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What's Making News At Roche, EYEN, STML, Sirona, TRVN?

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Axsome Therapeutics Inc. (AXSM) has initiated a phase II trial of AXS-12 (reboxetine) in narcolepsy, a sleep disorder.

The study, dubbed CONCERT, will enroll approximately 20 patients, all of whom will be treated with AXS-12 for three weeks and with placebo for three weeks. Eligible patients will be randomized to receive either AXS-12 followed by placebo, or placebo followed by AXS-12.

The Company expects topline results from the CONCERT trial in the second quarter of 2019.

AXSM closed Tuesday's trading at $8.15, up 0.12%.

The FDA has granted orphan designation for BioInvent International AB's (BINV.ST) proprietary antibody BI-1206 for the treatment of mantle cell lymphoma.

BI-1206 is currently in Phase l/ll trial for non-Hodgkin lymphoma and chronic lymphatic leukemia. Mantle cell lymphoma is one of the targeted sub-indications, along with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

Eyenovia Inc.'s (EYEN) phase III study evaluating MicroStat for pharmacologic mydriasis (eye dilation), dubbed MIST-1 study, has yielded positive results.

In the MIST-1 study, MicroStat has demonstrated robust efficacy and high tolerability.

The second phase III study in the MicroStat program for pharmacologic mydriasis, dubbed MIST-2 study, is underway, with results expected to be announced in short order.

EYEN closed Tuesday's trading at $2.63, down 3.31%.

Genentech, a member of the Roche Group (RHHBY.OB), has decided to discontinue its phase III clinical studies of Crenezumab in early Alzheimer's disease, dubbed CREAD 1 and CREAD 2, as the compound was unlikely to meet the primary endpoint.

The decision to pull the plug on the trials was based on a pre-planned interim analysis, conducted by the Independent Data Monitoring Committee, which assessed the safety and efficacy of Crenezumab.

However, the Company's other ongoing Alzheimer's disease programs namely, its phase III GRADUATE trials with Gantenerumab and phase II TAURIEL trial with the anti-tau molecule RG6100, as well as its imaging and fluid-based diagnostic solutions will continue.

RHHBY.OB closed Tuesday's trading at $32.27, up 0.44%.

Sirona Biochem Corp. (SBM.V) has provided an update on its current activities and anticipated developments for 2019.

The Company's proof of concept clinical trial evaluating TFC-1067 in lightening the skin of patients with melasma as well as balancing overall skin tone is slated to end late February, with results expected 1-2 weeks after trial completion.

Sirona Biochem's partner, Wanbang Biopharmaceuticals, continues to progress the development of TFC-039 for the treatment of type 2 diabetes. A joint announcement on their progress regarding the status of CFDA testing is expected to be made after the Chinese New Year, i.e., February 5.

SBM.V closed Tuesday's trading at C$0.08, unchanged from the previous day's close.

Stemline Therapeutics Inc.'s (STML) Marketing Authorization Application for ELZONRIS has been validated by the European Medicines Agency.

Validation of the application confirms that the submission is sufficiently complete to begin the formal review process.

Stemline is seeking approval of ELZONRIS for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

ELZONRIS was approved by the FDA on December 21, 2018, for the treatment of adult and pediatric patients, two years and older, with BPDCN. ELZONRIS is currently commercially available in the U.S.

STML closed Tuesday's trading at $10.70, up 5.21%.

Trevena Inc. (TRVN) has agreed to sell an aggregate of 10 million shares of its common stock to two healthcare-focused institutional investors at an offering price of $1.00 per share, in a registered direct offering.

The gross proceeds from the offering are expected to be $10.0 million, before deducting placement agent fees and offering expenses payable by Trevena. The offering is expected to close on or about February 1, 2019, subject to customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

TRVN closed Tuesday's trading at $1.27, up 6.72%. In pre-market trading on Wednesday, the stock is down 17.32% at $1.05.

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