Agenus Inc. (AGEN) said that its brain cancer vaccine candidate - Prophage G-100, plus the standard of care demonstrated a 146% increase in progression free survival and a 60% increase in overall survival compared to the standard of care alone in newly diagnosed glioblastoma multiforme patients in a phase II trial.
The results, which were preliminary, were presented during Plenary Session III at the 81st American Association of Neurological Surgeons Annual Scientific Meeting in New Orleans, Louisiana on May 1, 2013.
AGEN closed Wednesday's trading down 1.65% at $4.78. In after-hours, the stock fell further 3.77% to $4.60.
AVEO Pharmaceuticals Inc.'s (AVEO) experimental drug Tivozanib for the indication of advanced renal cell carcinoma faces an FDA panel review on May 2, 2013.
Tivozanib is an oral, once-daily, investigational tyrosine kinase inhibitor.
DiaMedica Inc. (DMA.V) has initiated a phase I/II trial of DM-199 in 36 healthy volunteers and in 40 Type 2 diabetic patients. DM-199 is a recombinant protein therapy proposed for the treatment of diabetes and associated complications. The company expects phase I and single dose phase II results from the phase I/II clinical trial in the second half of 2013.
Harvard Bioscience, Inc. (HBIO) affirmed its plan to spin-off its wholly-owned regenerative medicine device subsidiary - Harvard Apparatus Regenerative Technology Inc., or HART, to maximize value for its shareholders.
The company said it intends to effect the separation of its regenerative medicine business through the spin-off of 100% of HART's common stock to Harvard Bioscience stockholders in a pro-rata, tax-free dividend. Prior to such spin-off, Harvard Bioscience plans to contribute $15 million in cash to fund HART's initial operations. Harvard Bioscience also intends to apply to list HART's common stock on the NASDAQ Capital Market under the symbol "HART" in connection with the spin-off and related Form 10 filing.
HBIO closed Wednesday's trading at $4.85, down 5.27%. In extended trading, the stock gained 6.19% to $5.15.
Novadaq Technologies Inc. (NDQ.TO) (NVDQ) is offering US$50.3 million of common shares at a price to the public of $12.90 per common share, pursuant to an underwriting agreement with Canaccord Genuity Inc. Closing of the offering is expected to occur on or about May 7, 2013, subject to customary closing conditions.
NVDQ closed Wednesday's trading at $13.51, up 0.30%. In after hours, the stock fell 3.77% to $13.
Nuvo Research Inc. (NRI.TO) said its U.S. licensing partner, Mallinckrodt, the Pharmaceuticals Business of Covidien, will be submitting the pharmacokinetic study results comparing Pennsaid 2% to the original Pennsaid to the FDA in Q3 2013 which could lead to FDA approval of Pennsaid 2% in Q1 2014.
The NDA for Pennsaid 2% was issued a complete response letter in March of this year.
PENNSAID 2% is a follow-on product to original PENNSAID which is used for treating the signs and symptoms of osteoarthritis of the knee.
Oculus Innovative Sciences Inc.'s (OCLS) Microcyn-based antiseptic products, under the brand name Microdacyn, has received regulatory approvals in Panama and El Salvador. Oculus' Latin American partner, More Pharma, intends to begin commercialization of these new antiseptic products in both countries in the summer of 2013.
OCLS closed Wednesday's trading 6.46% higher at $5.60.
OncoGenex Pharmaceuticals Inc. (OGXI) plans to initiate a phase II trial of its experimental drug OGX-427 in combination with FDA-approved ABRAXANE and Gemcitabine in patients with previously untreated metastatic pancreatic cancer.
The trial, dubbed, Rainier will randomize about 130 patients to receive either OGX-427 or placebo in combination with ABRAXANE and Gemcitabine therapy. The primary endpoint of the trial will be overall survival, with additional analyses to evaluate progression-free survival, tumor response rates, safety, tolerability, and the effect of therapy on heat shock protein (Hsp27) levels.
OGXI shed 7.31% on Wednesday to close the day's trading at $9.39.
Paladin Labs Inc. (PLB.TO) said it has launched Silenor indicated for the treatment and symptomatic relief of insomnia characterized by frequent nocturnal awakening and/or early morning awakenings in Canada.
Paladin received rights to commercialize Silenor in Canada, South America and Africa from Somaxon Pharmaceuticals in June 2011. Somaxon was purchased by Pernix Therapeutic Holdings Inc. (PTX) in March 2013.
pSivida Corp. (PSDV) said that the resubmitted NDA for Iluvien for treatment of chronic diabetic macular edema has been accepted by the FDA, and a decision date has been set for October 17, 2013.
Iluvien is an intravitreal implant for diabetic macular edema, which is licensed to Alimera Sciences Inc. (ALIM).
PSDV closed Wednesday's trading at $2.35, up 3.52%.
Shares of Titan Pharmaceuticals Inc. (TTNP.OB), which trade over the counter, plunged nearly 74% after the company announced that its investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients - Probuphine, has failed to get FDA approval.
The regulatory agency has requested additional data supporting the efficacy of Probuphine in order for it to be approved.
An FDA panel voted 10-5 in favor of effectiveness, and 12-2 in favor of safety of Probuphine in March.
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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.