On August 7, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial (Press release, FibroGen, AUG 7, 2025, View Source [SID1234654975]).

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"We are very pleased with the feedback we received from the FDA regarding roxadustat in patients with LR-MDS and anemia with high transfusion burden. This indication, despite recent approvals, still represents a patient population with significant unmet need," said Thane Wettig, Chief Executive Officer of FibroGen. "We believe roxadustat’s differentiated mechanism of action, favorable tolerability profile, and oral route of administration can potentially be an important addition to the treatment options for patients with high transfusion burden. We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year."

"Anemia is a major cause of morbidity and complications in patients with LR-MDS, especially those with high transfusion burden, and is often associated with poor quality of life and shortened survival. While we have recent approvals of injectable drugs for this indication, there is a significant unmet need for novel, effective oral agents for this patient population," added Amer Zeidan, M.B.B.S, M.H.S., Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center, and the global principal investigator of the planned Phase 3 study. "Roxadustat has already shown promising efficacy in this group of patients in the post-hoc analysis of the MATTERHORN study, and I am glad we have agreed on a pathway with the regulators to explore the full potential of roxadustat in the upcoming Phase 3 trial. I am excited by the prospect of roxadustat potentially becoming a novel, safe, convenient, and effective therapy for LR-MDS patients with high transfusion burden."

FibroGen requested the Type C meeting based on the findings of a post-hoc analysis of data from the Phase 3 MATTERHORN trial of roxadustat in anemia-associated with LR-MDS. In patients with high RBC transfusion burden at baseline (≥4 units over 8 weeks1), a pronounced treatment effect was observed: 36% (8/22) of patients achieved transfusion independence (TI) for ≥ 56 days on roxadustat vs 7% (1/15) of patients on placebo within 28 weeks (nominal p-value of 0.041).

The planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with LR-MDS. Alignment was reached with the FDA on the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria. As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI.

FibroGen plans to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025.

About Myelodysplastic Syndromes Anemia
Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S, thereof 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

On August 7, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the second quarter ended June 30, 2025 (Press release, Nektar Therapeutics, AUG 7, 2025, View Source [SID1234654991]).

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Cash and investments in marketable securities on June 30, 2025 were $175.9 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities at June 30, 2025 do not include $107.5 million of approximate net proceeds from the secondary offering closed on July 2, 2025. With the net proceeds from the secondary offering, we expect our cash and investments in marketable securities to support our operations into the first quarter of 2027.

"This quarter, we announced transformative data for rezpegaldesleukin from the Phase 2b study in patients with moderate to severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "The 16-week induction data demonstrated that rezpegaldesleukin resulted in a rapid onset of EASI response and itch relief and showcased the advantage of a broad-based Treg mechanism over other mechanistic approaches in development to treat atopic dermatitis. We look forward to seeing the effect of continued treatment with rezpegaldesleukin when we report the 52-week data in early 2026. In alopecia areata, we will report the data from a separate Phase 2b study in December of this year. We believe the data from both randomized studies will demonstrate the potential of rezpegaldesleukin to provide a new treatment paradigm for patients with chronic and serious diseases that significantly impact quality of life. As a first-in-class, T regulatory cell biologic, rezpegaldesleukin is poised to become an important novel mechanism to treat millions of patients with autoimmune disorders."

"We are proceeding in our IND-enabling studies for our next T reg program, NKTR-0165, which targets the TNFR2 receptor to stimulate tissue-specific T regulatory cells," continued Robin. "Our goal is to advance NKTR-0165 into the clinic in 2026. Finally, we are making significant progress on advancing preclinical studies with a new bispecific antibody, NKTR-0166, which combines the TNFR2 epitope with a validated antibody target."

Summary of Financial Results

Revenue in the second quarter of 2025 was $11.2 million as compared to $23.5 million in the second quarter of 2024. Revenue for the first half of 2025 was $21.6 million as compared to $45.1 million in the first half of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the second quarter of 2025 were $47.4 million as compared to $73.3 million in the second quarter of 2024. Total operating costs and expenses in the first half of 2025 were $102.4 million as compared to $130.3 million in the first half of 2024. Operating costs and expenses for the first half of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility, as well as a decrease in restructuring and impairment charges.

R&D expense in the second quarter of 2025 was $29.9 million as compared to $29.7 million for the second quarter of 2024. R&D expense in the first half of 2025 was $60.4 million as compared to $57.1 million for the first half of 2024. R&D expense increased for the first half of 2025 primarily due to an increase in expenses for the development of rezpegaldesleukin and NKTR-0165, partially offset by a decrease in expense for the development of NKTR-255.

G&A expense was $17.1 million in the second quarter of 2025 as compared to $20.5 million in the second quarter of 2024. G&A expense was $41.4 million in the first half of 2025 as compared to $40.7 million in the first half of 2024. G&A expense increased slightly in the first half of 2025 due to an increase in legal expenses, partially offset by decreases in facilities and stock-based compensation expenses.

Non-cash restructuring and impairment charges were not material in the second quarter and first half of 2025. Non-cash restructuring and impairment charges in the second quarter of 2024 were $13.3 million and $14.3 million in the first half of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $2.4 million in the second quarter of 2025 and $6.8 million in the first half of 2025.

Net loss for the second quarter of 2025 was $41.6 million or $2.95 basic and diluted loss per share as compared to a net loss of $52.4 million or $3.761 basic and diluted loss per share in the second quarter of 2024. Net loss in the first half of 2025 was $92.5 million or $6.57 basic and diluted loss per share as compared to a net loss of $89.2 million or $6.631 basic and diluted loss per share in the first half of 2024. Excluding the $2.4 million and $6.8 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the second quarter and first half of 2025 were $39.2 million and $85.6 million, respectively, or $2.78 and $6.08 basic and diluted loss per share, respectively.

Recent Business Highlights

● In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.

● In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters’ option to purchase additional shares, raising $115 million in gross proceeds.

● In June of 2025, Nektar announced that the REZOLVE-AD study achieved statistical significance on the primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo and achieved statistical significance for key secondary endpoints at week 16, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA. The rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory T-cell mechanism as a first and best-in-class immune-modulator.

● In June of 2025, Nektar collaborators at the Fred Hutchinson Cancer Center presented oral data for NKTR-255 as adjunctive treatment to cell therapy at the 30th Annual European Hematological Association (EHA) (Free EHA Whitepaper) Congress entitled, "Enhanced CAR T-cell Expansion and Durable Complete Responses with NKTR-255 Plus Lisocabtagene Maraleucel in Relapsed/Refractory Large B-cell Lymphoma."

Conference Call to Discuss Second Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on August 7, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through September 8, 2025.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

On August 7, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a new drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, reported that US National Cancer Institute (NCI) sponsors Senhwa’s second program IND has been submitted to US FDA for clinical trial targeting MYC-aberrant lymphoma (Press release, Senhwa Biosciences, AUG 7, 2025, View Source [SID1234655010]). Following the initiation of the first trial using CX-5461 as a monotherapy in advanced solid tumors, the IND-submission of the second trial marks a milestone in the development of CX-5461.

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With sponsorship from the NCI, this program significantly reduces Senhwa’s clinical development expenditures, easing its R&D financial demands while enhancing the overall project value and commercialization potential—a major positive for the company’s future growth.

A Globally Innovative G4-Targeting Mechanism Against Hard-to-Treat MYC-Driven Lymphomas – 30% of Cancers Involve MYC Mutation

MYC is a critical oncogene, with approximately 28% of cancer patients exhibiting gene amplification or mutation, including in lung, breast, liver cancers, and lymphomas. The MYC protein drives cell proliferation, angiogenesis, and apoptosis suppression, playing a key role in multiple malignancies. CX-5461, developed by Senhwa, precisely stabilizes the G-quadruplex (G4) structures in DNA within cancer cells, suppressing MYC gene expression and effectively disrupting tumor growth pathways.

Preclinical research has demonstrated that CX-5461 exhibits strong inhibitory effects against MYC-overexpressing tumors, highlighting its potential as a next-generation targeted cancer therapy—especially promising for difficult-to-treat lymphomas.

With NCI Sponsorship Significantly Reduces R&D Costs

The clinical trial program is fully led and partially funded by the NCI, covering clinical trial design, operational personnel, trial sites, regulatory, and data management resources. According to Senhwa’s internal estimates, this sponsorship could reduce Senhwa’s clinical development expenditures, easing its R&D financial costs, enhancing development efficiency and accelerating commercialization progress.

Substantial Market Potential for B-cell Lymphomas – Global Annual Sales Expected to Surpass USD 10 Billion

According to BioSpace market data, global sales of B-cell lymphoma therapies reached USD 4.9 billion in 2024 and are projected to grow to USD 8.9 billion by 2035, with a steady compound annual growth rate (CAGR) of 5.79%. There is particularly strong demand for novel targeted therapies for relapsed and refractory lymphoma patients, revealing a significant market gap.

With its unique mechanism and precision medicine potential, Senhwa’s CX-5461 is well-positioned to enter the high-value niche market upon successful progression into late-stage clinical trials and potential regulatory approval, offering substantial commercial value.

CX-5461: The World’s First and Most Advanced G4-Quadruplex Stabilizer for Cancer Treatment

CX-5461 is the world’s first and most advanced anti-cancer investigational drug targeting G-quadruplex DNA structures. It specifically modulates the expression of key oncogenes like MYC, thereby inhibiting cancer cell proliferation and survival. The upcoming NCI-sponsored will evaluate CX-5461 dose optimization and treatment efficacy in Patients with MYC-aberrant, specific subtypes of aggressive B-cell non-Hodgkin lymphoma who have received at least one prior line of therapy and have no other available treatment options, aiming to address critical unmet medical needs with a potentially breakthrough therapeutic solution.

On August 7, 2025 LaNova Medicines Ltd. reported that its internally developed CEACAM5/4-1BB bispecific antibody, LM-24C5, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to initiate a Phase II clinical trial (Press release, LaNova Medicines, AUG 7, 2025, View Source [SID1234656022]). The trial will evaluate LM-24C5 in combination with other anti-tumor agents in patients with CEACAM5-positive advanced solid tumors.

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CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5) is highly expressed in various solid tumors—including non-small cell lung cancer, colorectal cancer, and gastric cancer—making it a promising target for cancer therapy[1]. LM-24C5 is a conditionally activated bispecific antibody engineered using LaNova’s proprietary 4-1BB agonist platform. It is designed to simultaneously bind CEACAM5 on tumor cells and 4-1BB on immune cells, thereby directing and activating immune responses within the tumor microenvironment while minimizing off-target immune activation and associated systemic toxicities.

Preclinical studies have demonstrated that LM-24C5 can induce durable anti-tumor immune memory and exhibits synergistic effects when used in combination with other immunotherapeutic agents. These results support its potential to become a first-in-class immunotherapy.

LM-24C5 is currently in Phase I/II clinical development in the United States.

On August 7, 2025 Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported second quarter 2025 financial results and recent portfolio and business updates (Press release, Alector, AUG 7, 2025, View Source [SID1234654960]). As of June 30, 2025, Alector’s cash, cash equivalents, and investments totaled $307.3 million.

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"The topline results from the pivotal INFRONT-3 Phase 3 trial of latozinemab, expected by mid-fourth quarter, represent a key inflection point for Alector and for the FTD community," said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. "FTD is a devastating form of dementia that affects people in the prime of life, has no approved treatments, and is often fatal within a decade of diagnosis. Heterozygous loss-of-function mutations in the GRN gene reduce progranulin levels by about 50%, impairing neuronal function and driving neurodegeneration. Latozinemab, our investigational therapy for FTD-GRN being developed in collaboration with GSK, is designed to restore progranulin levels in the brain. Supported by data from an open-label Phase 2 study, the FDA granted Breakthrough Therapy designation to latozinemab. The INFRONT-3 results will inform our next steps toward potential registration and may bring us one step closer to delivering a treatment for this relentless disease."

Dr. Rosenthal continued, "In parallel, we are advancing AL101 in early Alzheimer’s disease, with a placebo-controlled, double-blind, 76-week Phase 2 trial that is expected to complete in 2026. At the same time, we continue to build our preclinical and research pipeline, including brain-penetrant candidates enabled by our proprietary Alector Brain Carrier platform. Progressing late-stage clinical programs while investing in innovative early assets positions Alector to create near- and long-term value for both patients and shareholders. With a cash runway into the second half of 2027, we are well resourced to advance our scientific and strategic goals."

Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, "Over the past quarter, we’ve made steady progress across our wholly owned preclinical and research pipeline, including programs powered by our proprietary Alector Brain Carrier platform. This technology is designed to deliver therapeutic cargos, including antibodies, proteins, enzymes, and siRNA, across the blood-brain barrier, a critical challenge in treating neurodegeneration. Using this approach, we’re progressing brain-penetrant candidates, including our anti-amyloid beta antibody and anti-tau siRNA for Alzheimer’s disease, as well as our engineered GCase enzyme replacement therapy for Parkinson’s disease. This work underscores our commitment to developing first- and best-in-class therapies for patients with serious neurodegenerative diseases."

Recent Clinical Updates

Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK

Latozinemab

Alector and GSK remain on track to report topline data by the middle of the fourth quarter of 2025 from the pivotal, 96-week, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 trial evaluating latozinemab in frontotemporal dementia due to a GRN gene mutation (FTD-GRN). Pending the trial’s outcome, the companies are preparing for potential Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions in 2026.

The statistical analysis plan (SAP) for INFRONT-3 has been amended after engagement with the U.S. Food and Drug Administration (FDA). The SAP will include plasma progranulin (PGRN) as a co-primary endpoint along with the Clinical Dementia Rating plus National Alzheimer’s Coordinating Center Frontotemporal Lobar Degeneration Sum of Boxes (CDR plus NACC FTLD-SB).

Frontotemporal dementia (FTD) is a rare neurodegenerative disease and the most common form of dementia for people under the age of 60.1 It affects an estimated 50,000 to 60,000 individuals in the United States and roughly 110,000 in the European Union.2,3 There are several heritable forms of FTD, including FTD-GRN, which is caused by mutations in the GRN gene and represents about 5% to 10% of all cases.⁴ People with FTD often begin experiencing symptoms such as behavioral changes, lapses in judgment, and diminished language skills in their 40s and 50s.1 The disease typically progresses over 7 to 10 years and is ultimately fatal.5 Currently, there are no approved treatment options for any form of FTD.1

Heterozygous loss-of-function mutations in the GRN gene lead to haploinsufficiency, reducing PGRN levels in the central nervous system by 50%. These mutations are a known genetic cause of FTD.6 PGRN is a secreted glycoprotein that regulates lysosomal function, neuronal survival, and inflammation in the brain.6

Latozinemab is a novel, investigational human monoclonal antibody (mAb) designed to block and internalize the sortilin receptor to elevate PGRN levels in the brain. It is believed to be the most advanced therapeutic candidate in development for the treatment of FTD-GRN.

Latozinemab has been granted Breakthrough Therapy and Fast Track designations by the FDA for the treatment of FTD-GRN, as well as Orphan Drug designation by both the FDA and the European Medicines Agency for the treatment of FTD.

AL101/GSK4527226

The global, randomized, double-blind, placebo-controlled PROGRESS-AD Phase 2 clinical trial of AL101/GSK4527226 in early Alzheimer’s disease (AD) is ongoing, with enrollment completed in April 2025 and trial completion expected in 2026.

AL101 is an investigational human mAb designed to block and internalize the sortilin receptor to elevate PGRN levels in the brain. It is similar to latozinemab but has distinct pharmacokinetic and pharmacodynamic properties that may make it suitable for the potential treatment of more prevalent neurodegenerative diseases.

In July 2025, Alector published a manuscript titled "Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer’s disease" in Alzheimer’s Research & Therapy. The publication outlines preclinical and Phase 1 study results, demonstrating that AL101 bound to sortilin and decreased cell surface sortilin levels, leading to consistent elevations of PGRN across in vitro, preclinical, and Phase 1 studies. These results support continued development of AL101 and its investigation as a potential treatment for AD and other neurodegenerative conditions where PGRN could play a role.

Preclinical and Research Pipeline

Alector continues to advance its preclinical and early research pipeline, selectively supported by Alector Brain Carrier (ABC), the company’s proprietary blood-brain barrier technology platform.

The company is progressing ADP037-ABC, its brain-penetrant anti-amyloid beta antibody in AD; ADP050-ABC, its brain-penetrant engineered GCase enzyme replacement therapy in Parkinson’s disease; and ADP064-ABC, its brain-penetrant anti-tau siRNA in AD, all of which are enabled by ABC. Alector is currently evaluating potential candidates and continues to target clinical entry for ADP037-ABC and ADP050-ABC in 2026, pending resource allocation, lead candidate selection, and the results of preclinical studies.

Corporate News

Neil Berkley, M.B.A., assumed the role of Interim Chief Financial Officer in June 2025 while continuing as Chief Business Officer. With a proven track record in corporate development and business strategy, Mr. Berkley brings insightful leadership to Alector as the company advances through key clinical and research milestones in his expanded role.

In the third quarter of 2025, the U.S. Patent and Trademark Office issued a patent covering methods of treatment using latozinemab in individuals with FTD-GRN.

Second Quarter 2025 Financial Results

Revenue. Collaboration revenue for the quarter ended June 30, 2025, was $7.9 million, compared to $15.1 million for the same period in 2024. The $7.2 million decrease was mainly due to the satisfaction of the performance obligation associated with the AL002 program and the latozinemab FTD-C9orf72 Phase 2 trial in the fourth quarter of 2024.

R&D Expenses. Total research and development expenses for the quarter ended June 30, 2025, were $27.6 million, compared to $46.3 million for the quarter ended June 30, 2024. The decrease of $18.7 million was mainly due to a decrease in research and development expenses for the AL002 program and latozinemab program as well as a decrease in personnel related costs as a result of the reductions in force.

G&A Expenses. Total general and administrative expenses were $14.4 million for both the three months ended June 30, 2025, and the three months ended June 30, 2024.

Net Loss. For the quarter ended June 30, 2025, Alector reported a net loss of $30.5 million, or $0.30 per share, compared to a net loss of $38.7 million, or $0.40 net loss per share, for the same period in 2024.

Cash Position. Cash, cash equivalents, and investments were $307.3 million as of June 30, 2025. Management anticipates that this will be sufficient to fund Alector’s operations into the second half of 2027.

2025 Guidance. Management is updating its guidance for the year ending 2025. The company anticipates collaboration revenue to be between $13 million and $18 million, total research and development expenses to be between $130 million and $140 million, and total general and administrative expenses to be between $55 million and $65 million.