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AKCA Faces FDA Panel Tomorrow, ALDR To Report Data In June, TCMD Riding High


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(RTTNews.com) - Today's Daily Dose brings you news about Akcea's regulatory catalyst to watch out for on Thursday, Alder's near-term catalysts; Aralez Pharma shutting up shop in the U.S.; Foamix's progress in phase III acne study; Tactile Systems' stellar results and upbeat outlook; Natera's improved Q1 financial results, and Reata Pharma's upcoming milestones.

Read on…

Akcea Therapeutics Inc.'s ( AKCA ) New Drug Application for Volanesorsen is scheduled to be reviewed by an FDA panel on May 10, 2018.

Volanesorsen, co-developed by Ionis and Akcea, with the proposed brand name WAYLIVRA, is an investigational therapy for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS).

The FDA is expected to render its final decision on Volanesorsen on August 30, 2018.

If approved, Volanesorsen would be the first therapy indicated for FCS patients.

AKCA closed Tuesday's trading at $18.80, down 13.24%.

Alder Biopharmaceuticals Inc. (ALDR) has a couple of near-term catalysts to watch out for.

-- 6 month data from PROMISE 2, a phase III global trial of Eptinezumab for chronic migraine prevention is expected in June of this year.

The primary and secondary endpoint results of PROMISE 2 trial, were reported in January of this year. There was a reduction of 8.2 monthly migraine days from baseline following a single Eptinezumab administration compared to 5.6 days for placebo.

-- Results from an open-label safety study of Eptinezumab for migraine prevention are also expected in June 2018. -- Submit BLA for Eptinezumab for chronic migraine prevention to the FDA in the first quarter of 2019.

ALDR closed Tuesday's trading at $14.00, up 3.70%.

AnaptysBio Inc. (ANAB) expects to report top-line data from its ongoing double-blinded, placebo-controlled phase IIa trial of ANB020 in 24 adult patients with severe eosinophilic asthma in the third quarter of 2018.

A phase IIb study of ANB020 in 300 adult patients with moderate-to-severe atopic dermatitis evaluating different subcutaneously administered dose levels and dosing frequencies of ANB020 is ongoing, with data expected in 2019.

Data from the Company's Phase 1 healthy volunteer trial of ANB019, its wholly-owned anti-interleukin-36 receptor, or IL-36R therapeutic antibody, will be presented in a poster session on Tuesday, May 29, 2018 at the EAACI Congress 2018 in Munich.

A 10-patient open-label Phase 2 trial of ANB019 in generalized pustular psoriasis is underway, and a phase II trial of ANB019 in palmoplantar pustulosis (PPP), previously referred to as palmo-plantar pustular psoriasis, is expected to be initiated this year.

ANAB closed Tuesday's trading at $88.64, down 0.72%.

Shares of Aralez Pharmaceuticals Inc. (ARLZ) (ARZ.TO) plunged more than 67% on Tuesday, following the Company's decision to discontinue its remaining U.S. commercial business.

Going forward, the Company will focus on its Canadian business, supported by Toprol-XL and its authorized generic (the "Toprol-XL Franchise") as well as Vimovo royalties.

The Company is seeking to reduce its cost base, strengthen the organization, and improve its balance sheet and cash flow.

ARLZ closed Tuesday's trading at $0.49, down 67.34%.

Foamix Pharmaceuticals Ltd. (FOMX) has enrolled and dosed the final patient in the third phase III study of FMX101 (the Company's minocycline foam 4%) in patients with moderate-to severe acne.

The Company expects top-line results from the study in the third quarter of 2018. If all goes well, the NDA filing for FMX101 is planned for the end of 2018.

FOMX closed Tuesday's trading at $5.12, up 1.19%.

Natera Inc. (NTRA) has reported a narrower loss and higher revenue for the first quarter ended March 31, 2018.

Net loss for the first quarter of 2018 was $32.9 million or $0.61 per share compared to net loss of $33.5 million or $0.65 per share for the same period in 2017. Total revenues in the recent first quarter were $62.3 million compared to $49.4 million for the first quarter of 2017, an increase of 26%.

Looking ahead, the Company anticipates 2018 total revenue to be in the range of $250 million to $275 million. The total revenue in 2017 was $210.9 million.

NTRA closed Tuesday's trading at $11.73, down 0.85%.

Ovid Therapeutics Inc. (OVID) has important events coming its way in the second half of this year.

-- The top-line data from a 12-week phase II trial evaluating OV101 for the treatment of adults and adolescents ages 13 to 49 years with a confirmed diagnosis of Angelman syndrome, dubbed STARS, is expected to be reported in the third quarter of 2018.

-- Enrollment in a phase 1b/2a clinical trial of TAK-935/OV935 in adults with Developmental and Epileptic Encephalopathies is ongoing. Top-line data from this trial are expected in the second half of 2018.

OVID closed Tuesday's trading at $8.95, down 0.22%.

Pacific Biosciences of California Inc. (PACB) has got favorable outcome in the UK and German patent litigation against Oxford Nanopore and other parties related to "2D" sequencing products.

Armed with the positive verdict, Pacific Biosciences has entered into a five-year settlement agreement with Oxford Nanopore and other parties. As part of the agreement, Oxford Nanopore will refrain from offering "2D" sequencing products through the end of 2023 in the United Kingdom and Germany.

PACB closed Tuesday's trading at $2.41, unchanged from the previous day's close.

Reata Pharmaceuticals Inc. (RETA) has a couple of events to watch out for in the coming years.

The Company's lead product candidates are Bardoxolone methyl and Omaveloxolone.

A phase III trial of Bardoxolone methyl for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, is underway. Data from CATALYST are expected to be available during the first half of 2020. Previously, the Company was expecting to report the data during the second half of 2018.

Enrollment in a phase II trial of Bardoxolone methyl in autosomal dominant polycystic kidney disease (ADPKD), IgA nephropathy, and type 1 diabetic CKD (T1D CKD) cohorts of the study, dubbed PHOENIX, is expected to be completed by May, with full primary endpoint data from these three rare forms of chronic kidney disease expected to be available during the third quarter of 2018. Full primary endpoint data from the focal segmental glomerulosclerosis cohort of the PHOENIX study are expected to be available in the first half of 2019.

Interim data for the ADPKD and IgA nephropathy cohorts of the PHOENIX study will be presented in a late-breaking abstract at the European Renal Association and European Dialysis and Transplant Association (ERA-EDTA) meeting in Copenhagen on May 25, 2018.

Enrollment in the pivotal phase III trial of Bardoxolone methyl in Alport syndrome, dubbed CARDINAL is proceeding as planned. The clinical trial is expected to be fully enrolled in the second half of 2018, with top-line data available in the second half of 2019.

Enrollment in the pivotal Part 2 of the Phase II trial of Omaveloxolone in Friedreich's ataxia, dubbed MOXIe, is proceeding as planned. The clinical study is expected to be fully enrolled in the second half of 2018, with top-line data available in the second half of 2019.

RETA closed Tuesday's trading at $27.59, down 0.54%.

Supernus Pharmaceuticals Inc. (SUPN) has reported stellar results for the first quarter of 2018.

Total revenue, including product sales, in the recent first quarter was $90.4 million compared to $57.6 million in the year-ago period. Product sales in the first quarter of 2018 rose to $89 million from $56.4 million in the comparable year-ago quarter.

Net earnings in the recent first quarter were $26.4 million or $0.49 per share compared to $10.3 million or $0.19 per share in the year-ago quarter.

For full year 2018, the Company continues to expect net product sales to be in the range of $375 million to $400 million. Net product sales in 2017 were $294 million.

SUPN closed Tuesday's trading at $44.65, down 1.00%.

Shares of Tactile Systems Technology Inc. (TCMD) touched a new high, following stellar results for the first quarter ended March 31, 2018, and upbeat revenue outlook for the year.

Net loss for the first quarter of 2018 decreased to $0.1 million or $0.00 per share from a net loss of $1.5 million or $0.09 per share in the first quarter of 2017. Revenues for the recent first quarter increased 35% to $26.8 million from $19.9 million in the year-ago quarter.

Looking ahead, the Company has raised its revenue outlook for 2018 to a range of $132 million to $134 million from its prior guidance range of $131 million to $133 million. The annual revenue reported in 2017 was $109.3 million.

TCMD touched a new high of $44.44 in intraday trading on Tuesday, before closing the day's trading at $43.23, up 17.09%.


Read the original article on RTTNews (http://www.rttnews.com/2892721/akca-faces-fda-panel-tomorrow-aldr-to-report-data-in-june-tcmd-riding-high.aspx)


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This article appears in: Stocks , Politics
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