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ARAY Reports Record Revenue, PTIE Bleeds, EVOK To Face FDA In April

pharma daily 081518 lt

Today's Daily Dose brings you news about Accuray's financial results; stock offerings of AVEO and Pain Therapeutics; Evoke Pharma's upcoming regulatory catalyst in April and FDA approval for expanded indication for Eisai/Merck's Lenvatinib.

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Shares of Accuray Inc. (ARAY) were up more than 6% in after-hours trading on Thursday after it reported its financial results for the fourth quarter and fiscal year ended June 30, 2018.

Net loss narrowed to $0.9 million or $0.01 per share for the fourth quarter of fiscal 2018 on revenue of $113.8 million, the highest ever quarterly revenue reported. This compares with a net loss of $5.3 million or $0.06 per share and revenue of $112.1 million in the prior fiscal year fourth quarter.

Looking ahead to fiscal year 2019, the Company expects total revenue to be in the range of $415.0 million to $425.0 million. The total revenue in fiscal 2018 was $404.9 million.

ARAY closed Thursday's trading at $3.52, up 1.44%. In after-hours, the stock was up another 6.38% to $3.75.

Shares of AVEO Pharmaceuticals Inc. (AVEO) were down more than 6% in after-hours on Thursday after its proposed offering of common stock.

Near-term Catalyst:

The top line data readout from a pivotal phase III trial comparing lead drug candidate Tivozanib to FDA-approved Nexavar (sorafenib) in subjects with refractory advanced renal cell carcinoma, dubbed TIVO-3, is expected in the fourth quarter of 2018.

AVEO closed Thursday's trading at $2.26, up 3.67%. In after-hours, the stock was down 6.19% to $2.12.

Evoke Pharma Inc.'s (EVOK) New Drug Application for Gimoti, submitted under 505(b)(2) regulatory pathway, has been accepted for review by the FDA - with a decision date set for April 1, 2019.

Gimoti is a nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. If approved, Gimoti will be the first new non-oral drug treatment option for diabetic gastroparesis in four decades.

EVOK closed Thursday's trading at $2.37, up 2.60%.

Krystal Biotech Inc. (KRYS) has entered into a securities purchase agreement with Frazier Healthcare Partners for the private placement of 625,000 shares at $16 per share. The private placement will yield gross proceeds of $10 million and is expected to close on August 17, 2018.To know more about KRYS, please visit our Company Spotlight column.

KRYS closed Thursday's trading at $15.43, down 4.28%.

The FDA has approved Eisai Inc. and Merck's (MRK) supplemental New Drug Application for Lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Lenvatinib, marketed under brand name LENVIMA, is already approved by the FDA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. The drug is also approved in combination with Novartis' Afinitor (everolimus) for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy.

Eisai Inc. and Merck entered into a global strategic oncology collaboration for LENVIMA in March of this year. Under the agreement, Eisai and Merck will develop and commercialize LENVIMA jointly, both as monotherapy and in combination with Merck's KEYTRUDA.

MRK closed Thursday's trading at $68.85, up 2.20%. The stock touched a new high of $69 in intra-day trading.

Shares of Pain Therapeutics Inc. (PTIE) fell as much as 50% on Thursday to touch a new low after it announced an $11.3 million registered direct offering priced at the market.

The Company has entered into definitive agreements with several institutional investors for the purchase of 8.86 million shares of its common stock, at a purchase price per share of $1.15, for gross proceeds of approximately $10.19 million, in a registered direct offering priced at-the-market.

Additionally, Pain Therapeutics has also agreed to issue to the investors unregistered warrants to purchase up to 8.86 million shares of common stock, at a purchase price per warrant of $0.125, for gross proceeds of approximately $1.11 million.

The closing of the offering is expected to occur on or about August 17, 2018, subject to the satisfaction of customary closing conditions.

PTIE closed Thursday's trading at $1.03, down 47.45%. The stock touched a new low of $0.98 in intraday trading.

The FDA has approved Teva Pharmaceutical Industries Ltd.'s (TEVA) epinephrine auto injector drug-device combination product indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients.

Teva's epinephrine auto injector is a generic substitute of Mylan's branded product EpiPen.

The product, which utilizes the Antares Pharma VIBEX device, has been approved with an AP rating, defined as a therapeutically equivalent injectable aqueous solution and therefore fully substitutable to the EpiPen at the pharmacy.

TEVA closed Thursday's trading at $24.11, up 7.30%.

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