ACIP Backs HEPLISAV-B, GMED Hits New High, GWPH's Focal Seizures Trial Fails

Pharma 022218

Today's Daily Dose brings you news about Mesoblast's steroid refractory acute Graft versus Host Disease trial results; CHMP's positive trend vote for Rucaparib in ovarian cancer; HEPLISAV-B vaccine getting favorable recommendation from the CDC's Advisory Committee on Immunization Practices; Aimmune's stock offering; GW Pharmaceuticals' disappointing trial results of GWP42006 in adult patients with focal seizures, and Globus Medical's Q4 results and rosy outlook.

Read on...

Aimmune Therapeutics Inc. (AIMT) has offered to sell 5.50 million shares of its common stock at a price of $32.00 per share.

The underwriters have a 30-day option to purchase up to an additional 825,000 shares of common stock. The gross proceeds from the offering are expected to be $176 million.

The offering is slated to close on or about February 26, 2018.

On February 20, 2018, the Company announced that its pivotal phase III efficacy trial of AR101 for desensitization of patients with peanut allergy met the primary endpoint.

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.

AIMT closed Wednesday's trading at $32.21, down 7.87%.

Clovis Oncology Inc. (CLVS) has received a positive trend vote from the CHMP for its Rucaparib Marketing Authorization Application under review for the treatment of women with advanced BRCA-mutant ovarian cancer.

The CHMP is expected to vote on the Rucaparib Marketing Authorization Application next month. If all goes well as planned, the final approval by the European Commission would follow in Q2 2018.

In the U.S, Rucaparib received FDA approval for the treatment of women with advanced BRCA-mutant ovarian cancer in December 2016. The Company's supplemental New Drug Application for Rucaparib as maintenance therapy for women with recurrent ovarian cancer is under FDA review, with a decision expected on April 6, 2018.

CLVS closed Wednesday's trading at $54.93, up 2.27%. In after-hours, the stock was up 2.29% to $56.19.

Dynavax Technologies Corp.'s (DVAX) HEPLISAV-B vaccine has been unanimously recommended by the Advisory Committee on Immunization Practices, or ACIP, to be included on its list of recommended products for use to vaccinate adults against hepatitis B.

HEPLISAV-B is a two-dose vaccine that was approved by the FDA in November 2017 for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

The receipt of the ACIP recommendation is a key step in providing patients with broad access to HEPLISAV-B, noted the Company. Medical policies of many insurance plans and institutions require ACIP recommendation before a vaccine is covered or available to their patients.

Dynavax commercially launched HEPLISAV-B in the United States last month.

DVAX closed Wednesday's trading at $17.40, up 0.87%.

Globus Medical Inc. (GMED) touched an all-time high on Wednesday, following better-than expected Q4 results and rosy outlook.

On a non GAAP basis, net income for the fourth quarter of 2017 was $37.27 million or $0.38 per share on revenues of $176 million. Analysts polled by Thomson Reuters were expecting the Company to earn $0.35 per share on revenue of $166.53 million.

The non GAAP net income was $30.19 million or $0.31 per share on revenue of $151.59 million in the fourth quarter of 2016.

Looking ahead, the Company has forecast full year sales of $690 million and non-GAAP earnings per share of $1.50 for 2018. Wall Street analysts are expecting EPS of $1.43 and revenue of $684.72 million for the year.

GMED touched an all-time high of $49.32 in intraday trading on Wednesday, before closing at $48.00, down 0.50%.

GW Pharmaceuticals plc's (GWPH) phase 2a proof of concept study of GWP42006 in adult patients with focal seizures did not meet its primary endpoint.

In the trial, conducted outside the United States, primarily in Eastern Europe, both active and placebo arms showed similar reductions in focal seizures of approximately 40 percent.

The Company's lead product candidate is Epidiolex. A New Drug Application for Epidiolex in the treatment of Lennox-Gastaut syndrome and Dravet syndrome is under priority review by the FDA, with a decision expected on June 27, 2018.

Before the FDA announces its final decision on the Epidiolex NDA, it is slated to be reviewed by the regulatory agency's Peripheral and Central Nervous System Drugs Advisory Committee on April 19, 2018.

A Marketing Authorisation Application for Epidiolex was submitted to the European Medicines Agency in December 2017, with a decision expected in early 2019.

GWPH closed Wednesday's trading at $132.33, up 1.15%. In after-hours, the stock was down 5.17% to $125.49.

Mesoblast Ltd.'s (MESO) phase III trial of its allogeneic mesenchymal stem cell product candidate MSC-100-IV in children with steroid refractory acute Graft versus Host Disease has successfully met the primary endpoint.

The trial involved 55 children across 32 sites in the United States, and the primary endpoint of Day 28 overall response rate was 69%, a statistically significant increase compared to the protocol-defined historical control rate of 45%.

There are currently no products approved in the United States for treatment of steroid-refractory aGVHD. Full results from the ongoing trial will be reported in the second quarter of this year, noted the Company.

MESO closed Wednesday's trading at $5.41, up 2.75%. In after-hours, the stock was up 6.56% to $5.77.

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