Aveo Pharma - AVEO STOCK NEWS

AVEO Oncology (Nasdaq: AVEO) announced results from a Phase 2 study of ficlatuzumab with or without cetuximab in patients with metastatic HNSCC who are refractory to previous treatments. The combination showed a 38% response rate in HPV negative patients, highlighting prolonged progression-free survival (PFS) of 4.1 months. The study met its primary endpoint, leading to plans for a Phase 3 trial by mid-2022. The treatment was generally well tolerated, despite reports of two treatment-related deaths.

AVEO Oncology reported its Q1 2021 financial results, highlighting the FDA's approval and launch of FOTIVDA, its first commercial product, generating net revenues of $1.1 million. Cash reserves increased to $121.4 million, supporting operations for at least 12 months. Despite revenue growth, net loss rose to $22.1 million, primarily due to non-cash losses. The company plans to invest $40 million in commercial efforts and expects a gross margin in the mid-to-high 80s. Key clinical updates include upcoming pivotal trials for FOTIVDA and ongoing studies for other products.

AVEO Oncology (Nasdaq: AVEO) will report its first quarter 2021 financial results on May 10, 2021. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results and provide a business update. AVEO's lead candidate, FOTIVDA^®, received FDA approval on March 10, 2021, and became available for relapsed or refractory renal cell carcinoma on March 22, 2021. The company is also conducting clinical trials for additional product candidates, including ficlatuzumab and AV-380.

AVEO Oncology (Nasdaq: AVEO) announced the appointment of Dr. Kevin J. Cullen to its Board of Directors. Dr. Cullen, a leading clinical oncologist specializing in head and neck cancer, brings significant expertise, having directed the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center. His appointment coincides with AVEO's strategic focus on advancing its pipeline, particularly after the FDA approval of FOTIVDA® (tivozanib) for relapsed renal cell carcinoma. Dr. Cullen's insights are expected to enrich AVEO's development of new therapies targeting critical cancer needs.

AVEO Oncology (Nasdaq: AVEO) has announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include FOTIVDA^® (tivozanib) as a recommended subsequent therapy for advanced renal cell carcinoma (RCC) patients who have had prior systemic treatments. This recognition follows FOTIVDA's FDA approval in March 2021 based on pivotal clinical studies, including TIVO-3. AVEO's CEO emphasized the commitment to launch this treatment to enhance patient options in relapsed or refractory advanced RCC.

AVEO Oncology (Nasdaq: AVEO) has completed its underwritten public offering, successfully selling 6,900,000 shares at $8.00 each, totaling approximately $55.2 million in gross proceeds. This includes the underwriters' full exercise of their option to purchase an additional 900,000 shares. The funds will be directed toward working capital, general corporate purposes, and supporting commercialization activities for its FDA-approved drug, FOTIVDA^® (tivozanib), as well as advancing the company's pipeline.

AVEO Oncology has priced an underwritten public offering of 6,000,000 shares at $8.00 each, aiming to raise $48.0 million before expenses. All shares are being sold by AVEO, with a 30-day option for underwriters to buy an additional 900,000 shares. The offering's net proceeds will support working capital, commercial activities for FOTIVDA® and pipeline advancements. The offering is expected to close around March 26, 2021, subject to customary conditions.

AVEO Oncology (Nasdaq: AVEO) announced a public offering of 5,000,000 shares of its common stock, with an option for underwriters to purchase an additional 750,000 shares. The net proceeds will be utilized for working capital and general corporate purposes, including commercialization of FOTIVDA^® and the advancement of its pipeline. The offering is subject to market conditions, and details will follow in a prospectus supplement to be filed with the SEC.

AVEO Oncology (Nasdaq: AVEO) has announced the early commercial availability of FOTIVDA^® (tivozanib) in the U.S. following its FDA approval on March 10, 2021, for adults with relapsed or refractory advanced renal cell carcinoma (RCC) after two or more systemic therapies. The company has launched the AVEO ACE Patient Support program to enhance patient access and streamline treatment journeys for those eligible. FOTIVDA is delivered through a selective network of specialty pharmacies and distributors, aiming to meet the needs of RCC patients effectively.