DXCM Hits Record High, STAA Shines, INSM To Face FDA Panel On Aug.7

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

1. DexCom Inc. (DXCM)

DexCom is a medical device company focused on the development and commercialization of continuous glucose monitoring (CGM) systems in the United States and across the world.

Gained 30.65% to close Thursday's (Aug 2) trading at $124.69.

News: The Company reported strong Q2 financial results, and upped its revenue outlook for the full-year 2018.

On a non GAAP basis, net loss narrowed to $9.2 million or $0.10 per share in the recent second quarter from $12.4 million or $0.14 per share in the year-ago quarter. Revenue was $242.5 million for the second quarter of 2018, an increase of 42% from the $170.6 million in revenue for the same quarter of 2017.

Looking ahead to full-year 2018, the Company now expects revenue of approximately $925 million, up from its prior forecast range of $850 million to $860 million. Revenue in 2017 was $718.5 million.

2. STAAR Surgical Company (STAA)

STAAR Surgical is a developer of implantable lenses and companion delivery systems for the eye.

Gained 21.47% to close Thursday's trading at $38.75.

News: The Company reported encouraging results for the second quarter ended June 29, 2018, and raised its sales outlook for the year.

Adjusted Net Income for the second quarter of 2018 was $3.9 million or $0.09 per share compared to an Adjusted Net Loss in the prior year quarter of $0.4 million or $0.01 per share. Net sales were $33.9 million for the second quarter of 2018, up 55% compared to $21.9 million reported in the prior year quarter.

Looking ahead, the Company now expects full year fiscal 2018 sales growth to exceed 25% compared to its prior expectation of sales growth closer to 20% over 2017. Net sales in 2017 were $90.6 million.

3. Health Insurance Innovations Inc. (HIIQ)

Health Insurance Innovations is a distributor of individual and family health insurance plans, and supplemental products in the United States.

Gained 16.03% to close Thursday's trading at $44.15. The stock touched an all-time high of $44.40 in intraday trading.

News: The Company reported financial results for the second quarter ended June 30, 2018, and raised its annual guidance.

Adjusted net income for the second quarter of 2018 rose to $10.19 million or $0.61 per share on revenue of $71.7 million. This compared with an adjusted net income of $7.51 million or $0.46 per share and revenue of $61.8 million in the year-ago quarter.

For full-year 2018, the Company has boosted its revenue outlook range to be between $293 million and $303 million, up from its prior forecast range of $290 million and $300 million.

Adjusted EPS for the year is now expected to be between $2.47 and $2.57 compared to its previous guidance of $2.45 and $2.55.

Revenue in 2017 was $250.5 million and adjusted EPS was $1.65.

4. Insmed Inc. (INSM)

Insmed is a clinical-stage biopharmaceutical company developing therapies for patients with rare diseases.

Gained 13.36% to close Thursday's trading at $28.08.

News: The Company reported financial results for the second quarter ended June 30, 2018 and provided a business update.

For the second quarter of 2018, net loss was $76.4 million or $1.00 per share compared with a net loss of $44.7 million or $0.72 per share for the second quarter of 2017. No revenues were generated in Q2, 2018 and the comparable quarter.

Near-term Catalysts:

-- The NDA for ALIS for adult patients with Nontuberculous Mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) is scheduled to be reviewed by an FDA panel on August 7, 2018. -- The FDA decision on ALIS is expected to be announced on September 28, 2018.

5. Spring Bank Pharmaceuticals Inc. (SBPH)

Spring Bank Pharma is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases, and certain cancers.

Gained 11.16% to close Thursday's trading at $14.05.

News: The Company announced positive results from the third monotherapy cohort (100mg Inarigivir) of the ongoing ACHIEVE trial.

ACHIEVE is a phase 2a trial evaluating 4 monotherapy dosing regimens of Inarigivir, also known as SB 9200, namely, 25mg, 50mg, 100mg and 200mg, followed by Viread for the treatment of chronic hepatitis B virus (HBV).

The Company has already reported results from the 24-week trial of both the 25mg and 50mg cohorts.

According to the results reported today, the primary endpoints, safety and antiviral activity, were achieved with Inarigivir 100mg at both week 12 (Inarigivir monotherapy) and week 24 (following the switch to Viread 300mg after week 12).

Near-term Catalyst:

-- Top-line results from the fourth and final monotherapy cohort (200mg) of the ACHIEVE trial are expected to be announced by the end of 2018.