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Tag: CTIC

  • CTI BioPharma Corp (CTIC) stock is soaring in the pre-market. Here’s the reason

    The stock of CTI BioPharma Corp (CTIC) closed the regular trading session at $3.95, gaining 17.21% from the previous day’s trading session. On the last check, the stock of CTIC remained bullish in the pre-market and gained 3.04% to $4.07. The firm provided an update about the approval of VONJO by the FDA. The company also filed form 8-K with the SEC on 2 March 2022.

    News

    On 28 February 2022, CTIC provided an update for the compliance of VONJO by the FDA. VONJO is a medicine that is used in the therapy of myelofibrosis and thrombocytopenia in adults. The firm made an announcement that the FDA has accepted the VONJA to treat the victim with a low count of platelets. The suggested dose of VONJO is 200 mg by mouth, two times a day. VONJO is the initial therapy that explicitly orates the necessities of victims with myelofibrosis. The sped-up endorsement depends on the adequacy outcome from the critical Phase 3 investigation of VONJO in victims with myelofibrosis. The common side effects include nausea, and diarrhea, while the serious side effects include heart failure and pneumonia.

    The CEO of CTI BioPharma (CTIC), Adam R. Craig, stated that in the U.S., there are around 21,000 patients with myelofibrosis, 66% of which have cytopenia’s. He further added that we anticipate giving VONJO for cytopenic myelofibrosis treatment to the patients in 10 days. Moreover, Mr. Craig concluded that he is grateful to the CTI group for the persistent efforts, dedication, and emphasis on the requirements of victims.

    About CTIC

    CTI BioPharma Corp is a biopharmaceutical organization, which centers around the production, possession, and advertisation of novel designated treatments for blood cancers. Also, the firm has a market cap of $381.93 million with 96.69 million shares pending. CTIC has its base in Seattle, Washington, United States of America (USA).

  • CTI BioPharma Corp. (CTIC) Stock Rebounds Premarket Following FDA Accelerated Approval.

    CTI BioPharma Corp. (CTIC) a commercial-stage biotherapeutics company engaged in the purchase, manufacture, and marketing of innovative targeted therapeutics for blood cancer. The company’s one of the FDA-approved product is VONJO or pacritinib, used in treating intermediate or high-risk primary or secondary myelofibrosis. The company is also conducting Phase 3 PACIFICA trials for VONJO in patients with severe thrombocytopenia.

    The price of CTIC stock during the regular trading on February 28, 2022, was $1.9 with a decrease of 19.8%. At last check in the premarket on March 1, 2022, the stock rocketed by 53.68%.

    CTIC: Events and Happenings

    On February 28, 2022, CTIC reported the approval of VONJO by the FDA for treating myelofibrosis. It is the primary approved therapy that precisely addresses the requirements of patients with this condition. On February 18, 2022, CTIC updated that its Board of Directors had granted an equity inducement award to the company’s employees. The award was approved on February 16, following the Nasdaq Listing Rules.

    On December 13, 2021, CTIC announced its lead candidate’s poster presentations at the Virtual Annual Meeting & Exposition of 63rd American Society of Hematology held on December 11-14, 2021. On December 2, 2021, CTIC updated its management’s presentation at the Virtual JMP Securities Hematology & Oncology Summit on December 6, 2021.

    CTIC: Key Financials

    On July 29, 2021, CTIC released its financial statement for the second fiscal quarter of 2021 ended June 30, 2021. Some of the key features are discussed below.

    Revenue

    No revenue was recorded in Q2 2021 and the same quarter of 2020.

    EPS

    Basic and diluted net loss in Q2 2021 was $19.6 million or $0.21 per share compared to $14 million or $0.19 per share for the same quarter in 2020. The company observed an increase in its net loss over the year.

    Conclusion

    CTIC stock is at a new low for the past six months as it dipped by 42% due to the pandemic. The recent premarket stock leap is the result of the groundbreaking approval of its lead candidate by the FDA. The company is gearing for its earnings release date and expecting an EPS of -$0.30.

  • CTI BioPharma Corp. (CTIC) Stock Trends Higher Following Progress in Commercialization of Pacritinib

    CTI BioPharma Corp. (CTIC) stock prices stayed stable over the course of the trading day on June 25th, 2021. After-hours trading saw the stock climb by 6.84%, bringing it up to USD$2.50.

    Pacritinib Progress

    The company recently announced progress in their goal of providing pacritinib to myelofibrosis patients with thrombocytopenia, with current treatments leaving a large unaddressed need. The U.S Food and Drug Administration set a PDUFA action date of November 30th, 2021, following the acceptance of an NDA for the innovative drug.

    Ready for Commercialization

    Pushing for the commercialization and proliferation of their treatment, CTIC forecasts launching the drug in the US later in fiscal 2021. The most recent quarter has seen the ramping up of essential pre-commercial activities to facilitate a successful launch. These activities include, but are not limited to, coordinating market access, distribution, and supply chain, disease education, and force field planning and deployment.

    Operating and Net Loss Reports

    Operating loss for the first quarter of the fiscal year 2021 came out to USD$17.1 million, up from the USD$11.9 million reported for the three-month period ended March 31st, 2020. This difference is largely attributable to increases in research and development costs, as well as expenses from general and administrative activities associated with the build to the commercial launch of pacritinib.Net loss for the quarter came out to USD$17.3 million, representing a net loss of USD$0.23 per basic and diluted share. This is up from the USD$12.2 million reported in the prior-year quarter, which represented a net loss of USD$0.20 per basic and diluted share.

    Solid Liquidity Position

    The company reported a solid liquidity position as of March 31st, 2021, with cash, cash equivalents, and short-term investments coming out to USD$37.2 million. Despite being lower than the USD$52.5 million reported as of December 31st, 2021, the company forecasts being set to see its operations through to the fourth quarter of 2021. Significant contributions to this momentum was the equity financing that culminated on April 6th, 2021, generating net proceeds of USD$53.8 million.

    Future Outlook for CTIC

    Armed with a solid liquidity position, CTIC is poised to continue its trajectory of success. The company is keen to continue pushing for the eventual commercialization and proliferation of pacritinib. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • 3 Biotech Stocks Going Parabolic Today and With Potential for More Gains

    3 Biotech Stocks Going Parabolic Today and With Potential for More Gains

    The markets are up to slow day as investors continue to digest yesterday’s presidential debate.  The marker is still unsure of who is likely to win the election and this is likely to keep markets volatile in coming weeks.  The uncertainty comes not just from the polarized nature of the upcoming election, but also the fact that the policies of the two contenders are very different and could have a direct effect on the markets.

    There is also the fact that the markets still need a stimulus package and so far none has been agreed upon. Democrats have already advanced a $2.2 trillion stimulus package, but there are no guarantees that it will be agreed upon. The COVID-19 pandemic also continues to be a major risk to the economy. Recently, COVID-19 death numbers hit one million and until a vaccine is found, the economy will remain vulnerable.

    So vulnerable is the economy that oil prices have dropped as a reflection of declining demand in the economy. Despite the overall market weakness, biotech stocks have been performing quite well. This is largely due to the excitement that comes with positive biotech news. Some of the biotech stocks that have been gaining since pre-market and could keep gaining all through the day are as below:

    CTI Biopharma Corp [NASDAQ: CTIC]

    CTI Biopharma Corp gained by over 100% pre-market and doesn’t seem to be easing up. This follows the company’s announcement that would it had submitted an NDA requesting for accelerated approval for its treatment for people suffering from severe thrombocytopenia called pactrinib.  According to CEO Adam R. Craig, the company has been working closely with the FDA since it completed phase 2 dosing of this trial treatment in a bid to fast track the approval of this treatment of severe thrombocytopenia an unmet need that has very few treatment options. He added that the company’s treatment had so far shown the potential to become a new treatment.

    Iterum Therapeutics PLC [NASDAQ: ITRM]

    Iterum Therapeutics PLC is another stock that is gaining momentum and was up by over 100% pre-market.  Its upside momentum comes after the company announced that it had a positive pre-NDA meeting with the FDA for its treatment for uncomplicated urinary tract infections called Sulopenem. The company is targeting 6 million people with UUTI in the U.S.

    BioHiTech Global Inc [NASDAQ: BHTG]

    This stock is another top performer this morning and is gaining upside momentum. This comes after the company provided its first disinfectant system targeting the cruise industry. It’s exciting because it opens a new revenue stream for the company.