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Tag: Oncternal Therapeutics

  • Agreement with U.S. FDA: Oncternal Therapeutics Inc. (ONCT) Bullish After Hours

    Oncternal Therapeutics Inc. (ONCT) stock became bullish in the after-hours on news of its agreement with the FDA. On January 04, the company announced an agreement with the FDA on Phase 3 Registrational Study Design for Zilovertamab.

    In regular trading, the stock had a bearish momentum as it lost 3.70% at its closing price of $2.34. Following the announcement, ONCT rallied after hours to gain 8.97% at a heavy after-hours volume of 4.85 million shares. Consequently, the stock was trading at $2.55 per share in the after hours.

    Currently, the novel oncology therapies developer has a market capitalization of $120.11 million. Further, the company has 49.43 million shares outstanding in the market.

    ONCT’s Agreement with FDA

    As per Tuesday’s announcement, the company and FDA agreed on the key elements of its Phase 3 clinical study of zilovertamab. Moreover, the key design features, operational details, and statistical analysis plan was also reviewed and agreed upon. These details were a result of a successful End-of-Phase 2 meeting with the U.S. FDA. Currently, the statistical analysis plan is being finalized as per the FDA’s suggestions.

    Zilovertamab is ONCT’s investigational therapy for the treatment of MCL (mantle cell lymphoma) or CLL (chronic lymphocytic leukemia).

    The Phase 3 Trial

    The Phase 3 trial (ZILO-301) is a randomized, double-blind, placebo-controlled, multi-center study of Zilovertamab (plus Ibrutinib, VS Ibrutinib) for relapsed or refractory MCL. Furthermore, the primary endpoint of the study is progression-free survival (PFS). This will support Biologic License Application submission for regular FDA approval.

    In addition, the study is planned to be conducted in at least 50 centers internationally. The study is expected to commence in the second quarter of 2022.

    Added to ZILO-301, ONCT also plans to conduct an open-label companion study of zilovertamab plus ibrutinib, ZILO-302. The ZILO-302 study will be conducted in patients having progressive disease during the initial four months of monotherapy in ZILO-301.

    Q3 Financial Results

    On November 04, the company announced its financial results for the third quarter of 2021.

    In the third quarter of 2021, the company received multiple grant awards for its various ongoing studies. Subsequently, this resulted in grant revenue of $2.1 million in Q3 of 2021.

    ONCT ended the third quarter of 2021, with cash and cash equivalents of $97.4 million on September 30, 2021. The company believes it has enough cash runway for operation into 2023.

  • Why did Oncternal Therapeutics, Inc. (ONCT) shares plunge in the post-hours trading?

    Why did Oncternal Therapeutics, Inc. (ONCT) shares plunge in the post-hours trading?

    Oncternal Therapeutics, Inc. (NASDAQ: ONCT) stock dipped -24.6% to $4.75 in the after-hours session last-night as a biotech giant confirmed that owing to interest, the underwriter has decided to raise the size of the initially scheduled bid and buy on a firm commitment basis of 16,666,667 common stock shares of the Company, at a public price of $4.50 per share. The closing of the offering is scheduled to occur on or around December 14, 2020, subject to customary closing conditions being met.

    H.C, H.C. Wainwright & Co. acts with the offering as the sole book-running manager.

    The Firm also issued a 30-day option to the underwriter to buy up to an additional 2,495,000 common stock shares at the price of the public offering, less underwriting discounts, and commissions. After deducting underwriting discounts and fees and offering costs and assuming no exercise of the underwriter’s opportunity to buy additional common stock, Oncternal’s gross receipts are estimated to be approximately $75.0 million. The organization plans to use this offering’s net proceeds for general corporate purposes, including spending on the clinical and preclinical production of cirmtuzumab and TK216, on the preclinical development ROR1 CAR-T software, and working capital.

  • 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.