Latest news with #AutolusTherapeutics
Yahoo
31-07-2025
- Automotive
- Yahoo
European Commission Approves CAR-T Therapy With Lentiviral Vectors Manufactured by AGC Biologics
The Friendly CDMO Expert's Milan Cell and Gene Center of Excellence Achieves 10th Major Regulatory Product Approval MILAN, July 31, 2025--(BUSINESS WIRE)--Following news on July 21 that the European Commission has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel – obe-cel), AGC Biologics' Milan site achieved its 10th product approval from the European Medicines Agency or the U.S. Food and Drug Administration. Developed by Autolus Therapeutics, AUCATZYL® is now approved to treat adult patients (age 26 and older) in 27 European Union member states with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This follows the therapy's prior authorizations from the FDA in November 2024 and the U.K. Medicines and Healthcare products Regulatory Agency in April 2025. This latest step further solidifies AGC Biologics' Milan Cell and Gene Center of Excellence's reputation as a global leader in the field, built on a 30-year track record of quality, reliability, and regulatory success. "This European approval for Autolus is a milestone we are thrilled to be part of. Our goal is to be the industry's safe harbor: a trusted, friendly expert CDMO that de-risks the complex path to commercialization," said Alberto Santagostino, CEO and President, AGC Biologics. "By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients. Congratulations to the entire Autolus team." The partnership between Autolus and AGC Biologics Milan began in 2020, with the CDMO tasked to develop, manufacture, and supply the viral vectors for Autolus' obe-cel CAR-T product candidate. "From the start of our partnership in 2020, through the FDA approval and now this European authorization, our collaboration with Autolus has been a model of true partnership," said Luca Alberici, General Manager, AGC Biologics Milan. "The team's sustained dedication and technical excellence is a direct result of our ability to work seamlessly with the Autolus team to meet the demands of commercial-scale manufacturing for a global market." With its 30-year track record and 10 product approvals by the EMA and FDA, the AGC Biologics Milan site is a global leader with deep expertise in complex cell and gene therapy projects. The team has guided numerous products to commercial stages, manufactured hundreds of batches for clinical supply, and consistently met the highest global regulatory guidelines, quality performance metrics, and the unique complexities of technology transfers and manufacturing scale-up. To learn more about AGC Biologics' global cell therapy services, visit and for more on the CDMO's viral vector offerings, visit About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,600 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit AUCATZYL® (obecabtagene autoleucel – obe-cel) is a registered trademark of Autolus Therapeutics. View source version on Contacts AGC Inc. corporate contact: info-pr@ AGC Biologics media contact: ksills@ Sign in to access your portfolio
Yahoo
28-07-2025
- Business
- Yahoo
Unlocking Oncology's Future: 3 Trending Cancer Biotech Stocks with ‘Strong Buy' Ratings
Cancer remains one of the most relentless challenges in modern medicine. In 2025, over 2 million new cancer cases are expected to be diagnosed in the United States. More than 618,000 people will die from the disease, which is equivalent to about 1,700 deaths each day. The scale of this health crisis is driving substantial investments and innovation in cancer research and treatment. As a result, the global oncology market is projected to reach $208.9 billion in revenue by 2025, with forecasts suggesting it could surpass $900 billion by 2034. This growth is fueled by increased cancer incidence, advances in precision and immunotherapy drugs, and billions of dollars in new partnerships and funding, such as Bristol-Myers Squibb's (BMY) recent $11 billion stake in next-generation cancer therapies. More News from Barchart Warren Buffett Warns Inflation Turns Business Into 'The Upside-Down World of Alice in Wonderland' But Weeds Out 'Bad Businesses' Why GOOGL Stock May Be the Market's Next Big Winner Alphabet Posts Lower Free Cash Flow and FCF Margins - Is GOOGL Stock Overvalued? Get exclusive insights with the FREE Barchart Brief newsletter. Subscribe now for quick, incisive midday market analysis you won't find anywhere else. High-potential cancer specialists like Elicio Therapeutics (ELTX), Cellectis (CLLS), and Autolus Therapeutics (AUTL) are earning coveted 'Strong Buy' analyst ratings. Despite this recognition, each remains well below large-cap valuations, which leaves ample room for sharp upside if upcoming clinical and regulatory catalysts play out in their favor. Could one of these under-the-radar biotech firms deliver the next big breakthrough in cancer treatment — and major upside for investors? Let's dive into these three cancer biotech stocks now. Elicio Therapeutics Elicio Therapeutics (ELTX) is a clinical-stage biotech pioneering immunotherapies for solid tumors, with a market capitalization of $158 million. ELTX has posted a YTD gain of 92.7%, and is up 102.6% over the past 52 weeks. Its price-book ratio stands at an elevated 17.6x, well above the sector median of 2.47x. Elicio's lead asset, ELI-002 7P, is advancing through the pivotal Phase 2 AMPLIFY-7P trial targeting pancreatic ductal adenocarcinoma (PDAC), with a critical interim analysis focused on disease-free survival slated for Q3 2025. This interim analysis is a key milestone for the company, particularly for its potential impact on PDAC. Ahead of this readout, H.C. Wainwright analyst Robert Burns reiterated a 'Buy' rating on shares and maintained his $13 price target. Elicio reported Q1 2025 R&D expenses of $7.8 million, a slight increase from $7.6 million in Q1 2024, tied primarily to the ongoing Phase 2 AMPLIFY-7P trial. General and administrative expenses grew to $3 million, up from $2.7 million due to higher personnel costs. The Q1 2025 net loss narrowed to $11.2 million, compared to $11.8 million in the same quarter last year, with a net loss per share improving to $0.87 from $1.15. Notably, ELTX augmented its financial position in Q2 by securing a $10 million senior secured note, extending its operational runway into early 2026 and granting the company flexibility for near-term initiatives. Analyst sentiment skews highly bullish as the two surveyed analysts assign ELTX a 'Strong Buy' rating, with an average price target of $12.50. This places the upside potential at approximately 26% from current levels. Cellectis Cellectis (CLLS) is a clinical-stage biotech company specializing in gene-edited cell therapies with a market capitalization of approximately $140 million. The stock has gained 60% in the year to date, and shares are up 25.2% in the past 52 weeks. Cellectis has a price-sales ratio of 2.26x, below the sector median of 3.6x, and a price-book ratio of 0.96x, significantly under the sector median of 2.47x, suggesting potential undervaluation relative to its peers. CLLS reported solid results for Q1 2025, with consolidated revenues and other income rising to $12 million from $6.5 million a year prior. This increase mainly stems from $5.9 million recognized under the AstraZeneca Joint Research Collaboration Agreement (AZ JRCA). Its cash reserves stood at $246 million as of March 31, 2025, projected to sustain operations well into the second half of 2027, providing ample runway for ongoing development. Research and development expenses slightly decreased to $21.9 million compared to the previous year, reflecting efficient management despite continued investment in pipeline advancement and manufacturing capabilities in Paris and Raleigh. Strategically, Cellectis' partnership with AstraZeneca is a cornerstone of its growth story. AstraZeneca's $140 million investment enhances Cellectis' financial footing and grants AstraZeneca exclusive rights to 25 genetic targets, with options to develop up to 10 candidate products. So far this collaboration is advancing two CAR-T programs aimed at hematological malignancies and solid tumors. Analyst sentiment is unanimously bullish, with the five surveyed analysts assigning Cellectis a consensus 'Strong Buy' rating. The average price target of $5.60 implies compelling upside of approximately 91% from the current share price. Autolus Therapeutics Autolus Therapeutics (AUTL) develops advanced autologous CAR-T cell therapies for blood cancers, with a market capitalization of $670 million. The stock is up 8.7% year-to-date, but down 45% over the past 52 weeks. Its price-sales ratio of 69.4xx is markedly above the sector's 3.54x median, while its 1.89x price-book ratio remains below group averages of 2.47x. In Q1 2025, Autolus reported $9 million in net product revenue, driven largely by the commercial rollout of AUCATZYL (Obe-cel), its lead CAR-T therapy, across 39 fully activated U.S. centers. Patient access continues to grow, capturing coverage for roughly 90% of U.S. medical lives as payer uptake accelerates. Costs of sales totaled $18 million, including delivered but as-yet-unrecognized product tied to deferred revenue and royalty obligations, a natural part of early stage commercial launches. Research and development expenses dropped to $26.7 million from $30.7 million year-over-year, with much of that shift driven by the transition of manufacturing expenses to sales costs. Loss from operations widened to $65.2 million due to launch investments, and net loss reached $70.2 million or $0.26 per share. On the regulatory front, Autolus scored a critical win in July as AUCATZYL secured European approval for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This unlocks a larger addressable market and enhances the company's global competitive position in engineered cell therapies. The analyst outlook remains unequivocally positive as the nine surveyed analysts rate AUTL a consensus 'Strong Buy,' with a mean target of $9.84, implying 285% upside potential from current levels. Conclusion With major catalysts ahead and strong analyst backing, the odds favor upward momentum as data readouts and commercial expansion play out. Given their positioning and partnerships, these three stocks could deliver outsized gains in the coming quarters, especially if results come in strong. On the date of publication, Ebube Jones did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on
Globe and Mail
24-07-2025
- Business
- Globe and Mail
Autolus Therapeutics to Report Second Quarter 2025 Financial Results and Host Conference Call on August 12, 2025
LONDON and GAITHERSBURG, Md., July 24, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces that it will release its second quarter 2025 financial results and operational highlights before open of U.S. markets on Tuesday, August 12, 2025. Management will host a conference call and webcast at 8:30am EDT/13:30pm BST to discuss the company's financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus' website. About Autolus Therapeutics plc Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL ®, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit
Yahoo
26-06-2025
- Automotive
- Yahoo
Needham Reiterates a Buy Rating on Autolus Therapeutics (AUTL), Keeps the PT at $10
Autolus Therapeutics plc (NASDAQ:AUTL) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. Analyst Gil Blum from Needham reiterated a Buy rating on Autolus Therapeutics plc (NASDAQ:AUTL) on June 12, keeping the price target at $10.00. The analyst cited the promising results of the FELIX study for obe-cel in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) as one of the factors supporting the optimistic rating, stating that the updated analysis highlights a notable number of patients in remission with no need for further therapy. This is a positive indicator, according to the analyst, especially in comparison to other treatments such as Tecartus. A laboratory technician carefully studying a microscope with a biopharmaceutical product inside. While the analyst acknowledged that 38% of responders were still in remission with a median follow-up of 33 months, a slight drop from the 40% reported at 21.5 months, he stated that the results are still impressive. He also cited other promising factors, including the overall survival and event-free survival rates, as well as the absence of new safety concerns. According to Blum, these factors suggest a positive reception from physicians and the potential for higher commercial adoption of obe-cel, supporting the optimistic outlook for Autolus Therapeutics plc (NASDAQ:AUTL). Autolus Therapeutics (NASDAQ:AUTL) is a clinical-stage biopharmaceutical company based in the United Kingdom. It develops programmed T cell therapies for treating autoimmune diseases and cancer, with a focus on chimeric antigen receptor (CAR) T cell therapy. The company engineers controlled, targeted, and highly active T cell therapy product candidates designed to recognize target cells, break their defense mechanisms down, and eliminate them. It is doing so using a portfolio of proprietary and modular T-cell programming technologies. While we acknowledge the potential of AUTL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
24-06-2025
- Automotive
- Yahoo
Needham Reiterates a Buy Rating on Autolus Therapeutics (AUTL), Keeps the PT at $10
Autolus Therapeutics plc (NASDAQ:AUTL) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. Analyst Gil Blum from Needham reiterated a Buy rating on Autolus Therapeutics plc (NASDAQ:AUTL) on June 12, keeping the price target at $10.00. The analyst cited the promising results of the FELIX study for obe-cel in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) as one of the factors supporting the optimistic rating, stating that the updated analysis highlights a notable number of patients in remission with no need for further therapy. This is a positive indicator, according to the analyst, especially in comparison to other treatments such as Tecartus. A laboratory technician carefully studying a microscope with a biopharmaceutical product inside. While the analyst acknowledged that 38% of responders were still in remission with a median follow-up of 33 months, a slight drop from the 40% reported at 21.5 months, he stated that the results are still impressive. He also cited other promising factors, including the overall survival and event-free survival rates, as well as the absence of new safety concerns. According to Blum, these factors suggest a positive reception from physicians and the potential for higher commercial adoption of obe-cel, supporting the optimistic outlook for Autolus Therapeutics plc (NASDAQ:AUTL). Autolus Therapeutics (NASDAQ:AUTL) is a clinical-stage biopharmaceutical company based in the United Kingdom. It develops programmed T cell therapies for treating autoimmune diseases and cancer, with a focus on chimeric antigen receptor (CAR) T cell therapy. The company engineers controlled, targeted, and highly active T cell therapy product candidates designed to recognize target cells, break their defense mechanisms down, and eliminate them. It is doing so using a portfolio of proprietary and modular T-cell programming technologies. While we acknowledge the potential of AUTL as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
