Eidos Therapeutics initiated with a Buy at BTIG. BTIG analyst Thomas Shrader initiated Eidos Therapeutics with a Buy rating and a $38 price target, saying that most of Eidos’ stock growth over the next two years is “likely to result from appreciation of the TTR market size… and AG10’s attractive properties.”
Wednesday, April 17, 2019
NEJM reports ‘medical breakthrough’ in Mustang Bio cell and gene therapy
Mustang Bio announced that the New England Journal of Medicine has published data from St. Jude Children’s Research Hospital, the nation’s “leading hospital” for understanding, treating and curing childhood cancer and other life-threatening diseases. The data comes from a Phase 1/2 clinical trial of a lentiviral gene therapy for the treatment of newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as “bubble boy disease.” Under a licensing agreement with St. Jude, Mustang will develop the lentiviral gene therapy for commercial use as MB-107. The multi-center Phase 1/2 clinical trial is evaluating the safety and efficacy of a lentiviral vector to transfer a normal copy of the IL2RG gene to bone marrow stem cells in newly diagnosed infants under the age of two with XSCID, preceded by low exposure-targeted busulfan conditioning. A total of 10 infants have received the therapy to date in this clinical trial. Among the data highlights, bone marrow harvest, busulfan conditioning and cell infusion were well tolerated. In seven of the eight cases, normalization of naive T-cell and natural killer cell numbers occurred within three to four months after treatment, accompanied by vector marking in T, B, NK and myeloid cells and marrow progenitors. All patients cleared previous infections and are growing normally. Seven of the eight infants treated have developed normal IgM levels to date. Most patients were discharged from the hospital within one month.
LabCorp to purchase Envigo’s nonclinical contract research services business
LabCorp’s Covance Drug Development segment will acquire Envigo’s nonclinical research services business and Envigo’s Research Models Services business will acquire the Covance Research Products business. This will result in Envigo becoming a pure-play research models and services business, while Covance will expand its global nonclinical drug development capabilities. The proposed transactions are subject to labor consultations, regulatory approvals and customary closing conditions, and are expected to close within two months. Covance and the new Envigo research models and services entity will enter into a multi-year renewable supply agreement. The proposed transactions will result in net implied cash consideration to be paid by LabCorp of $485M. The net impact of the proposed transactions will be an incremental $156M in LabCorp’s revenues on a pro forma 2018 basis. The proposed transactions are expected to meet LabCorp’s financial criteria of earnings and cash accretion in year one and exceeding the cost of capital by year three.
Ultragenyx Analyst Day saw positive DTX701, DTX301 updates: Piper Jaffray
Piper Jaffray analyst Christopher Raymond kept his Overweight rating and $75 price target after its Analyst Day presentations which “highlighted meaningful updates across the board for clinical assets as well as early- and late-stage programs currently in development.” The analyst says he continues to recommend the stock given the “number of near-term catalysts on the horizon” along with “three additional programs expected to enter the clinic in 2020.”
FDA Approves Plenity, New Gel To Aid In Weight Loss
A powerful new tool in the battle of the bulge has just been approved by the FDA.
The new capsule is swallowed like a pill, but it’s not a drug, it’s a gel to make people feel full, reports CBS2’s Dr. Max Gomez.
The latest numbers show that about two-thirds of Americans are either overweight or obese.
Over the years there have been a number of weight loss drugs, and while most work to some degree, like all drugs they also have side effects.
Like so many people, Suzie Soto has been on a weight loss see-saw for years.
“I’ve tried pills,” she said. “A multitude amount of diet, shakes, everything else and just nothing worked.”
Now there’s a new option for the millions like Soto trying to lose weight, capsules called Plenity.
Dr. Louis Aronne, renowned obesity researcher at New York Presyterian Weill Cornell, conducted some of the clinical trials on Plenity and says they’re actually considered a powerful new weight loss technology.
“This opens up a whole new medical treatment to a huge new group of patients,” he said.
The FDA has approved Plenity for anyone with a body mass index, or BMI, of 25 to 40. You only have to be 10 or 15 pounds over ideal to qualify.
Once you swallow the capsules, they absorb 100 times their weight in water, forming a soft gel in the stomach.
Because of the unique molecular structure of the gel, it also binds and integrates with food, slowing its absorption.
This gel-food complex takes up about a quarter of the average stomach. Because the gel isn’t metabolized or absorbed, it has no more side effects than placebo, but it has a dual effect for weight loss.
“It makes you feel full sooner but by slowing down the absorption of calories, it has a damping effect on appetite beyond its filling effect,” said Aronne.
In clinical trials, volunteers lost an average of 6.5 percent of their body weight, but most actually lost 10-percent, including diabetics and pre-diabetics most at risk for weight health issues.
Plenity won’t actually be available until late this year. The cost and insurance coverage, hasn’t been determined.
Turning Point Therapeutics 9.25M share IPO priced at $18.00
The deal size was increased from 8.82M shares and priced at the top of the $16.00-$18.00 range. Goldman Sachs is acting as lead book running manager for the offering.
https://thefly.com/landingPageNews.php?id=2893545
https://thefly.com/landingPageNews.php?id=2893545
China’s GenScript starts on plasmid, virus making facility
Chinese CDMO GenScript Biotech already has a deal to produce a CAR-T drug being developed by its Legend Biotech unit and Janssen. But the contract manufacturer has started construction on a production facility to specialize in plasmids and viruses manufacturing for other clients as well.
GenScript Monday kicked off the project with a groundbreaking at a site in Zhenjiang, China. It says the 150,000-square-meter facility is being designed to meet FDA and EMA standards as well as China’s National Medical Products Administration.
The company said the plasmid service line will be equipped with single-use bioreactors while the virus line, will use suspension-based production processes. It said the facility will be able to handle Phase III clinical supplies and commercial production. Details on what the CDMO is investing or when the facility is slated to be complete were not provided.
Legend Biotech’s vice president of production Dr. David He said in a statement that Legend has a commercial production facility in the U.S. that is about ready to open but that in China it will work with GenScript. The CDMO also has a contract for two CAR-T projects under development by China’s Shanghai Longyao Biotechnology.
Johnson & Johnson’s Janssen in 2017 agreed to pay Legend $350 million upfront for U.S. and European rights to its CAR-T candidate after the biotech reported data at ASCO demonstrating its candidate could be a safe and effective way to treat relapsed or refractory multiple myeloma. JNJ-682845 has already been submitted for approval in China.
Subscribe to:
Posts (Atom)