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Wednesday, August 12, 2020 1:57:29 PM
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.
Recent TRVN News
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 01:16:34 PM
- Trevena Announces $2M Non-Dilutive Financing Tranche and Reduction in Outstanding Liabilities in Connection with Existing ex-US Royalty Financing • GlobeNewswire Inc. • 07/08/2024 01:15:00 PM
- Trevena Announces Preclinical TRV045 Data Providing Insight Into Novel Mechanism of Analgesic Effect in Chronic Neuropathic Pain Model and Demonstrating Statistically Significant Anti-Seizure Activity in Epilepsy Models • GlobeNewswire Inc. • 06/20/2024 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/18/2024 08:43:33 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 09:06:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:40:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:40:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:39:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:38:37 PM
- Form DEFR14A - Revised definitive proxy soliciting materials • Edgar (US Regulatory) • 05/17/2024 08:05:39 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 11:15:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 11:05:42 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 10:00:24 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 02/20/2024 09:06:01 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 07:34:30 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/09/2024 09:05:33 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 12:05:28 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/23/2024 09:15:32 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 01/23/2024 05:15:19 AM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 01/19/2024 09:30:30 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 01/10/2024 09:30:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/08/2024 12:01:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/28/2023 07:09:21 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/15/2023 11:57:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/15/2023 11:57:32 PM
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