0.820 -0.03 (-3.30%)
After hours: 5:08PM EDT
|Bid||0.820 x 900|
|Ask||0.850 x 1100|
|Day's Range||0.825 - 0.910|
|52 Week Range||0.760 - 3.578|
|Beta (3Y Monthly)||0.83|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
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.
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. 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.
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.
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...
The Chesterbrook, Pennsylvania-based company said it had a loss of 14 cents per share. The results topped Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research ...
On a per-share basis, the Chesterbrook, Pennsylvania-based company said it had a loss of 24 cents. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...
Trevena Inc’s (NASDAQ:TRVN): Trevena, Inc., a biopharmaceutical company, develops various therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions. The US$120.24M market-cap company’s lossRead More...
The company will next report results on Feb. 9, before the bell. Analysts are looking for earnings of 44-cents-per-share on revenues of $4 billion. When the company last reported on Nov. 10, a loss of 33-cents-per-share beat estimates by 10 cents on a 1.8% decline in revenues.