|Bid||0.4900 x 900|
|Ask||0.5900 x 800|
|Day's Range||0.5300 - 0.5650|
|52 Week Range||0.3820 - 3.5780|
|Beta (3Y Monthly)||2.56|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
One week after the Food and Drug Administration turned down the company's application for its lead new drug candidate, Trevena Inc. said it's reducing its workforce by about a third as part of a corporate restructuring. Trevena (NSADQ: TRVN) officials said the company is undertaking additional cost-saving initiatives that, in total, are expected to save it more than $3.5 million a year. "Following receipt of the Complete Response Letter for oliceridine, we must act to reduce operating costs and conserve our capital resources,” said Carrie L. Bourdow, Trevena's president and CEO, in a statement.
The Chesterbrook, Pennsylvania-based company said it had a loss of 6 cents per share. The biopharmaceutical company posted revenue of $3 million in the period. The company's shares closed at 61 cents. ...
Trevena says it plans to continue to work with the FDA to address the issues that caused the agency to reject the company's new drug application for Olinvo.
Trevena Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid injection for managing acute pain. The FDA in its complete response letter requested additional clinical data and indicated that the safety data was not adequate for the proposed dosing. Opioid addiction and overdose have become a serious public health crisis in the United States.
Trevena Inc (NASDAQ:TRVN), a US$81m small-cap, is a healthcare company operating in an industry, which continues to be affected by the sustained economic uncertainty and structural trends, such as an Read More...
Here's a roundup of top developments in the biotech space over the last 24 hours. Amid the market mayhem, no biotech or medical device companies made it to 52-week highs. Down In The Dumps (Biotech stocks ...
The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted eight against, and seven in favor of, supporting the approval of Trevena's new drug application.
Trevena Inc's opioid injection for managing acute pain failed to win the backing of an advisory panel to the Food and Drug Administration on Thursday, against the backdrop of opioid addiction in the United States reaching epidemic proportion. The panel voted 8-7 against approving the treatment which is administered in hospitals and ambulatory surgery centers and aims to manage acute pain in patients for whom an intravenous opioid is necessary.
The briefing document released by FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which is evaluating AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)'s new drug application for Dsuvia, said the dose and dosage regimen appear effective in the drug's proposed population and reasonably safe in the context of existing opioid therapy. The 30-mcg of sufentanil sublingual tablets are intended to treat moderate-to-severe acute pain that requires an opioid analgesic and for which alternative treatments are inadequate.
Trevena’s stock closed down 64 percent Tuesday after Food and Drug Administration review staff raised potential safety concerns about the Chesterbrook, Pa., biopharmaceutical company’s lead drug candidate. The new drug candidate for severe-to-moderate pain in patients in need of an intravenous opioid treatment has the proposed brand name Olinvo and the active ingredient oliceridine. In background materials prepared for the agency’s Anesthetic and Analgesic Drug Products Advisory Committee meeting to review Trevena’s application on Oct. 11, FDA staff's assessment says oliceridine has “an abuse potential, overdose potential and ability to produce physical dependence that is similar to other (opioids).” The published staff report sent the company’s stock down 64 percent to $1.07 per share.
Trevena Inc's opioid injection to treat acute pain could be abused and potentially lead to overdose, staff reviewers of the U.S. Food and Drug Administration said on Tuesday, sending the drugmaker's shares down 66 percent. The treatment, oliceridine, aims to manage moderate-to-severe acute pain in adult patients for whom an intravenous opioid is necessary and the injection should be administered in hospitals and ambulatory surgery centers.
Trevena Inc. completed its previously announced leadership transition on Monday. Carrie L. Bourdow, formerly the Chesterbrook, Pa., biopharmaceutical company's executive vice president and chief operating officer, has assuming the role of president and CEO and joined Trevena's board of directors. Maxine Gowen, the company’s founding president and CEO, has retired.
The biotech industry is performing reasonably well. Hence, it is a good idea to select stocks from the sector witnessing positive estimate revisions.
Every month brings plenty of catalysts for several biotech stocks. October is no exception. There are quite a few regulatory news to be announced next month. One biotech in particular could enjoy boosts to its stock if all goes well -- Trevena (NASDAQ:TRVN). Trevena could be on track to win FDA approval for its lead candidate oliceridine, a potential treatment for moderate to severe acute pain. But the first hurdle is an FDA advisory committee meeting scheduled for October 11 to discuss the NDA for oliceridine, which has a November 2 PDUFA date. While the advisory committee's vote doesn't automatically mean the FDA will decide on oliceridine in the same way, it should be a pretty good predictor. Historically, the FDA goes along with the advisory committee recommendation close to 90% of the time. Because of this high correlation, a positive recommendation by the advisory committee should result in a nice bump for Trevena stock. JMP analyst Jason Butler commented, "An AdComm has always been expected for the NDA, and we view the timing as consistent with expectations. We expect some debate at the meeting regarding the appropriate balance between ensuring patients' medical pain management needs are met while avoiding misuse. Given that oliceridine will be used in a controlled procedural setting, and there are no robust data supporting the use of opioids in the hospital with the risk of misuse in the community setting - we believe patients whose pain is well controlled on discharge are less likely to abuse pain control medicines in the community setting - we think the panel will support approval. Furthermore, we continue to believe that the Phase 2/3 trials for oliceridine support that it is a novel, differentiated opioid with more favorable respiratory and GI safety." As such, Butler reiterates a Buy rating on TRVN with a $15 price target (the highest on Wall Street), which implies a huge upside of over 800% from Tuesday's closing price. (To watch Butler's track record, click here) Echoing Butler's bullish views is Cowen's Ritu Baral: "We expect a positive outcome from the panel and anticipate approval on the PDUFA with a broad label. We anticipate a significant point of discussion of the panel will be the differentiated safety profile of oliceridine, particularly strong trends in the phase 3 dataset that suggest improved respiratory safety (as well as stat sig improvements in GI tolerability). We think positive discussions and conclusions from the panel could be a major driver for TRVN shares." As a sign of confidence in Trevena, Baral maintains an Outperform rating on the stock with a price target of $10.00. Baral is one of the top analysts on Wall Street covering the Biotechnology sector. Her picks average a 30.8% one-year return, and she's ranked #56 out of 4,874 analysts, according to TipRanks. Net net, when it comes to Wall Street’s bet, the odds are on this small-cap biotech stock. Based on seven analysts polled in the last 12 months, six are bullish on TRVN, while one remains sidelined. The 12-month consensus mean price target for the stock is $8.58, reflecting a 420% upside from current levels. #### More recent articles about TRVN: * Is It Game Over for Trevena (TRVN) Stock? * Trevena (TRVN): The AdCom Vote Was a Lot Closer Than You Think * Trevena (TRVN) Stock Hit with a Downgrade; Shares Tumble Over 10% * The Bullish Stance on Trevena (TRVN) Comes to an End; Analyst Downgrades the Stock
The Chesterbrook, Pennsylvania-based company said it had a loss of 13 cents per share. The biopharmaceutical company posted revenue of $2.5 million in the period. The company's shares closed at $1.49. ...
Trevena (NASDAQ: TRVN) is expecting an FDA decision on its pain drug oliceridine on November 2. Furthermore, the FDA has informed the company that it intends to convene an advisory committee meeting to discuss the oliceridine filing (likely in September), which could be a catalyst for shares if positive. Wall Street analysts continue to believe Olinvo will likely be approved by the FDA based on the draft guidelines and two positive pivotal Phase 3 APOLLO studies and ATHENA safety study.
Trevena (NASDAQ:TRVN) and Array Biopharma (NASDAQ:ARRY) investors could be celebrating soon enough, should these two drug makers achieve that triumphant FDA approval at the close of a winding biotech road. Between Trevena's opioid asset oliceridine, designed as an intravenous treatment of severe acute pain, and Array's BRAF-mutant melanoma combination therapy candidate encorafenib + binimetinib getting close to final FDA verdicts, two bulls at Cowen are out shedding light on the opportunity ahead. By Cowen's bet, these drug makers are steaming ahead to stamps of FDA approval. Let's dive in: Trevena: A Small-Cap Biotech Stock With Big Catalysts Trevena is eyeing a prospective FDA nod come its PDUFA date set November 2nd for moderate to severe acute pain management drug oliceridine. As of January, the FDA accepted this biotech player's NDA for oliceridine, which is the first G protein biased ligand of the MU receptor created to offer IV opioid pain relief with less correlated adverse impacts- from the common and less serious effects of nausea and vomiting to the rare and perilous effect of respiratory depression. Before the PDUFA will come an AdCom sometime potentially in September. With a DEA scheduling of controlled substances often due in the span of 90 days of a green light, the TRVN team is calling for a commercial launch in the U.S. in the first quarter of next year. Top analyst Ritu Baral at Cowen believes the spotlight here for TRVN moving forward will be on "differentiated safety at AdComm and on label," but she sees a pain management asset tracking for a win in November. Ultimately, "We expect a positive outcome from the meeting and anticipate broad indication for oliceridine. We anticipate a significant point of discussion of the panel will be the differentiated safety profile of oliceridine, particularly strong trends in the Phase 3 dataset that suggest improved respiratory safety (as well as stat sig improvements in GI tolerability). We think positive discussions and conclusions from the panel could be a major driver for TRVN shares," Baral surmises, liking the odds on oliceridine's approval. As such, the analyst maintains an Outperform rating on TRVN stock with a $10 price target, which implies a nearly 459% upside from current levels. Keep in mind, the company seeks alliances for its pain management asset, and newly walked into license deals with Pharmbio Korea and Jiangsu Nhwa Pharmaceutical in China. This international partnership offers the company both short-term capital while also driving long-term gains, the analyst cheers, adding: "Both companies have a strong track record of developing and commercializing products for anesthetics and analgesics in their respective geography’s hospital market." Under the terms of the agreement, Pharmbio Korea will pay $3 million in an upfront payment coupled with milestones as well as tiered royalties on product sales from high single digits to 20%. Jiangsu Nhwa also will shell out an upfront payment of $2.5 million along with a $3.0 million milestone payment once oliceridine wins an FDA nod. Moreover, Jiangsu Nhwa will pay further commercialization milestones as well as 10% royalties on every product sale in China. "We believe the partnership is critical as it provides the much-needed cash for TRVN and supports long-term growth for oliceridine ex-US. The company remains in active discussions for additional oliceridine licensing both in the US and ex-US, which could meaningfully impact cash runway. Potential US partners probably wait until after the PDUFA date to avoid approval risk," continues Baral. Ritu Baral has a very good TipRanks score with a 58% success rate and a high ranking of #21 out of 4,819 analysts. Baral yields 37.9% in average profits on the stock. However, when recommending TRVN, Baral forfeits 36.6% in average profits on the stock. TipRanks indicates a strong bullish consensus backing this biotech player. Out of 3 analysts polled in the last 3 months, all 3 are betting bullish on Trevena. With a monster return potential of nearly 310%, the stock's consensus target price stands tall at $7.33. Array BioPharma Boasts "Underappreciated" Commercial Potential Array BioPharma and its partner privately-held French biotech firm Pierre Fabre just posted data exhibiting that their combination therapy practically circles twice over the survival in BRAF-positive melanoma against the Roche drug Zelboraf (vemurafenib). The data unleashed from the pivotal Phase III COLUMBUS study reveals that when patients took a combination of encorafenib 450mg daily and binimetinib 45mg twice daily, overall survival reached 33.6 months, much higher than the 16.9 months seen for patients who took Zelboraf as a monotherapy. The combination appears to be mostly well-tolerated by patients, encouragingly. Notably, New Drug Applications are under review by the FDA to give a window to the utilization of a one-two combination punch of encorafenib and binimetinib in treating patients with BRAF-mutant advanced, unresectable, or metastatic melanoma. After hosting a conference presentation, Cowen analyst Chris Shibutani shares his bullish takeaways on the drug maker. Specifically, the analyst takes in stride that the team indicated "confidence in their preparedness for the anticipated commercialization of BRAFTOVI (enco) and MEKTOVI (bini) combination in BRAF+ melanoma." After all, pre-commercial endeavors are tracking with encouraging pacing, with the ARRY management team having just unleashed brand names BRAFTOVI for encorafenib capsules and MEKTOVI for binimetinib tablets. Shibutani sizes up ARRY's BRAFmutant melanoma candidate raring to launch as soon as it scores a win on its June 30th PDUFA date. Therefore, the analyst reiterates an Outperform rating on ARRY stock with a $19 price target, which implies a 15% upside from current levels. (To watch Shibutani's track record, click here) Meanwhile, Shibutani sees BEACON enrollment momentum rolling forward with enticing prospects for "more refined completion timelines" compared to the present guide calling for the year-end of 2018. This drug maker's opportunity is undervalued, as far as Shibutani is concerned: "Potential in 1st-line settings for both BRAF+ CRC and MSS CRC with bini +MRK’s PD1 combo underappreciated in our view." "Management highlighted key hires including head of Medical Affairs who joins from Novartis. Outside the US, ARRY commented that their partner in Europe, Pierre Fabre, in addition to having a presence in oncology, has a relevant franchise in the dermatology market, as well," adds the analyst. When glancing at the BRAF-mutant melanoma commercial prospects at play, the analyst runs the numbers for a domestic market for BRAF/MEK inhibitors presently annualizing at a $400 million run-rate- and nearing $1 billion globally. The ARRY team recognizes opportunity for further market gains, especially generated on back of unit growth, with the analyst drawing attention to market leader Novartis' current almost 90% share along with ARRY. Moreover, ARRY management spots prospects for longer duration of use, particularly considering the "relatively more favorable tolerability profile of ARRY's combination (versus the current extrapolated estimate of 4-5 months […]" notes Shibutani. That said, based on the Cowen's "Melanoma and Renal Cell Cancer" panels at the conference, the analyst notes that community oncologists especially will need "some time, building a base of experience with ARRY’s agents, essentially building empiric experience themselves with the profile of BRAFTOVI/MEKTOVI." In addition to musing as to how to calibrate a pricing formula, the ARRY team likewise is very aware of its prospects to tackle a meaningfully unmet need for patients in the 1st-line setting, the analyst explains, likewise drawing note to the "efficacy and tolerability profile demonstrated thus far." Bottom line, this drug maker has strategic standing to "capitalize" on MEK+IO combinations coupled with multiple collaborations. TipRanks suggests the bulls win out on consensus opinion circling ARRY stock's prospects, with all 4 analysts polled in the last 3 months rating a Buy on the biotech player. The 12-month average price target stands at $20.33, marking a healthy upside potential of 23% from where the stock is currently trading. #### More recent articles about ARRY: * Is It Game Over for Trevena (TRVN) Stock? * Trevena (TRVN): The AdCom Vote Was a Lot Closer Than You Think * Trevena (TRVN) Stock Hit with a Downgrade; Shares Tumble Over 10% * The Bullish Stance on Trevena (TRVN) Comes to an End; Analyst Downgrades the Stock
Investors seeking to increase their exposure to growth should consider companies such as Trevena and Redfin. Analysts are generally optimistic about the future of these stocks, based on how muchRead More...