FDA briefing document submitted April 24, 2025 in support of a meeting to align on pathway for tivoxavir marboxil (TXM, bird flu/seasonal flu) including potential for accelerated approval utilizing the “Animal Rule” Additional briefing document in support of a meeting to align on ratutrelvir for COVID including Long COVID - to be submitted to regulatory authorities in Q2 2025 Cash runway to support planned operations into Q1... Read More

Tivoxavir marboxil’s potential as a single dose therapeutic agent for bird flu supported by significant antiviral activity in three well accepted animal models and positive Phase 1 data Ongoing FDA interaction to align on path forward for tivoxavir marboxil, including potential for accelerated approval utilizing the “Animal Rule” Cash Runway to support planned operations into Q1 2026 Investor Update call today, March 31,... Read More

Werner Cautreels, PhD, to retire as CEO, while continuing as a Board Member Iain D. Dukes, D Phil, Executive Board Chairman, to become Interim CEO NEWTOWN, Pa., March 28, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today... Read More

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird Flu Ratutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical... Read More

Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimen Preparations are underway for FDA interactions and initiation of Phase 2 studies Data presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc.... Read More

Tivoxavir marboxil (TXM), administered as a single dose in non-human primates, significantly reduced lung viremia and prevented weight loss, two key measures of antiviral activity in preclinical bird flu models Results build on earlier positive findings of mortality benefit for TXM in ferrets and mice FDA briefing documents in preparation for discussion of potential accelerated path to approval Data presentation to be... Read More

Poster underscores Tivoxavir Marboxil’s potential for the treatment of bird flu, supported by 100% survival in a rodent challenge model, potent suppression of resistant viruses and Phase 1 data Full dataset to be highlighted during Investor Call on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 21, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage... Read More

NEWTOWN, Pa., March 03, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline results from ferrets infected with H5N1 bird flu, an accepted animal model for human influenza, when treated with tivoxavir marboxil as... Read More

NEWTOWN, Pa., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for the treatment of respiratory viral diseases, announced today that it has received confirmation from Nasdaq that Traws has regained compliance with the minimum stockholders’ equity requirements of Nasdaq Listing Rule 5550(b)(1), which... Read More

Phase I completed in healthy volunteers with pharmacokinetic data supporting dosing for both therapeutic and further development for bird flu prevention NEWTOWN, Pa. , Jan. 23, 2025 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases, today announced... Read More

SAN DIEGO , Jan. 10, 2025 /PRNewswire/ -- Expert Systems, a hybrid AI enabled drug discovery and development accelerator, announced a significant milestone in a development of Traws Pharma, Inc. 's (NASDAQ: TRAW) H5N1 antiviral program. The investigational drug, Tivoxavir Marboxil , has shown encouraging results as a single-dose treatment for H5N1 avian influenza, representing a potentially pivotal advance in addressing this... Read More

Initial tranche of $20 Million extends cash runway into 1H26, subsequent tranche of up to $52.6 Million will provide for runway 3+ years enabling the company to reach both near-term and long-term value inflecting readouts NEWTOWN, Pa. , Dec. 30, 2024 /PRNewswire/ -- Traws Pharma, Inc. (NASDAQ: TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing oral small molecule therapies... Read More

Investigational agent in development for treatment or prevention of H5N1 Bird Flu Phase 1 dosing completed in healthy volunteers Potent inhibition of drug-resistant and bird flu viruses in vitro In vivo study in mice, with H5N1 isolated from an infected dairy worker, showed potent protection and suppression of virus replication in lungs Phase 2 study expected to begin in H1 2025 Traws Pharma is expanding its influenza... Read More

COVID: Phase 1 pharmacokinetic profile supports the potential for ratutrelvir to be dosed as a once-a-day, single drug, 10-day treatment course, without ritonavir, and with a lower likelihood of clinical rebound and good overall tolerability Flu: Phase 1 pharmacokinetic profile supports the potential for tivoxavir marboxil to be a one-time treatment for flu, including pandemic and avian flu, with good overall tolerability... Read More

Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses Phase 2 study expected to begin in H1 2025... Read More

Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir Phase 2a study expected to begin in H1 2025 in patients with COVID Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023 NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”,... Read More

Experienced Life Sciences Executive Brings Strategic Expertise to Support Traws’ Further Transformation and Growth Director James J Marino Also to Step Down from Traws Board After a Decade of Service NEWTOWN, Pa., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory... Read More

Three proposals, including a reverse stock split, were submitted and approved Traws Board subsequently approved a 1-for-25 reverse stock split Traws’ shares expected to begin trading on a split-adjusted basis on September 23, 2024 NEWTOWN, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies... Read More

Merger with Trawsfynydd Therapeutics, Inc (“Trawsfynydd”) and concurrent private placement of $14 million (cash runway to support planned operations through year end), with recently achieved clinical milestones, put Traws on track to achieve key readouts for the clinical pipeline in H2 2024 and beyond Lead antiviral program, tivoxavir marboxil, for influenza, including avian flu, is dosing the first cohort in the Phase 1... Read More

NEWTOWN, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced that following the release of its second quarter financial results, the Company intends to host a conference call and live webcast on Thursday, August 15, at 8:00 AM ET to provide a corporate... Read More

NEWTOWN, Pa., April 02, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (Nasdaq: TRAW, “Traws”, the “Company”) today announced it has granted equity awards to new employees who joined Traws in connection with the recent acquisition of Trawsfynydd Therapeutics, Inc. by Onconova Therapeutics, Inc. (the “Merger”). On April 1, 2024, Traws granted restricted stock equity awards to Werner Cautreels, Iain Dukes, Nikolay Savchuk, C.... Read More

Closing cash balance of approximately $28 million expected from concurrent private placement led by OrbiMed and Torrey Pines Funding expected to advance development of three potential best-in-class/class leading assets: viroksavir, a cap-dependent endonuclease inhibitor for influenza; travaltrelvir, a protease inhibitor for COVID19; and narazaciclib, a next generation CDK4/6 inhibitor for low grade endometriod endometrial... Read More

NEWTOWN, Pa., March 08, 2024 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will present an abstract related to preclinical studies conducted by the Company and its collaborators to further characterize the mechanism of... Read More

Preclinical data show that narazaciclib treatment led to significant tumor growth inhibition, demonstrating synergy with standard-of-care ibrutinib, in ibrutinib-sensitive and -resistant settings Early Phase 1/2 studies suggest potential for an improved profile and daily dosing Dose escalation is underway in lead indication of Low Grade Endometrioid Endometrial Carcinoma (LGEEC), with plans to define the Recommended Phase 2... Read More

Differentiated profile of narazaciclib supported by positive results of studies demonstrating broad multi-kinase activity, with significant anti-tumor activity and increased anti-tumor immunity, compared to approved CDK4/6 inhibitors Data support the potential use of narazaciclib in breast and ovarian cancers Narazaciclib progressing towards RP2D and preparation for registrational studies, with a planned update in H1 2024... Read More

NEWTOWN, Pa., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc . (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will present at NobleCon19, Noble Capital Markets’ Nineteenth Annual Emerging Growth Equity Conference, being held... Read More

Narazaciclib progressing towards registrational studies; target engagement and acceptable safety profile support further dose escalation, affirming differentiated profile Update on the registrational preparations for the narazaciclib program and the rigosertib trial plan expected in the first half of 2024 Company to host conference call and webcast at 4:30 p.m. ET on Tuesday, November 14, 2023 NEWTOWN, Pa., Nov. 14, 2023... Read More

NEWTOWN, Pa., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. ( NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its third quarter 2023 financial results on Tuesday, November 14, 2023. Management plans to host a conference call and live... Read More

Preclinical data indicate that narazaciclib shows monotherapy and combination anti-tumor activity in ibrutinib-sensitive and resistant cells and xenograft models NEWTOWN, Pa., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that... Read More

Dr. Victor Moyo named Chief Medical Officer Meena Arora joins as Vice President Global Medical Affairs and R&D NEWTOWN, Pa., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company expanded its leadership team with the... Read More

Data for Mantle cell lymphoma (MCL) presented in Ireland on Oct. 7, 2023 Additional studies support broad potential, especially in cyclin-dependent cancers NEWTOWN, Pa., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that one of... Read More

NEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) -- (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract studying rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB), associated with... Read More

NEWTOWN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract reporting the use of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB) associated with advanced/metastatic... Read More

NEWTOWN, Pa., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven Fruchtman, M.D., President & CEO, will participate in the H.C. Wainwright 25 th Annual Global Investment Conference being held September 11-13, 2023.... Read More

Anticipate topline results from the Phase 1 monotherapy and Phase 1/2 combination study with letrozole in Q4 2023 Plans are underway for a registrational trial with rigosertib in patients with RDEB-associated squamous cell carcinoma based on a constructive Type B FDA meeting held in June Company to host conference call and webcast at 4:30 p.m. ET on Thursday, August 10, 2023 NEWTOWN, Pa., Aug. 10, 2023 (GLOBE NEWSWIRE) --... Read More

NEWTOWN, Pa., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its second quarter 2023 financial results on Thursday, August 10, 2023. Management plans to host a conference call and live webcast... Read More

NEWTOWN, Pa., June 14, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today presented preclinical data on narazaciclib at the 17 th International Conference on Malignant Lymphoma (ICML), which is taking place in Lugano, Switzerland, through June 17,... Read More

NEWTOWN, Pa., June 05, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the presentation of a Trials in Progress poster at the American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place June 2 – 6, 2023 in Chicago, Illinois and... Read More

NEWTOWN, Pa., May 25, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who... Read More

NEWTOWN, Pa., May 15, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended March 31, 2023, and provided a business update. Highlights for the first quarter of 2023 and recent weeks include: The first participant was... Read More

Showcase to feature presentations by key opinion leaders Drs. Gaël Roué and Bhavana Pothuri Showcase to take place on May 18, 2023 at 11:00 a.m. ET NEWTOWN, Pa., May 12, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that Steven M.... Read More

Prior data provide clinical proof-of-concept for narazaciclib’s mechanism of action in endometrial cancer Preliminary data from trial’s Phase 1 portion expected in 4Q 2023 NEWTOWN, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the... Read More

NEWTOWN, Pa., May 08, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced an upcoming presentation at the International Society of Investigative Dermatology (ISID) International Epidermolysis Bullosa Symposium, which is being held in Osaka,... Read More

NEWTOWN, Pa., May 04, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its first quarter 2023 financial results on Monday, May 15, 2023. Management plans to host a conference call and live webcast at... Read More

NEWTOWN, Pa., April 19, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced new preclinical data on narazaciclib in two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting. “Data being presented at AACR... Read More

NEWTOWN, Pa., April 06, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that its Chief Medical Officer (CMO) Mark Gelder, M.D., recently passed away unexpectedly. Michael Saunders, M.D., has been appointed the interim Chief Medical... Read More

Collaboration builds off clinical data demonstrating rigosertib’s activity against PLK1 and may inform a precision medicine approach towards rigosertib’s evaluation in new indications Collaboration will leverage ENLIGHT, a pan-cancer response predictor scalable to all cancer types and all targeted and immune checkpoint blockade (ICB) oncology drugs NEWTOWN, Pa. & TEL AVIV, Israel, March 23, 2023 (GLOBE NEWSWIRE) -- Onconova... Read More

NEWTOWN, Pa., March 16, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the twelve months ended December 31, 2022, and provided a business update. Highlights for the fourth quarter of 2022 and recent weeks include: Based upon... Read More

NEWTOWN, Pa., March 15, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the publication of two abstracts that have been accepted for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting, which is taking place at the... Read More

NEWTOWN, Pa., March 09, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company intends to release its fourth quarter and full year 2022 financial results on Thursday, March 16, 2023. Management plans to host a conference call and live webcast at... Read More

Data suggest rigosertib stimulates an anti-cancer immune response via NLRP3 activation, providing mechanistic support for clinical trials of rigosertib-checkpoint inhibitor combinations Data reveal potential targets engaged by rigosertib to inhibit the RAS-MAPK pathway, the overactivation of which is implicated in a range of cancers NEWTOWN, Pa., March 07, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX),... Read More

Two of two evaluable participants in an ongoing investigator-sponsored program of rigosertib in RDEB-associated squamous cell carcinoma (SCC) have achieved a complete response of all cancerous skin lesions First evaluable participant has been in complete remission with no signs of metastatic disease for >18 months; the second patient has achieved a complete response in all squamous cell skin lesions following four cycles of... Read More

NEWTOWN, Pa., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will be participating in the 2023 Guggenheim Oncology Conference taking place February 8-9, 2023 in New York City. Steven Fruchtman, M.D., President & CEO of Onconova,... Read More

NEWTOWN, Pa., Jan. 26, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced their participation in the Channelchek Takeaway Series from the J.P.Morgan Healthcare Conference, to be broadcast Thursday, January 26, starting at 10:00 EST. The J.P. Morgan Healthcare Conference... Read More

NEWTOWN, Pa., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced the appointments of Peter Atadja, Ph.D., and Trafford Clarke, Ph.D., as independent members of the Company’s Board of Directors. “It is my pleasure to welcome Peter and Trafford to our... Read More