Metsera | MedPath

Amneal Pharmaceuticals Reports Strong Q1 2025 Results with 5% Revenue Growth and Margin Expansion

8 days ago

• Amneal Pharmaceuticals reported Q1 2025 revenue of $695 million, a 5% year-over-year increase, with growth across all three business segments despite falling short of analyst expectations. • The company's Parkinson's disease treatment CREXONT continues to gain market traction, with insurance coverage expanding from 30% to 60% of U.S. covered lives in just six months. • Adjusted EBITDA increased 12% to $170 million, with adjusted diluted EPS rising 50% to $0.21, reflecting improved gross margins and operating expense leverage.

Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments

2 months ago

• Roche has entered into a $5.3 billion collaboration with Zealand Pharma to co-develop petrelintide, a promising amylin analog for obesity treatment, both as monotherapy and in combination with Roche's incretin asset CT-388. • The partnership includes upfront payments of $1.65 billion to Zealand Pharma, with profits and losses to be shared 50/50 in the US and Europe, while Roche gains exclusive commercialization rights for the rest of the world. • Clinical data suggests petrelintide could deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability, potentially addressing unmet needs in the obesity market that is projected to affect 4 billion people globally by 2035.

AbbVie Enters Obesity Market with $350M Gubra Deal for Novel Amylin Analog

3 months ago

• AbbVie makes its strategic entry into the obesity therapeutics market through a $350 million upfront licensing agreement with Danish biotech Gubra for their amylin analog GUB014295. • The deal includes potential milestone payments up to $1.875 billion plus tiered royalties, positioning GUB014295 as a promising obesity treatment that targets appetite suppression through amylin receptor activation. • Phase 1 clinical trials for GUB014295 are underway, with completed single ascending dose studies showing promising initial data in addressing the growing global obesity crisis affecting nearly 900 million adults.

Ascentage Pharma's IPO Funds Global Expansion of Cancer Therapies

4 months ago

• Ascentage Pharma raised $126.4 million in a U.S. IPO to support late-stage clinical development of olverembatinib and lisaftoclax, aimed at treating CML and CLL, respectively. • Olverembatinib, already approved in China for CML, is undergoing Phase 3 trials in the U.S., Canada, Australia, and China, with plans for an FDA submission in 2026. • Lisaftoclax, a Bcl-2 inhibitor, is under regulatory review in China for advanced CLL/SLL, with potential to compete with AbbVie and Genentech's Venclexta. • Takeda Pharmaceuticals holds an option to license olverembatinib outside of Greater China and Russia, potentially bringing Ascentage up to $1.2 billion in milestone payments.

Aardvark Therapeutics Files for $100M IPO to Advance Novel Hyperphagia Treatment

4 months ago

• Aardvark Therapeutics has filed for a $100 million IPO on NASDAQ, seeking to advance its Phase III drug candidate ARD-101 for treating hyperphagia in Prader-Willi syndrome. • The company's lead candidate ARD-101 is an oral gut-restricted small molecule that works by inhibiting bitter taste receptors, with Phase III trial results expected in early 2026. • Aardvark plans to expand ARD-101's clinical development to include Phase II trials for hyperphagia associated with acquired hypothalamic obesity from craniopharyngioma treatment.

Sionna Therapeutics Launches $191M IPO to Challenge Vertex in Cystic Fibrosis

4 months ago

• Sionna Therapeutics has launched a $191 million IPO to fund its cystic fibrosis drug development program, aiming to compete with Vertex Pharmaceuticals. • Sionna's approach focuses on stabilizing a difficult-to-drug region of the CFTR protein, potentially restoring function more effectively than existing therapies. • The company plans to advance a two-drug combination into late-stage testing and evaluate one of its stabilizers alongside Vertex's Trikafta. • Sionna has secured substantial venture funding and is among several biotechs pursuing IPOs, despite recent market challenges for newly public companies.

Clinical Trial Industry Faces Complex Challenges in 2025: Adaptive Designs, Political Shifts, and Diversity Requirements

4 months ago

• Clinical trials are becoming increasingly complex and expensive as they target smaller patient populations and face stricter regulations, driving the need for smarter and more efficient trial designs. • Political changes, including Trump's presidency, could lead to significant regulatory shifts in the clinical trial landscape, potentially affecting approval pathways and oversight mechanisms. • New legislation like the Inflation Reduction Act is expected to impact trial initiations and drug development, while diversity guidelines from WHO, FDA, and EMA present both opportunities and challenges for patient recruitment.

Kailera's HRS9531 Shows Strong Phase II Weight Loss, Pfizer Cautious on Danuglipron

4 months ago

• Kailera Therapeutics' HRS9531, a dual GLP-1/GIP receptor agonist, demonstrated a 21.1% placebo-adjusted weight reduction in Phase II trials over 36 weeks. • Pfizer CEO Albert Bourla expressed caution regarding their oral obesity candidate, danuglipron, despite plans for late-stage studies of the once-daily formulation. • Kailera reported that 59% of patients on HRS9531 achieved at least 20% body weight loss, with no plateau observed, suggesting potential for greater efficacy with longer use. • Pfizer abandoned a twice-daily danuglipron formulation due to toxicities, focusing on a once-daily version, but analysts remain divided on its prospects in the competitive obesity market.

Metsera Aims for $289 Million IPO to Advance GLP-1RA Obesity Treatment

4 months ago

• Metsera is seeking a $289 million IPO to fund the Phase III trial of its lead candidate, MET-097i, an injectable GLP-1 receptor agonist for obesity. • MET-097i demonstrated up to 20% weight loss in Phase II trials, showcasing a long half-life that could allow for less frequent injections. • The company is also advancing other pipeline candidates, including MET-233i (ultra-long acting injectable) and MET-002 (oral GLP-1RA), to address the growing obesity market. • Metsera's IPO is viewed as a positive sign for the biopharma fundraising landscape, potentially catalyzing other companies to enter the public markets.

Verdiva Bio Launches with $410M to Advance Oral GLP-1RA for Obesity

5 months ago

• Verdiva Bio launched with $410 million in Series A funding to develop next-generation therapies for obesity and cardiometabolic disorders. • The company's lead asset is an oral glucagon-like peptide-1 receptor agonist (GLP-1RA) poised for Phase II trials, offering a potentially less invasive treatment option. • Verdiva plans to expand its portfolio through in-licensing deals, aiming to create first-in-class and best-in-class treatments for weight loss and maintenance. • The company's approach reflects a growing trend of Western biotechs acquiring and advancing assets from Chinese pharmaceutical companies.

MBX Biosciences' MBX 1416 Shows Promise in Phase 1 Trial for Post-Bariatric Hypoglycemia

5 months ago

• MBX Biosciences announced positive topline results from its Phase 1 trial of MBX 1416 in healthy volunteers, indicating a favorable safety profile. • The trial supports once-weekly dosing of MBX 1416, with a median half-life of approximately 90 hours observed in the multiple ascending dose cohort. • MBX 1416 appeared to increase GLP-1 levels within 60 minutes of a mixed meal tolerance test, suggesting potential therapeutic benefits for PBH patients. • A Phase 2 study in patients with post-bariatric hypoglycemia is anticipated to begin in the second half of 2025, pending FDA alignment on study design.

Metsera's GLP-1 Therapy Shows Promise in Phase II Trial Amidst M&A Speculation

5 months ago

• Metsera reported promising Phase II data for its investigational subcutaneous GLP-1 therapy, positioning it as a potential acquisition target. • The GLP-1 space is expanding into new indications like heart disease, sleep apnea, and metabolic dysfunction-associated steatohepatitis (MASH). • The FDA approved 55 novel medicines in 2024 and is focusing on confirmatory trials, AI in drug development, and tissue biopsies in clinical trials.

Metsera's MET-097i Demonstrates Significant Weight Loss in Phase 2a Trial, Supporting Monthly Dosing Potential

5 months ago

• Metsera's MET-097i, an ultra-long acting GLP-1 receptor agonist, showed substantial placebo-adjusted weight loss of up to 11.3% after 12 weeks in a Phase 2a trial. • The study indicated a dose-dependent weight reduction with individual responses reaching ~20% in the 1.2mg dose cohort, and no weight loss plateau was observed. • MET-097i demonstrated a favorable tolerability profile, with mostly mild and transient gastrointestinal adverse events, particularly in the dose-escalated cohort. • Data support the feasibility of monthly dosing, with a four-fold increase in drug exposure over 12 weeks and well-tolerated step-up doses, paving the way for further studies.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

Merus' Petosemtamab and Mersana's Emi-Le Show Promise in Cancer Treatment

6 months ago

• Merus' petosemtamab demonstrates a 36% overall response rate in recurrent/metastatic head and neck squamous cell carcinoma, with median overall survival of 11.4 months. • Mersana Therapeutics' Emi-Le receives Fast Track designation for HER2-negative breast cancer, showing promising monotherapy activity in multiple tumors. • Petosemtamab's clinical trials are ongoing, including phase 3 studies in HNSCC and expanded evaluation in metastatic colorectal cancer, with data updates planned for 2025.

Metsera Secures $215 Million to Advance Obesity and Metabolic Disease Therapies

6 months ago

• Metsera has secured $215 million in Series B financing to advance its portfolio of Nutrient-Stimulated Hormone (NuSH) analog peptides for obesity and metabolic diseases. • The financing will support clinical trials of MET-097i, an injectable GLP-1 receptor agonist, which demonstrated a 7.5% reduction in body weight in Phase 1/2 trials. • Funds will also advance clinical trials for MET-233i, an ultra-long-acting amylin analog, and MET-002, an oral GLP-1 receptor agonist peptide. • Metsera is leveraging its HALO and MOMENTUM platforms to develop next-generation therapies with improved half-life and oral bioavailability.

Weight Loss Drug Race Heats Up: Zepbound Outperforms Wegovy, New Therapies Target Muscle Growth

6 months ago

• Eli Lilly's Zepbound demonstrated superior weight loss compared to Novo Nordisk's Wegovy in a head-to-head trial, with Zepbound users losing over 20% of body weight versus Wegovy's under 14%. • Several companies, including Eli Lilly, Regeneron, and Veru, are developing new weight loss drugs that aim to preserve or promote muscle growth, addressing concerns about muscle loss with existing GLP-1 therapies. • The obesity treatment market is experiencing rapid growth and innovation, with over 300 GLP-1R drugs in development and analysts projecting sales to potentially reach $150 billion annually by the early 2030s. • Upcoming trial readouts in 2025 from companies like Metsera, Skye Bioscience, and Eli Lilly may introduce novel mechanisms and improved convenience, further intensifying competition in the obesity market.

AI-Designed Drug ISM001-055 Shows Promise in Idiopathic Pulmonary Fibrosis Trial

6 months ago

• Insilico Medicine's ISM001-055, designed using generative AI, has shown positive results in a Phase IIa trial for idiopathic pulmonary fibrosis (IPF). • The study, involving 71 patients in China, demonstrated that the highest dose (60mg daily) led to improved lung function compared to the placebo group. • Patients receiving the 60mg dose of ISM001-055 also experienced improvements in their overall quality of life, according to the company's announcement. • Enveda has initiated clinical trials for ENV-294, an oral anti-inflammatory agent derived from plants using AI, targeting atopic dermatitis.

Metsera Secures $215 Million to Advance Weight Loss Drug Pipeline

6 months ago

• Metsera raised $215 million in a Series B funding round to advance its portfolio of GLP-1 receptor agonists for weight loss, bringing its total funding to over $500 million. • The lead asset, MET-097i, a long-acting injectable GLP-1RA, showed a 7.5% reduction in body weight over 36 days in Phase I trials, with Phase II data expected in H1 2025. • Metsera is also advancing MET-233i, an ultra-long-acting injectable, and MET-002, an oral GLP-1RA, with plans to explore combination therapies for enhanced efficacy. • The company has partnered with Amneal to establish manufacturing facilities in India, ensuring large-scale supply of its weight loss medicines.

Kailera Therapeutics Launches with $400M to Advance GLP-1 Based Obesity Therapies

8 months ago

• Kailera Therapeutics emerges with $400 million in Series A funding to develop next-generation GLP-1 therapies for obesity and related metabolic conditions. • The company's lead asset, KAI-9531, a dual GLP-1/GIP receptor agonist, has demonstrated promising Phase 2 results in obesity and type 2 diabetes. • Kailera's portfolio, licensed from Jiangsu Hengrui Pharmaceuticals, includes injectable and oral GLP-1 agonists, with plans to expand treatment options. • Led by CEO Ron Renaud and backed by prominent investors, Kailera aims to innovate beyond current market leaders in the rapidly evolving metabolic space.