AVEO Crashes, FDA Approves 1st Generic Of ADVAIR DISKUS, 'Tis Advantage TTNP

(RTTNews) - Today's Daily Dose brings you news about the delay in filing of AVEO Pharma's NDA for FOTIVDA for renal cell cancer; Corcept's lower-than-expected fourth quarter revenue; Edwards LifeSciences' strong profitability and 10 percent sales growth in Q4; suspension of OPKO Health's Benign Prostatic Hyperplasia trial; and FDA approval of first generic of Glaxo's ADVAIR DISKUS.

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Shares of AVEO Pharmaceuticals Inc. (AVEO) crashed over 60% on Thursday after being told by the FDA not to submit a New Drug Application for FOTIVDA with just the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial.

FOTIVDA is being developed for the treatment of advanced renal cell cancer in adults.

The Company now plans to make an NDA filing decision following the availability of more mature overall survival results. A more mature interim overall survival outcome is expected in the fourth quarter of 2019.

AVEO closed Thursday's trading at $0.69, down 60.49%.

Corcept Therapeutics Inc's. (CORT) preliminary revenue results for the fourth quarter and full-year 2018 have fallen short of analysts' expectations.

The preliminary fourth quarter 2018 revenue is $66.8 million, compared to $53.3 million in the fourth quarter of 2017. Preliminary 2018 revenue is $251.2 million, an increase of 58 percent from 2017.

However, analysts were expecting revenue of $70.42 million in the fourth quarter and $254.84 million in full-year 2018.

Looking ahead, Corcept projects 2019 revenue of $285 million to $315 million while analysts have a consensus estimate of $320.19 million.

CORT closed Thursday's trading at $11.18, down 4.44%. In after-hours, the stock was down 3.40% to $10.80.

Edwards Lifesciences Corporation (EW), a medical device company, has reported strong profitability and 10 percent sales growth for the fourth quarter ended December 31, 2018.

On an adjusted basis, in the fourth quarter of 2018, net income was $248.6 million or $1.17 per share and net sales were $982.7 million. In the fourth quarter of 2017, on an adjusted basis, net income was $203.1 million or $0.94 per share and net sales were $909.4 million.

Analysts polled by Thomson Reuters were looking for earnings of $1.17 per share and sales of $975.92 million for the fourth quarter of 2018.

For the first quarter of 2019, the Company projects total sales to be between $950 million and $1.01 billion, and adjusted EPS of $1.15 to $1.25.

EW closed Thursday's trading at $170.42, up 1.00%. In after-hours, the stock was down 1.33% to $168.16.

The Blue Cross Blue Shield of North Carolina has issued a positive coverage policy on Inspire Medical Systems Inc.'s (INSP) FDA-approved neurostimulation technology for moderate to severe obstructive sleep apnea.

This is the third coverage policy issued by a Blue Cross Blue Shield Association healthcare plan following BCBSA Evidence Street's January 7, 2019 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria.

Shares of Leap Therapeutics Inc. (LPTX) were down more than 12% in extended trading on Thursday, following a proposed public offering of common stock and warrants.

Raymond James & Associates, Inc. and Ladenburg Thalmann will act as book-running managers for the offering.

The Company intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock and/or warrants.

LPTX closed Thursday's trading at $1.95, down 10.34%. In after-hours, the stock was down 12.82% to $1.70.

The FDA has approved Mylan N.V.'s (MYL) Wixela Inhub, the first generic of Glaxo's ADVAIR DISKUS, for certain patients with asthma or chronic obstructive pulmonary disease.

Wixela Inhub will be available in the 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths for asthma patients and the 250 mcg/50 mcg strength for COPD patients. The product will be launched in the second half of February.

Evercore ISI's analyst Umer Raffat expects Wixela Inhub to bring home sales of $250 million for Mylan in 2019.

MYL closed Thursday's trading at $29.95, down 2.82%.

OPKO Health Inc. (OPK) has decided to suspend its phase II clinical trial evaluating the effect of 15mg and 25mg doses of OPK-88004 on prostate volume in patients with Benign Prostatic Hyperplasia as it has been found that the trans-rectal ultrasound method employed to measure one of the study's primary endpoints (decreases in prostate volume) is too imprecise to reliably determine the drug effect.

Also, increases in liver enzymes were observed in several men at these higher doses. The increases were transient in patients that completed the trial and returned to normal once the drug was withdrawn, the Company added.

OPKO is planning additional exploratory phase II clinical studies to assess the feasibility of OPK-88004 in other indications.

OPK closed Thursday's trading at $3.68, down 1.08%.

The FDA has turned down Sunovion Pharmaceuticals Inc.'s APL-130277, proposed as an intermittent therapy to overcome episodic off periods in Parkinson's disease.

APL-130277 is a sublingual film formulation of Apomorphine, a non-ergot dopamine agonist. Sunovion is Aquestive Therapeutics' partner and sponsor of APL-130277.

Keith Kendall, Chief Executive Officer of Aquestive Therapeutics said, "While APL-130277 is not an Aquestive pipeline program, it remains indicative of the future value in our intellectual property (IP) license with Sunovion. We will continue to proactively engage in opportunities to monetize all of our passive assets."

AQST closed Thursday's trading at $6.13, down 14.27%.

Titan Pharmaceuticals Inc. (TTNP) announced that the current market is highly receptive to the U.S. commercial relaunch of Probuphine (buprenorphine) implant, its unique six-month treatment for Opioid Use Disorder (OUD).

In December 2012, Titan had granted Braeburn exclusive rights to commercialize Probuphine in the United States and Canada under a license agreement. But this agreement was terminated, and Titan regained all rights to the commercialization and clinical development of Probuphine in the U.S. and Canada last June.

According to the Company, there has been a double-digit increase in total product shipments in the period following Titan's assumption of responsibility for Probuphine sales in mid-June 2018. Based on preliminary information, total shipments of Probuphine during the rest of the year increased sequentially by over 20%.

Titan expects to provide more details in its fourth quarter and full-year 2018 financial results, which it expects to release in late March 2019.

TTNP closed Thursday's trading at $1.23, up 2.50%. In after-hours, the stock was up 44.72% to $1.78.