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Tag: Regulus Therapeutics

  • Regulus Therapeutics (RGLS) Stock Gains Momentum In Pre-Hour Trades

    Regulus Therapeutics (RGLS) Stock Gains Momentum In Pre-Hour Trades

    Following the announcement of a merger agreement with Novartis AG, shares of Regulus Therapeutics Inc. (NASDAQ: RGLS) are on a notable 131.45% pre-market surge, trading at $7.80 as of the last check.

    Key Financial Data and the Merger’s Terms

    Novartis will acquire Regulus Therapeutics for $7.00 per share, or around $800 million, in cash. This offer is 274% higher than the company’s 60-day volume-weighted average stock price and 108% higher than RGLS’ closing price on April 29, 2025. Regulus Therapeutics shareholders will also get a contingent value right (CVR) of an additional $7.00 per share in addition to the upfront payment.

    This CVR is due when farabursen, RGLS’ primary experimental treatment for autosomal dominant polycystic kidney disease (ADPKD), receives regulatory clearance. The predicted total transaction value might exceed $1.7 billion if the milestone is met.

    Potential for Therapy and Strategic Rationale

    The merger has been unanimously authorized by the boards of directors of both companies. Through this strategic acquisition, Novartis seeks to accelerate the development and potential commercialization of farabursen, a first-in-class pharmaceutical candidate designed to treat ADPKD, a significant genetic cause of renal failure worldwide.

    Enhancing the Treatment Environment for ADPKD

    There are currently few available treatments for ADPKD. In comparison to current standards of treatment, farabursen is anticipated to improve patient outcomes because of its promising effectiveness, safety, and tolerability profile.

    Significant progress has been made by Regulus in promoting this candidate, and Novartis’ strong worldwide infrastructure positions it to expand its growth and market reach after receiving regulatory clearance.

    Timeline of Transactions and Prospects

    Subject to usual closing circumstances, such as the offer of the majority of Regulus Therapeutics’ outstanding shares and regulatory clearances, the purchase is anticipated to conclude in the second half of 2025. RGLS will continue to function on its own until the deal is completed.

  • Regulus (RGLS) Stock Skyrockets: Unveiling The Catalysts

    Regulus (RGLS) Stock Skyrockets: Unveiling The Catalysts

    The stock value of Regulus Therapeutics Inc. (NASDAQ: RGLS) has increased significantly, rising by 116.67% to $2.99 per share during the current trading session. This remarkable ascent coincides with the publication of encouraging clinical trial results and a calculated equity move.

    A final shares purchase agreement for a private placement with a limited group of accredited and institutional investors has been made public by the firm. Both new and old institutional investors, including well-known names like Deep Track Capital, Adage Capital Partners L.P., and New Enterprise Associates (NEA), have participated in the oversubscribed funding round.

    Regulus expects gross proceeds of around $100 million at completion, which is anticipated around March 14, 2024, subject to usual closing conditions. Alongside this financial advancement, Regulus has released encouraging topline data from the second patient cohort in their Phase 1b MAD research using RGLS8429, a medication used to treat autosomal dominant polycystic kidney disease (ADPKD).

    In order to evaluate RGLS8429’s safety, tolerability, and pharmacokinetics /pharmacodynamics at different dose levels, this research looks at a number of indicators, including total kidney volume, cyst architecture, urinary polycystins 1 and 2 (PC1 and PC2), and overall kidney function. The results from this group show enhanced activity of RGLS8429, and significant kidney volume decreases correlated with elevated PC1 and PC2 levels, indicating possible effectiveness.

    Based on these positive outcomes, RGLS intends to modify the trial procedure to include up to 30 patients. Furthermore, Regulus has initiated discussions with the FDA regarding an accelerated approval pathway for RGLS8429, following a constructive Type D meeting. This means that the drug’s promise has been acknowledged by the regulatory agency, and it allows for an accelerated approval process based on a single Phase 2 trial.

    Healthcare practitioners that treat patients with ADPKD must prioritize the development of innovative treatments. The encouraging results of Regulus’ clinical studies provide optimism for better treatment choices in the road. Awaiting more developments in the battle against ADPKD, stakeholders are excited about the company’s research and regulatory talks.

  • New Developments Related to RGLS8429: Regulus Therapeutics Inc. (RGLS) Soars High After Hours

    On January 20, Regulus Therapeutics Inc. (RGLS) announced the successful completion of the pre-IND meeting for RGLS8429 with the FDA. Consequently, the stock advanced further in the after hours.

    During the regular session, the stock fluctuated between $0.2500 and $0.2421 at 1.27 million shares. RGLS closed the session with a mild gain of 2.04% at $0.2449. Following the announcement, the stock added a further 6.12% at $0.2599 in the after-hours session.

    The clinical-stage biopharmaceutical company, Regulus Therapeutics Inc. has a market capitalization of $35.03 million. Currently, the company has 145.97 million shares outstanding in the market.

    RGLS’ Pre-IND Meeting

    As per the announcement, the pre-IND meeting with the FDA regarding RGLS8429 as a potential treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). The reason for the meeting was the FDA’s input on the pre-clinical, clinical, and regulatory matters of RGLS’ next-generation compound. Earlier this week, the company had received the formal minutes from the meeting.

    Moreover, the meeting resulted in the FDA’s agreement with an overall agreement with the Phase 1 trial design of RGLS8429 along with its length and the proposed starting dose. Therefore, the company is on track for the submission of the IND application in Q2 of 2022 for clearance of Phase 1 trial commencement.

    Phase 1 Clinical Trial of RGLS8429

    The phase 1 clinical study of the product will have two parts:

    Part 1

    Part 1 will be a single-ascending dose (SAD) study for evaluating safety and tolerability for pharmacokinetics characterization in healthy volunteers. Further, 32 volunteers will be randomized to RGLS8429 or placebo in the part one cohort.

    Part 2

    Part 2 will be a multiple-ascending dose (MAD) study in ADPKD adult patients. Furthermore, it will evaluate the safety and tolerability of the product for pharmacokinetics characterization and the dose-response. 36 patients will be randomized in the cohorts of this part.

    In addition, the updated clinical plans encompass extending dosing to three months in each cohort of ADPKD patients.

    RGLS Financial Analysis

    On November 10, the company declared its financial results for the third quarter of 2021.

    In the third quarter of 2021, RGLS incurred a net loss of $8.6 million, against $1.5 million in the year-ago period. Resultantly, the net loss per basic and diluted share was $0.10 in Q3 of 2021 and $0.04 in Q3 of 2020.

    Additionally, the company ended the quarter with cash and cash equivalents of $35.8 million.

  • Early Morning Vibes: 3 Best Performing Stocks Under

    Early Morning Vibes: 3 Best Performing Stocks Under $3

    On December 8, American stock exchanges closed at historic highs. The S&P 500 Index climbed 0.28% to 3702 points, the Dow Jones added 0.35%, the NASDAQ rose 0.5%. The purchases spurred hope for fiscal stimulus, as well as the start of the UK vaccine distribution. The health and energy sectors were the top gains, rising 0.73% and 1.57%, respectively. The real estate segment turned out to be an outsider, losing 0.5%.

    Corporate news

    Tesla (TSLA: + 1.3%) announced a $ 5 billion additional share issue.

    Productivity software maker Smartsheet (SMAR: + 11%) reported strong quarterly results and improved management forecasts.

    Apparel retailer Stitch Fix (SFIX: + 39%) posted a good quarterly report, with a pleasant surprise for investors the company’s profit at a consensus loss.

    Today, world stock markets are showing mostly positive dynamics. The likelihood of accepting an economic aid package is increasing. The day before, Treasury Secretary Stephen Mnuchin presented House Speaker Nancy Pelosi a $ 916 billion economic support bill. Unlike the bipartisan stimulus package last week, the bill provides for a one-time payment of $ 600 to each citizen instead of $ 300 weekly in addition to the unemployment. Republican leaders have already expressed support for Mnuchin’s bill. We believe that the congressmen have not yet been so close to a compromise in the past few months, and this is encouraging.

    Another supportive factor was a report released by the FDA that the Pfizer / BioNTech anticancer vaccine is completely safe and highly effective. The probability of its approval on December 10 is close to 100%, and on the 11th, the distribution of the drug in the United States may begin. We estimate the risk that the pharmaceutical giant will face difficulties in mass production of the vaccine as minimal, although not zero.

    Today Top Movers Under $3

    Cinedigm Corp (CIDM) is up 50.35% at $1.30 in early morning on Wednesday after

    Spherex revealed a strategic alliance with Cinedigm (NASDAQ: CIDM) to drive Cinedigm’s global growth.

    Usio Inc (USIO) is up 38.80% in Wednesday’s premarket session after reporting that it has entered into a non-binding Letter of Intent (LOI) to acquire the assets of Information Management Solutions, LLC (IMS).

    Recon Technology Ltd (RCON) was taking the aerial route in the after-market session as it surged 95.8% to $2.82, after a China-based independent solutions integrator in the oilfield service and environmental protection, electric power, and coal chemical industries, today announced its financial results for the fiscal year 2020.

    Top Upgrades & Downgrades

    JP Morgan turned bullish on Array Technologies Inc. (ARRY), upgrading the stock to “Overweight” and assigning a $41.0 price target.

    Community Trust Bancorp Inc. (CTBI) has won the favor of Piper Sandler’s equity research team. The firm upgraded the shares from Neutral to Overweight.

    Earlier Wednesday JP Morgan reduced its rating on Bloom Energy Corporation (BE) stock to Neutral from Overweight and assigned the price target to $26.0. With shares trading at around $30.59, the Wall Street firm thinks Bloom Energy Corporation’s stock could decline more than -62.5%.

    DZ Bank analysts reduced their investment ratings, saying in research reports covered by the media that its rating for American Express Company (AXP) has been changed to Hold from Buy and the new price target is set at $128.0.

    Analysts at KeyBanc downgraded Talos Energy Inc. (TALO)‘s stock to Sector Weight from Overweight Wednesday.

    Latest Insider Activity

    Freeport-McMoRan Inc. (FCX) Vice Chairman, President & CEO ADKERSON RICHARD C announced the sale of shares taking place on Dec 04 at $25.17 for some 467,887 shares. The total came to more than $11.78 million.

    Discovery Inc. (DISCA) Director LOWE KENNETH W sold on Dec 04 a total 1,202,403 shares at $25.22 on average. The insider’s sale generated proceeds of almost $2.32 million.

    Regulus Therapeutics Inc. (RGLS) 10% Owner Sonsini Peter W. declared the purchase of shares taking place on Dec 04 at $0.62 for some 4,398,602 shares. The transaction amount was around $2.74 million.

    Hepion Pharmaceuticals Inc. (HEPA) CEO and Director Foster Robert T bought on Dec 08 a total 25,259 shares at $1.58 on average. The purchase cost the insider an estimated $39,418.

    Earnings To Watch Today

    Top US earnings releases scheduled for today include Asana Inc. (NYSE:ASAN). It will announce its Oct 2020 financial results. The company is expected to report earnings of -$0.37 per share from revenues of $54.14M in the three-month period.

    Analysts expect Mesa Air Group Inc. (NASDAQ:MESA) to report a net income (adjusted) of -$0.02 per share, when the bank releases its quarterly results shortly. Revenue for the fiscal quarter ended Sep 2020 is predicted to come in at $92.95M.

    Adobe Inc. (ADBE), due to announce earnings after the market closes today, is expected to report earnings of $2.66 per share from revenues of $3.36B recently concluded three-month period.

  • 15 Trending Stocks in Biotechnology Industry

    15 Trending Stocks in Biotechnology Industry

    This year, biotech companies on the stock exchange have skyrocketed. This is no surprise since biotech firms are the leaders in the battle against the coronavirus pandemic. Even with Pfizer’s first vaccine in the UK, investors and pharmaceutical companies are well aware that the race is far ahead.
    Other diseases should not be ignored apart from coronavirus vaccines. The biotech sector is also creating headlines and innovating in areas linked to dementia, cancer, hereditary disorders, etc. Given the above, buyers are probably faced with the difficulty of choosing the best ones to purchase.

    Curis Inc. (NASDAQ:CRIS) shares were trading up 354.86% at $6.55 at the time of writing on Tuesday following announcement of proposed public offering of common stock.

    Curis Inc. (NASDAQ:CRIS) share price went from a low point around $0.62 to briefly over $3.59 in past 52 weeks, though shares have since pulled back to $6.55. CRIS market cap has remained high, hitting $409.70M at the time of writing, giving it price-to-sales ratio of more than 30.

    If we look at the recent analyst rating CRIS, Laidlaw initiated coverage on CRISshares with a Buy rating.

    Lexicon Pharmaceuticals Inc. (LXRX) last closed at $3.08, in a 52-week range of $1.03 to $5.33. Analysts have a consensus price target of $2.37. On November 17, 2020, the firmreported that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    IGM Biosciences Inc. (IGMS) stock soar by 57.75% to $115.03 after declaringpricing of upsized $200 million public offering. The most recent rating by Robert W. Baird, on July 17, 2020, is at an Outperform.

    Infinity Pharmaceuticals Inc. (NASDAQ:INFI) Shares headed rising, higher as much as 29.44%. The company will hold a conference call on Wednesday, December 9, 2020 at 10:00 a.m. ET to discuss clinical data from ongoing studies evaluating eganelisib in triple negative breast cancer (TNBC) The most recent rating by Oppenheimer, on June 27, 2019, is at an Outperform.

    Oncternal Therapeutics Inc. (NASDAQ:ONCT) rose 27.64% after gaining more than $1.1 on Tuesday after reporting updated interim clinical data from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial.

    Proteostasis Therapeutics Inc. (PTI) last closed at $1.23, in a 52-week range of $0.87 to $4.72. The firm reported on November 16, 2020. a net loss of approximately $8.2 million for the three months ended September 30, 2020, as compared to a net loss of $12.8 million for the same period in the prior year.

    InflaRx N.V. (IFRX) stock soar by 18.27% to $4.79. The most recent rating by SVB Leerink, on November 06, 2020, is at an Outperform.

    Syros Pharmaceuticals Inc. (NASDAQ:SYRS) Shares headed rising, higher as much as 17.47% after closing $90.5 million strategic financing. The most recent rating by H.C. Wainwright, on November 04, 2020, is at a Buy.

    Aerpio Pharmaceuticals Inc. (NASDAQ:ARPO) rose 16.28% after gaining more than $0.28 on Tuesday.

    Ampio Pharmaceuticals Inc. (AMPE) last closed at $1.35, in a 52-week range of $0.31 to $1.39. The firm recently revealed that it will conduct its annual meeting in a virtual format only on December 12, 2020 at 9:00 am MST.

    Regulus Therapeutics Inc. (RGLS)stock soar by 15.19% to $0.93 following the closing of $19.4 million private placement of equity. The most recent rating by B. Riley FBR Inc., on March 28, 2018, is at a Neutral.

    Cancer Genetics Inc. (NASDAQ:CGIX) Shares headed rising, higher as much as 14.79%. The most recent rating by Maxim Group, on December 07, 2017, is at a Buy.

    Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) fall -11.85% after losing more than -$1.85 on Tuesday. The healthcare firm lately declared pricing of $70 million public offering of common stock, which is expected to close on or about December 10, 2020.

    iBio Inc. (IBIO) last closed at $1.31, in a 52-week range of $0.19 to $7.45 after declaring pricing of $35 million public offering of common stock. Analysts have a consensus price target of $2.00.

    Vaccinex Inc. (VCNX) stock soar by 14.08% to $2.35. The most recent rating by BTIG Research, on September 23, 2020, is at a Neutral.