CRY Opens Wallet, LLY's JUNIPER Flops, MDXG Catches Eyes, RNN Awaits DATA In Q4

(RTTNews) - Today's Daily Dose brings you news about Allergan's pending regulatory catalyst; Astella's acute myeloid leukemia drug candidate securing Fast Track designation; CryoLife's acquisition of German-based, privately-held JOTEC AG; failure of Eli Lilly's JUNIPER trial; MiMedx's preliminary Q3 revenue and Vical's progress in phase 3 registration trial of ASP0113 in hematopoietic cell transplant recipients.

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Allergan plc's (AGN) New Drug Application for ulipristal acetate, an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids, has been accepted for review by the FDA.

The decision on ulipristal acetate is expected in the first half of 2018.

AGN closed Tuesday's trading at $207.42, up 2.21%.

Astellas Pharma Inc. (ALPMY.OB) has been granted Fast Track designation by the FDA for the development of Gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia (AML).

Gilteritinib is being investigated in various AML patient populations through four ongoing Phase 3 trials, including the registrational ADMIRAL trial in relapsed/refractory FLT3+ AML.

ALPMY.OB closed Tuesday's trading at $13.16, up 1.86%.

Astellas Pharma Inc. and Seattle Genetics Inc. (SGEN) has initiated a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor therapy.

The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

The companies also plan to initiate a combination trial of enfortumab vedotin with checkpoint inhibitor therapy in late 2017.

SGEN closed Tuesday's trading at $57.72, up 0.25%.

CryoLife Inc. (CRY) has entered into a definitive agreement to acquire German-based, privately-held JOTEC AG.

JOTEC generated revenue of approximately €41 million in 2016, representing compound annual growth of approximately 17 percent over the preceding five years.

Cryolife expects the acquisition to drive gross margin expansion and accelerate its trajectory towards 20 percent or higher operating margins. The Company expects it will be able to deliver growth in non-GAAP EPS at a CAGR of at least 20 percent over the next five years.

CRY closed Tuesday's trading at $23.30, down 0.21%.

Eli Lilly and Co.'s (LLY) phase III trial of Verzenio as monotherapy in KRAS-mutated, advanced non-small lung cancer, dubbed JUNIPER, has not met its primary endpoint of overall survival.

However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the Verzenio arm.

LLY closed Tuesday's trading at $86.16, down 1.01%.

MiMedx Group Inc. (MDXG) expects to report revenue of $84.6 million for the third quarter of 2017, which has come in above its guidance range of $79 million to $80 million.

The Q3, 2017 revenue reflects 31% growth over Q3 2016 revenue.

MDXG closed Tuesday's trading at $12.35, up 5.38%.

The European Medicines Agency's Committee for Orphan Medicinal Products has issued a positive opinion recommending orphan medicinal product designation for Rexahn Pharmaceuticals Inc.'s (RNN) RX-3117 for the treatment of pancreatic cancer.

RX-3117 is under a two stage Phase IIa clinical trial in patients with relapsed or refractory pancreatic cancer. An initial data readout is expected in 4Q, 2017.

RNN closed Tuesday's trading at $2.95, up 6.12%.

Ultragenyx Pharmaceutical Inc.'s (RARE) Biologics License Application for Burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia has been accepted for priority review by the FDA, with a decision date set for April 17, 2018.

Ultragenyx, Kyowa Hakko Kirin and Kyowa Kirin International, a wholly owned subsidiary of Kyowa Hakko Kirin, have been collaborating in the development and commercialization of Burosumab globally, based on the collaboration and license agreement between Kyowa Hakko Kirin and Ultragenyx.

RARE closed Tuesday's trading at $54.01, up 0.37%.

Vical Inc. (VICL), on Tuesday, announced that the last patient completed their final assessment during the one year follow-up period in the multinational Phase 3 registration trial of ASP0113 in hematopoietic cell transplant (HCT) recipients.

The trial completed enrollment in September 2016 with a total of 515 subjects. The primary endpoint of the trial is a composite of overall mortality and cytomegalovirus (CMV) end-organ disease which will be assessed one year after transplantation.

ASP0113 was initially developed by Vical and has been partnered with Astellas for further development and commercialization. Astellas Pharma expects top-line data to be available in the first quarter of 2018.

VICL closed Tuesday's trading at $2.97, up 7.61%.