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$ENTX Entera Bio Ltd Announces Positive Topline EB613 Phase 2Entera Bio Ltd Announces Positive Topline EB613 Phase 2 Biomarker Data ‒ Trial Met Primary Endpoint of Significant Increase in P1NP Based on Final Analysis of 3 Month Data ‒ Final Analysis of 6-Month Data, Including Change in Bone Mineral Density, Expected in Q2:21 ‒ The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. ‒ Similar to the increase in P1NP, a significant increase in Osteocalcin was also observed in the 2.5 mg group after 3 months (P <0.01). ‒ In line with a potential anabolic effect, a significant decrease in CTX was observed after 3 months of treatment (P <0.015). The decrease in CTX taken together with the increase in P1NP and Osteocalcin would indicate a potential positive impact on BMDand a reduced risk of fractures, which is the goal of an anabolic osteoporosis treatment. ‒ Entera intends to submit the full dataset for publication and/or presentation at an upcoming medical conference.
NASDAQ:ENTX
by AlenCiken
NLS Obtains License to Full Regulatory Data Package and know-howNLS Pharmaceutics Obtains License to Full Regulatory Data Package and Proprietary Know-How for Sanorex® (Mazindol) Agreement provides exclusive rights to all available data included in the original new drug application ("NDA") for mazindol in the U.S. $NLSP announces that it has entered into a License Agreement (the "Agreement") with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972. The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward. Under the Agreement, NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. finance.yahoo.com
NASDAQ:NLSP
by AlenCiken
Why $EYES Skyrocketed 1233% in March?$EYES Receives FDA Approval for the Argus 2s Retinal Prosthesis System $EYES today announced U.S. FDA has approved the Argus 2s Retinal Prosthesis System, a redesigned set of external hardware (glasses and video processing unit) initially for use in combination with previously implanted Argus II systems for the treatment of retinitis pigmentosa (RP). The Company expects that the Argus 2s will be adapted to be the external system for the next generation Orion Visual Cortical Prosthesis System currently under development. In addition to ergonomic improvements, the Argus 2s system offers significantly more processing power, potentially allowing for improved video processing. A decision on when or if to begin production of the newly approved hardware is pending completion of Second Sight’s planned business combination with Pixium Vision, which currently is in progress. Should the business combination be completed, the new management team will then evaluate how best to proceed with the Argus 2s Retinal Prosthesis System, as well as all other products in development. finance.yahoo.com
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by AlenCiken
Takeda Secures Global Rights from Ovid TherapeuticsTakeda Secures Global Rights from Ovid Therapeutics to Develop and Commercialize Soticlestat for the Treatment of Children and Adults with Dravet Syndrome and Lennox-Gastaut Syndrome. Ovid eligible to receive up to $856M in payments, including a $196M upfront payment, regulatory and commercial milestone payments and tiered double-digit royalties on product sales − Original 2017 collaboration between Ovid and Takeda to conclude; Ovid will have no further development or milestone obligations. In addition, Ovid will receive tiered royalties beginning in the low double-digits and up to 20 percent on sales of soticlestat, if approved and commercialized. Takeda intends to initiate Phase 3 studies of soticlestat in children and young adults with DS and LGS in calendar year Q2 2021. finance.yahoo.com
NASDAQ:OVID
by AlenCiken
$KMPH Announces FDA Approval of AZSTARYS™KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD Corium, Inc. will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement. Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S. finance.yahoo.com
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by AlenCiken
1
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
2
$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
2
$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
2
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
VERU log chart. Wedge within a megaphone and channel.This is a mighty COVID treatment play. It's a coin flip whether it will break up or down out of the blue dashed wedge, but when it does. . . there are many place it can go. Options prices remain elevated even for $10 strikes (around the lower ascending channel). All depends on the Phase III trial data and analysis. Personally, I bought 1000 shares in the February pullback before the mega rally, sold into strength, and still hold 150. I've been selling $10, $15 and $17.5 strike weekly puts and taking profits at 50% to 75%. I will take any long red candles as an opportunity to sell lower-strike puts. So my bias is long, but to sell into strength. Caveat emptor.
NASDAQ:VERULong
by decaro
BLUE has bottomedLove it or hate it, it's BLUE. Anecdotal, non-scientific evidence of a serious side effect prompted a halt of a trial of a product, and the company is investigating. No one knows anything else until the company reports. End. Of. Story. There is a strong bid today, and here you can see why. BLUE has clipped long-term support and bounced nicely off of it for it's largest intraday gain in (what seems like) a long time. My bet is that BLUE now remains in this ascending channel, which should entail some enjoyable rallies and frustrating pullbacks. You can sell $20/$25 put spreads and sleep at night, and the gamblers among you can buy calls in the upper half of the channel. Bon voyage, BLUE.
NASDAQ:BLUELong
by decaro
1
$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
1
$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
2
SDDGR: Selling Shovels During Gold RushWe are in the midst of a biotech boom. SDGR sits to profit greatly, selling cost/time saving software. They sell drug/material discovery software to biotechs and pharma companies. They also fully or jointly own some early stage/preclinical drug programs as well. Here are the investment highlights I believe are key. 1- Their physics based software makes new drug/material discovery cheaper/faster than traditional ways. This first step is the most costly/lengthy part in creating new drugs/materials. 2- They are a biotech in the respect that they are owners/co-owners of certain compounds in ongoing development/trails, giving them enormous upside. Joint ventures are as far as phase 2. 3- Strong balance sheet behind a secondary offering in August. Roughly 3.5 years worth of operating expenses in cash on the books. 4- Strong partnerships with big pharma such as Bristol-Meyers. Ongoing focus on research and development, putting 65% of revenue towards it. 5- Smart money is in on this. Bill/Melinda Gates foundation, billionaire investor David Shaw and his old life science hedge fund Deerfield along with another MP from Deerfield are all 10% owners. 6- Technically, it is also in a nice set up. It had been trading in a pretty tight channel before yesterdays' nonlogical sell off (no news). It has had a nice rebound today and I am expecting it to make a push back to that $97 resistance level. If it can break that, I think a move to the $130s is in store within the next 6 months
NASDAQ:SDGRLong
by RobertTheTrader
1
$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