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CDTX Fails To Impress, RXII On Watch, OTIC Falls On Analyst Downgrade

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The following are some of the stocks that lost the largest percentage in price today in the pharma/biotech sector.

1. Cidara Therapeutics Inc. (CDTX)

Lost 24.05% to close Monday's (Mar.19) trading at $6.00.

News: The Company reported positive top-line data from STRIVE - a phase II international trial of Rezafungin in the treatment of candidemia and invasive candidiasis. But looks like the incidence rate of treatment emergent adverse events spooked the investors.

The STRIVE trial included three groups - Group 1, in which patients received either 400 mg of Rezafungin administered intravenously once weekly for two to four weeks; Group 2, in which patients received 400 mg of Rezafungin for the first week followed by 200 mg of Rezafungin once weekly for up to four weeks in total, and Group 3 , the comparator arm, in which patients were administered Caspofungin intravenously according to the approved prescribing information, with an optional step down to oral fluconazole.

Group 2 had the highest efficacy rate in all assessments. Efficacy is defined as the clearance of Candida from the blood or other normally sterile sites, resolution of signs related to the infection, investigator assessment of clinical response and overall survival.

Treatment emergent adverse events were observed in most patients, with an incidence of 88.6 percent in Group 1, 94.4 percent in Group 2, and 81.8 percent in Group 3.
There were two serious adverse events possibly related to study drug: one in Group 2 and one in Group 3, and both patients fully recovered. There were no deaths related to study drug.

Near-term Catalysts:

-- A phase III study of Rezafungin in approximately 150 modified intention-to-treat (mITT) patients with candidemia and/or invasive candidiasis, dubbed ReSTORE, is expected to commence in mid-2018. Top-line data from this study is expected in 2020.
-- A phase III pivotal clinical trial in patients undergoing allogeneic bone marrow transplant to enable use of Rezafungin in a 90-day prophylaxis regimen to prevent infections due to Candida, Aspergillus and Pneumocystis, dubbed ReSPECT Prophylaxis, is also expected to be initiated in mid-2018. This trial is expected to produce an interim futility read-out in 2019 and provide top line results in 2020.

2. Prana Biotechnology Limited (PRAN)

Lost 18.40% to close Monday's trading at $2.16.

News: No news

3. CytRx Corporation (CYTR)

Lost 15.17% to close Monday's trading at $1.79.

News: The Company announced financial results for the year ended December 31, 2017.

Net loss for the year ended December 31, 2017 narrowed to $35.0 million or $1.46 per share from $50.8 million or $3.78 per share for the year ended December 31, 2016. Licensing revenue in 2017 dropped to $100K from $200K in the prior year.

Cash, and cash equivalents as of December 31, 2017 were $37.6 million.

4. RXi Pharmaceuticals Corp. (RXII)

Lost 14.47% to close Monday's trading at $4.61.

News: No news

Clinical Trials & Near-term Catalysts:

-- The lead compound is RXI-109, which successfully completed a phase II trial for dermal scarring last December.

RXI-109 is also being tested in a phase 1/2 study in an ophthalmology indication namely in patients with advanced, wet age-related macular degeneration and associated retinal scarring. Readouts from this trial are expected this month.

-- Also in the pipeline are Samcyprone, which is being evaluated in a phase IIa clinical trial in subjects with at least one cutaneous, plantar or periungual wart, and RXI-231, a cosmetic ingredient in a proprietary gel formulation designed to aid in the reduction of pigmentation to improve skin appearance.

The Company expects to share full read-outs from the Phase 2a clinical trial of Samcyprone for the treatment of cutaneous warts in Q1-Q2 2018 time period.

5. MYnd Analytics Inc. (MYND)

Lost 12.99% to close Monday's trading at $2.21.

MYnd is a predictive analytics company that has developed a decision support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

News: No news

Recent events:

-- Last November, the Company acquired revenue-generating Arcadian Telepsychiatry Services which is anticipated to generate rapid growth and benefits from cross-selling going forward.

The Company ended the fiscal year-end on September 30, 2017 with no long-term debt and over $5 million cash.

6. Otonomy Inc. (OTIC)

Lost 11.88% to close Monday's trading at $4.45.

News: JPMorgan downgraded the stock to underweight from Neutral.

Recent event:

-- On Mar.2, 2018, the FDA approved Otiprio for expanded indication of acute otitis externa.

Acute otitis externa, also known as swimmer's ear, is a common condition involving infection and inflammation of the ear canal typically caused by bacterial infection.

Otiprio, a single-dose form of the antibiotic ciprofloxacin, received its first FDA approval in December 2015 for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

The net sales of Otiprio for the fourth quarter of 2017 totaled $0.3 million, the same as that in the comparable year-ago quarter.

-- In November 2017, the Company announced the discontinuation of promotional support for OTIPRIO in order to significantly reduce operating expenses related to the product. OTIPRIO continues to be available for purchase by customers while Otonomy evaluates commercial partnering options for the product including divestiture.

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