Biotech Digest – XENT Gets FDA Approval, AGN Announces Acquisition, IONS Licenses Product

Top Pick of the Day: TYHT

Shineco Inc (TYHT) stock jumped as the company announced its share exchange and acquisition agreement with strategic partner Western Xinjiang Tiansheng Agricultural Development Co., Ltd. The terms and conditions of the agreement provide for Xinjiang Shineco Taihe Agricultural Technology Ltd. to receive a 51% stake in Xinjiang Tiansheng in exchange for a 14% stake in Xinjiang Taihe plus three cash payments with an aggregate value of RMB23.8M or $3.57 million, contingent on certain milestones.

Shineco stock gained over 12 percent in its previous trading session, trimming its 12 months losses to 36 percent.

Focus Ticker: XENT

Intersect ENT Inc. (XENT) reported the FDA approval for its SINUVA implant, designed to be used for treating recurrent nasal polyps in patients who have had previous ethmoid sinus surgery. The device delivers an anti-inflammatory steroid directly to the site of polyps, can be placed by a physician in an office setting. The FDA was expected to announce its decision on January 7, 2018.

The announcement sent the stock up by over 14 percent in its previous trading session. The stock has gained over 192 percent in the past 12 months and is now trading close to its 52 weeks high.

Sector News

Merck (MRK) announced the FDA approval for the review of its marketing application seeking approval for KEYTRUDA to treat adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL) who have relapsed after at least two prior lines of therapy. The agency's action date under Priority Review status has been set at April 3, 2018.

Regeneron Pharmaceuticals (REGN) announced that the FDA has accepted for review its marketing application seeking approval for a 12-week dosing interval for EYLEA (aflibercept) Injection in patients with wet AMD. The drug is currently approved for eight-week dosing after three initial doses every four weeks.The FDA's action date (PDUFA) is August 11, 2018.

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