Keep Close Watch On ALDX Today, ABBV Just Hit Another High, Fennec Uplisted

(RTTNews) - Today's Daily Dose brings you news about AbbVie's SELECT-BEYOND trial results; Aldeyra's clinical trial catalyst to watch out for today; Fennec's uplisting; Peregrine's quarterly results; Pulse Bio's withdrawal of 510(k) for PulseTx System and appointment of a new CEO at TEVA.

Read on...

AbbVie's (ABBV) phase III clinical trial of investigational Upadacitinib (ABT-494) in patients with moderate to severe rheumatoid arthritis, who did not adequately respond or were intolerant to treatment with biologic DMARDs, has yielded positive results.

Results of the trial, dubbed SELECT-BEYOND, showed that after 12 weeks of treatment, both once-daily doses of Upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity. All ranked secondary endpoints were also achieved with both doses.

ACR20 is defined as American College of Rheumatology 20 percent improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

ABBV touched a new all-time high of $87.10 on Monday, before closing the day's trading at $87.00, up 1.95%.

Aldeyra Therapeutics Inc. (ALDX) is scheduled to announce results from its phase IIa clinical trial of ADX-102 in Dry Eye Disease on Tuesday, September 12, 2017 at 8:00 a.m. EDT.

Dry eye syndrome is a common inflammatory disease characterized by insufficient moisture and lubrication in the anterior surface of the eye. Symptoms may include ocular irritation, burning or stinging, and severe cases may lead to decreased vision. In patients with dry eye syndrome, aldehydes may contribute to ocular inflammation as well as the impairment of lipids (fats) that lubricate the surface of the eye.

ALDX closed Monday's trading at $4.20, up 1.20%. In after-hours, the stock was down 5.95% to $3.95.

Fennec Pharmaceuticals Inc.'s (FRX.TO), (FENCF.OB) shares of common stock have been approved for listing on the Nasdaq Capital Market. Trading on the Nasdaq under the symbol "FENC" is expected to commence on September 13, 2017.

Rosty Raykov, CEO of Fennec said, "Our listing on the Nasdaq represents a significant corporate milestone as we continue our commitment towards serving an unmet medical need for pediatric patients with cisplatin chemotherapy pending the SIOPEL 6 results in Q4 2017."

FENCF.OB closed Monday's trading at $8.32, up 11.04%.

Shares of Peregrine Pharmaceuticals Inc. (PPHM) rose more than 12% on Monday, following financial results for the first quarter of fiscal year 2018 ended July 31, 2017.

The Company's consolidated net loss attributable to common stockholders narrowed to $2.65 million or $0.06 per share for the first quarter of FY 2018 from $12.44 million or $0.36 per share for the same prior year quarter.

Contract manufacturing revenue from its CDMO subsidiary, Avid Bioservices, was $27 million for the first quarter of FY 2018 compared to $5.61 million for the first quarter of FY 2017.

PPHM closed Monday's trading at $3.23, up 12.15%.

pSivida Corp. (PSDV) plans to file NDA for Durasert three-year treatment for posterior segment Uveitis by late December or early January 2018.

The Company has also reported financial results for the fourth fiscal quarter ended June 30, 2017.

Revenue for the recent fourth fiscal quarter totaled $701 thousand compared to $304 thousand for the prior year quarter. Net loss for the quarter ended June 30, 2017 improved to $6.1 million or $0.16 per share from $6.4 million or $0.19 per share for the prior year quarter.

PSDV closed Monday's trading at $1.37, up 7.03%.

Shares of Pulse Biosciences Inc. (PLSE) plunged 21% on Monday, following withdrawal of its initial application to the FDA for 510(k) clearance of its PulseTx System for a general indication for soft tissue ablation.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS.

The 510(k) for PulseTx System, which was filed on March 14, 2017, was voluntarily withdrawn on September 8, 2017. The withdrawal was the result of FDA's request for additional data that could not be provided within the Agency's 90-day review period that would have otherwise ended on September 10, 2017.

PLSE closed Monday's trading at $15.46, down 21.00%.

Teva Pharmaceutical Industries Ltd., (TEVA) on Monday, announced that it has entered into a definitive agreement with CooperSurgical to sell PARAGARD (intrauterine copper contraceptive) for $1.1 billion in cash.

The transaction includes Teva's manufacturing facility in Buffalo, NY, which produces PARAGARD exclusively. PARAGARD had revenues of approximately $168 million for the trailing twelve month period ending June 30, 2017.

The transaction is expected to close before the end of 2017.

In other news, Teva's Board of Directors has named Kåre Schultz as the Company's President and Chief Executive Officer. Schultz will succeed Yitzhak Peterburg, who will continue to serve as Interim Chief Executive Officer until Schultz joins the Company.

TEVA closed Monday's trading at $18.50, up 19.35%.

Ultragenyx Pharmaceutical Inc. (RARE) and Kyowa Hakko Kirin Co. Ltd. have announced positive data from two ongoing phase II studies of Burosumab - 40 week data from the study in children less than five years old with X-linked hypophosphatemia and 24 week data from the study in adult tumor-induced osteomalacia patients.

In the X-linked hypophosphatemia study, Burosumab increased mean serum phosphorus levels by 1.2 mg/dL into the low normal range after one week of treatment and these levels were maintained through week 40 with 77% of children achieving normal serum phosphorus levels at week 40. Serum 1,25 dihydroxy vitamin D levels were also increased from baseline to week 40 of treatment.

In the tumor-induced osteomalacia study, at week 24 there was a statistically significant increase in mean percent change from baseline levels of the bone turnover markers, Procollagen type 1 N-terminal propeptide (P1NP) and collagen type 1 cross-linked C-telopeptide of type I collagen (CTx).

RARE closed Monday's trading at $50.51, up 1.10%.