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AKAO Hits New Low, INSY Shifts Focus From Opioids, FDA Nod For Theratechnologies

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Today's Daily Dose brings you news about Achaogen's corporate restructuring; AVEO Oncology's TIVO-3 trial results; Mirati Therapeutics' near-term catalysts and FDA approval of Theratechnologies' supplemental New Drug Application of Egrifta.

Read on...

Shares of Achaogen Inc. (AKAO) touched a new 52-week low on Monday after the Company announced a review of strategic alternatives and corporate restructuring.

In connection with this review, the Company has engaged Evercore as an independent financial advisor.

The corporate restructuring is expected to reduce operating expenses by approximately 35-40 percent, excluding one-time charges. The restructuring is expected to be largely completed before the end of 2018.

In June of this year, the Company received FDA approval for Zemdri for the treatment of complicated urinary tract infections. The Company will provide an update on ZEMDRI commercialization and launch at its upcoming third quarter earnings call on November 8, 2018.

AKAO closed Monday's trading at $3.27, down 12.57%.

AVEO Oncology's (AVEO) phase III study comparing Tivozanib to Sorafenib in 351 subjects with highly refractory advanced or metastatic renal cell carcinoma, dubbed TIVO-3, has met the primary endpoint.

Tivozanib is approved in the European Union, as well as Norway and Iceland, under brand name FOTIVDA, for the first-line treatment of adult patients with renal cell carcinoma.

According to the trial results, FOTIVDA showed 44% improvement in median progression free survival, and 26% reduction in risk of progression or death compared to Sorafenib.

The Company's goal is to submit a New Drug Application for Tivozanib to the FDA in approximately six months.

AVEO closed Monday's trading at $2.54, down 8.96%.

EyePoint Pharmaceuticals Inc. (EYPT) has signed an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of EyePoint's three-year micro insert using the Durasert technology for chronic, non-infectious posterior segment uveitis in the greater China territory.

The Company received FDA approval for this product as recently as October 12, 2018, and will be marketing it in the U.S. under the brand name YUTIQ.

As part of the agreement, EyePoint will receive a one-time upfront payment of $1.75 million and an additional $10.0 million in milestone payments from Ocumension.

In exchange, Ocumension will receive exclusive rights to develop and commercialize the product in the greater China territory, which is comprised of China, Hong Kong, Macau and Taiwan, at its own cost and expense, with EyePoint supplying product for clinical trials.

EYPT closed Monday's trading at $2.31, down 6.48%. In after-hours, the stock was up 6.06% to $2.45.

INSYS Therapeutics Inc. (INSY) is assessing strategic alternatives for its portfolio of opioid-related assets, including SUBSYS, which has been commercially available in the United States since 2012, as well as formulations of buprenorphine and the combination of buprenorphine/naloxone.

The move comes amid the Company's shifting focus from opioids, and aspiration to become a leader in pharmaceutical cannabinoids and novel drug delivery systems.

INSY closed Monday's trading at $8.53, down 4.69%. In after-hours, the stock was down 4.81% to $8.12.

Mirati Therapeutics Inc. (MRTX) is slated to announce preliminary biomarker data from the ongoing phase II clinical trial of its lead drug candidate Sitravatinib in combination with OPDIVO in non-small cell lung cancer patients on November 10, 2018.

An updated data in the ongoing phase II clinical trial of Mocetinostat in combination with IMFINZI in non-small cell cancer lung patients is expected to be presented on November 11, 2018.

MRTX closed Monday's trading at $38.07, up 0.77%.

Otonomy Inc. (OTIC) has a couple of catalysts lined up for the coming months.

A phase I/II clinical trial for OTO-413 in patients with speech-in-noise hearing difficulty, and a phase I/II clinical trial for OTO-313 in tinnitus patients are expected to be initiated in the first half of 2019.

Otonomy expects to select a clinical candidate for its OTO-5XX CIHL otoprotection program by end of 2018 to address this important unmet medical need.

A phase III trial of OTIVIDEX in Ménière's Disease, dubbed AVERTS-2, is underway. Top-line results from this study are expected in the first half of 2020.

OTIC closed Monday's trading at $2.48, unchanged from the previous day's close. In after-hours, the stock was up 2.82% at $2.55.

The FDA has approved Theratechnologies Inc.'s (TH.TO) (THERF.OB) supplemental New Drug Application regarding the commercialization of a new single-vial formulation of Egrifta.

Egrifta, supplied as two-vial formulation - a vial containing 1 mg of tesamorelin as a lyophilized powder, and a separate vial for the diluent, i.e., sterile water for Injection, 10 Ml, was approved in November 2010 to reduce excess abdominal fat in HIV-infected patients with lipodystrophy (abdominal lipohypertrophy).

The new single-vial formulation, known as "F4", is four times more concentrated than the currently commercialized formulation of Egrifta. The F4 significantly reduces the volume of administration, is more user-friendly as it comes in a single vial instead of two, and is also is stable at room temperature which represents an added advantage.

The net sales of Egrifta in the third quarter of fiscal 2018 were US$9.81 million compared to US$8.72 million in the year-earlier quarter.

TH.TO closed Monday's trading at C$8.96, up 4.31%.

Ultragenyx Pharmaceutical Inc. (RARE) has reported better-than-expected revenue for the third quarter of 2018, thanks to growing demand for Crysvita from both children and adults with X-Linked Hypophosphatemia in the United States.

The total revenue in the recent third quarter was $11.8 million compared to $198 thousand in the year-ago quarter.

Net loss in the third quarter of 2018 was $87.3 million or $1.74 per share compared with a net loss of $79.2 million or $1.87 per share in the year-ago quarter.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $1.96 per share on revenue of $11.1 million.

RARE closed Monday's trading at $52.94, down 1.73%.

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