09.08.2018 04:58:04

AMPE Craters On Ampion Update, CTXR Keeps Hitting New Lows, DEPO To File NDA

(RTTNews) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Ampio Pharmaceuticals Inc. (AMPE)

Lost 78.71% to close Wednesday's (Aug 8) trading at $0.60.

News: The FDA does not consider the Company's phase III study of Ampion in adults with pain due to severe osteoarthritis of the knee, dubbed AP-003-C, to be adequate and well-controlled clinical trial.

The Company has been asked by the FDA to conduct an additional randomized trial with a concurrent control group.

However, another phase III trial of Ampion in adults with pain due to Osteoarthritis of the Knee, dubbed AP-003-A, is considered by the FDA to be adequate and well controlled, proving evidence of effectiveness.

In other news, the Company announced that it intends to offer and sell shares of its common stock and accompanying warrants to purchase shares of common stock in an underwritten public offering.

2. XOMA Corp. (XOMA)

Lost 21.06% to close Wednesday's trading at $19.30.

News: The Company posted a loss and recorded lower revenue in the second quarter of 2018.

Net loss for the second quarter of 2018 was $1.9 million or $0.23 per share compared to net income of $0.3 million or $0.02 per share for the second quarter of 2017. Revenue in the recent second quarter was $2.3 million, down from $10.9 million in the comparable year-ago quarter.

3. Citius Pharmaceuticals Inc. (CTXR)

Lost 18.57% to close Wednesday's trading at $1.14. The stock touched a new low of $1.12 in intraday trading.

News: No news

Pipeline:

A phase III trial of Mino-Lok Therapy in combination with systemic antibiotics in the treatment of catheter-related bloodstream infections enrolled the first patient as recently as February of this year. This trial is planned to enroll 700 patients in 50 participating institutions, all located in the U.S. There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.

Also in the pipeline is CITI-001 (Halo-Lido) to treat hemorrhoids, which has successfully completed a phase IIa study.

4. Depomed Inc. (DEPO)

Lost 16.77% to close Wednesday's trading at $7.76.

News: The Company reported a decline in total revenue in the second quarter of 2018, and lowered its net sales guidance range for its Neurology franchise for the year.

The total revenue for the recent second quarter was $63.27 million, down from $100.5 million in the year-earlier quarter. The Neurology franchise contributed $25.9 million in sales to the second quarter 2018 total revenue compared to $31 million in the year-earlier quarter.

Looking ahead, the Company now expects Neurology franchise net sales for the year to range between $105 million to $110 million, down from its earlier outlook of $120 million to $125 million.

Near-term Catalysts:

-- File a New Drug Application with the FDA for Cosyntropin depot by year end.

Cosyntropin depot is a long-acting, alcohol-free synthetic adrenocorticotropic hormone (ACTH) analogue.

-- The Company is expected to be rechristened Assertio Therapeutics in the coming week.

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Citius Pharmaceuticals Inc Registered Shs 0,17 -3,47% Citius Pharmaceuticals Inc Registered Shs
Xoma Corp Registered Shs 25,20 -5,26% Xoma Corp Registered Shs