0001654954-16-000534.txt : 20160622 0001654954-16-000534.hdr.sgml : 20160622 20160622103018 ACCESSION NUMBER: 0001654954-16-000534 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20160616 ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160622 DATE AS OF CHANGE: 20160622 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PERNIX THERAPEUTICS HOLDINGS, INC. CENTRAL INDEX KEY: 0001024126 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330724736 STATE OF INCORPORATION: MD FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14494 FILM NUMBER: 161725885 BUSINESS ADDRESS: STREET 1: 10 NORTH PARK PLACE STREET 2: SUITE 201 CITY: MORRISTOWN STATE: NJ ZIP: 07960 BUSINESS PHONE: (862) 260-8457 MAIL ADDRESS: STREET 1: 10 NORTH PARK PLACE STREET 2: SUITE 201 CITY: MORRISTOWN STATE: NJ ZIP: 07960 FORMER COMPANY: FORMER CONFORMED NAME: GOLF TRUST OF AMERICA INC DATE OF NAME CHANGE: 19961002 8-K 1 ptx_8k.htm CURRENT REPORT Blueprint
 

   UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): June 16, 2016
 
PERNIX THERAPEUTICS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
 
Maryland
 
001-14494
 
33-0724736
(State or other jurisdiction
 of incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
 
10 North Park Place, Suite 201
Morristown, NJ
 
 
07960
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (800) 793-2145
 
__________________________________________________________________
  (Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
 
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
 
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
 
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 
 
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
 
On June 17, 2016 Pernix Therapeutics Holdings, Inc. (the “Company”), received written notice that it is not currently in compliance with the $1 minimum closing bid price requirement of the Nasdaq Stock Market (“Nasdaq”) Listing Rule 5450(a)(1). The Nasdaq notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(a), the Company has until December 14, 2016 to regain compliance with the minimum bid requirements by having the closing bid price of the Company’s stock exceed $1 per share for 10 consecutive business days. The Company's Common Stock will continue to trade on the NASDAQ Global Market under the symbol "PTX".
 
In the event the Company does not regain compliance prior to December 14, 2016, the Company may apply to have its Common Stock listed on the Nasdaq Capital Market. If the Company meets the initial listing criteria for the Nasdaq Capital Market (other than the minimum bid price requirement) and provides written notice of its intention to cure the deficiency, then Nasdaq should provide the Company with an additional 180 days to comply with the minimum bid requirements. If the Company is not eligible for an additional 180-day cure period, Nasdaq will provide written notice that the Company's securities will be delisted. The Company then could appeal Nasdaq's determination to delist the Company's securities.
 
Item 8.01. Other Events.
 
On June 16, 2016, Pernix Therapeutics Holdings, Inc. issued a press release regarding the results of a study it conducted. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01   Financial Statements and Exhibits
 
(d)      Exhibits.
 
Exhibit Number
 
 Description
 
 
 
99.1
 
Press release by Pernix Therapeutics Holdings, Inc. dated June 16, 2016.
 
 
 
 
 
SIGNATURE
 
 Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
PERNIX THERAPEUTICS HOLDINGS, INC.
 
 
 
 
 
Dated:  June 22, 2016
By:
/s/ Sanjay Patel
 
 
 
Sanjay Patel
 
 
 
Chief Financial Officer
 
 
 
 
 
 
EX-99.1 2 ptx_ex991.htm PRESS RELEASE BY PERNIX THERAPEUTICS HOLDINGS, INC. DATED JUNE 16, 2016 Blueprint
Exhibit 99.1
 
 
Pernix Therapeutics Announces Positive Phase IV Results of Silenor® vs. Zolpidem Head-to-Head Arousability Study
Data demonstrated that Pernix Therapeutics’ Silenor® 6 mg was superior to zolpidem 10 mg on all measures evaluated.
 
Study results presented at SLEEP 2016 international meeting
MORRISTOWN, NJ – June 16, 2016 -- Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced positive final results from a Phase IV Study assessing the effects of nighttime administration of insomnia treatments, Silenor® 6 mg and zolpidem 10 mg, as well as placebo, on arousability, gait, balance, and cognitive performance, after going to sleep, in healthy male volunteers. These data were presented at the SLEEP 2016 International meeting, which took place on June 14th and 15th in Denver, Colorado.
The study assessed the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective Tmax (time the maximum serum concentrations are observed) in normal healthy adult male volunteers (n=52). The results of the study demonstrated that Silenor 6 mg was statistically superior to zolpidem 10 mg on the measures studied – arousability, gait, balance, and memory.
John Sedor, Chairman and CEO of Pernix Therapeutics, said, “The results of this head-to-head study further support certain key benefits of Silenor 6 mg. Pernix is encouraged by these data and the impact they could have on the sleep community and patients.”
The results also indicated that subjects taking Silenor 6 mg did not have impairment on arousability, gait, balance, and cognitive performance, and were comparable to placebo. Further, in addition to Silenor 6 mg, both placebo groups were also statistically superior to zolpidem on the measures evaluated, indicating that zolpidem subjects had statistically significant difficulty in waking up, with walking and balance and with memory. Finally, there were no differences in efficacy measures between zolpidem 10 mg and Silenor 6 mg, while several measures were significantly improved with Silenor 6 mg versus placebo.
“One of the most interesting findings in the study was that a majority of the subjects in the zolpidem group did not wake up until they were exposed to noise of at least 110 decibels (dB; 64%),” stated Heith Durrence, Ph.D., Sleep Expert and Medical Director at Pernix Therapeutics. “The awakening threshold data indicate that subjects taking zolpidem could have difficulty waking up to noises similar to a jackhammer (average of 100 dB), a potentially serious issue.” 
 
 
 
 
 
About Pernix Therapeutics Holdings, Inc.
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its two Pernix sales forces and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.
To learn more about Pernix Therapeutics, visit www.pernixtx.com.
About Silenor
SILENOR® is a prescription sleep medicine that is used to treat people with insomnia who have trouble staying asleep.
 
Important Safety Information about Silenor
Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
Be sure that you are able to devote 7 to 8 hours to sleep before being active again. SILENOR® should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. If you are on a monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the past two weeks, you should not take SILENOR®. You should not take SILENOR® if you have an eye problem called narrow angle glaucoma that is not being treated, if you have severe urinary retention, or if you are allergic to any of the ingredients in SILENOR®. You should not drive or operate machinery at night after taking SILENOR®. Until you know how you will react to SILENOR®, you should be careful in performing such activities during the day following taking SILENOR®. Before you take SILENOR®, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking SILENOR® you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
 
 
 
 
Silenor® is a registered trademark of Pernix Therapeutics Holdings, Inc.
To learn more about Silenor, visit www.silenor.com
Pernix Therapeutics Holdings, Inc.
 
Investor Relations
Sanjay Patel, 800-793-2145 ext. 1009
Chief Financial Officer
spatel@pernixtx.com
 
Matthew P. Duffy, 212-915-0685
LifeSci Advisors, LLC
matthew@lifesciadvisors.com
 
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