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Tag: ONCT

  • 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.

  • What changed for these 31 stocks in Pre Market Session

    What changed for these 31 stocks in Pre Market Session

    Xenetic Biosciences Inc. (XBIO) stock plunged -15.46% to $2.68 in the pre-market trading following the company’s announcement of $6.0 million registered direct offering priced at-the-market under Nasdaq Rules. The most recent rating by Maxim Group, on January 08, 2020, is a Buy.
    Curis Inc. (CRIS), a Biotechnology company, dropped about -5.72% at $7.25 in pre-market trading Thursday after declaring the pricing of an underwritten public offering of 25,652,174 shares of its common stock at a public offering price of $5.75 per share for total gross proceeds of approximately $147.5 million.
    ZW Data Action Technologies Inc. (CNET) lost over -11.33% at $1.8 in pre-market trading Thursday December 10, 2020 after reporting the official opening of its first live streaming platform in Guangzhou, China.
    Genius Brands International Inc. (GNUS) is up more than 9.74% at $1.69 in pre-market hours Thursday December 10, 2020. The firm recently revealed that it will be presenting at the 13th Annual LD Micro investor conference on Tuesday, December 15th at 10:00 a.m. PST / 1:00 p.m. EST. The stock had dropped over -4.35% to $1.54 in the last trading session.
    Rocket Companies Inc. (RKT), a Mortgage Finance company, rose about 3.09% at $21.71 in pre-market trading Thursday following the release of Clear HOI platform from its subsidiary to mortgage lenders nationwide.
    Intec Pharma Ltd (NTEC) stock moved down -7.76 percent to $4.28 in the pre-market trading. Intec Pharma Announces Cannabinoid Research Collaboration with GW Pharma.
    Atossa Therapeutics Inc. (ATOS) gained over 2.31% at $0.8919 in pre-market trading Thursday December 10, 2020 after revealing cannabinoid research collaboration with GW Pharma.
    Nano Dimension Ltd. (NNDM) is up more than 2.25% at $6.82 in pre-market hours Thursday December 10, 2020 following the declaration from the company that it has closed the registered direct offering of 30,000,000 of the Company’s American Depositary Shares at a price of $6.00 per ADS. The stock had dropped over -6.06% to $6.67 in the last trading session.
    Before the trading started on December 10, 2020, Sorrento Therapeutics Inc. (SRNE) is down -2.44% to reach $8.01 following the FDA acceptance of its Investigational New Drug (IND) application for its Phase 1 clinical trials for intravenous (IV) STI-2020 (COVI-AMG). It has been trading in a 52-week range of $1.55 to $19.39.
    Genetic Technologies Limited (GENE) stock plunged -9.17% to $4.06 in the pre-market trading.
    Greenwich LifeSciences Inc. (GLSI) grew over 46.76% at $83.8 in pre-market trading today after reporting the publication of a poster for the GP2 Phase IIb clinical trial final efficacy analysis at the San Antonio Breast Cancer Symposium in a virtual format.
    Lipocine Inc. (LPCN), a Biotechnology company, dropped about -5.3% at $1.25 in pre-market trading Thursday after announcing that the U.S. Food and Drug Administration has granted tentative approval to TLANDO.
    SELLAS Life Sciences Group Inc. (SLS) stock moved up 51.8 percent to $9.7 in the pre-market trading. The biotechnology firm recently revealed exclusive license agreement with 3D Medicines for development and commercialization of Galinpepimut-S (GPS) and GPS+ in Greater China.
    Francesca’s Holdings Corporation (NASDAQ: FRAN) shares are trading down -10.68% at $2.51 at the time of writing after receiving court approval of “First Day” motions to support ongoing operations. Company’s 52-week ranged between $1.70 to $19.91. Analysts have a consensus price target of $2.50.
    Oncternal Therapeutics Inc. (ONCT) tumbled over -27.78% at $4.55 in pre-market trading today after announcing that the firm increased its previously declared bought deal to $75.0 million.
    Gran Tierra Energy Inc. (GTE) is down more than -2.83% at $0.35 in pre-market hours Thursday December 10, 2020. The company recently declared a financial update and the Company’s 2021 capital budget and production guidance. The stock had dropped over -5.68% to $0.36 in the last trading session.
    Before the trading started on December 10, 2020, Fisker Inc. (FSR) is down -4.04% to reach $16.15. The firm recently confirmed that it has signed agreements with Cox Automotive U.K. (“Cox”) and Rivus Fleet Solutions for delivery, servicing, fleet management and reselling programs in the United Kingdom. It has been trading in a 52-week range of $8.70 to $23.63.
    Immutep Limited (IMMP) stock soared 89.35% to $4.09 in the pre-market trading after declaring that its Chinese partner, EOC Pharma will commence a new Phase II clinical trial in up to 152 metastatic breast cancer patients in China. The most recent rating by B. Riley FBR, on September 28, 2018, is a Buy.
    Remark Holdings Inc. (MARK), a Internet Content & Information company, rose about 3.09% at $1.67 in pre-market trading Thursday after reporting that Remark’s KanKan AI business successfully released its edge computing systems, the S and T Series Smart Boxes.
    Baidu Inc. (BIDU) gained over 2.42% at $155.26 in pre-market trading Thursday December 10, 2020. The firm recently released new intelligent vehicle solutions for automakers and several high-end intelligent driving products during the second Apollo Ecosystem Conference.
    Before the trading started on December 10, 2020, Editas Medicine Inc. (EDIT) is up 9.13% to reach $55.2 after reporting submission of IND application for EDIT-301 with the FDA. It has been trading in a 52-week range of $14.01 to $43.65.
    Artelo Biosciences Inc. (ARTL) stock plunged -2.47% to $0.66 in the pre-market trading. The healthcare firm recently declared that it has filed a composition of matter patent application directed to a new solid dosage formulation, including its method of use, with the UK Patent Office.
    AquaBounty Technologies Inc. (NASDAQ: AQB) shares are trading down -17.07% at $7.19 at the time of writing following the selection of Innovasea as the Recirculating Aquaculture Systems (“RAS”) technology provider for its planned 10,000 metric ton farm. Company’s 52-week ranged between $1.52 to $11.40. Analysts have a consensus price target of $5.
    Pluristem Therapeutics Inc. (PSTI) lost over -5.57% at $6.61 in pre-market trading Thursday December 10, 2020 after declaring DMC recommendation following interim analysis of its phase III CLI study.
    Before the trading started on December 10, 2020, Veru Inc. (VERU) is up 25.96% to reach $4.9 after reporting that it has exclusively licensed worldwide rights to enobosarm, a late-stage oral novel androgen receptor (AR) targeting agent for the treatment of endocrine resistant ER+ HER2- metastatic breast cancer. It has been trading in a 52-week range of $2.10 to $4.74.
    Uranium Energy Corp. (AMEX: UEC) shares are trading down -4.32% at $1.33 at the time of writing. Company’s 52-week ranged between $0.35 to $1.59. Analysts have a consensus price target of $1.50.
    Boxlight Corporation (BOXL), a Communication Equipment company, rose about 7.23% at $1.78 in pre-market trading Thursday. The firm recently confirmed that they are the recipients of three THE Journal’s Best New EdTech Product Awards.
    Regulus Therapeutics Inc. (RGLS) stock moved up 19.34 percent to $1.07 in the pre-market trading. The company lately announced closing of $19.4 million private placement of equity.
    Before the trading started on December 10, 2020, Sea Limited (SE) is down -3.3% to reach $196.0 after reporting that it proposes to offer 11,000,000 American Depositary Shares, each representing one Class A ordinary share of the Company, in an underwritten public offering. It has been trading in a 52-week range of $35.61 to $207.51.
    Barclays PLC (NYSE: BCS) shares are trading down -3.85% at $7.5 at the time of writing. The firm recently revealed the launch of BARX Book for Equities, a new single-dealer platform developed in partnership with Nasdaq (Nasdaq: NDAQ). Company’s 52-week ranged between $3.41 to $10.22.
    Qualigen Therapeutics Inc. (QLGN) stock moved up 13.85 percent to $4.44 in the pre-market trading. The company recently announced board member Amy Broidrick as EVP, Chief Strategy Officer and named Sidney Emery, Jr. to its board.

  • 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.

  • Stocks to Watch as Markets Price-in a Biden Presidency

    The markets are up this morning, a reflection of their adjustment to a Joe Biden presidency. This comes after a highly volatile election week that was unmarked by uncertainty as to who had won the election.

    The markets are expecting a presidency that is likely to be more moderate and pro-business. One aspect of a Joe Biden presidency that is exciting the market is the possibility of a big fiscal stimulus package, State investments in sustainability projects, and better policies in international trade. In his speech on Saturday, Biden stated that he would work towards the unity that has shown to be highly divided.

    The markets are also excited that some negative aspects of a Biden presidency such as higher taxes could be mitigated by a republican-controlled senate. Essentially, the markets expect more predictability in how business interacts with the Whitehouse. The Fed also recently announced that it would do everything possible to keep supporting the economy.

    This means that the economy could be headed for some good times ahead and the markets are responding to the same. With this expected stability and growth, stocks in industries likely to benefit the most such as biotech and cannabis stocks are doing quite well. Some of the top performers pre-market that could gain all day are as below:

    Aptevo Therapeutics Inc [NASDAQ: APVO]

    Aptevo Therapeutics Inc is making big moves in continuation of its Friday’s price action. The stock is up by more than 100% pre-market and gaining. This follows the company’s announcement that it had adopted a limited duration stockholder rights plan.

    The company announced that its board had approved the plan that would help protect stockholders from the actions of third parties determines are not in the company’s best interest, and help them get the most value from the company. This seems to have excited traders if its price action is anything to go by.

    Oncternal Therapeutics Inc [NASDAQ: ONCT]

    Oncternal Therapeutics Inc is a top performer this morning and is up by over 50%. This follows the company’s announcement of its Q3 results and offered a business update. The company announced that in Q3, its balance sheet strengthened all thanks to $10.1 million that it got in equity financing. The company also reported that in Q3, it had received a rare pediatric disease designation for its treatment called TK216 from the FDA.

    Tilray Inc [NASDAQ: TLRY]

    Tilray Inc is a top performer this morning and is up by over 40%. This is in line with other cannabis stocks that are all set to benefit from liberal weed policies in more states across the U.S. The company’s revenues are set to go up thanks to these policies and its price action is reflecting the same.