|Over a week ago|
Onconova appoints Mark Gelder as CMO » 08:0506/0106/01/21
Onconova Therapeutics announced that Mark Gelder, M.D. will be joining Onconova as CMO, effective as of June 14, 2021. He was most recently the CMO of Elevar Therapeutics, where he led the company's clinical development, medical affairs, regulatory affairs, and preclinical teams.
Fly Intel: Wall Street's top stories for Friday » 16:4405/2105/21/21
DE, PANW, KSU, CNI, CP, T, GSK, VIR, KO, GM, VOSO, ANVS, YALA, FL, ONTX, VFC
The major averages had a…
Fly Intel: Wall Street's top stories at midday » 12:0505/2105/21/21
DE, T, PANW, VIR, ANVS, GSK, YALA, FL, ONTX, VFC
The major averages are…
Onconova announces initial dosing of first patient in Phase 1 trial of ON 123300 » 08:0905/2105/21/21
Onconova Therapeutics announced that the first patient has been dosed in the U.S. Phase 1 clinical trial of ON 123300, the Company's proprietary, novel multi-kinase inhibitor. The trial is expected to include three U.S. sites that will enroll patients with advanced cancer including, but not limited to, HR+ HER 2- metastatic breast cancer patients who are refractory to, or progressing on, currently approved CDK 4/6 inhibitors. The Phase 1 trial is designed to assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. Following completion of the dose-escalation phase of the trial and once the recommended Phase 2 dose is established, additional patients with HR+ HER 2- metastatic breast cancer with at least one prior line of therapy, which are expected to include approved CDK 4/6 inhibitors, will be enrolled into the trial with the intent to identify signals of efficacy. Additional cancer indications are also under consideration for study, and will be chosen based on preclinical and developing data.
Onconova announces one-for-fifteen reverse stock split » 09:0305/2005/20/21
Onconova Therapeutics announced a one-for-fifteen reverse stock split of its common stock, effective May 20, 2021. Beginning at the open of trading on May 21, 2021, Onconova's common stock will trade on the Nasdaq Capital Market on a split-adjusted basis. At Onconova's 2021 reconvened annual meeting of stockholders on April 30, 2021, Onconova stockholders authorized the Company's Board of Directors to amend the Tenth Amended and Restated Certificate of Incorporation, as amended, to effect a reverse stock split at a ratio in the range of one-for-five to one-for-fifteen. Onconova's Board of Directors subsequently approved a reverse stock split ratio of one-for-fifteen, and the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to its Certificate of Incorporation to effect the reverse stock split, which became effective upon the filing of the Certificate of Amendment with the Secretary of State of the State of Delaware on May 20, 2021. Upon effectiveness of the reverse stock split, each fifteen shares of Onconova's common stock, par value of $0.01 per share, issued and outstanding immediately prior to the effective time automatically were reclassified, combined, converted and changed into one fully paid and non-assessable share of common stock, par value of $0.01 per share. In addition, a proportionate adjustment will be made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding options, warrants, and convertible preferred stock entitling the holders to purchase shares of our common stock. In particular, at the effective time of the reverse stock split, the Company adjusted its outstanding tradable warrants currently trading on the Nasdaq Capital Market under the symbol "ONTXW" in accordance with the terms of such tradable warrants to reflect the reverse stock split. As a result of these adjustments), each tradable warrant now entitles its holder to purchase one- two hundred and twenty-fifth of a share of Onconova's common stock at an exercise price of $1,107.00 per share of common stock. No fractional shares will be issued as a result of the reverse stock split. Instead, Onconova's stockholders who otherwise would have been entitled to a fraction of a share, will receive a full share of common stock. If a holder of the tradable warrant would be entitled to receive a fraction of a share upon the exercise of the warrant, such fractional share will be rounded down to the nearest whole share. Fractional shares resulting from exercise of other common stock warrants and conversion of outstanding convertible preferred stock will be rounded in accordance with the terms of such securities. The reverse stock split will decrease the number of common shares issued and outstanding from approximately 236.714 million shares to approximately 15.781 million shares.
Onconova initiated with a Buy at Guggenheim » 06:1505/1805/18/21
Guggenheim analyst Etzer…
Guggenheim analyst Etzer Darout initiated coverage of Onconova with a Buy rating and $4 price target.
|Over a month ago|
Onconova announces first patient dosed in phase 2 study of Rigosertib » 08:2004/2204/22/21
Onconova Therapeutics announced that the first patient has been dosed in an investigator-initiated Phase 2 study to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa, or RDEB, -associated locally advanced/metastatic squamous cell carcinoma, or SCC. The patient was dosed at the EB House Austria, a center of expertise for epidermolysis bullosa at the University Hospital Salzburg, Austria. Additional sites are anticipated to be opened in the UK and in the US to study this disease. In this open-label investigator-initiated study, 12 patients will receive either oral or intravenous rigosertib at the clinician's discretion given the various clinical manifestations of the disease, which may dictate the need for either oral or intravenous administration of rigosertib. Patients will receive either oral rigosertib in four-week cycles for up to 13 cycles, with 560 mg of oral rigosertib in the morning and again in the afternoon, for a total of 1,120 mg/day. Alternatively, patients will receive intravenous rigosertib as a 72-hour IV infusion on days 1, 2 and 3 of eight 2-week cycles, and on days 1, 2 and 3 of nine 4-week cycles thereafter, with each 24-hour infusion consisting of 1,800 mg of rigosertib. The study has two primary endpoints. The first is to determine the anti-tumor activity of rigosertib in RDEB patients with advanced SCC who have failed prior standard of care through the overall response rate, defined as the proportion of patients who achieve either a complete response or a partial response. The second primary endpoint is to evaluate the safety and tolerability of rigosertib in this population. Secondary study endpoints include quality of life and a biomarker analysis performed on archival tissue from all patients. Patients will be dosed for up to one year, with trial duration anticipated to be approximately two-and-a-half years.
Onconova announces enrollment in Phase 1 study with ON 123300 in China » 08:0304/0104/01/21
Onconova Therapeutics announces that its corporate partner HanX Biopharmaceuticals has enrolled three patients in the second dosing cohort of its Phase 1 study with ON 123300 in HR+ HER2- metastatic breast cancer and other advanced relapsed/refractory cancers in China. The HanX trial has enrolled six patients to date in two cohorts and may continue to enroll patients with advanced relapsed/refractory cancer at increasing doses with three to six patients per dose until the recommended Phase 2 dose is identified. To date, patients have been dosed at the 40 mg and 80 mg dosage levels. HanX recently opened a third site, in Shanghai, for the conduct of the study.
|Over a quarter ago|
Onconova regains compliance with Nasdaq continued listing requirement » 08:1702/2402/24/21
Onconova Therapeutics announces receipt of notification from Nasdaq that the Company has regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5550(a)(2) because the Company's common stock had a closing price of at least $1.00 per share for a minimum 10 consecutive business days. As previously reported, the Company was granted until April 5, 2021 to meet this requirement.
Onconova 25M share Spot Secondary priced at $1.00 » 05:0102/1102/11/21
Guggenheim acted as lead…
Guggenheim acted as lead book running manager for the offering.