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FDA Approves AZN's Calquence, GLYC's Data To Be Delayed, ENLV Withdraws Offering

pharma 060917 21nov19 lt

Today's Daily Dose brings you news about FDA approval of AstraZeneca's CALQUENCE; delay in the release of GlycoMimetics' phase III trial of Uproleselan in AML and Onconova's agreement with Knight Therapeutics.

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The FDA has approved AstraZeneca plc's (AZN) CALQUENCE for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The approval was granted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, to receive simultaneous review decisions in the U.S., Australia, and Canada.

In clinical trials, CALQUENCE in combination with Obinutuzumab or as a monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, in adult patients with chronic lymphocytic leukemia.

AZN closed Thursday's trading at $47.61, up 1.28%.

Shares of GlycoMimetics Inc. (GLYC) were down more than 16% on Thursday, following an update related to the Company's phase III trial of Uproleselan in relapsed/refractory AML.

The top-line results from the trial are now expected in 2021, and not by the end of 2020 as was previously expected.

The study, sponsored by National Cancer Institute, is evaluating the addition of Uproleselan to a standard cytarabine/daunorubicin regimen in older adults with previously untreated AML who are suitable for intensive chemotherapy.

GLYC closed Thursday's trading at $5.32, down 16.87%.

Onconova Therapeutics Inc. (ONTX) has entered into a Distribution, License and Supply Agreement with Knight Therapeutics Inc., a Canadian-based specialty pharmaceutical company, for Rigosertib in Canada.

Rigosertib is Onconova's lead candidate, under a phase III trial in high-risk myelodysplastic syndromes, dubbed INSPIRE.

As per the agreement, Knight receives an exclusive license to commercialize Rigosertib in Canada. In turn, Onconova is entitled to receive up to C$33.95 million in clinical, regulatory, and sales-based milestones and tiered double-digit royalties.

In other news, Onconova priced a public offering of an aggregate of 55 million shares of its common stock (or common stock equivalents), together with accompanying common stock warrants, at a public offering price of $0.20 per share and associated warrant.

ONTX closed Thursday's trading at $0.16, down 45.71%.

Bio-Path Holdings, Inc., (BPTH) has been given the go-ahead by the FDA to commence a phase I clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients.

The phase I clinical trial is expected to be conducted at several leading cancer centers, including The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days, according to the Company.

BPTH closed Thursday's trading at $7.62, down 22.24%.

Enlivex Therapeutics Ltd. (ENLV) has withdrawn its previously announced proposed underwritten public offering of ordinary shares due to market conditions.

The Company currently believes that it is not in the best interest of its shareholders to raise equity capital in the current market environment. The Company remains well-capitalized with cash and cash equivalents, together with short term deposits, of approximately $13.5 million as of September 30, 2019, which the Company believes will be sufficient to fund its current operations through the beginning of the second quarter of 2021.

Enlivex Therapeutics Ltd is the result of the merger of publicly-traded Bioblast Pharma Ltd. with Enlivex Therapeutics Ltd., a VC-funded privately-held immunotherapy company. The merger agreement was executed on November 19, 2018.

Enlivex Therapeutics was listed on the NASDAQ on March 26, 2019. The Company's shares were dual-listed on the Tel Aviv Stock Exchange, under the symbol ENLV, on July 22, 2019.

ENLV closed Thursday's trading at $7.63, down 7.85%.

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