LXRX On Watch, NKTR To Face FDA In May, TNDM Boosts Sales Outlook

(RTTNews) - Today's Daily Dose brings you news about second quarter financial results of GenMark, Illumina and Tandem; anticipated milestones of Lexicon Pharma; Nektar's regulatory catalyst and FDA approval of Progenics' radioactive therapeutic Azedra, among others.

Read on... GenMark Diagnostics Inc. (GNMK) reported a narrower loss and 21% revenue growth in the second quarter ended June 30, 2018.

Net loss for the recent second quarter improved to $16.52 million or $0.30 per share from $17.99 million or $0.37 per share in the year-ago quarter. Revenue was $14.9 million in the second quarter of 2018, an increase of 21% over $12.4 million in the second quarter of 2017.

Looking ahead, the Company continues to expect revenue of $68 million to $72 million in 2018. Revenue in 2017 was $52.5 million.

GNMK closed Wednesday's trading at $6.04, up 1.34%.

Illumina Inc. (ILMN) has reported stellar financial results for the second quarter ended July 1, 2018.

Non-GAAP net income attributable to Illumina stockholders for the recent second quarter rose to $212 million or $1.43 per share from $121 million or $0.82 per share for the second quarter of 2017.

Revenue in the second quarter of 2018 was $830 million, a 25% increase compared to $662 million in the year-ago quarter.

For fiscal 2018, the Company now projects revenue growth of approximately 20%, and non-GAAP earnings per share attributable to Illumina stockholders of $5.35 to $5.45. In fiscal 2017, the Company had reported revenue of $2.75 billion and non-GAAP EPS attributable to Illumina stockholders of $4.00.

ILMN closed Monday's trading at $289.24, down 3.95%.

Lexicon Pharmaceuticals Inc. (LXRX) has a couple of catalysts to watch out for in the second half of this year.

-- Sotagliflozin data presentations at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD; October 1-5, 2018; Berlin, Germany). Sotagliflozin is an oral anti-diabetic drug candidate. -- Phase 1b data for LX2761 in type 2 diabetes. -- Initiation of clinical development of Telotristat ethyl in oncology. -- Phase 1a data for LX9211 (neuropathic pain candidate) in healthy volunteers. -- Manuscript publications for XERMELO and Sotagliflozin. -- Launch of XERMELO by Ipsen in additional European countries.

The New Drug Application for Sotagliflozin for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus is under FDA review, with a decision expected on March 22, 2019. Sanofi licensed rights to Sotagliflozin from Lexicon in 2015.

LXRX closed Monday's trading at $11.43, down 7.45%.

Nektar Therapeutics' (NKTR) New Drug Application for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy has been accepted for review by the FDA, with a decision date set for May 28, 2019.

NKTR-181 is a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics, according to the Company.

NKTR closed Monday's trading at $51.03, up 0.99%.

The FDA has approved Progenics Pharmaceuticals Inc.'s (PGNX) radioactive therapeutic Azedra for the treatment of adult and pediatric patients 12 years and older with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma.

Azedra is the first and only approved therapy for these rare, life-threatening neuroendocrine cancers.

The drug can cause serious side effects including risk from radiation exposure, bone marrow problems and other cancers (myelosuppression and secondary malignancies), thyroid problems (hypothyroidism), elevations in blood pressure, kidney problems (renal toxicity), respiratory problems (pneumonitis), pregnancy warning (embryo-fetal toxicity), and fertility problem, according to the Company.

Analysts expect Azedra to rake in peak sales of between $200 million and $300 million.

PGNX closed Monday's trading at $8.31, up 8.49%.

Pulse Biosciences Inc. (PLSE) has treated the first patient in a clinical study to evaluate Nano-Pulse Stimulation in Basal Cell Carcinoma, a common skin cancer.

Patients in the study will be treated with Nano-Pulse Stimulation prior to resection of the Basal Cell Carcinoma (BCC) lesion, which is the standard of care for BCC lesions.

The Company aims to achieve its goal of enrolling 75 patients in the trial by the end of 2018, and complete data follow-up in Q1 2019.

PLSE closed Monday's trading at $13.75, down 2.27%.

Medical Technology Company SeaSpine Holdings Corp. (SPNE) has narrowed its loss and registered a 6.5% revenue growth in the second quarter ended June 30, 2018.

Net loss for the second quarter of 2018 was $7.4 million or $0.50 per share compared to a net loss of $8.0 million or $0.68 per share for the same period of the prior year. Total revenue for the recent second quarter was $36.4 million, a 6.5% increase compared to the same period of the prior year.

SeaSpine expects full-year 2018 revenue to be in the range of $136 million to $139 million, reflecting growth of 3.2% to 5.5% over full-year 2017 revenue.

SPNE closed Monday's trading at $12.25, unchanged from the previous day's close.

The FDA has granted orphan drug designation to Surface Oncology's (SURF) lead investigational candidate SRF231 for the treatment of patients with multiple myeloma.

SRF231 is currently being evaluated in a Phase I trial to assess safety and tolerability in multiple ascending doses with the goal of establishing a recommended dose for further study.

SURF closed Monday's trading at $10.93, down 1.80%.

Tandem Diabetes Care Inc. (TNDM) has reported a 60% jump in Q2 sales and has lifted its annual sales guidance for 2018.

For the second quarter ended June 30, 2018, sales increased 60 percent to $34.1 million from $21.3 million in the year-ago period.

Net loss for the recent second quarter was $59.4 million or $1.17 per share compared to a net loss of $21.8 million or $4.36 per share in the year-ago quarter.

For the year ending December 31, 2018, the Company now expects sales to be in the range of $140 million to $148 million, which represents an annual sales growth of 30 percent to 38 percent compared to 2017. Previously, the Company had forecast 2018 annual revenue in the range of $132 million to $140 million.

TNDM closed Monday's trading at $24.84, down 2.97%.