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FDA Nod For TXMD, Genmab's Multiple Myeloma Study Meets Goal, AMED On Watch

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Today's Daily Dose brings you news about FDA approval of TherapeuticsMD's BIJUVA; CTD Holdings' patent filing related to methods for treating Alzheimer's disease; Amedisys' third-quarter results and rosy outlook for the year, and Genmab's phase III multiple myeloma study.

Read on...

Amedisys Inc. (AMED) has reported better-than-expected third quarter financial results, and provided a rosy outlook for the year.

The adjusted net income attributable to the Company in the recent third quarter is $30.93 million or $0.95 per share on net service revenue of $417.3 million. Analysts had expected the company to earn $0.77 per share, according to figures compiled by Thomson Reuters.

The adjusted net income attributable to the Company in the third quarter of 2017 was $19.2 million or $0.56 per share on net service revenue of $373.7 million.

Looking ahead to full year 2018, the Company anticipates adjusted EPS to be in the range of $3.54 to $3.60, and net service revenue to be in the range of $1.65 billion to $1.67 billion. Analysts polled by Thomson Reuters expect the Company to earn $3.40 per share on revenue of $1.65 billion.

AMED closed Monday's trading at $100.89, up 2.74%.

Shares of CTD Holdings Inc. (CTDH.OB) rose more than 26% on Monday, following the Company's filing of a patent application titled "Methods for Treating Alzheimer's Disease."

The patent application is directed to using hydroxypropyl beta cyclodextrins, including the Company's Trappsol Cyclo, for the treatment of Alzheimer's disease.

Hydroxypropyl beta cyclodextrins have been shown in animal models and cell culture to reduce the formation of amyloid beta, one of the hallmarks of Alzheimer's disease.

CTDH.OB closed Monday's trading at $0.69, up 26.11%.

Genmab A/S' (GMXAY.OB) phase III study of Daratumumab in front line multiple myeloma has met the primary endpoint.

In the study, dubbed MAIA , patients were randomized to receive either Daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone.

The study met the primary endpoint of improving progression free survival, or PFS, resulting in a 45% reduction in the risk of progression or death in patients treated with Daratumumab in combination with lenalidomide and dexamethasone.

The median PFS for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 31.9 months for patients who received lenalidomide and dexamethasone alone.

GMXAY.OB closed Monday's trading at $12.88, up 2.83%.

The FDA has approved TherapeuticsMD Inc.'s (TXMD) BIJUVA for the treatment of moderate to severe vasomotor symptoms (commonly known as hot flashes or flushes) due to menopause in women with a uterus.

BIJUVA is the first and only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule. The drug, which is expected to be available in pharmacies in the second quarter of 2019, will sport a boxed warning.

BIJUVA is the third drug of the Company to secure FDA approval this year, with the other two being - ANNOVERA, the first and only birth control as a vaginal system, approved on August 10, and IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), approved on May 30.

TXMD closed Monday's trading at $4.76, down 6.48%. In after-hours, the stock was down another 2.10% to $4.66.

vTv Therapeutics Inc.'s (VTVT) application to list its Class A Common Stock on The Nasdaq Capital Market has been approved by the NASDAQ Stock Market LLC.

The Company's securities will be transferred from The Nasdaq Global Market to The Nasdaq Capital Market at the opening of business on October 30, 2018.

There are three tiers of Nasdaq listing - the Global Select Market, Global Market and Capital Market.

Last week, the Company announced positive results of a subgroup analysis from its phase III STEADFAST trial, indicating potential benefit of treatment with Azeliragon for patients with Type 2 Diabetes and Alzheimer's disease.

The STEADFAST is a phase III trial that evaluated Azeliragon in patients with mild Alzheimer's disease.

VTVT closed Monday's trading at $2.90, down 3.01%. In after-hours, the stock was up 4.82% to $3.04.

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