FibroGen, Inc. | MedPath

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Pharma Leadership Shuffle: Key Executive Moves in Early 2025 Reshape Industry Landscape

14 days ago

• The pharmaceutical industry has experienced significant leadership changes in early 2025, with major transitions at companies including Pfizer, Boehringer Ingelheim, and Takeda. • Former FDA CDER Director Patricia Cavazzoni's move to Pfizer as Chief Medical Officer has sparked "revolving door" criticisms, highlighting ongoing concerns about regulatory-industry transitions. • Several biotechnology firms have strengthened their executive teams with specialized expertise in clinical development, particularly in areas like stroke treatment, antibody-drug conjugates, and neuropsychiatric therapies.

CD46-Targeting ADC FG-3246 Shows Promising Results in Advanced Prostate Cancer Trial

2 months ago

• FG-3246, a first-in-class antibody-drug conjugate targeting CD46, demonstrated an 80% disease control rate and 20% objective response rate in heavily pre-treated metastatic castration-resistant prostate cancer patients. • The phase 1 trial established 2.7 mg/kg as the maximum tolerated dose, with manageable safety profile including neutropenia as the most common adverse event, while showing a median radiographic progression-free survival of 8.7 months. • FibroGen plans to advance FG-3246 with a phase 2 monotherapy study by mid-2025 and will disclose results from a combination trial with enzalutamide in the second half of 2025.

AstraZeneca Invests $2.5 Billion in Beijing to Establish Sixth Global R&D Center

2 months ago

• AstraZeneca has announced a $2.5 billion investment in Beijing over the next five years to establish its sixth global strategic R&D center, despite ongoing investigations into alleged illegal activities in China. • The new R&D hub will focus on early-stage research and clinical development enabled by AI and data science, with plans to expand the Beijing workforce from 600 to 1,700 employees. • As part of the investment, AstraZeneca is forming strategic partnerships with Beijing Cancer Hospital and three Chinese biotech companies—Harbour BioMed, Syneron Bio, and BioKangtai—including its first vaccine manufacturing facility in China.

AstraZeneca Acquires FibroGen China for $160 Million, Strengthening Roxadustat Position

3 months ago

• FibroGen has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million, comprising $85 million in enterprise value plus an estimated $75 million in net cash holdings. • The strategic sale will extend FibroGen's cash runway into 2027 and enable continued development of its oncology pipeline, including the Phase 2 trial of FG-3246 for metastatic prostate cancer. • Upon closing in mid-2025, AstraZeneca will acquire all rights to roxadustat in China, where it leads the market for chronic kidney disease anemia treatment.

Pamrevlumab Plus Chemotherapy Fails to Improve Survival in Advanced Pancreatic Cancer

4 months ago

• The phase 3 LAPIS trial evaluated pamrevlumab in combination with chemotherapy for locally advanced, unresectable pancreatic cancer. • Results showed no statistically significant improvement in overall survival (OS) with the pamrevlumab combination compared to placebo plus chemotherapy. • The median OS was 17.3 months in the pamrevlumab arm versus 18.0 months in the placebo arm (HR, 1.08; 95% CI, 0.83-1.41; P = .5487). • The addition of pamrevlumab to chemotherapy did not result in increased toxicity, but also did not demonstrate a survival benefit.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Novavax Launches Clinical Trial for JN.1 Subvariant COVID-19 Vaccine

5 months ago

Novavax initiates a new clinical trial to evaluate the safety and immunogenicity of its JN.1 subvariant vaccine (NVX CoV2705) with Matrix-M adjuvant. The study will compare results with the previously authorized NVX-CoV2601 vaccine, marking a significant step in addressing emerging COVID-19 variants.

Pancreatic Cancer: Advances in Treatment and Research Bring Hope in 2024

5 months ago

• The five-year relative survival rate for pancreatic cancer has risen to 13%, marking the third consecutive year of improvement, yet it remains the lowest among major solid tumors. • Four new drug approvals for pancreatic cancer occurred in 2024, including one first-line treatment and three targeted agents for previously treated advanced disease. • A Phase 3 clinical trial demonstrated an overall survival benefit using Tumor Treating Fields (TTFields) in combination with chemotherapy for unresectable, locally advanced pancreatic cancer. • Precision medicine is advancing with the FDA approval of Bizengri for NRG1 fusion-positive pancreatic cancer and the ongoing RASolute 302 trial evaluating RMC-6236, a RAS inhibitor.

Olaparib Shows Sustained Benefit in Early-Stage BRCA-Mutated Breast Cancer

5 months ago

• Olaparib improves long-term survival in women with high-risk, early-stage breast cancer and BRCA1/2 mutations, reducing cancer recurrence risk by 35%. • After six years, 87.5% of olaparib-treated patients were alive, compared to 83.2% in the placebo group, demonstrating a significant survival advantage. • The OlympiA trial reinforces the importance of BRCA testing to identify patients who can benefit from personalized olaparib treatment early. • Olaparib is now recommended by NICE in England and Wales for early-stage, high-risk breast cancer with BRCA1/2 mutations, improving survival chances.

IPF Drug Development Heats Up with Novel Targets and Clinical Advances

6 months ago

• Refoxy Pharma secured $9.58 million to advance its FOXO3-targeting IPF drug, RP-01, aiming to modulate tissue repair mechanisms. • Boehringer Ingelheim plans to submit an NDA for nerandomilast after a successful Phase 3 trial showing improved lung function in IPF patients. • Endeavor BioMedicines' ENV-101 and Insilico Medicine's ISM001-055 demonstrate promising results in improving lung function and reducing fibrosis in Phase 2 trials. • Bristol Myers Squibb's BMS-986278, an LPA1 antagonist, received FDA Breakthrough Therapy Designation after reducing the rate of FVC decline by 69% in a Phase 2 study.

DMD Pipeline Shows Promise with Over 75 Therapies in Development

7 months ago

• Over 75 drugs are in development for Duchenne Muscular Dystrophy (DMD), targeting various mechanisms and routes of administration. • REGENXBIO initiated a Phase I/II trial of RGX-202 in young boys with DMD to assess safety and efficacy. • Emerging therapies focus on gene modulation, dystrophin replacement, and anti-inflammatory approaches to combat DMD. • Key companies like Sarepta Therapeutics, Italfarmaco, and FibroGen are advancing DMD therapeutics through clinical trials.

STRIDE Regimen Demonstrates Doubled 5-Year Survival in Unresectable Hepatocellular Carcinoma

8 months ago

• The STRIDE regimen (durvalumab plus tremelimumab) shows a significant 5-year survival benefit in patients with unresectable hepatocellular carcinoma (uHCC). • The HIMALAYA trial's 5-year analysis revealed a 19.6% survival rate with STRIDE compared to 9.4% with sorafenib, marking a 24% reduction in mortality risk. • Patients achieving disease control with STRIDE experienced more than double the survival time compared to those on sorafenib (28.7% vs. 12.7% at 5 years). • The safety profile of STRIDE remained consistent with previous analyses, with no new safety concerns identified during the extended follow-up period.

FibroGen Terminates Pamrevlumab Development After Failed Pancreatic Cancer Trials, Announces Major Workforce Reduction

10 months ago

• FibroGen's lead drug pamrevlumab fails to demonstrate survival benefits in two pivotal pancreatic cancer trials, leading to complete termination of the program. • The company announces plans to reduce its workforce by 75% following the drug's failure, marking a significant setback after previous unsuccessful trials in Duchenne muscular dystrophy. • Despite setbacks, FibroGen maintains a $215 million cash reserve and continues development of other pipeline candidates, including promising ADC therapy FG-3246 for prostate cancer.

FibroGen Highlights Pamrevlumab's Potential in Pancreatic Cancer and Roxadustat's Growth in Q1 2024 Earnings Call

a year ago

• FibroGen anticipates top-line data from Phase 3 trials of pamrevlumab in metastatic and locally-advanced pancreatic cancer, addressing a significant unmet need. • Roxadustat sales in China increased by 24% year-over-year, driven by a 39% volume increase, with potential for further growth pending approval for chemotherapy-induced anemia. • FG-3246, a first-in-class ADC, shows promising Phase 1 results in metastatic castration-resistant prostate cancer, with plans for a Phase 2/3 study in late 2024. • FibroGen's strong cash position of $214.7 million is expected to fund operations into 2026, supporting the advancement of its clinical programs.

Aldeyra Therapeutics Plans Reproxalap NDA Resubmission for Dry Eye Disease Following FDA Feedback

a year ago

• Aldeyra Therapeutics plans to resubmit its NDA for reproxalap to treat dry eye disease after addressing FDA concerns. • A new dry eye chamber study will be initiated in H1 2024 to assess ocular discomfort as the primary endpoint. • The company expects to resubmit the NDA in H2 2024, with a potential six-month review period by the FDA. • Aldeyra's cash reserves of $142.8 million are projected to fund operations beyond 2026, supporting ongoing clinical development.

Vertex Initiates Rolling NDA Submission for Suzetrigine in Acute Pain Management

a year ago

• Vertex Pharmaceuticals has begun a rolling NDA submission to the FDA for suzetrigine (VX-548) for moderate-to-severe acute pain, with completion expected in Q2 2024. • Phase III trials demonstrated suzetrigine's efficacy in reducing pain intensity across various surgical and non-surgical pain conditions, supporting the NDA submission. • Vertex is also advancing suzetrigine in neuropathic pain, with phase III trials planned for diabetic peripheral neuropathy (DPN) in the second half of 2024. • Suzetrigine holds FDA Fast Track and Breakthrough Therapy designations for acute pain and DPN, highlighting its potential to address unmet needs in pain management.

Stoke Therapeutics' STK-001 Shows Promising Results in Dravet Syndrome Trials

a year ago

• Stoke Therapeutics' STK-001 demonstrated substantial reductions in convulsive seizure frequency in children and adolescents with Dravet syndrome. • The treatment also showed improvements in cognition and behavior, suggesting potential disease modification in this patient population. • The FDA has allowed Stoke to proceed with a dosing regimen of 70mg followed by 45mg, paving the way for registrational studies. • Stoke Therapeutics is preparing to meet with regulatory agencies to discuss a registrational study based on the encouraging data.

Sarepta's DMD Therapy Elevidys Receives Accelerated FDA Approval; Other Biotech Updates

2 years ago

• Sarepta Therapeutics' Elevidys (delandistrogene moxeparvovec) gains accelerated FDA approval for treating ambulatory pediatric Duchenne muscular dystrophy (DMD) patients aged 4-5. • Bristol Myers Squibb's Camzyos (mavacamten) is approved in the EU for symptomatic obstructive hypertrophic cardiomyopathy (HCM) based on positive Phase III trial results. • FibroGen's pamrevlumab fails in a Phase III trial for idiopathic pulmonary fibrosis (IPF), leading to discontinuation of further studies. • Intercept Pharmaceuticals receives a Complete Response Letter from the FDA for obeticholic acid (OCA) in treating pre-cirrhotic fibrosis due to NASH, prompting restructuring.