| Wednesday | ||||
Trevena announced that it… Trevena announced that it has received a $3M milestone payment from its partner in China for the Chinese approval of OLINVYK. Jiangsu Nhwa Pharmaceutical holds an exclusive license agreement to develop, manufacture, and commercialize OLINVYK in China. "We look forward to continuing to work closely to support Nhwa in their commercial efforts. They have already begun commercial efforts in China and we are excited to see OLINVYK made available in such an important market," said Carrie Bourdow, President and CEO of Trevena, Inc. The Company also reaffirmed the expected receipt of $15 million in non-dilutive financing from R-Bridge upon first commercial sale of OLINVYK in China, which Nhwa believes will occur in 3Q 3023. | ||||
| Tuesday | ||||
The Company also… The Company 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 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, 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 | ||||
Trevena announced that it… Trevena announced that it has received notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC 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. | ||||
| Over a week ago | ||||
Cash, cash equivalents… Cash, cash equivalents and marketable securities were $27.4 million as of March 31, 2023, which the Company believes will be sufficient to fund the Company's operations through year-end 2023. Together with the expected $3 million Nhwa Milestone payment and $15 million available under the R-Bridge Financing upon Nhwa's first commercial sale of OLINVYK in China, the Company believes this will be sufficient to fund operations to mid-2024. | ||||
Reports Q1 revenue… Reports Q1 revenue $6,000, consensus $230,000. "This is an important year for Trevena as we expect topline data from two TRV045 proof-of-concept studies, one to support potential use in epilepsy and the other in chronic pain, and new OLINVYK respiratory data from the VOLITION study with Cleveland Clinic," said Carrie Bourdow, President and CEO of Trevena. "We were also pleased that Jiangsu Nhwa recently received approval of OLINVYK in China which will allow patients there to have access to this innovative therapeutic option". | ||||
These names in the…
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Trevena announced that… Trevena announced that its partner in China, Jiangsu Nhwa, received formal approval from the National Medical Products Administration for OLINVYK. It has been approved for use in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. "We are very pleased to see our partners, Jiangsu Nhwa, achieve this important milestone which will allow Chinese patients to benefit from OLINVYK," said Carrie Bourdow, President and CEO of Trevena. "We have worked closely with our partners during their submission process, and look to our continued collaboration as they move forward with launch and full commercialization of OLINVYK in China." | ||||
| Over a month ago | ||||
H.C. Wainwright lowered… H.C. Wainwright lowered the firm's price target on Trevena to $9 from $11 and keeps a Buy rating on the shares. Olinvyk's launch has proven disappointing, though the COVID-19 pandemic created a "nearly impossible environment and many of the headwinds persist despite normalization in many respects," the analyst tells investors in a research note. | ||||
Treven announced initial… Treven announced initial topline OLINVYK data from two related real-world outcomes studies: VOLITION and ARTEMIS. The VOLITION study, a real-world, open-label, multi-site study, assessed the potential impact of OLINVYK on respiratory, gastrointestinal, and cognitive function outcomes in the postoperative setting, and was led by clinical outcomes research experts from the Cleveland Clinic and the Wake Forest Baptist Health Medical Center. Initial GI and cognition data are available, with respiratory outcome data expected mid-2023. The ARTEMIS study was an electronic medical records based assessment focused on clinical and health resource utilization outcomes. The study reviewed OLINVYK-treated patients in the VOLITION study with comparable surgical patients treated with other IV opioids, at the same institutions and during the same general time period. Initial ARTEMIS data from Wake Forest Baptist Health is currently available, representing 96 OLINVYK-treated patients and 457 matched patients treated with other IV opioids. VOLITION Preliminary Topline Results: GI Complete Responder Rate. 52.2% of OLINVYK-treated patients were classified as GI complete responders, defined as no vomiting and no antiemetic use throughout the postoperative period. As reference, in pooled data for the Company's pivotal Phase 3 studies of OLINVYK, the GI complete response rate was 46.2% and 39.7%. As reflected in the OLINVYK label, nausea and vomiting were two of the most common adverse events reported in the controlled clinical trials. Wakefulness / Sedation. Over 90% of OLINVYK-treated patients reported feeling "alert and calm" from the morning of the first post-operative day and at every observation point thereafter, based on the Richmond Agitation-Sedation Scale. Sedation is an established risk of opioids including OLINVYK. Cognition. Only 3.9% of OLINVYK-treated patients exhibited symptoms suggesting delirium at any point in the 48-hour post-operative period. Symptoms suggestive of delirium were assessed based on the validated 3D-CAM screening tool. Data from Primary, Secondary and Other Exploratory Endpoints. Data is not yet available for other endpoints, including the primary and secondary respiratory endpoints, as well as other prespecified exploratory endpoints. The Company expects to report these data mid-2023. Tolerability. No drug-related serious adverse events and no deaths were reported in the VOLITION study. Data on other adverse events is not yet available, and the Company expects to report these data mid-2023. ARTEMIS Initial Results from Wake Forest Baptist Health Healthcare Utilization Measures. OLINVYK-treated patients had a statistically significant 1.6 day reduction in average overall hospital length of stay compared to matched patients treated with other IV opioids, based on initial EMR analysis of matched patients at the Wake Forest Baptist Health study site. There was no statistically significant difference in the average duration of time in the post-anesthesia care unit with 2.4 hours observed for both OLINVYK-treated and matched patients. Delirium. Twenty matched patients experienced ICD-coded delirium or altered consciousness, compared to one patient with OLINVYK, though this difference was not statistically significant. Patients receiving any IV opioid who experienced delirium or altered consciousness in this study had an average hospital length of stay 10.5 days longer than patients who did not experience this event. ICD-coding was used for this comparative analysis as 3D-CAM is not generally used in the general patient population. Initial EMR Data Set. ARTEMIS is an electronic medical records data analysis, with records available from the Wake Forest Baptist Health study site. While an EMR analysis does not provide definitive data of group differences as seen in a prospectively randomized study, we believe EMR data bring a unique perspective to an understanding of how drugs may perform in the real world. | ||||
Cash and cash equivalents… Cash and cash equivalents were $38.3 million as of December 31, 2022, which the Company believes will be sufficient to fund the Company's operating expenses and capital expenditure requirements into the fourth quarter of 2023. | ||||
