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Strong pan-coronavirus effectiveness of clinical drug candidatesPan-coronavirus Clinical Drug Candidates for the Treatment of COVID-19 Are Highly Effective in Pre-clinical Cell Culture Studies Performed in Preparation of FDA Pre-IND Application $NNVC reported yesterday on the strong pan-coronavirus effectiveness of its two COVID-19 clinical drug candidates for which the Company is preparing a pre-IND application. NV-CoV-2 is the Company's broad-spectrum anti-coronavirus clinical lead drug candidate for the treatment of COVID-19 patients based on its nanoviricides® platform. $NNVC is also developing NV-CoV-2-R, a drug treatment that combines the power of both NV-CoV-2 and remdesivir in a single drug that encapsulates and protects remdesivir inside NV-CoV-2. Both NV-CoV-2 and NV-CoV-2-R are expected to work against most, if not all , coronaviruses and their variants, based on the Company's findings on their pre-clinical effectiveness discussed below. NV-CoV-2 and NV-CoV-2-R were found to be highly effective in comparison to remdesivir against two distinctly different coronaviruses in our new cell culture studies leading towards a pre-IND application and thereafter an IND submission for these COVID-19 drug candidates. The Company intends to report on the results of these studies in its pre-IND application to the US FDA to obtain guidance regarding human clinical trials for treatment of COVID-19 patients. Additionally, the Company is actively seeking opportunities to engage appropriate sites for human clinical trials. Further, the Company is engaged in the preparation of clinical trial protocols and other activities that would be necessary for submitting an IND application to the US FDA. The Company has developed NV-CoV-2 based on its platform nanoviricides® technology. This approach enables rapid development of new drugs against a number of different viruses. finance.yahoo.com
AMEX:NNVC
by AlenCiken
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$MORF Reports Positive Interim Results from Phase 1Morphic Reports Positive Interim Results from Single Ascending Dose Phase 1 Clinical Trial of MORF-057 1. MORF-057 well tolerated in all dose cohorts. 2. MORF-057 achieved greater than 95% mean receptor occupancy of integrin at three highest dose levels; demonstrates ability to saturate receptor 3. Data provide early clinical proof of concept for MORF-057 as an oral, selective inhibitor. 4. Phase 1 multiple ascending dose and food effect trials ongoing “We’re excited to present the totality of the Phase 1 trial data later this year and to leverage this emerging data set to inform the optimal study design for Phase 2 trials in ulcerative colitis and beyond.” In the Phase 1 SAD trial, MORF-057 was well tolerated in all 5 cohorts receiving MORF-057 in single doses ranging from 25 mg to 400 mg with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. Morphic expects to present the full data set from the MORF-057 Phase 1 clinical trial at an appropriate medical meeting in mid-2021. finance.yahoo.com Meanwhile, the company's long-standing partnership with pharma giant AbbVie is moving forward. Under the collaboration agreement between these two entities, which started more than two years ago, AbbVie initially paid $100 million up front to Morphic to acquire exclusive license options for some of Morphic's candidates. Morphic Holding would be responsible for conducting research and development for these products up to the completion of investigational new drug enabling studies. AbbVie would then be able to exercise its license option for a fee to take up the development of these programs. Today, Morphic Holding announced that AbbVie paid a $20 million fee to assume the responsibility to develop and commercialize a couple of Morphic's pipeline candidates. Lastly, Morphic has a partnership with Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), which focuses on developing integrin therapeutics for conditions for which there are few adequate therapy options. Morphic announced that it has expanded this partnership with the pharma company. For a drugmaker with no products on the market, lucrative deals with well-established pharmaceutical companies are important. Morphic Holding will be able to use the funds it received from AbbVie to fund the clinical development of some of its other candidates, while its partnership with Janssen could bear fruit in the form of promising clinical compounds. These factors explain why investors are bidding up shares of Morphic Holding today. www.fool.com
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by AlenCiken
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Why Lixte Biotechnology Soared heavily on friday?Why Lixte Biotechnology Soared heavily on friday? It seems as though retail investors are banding behind this ultra-low float stock, lifting demand and therefore, lifting its price. the company hasn’t issued any news. Nonetheless, it seems as though the retail crowd on Wall Street is banding behind the stock. there is quite a bit of discussion about the stock on Wall Street Bets, StockTwits, and Twitter, suggesting that the retail crowd is interested. At the moment, LIXT trades with a public float of just 4.5 million shares. That’s an incredibly low share supply. As the law of supply and demand tells us, when supplies of anything are very low and a flood of demand comes in, the price must increase. With retail investors diving into LIXT, and such a tiny public float, it only makes sense that the stock is experiencing dramatic gains. cnafinance.com
NASDAQ:LIXT
by AlenCiken
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$JAN to Sell its Legacy Recycling Business for $25 MillionJanOne Announces Definitive Agreement to Sell its Legacy Recycling Business for $25 Million Successful disposition will facilitate continued strategic focus on high-value late-stage biopharma asset JAN101 for the treatment of peripheral artery disease (PAD) The transaction is expected to close on or before August 18, 2021 JanOne recently completed production of JAN101 under Current Good Manufacturing Practices (cGMP) for the anticipated Phase 2b PAD trials. The Company plans to submit the Phase 2b protocol and related documents to the FDA under its Investigational New Drug Application (IND) for PAD in March 2021 . finance.yahoo.com
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by AlenCiken
Viracta Therapeutics Announces Closing of Merger with $SNSSViracta Therapeutics Announces Closing of Merger with Sunesis Pharmaceuticals and $65M Private Placement Shares of Viracta to commence trading on the Nasdaq Global Select Market on February 25, 2021 under ticker symbol 'VIRX' Cash and cash equivalents of over $120 million as of merger close Registration trial for the treatment of relapsed/refractory EBV-positive lymphoma expected to begin in 1H2021, and a Phase 1b/2 trial in EBV-positive solid tumors in 2021. The combined, publicly traded company will focus on the advancement and expansion of Viracta's clinical stage pipeline, including Viracta's lead program for the treatment of Epstein-Barr virus (EBV)-positive lymphoma. Immediately prior to the closing of the merger, Viracta also closed the previously announced $65 million private placement of its common stock. On February 24, 2021, and in connection with the closing of the merger, Sunesis effected a 1-for-3.5 reverse stock split . All issued and outstanding shares of common stock of Sunesis were subject to the reverse stock split. Viracta has approximately 37.0 million shares of common stock outstanding , with pre-merger Viracta shareholders collectively owning approximately 86.05% of the combined company and pre-merger Sunesis shareholders collectively owning approximately 13.95% of the combined company. finance.yahoo.com
NASDAQ:VIRX
by AlenCiken
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ASLAN Pharmaceuticals Announces $18 Million Private PlacementASLAN Pharmaceuticals Announces $18 Million Private Placement ASLAN today announced that it has entered into a securities purchase agreement to raise gross proceeds of approximately $18 million resulting from the sale of its ordinary shares through a private placement to new institutional investors, Vivo Capital and Surveyor Capital (a Citadel company). the Company will issue an aggregate of 25,568,180 ordinary shares (equivalent to 5,113,636 American Depositary Shares (“ADSs”)) at an equivalent price of $3.52 per ADS, equal to the last closing price of the Company’s ADSs. The Company intends to use the net proceeds from the private placement primarily to advance clinical development of ASLAN004, as well as for general corporate purposes. “These additional resources position us well as we look forward to unblinding the interim data from our ongoing study of ASLAN004 in atopic dermatitis in early March and look towards initiating our phase 2b program later in 2021.” finance.yahoo.com
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by AlenCiken
$ONCY initiated with a Buy at H.C. Wainwright -302.14% potentialOncolytics initiated with a Buy at H.C. Wainwright H.C. Wainwright analyst Patrick Trucchio initiated coverage of Oncolytics Biotech with a Buy rating and $15 price target. The company is "on the cusp of demonstrating potential to upend the treatment paradigms of several cancers," Trucchio tells investors in a research note. He believes Oncolytics is well positioned for the "oncolytic virus trend." The price target was set to $ 15.00. At a current price of $ 3.73 there is upside potential of 302.14%.
NASDAQ:ONCY
by AlenCiken
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$SNSS Definitive Merger Agreement CASE STUDYSunesis Pharmaceuticals and Viracta Therapeutics Announce Definitive Merger Agreement Merger to create Nasdaq-listed company focused on developing Viracta’s precision oncology pipeline targeting virus-associated malignancies Leading institutional investors committed a total of $105 million in private financings with Viracta Combined company expected to have approximately $120 million cash balance following the close of the merger intends to be listed on the Nasdaq Global Market under the ticker symbol “VIRX.” Viracta plans to initiate a registration trial for the treatment of EBV-positive lymphoma in the first half of 2021, and also plans to initiate a Phase 1b/2 trial in EBV-positive solid tumors in 2021. The transaction is expected to close in the first quarter of 2021. finance.yahoo.com
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by AlenCiken
$SLDB FDA Lifts Clinical Hold case studySolid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions. “We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.” finance.yahoo.com
NASDAQ:SLDB
by AlenCiken
$CLSN received Fast Track designation from the FDA$CLSN today announced that it has received Fast Track designation from the U.S. FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase II development for the treatment of advanced ovarian cancer. Fast Track designation is intended to facilitate the development and expedite the regulatory review of drugs to treat serious conditions and fill an unmet medical need. Presuming the encouraging data we are generating in early clinical studies continues, this designation supports an expedited path to market,” said Michael H. Tardugno Fast Track allows for more frequent communication with the FDA to discuss development plans and clinical trial design. finance.yahoo.com
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by AlenCiken
This penny stock $OBSV could skyrocket 100% in 2021The company’s lead drug candidate, linzagolix (branded as Yselty), is an orally administered GnRH receptor antagonist that has completed two Phase 3 studies, PRIMROSE 1 in the US and PRIMROSE 2 in both the US and Europe. The clinical trials enrolled 574 and 535 patients, respectively, and used doses of 100mg or 200mg to treat heavy menstrual bleeding associated with uterine fibroids. The results from both studies were positive, supporting Linzagolix's favorable safety and efficacy profile. In an update announced last month, ObsEva reported that, pursuant to Phase 3 results, the European Medicines Agency (EMA) had validated for review the company's Marketing Authorization Application (MAA) for Yselty (100mg and 200mg). Potential MAA approval is anticipated in Q4:21. The drug is also slated to be the subject of a New Drug Application (NDA) that is due to be submitted to the FDA in Q2. Wedbush analyst Liana Moussatos said that Linzagolix has the potential to achieve best-in class oral GnRH receptor antagonist status based on a flexible dosing regimen either with or without the add-back hormone therapy (ABT)—a key differentiator from other GnRH receptor antagonists… Based on the positive PRIMROSE 1 and PRIMROSE 2 primary endpoint results for YSELTY®/UF and additional follow-up data, we project annual sales of more than $750 million in 2027 for Linzagolix/UF,” Moussatos opined. To this end, Moussatos rates OBSV a Buy along with a $28 price target. finance.yahoo.com
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by AlenCiken
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$EOLS skyrocketed after end of Intellectual Property LitigationAbbVie, Evolus, and Medytox Announce Resolution of Intellectual Property Litigation AbbVie (NYSE: ABBV), Evolus (NASDAQ: EOLS) and Medytox announce settlement agreements to fully resolve all outstanding litigation, including the United States International Trade Commission (ITC) case regarding the sale of Jeuveau®, between the companies. A California court case filed by Medytox against Evolus will be dismissed. Under the terms of the settlement agreements, AbbVie and Medytox will release all claims against Evolus related to the alleged misappropriation of Medytox's trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States and Nuceiva™ in all other territories in which Evolus has licensing rights. AbbVie and Medytox will receive milestone and royalty payments from Evolus. In addition, Evolus will issue common stock to Medytox. finance.yahoo.com
NASDAQ:EOLS
by AlenCiken
Jefferies $PRTA buy recommendation with price target of $6Why VistaGen Therapeutics Stock Soared yesterday The big jump came after Jefferies analyst Andrew Tsai initiated coverage on the stock with a buy recommendation. Tsai also set a one-year price target of $6, nearly three times the price of VistaGen's shares at the market close on Wednesday. Why bullish? Tsai really likes the potential for VistaGen's lead pipeline candidate PH94B . It's a nasal spray that VistaGen is evaluating in phase 2 studies targeting multiple neurological disorders. The company has already reported positive data from one of those studies, with PH94B showing promise in treating acute social anxiety disorder . There are still plenty of risks for PH94B and VistaGen's two other pipeline candidates. www.fool.com
NASDAQ:VTGN
by AlenCiken
$ONTX Closing of $28.75 Million Public Offering of Common StockOnconova Therapeutics to Present Corporate Update at the 2021 BIO CEO & Investor Digital Conference-February 16-18, 2021 finance.yahoo.com Onconova Therapeutics, Inc. Announces Closing of $28.75 Million Public Offering of Common Stock Including Full Exercise of the Over-Allotment Option. A total of 28,750,000 shares of its common stock were sold, including 3,750,000 shares of common stock following the exercise by the underwriters of their over-allotment option, at a public offering price of $1.00 per share. finance.yahoo.com
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by AlenCiken
$NVCN Regains Compliance with Nasdaq Minimum Bid Price RuleNeovasc Regains Compliance with Nasdaq Minimum Bid Price Rule Currently, the Company is still not in compliance with the minimum market value requirement set forth in Nasdaq Rules for continued listing on the Nasdaq. Nasdaq Listing Rule 5550(b)(2) requires companies to maintain a minimum market value of US$35 million; the Company has until June 8, 2021 to regain such compliance. The Company is also listed on the Toronto Stock Exchange and regaining compliance on the Nasdaq does not affect the Company’s compliance status with such listing. finance.yahoo.com
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by AlenCiken
Topline data from the open-label, Phase 1b clinical trialDiffusion Pharmaceuticals Increases Previously Announced Bought Deal Offering of Common Stock to $30 Million, due to demand announced today that, due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 29,268,294 shares of common stock of the Company at a price to the public of $1.025 per share, less underwriting discounts and commissions. finance.yahoo.com Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients No Dose Limiting Toxicities or Serious Adverse Events Observed in Dosing Regimen Previously Untested in Clinical Trial Setting. completion and topline data from the open-label, Phase 1b clinical trial of its novel. finance.yahoo.com
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by AlenCiken
Jefferies upgraded $PRTA to buy from neutral-100% upside1. Jefferies upgraded the stock to buy from neutral expecting a 100% upside to the stock. Citing the ‘positive momentum and pipeline execution’ and rising investor attention, the analyst Michael Yee ups the price target to $30 from $15, nearly double its previous close. Prothena’s pipeline has significantly expanded and improved. The company’s early-stage candidates for Alzheimer’s disease ‘should start to garner more attention,’ Yee argues, projecting the three mid-to-late-stage assets to yield ‘a significant upside.’ Add more than $300M in cash and the partnerships with Bristol Myers and Roche, the stock ‘is primed to move up 100% towards $30+,’ concluded the analyst. Out of Prothena's two candidates, PRX012 and multi-immunogen vaccine, targeting the Alzheimer’s disease, the former is on track for an IND filing in Q1 2022, the company disclosed in the recent R & D update. ------------------------------------------------------------------------------------------------------------------------------------------------- 2. BTIG Research upgraded $PRTA from neutral to buy with price target $29. seekingalpha.com
NASDAQ:PRTA
by AlenCiken
2
$ARTL surged 92% on buy rating from Ladenburg analystArtelo Biosciences surged 92% on buy initiation from Ladenburg Shares of $ARTL Artelo Biosciences surged on friday after Ladenburg analyst Michael Higgins initiated the company with a buy rating. They give the biopharma a $7 price target. It also represents a potential 329% upside over the stock’s closing price on Thursday. Ladenburg analyst cites Artelo's focus on candidates targeting the endocannabinoid system. Artelo Biosciences is a biopharma company focused on developing treatments that improve patients’ lives. That includes developing new therapies. The company’s pipeline includes ART27.13, which is designed to treat cancer patients suffering from anorexia. This treatment is currently undergoing a Phase 1 clinical trial. seekingalpha.com investorplace.com
NASDAQ:ARTL
by AlenCiken
Why $ANCN Anchiano Therapeutics Is Surging Today?Why $ANCN Anchiano Therapeutics Is Surging Today? Thanks to some news in December in the biopharma space, $ANCN stock is racing higher. So what was that news? And what else do you need to know? $ANCN Anchiano Therapeutics is captivating investors thanks to its Definitive Merger Agreement with Chemomab news in december. The proposed merger will create a public company focused on advancing Chemomab’s lead product, CM-101, a first in class anti-CCL24 antibody into advanced clinical development for fibrosis-related diseases with significant unmet medical need Concurrent PIPE financing to be used to fund clinical trials for CM-101 in fibrotic indications, focusing on two rare diseases and backed by leading healthcare-focused investors OrbiMed and Peter Thiel. Concurrent with the merger, Chemomab seeks to complete a PIPE financing to advance CM-101 into Phase 2 clinical trials in rare fibrotic indications, as well as to further develop Chemomab’s earlier-stage pipeline. We intend to hold a special meeting of Anchiano’s shareholders in the first quarter of 2021 to vote on this merger." finance.yahoo.com
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by AlenCiken