Trevena (TRVN) resubmits the NDA to the FDA for IV oliceridine for the management of moderate-to-severe acute pain.
Insider Monkey has processed numerous 13F filings of hedge funds and successful value investors to create an extensive database of hedge fund holdings. The 13F filings show the hedge funds' and successful investors' positions as of the end of the first quarte…
Just in time for Easter, the market delivered two consecutive sessions of gains. All three of the major U.S. stock indexes closed in the green on the last two days of the holiday-shortened trading week, rallying on the U.S. government’s additional interventions to mitigate COVID-19's economic impact. While the most recent surge was a welcome piece of good news, it came as somewhat of a surprise as the deadly virus continues to rampage parts of the U.S. and businesses remain shut down indefinitely. As a result, Wall Street pros argue that while we might not be out of the woods just yet, those ready to take on some risk have been presented with exciting opportunities. Specifically pointing to the biotech space, several compelling names are trading at low levels, making it affordable to snap up shares before a particular stock takes off. Seemingly at the drop of a hat, biotech companies can see their share prices soar on a single positive catalyst like favorable clinical data or regulatory approvals.With this in mind, we used TipRanks’ database to zero in on three biotech stocks trading for under $2 per share. After conducting our research, we found out that each is Buy-rated and boasts some serious upside potential.Trevena, Inc. (TRVN) Focused on developing therapies to improve the lives of patients with central nervous system (CNS) disorders, Trevena has an impressive development pipeline that could potentially help it do just that. While shares have fallen 37% year-to-date, putting the current share price at $0.51, some analysts believe its lead candidate, oliceridine, can drive massive upside. Oliceridine, an IV injection designed as an alternative to IV morphine for moderate to severe acute pain management, could be granted approval this summer, as the FDA recently accepted TRVN’s resubmission for review and set an August 7 PDUFA date. Based on a key opinion leader’s evaluation, JMP Securities analyst Jason Butler thinks there’s a strong likelihood the drug will ultimately be approved. While TRVN received a Complete Response Letter (CRL) in November 2018, new data from the QT trial addressed the safety concerns. Additionally, Dr. Timothy Beard, M.D., Chair of the Department of Surgery at Summit Medical Group, sees oliceridine as being an innovative drug. Butler wrote, “Dr. Beard stated that he is very familiar with the clinical data for oliceridine and believes the drug represents a truly novel advancement in pain management. He is impressed by the pain relief achieved with the drug and views the side effect profile as differentiated. He also commented that the data from the open-label extension trial is encouraging as it included a diverse range of patient populations.” On top of this, the candidate has demonstrated a clear role in higher-risk patients as well as the potential to improve patient experience and time to discharge in outpatient procedure centers. This is significant because performing procedures in an outpatient setting rather than in a hospital results in substantial savings for insurance companies. With three other candidates in development, it’s no wonder Butler is optimistic about TRVN. In line with this take, the four-star analyst maintained a Market Outperform rating and $4 price target. Should this target be met, shares could be in for a 684% twelve-month gain. (To watch Butler’s track record, click here) Looking at the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Only one other analyst has published a review recently, but it was also bullish, making the consensus rating a Moderate Buy. At $3.75, the average price target implies 635% upside potential. (See Trevena price targets and analyst ratings on TipRanks)Zosano Pharma Corporation (ZSAN) Another biotech targeting CNS conditions, Zosano has developed an intracutaneous microneedle patch system to deliver therapeutics and other bioactive molecules. At $0.60 apiece, the share price could represent the ideal time to acquire a position. Weighing in for H.C. Wainwright, analyst Raghuram Selvaraju commented, “In our view, Zosano looks like a sleeper that investors would be wise to assess carefully—the company's sole clinical-stage product candidate, Qtrypta, has completed pivotal development in acute migraine therapy with what we consider to be stellar results and is the subject of a potential October 20, 2020, U.S. approval decision.” The candidate is a formulation of an existing anti-migraine drug, zolmitriptan, in ZSAN’s patented microneedle array-containing, patch-based delivery device. According to pivotal data, the drug was able to produce fast onset pain relief, with 23% of patients experiencing results within 15 minutes and more than 80% of patients within two hours. Qtrypta achieved a strong result in terms of pain freedom and works well for patients with nausea who can’t swallow oral tablets and patients with a fear of visible needles, and thus, can’t use injectable triptans. Selvaraju added, “Only about 2% of patients in the Phase 3 trial reported triptan-like side effects (i.e., dizziness and paresthesia), indicating that Qtrypta may have a substantial safety and tolerability edge vs. other triptan-class drugs.” With Selvaraju expecting the company to target the roughly 5,000 specialist prescribers who routinely treat migraines and predicting it will be priced comparably to Eli Lilly’s drug, he estimates that Qtrypta could generate $30 million in sales during 2021 and peak sales of almost $300 million in 2026. Adding to the good news, COVID-19's effect on the company should be relatively limited as Qtrypta has already wrapped up pivotal testing and is under FDA review. To this end, Selvaraju kicked off his ZSAN coverage by issuing a Buy rating. Along with the bullish call, he set a $4 price target, suggesting shares could skyrocket 567% in the next year. (To watch Selvaraju’s track record, click here) Given that the biotech has received 2 Buy ratings compared to no Holds or Sells in the last three months, the word on the Street is that ZSAN is a Moderate Buy. Thanks to the $3 average price target, shares could potentially climb 400% higher in the next twelve months. (See Zosano price targets and analyst ratings on TipRanks)Moleculin Biotech, Inc. (MBRX) Last up, we have biotech company Moleculin, which has used its three core technologies to develop therapies for various forms of cancer. Unlike the other two names on our list, shares are up 143% in the last month, and at $1.14, its price tag still presents investors with an attractive entry point. The excitement surrounding MBRX is partly related to its potential treatment for COVID-19. The company announced that the University of Frankfurt’s research indicated 2-deoxy-D-glucose, “2-DG”, reduces COVID-19 replication by 100% in vitro. Even though this is promising, 2-DG metabolizes too quickly to be delivered to patients effectively, and thus, can only be used in vitro. That’s where MBRX comes in. It designed its candidate, WP1122, as a 2-DG pro-drug that could possibly address the metabolic challenges associated with 2-DG. Explaining the therapy’s implications, Maxim Group analyst Jason McCarthy stated, “WP1122 solves this problem with a modification to make a pro-drug which significantly increases the molecule's stability and permeability. Once WP1122 gets into a cell, the pro-drug acetyl groups are cleaved by esterases in the cytoplasm, and the active 2-DG molecule is released. This process induces 10X-plus uptake into tissues, something that standard 2-DG cannot achieve...WP1122 could change that for viral diseases, including COVID-19, as well as cancer indications.” Sure, additional clinical testing needs to take place, but McCarthy believes that early data is encouraging and he expects an IND filing for the candidate to come very soon. It should also be noted that MBRX has a research agreement with the University of Texas Medical Branch at Galvaston to study the efficacy of its compounds, including WP1112, in battling several viruses. Based on all of the above, McCarthy stayed with the bulls, reiterating a Buy recommendation and $3 price target. This implies shares could soar 165% in the next twelve months. (To watch McCarthy’s track record, click here) MBRX’s Moderate Buy consensus rating breaks down into only Buys, 2 to be exact. With a $2.50 average price target, the upside potential lands at 121%. (See Moleculin price targets and analyst ratings on TipRanks)
Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company’s lead investigational asset for the management of moderate-to-severe acute pain.
Tamuro Bio, a new Wayne-based biotechnology company led by former Trevena CEO Maxine Gowen has raised $4 million in a private stock sale. The equity financing was disclosed in documents Tamuro filed with the Securities and Exchange Commission. Gowen, listed as the chief executive officer of Tamuro in the SEC filing, declined to discuss the focus of her new venture saying the company is still operating in a "stealth mode." Tamuro has not yet set up a website.
Q4 2019 Trevena Inc Earnings Call
NEW YORK, May 19, 2020 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for TOPS, GE, ONCY, TRVN, and NERV. To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selec…
Is (TRVN) Outperforming Other Medical Stocks This Year?
CHESTERBROOK, Pa., May 01, 2020 -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients.
Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today. The publication is titled “Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain”, with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony Brook Medicine (DOI: 10.1358/dot.2020.56.4.3107707). “I am pleased to have the opportunity to provide a comprehensive overview of the data we have amassed over the entire oliceridine development program from over 1,800 individuals,” said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. “This monograph is the latest addition to the compelling body of peer-reviewed published literature for oliceridine, and summarizes the novel characteristics that make it a potentially differentiated treatment option for moderate-to-severe acute pain in hospital settings.”
We often see insiders buying up shares in companies that perform well over the long term. Unfortunately, there are...
Trevena has been on a bit of a cold streak lately, but there might be light at the end of the tunnel for this overlooked stock.
The Chester County company said its new drug candidate works differently than traditional opioids and is designed to have fewer adverse side effects.
CHESTERBROOK, Pa., March 05, 2020 -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients.
Insider Monkey has processed numerous 13F filings of hedge funds and successful value investors to create an extensive database of hedge fund holdings. The 13F filings show the hedge funds' and successful investors' positions as of the end of the first quarte…
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week highs on March 4) * 89bio Inc (NASDAQ: ETNB) * Arcus Biosciences Inc (NYSE: RCUS) * Arcturus Therapeutics Ltd (NASDAQ: ARCT)(announced a partnership with Duke-NUS Medical School to develop a COVID-19 vaccine for Singapore) * Cue Biopharma Inc (NASDAQ: CUE) * IGM Biosciences Inc (NASDAQ: IGMS) * Inovio Pharmaceuticals Inc (NASDAQ: INO) * Ocular Therapeutix Inc (NASDAQ: OCUL)(reacted to its preliminary fourth-quarter results and interim data from a Phase 1 study evaluating its eye implant OTX-TKI in patients with wet age-related macular degeneration) * Quest Diagnostics Inc (NYSE: DGX) * Regeneron Pharmaceuticals Inc (NASDAQ: REGN)(CEO Leonard Schleifer reportedly told CNBC the company hopes to produce COVID-19 treatment candidate that could be ready for human testing by August) * Revolution Medicines Inc (NASDAQ: RVMD) (IPOed mid-February) * SpringWorks Therapeutics Inc (NASDAQ: SWTX) * Syndax Pharmaceuticals Inc (NASDAQ: SNDX)(reacted to the company's fourth-quarter results) * Syneos Health Inc (NASDAQ: SYNH) * Viela Bio Inc (NASDAQ: VIE)Down In The Dumps (Biotech Stocks Hitting 52-week lows on March 4) * Alterity Therapeutics Ltd (NASDAQ: ATHE) * AngioDynamics, Inc. (NASDAQ: ANGO) * Aptevo Therapeutics Inc (NASDAQ: APVO) * CASI Pharmaceuticals Inc (NASDAQ: CASI) * Enlivex Therapeutics Ltd (NASDAQ: ENLV) * Evogene Ltd (NASDAQ: EVGN)(reacted to fourth-quarter results) * Evolus Inc (NASDAQ: EOLS)(reacted to comments by Korean drug maker Medytox about an ITC case brought up by the company against Daewoong and partner Evolus on intellectual property related to Medytox' botulinum toxin) * Mylan NV (NASDAQ: MYL) * Orthofix Medical Inc (NASDAQ: OFIX) * Passage Bio Inc (NASDAQ: PASG)(IPOed last week) * Titan Medical Inc. (NASDAQ: TMDI)See also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates Stocks In Focus Co-Diagnostics' COVID-19 Detection Kit Demand Surges Co-Diagnostics Inc (NASDAQ: CODX) said demand, both domestic and international, surged for its COVID-19 detection kits in recent weeks, leading to increased product shipments. The increase comes after the FDA changed its policy Feb. 20 and the number of cases testing positive for the disease burgeoned worldwide.The stock was surging 27.17% to $15.26 in pre-market trading.Castle Biosciences Gets First Patent For Skin Cancer Gene Expression Profile Test Skin cancer diagnostic company Castle Biosciences Inc (NASDAQ: CSTL) said the U.S. patent office has issued it the first U.S. patent related to the DecisionDx -Melanoma gene expression profile test for patients with cutaneous melanoma.FDA Accepts Trevena's Resubmitted NDA for Pain Drug Trevena Inc (NASDAQ: TRVN) said the FDA has acknowledged the receipt of and accepted the resubmitted NDA for intravenous oliceridine, its lead investigational asset, for the management of moderate-to-severe acute pain. The PDUFA date has been set for Aug. 7.In pre-market trading, shares were rising 12.35% to 91 cents.Can-Fite To Explore Treatment For COVID-19 Can-Fite BioPharma Ltd. (NASDAQ: CANF) said it is exploring a collaboration to explore if its investigational asset Piclidenoson, being evaluated for autoimmune inflammatory disease, is effective against coronavirus following reports that rheumatoid arthritis drugs have been introduced for the treatment of the same.The stock was jumping 26.28% to $1.97 in pre-market trading.RA Medical Says NYSE Accepts Plan to Regain Compliance RA Medical Systems Inc (NYSE: RMED) said the NYSE has accepted the company's business plan to regain compliance with the NYSE listing standards. Late last year, the company was notified by the NYSE regarding flouting of listing standards pertaining to average market capitalization being less than $50 million over a recent consecutive 30 days.MacroGenomics' Chief Medical Officer Resigns to Pursue Another Opportunity MacroGenics Inc (NASDAQ: MGNX) announced the resignation of Jon Wigginton as its SVP, Clinical Development & Chief Medical Officer, effective March 27, as he pursues a new opportunity. The role will be assigned on an interim basis to Ezio Bonvini, who is currently serving as SVP, Research and Chief Scientific Officer, the company said.Morphosys To Issue Additional Shares For Subscription By Incyte As Part of Tafasitamab Licensing Deal Morphosys Ag (NASDAQ: MOR) said its Management Board has resolved to increase the share capital of the company by issuing 907,441 new ordinary shares from the authorized capital to facilitate purchase of 3.63 million ADSs by Incyte Corporation (NASDAQ: INCY). The newly issued shares represent about 2.84% of the registered share capital of MorphoSys prior to the consummation of the capital increase.View more earnings on TRVNIncyte's purchase of ADSs amounting to $150 million or $41.32 per ADS is part of the consideration due to MorphoSys for the former acquiring licensing rights to develop and commercialize the latter's investigational compound tafasitamab.In pre-market trading, MorphoSys shares were slipping 3.70% to $28.89.Earnings Specialty pharma company Opiant Pharmaceuticals Inc (NASDAQ: OPNT), which develops treatment for treating addictions and drug overdose, reported fourth-quarter revenues of $7.7 million compared to $4.8 million in the fourth quarter of 2018. The company reversed to a profit of 20 cents per share from a loss of $2.49 per share last year, while analysts had estimated a loss of $2.13 per share, on average.The stock rallied 17.09% to $13.70 in after-hours trading.Offerings BridgeBio Pharma Inc (NASDAQ: BBIO) priced the upsized offering of $475 million aggregate principal amount of 2.50% convertible senior notes due 2027 in a private offering to qualified institutional buyers. The company said the notes will bear interest at a rate of 2.50% per year, payable semi-annually in arrears on March 15 and Sept. 15 of each year. Beginning Sept. 15, 2020.The company estimates to raise net proceeds of about $463.7 million from the offering.On The Radar Earnings * Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open) * BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open) * Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open) * Xtant Medical Holdings Inc (NYSE: XTNT) (before the market open) * Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open) * Syros Pharmaceuticals Inc (NASDAQ: SYRS) (before the market open) * Obseva SA (NASDAQ: OBSV) (before the market open) * OptiNose Inc (NASDAQ: OPTN) (before the market open) * Caladrius Biosciences Inc (NASDAQ: CLBS) (after the close) * Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close) * BioNano Genomics Inc (NASDAQ: BNGO) (after the close) * Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close) * Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) (after the close)See more from Benzinga * GenMark Spikes Higher On COVID-19 Test Kit Shipment * The Daily Biotech Pulse: GenMark Diagnostics Ships COVID-19 Test Kits, Karyopharm To Offer Shares, And More * How The COVID-19 Outbreak Is Benefiting Biotech Investors(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
CHESTERBROOK, Pa., Feb. 05, 2020 -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients.
Trevena, Inc. (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 resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV oliceridine, the Company’s lead investigational product for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.
Trevena Reports First Quarter 2020 ResultsFDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020 IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing.
NEW YORK, May 18, 2020 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for SRNE, CHK, TRVN, DAL, and RCL. To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by select…
PDUFA date of August 7, 2020 for IV oliceridine; FDA considers NDA resubmission complete Initiated proof-of-concept studies for acute migraine (TRV250) and opioid use disorder.
NEW YORK, May 19, 2020 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for TOPS, GE, ONCY, TRVN, and NERV. To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selec…
NEW YORK, May 18, 2020 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for SRNE, CHK, TRVN, DAL, and RCL. To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by select…
Is (TRVN) Outperforming Other Medical Stocks This Year?
Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the appointment of Scott Applebaum as Chief Legal and Compliance Officer and Senior Vice President of Regulatory Affairs. Mr. Applebaum comes to the Company with over 20 years of experience in a variety of senior leadership roles at both large and small companies at various stages of development and commercialization in the biopharmaceuticals sector.
FDA accepts Trevena's (TRVN) NDA for opioid analgesic, oliceridine, re-submitted last month. A decision is expected in August.
CHESTERBROOK, Pa. (AP) — Trevena Inc. (TRVN) on Thursday reported a loss of $5.7 million in its first quarter.