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NVAX Turns Heads, EPZM On The Rise, TTOO Already Up 25%, GBT Hits Record High

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The following are some of today's top gainers in the pharma/biotech sector.

1. Novavax Inc. (NVAX)

Gained 59.40% to close Wednesday's (Jan.10) trading at $2.12.

News: B.Riley FBR analyst George Zavoico has reiterated Novavax at Buy and increased its price target from $2.25 to $10.

Clinical Trials & Near-term Catalysts:

-- A global pivotal phase III trial of RSV F Vaccine to protect infants via maternal immunization, dubbed Prepare, is underway.

The trial has enrolled more than 3,000 pregnant women to date. About 4,600 pregnant women are expected to be enrolled by Q2, 2018.

-- An informational analysis of the Prepare trial conducted by Data Safety Monitoring Board, last month, indicate an observed vaccine efficacy in the range of 45-100%. The informational analysis provides an indication of the vaccine's potential efficacy, and it targeted an efficacy threshold against the primary endpoint at day 90 of more 40%.

-- Interim analysis is projected to be complete by 4Q 2018/1Q 2019.

-- If all goes well as planned, the Company expects to make BLA filing for maternal RSV Vaccine by 4Q 2019/1Q 2020.

2. Tandem Diabetes Care Inc. (TNDM)

Gained 19.93% to close Wednesday's trading at $3.43.

News: The Company forecast preliminary results for the year and quarter ended December 31, 2017, well above analysts' expectations.

On a non-GAAP basis, the Company expects fourth quarter sales of about $39 million to $40 million, and analysts polled by Thomson Reuters anticipate $34.41 million. Non GAAP sales in the fourth quarter of 2016 were $24.8 million.

For full year 2017, non-GAAP sales are anticipated to be roughly $101 million to $102 million, while Wall Street analysts' consensus estimate is $98.32 million. The Company had reported non GAAP sales of $88.5 million in 2016.

The Company intends to report its fourth quarter and full year 2017 financial and operating results on Thursday, March 1, 2018 after the markets close.

3. Epizyme Inc. (EPZM)

Gained 19.20% to close Wednesday's trading at $14.90.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead drug candidate is Tazemetostat, which is under phase II programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma (NHL); certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; mesothelioma; and combination studies in DLBCL.

The Company expects to present updated data from its clinical trials this year.

The first NDA for Tazemetostat under accelerated approval pathway in the indication of epithelioid sarcoma is expected to be submitted in the second half of 2018.

4. Global Blood Therapeutics Inc. (GBT)

Gained 17.60% to close Wednesday's trading at $55.45. This is the second straight day of double-digit gain for the stock. GBT touched a new all-time high of $55.65 in intraday trading today.

News: No news

Pipeline:

The Company's lead drug candidate is Voxelotor, which is being studied in a phase III trial in patients aged 12 and older with sickle cell disease, dubbed HOPE, and in phase IIa study in pediatric patients (age 6 to 17) with sickle cell disease, known as HOPE-KIDS 1.

Recent event:

-- On Jan.9, 2018, the FDA granted Voxelotor Breakthrough Therapy Designation for treatment of sickle cell disease.

Near-term Catalysts:

-- The Company expects to report top-line data from Part A of the Phase 3 HOPE Study in the first half of 2018.
-- Report top-line data from Part B of the Phase 3 HOPE Study in the first half of 2019.

5. Amicus Therapeutics Inc. (FOLD)

Gained 9.15% to close Wednesday's trading at $15.51.

News: No news

Recent event:

-- On January 8, 2018, the Company announced that it recorded about $36 million in full-year 2017 revenue from commercial sales and reimbursed expanded access programs for Galafold for Fabry disease. For the full-year 2018 the Company anticipates total Galafold revenue of $75 million to $85 million.

Galafold (Migalastat) is approved in the European Union, Switzerland, Israel, Canada, Australia, and South Korea. It is not approved in the U.S. yet.

Upcoming Event:

The Company is slated to report Q4 and full year 2017 financial results on Feb.27, 2018.

Near-term Catalysts:

-- The NDA for Migalastat (Galafold) for Fabry disease was submitted to the FDA last month. The FDA acceptance of the NDA is expected this quarter (Q1, 2018).
-- Migalastat is under regulatory review in Japan, and a decision is expected in the first half of 2018.

6. T2 Biosystems Inc. (TTOO)

Gained 8.81% to close Wednesday's trading at $5.56.

News: No news

Recent event:

-- On January 4, 2018, the Company announced preliminary fourth quarter 2017 financial results, and provided an update on its T2Bacteria Panel.

Total revenue in the fourth quarter is expected to exceed the previously guided range of $1.1 million to $1.3 million, thanks to the demand for the Company's T2Dx Instrument and the T2Candida Panel.

Analysts polled by Thomson Reuters are expecting revenue of $1.18 million for the quarter.

As for the FDA clearance of T2Bacteria Panel, the Company expects to receive the regulatory nod in the first quarter of 2018.

TTOO was trading around $2.96 when we alerted our premium subscribers to this stock on August 8, 2017.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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