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NEWS OUT!
Trevena Announces Initiation of TRV027 Study in COVID-19 Patients in Collaboration With Imperial College London
BY GlobeNewswire
— 7:00 AM ET 08/24/2020
CHESTERBROOK, Pa., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (TRVN) , a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced Imperial College London (ICL) has initiated a proof-of-concept study for TRV027 in COVID-19 patients. Through an ongoing collaboration with ICL, the Company is evaluating the potential of TRV027 to treat acute lung damage / abnormal blood clotting associated with COVID-19. ICL is sponsoring and funding the study, with additional support through the British Heart Foundation Centre for Research Excellence Award.
“I am very pleased that Imperial College London has reached this important milestone of trial initiation,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. (TRVN) “As the global search for solutions to combat the COVID-19 pandemic continues, there remains an urgent need for new therapies that can prevent the severe multi-organ damage caused by the virus. TRV027 represents a uniquely targeted approach to potentially treating some of the serious and deadly complications associated with COVID-19.”
In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance at the AT1 receptor. This results in acute lung damage, which often progresses to acute respiratory distress syndrome (ARDS), as well as abnormal blood clotting throughout the body. TRV027 specifically binds to and rebalances AT1 receptor activation, blocking the damaging pathway that leads to ARDS and abnormal blood clotting conditions such as stroke. Additionally, the unique mechanism of action of TRV027 selectively targets the reparative pathway that improves lung function and promotes anti-inflammatory effects.
This is a randomized, double-blind, placebo-controlled study that will enroll approximately 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19. The study will also assess the effect of TRV027 on lung function and other clinical outcomes. The Company currently expects to report topline data in Q1 2021.
$TRVN Trevena Inc (TRVN)
1.65 ? -0.34 (-17.09%)
Volume: 22,444,431 @08/21/20 7:59:59 PM EDT
Bid Ask Day's Range
1.63 1.65 1.52 - 1.96
TRVN Detailed Quote
What I find strange is the lack of any solid plan for who will sell the
newly approved product. The past investor presentations alluded to JV
partners...suddenly, that part is no longer part of the newest investor
presentation.
Whoever, or whatever will be selling Olinvyk had better be decided
soon with a scheduled 1st quarter launch. Will TRVN hire its own
sales team? Will they announce a JV partnership for the US? Will
some BP decide its time to swoop in and acquire the company? Most
confounding is the fact that an FDA approved product with a $1 billion
plus peak sales potential would have such a low market cap as what
exists today.
Important to keep in mind that the call options here indicate that
a move to the upside is expected by someone. Could something be
pressuring the price down to get management to accept a deal of
some type? Why no mention (that I have seen) of a plan for Europe?
I asked the IR guy about that on Friday and he was stumped...Very
strange that TRVN has no plan for Olinvyk in Europe. If I am wrong
about this please let me know!
So the co got FDA approval - Product has a lot of potential - the stock tanked
Anyone knows the reason? Is it time to sell or buy morezz?
Awesome and welcome
I bought some at 1.65 on a GTC a very good price $$$$
I have not found a rational reason for the massive push down. Who
would want this stock so low in price? Well, if there were a BP who
would like to acquire the company for a bargain price, driving down the
share price relentlessly may be one way to get management to accept a
less than generous offer. I doubt if TRVN is seriously going to hire
their own sales team as that is usually a strategy that fails. Having
over $100 million in cash gives TRVN time to select the right offer
be it a JV or a complete BO. Time will tell.
* * $TRVN Video Chart 08-21-2020 * *
Link to Video - click here to watch the technical chart video
Good for you! There’s no reason for this price drop other than the usual games of manipulation. Monday I will be on a buying spree too!
i`m adding today at 180...then at 170...160...and a "boat-load" if it should hit $1.50 $$$$$$$$$$$$$$ TRVN $$$$$....gla
Very old news current study ongoing in England
Nice I been adding here all along
Added back in at $1.95 today. I like the news today
Trevena Announces Receipt of Milestone Payment Under Partnership in China With Jiangsu Nhwa Pharmaceutical Co.
August 20, 2020 07:36 ET | Source: Trevena Inc.
--
$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
--
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.
About Us
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
© 2020 GlobeNewswire, Inc. All Rights Reserved.
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
never know slowly ticking up after hours..lol
Wow...We have gotten our @zz kicked since approval...
* * $TRVN Video Chart 08-18-2020 * *
Link to Video - click here to watch the technical chart video
Yep, it keeps dropping
I hope so then I can buy more cheaper
This one will continue to go down
Ok plenty of other stocks out there
Nope would not touch this!
What in the world is driving this down. Am I missing something?
TRVN in buying zone for cheapies
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
After the offering TRVN should have over $100 million in cash and
a market cap of under $500 million. The "initial" target market
in the US for Oli is $1.5 billion. Anything close to $1 billion
as "peak" sales would justify a market cap closer to $3 billion.
That would equate to a future share price of $15 billion...
Of course, that excludes the rest of the US injectable morphine
market...which totals around $8 billion (?) Plus, it excludes
all of Europe (have not read what the game plan is for that market.)
Then, our China partner could in time be significant.
I can't see how TRVN will be able to avoid a BO...sooner or later
it should be obvious that is where it will end up.
I make $10,000 so far so I am all good.....LMAO....other play is dumping too much and losing big money
May 18th headline...
KG ;)
TREVENA - HAS RECEIVED INTEREST FROM MULTIPLE INSTITUTIONS REGARDING POTENTIAL STUDIES THAT COULD EVALUATE USE OF TRV027 IN COVID-19 PATIENTS Source text: [bit.ly/3cG4FRO] Further company coverage: (Reuters.Briefs@thomsonreuters.com)
https://www.reuters.com/article/brief-trevena-has-received-interest-from-idUSFWN2D00K9
TREVENA - HAS RECEIVED INTEREST FROM MULTIPLE INSTITUTIONS REGARDING POTENTIAL STUDIES THAT COULD EVALUATE USE OF TRV027 IN COVID-19 PATIENTS Source text: [bit.ly/3cG4FRO] Further company coverage: (Reuters.Briefs@thomsonreuters.com)
https://www.reuters.com/article/brief-trevena-has-received-interest-from-idUSFWN2D00K9
looking good today the dust has settled and buyers are seeing the value here. Im glad I avg in yesterday at the placement price it was a no brainer for me. The placement got a great price thats the way the markets work. Remember the shares that were placed have time restrictions for selling them so it doesnt add any sell pressure now.
Agreed just a matter of time here
flipped, out, have a nice day
Public Offering Price
$2.30 $50,000,000
Underwriting Discounts and Commissions(1)
$0.138 $3,000,000
Proceeds Before Expenses, to Us
$2.162 $47,000,000
TRVN$ I feel bad for the run up to $4.50 it ran up way to fast. 3.09 was a much better price than $4.50 . Im glad I waited to buy the dip. a month from now we will see new highs
Very obvious TRVN stock was being shorted and/or sold off prior to
approval. Little to no risk if you knew the stock offering would
hit one day after approval. On the positive side the stock should
be allowed to move up as these games come to an end. Insiders
buying or holding the stock at these levels know that they are
getting a good deal.
Ok, so we don't know what the underwriter's discount was.
That's fine, it was just implied we did know and I was asking for a link to it. If they close tomorrow or Friday, guess we'll know it then.
* * $TRVN Video Chart 08-12-2020 * *
Link to Video - click here to watch the technical chart video
I have a similar theory, cbb.
@SuperDuperInvst @khammaker9 Insiders had been selling $TRVN prior to FDA decision. Perhaps the approval surprised them? If so, a secondary would allow them to get back in at pre-approval share price. https://t.co/6lXJKydJcY
— Peaceinmiddleeast (@biotechinvestr) August 11, 2020
My Theory: Management (or underwriters) clued some large investors into
the offering being imminent after FDA decision on approval...The
investor(s) then shorted the stock on Friday knowing that if the
approval was denied the share price would plunge, and if approved
they would continue to short more shares, all the while knowing
that the offering would tank the stock. TRVN management (my speculation)
wanted the offering stock in friendly hands at a discounted price, and
allow management to be issued new stock or options at low, instead of
high prices. Maybe management does not want the share price to move
up until they and their buddies are fully invested for what should
be the real move up. That is how Wall Street works. Management here
was unethical in what they showed in Monday's presentation that they
were in solid financial condition and could run operations until 2021
year end. Typical greedy management that cares nothing about small
investors who actually read the presentations provided. Pathetic!
I am ready today was the day to jump in & profit
$TRVN added back some $2.27 and $2.28....looks like bottom in and move up from here
Trevena (TRVN) Stock Could Hit $5, Says Analyst
August 11, 2020, 6:05 PM
https://finance.yahoo.com/news/trevena-trvn-stock-could-hit-220518885.html
There’s a new FDA-approved pain medication on the scene. On Monday, Trevena (TRVN) announced that Olinvyk (oliceridine), the company’s opioid agonist, finally received the FDA’s nod of approval for the management of acute pain in adults who need an intravenous opioid pain reliever. The drug is to be administered in hospitals or other controlled clinical settings.
The approval brings to an end a process stretching back to 2018, when Trevena received the dreaded complete response letter (CRL) from the FDA, citing concerns regarding the size of the safety database and potential for QT prolongation.
H.C. Wainwright analyst Douglas Tsao calls the approval a “big win for Trevena.” Trevena will launch Olinvyk in Q4 and Tsao anticipates the approval will act as a catalyst for several of Trevena’s ex-US partners “to provide critical non-dilutive capital in the form of milestone payments.”
Even though the analyst expects initial adoption to take place amongst high-risk patients, Tsao believes the drug will get more widespread use eventually. Additionally, the label’s lack of restrictive language such as "moderate-to-severe acute pain” will provide Trevena with “leeway to promote the product for a wide range of surgical procedures.”
Furthermore, Tsao argues Olinvyk’s distinctive properties sets it apart from other drugs.
“Though the drug was shown to be as fast and effective as IV morphine in treating post-surgical pain,” Taso noted, “its unique mechanism of action that bypasses the ß-arrestin pathway, improves the drug’s respiratory safety and gastrointestinal tolerability. These features are important differentiators versus traditional opioids.”
The analyst anticipates peak US sales of $284 million, although he “would not be surprised to see upside,” and following the approval, increases the probability of success for Olinvyk to 100%.
The confidence is rewarded with a price target boost to boot. The figure moves from $4 to $5 and represents possible upside of 60% over the coming months. To this end, the analyst’s Buy rating stays as is. (To watch Tsao’s track record, click here)
Though not many have weighed in with an opinion on Trevena, those who have are singing its praises loudly. Overall, two analysts rate the drug maker a Buy. Meanwhile, the average price target stands tall at $5.50, suggesting the stock could double over the next 12 months.
Your right, they didn't list the discount and fee's
I have never seen a price lowered after it was already published
Ok, you'll have to help me, as I don't see the underwriter's discount anywhere. The prospectus published hasn't been updated to show that detail, and it wasn't in the PR.
yes, same price. If you wanted to flip a few pennies, buy under 2.3 for a couple of days. It closes on 8/14.
If there wasn't enough buyers, the market makers would have told them to do an ATM at-the-market, over time.
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Trevena, Inc. (NASDAQ: TRVN) is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders.
The company has five novel and differentiated drug development programs. OLINVYK™ is approved by the FDA. Please see Important Safety Information including Boxed Warning in the full prescribing information available at OLINVYK.com.
The company has four investigational drug candidates including TRV 027 for acute respiratory distress syndrome and abnormal clotting, TRV 250 for the acute treatment of migraine and TRV 734 for maintenance treatment of opioid use disorder. The company has also identified TRV 045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain and CNS disorders.
Trevena is guided by an innovative spirit and an unwavering commitment to patients. It is a place driven by its employees – passionate and talented industry experts who operate with integrity, transparency, and respect for one another. Trevena employees are united in one mission: to deliver new medicines that address critical areas of need in CNS disorders.
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