On October 26, 2023 Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported results for the third quarter ended September 30, 2023, and updated full-year guidance (Press release, LabCorp, OCT 26, 2023, View Source [SID1234636376]).

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"Labcorp delivered strong third quarter results in our Diagnostics Laboratories and Biopharma Laboratory Services businesses," said Adam Schechter, chairman and CEO. "The company has momentum in our health system strategy and is significantly advancing our specialty testing capabilities. We continue to harness science and technology to drive innovation and accelerate growth."

The company continues to advance its hospital and health system strategy by establishing and expanding strategic collaborations to enhance laboratory services for patients and providers. During the quarter Labcorp achieved a number of important milestones:

Tufts Medicine: Closed the acquisition of the outreach laboratory business and select operating assets, and entered into a separate agreement to manage the hospital laboratories
Providence Health & Services – Oregon: Closed the acquisition of select outreach laboratory assets
Legacy Health: Signed an agreement to acquire the outreach laboratory business and manage the hospital laboratories
Baystate Health: Signed an agreement to acquire the outreach laboratory business and select operating assets
Additionally, in September Labcorp introduced its ATN Profile, a first-of-its-kind blood-based test that combines three well-researched blood biomarkers to identify and assess biological changes associated with Alzheimer’s disease, aiming to accelerate the path to diagnosis and intervention. The ATN Profile is available through physicians for use with patients being evaluated for possible Alzheimer’s disease or other causes of cognitive impairment and supports more informed decision-making and improved personalized patient care.

On September 14, 2023, Labcorp hosted an Investor Day highlighting the company’s go-forward strategy followed by business overviews and a longer-term financial outlook provided by members of the leadership team. A replay of the webcast and supporting materials are available on the Investor Relations section of the Company’s website at View Source

On October 12, 2023, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on December 12, 2023, to stockholders of record at the close of business on November 8, 2023.

Consolidated Results

Third Quarter Results

Revenue for the quarter was $3.06 billion, an increase of 6.6% from $2.87 billion in the third quarter of 2022. The increase was due to organic revenue of 3.7%, acquisitions, net of divestitures, of 2.2%, and foreign currency translation of 0.7%. The 3.7% increase in organic revenue was driven by a 10.1% increase in the company’s organic Base Business, partially offset by a (6.3%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing). Compared to the Base Business last year, Base Business revenue grew 14.0%. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $252.3 million, or 8.3% of revenue, compared to $374.0 million, or 13.0%, in the third quarter of 2022. The company recorded amortization, restructuring charges, and special items, which together totaled $171.6 million in the quarter, compared to $116.6 million during the same period in 2022. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $423.9 million, or 13.9% of revenue, compared to $490.6 million, or 17.1%, in the third quarter of 2022. The decrease in operating income was due to a reduction in COVID-19 Testing. The margin decline was due to lower COVID-19 Testing as well as the mix impact from the Ascension lab management agreement.

Net earnings from continuing operations for the quarter were $183.6 million compared to $277.3 million in the third quarter of 2022. Diluted EPS from continuing operations were $2.11 in the quarter compared to $3.06 during the same period in 2022. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $3.38 in the quarter compared to $4.01 in the third quarter of 2022.

Operating cash flow from continuing operations for the quarter was $275.5 million compared to $253.0 million in the third quarter of 2022. The increase in operating cash flow was due to higher cash earnings. Capital expenditures totaled $104.9 million compared to $82.8 million a year ago. As a result, free cash flow from continuing operations (operating cash flow from continuing operations less capital expenditures) was $170.6 million compared to $170.2 million in the third quarter of 2022.

At the end of the quarter, the company’s cash balance was $0.73 billion and total debt was $5.42 billion, respectively. During the quarter, the company invested $379.8 million on acquisitions, paid out $63.9 million in dividends, and used $1.00 billion for share repurchases that we expect will be completed by year end.

Year-To-Date Results

Revenue was $9.13 billion, an increase of 2.2% from $8.93 billion, in the first nine months of 2023. The increase was due to acquisitions, net of divestitures, of 1.8%, organic revenue of 0.3% and favorable foreign currency translation of 0.1%. The 0.3% increase in organic revenue was driven by a 10.0% increase in the company’s organic Base Business, partially offset by a (9.6)% decrease in COVID-19 Testing.

Operating income was $848.4 million, or 9.3% of revenue, compared to $1,408.0 million, or 15.8%, in the first nine months of 2023. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $471.6 million in the first nine months of 2023 compared to $352.0 million during the same period in 2022. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $1,320.0 million, or 14.5% of revenue, compared to $1,760.0 million, or 19.7%, in the first nine months of 2022. The decrease in operating income was due to a reduction in COVID-19 Testing. The margin decline was due to lower COVID-19 Testing as well as the mix impact from the Ascension lab management agreement.

Net earnings from continuing operations were $547.2 million compared to $966.4 million in the first nine months of 2022. Diluted EPS were $6.19 in the first nine months of 2023 compared to $10.45 during the same period in 2022. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $10.26 in the first nine months of 2023 compared to $13.57 during the same period in 2022.

Operating cash flow from continuing operations was $622.7 million compared to $1,157.6 million in the first nine months of 2022. The decrease in operating cash flow was due to lower COVID-19 Testing earnings, spin-related items and higher working capital, partially offset by increased Base Business earnings. Capital expenditures totaled $286.4 million compared to $330.2 million during the same period in 2022. As a result, free cash flow from continuing operations (operating cash flow from continuing operations less capital expenditures) was $336.3 million compared to $827.4 million in the first nine months of 2022.

Third Quarter Segment Results

The company’s two segments include Diagnostics Laboratories and Biopharma Laboratory Services (comprised of Central Laboratories and Early Development Research Laboratories). The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics Laboratories

Revenue for the quarter was $2.34 billion, an increase of 6.2% from $2.21 billion in the third quarter of 2022. The increase was due to organic growth of 3.4% and acquisitions of 3.0%, partially offset by foreign currency translation of (0.1%). The 3.4% increase in organic revenue was due to an 11.6% increase in the Base Business, partially offset by a (8.2%) decrease in COVID-19 Testing. Total Base Business growth compared to the Base Business in the prior year was 15.9%. The Ascension lab management agreement contributed approximately 6% of the Base Business growth.

Total volume (measured by requisitions) increased by 2.3% as acquisition volume contributed 3.4%, while organic volume decreased by (1.1%). Organic volume was impacted by a (4.5%) decrease in COVID-19 Testing, partially offset by a 3.4% increase in the Base Business. Price/mix increased by 3.9% due to organic Base Business growth of 8.2%, partially offset by COVID-19 Testing of (3.7%), acquisitions of (0.4%), and currency of (0.1%). Base Business volume increased 7.2% compared to the Base Business last year. Price/mix was up 8.8% in the Base Business compared to the Base Business last year, which includes the benefit of the Ascension lab management agreement.

Adjusted operating income for the quarter was $386.3 million, or 16.5% of revenue, compared to $439.8 million, or 19.9%, in the third quarter of 2022. The decrease in adjusted operating income was due to a reduction in COVID-19 Testing, while the margin was also affected by the mix impact from Ascension. Excluding the mix impact from Ascension, Base Business margin was up as the benefit of organic growth and LaunchPad savings were partially offset by higher personnel expense.

Biopharma Laboratory Services

Revenue for the quarter was $719.1 million, an increase of 7.9% from $666.4 million in the third quarter of 2022. The increase was primarily due to organic growth of 4.9% and foreign currency translation of 3.3%, partially offset by divestitures of (0.2%).

Adjusted operating income for the quarter was $109.0 million, or 15.2% of revenue, compared to $105.0 million, or 15.8%, in the third quarter of 2022. Adjusted operating margin decreased due to stranded costs as a result of the spin of Fortrea, which is timing related. Excluding stranded costs, margins were up as the benefit of top line growth and LaunchPad savings were mostly offset by higher personnel costs.

Net orders and net book-to-bill during the trailing twelve months were $3.05 billion and 1.12, respectively. Backlog at the end of the quarter was $7.79 billion, an increase of 7.7% compared to last year. The company expects approximately $2.41 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2023

Labcorp is updating 2023 full year guidance to reflect its third quarter performance and full year outlook. The following guidance assumes foreign exchange rates effective as of September 30, 2023, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

On October 26, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will report third quarter 2023 financial results after the close of U.S. financial markets on Thursday, November 2, 2023 (Press release, Kura Oncology, OCT 26, 2023, View Source [SID1234636375]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing (888) 886-7786 for domestic callers and (416) 764-8658 for international callers. A live webcast and archived replay of the event will be available here or online from the investor relations section of the company website at www.kuraoncology.com.

On October 26, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its sales performance for the year to date and the third quarter of 2023 (Press release, Ipsen, OCT 26, 2023, View Source [SID1234636374]).

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YTD
2023 YTD
2022 % change Q3
2023 Q3
2022 % change
€m €m Actual CER1 €m €m Actual CER1
Oncology 1,744.1 1,767.2 -1.3% 0.8% 574.5 603.1 -4.7% 0.8%
Neuroscience 489.0 407.7 19.9% 24.5% 164.8 160.7 2.5% 13.7%
Rare Disease 76.0 33.6 n/a n/a 33.2 11.0 n/a n/a
Total Sales 2,309.1 2,208.5 4.6% 7.1% 772.4 774.8 -0.3% 6.5%

Sales and pipeline highlights

Total-sales growth in the year to date of 7.1% at CER1, or 4.6% as reported, driven by the performance of the growth platforms2, up by 16.1%1, with Dysport (abobotulinumtoxinA) up by 24.7%1 and Cabometyx (cabozantinib) up by 24.4%1, respectively. The performance included contributions from new medicines Bylvay (odevixibat), Tazverik (tazemetostat) and Sohonos (palovarotene)
Further pipeline progress, including the regulatory approval and launch in the U.S. of Sohonos in Rare Disease and initial results from the CONTACT-02 Phase III trial of Cabometyx plus atezolizumab in Oncology
David Loew, Chief Executive Officer, commented:
"Ipsen’s strategic success has been reflected in further sales and pipeline progress so far this year. Our portfolio has performed well across the three therapy areas, driven by strengthened commercial execution and the results of our external-innovation strategy. Based on the solid sales momentum, today we are confirming our guidance for the full year.

Further good news from the pipeline, including the regulatory approval of Sohonos in the U.S., continue to provide additional options for patients with real unmet medical needs. In the final quarter of the year, we look forward to regulatory steps for elafibranor in primary biliary cholangitis, as well as sharing further details on sustainable growth opportunities across our portfolio and pipeline at our forthcoming capital-markets day."

Full-year 2023 guidance
Ipsen has confirmed its financial guidance for FY 2023:

Total-sales growth greater than 6.0%, at constant exchange rates. Based on the average level of exchange rates in September 2023, an adverse impact on total sales of around 3.5% from currencies is expected
Core operating margin greater than 30% of total sales
Pipeline development

In August 2023, it was announced that the U.S. Food and Drug Administration (FDA) had approved Sohonos, the first and only treatment for people with fibrodysplasia ossificans progressiva.

It was also announced that the global CONTACT-02 pivotal Phase III trial of Cabometyx plus atezolizumab in metastatic castration-resistant prostate cancer met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival at the primary analysis.

In October 2023, the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products confirmed its negative opinion recommending not to maintain the orphan designation for Bylvay in Alagille syndrome (ALGS). This was despite a positive opinion from the Committee for Medicinal Products for Human Use in July 2023. To maintain Bylvay’s orphan designation in the approved treatment of progressive familial intrahepatic cholestasis, Ipsen is planning to resubmit to the EMA under a new brand name for the treatment of ALGS by the end of 2023.

Galderma partnership

In September 2023, the Arbitral Tribunal of the International Chamber of Commerce issued a final decision following a difference of opinion on the regulatory-submission strategy for the liquid botulinum toxin type A, QM1114. In October 2023, Ipsen announced that its partner, Galderma, had received a Complete Response Letter from the U.S. FDA related to its Biologics License Application for QM1114.

A second arbitration proceeding, related to the territorial scope of the Dysport/Azzalure aesthetics’ partnership, is anticipated to conclude next year.

AASLD call
To accompany the presentation of the ELATIVE Phase III trial results at the American Association for the Study of Liver Diseases (AASLD) 2023 Annual World Congress, Ipsen plans to host a conference call for analysts and investors on 14 November 2023, at 4.30pm CET. Participants can access the call and its details by registering here; webcast details can be found here. A recording will be available on ipsen.com.

Capital-markets day
The Company is planning to host a capital-markets event, starting at 12.30pm GMT on 7 December 2023 in London. The event will be webcast live and details will be available on ipsen.com in due course. In-person attendance will be by invitation only.

Calendar
Ipsen intends to publish its full-year and fourth-quarter results on 8 February 2024.

Conference call: YTD 2023
A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the call and its details by registering here; webcast details can be found here. A recording will be available on ipsen.com.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the nine-month period to 30 September 2023 (YTD 2023) and the three-month period to 30 September 2023 (Q3 2023), compared to nine-month period to 30 September 2022 (YTD 2022) and the three-month period to 30 September 2022 (Q3 2022), respectively, unless stated otherwise. Commentary is based on the performance in YTD 2023, unless stated otherwise.

On October 26, 2023 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, Insmed, OCT 26, 2023, View Source [SID1234636373]).

"Insmed made tremendous progress in the third quarter of 2023, punctuated by positive topline results from the ARISE study, encouraging blinded data from the Phase 2 trials of TPIP in PH-ILD and PAH, and the strongest quarter of ARIKAYCE revenues to date," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Each of our mid- to late-stage pipeline assets continue to demonstrate strong performance in the clinic and Insmed’s enormous potential. We are extremely excited about the robust series of clinical, regulatory, and commercial catalysts that lie ahead as we strive to bring forward first-in-class or best-in-class medicines to patients in need."

Recent Pillar Highlights

Pillar 1: ARIKAYCE

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•
ARIKAYCE global revenue grew 17% in the third quarter of 2023 compared with the third quarter of 2022, reflecting the strongest quarter of sales since commercial launch and continued sequential quarterly revenue growth in the U.S. and Japan.

•
Insmed continues to execute on its post-marketing, confirmatory trial program for ARIKAYCE, including the recently completed ARISE study and the ongoing ENCORE study in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics.

•
The Company announced positive topline efficacy and safety data from the ARISE trial in September of 2023. The study met its primary objective of validating a patient-reported outcome (PRO) instrument in patients with MAC lung disease. In addition, ARIKAYCE-treated patients had nominally statistically significantly higher culture conversion rates at Month 7 versus the comparator arm. Based on the results of ARISE, Insmed plans to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease.

•
The Company remains on track to enroll 250 patients in the registrational ENCORE study by the end of 2023. Enrollment is expected to continue into 2024, pending additional discussions with the U.S. Food and Drug Administration (FDA). Insmed anticipates reporting topline data from the ENCORE study in 2025.

1
Pillar 2: Brensocatib

•
Insmed continues to expect topline data from the ASPEN study, a global Phase 3 trial designed to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis, in the second quarter of 2024.

•
The Company has opened several study sites in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and is nearing randomization of the study’s first patients.

Pillar 3: TPIP

•
Insmed continues to enroll patients in a Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and a Phase 2 study in pulmonary arterial hypertension (PAH).

•
In the ongoing studies, 80% of the first 10 PH-ILD patients and 83% of the first 24 PAH patients who reached the Week 5 visit, which is the last possible point at which the dose can be increased in the trial, were able to titrate up to the maximum dose of 640 micrograms or matching placebo.

•
Adverse events observed to date in these trials have been consistent with the events commonly seen in patients with PAH or PH-ILD and with the known effects of inhaled prostacyclin therapies. In addition, adverse events related to cough have been mostly mild and there have been no instances of throat irritation or pain to date. A meeting of the Data Safety and Monitoring Board was held in October of 2023, where it was recommended that both studies continue as planned.

•
Based on a review of 22 patients who had completed 16 weeks of treatment in the ongoing PAH study, including patients receiving placebo, the average reduction in PVR from baseline was 21.5%. The average PVR reduction among the 64% of patients who had an improvement in PVR was 47%.

•
Insmed remains on track to report topline results from the Phase 2 study of TPIP in PH-ILD in the first half of 2024.

Pillar 4: Early-Stage Research

•
Insmed’s early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies.

•
The Company is continuing to advance its gene therapy program in Duchenne muscular dystrophy (DMD), including additional pre-clinical studies to further characterize its novel intrathecal route of gene therapy administration. Pending completion of this work, the Company expects to initiate clinical trials in patients. In parallel, the Company continues to advance its mid-length dystrophin DMD gene therapy program using its proprietary RNA-end-joining technology.

•
The Company continues to anticipate the totality of its early-stage research programs will comprise less than 20% of overall spend.

2
Third-Quarter 2023 Financial Results

•
Total revenue for the third quarter ended September 30, 2023 was $79.1 million, reflecting the Company’s strongest quarter of sales to date and 17% growth compared to total revenue of $67.7 million for the third quarter of 2022.

•
Total revenue for the third quarter of 2023 was comprised of ARIKAYCE net sales of $59.2 million in the U.S., $16.0 million in Japan, and $3.8 million in Europe and rest of world. Third-quarter sales reflect year-over-year growth of 20% and 11% in the U.S. and Japan, respectively, as well as the highest quarter of sales to date in these two regions.

•
Cost of product revenues (excluding amortization of intangibles) was $16.7 million for the third quarter of 2023, compared to $13.5 million for the third quarter of 2022, reflecting increased sales volumes of ARIKAYCE.

•
Research and development (R&D) expenses were $109.1 million for the third quarter of 2023, compared to $99.9 million for the third quarter of 2022 and $197.0 million for the second quarter of 2023. R&D expenses in third-quarter 2023 reflected continued investment in the Company’s early and mid- to late-stage pipelines.

•
Selling, general and administrative (SG&A) expenses for the third quarter of 2023 were $90.6 million, compared to $75.6 million for the third quarter of 2022 and $84.4 million for the second quarter of 2023. The year-over-year increase in SG&A expenses resulted primarily from an increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as increased fees and expenses driven by commercial readiness activities for brensocatib.

•
Insmed reported a net loss of $158.9 million, or $1.11 per share, for the third quarter of 2023, compared to a net loss of $131.1 million, or $1.09 per share, for the third quarter of 2022, and a net loss of $244.8 million, or $1.78 per share, for the second quarter of 2023.

Balance Sheet, Financial Guidance, and Planned Investments

•
As of September 30, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $786 million, down from $918 million as of June 30, 2023, reflecting the ongoing support of the ARIKAYCE franchise, commercial readiness activities for brensocatib, and clinical operations for its mid- to late-stage pipeline programs.

•
Insmed is reiterating its sales guidance for full-year 2023 global revenues for ARIKAYCE in the range of $295 million to $305 million.

•
Insmed continues to anticipate that over 80% of total expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company’s historical approach to spending.

•
The Company plans to continue to invest in the following key activities during the remainder of 2023:

(i)
commercialization and expansion of ARIKAYCE globally;

(ii)
advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, which is expected to be completed in the second quarter of 2024, and commercial launch readiness activities, as well as the Phase 2 trial in patients with CRSsNP, which is nearing randomization;

(iii)
advancement of the clinical trial program for ARIKAYCE (ARISE and ENCORE), which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;

(iv)
advancement of its Phase 2 clinical development programs for TPIP; and

(v)
development of its early-stage research platforms.

3
Conference Call

Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately 1 hour after its completion through November 25, 2023, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.

On October 26, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported that the U.S. Food and Drug Administration (FDA) has accepted for review ImmunityBio’s resubmission of its Biologics License Application (BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease, and considered it as a complete response to the FDA’s May 9, 2023 complete response letter (Press release, ImmunityBio, OCT 26, 2023, View Source [SID1234636372]). The FDA has set a user fee goal date (PDUFA date) of April 23, 2024.

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"We are pleased that the FDA has accepted ImmunityBio’s resubmission of the BLA as a complete response, following our productive interactions leading up to the resubmission. We look forward to working closely with the Agency to finalize the review and to bringing this important immune-enhancing therapeutic to patients suffering from bladder cancer," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

ImmunityBio’s IL-15 superagonist N-803 (also called Anktiva and nogapendekin alfa inbakicept)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel investigational IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its proposed mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding with generation of memory T-cells while avoiding T-reg stimulation. N-803 is designed to have improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

N-803 is currently being evaluated in adult patients in two clinical NMIBC trials. QUILT-2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT-3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC CIS and Papillary Disease.

N-803 is investigational. Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.