MediciNova Announces FDA Approval of the Second Phase 2 Protocol for MN-001 in NASH Which Targets NASH Patients With Hypertriglyceridemia

LA JOLLA, Calif., July 27, 2015 -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), today announced that FDA (U.S. Food and Drug Administration) has approved a second protocol for a clinical trial evaluating MN-001 (tipelukast) for a NASH indication. This study targets NASH patients with hypertriglyceridemia to evaluate the ability of MN-001 to improve cardiovascular risk by assessing cholesterol-efflux capacity and serum triglyceride levels as well as reduction of percent fat in the liver, as assessed by MRI.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased to have successfully completed the FDA review period and look forward to initiating patient enrollment shortly. The safety and efficacy data from this trial will be important to our overall development efforts targeting NASH and should be complementary to efforts underway.

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Nymox Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint. Company Plans to File for Regulatory Approvals for Fexapotide Triflutate (NX-1207).

HASBROUCK HEIGHTS, N.J., July 27, 2015 -- Nymox Pharmaceutical Corporation (NYMX) announced today that the Company's U.S. long-term extension prospective double-blind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies (n=978).

The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories.

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IGI Laboratories Announces Second Quarter 2015 Results

Sales Grow 37% Over 2014, Pipeline to Date Increases to 28 ANDAs on File

BUENA, N.J., July 23, 2015 -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey-based specialty generic pharmaceutical company, announced its financial results for the second quarter ended June 30, 2015.

Second Quarter 2015 Highlights

  • Total revenues of $8.9 million in the second quarter of 2015, an increase of 37% over the same quarter in 2014
  • Total net revenues generated from the sale of IGI label generic topical pharmaceutical products for the three months ended June 30, 2015 and 2014 of $6.7 million and $3.4 million, respectively
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Neos Therapeutics Announces Pricing of Initial Public Offering

DALLAS/FORT WORTH, Texas, July 23, 2015 -- Neos Therapeutics, Inc. ("Neos" or "the Company") today announced the pricing of its initial public offering of 4,800,000 shares of common stock at an initial public offering price of $15.00 per share. In addition, Neos has granted the underwriters a 30-day option to purchase up to an additional 720,000 shares of common stock at the initial public offering price. The shares of Neos' common stock are expected to begin trading on the NASDAQ Global Market on July 23, 2015 under the ticker symbol "NEOS." The offering is expected to close on July 28, 2015, subject to customary closing conditions.

UBS Investment Bank, BMO Capital Markets and RBC Capital Markets are acting as joint book-running managers and JMP Securities is acting as a lead manager for the offering.

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Cara Therapeutics Announces Positive Results From Phase 2 Trial in Uremic Pruritus

Novel peripheral kappa opioid I.V. CR845 achieved statistically-significant results on primary endpoint of reducing worst itch intensity
Trial demonstrated statistically significant results on secondary endpoint of quality of life improvements with additional positive trend on itch-related sleep disturbances
I.V. CR845 found to be safe and well-tolerated in dialysis patients
Conference call today at 8:30 a.m. ET to discuss results and next steps

SHELTON, Conn., July 23, 2015 -- Cara Therapeutics, Inc. (CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced statistically significant topline results from its Phase 2 trial of its lead kappa opioid agonist, CR845, for the treatment of moderate to severe uremic pruritus (UP). Uremic pruritus is a chronic systemic itch condition in patients with renal failure, often receiving hemodialysis. There are currently no approved products in the United States for the condition.

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