Plus   Neg

ABIO's Trial Hits Mixed Notes, IRIX Slumps On Recall, EGRX On Watch

Feb26 down 022618 lt

The following are some of the stocks that lost the largest percentage in price today in the pharma/biotech sector.

1. ARCA biopharma Inc. (ABIO)

Lost 71.88% to close Monday's (Feb.26) trading at $0.45.

News: The Company reported mixed results from its GENETIC-AF trial.

GENETIC-AF is a phase 2B double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio's investigational drug Gencaro to active control 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 trial involved patients from the U.S., Canada and Europe.
When all patients were taken into consideration, Gencaro and the active control, TOPROL-XL, demonstrated a similar treatment benefit, which means that Gencaro didn't demonstrate superiority.

However, in certain subsets of patients, there was a trend for potential superior benefit in favor of Gencaro. For example, in the U.S. patients (127 of 267 total patients), a trend for potential superior benefit in favor of Gencaro (approximately 30% risk reduction over TOPROL-XL), was observed for the primary endpoint of time to recurrence of AF. Additionally, in U.S. patients, Gencaro demonstrated a trend for potential superior benefit in favor of Gencaro (approximately 51% risk reduction over TOPROL-XL) in a subset of patients who underwent continuous heart rhythm monitoring with Medtronic implanted devices.

2. IRIDEX Corp. (IRIX)

Lost 16.87% to close Monday's trading at $6.16.

News: The Company has initiated a voluntary recall of a specific laser accessory called the TruFocus LIO Premiere.

The LIO is a headmounted indirect ophthalmoscope that connects to an IRIDEX laser console and is used to view and perform laser treatments on a patient's eye.

3. InflaRx N.V. (IFRX)

Lost 11.53% to close Monday's trading at $28.31.

News: No news


The lead compound is IFX-1, which is being explored in the indication of moderate to severe Hidradenitis Suppurativa.

Inflarx reported positive top line data from an exploratory phase IIa trial of IFX-1 in Hidradenitis Suppurativa in September of 2017.

Near-term Catalyst:

A phase IIb study of IFX-1 in patients with moderate or severe Hidradenitis Suppurativa is expected to be initiated this quarter. The study, which will be conducted at approximately 50 sites in several countries, is expected to enroll roughly 175 patients.

4. Benitec Biopharma Limited (BNTC)

Lost 9.67% to close Monday's trading at $2.99.

News: No news


BB-301 for oculopharyngeal muscular dystrophy, BB-401 and BB-501 for head & neck squamous cell carcinoma, BB-201 for wet age-related macular degeneration and BB-103 for hepatitis B are the drug candidates in the Company's pipeline.

Near-term Catalysts:

--BB-301 is expected to move into a phase 1/2 clinical study by the end of calendar year 2018.
-- A phase II clinical trial for BB-401 for the treatment of patients with HNSCC is planned to start in the first quarter calendar year 2018.

5. Eagle Pharmaceuticals Inc. (EGRX)

Lost 8.88% to close Monday's trading at $60.92.

News: The Company announced financial results for the three- and twelve-months ended December 31, 2017.

Q4 2017 Adjusted Non-GAAP net income was $15.6 million or $1.00 per share, on revenue of $46.8 million. This compared with Adjusted Non-GAAP net income of $17.2 million or $1.05 per share and revenue of $81.1 million in the prior year quarter.

Analysts polled by Thomson Reuters were expecting earnings of $1.00 per share and revenue of $52.91 million.

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