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Valeant's (VRX) Glaucoma Candidate Gets PDUFA Date from FDA

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Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the FDA has set a PDUFA date of Aug 24 for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%.

We note that latanoprostene bunod was licensed by Nicox to Bausch + Lomb.

Latanoprostene bunod is an intraocular pressure (IOP) lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Upon approval, latanoprostene bunod would be the first nitric oxide donating prostaglandin F2α analog for ophthalmic use.

However, stiff competition remains a major challenge in the glaucoma market due to the presence of other players in the same space. We note that Aerie Pharmaceuticals’ two lead product candidates -- Rhopressa and Roclatan – are once-daily intraocular pressure (IOP)-lowering therapies with novel mechanisms of action (MOAs) to treat patients with glaucoma or ocular hypertension.

Concurrently, Valeant announced that holders of its outstanding 6.75% senior notes due 2018 had validly tendered $1,552,046,000 in aggregate principal amount of the notes in connection with the company's offer to purchase for cash up to $1,100,000,000 aggregate principal amount of the notes which began on Mar 7.

Once an acquisition giant, Valeant was caught up in various controversies in 2016-price hike of specialty drugs, erroneous financial reporting and termination of contracts with Philidor Rx Services. With its new CEO, Joseph C. Papa, Valeant started a rebuilding process in 2016.

We note that the shares of Valeant have underperformed the Zacks classified Medical-Drugs industry in the last one year. The stock lost 66.7% as compared to the industry’s gain of 10.9%.

The company recently reported fourth-quarter results which beat expectations but provided a disappointing guidance for 2017. The outlook poses concerns about the company’s organic growth. Valeant witnessed an improvement in sales force turnover owing to some voluntary and involuntary changes. Moreover, generic competition of key drugs will continue to impact results. While the company’s neurology products are facing generic competition, the dermatology segment is also experiencing weakness.

Zacks Rank & Key Picks

Valeant currently carries a Zacks Rank #5 (Strong Sell).

Other better-ranked stocks in the health care sector include Heska Corp. and Retrophin, Inc. . Heska and Retrophin both sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 30% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.  

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