Invitae acquires Singular Bio for ~$55M

Invitae (NVTA +1.1%) announces the acquisition of Singular Bio, Inc., for ~$55M, subject to certain adjustments, mostly in stock with the balance in cash.

Singular Bio’s is a privately held company developing single molecule detection technology that enables lower costs and expanded use of high-quality, cell-free, nucleic acid analysis, initially for application in non-invasive prenatal screening.

Invitae expects the transaction will be cash neutral at close; and is expected to close in the coming weeks, subject to customary closing conditions.

https://seekingalpha.com/news/3471763-invitae-acquires-singular-bio-55m

ContraVir Pharma encouraged by liver disease treatment results

ContraVir Pharmaceuticals (CTRV +40%) surges after reporting “compelling positive results” from experiments involving the company’s CRV431 drug candidate for the treatment of liver disease arising from non-alcoholic steatohepatitis and chronic viral infection.

CTRV says co-administration of CRV431 was found to be 100% effective at preventing fibrosis induction beyond baseline levels and at clinically relevant concentrations also partially or completely blocked several genetic and protein biomarkers of inflammation.

“Precision cut liver slices adds to the growing list of experiments where CRV431 has demonstrated effectiveness and gives us great confidence in developing CRV431 for NASH and other liver diseases,” the company says.

https://seekingalpha.com/news/3471760-contravir-pharma-encouraged-liver-disease-treatment-results

Ultragenyx (RARE) Upcoming Data Could Move Shares – Morgan Stanley

Analyst Jeffrey Hung reiterated an Overweight rating and $83.00 price target

https://www.streetinsider.com/Analyst+Comments/Ultragenyx+Pharma+%28RARE%29+Upcoming+Data+Could+Move+Shares+-+Morgan+Stanley/15617324.html

CASI in-licenses rights to anti-CD19 T-cell therapy

CASI Pharmaceuticals (NASDAQ:CASI) has signed a license agreement for exclusive worldwide rights to an anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd., a China-based domestic company.

Juventas will continue to develop CNCT19 with CASI’s participation on the program’s steering committee. CASI will make certain milestone payments and sales royalties.

In connection with the license, CASI will invest RMB 80M (~$11.6M) in Juventas through a wholly owned Chinese subsidiary in lieu of the upfront payment for the license.

Shares are up 5% premarket.

https://seekingalpha.com/news/3471658-casi-licenses-rights-anti-cd19-t-cell-therapy-shares-5-percent-premarket

Xeris reports positive trial results for RTU glucagon in hypoglycemia

Xeris Pharmaceuticals’ (NASDAQ:XERS) ready-to-use glucagon auto-injector showed comparable efficacy with Novo Nordisk’s GlucaGen HypoKit for achieving plasma glucose of greater than 70 mg/dl or greater than or equal to 20 mg/dl increase in glucose concentration within 30 minutes of glucogon administration in a Phase 3 non-inferiority study in Europe and North America.

Xeris gains 0.7% to in $9.61 premarket trading.

Study conducted among 132 adults with type 1 diabetes to evaluate the Xeris RTU glucagon auto-injector as a treatment for severe hypoglycemic events.

Study also found that time to resolution of hypoglycemia symptoms as well as time to resolution of the overall feeling of hypoglycemia was comparable between Xeris RTU glucagon and the marketed emergency kit.

Overall, no safety or tolerability concerns were noted.

NDA for the investigational product, to be branded Gvoke HypoPen in the U.S., is currently under review with the U.S. Food and Drug Administration, with a decision expected Sept. 10, 2019.

https://seekingalpha.com/news/3471709-xeris-reports-positive-trial-results-rtu-glucagon-hypoglycemia

Merit Medical acquires Brightwater Medical

Merit Medical Systems (MMSI +0.8%) has acquired Brightwater Medical where, the transaction consists of a $35M upfront payment and potential earn-out payments of up to $15M.

Merit Medical’s management estimates that the transaction will be ~$(0.05) decretive to GAAP EPS and ~$(0.03) decretive to Non-GAAP EPS for the year ending December 31, 2019.

Management’s current revenue expectations for the ConvertX® product for CY 2019 are ~$1M with expectations of growth to ~$25M in the fifth full year of sales.

Upon transfer of the ConvertX® manufacturing operations to Merit’s Pearland facility, management believes Non-GAAP gross margins in the 70-75% range are attainable.

https://seekingalpha.com/news/3471741-merit-medical-acquires-brightwater-medical

BeiGene regains global rights to investigational anti-PD-1 antibody

BeiGene (BGNE) will get back its rights to tislelizumab from Celgene (CELG+0.4%) plus $150M ahead of Celgene’s merger with Bristol-Myers Squibb.

Tislelizumab, the first drug candidate produced from BeiGene’s immuno-oncology biologic program, is being developed as a monotherapy and in combination with other therapies to treat an array of solid tumor and hematologic cancers.

BeiGene expects tislelizumab to receive its first regulatory approval later this year.

Last month, BeiGene’s supplemental new drug application for tislelizumab was accepted by the China National Medical Products Administration for the the treatment of patients with previously treated locally advanced or metostatic urothelial carcinoma.

https://seekingalpha.com/news/3471743-beigene-regains-global-rights-investigational-anti-pdminus-1-antibody