The best news in biotech, August 25 - 31

Hello!

We closed out the last week of August with a respectable $369M raised across 10 private funding rounds - somewhat light but with some exciting raises worth celebrating nonetheless.

Also in exciting news, 2 new healthcare/life science funds were announced with a massive combined $3.6B in their collective war chests ready to be deployed.

We tracked 6 collaborations with focuses including brain shuttle technologies, cell therapies, RNA therapeutics and immunology medicines, as well as a $2B deal for a neuro-psychiatric drug.

There were 21 positive clinical development updates including data on some big programs in obesity and PD-1×VEGF targeting bi-specifics, as well 6 approvals in the US and Europe.

Enjoy!

🚀🧬 New Biotech Launches & Private Raises… 

• Wugen, a biotech based in MO, USA, raised a $115M financing round. It develops allogeneic cell therapies, with its lead off-the-shelf CAR-T WU-CART-007 program for relapsed/refractory T-ALL entering a pivotal study. Proceeds fund the pivotal trial and broader platform advancement. Link

• Plexium, a biotech based in CA, USA, raised a $60M financing round. The AbbVie-partnered targeted protein degrader specialist advances molecular glue/TPD programs toward the clinic after prior restructuring. Funds support pipeline progression and platform refinement. Link.

• Mid-Atlantic BioTherapeutics (MABT), a biotech based in PA, USA, secured up to $50M investment commitment. The clinical-stage company targets anti-aging indications including neurological diseases and cancer, with plans for a Phase 3 viral encephalitis program in 2026. The funds will enable the company to worth towards clinical, research, and regulatory milestones. Link

• Leal Therapeutics, a biotech based in MA, USA, raised a $30M Series A. Leal develops first-in-class neuro-metabolic therapies for neurodegenerative and neuropsychiatric disorders, with proceeds being used to advance lead programs toward the clinic. Link

• Arnatar Therapeutics, a biotech based in CA, USA, raised a $52M Series A. The dual-modality RNA platform (siRNA + upregulating ASOs) advances ART4 for Alagille syndrome, which holds FDA orphan and rare pediatric disease designations. Funds will support platform and pipeline development. Link

• Osivax, a biotech based in France, received a $19.5M non-dilutive BARDA award to further develop its oligoDOM™ nanoparticle vaccines. It's lead universal influenza A candidate OVX836 (Phase 2; >1,400 subjects dosed) will use funds for continued clinical development and preparation for large efficacy trials. Link

• Shenandoah Therapeutics Inc., a biotech based in CA, USA, raised a $21.5M seed round. The Stanford spinout turns oncogenic drivers against tumors, with seed proceeds being used to build the platform and advance preclinical oncology programs. Link

• Incyclix Bio, a biotech based in NC, USA, raised an $11.25M Series B extension. It develops CDK2 inhibitors, including its lead INX-315 program currently in Phase 1/2 for solid tumors. Proceeds extend runway and support clinical advancement. Link.

• EnsiliTech, a biotech based in the UK, raised a £4.5M seed round. Its ensilication platform stabilizes biologics and vaccines at room temperature, and fund will be used to scale R&D, manufacturing and regulatory steps toward clinical applications. Link.

• Seneca Therapeutics, Inc., a biotech based in PA, USA, raised a $3.9M Series B extension. Its oncolytic Seneca Valley virus (SVV-001) program is in an ongoing Phase I/II in high-grade neuroendocrine neoplasms, with proceeds funding trial completion and operations. Link

💼💸 New VC funds… 

• Patient Square Capital, In its interim close of a second fund, secured at least $3.1 billion, according to regulatory filings. The investor, led by Jim Momtazee, aims to continue building its war chest to deploy across healthcare and life-sciences opportunities. Link

• Fund for Science and Technology, a new U.S. foundation backed by Paul G. Allen’s estate has rolled out its inaugural grants, targeting institutions in bioscience, environment, and AI. It unveiled seed awards to organizations like Fred Hutchinson and Seattle Children’s, with a pledge to deploy at least $500 million over the next four years to catalyze transformational scientific and technological solutions. Link

🤝🔬 Collaborations & Partnerships… 

• BioArctic, a biotech based in Sweden developing CNS therapies, and Novartis, a pharma based in Switzerland, have entered a collaboration to apply BioArctic’s BrainTransporter technology to enhance brain delivery of undisclosed biologics. The deal is worth $30M upfront plus up to $700M in milestones and royalties. Link.

• Lineage Cell Therapeutics, a biotech based in CA, USA developing allogeneic cell therapies, and William Demant Invest, a Denmark-based life science investor, have entered a collaboration to advance ReSonance ANP1 for hearing loss. The partnership combines Lineage’s cell therapy expertise with Demant’s audiology capabilities to accelerate development of regenerative solutions. Link.

• Fresenius Kabi, a pharma and biosimilars company based in Germany, and Charles River Laboratories, a preclinical CRO, have expanded collaboration within an EU-funded consortium to scale CAR-T manufacturing. They will optimize viral vector and cell therapy production processes to support wider European access to novel therapies. Link.

• Flagship Pioneering, a biotech venture firm based in MA, USA, and IQVIA Biotech, a CRO based in NC, USA, have expanded a collaboration to provide operational support across Flagship’s portfolio companies. IQVIA will deliver clinical, regulatory, and commercial services, aiming to accelerate multiple early-stage programs from preclinical to clinical proof of concept. Link.

• Novo Nordisk, a pharma based in Denmark, and Replicate Bioscience, Inc., a biotech based in CA, USA developing srRNA therapeutics, have entered a collaboration to apply srRNA for obesity and diabetes. The deal is worth $50M upfront plus up to $500M in milestones. Replicate will engineer RNA constructs while Novo advances selected programs. Link.

• sitala bio, a biotech based in the UK developing immune disease therapies, and Fosun Pharma, a pharma based in China, have entered a collaboration to develop immune-modulating drugs. The deal is worth $16M upfront plus up to $654M in milestones, supporting Sitala’s programs in immune-mediated diseases with Fosun’s clinical and commercial reach. Link.

🔄💼 M&A… 

• AbbVie, a pharma headquartered in IL, USA, is to acquire Gilgamesh Pharmaceuticals' lead program Bretisilocin currently in Phase 2 for major depressive disorder. The deal is worth $265M upfront plus an additional $1.95B in milestones. Link.

• MannKind Corporation, a pharma headquartered in CA, USA, is to acquire scPharmaceuticals, a biotech based in MA, USA developing therapies for cardiovascular and infectious diseases and its lead program Furoscix currently marketed for heart failure. The deal is worth $243M upfront plus an additional $120M in milestones. Link.

⚕️🌟 Positive clinical development updates… 

• AstraZeneca announced positive data from the Phase III trial of its small-molecule aldosterone synthase inhibitor for hard-to-control hypertension, baxdrostat. BaxHTN met the primary and all key secondary endpoints with clinically meaningful SBP reductions. Link

• Eli Lilly and Company announced positive topline results from the Phase 3 monarchE trial of its small molecule CDK4/6 inhibitor Verzenio (abemaciclib) in HR+, HER2- early breast cancer. The primary overall-survival analysis showed a statistically significant improvement. Link

• Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-2 trial of its oral GLP-1 small-molecule obesity drug orforglipron. All doses met the primary and key secondary endpoints (weight loss, A1C and cardiometabolic markers). Link

• Novo Nordisk reported positive real-world STEER study data showing Wegovy (semaglutide 2.4 mg) was associated with lower MACE versus tirzepatide in people with obesity and established CVD. Link

• Regeneron announced positive results from the Phase 3 NIMBLE trial of its siRNA cemdisiran in generalized myasthenia gravis. Cemdisiran monotherapy met the primary and key secondary endpoints (MG-ADL and QMG improvements). Link

• Alnylam Pharmaceuticals announced positive Phase II data and advancement plans for its RNAi hypertension candidate zilebesiran (co-developed with Roche), supporting initiation of a global Phase III cardiovascular outcomes trial. Link

• ImmunityBio, Inc. announced encouraging early initial data from a pilot study combining IL-15 agonist ANKTIVA NK-cell therapy plus the Optune Gio device in recurrent glioblastoma. 5/5 patients had disease control, with two near-complete responses from an early cohort. Link

• Genmab announced positive data from the Phase 1/2 RAINFOL-01 trial of its FRα-targeted ADC rinatabart sesutecan (Rina-S) in advanced endometrial cancer. Cohort B2 showed encouraging responses (about 50% confirmed ORR). Link

• jCyte, Inc. announced publication of Phase I/IIa safety results for its retinal progenitor cell tehrapy in retinitis pigmentosa. The study reported the injection was well tolerated and exploratory signals of vision benefit. Link

• BeOne Medicines announced positive topline results from the Phase 1/2 trial of its BCL2 inhibitor sonrotoclax in relapsed/refractory mantle cell lymphoma. The study met its primary endpoint (ORR) with promising secondary endpoint signals. Link

• Tris Pharma announced positive data from the Phase 3 trial of its oral small molecule dual NOP/MOP agonist acute-pain drug cebranopadol. Pivotal ALLEVIATE-1 showed statistically significant pain reduction vs placebo. Link

• Hope Biosciences secured FDA RMAT designation for its adipose-derived mesenchymal stem cell therapy for relapsing-remitting multiple sclerosis. Link

• Akeso (with Summit Therapeutics, Inc.) announced positive final analysis data from the Phase 3 trial of its PD-1×VEGF bispecific (ivonescimab) for EGFR-mutated non-small cell lung cance. The final analysis showed a statistically significant overall survival benefit. Link

• RemeGen Biosciences (with Vor Bio) announced positive data from a Phase 3 trial of the injected biologic telitacicept for IgA nephropathy. Stage A met the primary endpoint (55% reduction in 24-hour UPCR at 39 weeks). Link

• Akiram Therapeutics announced positive interim safety data from the Phase 1 trial of its radiopharmaceutical AKIR001 for aggressive solid tumours. First cohort completed with no safety concerns, allowing dose-escalation to continue. Link

• Cytokinetics announced positive primary results from the Phase 3 MAPLE-HCM trial of its small-molecule myosin inhibitor aficamten for obstructive hypertrophic cardiomyopathy. The study met its primary endpoint (improved peak VO₂) with a favorable safety profile. Link

• BioXcel Therapeutics, Inc. announced positive topline results from the Phase 3 SERENITY At-Home trial of its sublingual film (BXCL501/IGALMI) for acute agitation in bipolar disorder/schizophrenia. The study met its primary tolerability endpoint supporting an at-home label expansion. Link

• PDS Biotechnology announced positive Phase 2 data from its therapeutic cancer-vaccine combination (PDS0101 + Keytruda) in recurrent/metastatic HPV16-positive head and neck cancer. Versatile-002 reported median overall survival of 39.3 months. Link

• argenx announced positive topline results from the Phase 3 ADAPT SERON trial of its FcRn-blocking biologic VYVGART (efgartigimod) in AChR-Ab seronegative generalized myasthenia gravis. The study met its primary endpoint (p=0.0068). Link

• Cereno Scientific was granted FDA Fast Track Designation for CS1 in Rare Disease Pulmonary Arterial Hypertension (PAH). The designation highlights CS1’s potential as a differentiated treatment approach for PAH, a rare and progressive disease where safer, disease-modifying therapies are urgently needed. Link

✅🏆 Regulatory Approvals… 

• Pfizer and BioNTech SE’s mRNA therapeutic Comirnaty was approved for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19, including updated formulations for current variants. Link

• Sanofi’s monoclonal antibody therapeutic rilzabrutinib was approved in the USA for the treatment of adults with persistent or chronic immune thrombocytopenia. Link

• Gilead Sciences’ capsid inhibitor therapeutic Yeytuo (lenacapavir) was approved in the EU for HIV prevention, as the first twice-yearly injectable PrEP option. Link

• Travere Therapeutics’ small-molecule therapeutic Filspári (sparsentan) received FDA approval in the USA for a REMS modification in IgA nephropathy, easing access requirements. Link

• BeiGene’s PD-1 antibody therapeutic Tevimbra (tislelizumab) was approved in the EU as a neoadjuvant and adjuvant treatment for non-small cell lung cancer. Link

• ExCellThera’s cell therapy therapeutic Zemcelpro (UM171-expanded stem cells) was approved in the EU for blood cancer patients lacking access to suitable donor cells. Link

That's all for this week, thanks for tuning in. Subscribe for weekly alerts covering the latest positive news in the biotech industry delivered to your inbox every Monday ⬇️🔔