Cowen analyst Joshua Jennings reiterated a Outperform rating and $9.50 price target on Cerus (NASDAQ: CERS) after meeting with management
Friday, July 5, 2019
Sernova touts first-in-human results from insulin-secreting cell implant for diabetes
In the first patient to receive its pancreatic cell implant for type 1 diabetes, Sernova’s insulin-secreting Cell Pouch showed no adverse events related to the therapy, and was able to help maintain blood sugar levels over at least two weeks.
In interim results from the phase 1/2 study, the transplant of purified islets demonstrated the production of insulin as well as stimulated C-peptide, a biomarker of the pancreas’ effectiveness in responding to rising glucose levels after eating.
Additionally, the regenerative Cell Pouch was found to integrate well with the blood and lymph vessels of the patient—who saw a weight loss of about 14 pounds (6.35 kg), or about 12% of total body weight.
“The first of two doses of islets transplanted into the Cell Pouch is showing safety and early indicators of efficacy. Importantly, demonstration of glucose-stimulated C-peptide and insulin present in the bloodstream is definitive proof of islet survival and function in the Cell Pouch,” said principal investigator Piotr Witkowski, director of the pancreatic and islet transplant program at the University of Chicago.
Using a continuous glucose monitoring system, the patient saw an 87.5% reduction in hypoglycemic events compared to baseline over a two-week period, according to Sernova. In addition, stimulated blood levels of C-peptide and insulin were observed 90 days after the transplant, in a mixed meal tolerance test.
“These results are an important first step towards a paradigm shift in the treatment of this debilitating disease. Our team is looking forward to reporting longer-term results in enrolled patients as the trial progresses,” Witkowski said. The data were presented at the World Congress of the International Pancreas and Islet Transplantation Association in Lyon, France.
Newly enrolled patients with severe hypoglycemia unawareness—where sharp drops in blood sugar fail to trigger the release of epinephrine and common symptoms—will be implanted with cell pouches and stabilized on immunosuppression following the development of vascular tissue and a dose of purified islets.
After six months of monitoring and an assessment of the transplant’s success, patients may receive a second dose of islet cells and will be followed for another year.
Saliva-based monitor Glucose Biosensor Systems re-files for a $23 million US IPO
Glucose Biosensor Systems (Greater China) Holdings, which is developing a saliva-based glucose monitoring system for diabetes in China, filed on Friday with the SEC to raise up to $23 million in an initial public offering.
Glucose Biosensor Systems originally filed to list on the Nasdaq in October 2018 under Regulation A+ in a $9 million to $25 million best-efforts offering with Cuttone & Co serving as placement agent; it withdrew its Reg A+ filing in March 2019.
The New York, NY-based company was founded in 2016 and booked $0.7 million in revenue for the 12 months ended March 31, 2019. It plans to list on the NYSE American under the symbol GBSG. Glucose Biosensor Systems filed confidentially on May 13, 2019. Aegis Capital Corp. is the sole bookrunner on the deal. No pricing terms were disclosed.
Karyopharm up as analysts boost targets on FDA approval
Karyopharm Therapeutics (NASDAQ:KPTI) is up 3% on its return to regular-session trading after it spiked 36% in Wednesday’s shortened session amid an FDA approval for its selinexor, for treatment of penta-refractory multiple myeloma.
Shares today hit their highest point since mid-November, while analysts responded by raising price targets.
Baird boosted its target to $25 from $15 — implying 173% upside — and modeled $150M peak annual sales for the later-line approval. It says accelerated approval de-risks the market in second-line relapsed multiple myeloma, the more meaningful market.
Meanwhile RBC raised its target to $22 from $16, pointing to the lack of the most serious caution on the label: “The label includes no boxed warning, a win, and while it describes in detail the many AEs (adverse events) associated with Xpovio and the need for monitoring, it provides clear dose- adjustment schemes and guidelines for AE management.”
Drug stocks slip after Trump talks up `favored nations’ plan
Pharmaceutical stocks dip after President Trump says his administration is working on a system that would allow the U.S. to buy drugs based on the lowest prices paid by other countries.
“We’re working on right now a favored-nations clause,” he told reporters at the White House.
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