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AKBA Abuzz, ANTH On Track For RESULT, IMUC Faces Cash Crunch, IONS Falls

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Today's Daily Dose brings you news about MabVax' stock offering; Caladrius Q1 results; ImmunoCellular's uncertainty surrounding its financial resources; Sophiris' upcoming catalyst; Akebia's license agreement related to Vadadustat; Ionis' phase III study results of Inotersen and Pernix' liquidity position.

Read on.

Akebia Therapeutics Inc. (AKBA) and global specialty pharmaceuticals company Vifor Pharma Group have entered into an exclusive license agreement to sell Vadadustat to Fresenius Medical Care dialysis clinics in the United States, upon FDA approval.

Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer currently in phase III development by Akebia for the treatment of anemia associated with chronic kidney disease.

Vifor Pharma will also make a $50 million equity investment in Akebia at $14 per share.

AKBA closed Monday's trading at $12.90, up 1.65%. In after-hours, the stock was up 16.20% to $14.99.

Anthera Pharmaceuticals (ANTH) expects topline data from its phase III study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis, dubbed RESULT, at the end of 2017 or early 2018.

The RESULT study is designed to evaluate the non-inferiority of Sollpura at individualized doses compared to approved, porcine-derived, enteric-coated PERT when administered to patients with exocrine pancreatic insufficiency due to cystic fibrosis.

ANTH closed Monday's trading at $2.12, down 0.47%. In after-hours, the stock was up 2.36% to $2.17.

Caladrius Biosciences Inc. (CLBS) reported worse-than-expected results for the first quarter ended March 31, 2017, but the numbers were definitely an improvement over the year-ago quarterly results.

The net loss attributable to Caladrius common stockholders for the first quarter of three months ended March 31, 2017 narrowed to $9.4 million or $1.12 per share on total revenue of $7.9 million.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.72 per share and revenue of $9.5 million.

In the first quarter of 2016, the Company had reported a net loss of $12.0 million or $2.09 per share and revenue of $7.5 million.

A phase II study of CLBS03 for the treatment of type 1 diabetes, dubbed T-Rex, is underway. The trial is expected to reach the half-way treatment mark in mid-year, and enrollment of the 70th subject will trigger an additional infusion of capital in the coming months, according to the Company.

CLBS closed Monday's trading at $5.33, up 8.11%. In after-hours, the stock was up another 5.63% to $5.63.

Shares of ImmunoCellular Therapeutics Ltd. (IMUC) tumbled more than 11% in extended trading on Monday, after the Company revealed that its ability to access sufficient additional financial resources for completing the ongoing phase 3 registration trial of ICT-107 and continue its ongoing operations are limited.

ICT-107, the Company's lead product candidate, is a patient-specific, dendritic cell-based immunotherapy targeting glioblastoma.

The Company is considering restructuring its business if a partner or acquirer for ICT-107 is not identified in the near term, but in any event, not later than 30 days.

IMUC closed Monday's trading at $1.59, up 3.25%. In after-hours, the stock fell 11.95% to $1.40.

Shares of Ionis Pharmaceuticals Inc. (IONS) fell more than 6% on Monday, despite its phase III study of Inotersen in patients with familial amyloid polyneuropathy meeting both primary endpoints.

In the phase III study, dubbed NEURO-TTR, at eight months and over the 15-month period, Inotersen-treated patients achieved statistically significant benefit compared to placebo in the modified Neuropathy Impairment Score +7 and the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy.

However, two key safety findings namely thrombocytopenia and renal observation in Inotersen-treated patients have dimmed the sheen of the results.

The Company noted that the two key safety findings observed during the study required changes to the monitoring schedule.

IONS closed Monday's trading at $43.90, down 6.75%.

MabVax Therapeutics Holdings Inc. (MBVX) has offered to sell 1.34 million shares of its common stock and an aggregate of 1 million shares of 0% Series G Convertible Preferred Stock to the public at a price of $1.75 per share of Common Stock and Series G Preferred Stock.

The underwriters have an option for a period of up to 45 days from the date of the Company's prospectus to purchase up to an aggregate of 201,428 additional shares of its common stock at the public offering price of $1.75 per share, less the underwriting discount.

The offering is expected to close on May 19, 2017.

MBVX closed Monday's trading at $2.03, up 4.11%.

Pernix Therapeutics Holdings Inc. (PTX) slumped over 30% in extended trading on Monday, following lacklustre first-quarter 2017 financial results and its liquidity position.

Net loss for the first quarter of 2017 was $29.5 million or $2.94 per share compared to net loss of $25.9 million or $4.24 per share in the year-ago quarter. First quarter 2017 net revenues decreased 8.6% to $29.7 million from $32.5 million in Q1, 2016.

At March 31, 2017, the total principal amount of debt outstanding was approximately $320.8 million.

The Company noted that it intends to transition to another financing source on or before July 31, 2017, and that a failure to repay all borrowings under the revolving credit facility on or before July 31, 2017 would constitute an event of default under the revolving credit facility.

PTX closed Monday's trading at $5.73, down 2.05%. In after-hours, the stock fell 30.19% to $4.00.

Sophiris Bio Inc. (SPHS) expects to receive the six-month biopsy data for all patients from its phase II open-label study of Topsalysin for localized prostate cancer in the first quarter of 2018, assuming enrollment is completed as expected.

The Company expects to have complete data on all patients who receive a second dose by the fourth quarter of 2018.

SPHS closed Monday's trading at $2.59, down 2.26%. In after-hours, the stock was up 2.32% to $2.65.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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