Biotech Stocks Race Towards Solutions for Cutaneous T-Cell Lymphoma (CTCL)

Rhea-AI Summary

Biotech stocks are racing towards solutions for Cutaneous T-Cell Lymphoma (CTCL), with the market projected to reach $1.38 Billion by 2030. Citius Pharmaceuticals (NASDAQ: CTXR) is approaching the FDA target date of August 13th for its LYMPHIR product candidate. The FDA has accepted the resubmission of Citius' Biologics License Application (BLA) for LYMPHIR, an IL-2-based immunotherapy for relapsed or refractory CTCL. EF Hutton initiated coverage of CTXR with a Buy recommendation and a $6.00 price target. Other companies like Soligenix and Takeda-Pfizer are also making progress in CTCL and lymphoma treatments, highlighting the growing interest and potential in this market.

Positive

• FDA accepted resubmission of BLA for LYMPHIR with PDUFA goal date of August 13, 2024
• EF Hutton initiated coverage with Buy recommendation and $6.00 price target
• CTCL market projected to reach $1.38 Billion by 2030
• No safety or efficacy issues cited in FDA's Complete Response Letter

Negative

• Current CTCL therapies are non-curative and often have duration of response
• Existing targeted therapies for CTCL are often poorly tolerated or have efficacy

Insights

Financial Analyst

Citius Pharmaceuticals (NASDAQ: CTXR) is approaching a key milestone with the FDA's upcoming decision on LYMPHIR™, an IL-2-based immunotherapy targeting Cutaneous T-Cell Lymphoma (CTCL). This is significant because an FDA approval generally leads to a positive stock market reaction, potentially boosting investor confidence and share price. The U.S. market for CTCL treatments is projected to reach 1.38 billion by 2030, presenting a substantial revenue opportunity if LYMPHIR™ is approved. This decision will also impact Citius's market position, especially as current CTCL therapies are non-curative and have limited efficacy.

Additionally, EF Hutton's initiation of coverage with a 'Buy' recommendation and a price target of 6.00 further enhances market sentiment. This recommendation could attract retail investors looking for potential growth stocks in the biotech sector. It's essential to note that while analyst recommendations are influential, they should be considered alongside other financial metrics and market conditions.

In the short term, the FDA's decision will likely be the primary driver of stock movement. In the long term, the overall market potential and competitive position of LYMPHIR™ will influence sustainable growth prospects and revenue generation for Citius Pharmaceuticals.

Medical Research Analyst

The development of LYMPHIR™, particularly its resubmission after addressing FDA's concerns, is a pivotal event. The fact that no safety or efficacy issues were noted in the Complete Response Letter (CRL) is promising. This suggests that the primary hurdles were related to manufacturing and product testing, which Citius believes it has resolved.

For those unfamiliar, CTCL is a rare type of cancer affecting the skin and existing treatments often fall short in terms of efficacy and tolerability. LYMPHIR™'s unique mechanism of action (MOA), leveraging the properties of IL-2 (a growth factor for white blood cells), may offer a non-cross-resistant option, potentially benefiting patients who have exhausted other treatments. This could position LYMPHIR™ as a significant treatment option in an otherwise limited therapeutic landscape.

Furthermore, the Phase 3 study supporting the BLA (Biologics License Application) underscores LYMPHIR™'s robustness. Successful trial results often translate into greater clinical acceptance and can rapidly build a product's market share.

Market Research Analyst

The CTCL treatment market, currently valued at approximately 399 million as of 2021, is projected to grow significantly, reaching 1.38 billion by 2030. This growth is driven by the need for more effective and tolerable therapies, as current treatments often face resistance and are non-curative. LYMPHIR™'s potential approval aligns well with these market needs, signaling a positive outlook for its commercial success.

It's also important to consider the competitive landscape. Other companies, such as Soligenix, are also developing treatments for CTCL. However, LYMPHIR™'s differentiated MOA could provide a competitive edge. Investors should watch for future comparative studies and real-world data, which will further clarify LYMPHIR™'s position in the market.

EF Hutton's valuation assumption of 200,000 per treatment, consistent with competing therapies, provides an insight into the potential revenue per patient. This high price point reflects the premium market for advanced treatments in rare diseases but also indicates the necessity of proving LYMPHIR™'s clinical and economic value to secure insurance coverage and physician adoption.

Vancouver, Kelowna, and Delta, British Columbia--(Newsfile Corp. - July 18, 2024) - Investorideas.com, a go-to investing platform releases the second of a two-part series looking at biotech/biopharma stocks, featuring Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates.

Read the full article on Investorideas.com
https://www.investorideas.com/News/2024/biotech/07180Cutaneous-T-Cell-Lymphoma.asp

Looking specifically at the opportunity for Cutaneous T-Cell Lymphoma (CTCL) treatments, the market was approximately USD 399 Million in 2021 says Delveinsight. "CTCL has an active pipeline as many pharmaceutical companies are working toward developing an effective and affordable therapy. The disease has a tendency to show resistance to medications creating a need for a more efficacious and effective drug."

The US Cutaneous T-cell Lymphoma Market is projected to reach $1.38 Billion by 2030 reports Insights10.

Citius Pharmaceuticals (NASDAQ: CTXR) is approaching the FDA target date of August 13^th for its LYMPHIR product candidate to address this unmet need.

Citius announced earlier this year that the US Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024.

"The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL. No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA submission," stated Leonard Mazur, Chairman and CEO of Citius.

"We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative. We are grateful for the FDA's vital support for rare disease drug development as we work to expand treatment options for patients with cutaneous T-cell lymphoma. We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL," added Mazur.

More from the news: The BLA is supported by a pivotal Phase 3 study (NCT01871727). The resubmission follows dialog with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023. Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter. There were no safety or efficacy issues cited and no additional trials required.

EF Hutton just initiated coverage of Citius Pharmaceuticals (NASDAQ: CTXR) with a Buy recommendation with a price target of $6.00. Analyst Jason Kolbert sees the stock as low risk - high reward based on their two late stage therapeutics, Mino-Lok and LYMPHIR.

Talking about LYMPHIR he said, "Since CTCL treatments are non-curative and often have a limited duration of response and/or discontinued early, patients are put on multiple alternative therapies.

"LYMPHIR's differentiated MOA reinforces rationale for inclusion among the current core therapeutic options in the US market."

Kolbert also notes, "We assume a price of $200,000 per treatment, consistent with competing therapies in the CTCL space."

Soligenix, Inc., a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, on July 9^th announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date six patients have been enrolled and treated with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the remaining three patients, two have only recently started HyBryte™ therapy and have not yet reached their first efficacy evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but has not yet achieved the success threshold. In addition, HyBryte™ appears to be safe and well tolerated in all patients, with no treatment-related adverse events reported to date.

Continued: "In the Phase 3 FLASH study, HyBryte™ was shown to be efficacious with a promising safety profile. With limited treatment options, especially in the early stages of their disease, CTCL patients are often searching for alternative treatments. In our U.S. Food and Drug Administration (FDA)-funded study, initial results evaluating the expanded use of HyBryte™ in a 'real world' treatment setting are promising, further supporting and extending results from the previous positive Phase 2 and 3 clinical trials," noted Dr. Kim, Principal Investigator of the IIS. "We look forward to continuing to work with the FDA to complete this study and to participating in the upcoming confirmatory Phase 3 placebo-controlled study."

In June, Takeda and Pfizer announced Four-Year results from positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma.

The four-year analysis presented by the GHSG showed superior progression-free survival (PFS) and improved tolerability for patients compared to a current standard of care regimen used in Europe in this setting.

"In our ongoing effort to improve outcomes for patients with lymphoma, we've partnered with the GHSG on the HD21 study to deepen our understanding of how ADCETRIS could further benefit patients in need of new options," said Awny Farajallah, Chief Medical Officer, Global Oncology at Takeda.

The HD21 study is a Phase 3, randomized, multi-country, prospective, open-label study, sponsored by the GHSG and supported by Takeda, designed to evaluate ADCETRIS in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone (BrECADD) in comparison to a standard of care treatment - escalated doses of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone (eBEACOPP) - in patients with newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. At a preplanned three-year analysis, the study met its co-primary endpoints, with the ADCETRIS combination regimen demonstrating significantly.

More from the news: ADCETRIS received conditional marketing authorization from the European Commission in October 2012, and the specific obligations of the conditional marketing authorization were fulfilled in May 2022. The approved indications in the European Union are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage III & IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, (5) for the treatment of adult patients with previously untreated sALCL in combination with CHP and (6) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL.

Continued: ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Pfizer and Takeda fund joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) says on its website, "There is no single standard-of-care for the treatment of CTCL, with only a few FDA-approved targeted therapies for patients with advanced CTCL. Existing targeted therapies are often poorly tolerated or have limited efficacy and may be discontinued due to toxicity, adverse events, or the development of resistance to treatment. As such, we expect LYMPHIRTM, with its unique non-cross-resistant mechanism-of-action and ONTAK's prior well documented safety and efficacy profile, to be an important option for patients and their physicians in the management of this disease."

Read part one of this series - Analysts Hunt for Undervalued Biotech Stocks
https://www.investorideas.com/news/2024/biotech/07113Transformative-Biopharma-Stocks.asp

Research and find more biotech stocks at Investorideas.com
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FAQ

What is the FDA target date for Citius Pharmaceuticals' LYMPHIR product?

The FDA target date for Citius Pharmaceuticals' (NASDAQ: CTXR) LYMPHIR product is August 13, 2024.

What is the projected market size for Cutaneous T-Cell Lymphoma (CTCL) by 2030?

The US Cutaneous T-cell Lymphoma Market is projected to reach $1.38 Billion by 2030.

What is EF Hutton's price target for Citius Pharmaceuticals (CTXR) stock?

EF Hutton initiated coverage of Citius Pharmaceuticals (NASDAQ: CTXR) with a Buy recommendation and a price target of $6.00.

What is LYMPHIR designed to treat?

LYMPHIR is an IL-2-based immunotherapy designed to treat patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.