BLFS Q1 Revenue Up 61%, VRAY Garners Attention, AKCA Gets FDA Panel Nod

(RTTNews) - Today's Daily Dose brings you news about FDA panel's stance on Akcea's drug candidate for a rare lipid disorder called familial chylomicronemia syndrome; ViewRay's better-than expected first-quarter results; Synergy Pharma's lackluster Q1 TRULANCE sales; Regulus' pipeline update; BioLife's record revenue for the first quarter of 2018; KemPharm's positive, top line results of its ADHD product candidate KP415, and Sepro's upcoming milestones.

Read on…

An FDA panel has voted 12-8 to support approval of Akcea Therapeutics Inc.'s (AKCA) WAYLIVRA for the treatment of a rare lipid disorder called familial chylomicronemia syndrome.

WAYLIVRA, previously known as Volanesorsen, is co-developed by Ionis and Akcea.

The FDA is expected to render its final decision on Volanesorsen on August 30, 2018. The regulatory agency usually follows the recommendations of its advisory panels, although it is not required to do so.

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

AKCA closed Thursday's trading at $20.66, up 9.89%.

BioLife Solutions Inc. (BLFS) has reported record revenue for the first quarter of 2018, driven by sales of CryoStor and HypoThermosol clinical-grade biopreservation media.

Revenue in the first quarter of 2018 was $3.8 million, an increase of 61% from the first quarter of 2017 and an increase of 22% from the fourth quarter 2017.

Net loss attributable to common stockholders for the first quarter of 2018 narrowed to $103,000, or $0.01 per share from $870,000 or $0.07 per share for the first quarter of 2017.

The Company has also affirmed its biopreservation media revenue outlook in the range of $14.5 million to $15.5 million, representing growth of 32% to 41% over 2017.

BLFS closed Thursday's trading at $8.25, down 0.24%.

Shares of Synergy Pharmaceuticals Inc. (SGYP) fell 11% in extended trading on Thursday, following the Company's lower-than-expected Q1, 2018 TRULANCE net sales.

Net loss in the recent first quarter narrowed to $36 million or $0.15 per share on TRULANCE net sales of $8.6 million. Analysts polled by Thomson Reuters were expecting a loss of $0.16 per share and revenue of $11.5 million.

TRULANCE net sales of $8.6 million in the first quarter of 2018 were lower than the net sales of $9.4 million during the fourth quarter of 2017.

In the first quarter of 2017, the net loss was $64.6 million or $0.30 per share on revenue of $98 thousand.

SGYP closed Thursday's trading at $1.63, down 2.40%. In after-hours, the stock was down another 11.04% to $1.45.

Regulus Therapeutics Inc. (RGLS), which continues to make progress in its pipeline, has provided an update.

The Company expects data from a Phase 1 single ascending dose (SAD) trial, and a Phase 1 multiple ascending dose study of RGLS4326 for autosomal dominant polycystic kidney disease in the second half of 2019.

Based on robust human in vitro data and murine in vivo data, the Company is advancing programs in Hepatitis B virus and immunology (targets undisclosed).

A phase II study of RG-012 for Alport syndrome, dubbed HERA, is ongoing and data from the Phase 1 renal biopsy study is anticipated by year-end 2018.

RGLS closed Thursday's trading at $0.72, down 0.34%.

KemPharm Inc. (KMPH) has announced positive, top line results from the first of three pivotal human abuse potential trials for its product candidate, KP415.

KP415 is based on a prodrug of d-methylphenidate for the treatment of attention deficit/hyperactivity disorder (ADHD).

The study was designed to measure the pharmacokinetics and pharmacodynamic effects of KP415 Prodrug, d-methylphenidate hydrochloride and placebo after intravenous (IV) administration in recreational stimulant users. KP415 Prodrug and d-methylphenidate hydrochloride were dosed at equimolar (equivalent) levels.

According to the Company, KP415 Prodrug demonstrated statistically significant differences compared to d-methylphenidate hydrochloride in the primary endpoint, maximal Drug Liking (Emax), and no statistical difference compared to placebo.

The Company expects to file the New Drug Application for KP415 as soon as the first quarter of 2019.

KMPH closed Thursday's trading at $5.30, up 4.95%.

Spero Therapeutics Inc. (SPRO) has a couple of catalysts to keep an eye on in the coming months.

The Company continues to expect top-line data from Phase 1 trial of SPR994 for use in adults to treat MDR Gram-negative infections in mid-2018.

A Phase 1b drug-drug interaction trial of SPR741 in healthy volunteers as a single dose in combination with compounds from the beta-lactam class of antibiotics is ongoing, with top-line data expected during the second quarter of 2018.

Additional data from the SPR206 IND-enabling studies are anticipated in the second quarter of 2018. SPR206 is designed to have antibiotic activity as a single agent against MDR and extremely drug resistant (XDR) bacterial strains.

Additional data from the IND-enabing studies of SPR720 are expected in the second half of 2018. SPR720 is an oral antibiotic designed for the treatment of an orphan disease, pulmonary non-tuberculous mycobacterial (NTM) infection.

SPRO closed Thursday's trading at $11.59, down 4.92%.

ViewRay Inc. (VRAY) has reported better-than expected financial results for the first quarter ended March 31, 2018.

Net loss for the recent first quarter narrowed to $7.5 million or $0.11 per share on revenue of $26.2 million. Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.20 per share on revenue of $11.94 million.

In the first quarter of 2017, the Company had reported a net loss of $28.0 million or $0.54 per share on revenue of $1.2 million.

Looking ahead, the Company reiterated 2018 total revenue to be in the range of $80 million to $90 million while analysts are looking for revenue of $78.28 million.

VRAY closed Thursday's trading at $7.74, up 2.38%. In after-hours, the stock was up 10.72% to $8.57.