticipated given the prior negative CHMP opinion disclosed on June 1. While a CHMP nod would have represented further upside on the commercial front, the company’s calendar is “chalk full of value drivers” over the next 12 to 18 months, said Chattopadhyay, who remains a buyer on the CHMP-related pullback. He keeps a Buy rating and $267 price target on Sarepta shares, which are down 2% to $149.60 in late morning trading.
Spectrum to hold a conference call
Management discusses the new interim Poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study on a conference call to be held on September 24 at 4:30 pm. Weblink: https://edge.media-server.com/m6/p/rkpd2qij
Baxter eyes big business opportunities in China
Baxter International Inc reported close to double-digit growth in core business revenue over the past few years, given the vast opportunities in the country’s healthcare market, according to its president of the Asia-Pacific region.
Andrew Frye, president of APAC at Baxter and senior vice-president of the company, said China is an “exciting” market.
“In terms of sales, China is the second-largest market for Baxter worldwide. It offers us big business opportunities. China’s acceleration has been dramatic.”
Last year, China contributed a decent portion of the company’s global revenue. The country was second only to Baxter’s home market of the United States, which contributed around 40 percent.
The US-headquartered company said it recognizes the Chinese government’s commitment to expand healthcare to all Chinese people, both rural and urban, as well as its commitment to drive innovation in manufacturing and product development.
“We move with the government initiatives, like the Healthy China 2030 strategy, as well as the increasingly higher-quality standards of products sold in China,” Frye said.
For rural areas in China where there is limited medical access, the company launched a program called “Study on the Accessibility of Peritoneal Dialysis Treatment to Patients with End-Stage Renal Disease and the Grass-Root Management Mode” in 2012, offering home therapy for end-stage renal disease patients.
Joining hands with the National Institute of Hospital Administration under the National Health Commission, Baxter’s dialysis products are delivered directly to patients’ homes in Liaoning, Jiangsu, Zhejiang, Henan, Hubei and Hunan provinces. The initial investment behind the project totaled $5 million.
This kind of home dialysis therapy improves patients’ quality of life, as they do not need to go to the hospital three times a week for dialysis.
“Many people really appreciate that, especially students and elderly people. We also educate doctors to help them teach patients to do the therapy at home.
“Baxter’s mission is to save and sustain lives. We help them to maintain not just their physical health, but their psychological health, so that they can still see friends, and don’t have to undergo blood purification at the hospital,” Frye said.
Fu Qiang, deputy director of the National Institute of Hospital Administration, said, “The program offers a great example of dialysis management. It increases patients’ quality of healthcare and life. It also improves the accessibility of medical care in rural areas.”
In 2017, the company’s sales revenue stood at $10.6 billion, growing 4 percent year-on-year.
On Sept 14, Baxter received the Aon Best Employer award in both China and the Asia Pacific region. The program was designed to improve employee engagement, leadership effectiveness, and employer branding and culture to drive high performance.
Novartis: to file for new Lucentis indication in retinopathy of prematurity
* In the Phase III RAINBOW study, despite marginally missing statistical
significance for the primary endpoint of demonstrating superiority of
Lucentis(®) to laser surgery, Lucentis was shown to be an efficacious, safe
and well-tolerated treatment for infants with ROP [1]
significance for the primary endpoint of demonstrating superiority of
Lucentis(®) to laser surgery, Lucentis was shown to be an efficacious, safe
and well-tolerated treatment for infants with ROP [1]
* Laser surgery, the current standard of care for ROP in infants, destroys
diseased retinal tissue responsible for elevated vascular endothelial growth
factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and
reduces VEGF[2]
diseased retinal tissue responsible for elevated vascular endothelial growth
factor (VEGF) whereas Lucentis is an anti-VEGF that directly targets and
reduces VEGF[2]
* With 80% of patients achieving treatment success with 0.2mg Lucentis versus
66% with laser, these data are clinically relevant[1]
66% with laser, these data are clinically relevant[1]
* Novartis plans to file ex-US for a new indication in ROP to bring
transformative treatment to premature infants facing severe vision loss –
the first anti-VEGF product to seek an ROP indication
transformative treatment to premature infants facing severe vision loss –
the first anti-VEGF product to seek an ROP indication
DAIICHI SANKYO to test cancer drug combo
Daiichi Sankyo has entered into a clinical trial collaboration agreement with a subsidiary of MSD to evaluate a potential new combination therapy for breast or lung cancers.
The combination consists of Daiichi Sankyo`s investigational HER2 targeting antibody drug conjugate DS-8201 and MSDs immunotherapy Keytruda.
Under the agreement, Daiichi Sankyo will carry out a two-part Phase Ib multicenter, open-label study to determine the safety, tolerability and dose of the combination and its efficacy in patients with HER2 expressing advanced/metastatic breast cancer and patients with HER2 expressing or HER2 mutant advanced/metastatic non small cell lung cancer (NSCLC).
The primary endpoints of the study are maximum tolerated dose/recommended expansion dose and overall response rate. Secondary endpoints include duration of response, disease control rate, progression-free survival, overall survival, time to response and safety, the firms said.
“We are excited to pursue this opportunity to evaluate the safety, tolerability and activity of DS-8201 in combination with Keytruda and whether this combination may provide a potential new treatment approach for patients with HER2 expressing advanced breast and non-small cell lung cancer,” said Tom Held, vice president, head, Antibody Drug Conjugate Task Force, Oncology Research and Development, Daiichi Sankyo.
“Strategic collaborations like this support our goal to pursue, investigate and maximize the application of DS-8201 in combination with other compounds that target different pathways to address unmet needs of patients with cancer.”
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