Fierce Biotech

The biopharma industry is rapidly evolving, with innovative concepts emerging every day. Subscribers turn to FierceBiotech as their essential resource for up-to-date news, insights, and information regarding biotechnology and pharmaceutical research and development. Each business day, FierceBiotech and its associated publications provide comprehensive coverage of the drug development and MedTech sectors. This includes everything from early-stage scientific research and initial funding rounds to IPOs, licensing agreements, clinical trials, regulatory updates, mergers, and acquisitions, and much more.

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Invivyd claims Pemgarda mAB follow-up could hold its own against COVID vaccines

1 day ago | fiercebiotech.com | James Waldron

Invivyd has touted its follow-up to the FDA-authorized monoclonal antibody Pemgarda as potentially offering better protection against COVID-19 than available vaccines. Pemgarda received emergency use authorization from the FDA last year for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise.
Altimmune’s stock sinks on mixed phase 2 MASH results for GLP-1 drug

1 day ago | fiercebiotech.com | James Waldron

Altimmune’s GLP-1/glucagon dual receptor agonist achieved a hit and a miss when it came to the dual goals of a phase 2 metabolic dysfunction-associated steatohepatitis (MASH) study, while still showcasing the asset’s weight loss potential. Investors appeared disheartened by the results, sending Altimmune’s stock down 59% to $3.18 in pre-market trading Thursday from a Wednesday closing price of $7.71.
Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug

2 days ago | fiercebiotech.com | James Waldron

Hummingbird Biosciences could one day feather its nest with up to $290 million if its decision to license a phase 2-ready cancer drug to Percheron Therapeutics pays off. In return for up to $290 million in upfront and potential milestone payments—Hummingbird didn’t offer a breakdown of the financial details—Percheron has received the license to HMBD-002, an anti-VISTA monoclonal antibody designed to inhibit tumor growth.
Arbutus regains China rights to potential functional hep B cure as part of strategic rethink

2 days ago | fiercebiotech.com | James Waldron

Arbutus Biopharma had made no secret of its plans to step up its work on imdusiran. Now, the company has regained the China rights to the potential functional cure for hepatitis B. China-based Qilu Pharmaceutical secured the regional rights to imdusiran, then known as AB-729, back in 2021 for a $40 million upfront fee. If Arbutus had stuck with the deal, it could have been in line for up to $245 million in development, regulatory and sales milestones payments.
Biogen’s Spinraza follow-up helps children with SMA who didn’t benefit from Zolgensma

2 days ago | fiercebiotech.com | James Waldron

Biogen has pointed to an early readout from a small phase 1 trial as evidence that its antisense oligonucleotide salanersen could help children with spinal muscular atrophy (SMA) who are still struggling to sit independently despite having received Novartis’ Zolgensma.
Bayer-owned BlueRock lays off 50 employees, shuts Cambridge research labs

2 days ago | fiercebiotech.com | James Waldron

Bayer-owned BlueRock Therapeutics is laying off 50 employees and shuttering its research labs in Cambridge, Mass., in order to focus its resources on its priority cell therapies. The layoffs are spread across all of BlueRock’s sites, including the labs in Cambridge, a spokesperson for the biotech explained to Fierce via email. The Bayer subsidiary will continue to locate its headquarters in Cambridge, with research conducted at its New York and Toronto sites.
Rivus’ weight loss drug scores MASH phase 2 win, showcases muscle-sparing potential

3 days ago | fiercebiotech.com | James Waldron

Rivus Pharmaceuticals’ fat-busting, muscle-sparing drug candidate reduced liver fat in a phase 2 trial while showcasing the drug's obesity potential. The biotech evaluated the candidate, dubbed HU6, in doses of either 150 mg, 300 mg or 450 mg in the mid-stage study of 221 adults with metabolic dysfunction-associated steatohepatitis (MASH) over six months.
Stuart sees dry eye disease drug fail phase 3 tear test, plans another study

3 days ago | fiercebiotech.com | James Waldron

Stuart Therapeutics’ dry eye disease drug has failed to demonstrate that it can increase tear production in a phase 3 test. The ophthalmic solution, called ST-100 or vezocolmitide, is a collagen mimetic peptide that is designed to repair disease-damaged collagen and improve cell health. ST-100 failed to demonstrate a significant rise in the proportion of patients who saw a more than 10mm increase in tear production after 29 days when compared to vehicle, missing the study’s primary endpoint.
Amgen rolls out ph. 3 dosing plan for lead obesity candidate after midstage trial sees high discontinuation, vomiting rates

3 days ago | fiercebiotech.com | Zoey Becker

While Amgen’s monthly obesity candidate MariTide helped patients lose significant amounts of weight in a phase 2 study, prevalent gastrointestinal side effects are leading the company to use a slower dosing schedule in its late-stage trials. Amgen presented the results of part 1 of its phase 2 MariTide study at the American Diabetes Association (ADA) 85 Scientific Sessions in Chicago on Monday, and the data were simultaneously published in the New England Journal of Medicine (NEJM).
Royalty signs off on $2B to bankroll Revolution's RAS cancer drug's road to regulators

3 days ago | fiercebiotech.com | James Waldron

Revolution Medicines has secured a potential funding infusion of up to $2 billion from Royalty Pharma in return for a slice of the profits if Revolution’s lead cancer drug makes it to market. Revolution launched a second phase 3 study of the candidate, a RAS(ON) multi-selective inhibitor called daraxonrasib, in patients with RAS mutant non-small cell lung cancer (NSCLC) last month. A late-stage study of daraxonrasib in patients with pancreatic ductal adenocarcinoma (PDAC) is ongoing.