Recent Updates
Recently added Catalysts
TRVN

Trevena Regains Compliance with Nasdaq Listing and Reaffirms Expected Near-Term Milestones CHESTERBROOK, Pa.

Key Takeaway: Regains Compliance with Nasdaq Listing and Reaffirms Expected Near-Term Milestones Pa., May 30, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nerv

Full Press Release Details

Regains Compliance with Nasdaq Listing and
Reaffirms Expected Near-Term Milestones
Pa., May 30, 2023 (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 that it has received notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC (Nasdaq) informing
Trevena that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2). The Company maintained
a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days and, as a result of regaining compliance, its common
stock will continue to be listed on the Nasdaq Capital Market.
also reaffirmed expected timing of its many near-term milestones:
TRV045 Target Engagement Study . Topline data from the clinical proof-of-concept study, expected 3Q 2023
TRV045 Transcranial Magnetic Stimulation (TMS) Study. Topline data from the clinical proof-of-concept study, expected 3Q 2023
OLINVYK New Respiratory Data and Additional Health Utilization and Cost Analyses. Data and analyses from ~200 patient real-world clinical outcomes study, expected mid-2023
$3M Nhwa Milestone. Receipt of $3 million milestone payment for OLINVYK regulatory approval in China from Jiangsu Nhwa Pharmaceuticals (Nhwa), expected 2Q 2023
$15M R-Bridge Tranche. $15 million non-dilutive financing tranche from R-Bridge upon first commercial sale of OLINVYK in China, which Nhwa expects 3Q 2023
OLINVYK (oliceridine) injection
OLINVYK is a new chemical entity approved by
the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential for
abuse similar to other opioids. 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 is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and
a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater
than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including
the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS
ABUSE, AND MISUSE - OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which
can lead to overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the
development of behaviors or conditions.
RESPIRATORY DEPRESSION - Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor
for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
OPIOID WITHDRAWAL SYNDROME - Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome,
which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology
experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal
syndrome and ensure that appropriate treatment will be available.
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS - Concomitant use of opioids with benzodiazepines
or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant
prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required;
and follow patients for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management
of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or
opioid combination products]:
The cumulative total daily dose should not exceed 27 mg, as total
daily doses greater than 27 mg may increase the risk for QTc interval prolongation.
OLINVYK is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
Adverse reactions are described in greater detail in the Prescribing
The most common (incidence 10%) adverse reactions in Phase 3 controlled
clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
medical inquiries or to report an adverse event, other safety-related information or product complaints for a company product, please
contact the Trevena Medical Information Contact Center at 1-844-465-4686 or email MedInfo@Trevena.com.
are encouraged to report suspected adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
TRV045 is a novel, selective sphingosine-1-phosphate subtype 1 (S1P1)
receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy.
Through a collaboration with the National Institutes of Health, and this proof-of-concept study, Trevena is also exploring TRV045 as
a potential treatment for epilepsy.
S1P receptors are located throughout the body, including the central
nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability.
Trevena's discovery efforts have identified a family of compounds
that are highly selective for the S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical
models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and
produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical
studies. TRV045 is an investigational drug and has not been approved by the FDA.
Trevena, Inc. is a biopharmaceutical company focused on the development
and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States,
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's novel pipeline is based on Nobel
Prize winning research and includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy,
TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder.
more information, please visit www.Trevena.com
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 and other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "predict,"
"project," "suggest," "target," "potential," "will," "would,"
"could," "should," "continue," and 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 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 discussions with FDA; 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 approved product; 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.
For more information, please contact:
LifeSci Advisors, LLC
SVP and Chief Business Officer
Last updated: May 30, 2023