AIMT Meets Study Goals, TTPH Keeps Hopes Alive, Opportunities Galore For TXMD

(RTTNews) - Today's Daily Dose brings you news about the outcome of the European Medicines Agency's oral explanation meeting related to Portola's drug candidates; HealthStream's Q4 financial results; Aimmune's PALISADE trial results; Ultragenyx Pharma's upcoming milestones and TherapeuticsMD's pending regulatory catalyst.

Read on...

Aimmune Therapeutics Inc.'s (AIMT) pivotal phase III efficacy trial of AR101 for desensitization of patients with peanut allergy has met the primary endpoint.

In the 554-patient phase III study, dubbed PALISADE, 67.2% of AR101 patients ages 4-17 tolerated at least a 600-mg dose of peanut protein in the exit food challenge compared to 4.0% of placebo patients, and 50.3% of AR101 patients ages 4-17 tolerated a 1000-mg dose of peanut protein in the exit food challenge, compared to 2.4% of placebo patients.

According to the Company, 79.6% of AR101 patients ages 4-17 completed the trial, and of the 20.4% who discontinued treatment, 12.4% withdrew due to treatment-related adverse events.

Aimmune expects to submit a Biologics License Application for AR101 with the FDA by the end of 2018, followed by a Marketing Authorisation Application with the European Medicines Agency in the first half of 2019.

In other news, the Company also announced that it has commenced an underwritten public offering of up to $150 million of shares of its common stock.

AIMT closed Tuesday's trading at $34.96, down 6.02%. In after-hours, the stock was down 3.72% to $33.66.

HealthStream Inc. (HSTM) has reported better-than-expected financial results for the fourth quarter ended December 31, 2017.

Net income was $3.9 million or $0.12 per share in the fourth quarter of 2017 on revenue of $62.8 million. This compared with a net loss of $0.3 million or $0.01 per share and revenue of $58.7 million for the fourth quarter of 2016.

Analysts polled by Thomson Reuters expected the Company to earn $0.03 per share on revenue of $62.33 million for the fourth quarter of 2017.

Looking ahead, the Company expects consolidated revenues for 2018 to increase six to eight percent as compared to 2017. For 2017, revenues were $247.7 million, up 10% over revenues of $226.0 million in 2016.

HSTM closed Tuesday's trading at $23.67, down 1.17%.

It was a mixed outcome from the European Medicines Agency's oral explanation meeting related to Portola Pharmaceuticals Inc.'s (PTLA) Andexanet Alfa and Betrixaban.

The European Medicines Agency rendered a positive trend vote on the Marketing Authorisation Application for Andexanet Alfa, and a negative trend vote for Betrixaban.

Portola is seeking conditional approval for Andexanet Alfa for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding. In the U.S., Andexanet Alfa is under FDA review, with a decision anticipated on May 4, 2018.

Betrixaban is developed for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE. It was approved by the FDA last June, and is marketed under the trade name Bevyxxa.

A negative trend vote means it is unlikely that a positive Committee for Medicinal Products for Human Use (CHMP) opinion related to Betrixaban will be attained at the formal decision vote scheduled for March 2018, and that additional steps would be needed to gain marketing approval in Europe.

PTLA closed Tuesday's trading at $48.22, up 1.11%. In after-hours, the stock was down 8.75% to $44.00.

TherapeuticsMD Inc. (TXMD) sees tremendous opportunity in 2018.

The Company submitted the NDA for TX-001HR for the treatment of moderate-to-severe vasomotor symptoms due to menopause on December 28, 2017. Acceptance of the NDA is expected in March 2018.

The resubmitted NDA for TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual intercourse, a symptom of vulvar and vaginal atrophy due to menopause, is under FDA review - with a decision expected on May 29, 2018.

TXMD closed Tuesday's trading at $5.31, down 4.84%. In after-hours, the stock was up 5.08% to $5.58.

Tetraphase Pharmaceuticals Inc. (TTPH) has entered into an exclusive licensing agreement with Everest Medicines Limited to develop and commercialize Eravacycline in mainland China, Taiwan, Hong Kong, Macau, South Korea, and Singapore.

Eravacycline is an investigational drug for the treatment of complicated intra-abdominal infections (cIAI) and other serious infections, including those caused by multidrug-resistant (MDR) pathogens.

A New Drug Application for Eravacycline in the treatment of complicated intra-abdominal infections was submitted to the FDA last month. Eravacycline is also under review by the European Medicines Agency for the treatment of complicated intra-abdominal infections.

Last week, the Company announced that its phase III clinical trial evaluating once-daily IV Eravacycline against FDA-approved injectable ertapenem (1g every 24 hours) for the treatment of complicated urinary tract infections, dubbed IGNITE3, failed to meet the co-primary efficacy endpoints. The news sent the stock down 60% to $2.15 on February 14, 2018.

TTPH closed Tuesday's trading at $2.08, down 1.89%. In after-hours, the stock was up 9.13% to $2.27.

Ultragenyx Pharmaceutical Inc. (RARE) has a couple of catalysts to watch out for in the coming months.

-- The Company's Biologics License Application for Burosumab to treat pediatric and adult patients with X-Linked Hypophosphatemia is under FDA review, with a decision expected on April 17, 2018. -- A phase III trial comparing the efficacy and safety of Burosumab to oral phosphate and active vitamin D therapy in pediatric patients with X-Linked Hypophosphatemia is underway, with data expected in the second half of 2018. -- Data from a phase II study evaluating the safety and efficacy of Burosumab in 17 adult patients with tumor-induced osteomalacia is expected in the first half of 2018. -- Data from a phase III study of UX007 in Glucose transporter type-1 deficiency syndrome patients is expected in the second half of 2018.

RARE closed Tuesday's trading at $48.18, up 2.25%.