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Eagle's Wings Clipped, FDA Panel Snubs IPCI, No Respite For CUR, MDXG On Watch


Today's Daily Dose brings you news about FDA rejection of Eagle Pharma's RYANODEX for an additional indication; Anika's stellar second quarter results; FDA panel giving thumbs down to Intellipharmaceutics' Rexista; MiMedx Group's record Q2 results and rosy outlook and Neuralstem's stock offering.

Read on...

Shares of Anika Therapeutics Inc. (ANIK) climbed more than 5% in extended trading on Wednesday, following its strong double-digit revenue and earnings growth in the second quarter of 2017.

Net income for the second quarter of 2017 increased 32% to $11.4 million or $0.76 per share on total revenue of $33.5 million. This compared with a net income of $8.6 million or $0.57 per share and total revenue of $26.6 million for the second quarter of 2016.

ANIK closed Wednesday's trading at $47.99, down 0.56%. In after-hours, the stock was up 5.23% to $50.50.

Aratana Therapeutics Inc.'s (PETX) pivotal field effectiveness study results of AT-003 in cats have met protocol-defined efficacy success criteria, which were statistically significant.

AT-003, under brand name Nocita, was granted approval in August 2016 for local post-operative analgesia for cranial cruciate ligament surgery in dogs.

PETX closed Wednesday's trading at $7.28, up 0.41%.

Shares of Eagle Pharmaceuticals Inc. (EGRX) slumped nearly 24% on Wednesday as the FDA refused to approve RYANODEX for the treatment of exertional heat stroke, in conjunction with external cooling methods.

Ryanodex is already approved for the treatment of malignant hyperthermia, a potentially fatal, inherited disorder causing a rapid rise in body temperature (fever) and severe muscle contractions associated with administration of certain general anesthetics and/or the drug succinylcholine.

The drug brought in sales of $11.7 million for Eagle Pharma last year.

EGRX closed Wednesday's trading at $53.37, down 23.80%.

Esperion Therapeutics Inc. (ESPR) has initiated a phase II clinical study to assess the efficacy and safety of Bempedoic acid when added-on to an injectable proprotein convertase subtilisin/kexin type 9 inhibitor therapy in patients with elevated Low-density lipoprotein cholesterol (LDL-C) levels.

The eight-week study will evaluate the efficacy and safety of once-daily, oral Bempedoic acid 180 mg and once-monthly injection of Repatha 420 mg versus placebo. The study is expected to enroll approximately 50 patients with hypercholesterolemia at approximately 20 sites across the U.S.

The top-line results from the study are expected by the first quarter of 2018.

ESPR closed Wednesday's trading at $49.65, up 1.68%.

An FDA panel has voted against recommending approval of Intellipharmaceutics International Inc. (IPCI) (IPCI.TO) Rexista, intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride, for the relief of pain.

The panel members voted 22 to 1 in finding that the Company's New Drug Application for Rexista abuse-deterrent oxycodone hydrochloride extended release tablets should not be approved at this time. The members also voted 19 to 4 that the Company has not demonstrated that Rexista has properties that can be expected to deter abuse by the intravenous route of administration, and 23 to 0 that there are not sufficient data for Rexista™ to support inclusion of language regarding abuse-deterrent properties in the product label for the intravenous route of administration.

The FDA's final decision on Rexista is set for September 25, 2017. The regulatory agency usually follows the recommendations of its advisory panels, although it is not required to do so.

Trading in shares of IPCI was halted on Wednesday.

Shares of MiMedx Group Inc. (MDXG) were up more than 7% in extended trading on Wednesday, following record Q2 results and rosy outlook for the full year of 2017.

The Company's net income for the recent second quarter was $8.1 million or $0.07 per share on revenue of $76.4 million. This compares with a net income of $2.0 million or $0.02 per share and revenue of $57.34 million in the year-ago quarter. Analysts polled by Thomson Reuters expected the Company to earn $0.07 per share on revenue of $74.22 million for Q2, 2017.

For the third quarter of 2017, the Company expects revenue to be in the range of $79 to $80 million, well above consensus analysts' forecast of $76.17 million.

Looking ahead to full year 2017, the Company boosted its revenue guidance to the range of $309 to $311 million from its prior forecast range of $303.5 to $307 million. Wall Street analysts expect the Company to report revenue of $304.65 million for the year.

MDXG closed Wednesday's trading at $14.65, down 1.48%. In after-hours, the stock climbed 7.17% to $15.70.

A day after reporting disappointing results from its phase II trial of NSI-189 for major depressive disorder, Neuralstem Inc. (CUR) has proposed public offering of common stock and warrants.

Canaccord Genuity is acting as sole book-running manager for the offering.

CUR closed Wednesday's trading at $2.47, down 12.10%. In after-hours, the stock fell another 17% to $2.05.

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