Biotech/Pharma Stocks
to Watch Citius Pharmaceuticals (Nasdaq: $CTXR), Soligenix (Nasdaq: $SNGX),
Takeda (NYSE: $TAK), Pfizer (NASDAQ: $PFE)
The
Race for Solutions for Cutaneous T-Cell Lymphoma (CTCL)
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.
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 13th
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.
Paid news
dissemination for Citius Pharmaceuticals.
Read this
article featuring CTXR in full at https://www.investorideas.com/news/2024/biotech/07181Cutaneous-T-Cell-Lymphoma.asp
"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. (Nasdaq: SNGX), a late-stage biopharmaceutical
company focused on developing and commercializing products to treat rare
diseases where there is an unmet medical need, on July 9th
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 (NYSE: TAK) and Pfizer (NASDAQ: PFE) 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
https://www.investorideas.com/BIS/Stock_List.asp
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