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EARS Down But Not Out, Major Event Awaits AMRN In Q3, Exciting Time For TTOO

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Today's Daily Dose brings you news about an update on Auris' phase III clinical trial of AM-111; Mallinckrodt's progress with Stannsoporfin NDA; preliminary revenue results of T2 Biosystems and Amarin, and RTI Surgical's acquisition.

Read on...

Amarin Corp. plc (AMRN) expects net product revenue for Q4 2017, and full year 2017 above analysts' estimates.

For Q4 2017, the Company has forecast net revenue to range between $51 million and $54 million, and for full year 2017, it is estimated to have reached between $177 million and $180 million.

Analysts polled by Thomson Reuters expect the Company to report revenue of $49.6 million and $176.5 million in Q4 and full year 2017, respectively.

The Company announced that it is on track to report clinical results from its REDUCE-IT trial before the end of Q3, 2018.

REDUCE-IT is a phase III cardiovascular outcomes study to determine whether the Company's approved drug Vascepa will reduce cardiovascular risk in statin treated patients that still have elevated or high triglyceride levels.

Approved in July 2012, Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
The REDUCE-IT study has enrolled 8,175 patients who have been randomized, in accordance with the study protocol, on a 1:1 basis between Vascepa and placebo.

The final patient visits of the study are expected to commence on March 1, 2018. The onset of the targeted 1,612th primary major adverse cardiovascular event (MACE) in this study is projected to occur before the end of Q1 2018.

AMRN closed Thursday's trading at $4.19, unchanged from the previous day's close. In after-hours, the stock was up 7.16% to $4.49.

Auris Medical Holding AG (EARS) will be meeting the FDA and EMA to discuss the path forward for AM-111 in the treatment of acute inner ear hearing loss in the second quarter of 2018.

A phase III clinical trial of AM-111 in the treatment of acute inner ear hearing loss, dubbed HEALOS, the results of which were announced on November 28, 2017, had not met the primary efficacy endpoint in the overall study population.

However, an update on the trial post-hoc analyses of top-line data, provided by the Company on Thursday, reveals a clinically and statistically significant hearing improvement with AM-111 from baseline to Day 28 in the subpopulation of patients with profound hearing loss.

Also, in the profound acute hearing loss subpopulation, AM-111 treated patients had a lower incidence of no hearing improvement, which confirms AM-111's otoprotective effects, the Company added.

Another phase III trial of AM-111 in patients with severe to profound idiopathic sudden sensorineural hearing loss, dubbed ASSENT, was being conducted in the U.S., Canada, and South Korea.

Based on the findings from the HEALOS trial, Auris Medical, on November 28, 2017, had announced that it is terminating the ASSENT trial since its design was very similar to the HEALOS trial.

The Company expects to provide data from 31 patients who enrolled in the ASSENT trial with profound acute hearing loss towards the end of the first quarter of 2018.

Hinrich Staecker, MD, PhD, Professor, Department of Otolaryngology Head and Neck Surgery, University of Kansas Medical Center, Kansas City said, "These new data from the HEALOS trial are promising, demonstrating a clinically meaningful hearing improvement in those patients with profound hearing loss. If approved, AM-111 has the potential to address the unmet need for novel therapeutics which can improve hearing during the acute stage of profound sudden deafness and reduce the substantial risk of severe life-long hearing impairment."

EARS closed Thursday's trading at $0.53, down 11.52%. In after-hours, the stock was down another 1.89% to $0.52.

Mallinckrodt plc (MNK) has successfully completed the rolling submission of its NDA to the FDA, seeking approval of its recently acquired developmental product Stannsoporfin.

Stannsoporfin, proposed for the treatment of newborns at risk for developing severe jaundice, came under Mallinckrodt's fold last August when it acquired InfaCare Pharmaceutical Corp.

If approved, the drug is expected to become the first and only pharmacologic option in the U.S. indicated for treatment of neonates at risk for developing severe hyperbilirubinemia, or severe jaundice.

MNK closed Thursday's trading at $23.40, down 0.47%.

RTI Surgical Inc. (RTIX) has agreed to acquire privately-held spine-focused medical device company Zyga Technology Inc. Terms of the deal are kept under wraps.

Zyga Technology, whose primary product is the SImmetry Sacroiliac Joint Fusion System, records approximately $4 million in annual revenue.

The sacroiliac joint fusion (SIJF) market, which is currently $100 million in the United States, is projected to exceed $200 million by 2024.

RTIX closed Thursday's trading at $4.30, up 2.38%. In after-hours, the stock was up 1.16% to $4.35.

Regenxbio Inc. (RGNX) has provided interim updates on phase I trial of RGX-314 for wet AMD, and phase I/II clinical trial of RGX-501 for homozygous familial hypercholesterolemia (HoFH).

As of December 31, 2017, 13 participants had been treated with a single administration of RGX-314 in the phase I wet AMD trial, and there were no drug-related serious adverse events. The Company has received clearance from an independent Data Safety and Monitoring Board to dose a third cohort in the phase I trial.

In the phase I/II clinical trial of RGX-501 for homozygous familial hypercholesterolemia (HoFH), three participants had been treated as of December 31, 2017, with no dose limiting toxicities reported, and a fourth participant was recently treated. An independent DSMB has given the go-ahead to the Company to dose a second cohort in the study.

Near-term Catalysts:

-- Complete enrollment in the Phase I clinical trial of RGX-314 for the treatment of wet AMD in the first half of 2018.
-- Present topline data from the Phase I clinical trial of RGX-314 for the treatment of wet AMD in late 2018.
-- Complete enrollment in the Phase I/II clinical trial of RGX-501 for the treatment of HoFH in mid-2018.
-- Present topline data from the Phase I/II clinical trial of RGX-501 for the treatment of HoFH in late 2018.
-- Begin enrollment in a Phase I clinical trial of RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I) in the first half of 2018.
-- Begin enrollment in a Phase I/II clinical trial of RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II) in the first half of 2018.

The Company said that it ended the year 2017 with cash of more than $175 million. The full-year 2018 cash burn is expected to be between $85 million and $95 million.

RGNX closed Thursday's trading at $35.20, down 1.68%. In after-hours, the stock was down 17.76% to $28.95.

Shares of T2 Biosystems Inc. (TTOO) were up more than 3% in extended trading on Thursday, after the Company announced preliminary fourth quarter 2017 financial results, and provided an update on its T2Bacteria Panel.

Total revenue in the fourth quarter is expected to exceed the previously guided range of $1.1 million to $1.3 million, thanks to the demand for the Company's T2Dx Instrument and the T2Candida Panel.

Analysts polled by Thomson Reuters are expecting revenue of $1.18 million for the quarter.

As for the FDA clearance of T2Bacteria Panel, the Company expects to receive the regulatory nod in the first quarter of 2018.

TTOO closed Thursday's trading at $4.67, up 0.65%. In after-hours, the stock was up 3.85% to $4.85.

TTOO was trading around $2.96 when we alerted our premium subscribers to this stock on August 8, 2017.

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