Biotech Digest – URGN Receives Fast Track Designation, MDVX Receives Australian Approval, AZN Inks A New Deal

Top Pick of the Day: TRHC

Tabula Rasa Healthcare (TRHC) stock perked up as the company announced inking a new deal with CenterLight Healthcare to provide medication risk management services. The company inked the deal through its wholly owned subsidiary CareKinesis. The agreement will be effective from September 1. It will begin with a single launch center with addition of more sites over a period of time. The companies did not disclose the financial terms of the contract.
The stock gained over 8 percent in its previous trading session. In the past 12 months, the stock gained 46 percent while its gain on Year to Date basis stands at 45 percent.

Focus Ticker: RNN

Rexahn Pharmaceuticals (RNN) stock shot up as the company announced the issuance of a new patent by the USPTO. The patent no. 9,744,167 covers storage-stable nanoparticulate compositions and formulations of piperazine compounds used to treat and prevent proliferative diseases, including cancer. The company mainly focuses on developing cancer therapies. Its pipeline includes drug candidates such as RX-3117 and Archexin. RX-3117 is an oral prodrug activated by a unique cancer cell enzyme called uridine cytidine kinase while Archexin is an antisense drug that inhibits a cancer cell signaling protein called Akt-1. The company also has Supinoxin, which is an orally available small molecule inhibitor of a cancer protein called P-p68.
The stock gained over 27 percent in its previous trading session, taking its Year to Date gain to 74 percent.

Sector News

UroGen Pharma (URGN) announced that the FDA has designated its MitoGel for Fast Track review for the treatment of patients with low-grade upper urinary tract urothelial carcinoma (UTUC) not suitable for endoscopic resection or contraindicated for the removal of the kidney and upper urinary tract (nephroureterectomy), including impaired renal function.
Abeona Therapeutics (ABEO) announced receiving the Breakthrough Therapy designation for its EB-101 drug candidate for the treatment of epidermolysis bullosa, a rare inherited disorder characterized by large painful blisters on the skin. The drug is already Orphan Drug tagged and is in Phase 2 development.

Approvals

Medovex (MDVX) announced receiving the Australian Therapeutic Goods Administration’s approval for its DenerveX System for the treatment of back pain related to spinal osteoarthritis or Facet Joint Syndrome. The company will launch the product through the local distributors next month.

Moleculin Biotech (MBRX) announced filing an Investigational New Drug (IND) application with the FDA seeking approval to start clinical trials to investigate Annamycin for the treatment of relapsed/refractory acute myeloid leukemia. The company may begin clinical studies in the fourth quarter, subject to approval.

Deals and Collaborations

AstraZeneca (AZN) inked a new deal with Takeda Pharmaceutical for the purpose of co-developing and co-commercializing MEDI1341, an alpha-synuclein antibody for the potential treatment of Parkinson's disease. The agreement requires AstraZeneca to lead Phase 1 development while Takeda is responsible for later-stage development.

Seattle Genetics (SGEN) reported exercising its option to co-develop tisotumab vedotin with Genmab A/S. The company had received the right under its October 2011 agreement. Both the companies will share future development costs and profits on an equal basis.

Analyst Ratings

Brokerage Action Company Rating Price Target
HC Wainwright Set Price Target Alimera Sciences (ALIM)
Buy $5.00
HC Wainwright Set Price Target Apricus Biosciences (APRI)
Buy $5.00
Maxim Group Reiterates Benitec Biopharma Limited (BNTC)
Hold
J P Morgan Chase & Co Initiates La Jolla Pharmaceutical Company (LJPC)
Overweight $36.00
Cantor Fitzgerald Reiterates Mesoblast Limited (MESO)
Buy
Maxim Group Set Price Target Mesoblast Limited (MESO)
Buy $14.00

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