SMA Data Endears IONS To Investors, PFE Opens Wallet, Busy Months Ahead For DRRX

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZ.TO) has signed an exclusive license agreement with Rafa Laboratories Ltd. for lead anti-cancer compound, Zoptrex, for the initial indication of endometrial cancer, for Israel and the Palestinian Territories.

Aeterna's Zoptrex is under phase III clinical trial in endometrial cancer, and the study is expected to be completed this quarter (Q3, 2016).

AEZS closed Monday's trading at $3.44, up 2.08%.

DBV Technologies (DBVT) has initiated a phase III trial designed to assess the use and safety of Viaskin Peanut 250 µg in routine clinical practice. The study is dubbed REALISE, and it marks the expansion of the largest global clinical development program to date in children suffering from peanut allergy.

Viaskin Peanut is the company's lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin.

Another phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 µg in children ages four to 11 years, dubbed PEPITES, is underway.

Topline results from both trials are expected in the second half of 2017.

DBVT closed Monday's trading at $34.79, up 0.56%.

DURECT Corp.'s (DRRX) first phase 1b trial of oral DUR-928 in nonalcoholic steatohepatitis patients is underway in Australia, and the company expects to start obtaining results from this trial in the third quarter of 2016.

Another phase Ib trial of DUR-928 in patients with impaired kidney function is also ongoing in Australia, and this trial is expected to be completed in 2016.

The NDA for REMOXY submitted by DURECT's licensee Pain Therapeutics (PTIE) is under FDA review - with a decision date set for September 25, 2016.

DRRX closed Monday's trading at $1.90, down 2.06%.

EyeGate Pharmaceuticals Inc. (EYEG) has announced positive data from its Phase 1b/2a trial of its lead product candidate, iontophoretic EGP-437, in the treatment of post-operative ocular inflammation and pain in cataract surgery patients.

Patients were divided into four cohorts and administered iontophoretic EGP-437 at either 9mA-min or 14mA-min on Day 0, Day 1 and Day 2 or Day 0, Day 1 and Day 4, with potential for an additional treatment at Day 7 in all cohorts.

According to the trial results, subjects receiving the 14 mA-min dose at days 0, 1 and 4 demonstrated the most significant positive response. All subjects in the 14 mA-min cohort experienced reduction in pain at all time points with 90% having no pain as early as day 1 and increasing to 100% on day 14 again.

The company expects top-line data from the additional cohorts in the fourth quarter of 2016, and remains on track to initiate a randomized, placebo-controlled trial of iontophoretic EGP-437 in cataract surgery patients by the end of the year.

EYEG closed Monday's trading at $2.09, up 3.47%.

Shares of Ionis Pharmaceuticals Inc. (IONS) rose over 30% on Monday, following encouraging data from its phase III trial of Nusinersen in infantile-onset spinal muscular atrophy.

In the trial, dubbed ENDEAR, infants receiving Nusinersen experienced a statistically significant improvement in the achievement of motor milestones compared to those who did not receive treatment. Nusinersen demonstrated an acceptable safety profile in the trial.

Ionis is collaborating with Biogen Inc. (BIIB) to develop and potentially commercialize Nusinersen for the treatment of spinal muscular atrophy.

Following the positive results, Biogen has exercised its option to develop and commercialize Nusinersen globally and paid Ionis a $75 million license fee. Biogen will initiate regulatory filings globally in the coming months.

IONS closed Monday's trading at $38.01, up 30.22%.

In a move that will expand its expertise in gene therapy, Pfizer Inc. (PFE) is acquiring privately-held Bamboo Therapeutics Inc. in a deal valued at $645 million.

Pfizer previously acquired roughly 22 percent of Bamboo's fully diluted equity during the first quarter of 2016 for a payment of about $43 million. The remaining equity of Bamboo has now been acquired for an upfront payment of $150 million, and Bamboo's selling shareholders will be eligible for potential milestone payments of up to $495 million contingent upon the progression of key assets through development, regulatory approval and commercialization.

The acquisition combines Bamboo's gene therapy portfolio, advanced vector design, and production technologies and capabilities with Pfizer's global scale, research, development and commercialization experience.

Following the acquisition, Bamboo is now a wholly-owned subsidiary of Pfizer.

PFE closed Monday's trading at $37.31, up 1.14%.

RedHill Biopharma Ltd. (RDHL) expects top-line final results from its phase IIa proof-of-concept clinical study evaluating RHB-104 in patients treated for relapsing-remitting multiple sclerosis in the fourth quarter of 2016.

A phase III clinical study evaluating RHB-104 as a treatment for Crohn's disease, dubbed MAP US study, is underway - with interim data and safety monitoring board (DSMB) analysis expected in the fourth quarter of 2016.

RDHL closed Monday's trading at $14.55, up 10.81%.

SCYNEXIS Inc.'s (SCYX) phase II study evaluating the pharmacokinetics, safety, and tolerability of SCY-078 as an oral step-down treatment in patients initially treated with intravenous echinocandin therapy for invasive Candida infections has met all primary objectives.

The main primary study objective was the identification of the oral dose of SCY-078 that would achieve the target exposure in at least 80% of patients. The interim population PK model predicts that the dose of 750mg will successfully achieve the target exposure at steady state in more than 80% of the population. SCY-078 was also safe and well tolerated, noted the company.

SCYX closed Monday's trading at $2.00, down 0.99%.