Iovance Biotherapeutics

Iovance Biotherapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of cell therapies as novel cancer immunotherapy products. Its lead product candidate, LN-144 for metastatic melanoma, is an autologous adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL), which are T cells derived from patients' tumors. The company was founded by Robert T. Brooke on September 17, 2007, and is headquartered in San Carlos, CA.

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Iovance Biotherapeutics progresses on BLA for lifileucel, faces recruitment challenges

Iovance Biotherapeutics is on track with BLA completion expected this quarter, strong pipeline progress, and manufacturing capacity expansion. Challenges include study recruitment uncertainties and the ongoing CEO search. Opportunities exist in new program data releases, European expansion, and pivotal study enrollment.

Iovance Biotherapeutics advances TIL therapy pipeline with strong financials

Iovance Biotherapeutics is on track with key milestones in TIL therapy development and commercialization.
The company's financial position is stable, with strategic investments supporting future growth.
Challenges include operational efficiency, FDA interactions, and trial progress management.
Opportunities lie in international trials, market expansion, and revenue growth post-launch.

Iovance Biotherapeutics reports Q2 loss, eyes lifileucel FDA review

Iovance Biotherapeutics faces financial challenges with a significant net loss in Q2 2023, despite positive milestones and revenue from Proleukin sales.
The company's TIL therapy pipeline shows promise with progress in key clinical trials, while opportunities exist for market differentiation and revenue growth.
Challenges include ongoing financial losses, longer timelines for pivotal studies, and potential delays in trial enrollment, requiring strategic management.

Iovance Biotherapeutics progresses on Lifileucel commercialization and pipeline expansion

Iovance Biotherapeutics is making significant strides in advancing its pipeline and commercialization efforts, with a strong focus on FDA approval for Lifileucel and expanding into key markets. The company faces challenges in labeling discussions and efficacy benchmarks but has opportunities in European marketing, new therapy programs, and potential partnerships for international growth.

Iovance Biotherapeutics excels with Amtagvi approval and clinical progress

Iovance Biotherapeutics showcased strong performance with the FDA approval of Amtagvi and progress in clinical trials, positioning the company for growth.
While facing challenges in scaling operations and regulatory hurdles, the company's focus on efficiency and clinical research strengths bode well for the future.
With opportunities in label expansion, market penetration, and revenue growth, Iovance is poised to capitalize on its innovative therapies and drive value for stakeholders.

Iovance Biotherapeutics reports Q1 loss, Amtagvi launch success

Iovance Biotherapeutics shows promising performance with a focus on Amtagvi's commercial success and pipeline advancements.
Strengths include positive reimbursement trends, successful patient selection processes, and efficient manufacturing operations.
Challenges lie in patient screening failures, financial clearance issues, and variability in bridging therapy usage.
Opportunities for growth include market expansion, high patient conversion rates, and accelerated submission processes for new therapies.

Iovance Biotherapeutics (IOVA) exceeds Q3 revenue targets, eyes global expansion

Iovance Biotherapeutics (IOVA) had a strong Q3 performance, exceeding revenue guidance and showcasing growth potential.
The company's focus on Amtagvi and global expansion presents opportunities for revenue diversification and market penetration.
Challenges lie in maintaining adoption rates, meeting revenue targets, and effectively managing increased manufacturing capacity.
Overall, IOVA's strategic initiatives position it for continued growth and success in the biopharmaceutical market.

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IOVA's marketing application for lifileucel is still awaiting approval from the FDA, with a new decision date set for February 24, 2024. Despite the delay, IOVA suggests a possible early approval in January 2024. IOVA expects its current cash to last it until 2025, although an offering or use of an at-the-market facility could still come with any potential approval.

Iovance Biotherapeutics: The Easiest Money May Have Been Made, But Approval Does Seem Likely

Viking Therapeutics

Small to mid-cap biotechs are known for their extreme volatility, and sometimes, market-crushing returns on capital. Iovance Biotherapeutics and Viking Therapeutics are two of the most popular stocks within this group.

Better Growth Stock: Viking Therapeutics or Iovance Biotherapeutics?

Wall Street analysts following Iovance Biotherapeutics set price targets that suggest the stock can triple your money in 2024. Iovance Biotherapeutics is developing cell-based cancer therapies, and the FDA is reviewing an application for its lead candidate.

A Bull Market Is Coming: 1 Stock That Could Rocket 219% Higher in 2024, According to Wall Street

Iovance Biotherapeutics (IOVA) reported earnings 30 days ago. What's next for the stock?

Why Is Iovance Biotherapeutics (IOVA) Up 53% Since Last Earnings Report?

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In this market cycle that we are experiencing, new opportunities arise to take advantage of over the next few years. There is no better way to take advantage of these opportunities than through penny stocks.

3 Penny Stocks to Buy to Turn $1 into $100: November 2023

Goldman Sachs initiated a buy recommendation on Iovance with a $12 price target. Many on Wall Street like the stock because of the potential near-term approval of its promising melanoma drug.

Why Iovance Biotherapeutics Stock Is Jumping Today

Biotech stocks are slumping yet again today. However, Iovance Biotherapeutics is swimming against the current thanks to excitement over its adoptive cell therapy.

Why Iovance Biotherapeutics Stock Is Marching Higher Today

Iovance's (IOVA) third-quarter earnings meet estimates, but sales miss the same.

Iovance's (IOVA) Meets Q3 Earnings, Lags Sales Estimates

Iovance Biotherapeutics, Inc. (IOVA) Q3 2023 Earnings Call Transcript

FDA Priority Review of Biologics License Application (BLA) on Track for Lifileucel in Advanced Melanoma with Prescription Drug User Fee Act Action (PDUFA) Date of February 24, 2023

Iovance Biotherapeutics Reports Third Quarter and Year-to-Date 2023 Financial Results and Corporate Updates

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Let us take a look at what's in store for biotech/drug stocks GILD, PRGO, VTRS, SAGE and IOVA, which are scheduled to report on Nov 7.

Biotech/Drug Stocks Q3 Earnings Due Nov 7: GILD, PRGO, VTRS & More

SAN CARLOS, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will report its third quarter and year-to-date 2023 financial results on Tuesday, November 7, 2023. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET.

Iovance Biotherapeutics to Host Third Quarter and Year-to-Date 2023 Financial Results Conference Call and Webcast on Tuesday, November 7, 2023

SAN CARLOS, Calif., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the publication of abstracts for poster presentations reporting clinical data and trial design for tumor infiltrating lymphocyte (TIL) therapies at the Society for Immunotherapy of Cancer's (SITC) 38 th Annual Meeting in San Diego, CA, November 1-5, 2023.

Iovance Biotherapeutics to Present Clinical and Pre-Clinical Data for Tumor Infiltrating Lymphocyte (TIL) Therapies at Society for Tumor Immunotherapy of Cancer's (SITC) 38th Annual Meeting

Iovance Biotherapeutics is on the cusp of its first FDA approval for its TIL therapy in the treatment of metastatic melanoma. The company operates on the belief that adoptive cell therapy can effectively fight solid tumors while avoiding side effects. Iovance's lead candidate, lifileucel, has shown promising results in clinical trials for metastatic melanoma, and the company has filed a BLA with the FDA.

Iovance Biotherapeutics: Testing Shareholders' Patience

Iovance Biotherapeutics' lifileucel, a tumor infiltrating lymphocyte product, is under FDA review for the treatment of advanced melanoma. The FDA decision on the biologics license application for lifileucel has been delayed until February 24, 2024.

Iovance Biotherapeutics: Good Trade Setup Created By The FDA Delay Gets Even Better

SAN CARLOS, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the publication of an abstract reporting clinical data for lifileucel which will be presented at the European Society for Medical Oncology ESMO Congress 2023, October 20-24, 2023 in Madrid, Spain.

Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Advanced Mucosal Melanoma at the European Society for Medical Oncology (ESMO) Congress

Iovance Biotherapeutics shows promise in T-cell therapies for solid tumors despite FDA delays; robust financials with a cash runway of 13.1 months. Insider buying and strategic ATC investments indicate market confidence; however, clinician adoption and post-market data remain potential risks. Upgrading investment recommendation to "Buy" based on favorable regulatory outlook, solid liquidity, and promising commercial strategies, though due diligence is advised.

Iovance Biotherapeutics: Navigates Regulatory Delays With Strategic Finesse (Rating Upgrade)

Iovance's lead therapy lifileucel still has a chance at an early approval to treat advanced melanoma. Lifileucel is also being tested to treat several other types of cancer.

Why Shares of Iovance Biotherapeutics Jumped Monday

At first glance, the latest regulatory news is a setback. However, there were more than a few silver linings in this development.

Why Iovance Biotherapeutics Stock Rocketed 13% Higher Today

Iovance Biotherapeutics (NASDAQ: IOVA) stock price defied gravity on Friday as investors cheered the latest FDA update about its drug. The shares jumped by more than 15% even as the Nasdaq 100 and S&P 500 indices retreated.

IOVA stock price soared but risk/reward is unfavourable for now

Iovance (IOVA) rises despite the FDA's postponement of the decision date regarding the regulatory filing for its lead candidate, lifileucel, to treat advanced melanoma due to resource constraints.

Iovance (IOVA) Up Despite FDA's Delayed Decision on Melanoma Drug

Iovance Biotherapeutics (NASDAQ:IOVA) stock looked to soar at Friday's market open, recovering from a steep loss on Thursday after the company said the US Foood and Drug Administration (FDA) needed more time to complete the priority review of its Biologics License Application (BLA) for its lifileucel melanoma therapy due to resource constraints. In a statement, the company said the FDA extended the new target action date for a decision under the Prescription Drug User Fee Act (PDUFA) to February 24, 2024, but agreed to work with Iovance to expedite the remaining review for a potentially earlier approval date.

Iovance Biotherapeutics stock soars, recovering on positive engagement with FDA

Priority Review Continues with Successful Facility Inspections Completed, no Major Review Issues FDA Extends PDUFA Date to February 24, 2024 on Resource Constraints and Agrees to Work with Iovance to Expedite Remaining Review SAN CARLOS, Calif., Sept. 14, 2023 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the U.S. Food and Drug Administration (FDA), because of resource constraints, requires additional time to complete the Priority Review of Iovance's Biologics License Application (BLA) for lifileucel.

U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma

One analyst downgraded his price target for the stock on Wednesday. Iovance's lead therapy is Lifileucel, which treats multiple cancer types.

News for Iovance Biotherapeutics Stock (IOVA)