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GLPG's FLORA Blooms, DVAX, ESPR Price Offering, SGMO Abuzz, HRTX On Track

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Today's Daily Dose brings you news about the outcome of Data and Safety Monitoring Board' interim analysis of ARCA biopharma's GENETIC-AF trial; stock offerings of Dynavax and Esperion; results of Galapagos' idiopathic pulmonary fibrosis study; Heron's progress in phase III program of HTX-011 and Sangamo's encouraging financial results.

Read on...

The Data and Safety Monitoring Board has completed the pre-specified interim analysis of ARCA biopharma Inc.'s (ABIO) GENETIC-AF trial. The DSMB has asked the Company to continue the trial with no changes.

GENETIC-AF is a phase 2B/3 double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio's investigational drug Gencaro to an approved drug TOPROL-XL for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).

The Company expects reporting top-line results from the GENETIC-AF trial in the first quarter of next year.

ABIO closed Wednesday's trading at $1.70, down 8.11%. In after-hours, the stock gained 8.82% and was at $1.85.

Dynavax Technologies Corp. (DVAX) has offered to sell 5 million shares of its common stock to the public at a price of $15.00 each.

The Company has granted the underwriters a 30-day option to purchase at the public offering price up to an aggregate of 750,000 additional shares of its common stock to cover over-allotments, if any. The gross proceeds to Dynavax from this offering are expected to be approximately $75 million.

The offering is expected to close on or about August 15, 2017, subject to customary closing conditions.

The Company's New Drug Application for Heplisav-B, an experimental hepatitis B vaccine, is under FDA review, with a decision date set for November 10, 2017.

DVAX closed Wednesday's trading at $17.20, down 7.77%.

Esperion Therapeutics Inc. (ESPR) has offered to sell 3.10 million shares of its common stock to the public at a price of $49.00 per share.

The underwriters have a 30-day option to purchase up to an additional 465,000 shares of its common stock. The gross proceeds from this offering to Esperion are expected to be $151.9 million.

The offering is expected to close on or about August 15, 2017, subject to customary closing conditions.

Esperion shares touched an all-time intraday high of $57.38 on Aug.8, 2017, following positive top-line results from its phase II study evaluating the LDL-C lowering efficacy and safety of the Bempedoic acid/Ezetimibe combination plus Atorvastatin against placebo in patients with hypercholesterolemia.

ESPR closed Wednesday's (Aug.9) trading at $50.54, down 3.05%.

Galapagos NV (GLPG) has announced positive topline results from its phase 2a trial of GLPG1690 in patients with idiopathic pulmonary fibrosis (IPF).

In the trial, dubbed FLORA, over the 12-week period, patients receiving GLPG1690 showed an FVC (forced vital capacity) increase of 8 mL, which is of statistical significance, while patients on placebo showed an expected FVC reduction of 87 mL (mean from baseline).

The Company plans to rapidly progress GLPG1690 in a late stage trial and had already discussions with regulators regarding trial design.

GLPG closed Wednesday's trading at $62.63, down 1.86%.

Heron Therapeutics Inc. (HRTX) has initiated patient enrollment in its phase III program of HTX-011, an investigational drug to prevent postoperative pain for the first 72 hours after surgery.

The program includes two pivotal Phase 3 efficacy studies in bunionectomy and hernia repair, representing a bony model and a soft tissue model, respectively.

The primary endpoints of the Phase 3 efficacy studies will be the difference in mean area under the curve (AUC) of pain intensity scores through 72 hours compared with placebo.

The phase III program is expected to be completed in the first half of 2018.

HRTX closed Wednesday's trading at $15.30, down 3.47%. In after-hours, the stock was up 4.87% to $16.04.

Organovo Holdings Inc. (ONVO) has reported better-than expected revenue for fiscal first quarter of 2018 while its quarterly loss has come in line with analysts' estimate.

In the three months ended June 30, 2017, total revenue rose to $990 thousand from $891 thousand in the comparable period of fiscal 2017. Analysts polled by Thomson Reuters were expecting revenue of $940 thousand.

Net loss was $10.1 million or $0.10 per share for the fiscal first quarter of 2018, in line with analysts' estimate. This compared with a net loss of $8.8 million or $0.09 per share for the fiscal first quarter of 2017.

Looking ahead, the Company expects total revenue of between $6.0 million and $8.5 million for fiscal-year 2018. Fiscal 2017 total revenue was $4.2 million. Wall Street analysts' consensus revenue estimate for fiscal 2018 is $7 million.

ONVO closed Wednesday's trading at $2.08, down 0.95%. In after-hours, the stock was up 8.17% to $2.25.

Sangamo Therapeutics Inc. (SGMO) has reported a narrower loss and higher revenue.for the second quarter 2017.

For the second quarter ended June 30, 2017, Sangamo's consolidated net loss is $12.5 million or $0.17 per share on revenue of $8.3 million. This compared with a net loss of $26.6 million or $0.38 per share and revenue of $3.7 million for the same period in 2016.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.19 per share and revenue of $5.98 million.

As of June 30, 2017, the Company had cash of $266.5 million.

SGMO closed Wednesday's trading at $8.45, down 2.87%. In after-hours, the stock was up 5.33% to $8.90.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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