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EARS Tumbles, APLS Pauses Dosing, PTE Plunges On Short-seller Report Again


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

1. Auris Medical Holding AG (EARS)

Lost 27.35% to close Thursday's (Oct.18) trading at $0.85. This is the second straight day of double-digit loss for the stock.

News: No news

Recent event:

On October 17, the Company announced positive results from its second Phase 1 trial evaluating intranasal betahistine in healthy volunteers.

The intranasal betahistine program includes AM-125 for the treatment of vertigo, and AM-201 for the treatment of antipsychotic-induced weight gain and somnolence.
The phase I study results announced today have confirmed significantly higher bioavailability and favorable safety profile.

Near-term Catalysts:

-- The Company plans to initiate a phase II trial evaluating AM-125 in patients suffering from acute vertigo following vestibular schwannoma resection, dubbed TRAVERS, in the first quarter of 2019.
-- Conduct a phase 1 pharmacokinetic/pharmacodynamic study in healthy volunteers to evaluate AM-201 in the prevention of olanzapine-induced weight gain in the first quarter of 2019.

Also in the pipeline are two phase III programs - AM-111 for acute inner ear hearing loss, and Keyzilen (AM-101) for acute inner ear tinnitus.

2. OpGen Inc. (OPGN)

OpGen is focused on addressing the rising antibiotic resistance crisis.

Lost 21.30% to close Thursday's trading at $1.33.

News: The Company has offered to sell approximately 2.2 million shares of its common stock to the public at a price of $1.45 per share.

The gross proceeds to OpGen from this offering are expected to be approximately $3.2 million. The offering is expected to close on or about October 22, 2018, subject to customary closing conditions.

The underwriters have a 45-day option to acquire an additional 330,751 shares.

3. Concord Medical Services Holdings Limited (CCM)

Concord is a cancer hospital operations management solutions provider and operator of a network of radiotherapy and diagnostic imaging centers in China.

Lost 21.30% to close Thursday's trading at $1.33.

News: No news

Recent event:

On August 29, 2018, the Company announced financial results for the six months ended June 30, 2018.

Non-GAAP net loss in the first half of 2018 widened to RMB121.5 million ($18.4 million) from RMB100.1 million in the same period last year. Non-GAAP basic and diluted loss per ADS in the first half of 2018 were both RMB2.81 ($0.42). Total net revenue was RMB105.1 million ($15.9 million) in the first half of 2018, representing a 49.0% decrease from total net revenue of RMB206.2 million in the same period last year.

4. Apellis Pharmaceuticals Inc. (APLS)

Apellis is a clinical-stage biopharmaceutical company focused on developing novel therapeutic compounds for autoimmune and inflammatory diseases. The Company's lead product candidate is APL-2, whose potential is being tested as a treatment in the areas of ophthalmology, hematology, and nephrology.

Lost 17.06% to close Thursday's trading at $13.86.

News: The Company announced that 4 patients in its phase III geographic atrophy program and 4 patients in its phase II wet AMD study, treated with APL-2 from a single manufacturing lot developed non-infectious inflammation.

Dosing in the phase III geographic atrophy program has been temporarily paused. Dosing in the phase II wet AMD is continuing with a different APL-2 intravitreal manufacturing lot.

Inflammation in seven of the eight patients has completely resolved and the other is expected to resolve.

5. PolarityTE Inc. (PTE)

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.

Lost 17.05% to close Thursday's trading at $12.11.

News: Short seller Citron Research has published a report titled " PolarityTE: This Game Is Over!, wherein, it claims that PolarityTE has always had the signs of a stock scheme, and that the stock is a ZERO.

The Company has issued a statement rebutting the claims made in the Citron Research report, and it is as follows:

"The false and misleading assertions made by Citron, a publication well-known to be used as tool by notorious short sellers, are designed to negatively impact PolarityTE's share price for the benefit of short sellers and other colluding agents, and are contrary not only to PolarityTE's view, but also to that of our physician partners, KOLs, and SkinTE patients".

On June 25, 2018, PolarityTE shares suffered a similar attack, following a report by Citron research. In that report, Citron had called PolarityTE a "fraud," and accused the Company of keeping investors in the dark about the rejection of its key technology by the United States Patent and Trademark Office.

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