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ADXS Cervical Cancer Trial Put On Hold, GIS Recalls Flour, NCNA, URGN Slump

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Today's Daily Dose brings you news about stock offerings of Ohr Pharma, NuCana, UroGen; General Mills' recall of Gold Medal Unbleached Flour; partial clinical hold on Advaxis' cervical cancer trial; and Ironwood Pharma's progress with central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator IW-6463.

Read on…

Advaxis Inc.'s (ADXS) ongoing phase III pivotal study of Axalimogene filolisbac in high-risk, locally advanced cervical cancer has been placed on partial clinical hold.

The partial hold is related to the FDA's request for additional information pertaining to certain Axalimogene filolisbac chemistry, manufacturing and controls matters. No safety issues are related to the trial and all currently enrolled patients will continue to receive treatment, per the trial protocol, noted the Company.

However, new patients can enroll in the trial only after the partial hold is lifted.

ADXS closed Wednesday's trading at $0.31, down 10.09%. In after-hours, the stock was down 3.85% to $0.30.

General Mills Inc. (GIS) is voluntarily recalling five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020, due to potential contamination with Salmonella.

The presence of the bacteria was discovered during sampling of the five-pound bag product.

The recall only affects only the above-mentioned date code of Gold Medal Unbleached Flour five-pound bags. No other types of Gold Medal Flour are affected by this recall.

GIS closed Wednesday's trading at $44.01, up 1.78%.

Ironwood Pharmaceuticals Inc. (IRWD) has initiated a phase I study evaluating IW-6463 in healthy volunteers.

IW-6463 is an orally administered central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator that is being developed for the treatment of serious and orphan CNS disorders. Data from the Phase 1 study are expected in the second half of 2019.

IRWD closed Wednesday's trading at $12.42, down 2.36%.

NuCana plc (NCNA) has offered to sell $75 million of American Depositary Shares representing ordinary shares in an underwritten U.S. public offering. Each ADS represents one ordinary share of NuCana.

The Company also intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of ADSs at the offering price.

Goldman Sachs & Co. LLC, Jefferies LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey, Inc. is acting as lead manager for the offering.

Anticipated Milestones in 2019:

-- Report interim data from a phase II study of Acelarin for patients with platinum-resistant ovarian cancer.
-- Report initial data from the ongoing phase Ib study of NUC-3373 in patients with advanced colorectal cancer in combination with other approved agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan.
-- Report additional data from the ongoing Phase I study of NUC-3373 in patients with advanced solid tumors.

NCNA closed Wednesday's trading at $14.17, down 3.14%. In after-hours, the stock was down 4.80% to $13.49.

Ohr Pharmaceutical Inc.'s (OHRP) board of directors has determined to implement a one-for-twenty reverse stock split of the Company's common stock, par value $0.0001 per share, on February 4, 2019.

The reverse stock split is primarily intended to bring the Company into compliance with the minimum bid price requirement for maintaining its listing on the Nasdaq Capital Market.

Ohr Pharma is all set to merge with NeuBase Therapeutics Inc., subject to the approval of its shareholders at a special meeting of shareholders, which is expected to occur in the first half of 2019.

Upon closing of the transaction, the combined company will operate under the name "NeuBase Therapeutics Inc." and will trade on the NASDAQ under the symbol "NBSE". The executive team of NeuBase will serve as the executive team of the combined company, led by Dietrich A. Stephan, as Chief Executive Officer.

OHR closed Wednesday's trading at $0.12, down 0.24%.

UroGen Pharma Ltd. (URGN) has offered to sell 3.66 million ordinary shares at a public offering price of $41.00 each.

The offering is expected to close on or about January 28, 2019, subject to customary closing conditions, and the gross proceeds from the offering are expected to be about $150.0 million.

The underwriters have a 30-day option to purchase up to an additional 548,780 ordinary shares at the public offering price, less underwriting discounts, and commissions.

Goldman Sachs & Co. LLC, J.P. Morgan, and Jefferies are acting as joint book-running managers for the offering. Oppenheimer & Co. is acting as lead manager for the offering.

The Company's most advanced drug candidate is UGN-101 for the non-surgical treatment of low-grade upper tract urothelial cancer. The rolling submission of the New Drug Application for UGN-101 to the FDA was initiated in December 2018.

If approved, UGN-101 would be the first drug approved for the non-surgical treatment of low-grade upper tract urothelial cancer.

URGN closed Wednesday's trading at $45.93, down 14.41%. In after-hours, the stock fell another 6.38% to $43.

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