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18.12.2018 04:38:29

DOVA Plunges On Tepid Sales Outlook, ADIL Cooling Off, ACHN On Watch

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

1. Sophiris Bio Inc (SPHS)

Lost 40.29% to close Monday's (Dec.17) trading at $1.23.

News: No additional benefit was observed in patients after re-treatment with a second administration of Topsalysin in a phase 2b study of the drug candidate for localized prostate cancer.

The Company has reiterated its plans to move to phase III with single administration of Topsalysin.

2. Dova Pharmaceuticals Inc. (DOVA)

Lost 39.16% to close Monday's trading at $9.01. In intraday trading, the stock touched a new all-time low of $8.91.

News: Dova announced that Alex Sapir is no longer President and Chief Executive Officer of the company, effective as of December 16, 2018. David Zaccardelli has been appointed President and CEO.

The Company also provided preliminary estimates of fourth quarter net product sales of $2.4 to $2.7 million for DOPTELET. In the third quarter, net product sales of DOPTELET were $2.9 million.

DOPTELET indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure received FDA approval in May of this year.

3. PLx Pharma Inc. (PLXP)

Lost 35.63% to close Monday's trading at $2.75.

News: No news

PLx is a late-stage specialty pharmaceutical company focused on commercializing two patent-protected products, Vazalore 325 mg and Vazalore 81 mg (referred to together as "Vazalore").

Vazalore 325 mg is an FDA-approved aspirin product being developed to provide high-risk cardiovascular and stroke patients.

The Company is focused on manufacturing, scale-up and label finalization for Vazalore 325 mg aspirin dosage form and preparing an sNDA for Vazalore 81 mg maintenance dose form.

The launch of Vazalore is planned for mid-2020.

4. Adial Pharmaceuticals Inc. (ADIL)

Lost 26.32% to close Monday's trading at $2.80.

News: No news

Recent event:

On December 13, the Company announced that it is planning to explore the potential of its lead asset AD04, beyond alcohol use disorder, to include its potential use in patients with opioid use disorder. The news sent the stock as much as 113% to $4.33 that day. However, ADIL has given back most of its gains since then.

Clinical Trial & Near-term Catalyst:

The lead investigational product is AD04 for the treatment of alcohol use disorder "AUD".

A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns, according to the Company.

A phase III clinical trial of AD04 is expected to begin in the first half of 2019.

5. Kezar Life Sciences Inc. (KZR)

Lost 24.32% to close Monday's trading at $22.69.

News: No news

Clinical Trials & Near-term Catalysts:

-- Enrollment continues in phase Ib/II trial of KZR-616 in lupus and lupus nephritis, with top-line results from the initial two cohorts of the Phase 1b expected in the first half of 2019. -- The phase II portion of the trial in lupus nephritis patients is expected to be initiated during the first half of 2019.

Recent event:

The Company went public on the Nasdaq Global Select Market on June 21, 2018, offering its shares at a price of $15 per share.

6. Achillion Pharmaceuticals Inc. (ACHN)

Lost 22.83% to close Monday's trading at $2.40.

News: The stock plunged ahead of the report of interim data from the Company's phase II clinical trials of ACH-4471 in PNH and C3G, as well as initial phase I data on its next generation factor D inhibitors ACH-5228 and ACH-5548.

The Company reported positive results after the bell.

In the phase II trial of ACH-4471, proof of concept was validated in both paroxysmal nocturnal hemoglobinuria as monotherapy and in combination with a C5 Inhibitor. In the phase II trial of ACH-4471 in C3 glomerulopathy, proof of mechanism has been validated, with an end of Phase 2 Meeting targeted for 4Q 2019.

The phase I trial of ACH-5228 has demonstrated 3 times to 4 times greater potency and extended Half-life. A phase I multiple ascending dose trial of ACH-5228 is expected to begin in January 2019.

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