BIIB One Step Closer, MBVX To Be Delisted, RGLS In The Red On Pink Slip Woes

pharma daily 070518

Today's Daily Dose brings you news about favorable results from Eisai/Biogen's phase II study of BAN2401 in Alzheimer's; MabVax' delisting from the Nasdaq; Regulus' workforce reduction; FDA approval of fully wristed, 60mm stapler and Zynerba pulling the plug on THC Prodrug ZYN001.

Read on...

Eisai Co., Ltd. and Biogen Inc.'s (BIIB) Phase II study of BAN2401 in patients with early Alzheimer's disease has yielded positive results.

After 18 months of treatment, BAN2401 at the highest treatment dose (10 mg/kg biweekly) demonstrated statistically significant slowing in clinical decline and reduction of amyloid beta accumulated in the brain.

BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration, noted the companies.

BIIB closed Thursday's trading at $298.81, up 1.81%. In after-hours, the stock was up 6.42% at $318.

Clovis Oncology Inc.'s (CLVS) marketing authorization application for a new indication for Rubraca as a maintenance treatment for women with recurrent Ovarian Cancer has been validated by the European Medicines Agency.

The company anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) by end of 2018.

In the U.S., Rubraca received FDA approval as a maintenance Treatment of recurrent Ovarian Cancer in April of this year.

CLVS closed Thursday's trading at $45.55, down 3.90%.

The FDA has approved Intuitive Surgical Inc.'s (ISRG) fully wristed, 60mm stapler, SureForm 60, which is an industry first and a new breed of da Vinci stapling compatible with the da Vinci Xi and X surgical systems.

SureForm 60 has general, thoracic, gynecologic, urologic, and pediatric indications. It expands and evolves Intuitive's da Vinci stapling portfolio, which includes 30 and 45mm stapler instruments.

ISRG closed Thursday's trading at $487.39, up 0.37%.

MabVax Therapeutics Holdings Inc. (MBVX) will be delisted from the Nasdaq at the open of business on Wednesday, July 11, 2018, due to Delinquent Filing for the period ended March 31, 2018, as well its non-compliance with the $2.5 million stockholders' equity requirement.

MBVX closed Thursday's trading at $0.64, up 10.34%. In after-hours, the stock was up 6.25% to $0.60.

Shares of Regulus Therapeutics Inc. (RGLS) were down over 45% in extended trading on Thursday, following a strategic update and corporate restructuring being implemented with the goal of extending its cash runway.

The Company has decided to reduce its workforce by roughly 60%; pause recruitment activities for the phase II RG-012 clinical program in Alport syndrome, and pause the Phase 1 multiple ascending dose (MAD) study of RGLS4326 for the treatment of autosomal dominant polycystic kidney disease due to unexpected observations in a mouse chronic toxicity study.

The drastic actions are anticipated to yield over $20 million of annualized savings, which are intended to extend the Company's cash runway into mid-2019.

RGLS closed Thursday's trading at $0.73, up 1.46%. In after-hours, the stock was down 45.17% at $0.40.

Stellar Biotechnologies Inc.'s (SBOT) customer and joint venture partner Neovacs, S.A. has reported favorable Phase 2b study results of IFN-Alpha-Kinoid immunotherapy in systemic lupus erythematosus.

Neovacs' IFN-Alpha-Kinoid immunotherapy utilizes Stellar's proprietary Keyhole Limpet Hemocyanin.

Neovacs is preparing for its pivotal Phase 3 clinical studies of IFN-Alpha-Kinoid immunotherapy.

SBOT closed Thursday's trading at $1.84, up 1.66%.

Zynerba Pharmaceuticals Inc. (ZYNE) has pulled the plug on ZYN001, a pro-drug of tetrahydrocannabinol (THC) THC-based patch, in phase I development.

The phase I trial assessed the safety and pharmacokinetics in single and multiple doses of several formulations of ZYN001, and the target blood levels of 5 to 15 ng/ml THC were not achieved.

The Company will focus its development efforts and investments on the ZYN002 Fragile X syndrome, developmental and epileptic encephalopathy (DEE) and adult refractory epilepsy programs.

A phase II study of ZYN002 in Developmental and Epileptic Encephalopathy, dubbed BELIEVE 1, is underway. The top line results from the BELIEVE 1 study are expected in 2019.

ZYNE closed Thursday's trading at $9.17, down 4.58%.

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