ALNY To Face FDA In Feb., PODD Ups Outlook Again, Catalysts Galore For XLRN

(RTTNews) - Today's Daily Dose brings you news about Cardiovascular Systems's acquisition; upcoming catalysts of Revance Therapeutics and Acceleron Pharma; Insulet's stellar revenue outlook; and Axonics's Q2 financial results, to name a few.

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Acceleron Pharma Inc. (XLRN) has a couple of catalysts to watch out for in the coming months.

The Company's Biologics License Application for Luspatercept for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions is under priority review, with a decision date set for December 4, 2019.

The Biologics License Application for Luspatercept for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions is also under FDA review, with a decision expected on April 4, 2020.

Luspatercept in adult patients with MDS- or beta-thalassemia-associated anemia is being reviewed by the European Medicines Agency also, and a decision is expected in the second half of 2020.

A phase II trial of Luspatercept in patients with Myelofibrosis is underway, with results expected later this year.

The other ongoing trials with Luspatercept are a phase III study in patients with treatment-naïve lower-risk MDS, dubbed COMMANDS, and phase II study in patients with non-transfusion-dependent beta-thalassemia, dubbed BEYOND. Topline results from the BEYOND trial are expected by year-end 2020.

Also in the pipeline is ACE-083, which is under phase II studies in Facioscapulohumeral Muscular Dystrophy and Charcot-Marie-Tooth disease. The topline results from the facioscapulohumeral muscular dystrophy trial are expected in the second half of 2019, and data from the Charcot-Marie-Tooth disease trial are anticipated in the first quarter of 2020.

A phase II trial of Sotatercept in pulmonary arterial hypertension, dubbed PULSAR, is ongoing, with topline results expected in the first quarter of 2020.

XLRN closed Monday's trading at $41.49, down 5.79%.

Alnylam Pharmaceuticals Inc.'s (ALNY) New Drug Application for Givosiran for the treatment of acute hepatic porphyria has been accepted for priority review by the FDA, with a decision expected on February 4, 2020.

The Company has been informed by the FDA that there may not be an advisory committee meeting as part of the NDA review.

Givosiran is also under accelerated assessment by the European Medicines Agency.

ALNY closed Monday's trading at $71.41, down 3.47%.

Axonics Modulation Technologies, Inc. (AXNX) has reported financial results for the second quarter ended June 30, 2019.

Net loss for the second quarter of 2019 was $19.1 million or $0.68 per share compared to a net loss of $8.6 million or $3.07 per share in the prior-year quarter.

Net revenue was $1.5 million in the second quarter of 2019 compared to $12 thousand in the year-ago period. Revenue is derived from the sale of the Company's r-SNM Systems to customers in Europe and Canada. The device is indicated for patients with urinary and bowel dysfunction.

In the U.S., Axonics r-SNM System is currently under review by the FDA, with a decision expected toward the end of the third quarter or early fourth quarter of 2019.

AXNX closed Monday's trading at $33.77, down 6.48%.

Cardiovascular Systems Inc. (CSII) has acquired the WIRION Embolic Protection System and related assets from Gardia Medical Ltd., a wholly-owned Israeli subsidiary of Allium Medical Solutions Ltd.

The WIRION Embolic Protection System is CE marked and FDA cleared, and CSI plans to commercialize the device in the United States following the transfer of manufacturing from Gardia Medical, which is expected to be completed after a 12- to 15-month transition period.

The Company is scheduled to report results for its fiscal fourth quarter ended June 30, 2019, and its financial outlook on August 6, 2019.

CSI closed Monday's trading at $42.73, down 4.09%.

Insulet Corp. (PODD) has reported a profit for the second quarter ended June 30, 2019, on 43 percent revenue growth, and has increased its revenue outlook for the year.

Net income for the second quarter of 2019 was $1.4 million or $0.02 per share, compared to a net loss of $1.7 million or $0.03 per share in the year-ago quarter. The recent second-quarter revenue was $177.1 million, up 43%, compared to revenue of $124.3 million in the second quarter of 2018.

For the year ending December 31, 2019, the Company has raised its revenue guidance to a range of $700 to $715 million, from its prior revenue outlook of $667 to $690 million. This is the second time that Insulet is raising its revenue outlook for full-year 2019.

PODD closed Monday's trading at $117.93, down 2.45%.

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi's (SNY) pivotal phase III trial evaluating Dupixent to treat severe atopic dermatitis in children aged 6 to 11 years has met its primary and secondary endpoints.

Dupixent is the first and only biologic to show positive results in this pediatric atopic dermatitis population, according to the Company.

In the U.S., Dupixent is currently approved in patients 12 years and older with moderate-to-severe atopic dermatitis, as well as moderate-to-severe asthma and adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP).

Sales of Dupixent were 825 million euros ($917 million) in the first half of 2019, up 175% compared with the first half of 2018.

A supplemental Biologics License Application seeking FDA approval of Dupixent for children is expected to be filed in the fourth quarter of this year.

SNY closed Monday's trading at $40.34, down 2.35%.

Revance Therapeutics Inc. (RVNC) is on track to submit its Biologics License Application to the U.S. FDA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines this fall.

DaxibotulinumtoxinA for Injection is also being evaluated forehead lines and crow's feet, and phase II trials in the two indications are underway. Topline results for both the trials are expected in the first half of 2020.

The Company ended June 30, 2019, with cash of $241.9 million.

RVNC closed Monday's trading at $11.94, down 2.69%.