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Maybe 2021?
Trevena Loses Bid to End Shareholder Lawsuit Over Drug Approval
Sept. 1, 2020, 3:15 AM
Suit claims Trevena misled investors about conversations with FDAJudge dismisses some conclusory allegations against chief medical officer
Trevena, Inc. will have to continue litigating with shareholders over its recently approved morphine alternative oliceridine, now marketed as Olinvyk, after a district court largely denied or otherwise declined to consider the defendants’ motions to dismiss.
The U.S. District Court for the Eastern District of Pennsylvania on Friday denied Trevena and former chief executive officer Maxine Gowen’s motions to dismiss after striking documents integral to their arguments. Judge Cynthia M. Rufe did, however, consider and grant some of former chief medical David Soergel’s motion to dismiss.
https://news.bloomberglaw.com/class-action/trevena-loses-bid-to-end-shareholder-lawsuit-over-drug-approval
Trevena Announces Receipt of Milestone Payment Under Partnership in China With Jiangsu Nhwa Pharmaceutical Co.
August 20, 2020 07:36 ET | Source: Trevena Inc.
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$3 million milestone payment for U.S. approval of OLINVYK™ (oliceridine) injection
Additional approval and commercialization milestone payments expected as well as 10% royalties on net sales in China
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CHESTERBROOK, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has a received a $3 million milestone payment from its partner in China for the U.S. approval of OLINVYK. Nhwa holds an exclusive license agreement to develop, manufacture, and commercialize OLINVYK in China.
“With U.S. approval of OLINVYK now in hand, I am pleased that our ex-U.S. partnerships also continue to make meaningful progress,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “We look forward to supporting Nhwa as they continue to advance OLINVYK towards regulatory approval in China.”
In June 2020, the Company announced that Nhwa had been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials. The Company expects to receive future milestone payments, as well as a 10% royalty on net sales of OLINVYK in China.
About OLINVYK™ (oliceridine) injection
OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. For more information, please visit www.OLINVYK.com.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company’s therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
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https://www.globenewswire.com/news-release/2020/08/20/2081256/0/en/Trevena-Announces-Receipt-of-Milestone-Payment-Under-Partnership-in-China-With-Jiangsu-Nhwa-Pharmaceutical-Co.html
For OLINVO, Trevena has established commercial supply agreements for the manufacture of the API and finished (compounded, filled and packaged) drug product. Alcami Corporation, or Alcami, is contracted to supply 100% of its commercial API from its Germantown, WI manufacturing facility. Trevena has existing commercial supply agreements with two separate companies for the supply of drug product. Alcami is contracted to supply commercial drug product from its facilities in Charleston, SC and Wilmington, NC. Pfizer CentreOne (formerly Hospira) is also contracted to supply commercial drug product from its facility in McPherson, KS. The company anticipate that OLINVO will be classified as a Schedule II controlled substance. All third-party facilities throughout the supply chain have the appropriate DEA licenses for handling Schedule II controlled substances according to each of their respective contractual roles (manufacturing, testing, distribution, etc.).
Pfizer CentreOne and Alcami Products OLINVO
https://finpedia.co/bin/Trevena/#HManufacturing-1
What happens now? what did the suspension bring or what was it carried out on?
The U.S. Securities and Exchange Commission announced the temporary suspension of trading in the securities of the following issuer, commencing at 9:30 a.m. EDT on October 31, 2019 and terminating at 11:59 p.m. EST on November 13, 2019:
should we buy again?
thanks for all the information. I've been here for 6 years, looking forward to the development.
what does that mean?
The Deal is 150 mio $
Bulish?? Bullshit For months, it's always heading south. CLP is dead !!
Do you know how much the real estate is worth?
Judge gives ok for provisional permits
Starting at $ 0,115, it's heading north $ 0.18
CLP probably has several interests in the sale of assets. That's why there will be an auction on 21.06.2019. Looks very good.
How did Peabody Energy run out? declaration of bankruptcy
does anyone know?
yes, you were right. sell all before it's too late. otherwise you will not have any more in the end. get out quickly here !!
The data is not up to date from the last quarter of 2018
you are a theoretician, this is about jobs and dependencies of coal 40% of the electricity is still running on coal-fired power plants I see here after May 1 0.22 $
There is never a guarantee, I say buy now and sell at 22
No bankruptcy!!!
https://whatsonthorold.com/2019/04/14/a-reversal-for-cloud-peak-energy-inc-nysecld-is-not-near-the-stock-has-rise-in-shorts/#!/history
The Cloud Peak Energy Inc. (NYSE: CLD) share was up 47.11% in short interest. CLD's total short-term interest rates were 16.93 million shares in April, as published by FINRA. Its increase of 47.11% from 11.51 million shares previously reported. With an average volume of 8.95 million shares, short sellers will need 2 days to cover the short positions of their CLD.
Officials believe Cloud Peak will pay taxes
https://www.torringtontelegram.com/article/officials-believe-cloud-peak-will-pay-taxes
let's wait on friday we know more ... hope dies last.
Who is the message from? Why does the company opt for the 30-day option if they are insolvent anyway? Why did the big investors increase their shares? I say wait until the info comes from Cloud Peak Energy itself and not from any WYCO researcher.
Get out of the stock that is dead. Amk
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