The best news in biotech, July 7 - August 9

Hello!

After a few weeks break we are back and have a lot to catch up on. Don't worry, all the major news since the last edition is covered.

I am happy to report a bounceback in VC activity after a very slow June - We tracked 25 deals worth $1.9B in VC investments over the past 4 weeks, all listed below! This follows just $1.1B raised in June, the lowest amount raised by month since we started this newsletter in July 2024. Although the trailing 3 month average remains low by the last 12 months' standards.

I am also excited to report two new funds announced top life science venture firms, despite the challening market conditions.

There were 6 acqusitions announced including two big pharma single digit $B spends for advanced pipleines in cardiovascular and rare diseases as well as many updates to catch up on in the clinic and with regulatory approvals.

Enjoy!

🚀🧬 New Biotech Launches & Private Raises… 

• MapLight Therapeutics, Inc. , a biotech based in CA, USA launched with $372.5 million in Series D financing. The company is focused on developing novel therapeutics for neuropsychiatric and neurological disorders, with the funds intended to advance its clinical-stage pipeline and platform. Link
• A new, unnamed company, launched with a $300 million financing commitment from Bain Capital . The company, a collaboration between Bristol Myers Squibb and Bain Capital, will focus on developing innovative immunology therapies to address unmet medical needs of patients, with a pipeline of five assets in-licensed from BMS. Link
• Dispatch Bio , a biotech based in CA, USA and PA, USA launched with $216M in financing to deliver universal treatment for solid tumors with a novel immunotherapy approach. The company's platform leverages advances in cell therapy engineering and immune system activation, with funds supporting first-in-human studies. Link
• Strand Therapeutics , a biotech based in MA, USA, raised $153 million in Series B financing to further advance its programmable mRNA therapeutic pipeline. The company is developing next-generation mRNA therapeutics for cancer and other diseases, with the funds to be used for advancing its lead candidate into the clinic. Link
• ARTBIO , a biotech based in the United Kingdom, announced $132 million in Series B financing to advance its pipeline of alpha radioligand therapies. The funds will be used to expand its manufacturing and supply chain infrastructure and to advance its lead programs for the treatment of cancer. Link
• Avalyn Pharma , a biotech based in WA, USA, completed an oversubscribed $100 million Series D financing to further advance clinical development of novel inhaled therapies for pulmonary fibrosis. The company is developing a pipeline of inhaled formulations of approved medicines to reduce systemic exposure and deliver medication directly to the site of disease. Link
• CoRegen Inc. , a biotech based in TX, USA, closed more than $93 million in Series C financing. The company is developing novel cancer therapies, and the funds will be used to advance its pipeline of precision medicines for the treatment of solid tumors and hematological malignancies. Link
• Actithera , a biotech based in MA, USA and Norway, raised $75.5 million in an oversubscribed Series A financing to redefine precision radioligand therapy. The company is developing a new class of radiopharmaceuticals with enhanced tumor retention, and the funds will be used to advance its lead candidates into the clinic. Link
• Chai Discovery , a biotech based in CA, USA, announced a $70 million Series A to transform molecular design. The company has built a generative AI platform for drug discovery, and the funds will be used to expand its team and to advance its pipeline of small molecule therapeutics. Link
• VelaVigo , a biotech based in China and the USA, raised over $50 million in a Series B financing. The company is focused on the discovery and development of innovative drugs for autoimmune diseases and cancer, with the funds intended to advance its pipeline of novel therapeutics and to expand its discovery platform. Link
• NUCLIDIUM AG , a biotech based in Switzerland, closed a CHF 79 million Series B financing. The company is advancing the clinical development of its copper-based radiopharmaceutical platform. The funds will be used to progress its lead candidate, NCD-680, into a Phase I/IIa clinical trial for the treatment of prostate cancer. Link
• Renasant Bio , a biotech based in CA, USA, launched to pioneer next-generation disease-modifying small molecule treatments for ADPKD. The company, launched by BridgeBio Pharma and Lapam Capital, will use its undisclosed funding to advance a lead clinical-stage candidate through the next phase of development. Link
• Centivax , a biotech based in CA, USA, raised an oversubscribed $45 million Series A financing. The funds will be used to advance its universal flu vaccine candidate into the clinic and to expand its portfolio of universal vaccines against other rapidly mutating viruses using its proprietary platform. Link
• Aqtual, Inc. , a biotech based in CA, USA, raised over $30 million in a Series A financing as it scales its novel cfDNA platform. The company is developing technology for early cancer detection and monitoring, and the funds will support the expansion of its platform for applications in oncology and other diseases. Link
• One Biosciences , a biotech based in France, announced a €15 million Series A financing. The company is building a discovery engine that combines single-cell analysis and AI to identify novel targets and develop precision medicines, with an initial focus on cardiometabolic diseases. The funds will advance its clinical single-cell profiling platform. Link
• SNIPR Biome - A CRISPR Company , a biotech based in Denmark, raised €35 million in a Series C extension. The company is targeting antimicrobial resistance in diseases like cancer using its CRISPR-based technology. The funds will be used to advance its lead program, which aims to selectively target E. coli in cancer patients. Link
• Synfini, Inc. , a biotech based in the United Kingdom, added £8.9m in discovery funding to speed small molecule drug development. A spinout from the University of Cambridge, the company will use the funds to build out its AI-powered platform and team to discover novel drug candidates. Link
• ScienceMachine , a biotech based in the United Kingdom raised €2.9 million in a pre-seed round. The company is developing a platform for biotech analysis to help companies interpret experimental data more efficiently. The funds will be used for product development and to expand the team. Link
• AbOliGo , a biotech based in the UK, closed an oversubscribed and undisclosed funding round to accelerate its multiomic research tools for Antibody-Oligo R&D. The funds will be used to expand its product portfolio and commercial activities for its tools that enable high-resolution analysis of biological samples for research purposes. Link
• Centauri Therapeutics Limited , a biotech based in the United Kingdom, received £3.8 million in follow-on funding. The financing will support the advancement of its Alphamer platform, which redirects the immune system to fight life-threatening diseases, with an initial focus on hospital-acquired bacterial infections. Link
• Isobio , a biotech based in the United Kingdom, raised £5 million in seed funding. The investment from ASP Isotopes will be used to advance the development and manufacturing of its radioisotope production technology for use in cancer diagnostics and therapeutics, addressing supply chain challenges for critical medical isotopes. Link
• Oncomatryx Biopharma , a biotech based in Spain, secured an undisclosed amount of EU funding from the EIC Accelerator program. The funds will be used to advance its antibody-drug conjugate (ADC) platform, which is designed to develop novel therapies for solid tumors characterized by a dense tumor microenvironment. Link
• PAhR Therapeutics , a biotech based in CA, raised $14 million in seed financing. The company launched to pursue innovative treatments for Pulmonary Arterial Hypertension (PAH). The funds will support the advancement of its novel therapeutic approach from the discovery phase into preclinical development. Link
• ASTRA Therapeutics , a biotech based in Switzerland, raised €8.3 million in a seed round. The company will use the funds to advance its platform for developing precision parasiticides for animal health, aiming to create novel, targeted solutions to combat growing resistance in parasites affecting livestock and companion animals. Link
• Targepeutics , a biotech based in MA, USA, announced an undisclosed strategic investment from the Yuvaan Tiwari Foundation . The funding will support the advancement of its lead candidate, GB13, into clinical trials for Diffuse Intrinsic Pontine Glioma (DIPG), a highly aggressive and rare pediatric brain cancer. Link

💼💸 New VC funds… 

• OrbiMed , a healthcare investment firm based in NY, USA, has closed a new suite of funds totaling $1.8 billion. The capital will be deployed globally across a wide range of healthcare companies, from early-stage private biotechs to royalty and credit opportunities, continuing OrbiMed's multi-strategy investment approach. Link
• Frazier Life Sciences , a venture capital firm based in CA, USA and WA, USA, has closed its oversubscribed Frazier Life Sciences XI fund at $1.3 billion. The fund will continue the firm’s strategy of investing in private and public life sciences companies, with a focus on company creation and early-stage ventures. Link
• Vie Ventures , a life sciences venture capital firm based in CA, USA and MA, USA, has launched with an undisclosed initial investment. The firm will focus on founding and investing in companies developing next-generation therapies for autoimmune and inflammatory diseases, employing a data-driven, hub-and-spoke model. Link

🤝🔬 Collaborations & Partnerships… 

• Sartorius , a life science company based in Germany, and Sensible Biotechnologies , a biotech based in the United Kingdom, have entered a collaboration to scale up Sensible's unique cell-based mRNA manufacturing platform. This partnership aims to improve the cost-effectiveness and scalability of mRNA production by leveraging Sensible's innovative E. coli-based technology. Link
• AbbVie , a global biopharmaceutical company based in IL, USA, and IGI , a biotech focused on multispecific antibodies based in Switzerland, have entered a collaboration for ISB 2001. The agreement grants AbbVie an exclusive global license to develop, manufacture, and commercialize this first-in-class CD38xBCMAxCD3 trispecific antibody being investigated for relapsed/refractory multiple myeloma. Link
• Gate Bioscience , a biotech based in CA, USA, and an undisclosed leading global pharmaceutical company, have entered a collaboration to discover and develop novel molecular glues for cancer therapeutics. The multi-target partnership will leverage Gate's platform to identify small molecules that can induce degradation of previously undruggable cancer targets, with undisclosed financials. Link
• Matchpoint Therapeutics , a biotech based in MA, USA, and Novartis , a global healthcare company based in Switzerland, have entered a collaboration to develop oral covalent inhibitors for inflammatory diseases. The agreement grants Novartis an exclusive option to license Matchpoint's advanced covalent chemistry platform to discover small molecule candidates against a specific, undisclosed immunology target. Link
• Kling Biotherapeutics , a biotech based in the Netherlands, and Sanofi , a global healthcare company based in France, have entered a collaboration for the accelerated discovery of neutralizing antibodies. The partnership will use Kling Bio's high-throughput discovery platform to identify novel antibody drug candidates against multiple undisclosed targets from Sanofi's pipeline, with undisclosed financial terms. Link
• Revanatx, a biotech based in the United Kingdom, and ExsoMed , a US-based biopharmaceutical company, have entered a licensing deal to develop and commercialize a novel drug delivery platform. The deal is focused on Revanatx's technology for delivering therapeutics for cancer and other diseases. The deal is worth an undisclosed upfront payment plus up to $1 billion in milestone payments. Link
• Viridian Therapeutics, Inc. , a biotech based in MA, USA, and Kissei Pharmaceutical Co Ltd , a pharmaceutical company based in Japan, have entered a collaboration to develop and commercialize two product candidates for thyroid eye disease in Japan. Kissei gains exclusive rights to develop Veligrotug and VRDN-003. The deal is worth $70 million upfront plus up to $315 million in milestone payments. Link
• Madrigal Pharmaceuticals , a biopharmaceutical company based in PA, USA, and a leading global pharmaceutical company, have entered an exclusive global license agreement for one of Madrigal’s internally discovered programs. The deal allows the partner to develop a portfolio of compounds for undisclosed indications outside of Madrigal's core focus. The deal is worth $20 million upfront plus up to $550 million in milestone payments. Link
• Sanofi , a global healthcare company based in France, and Visirna Therapeutics , a biotech based in China, have entered a licensing agreement for plozasiran in Greater China. Sanofi gains exclusive rights to develop and commercialize the investigational RNAi therapeutic for patients with severe hypertriglyceridemia. The deal is worth up to $130 million. Link
• XtalPi Inc. , an AI drug discovery company based in MA, USA, and @Dovetree, a biotech based in China, have entered a collaboration to di scover and develop small molecule drugs against over 100 targets. The deal leverages XtalPi's AI platform for multiple therapeutic areas. The deal is worth up to $6 billion in potential milestone payments. Link
• Formation Bio , a tech-driven biotech based in NY, USA, and IMIDomics Inc. , a precision medicine biotech based in Spain, have entered a collaboration for a first-in-class anti-CD226 autoimmune program. Formation Bio licensed exclusive rights to develop and commercialize the antibody, discovered via Imidomics' platform, for autoimmune diseases, with undisclosed financial terms. Link
• Rallybio , a clinical-stage biotech based in CT, USA, and Recursion , a techbio company based in UT, USA, have entered an agreement for the sale of Rallybio’s REV102 program. The deal provides Recursion with a clinical-stage C5 inhibitor, allowing Rallybio to focus on its core pipeline. The deal is worth $2.5 million upfront plus up to $22.5 million in milestone payments. Link

🔄💼 M&A… 

• MSD , a global biopharmaceutical company based in NJ, USA, has entered an agreement to acquire Verona Pharma , a biotech based in the United Kingdom. This deal expands MSD's portfolio with Verona's lead asset, Ohtuvayre (ensifentrine), a first-in-class maintenance therapy for adults with chronic obstructive pulmonary disease (COPD). The transaction is valued at approximately $4.1 billion. Link
• Sanofi , a global healthcare company based in France, has entered an agreement to acquire Inhibrx, a biotech based in CA, USA. The acquisition gives Sanofi full rights to INBRX-101, an investigational therapy for the rare genetic disease alpha-1 antitrypsin deficiency (AATD), strengthening its rare disease pipeline. The deal is worth $1.7 billion upfront plus up to $296 million in milestone payments. Link
• TandemAI , a drug discovery company based in China and MA, USA, and Perpetual Medicines, a biotech based in China and MA, USA, have announced a strategic merger. The new entity will expand its physics- and AI-based drug discovery capabilities, integrating TandemAI's computational platform with Perpetual's wet lab and clinical development expertise to create an end-to-end discovery engine. Link
• Concentra , a biopharmaceutical company based in DE, USA, has entered an agreement to acquire CARGO Therapeutics , a CAR T-cell therapy biotech based in CA, USA. The deal adds CARGO's next-generation oncology pipeline, focused on overcoming resistance to cancer immunotherapy, to Concentra's portfolio. The transaction is valued at approximately $536 million plus a contingent value right. Link
• SERB Pharmaceuticals , a specialty pharma company based in Belgium, has entered an agreement to acquire Y-mAbs Therapeutics, Inc. , a biotech based in NY, USA. The acquisition gives SERB control of Y-mAbs's approved rare disease oncology drug, Danyelza, which is used to treat high-risk neuroblastoma. The deal is worth up to $412 million, including milestone payments. Link

🏢🧪 New and expanding research facilities… 

• Biogen , a global biotechnology company based in MA, USA, has announced a $2 billion manufacturing investment in North Carolina, USA. The funds will be used to construct a new, advanced manufacturing facility focused on producing biologics, including complex antibody and gene therapies, to support the company’s growing pipeline and future commercial needs. Link
• AstraZeneca , a global biopharmaceutical company based in the United Kingdom, has announced plans to invest $50 billion in the United States over the next decade. This significant investment will expand the company's R&D footprint, enhance its manufacturing capabilities, and support the clinical development of its pipeline across key therapeutic areas, reinforcing its commitment to innovation in the US. Link

⚕️🌟 Positive clinical development updates… 

• ViiV Healthcare announced positive real-world data from studies of its long-acting injectable HIV treatment Cabenuva. The data showed high effectiveness and a strong safety profile in maintaining viral suppression for people living with HIV, reinforcing the benefits of its long-acting injectable regimen over daily oral therapy. Link
• Pfizer announced positive data from the Phase 3 trial of its small molecule prostate cancer drug Xtandi. The trial, which met its primary endpoint, showed that Xtandi plus leuprolide significantly improved metastasis-free survival in men with non-metastatic hormone-sensitive prostate cancer at high risk of recurrence. Link
• Novo Nordisk announced positive data from the Phase 3 trial of its small molecule sleeping sickness drug acoziborole. The trial, which met its primary endpoint, demonstrated that a single oral dose of acoziborole was effective and safe for the treatment of sleeping sickness, a parasitic disease endemic in sub-Saharan Africa. Link
• Biogen and Stoke Therapeutics announced positive data from studies of the antisense oligonucleotide Dravet syndrome drug STK-001. The data from Phase 1/2a and open-label extension studies showed substantial and durable reductions in seizure frequency and improvements in cognition and behavior in children and adolescents with Dravet syndrome. Link
• Amylyx Pharmaceuticals announced positive data from the Phase 2 and Phase 2b trials of its small molecule post-bariatric hypoglycemia drug avexitide. New exploratory analyses of the trials showed that avexitide significantly reduced the frequency and severity of hypoglycemic episodes in patients with post-bariatric hypoglycemia, a complication of bariatric surgery. Link
• Verastem Oncology announced positive data from the Phase 2 RAMP 201 trial of its small molecule ovarian cancer drug avutometinib in combination with defactinib. The results, published in the Journal of Clinical Oncology, demonstrated a clinically meaningful and durable response in patients with recurrent low-grade serous ovarian cancer. Link
• Pfizer and Astellas Pharma announced positive data from the Phase 3 EMBARK trial of the small molecule prostate cancer drug Xtandi plus leuprolide. The trial met its primary endpoint, showing a statistically significant improvement in metastasis-free survival for men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. Link
• LEO Pharma announced positive 16-week interim results from the ADHAND Phase 3 trial of its monoclonal antibody atopic dermatitis drug tralokinumab. The trial met its primary and all secondary endpoints, demonstrating that tralokinumab significantly improved outcomes for patients with moderate-to-severe atopic dermatitis on the hands who are candidates for systemic therapy. Link
• Rhythm Pharmaceuticals Inc. announced positive data from a Phase 2 trial of its oral small molecule obesity drug. The trial met its primary endpoint, showing statistically significant weight loss in patients with obesity, sending the company's stock price up. Link
• Cereno Scientific announced positive data from the Phase 1 trial of its small molecule pulmonary arterial hypertension drug CS014. CS014 was safe and well tolerated at exposure levels that are expected to be sufficient to impact pathological pulmonary vascular remodeling and reduction of fibrosis — key drivers in several rare cardiovascular and pulmonary diseases. These findings position CS014 as a promising candidate in IPF and other rare diseases involving vascular remodeling and fibrosis. Link
• Sanofi announced positive data from the Phase 3 IMROZ trial of its monoclonal antibody multiple myeloma drug Sarclisa. The trial met its primary endpoint, showing a statistically significant improvement in progression-free survival in patients with newly diagnosed multiple myeloma who are not eligible for transplant. Link
• Sanofi announced positive data from the Phase 3 NOTUS trial of its monoclonal antibody chronic obstructive pulmonary disease (COPD) drug Dupixent. The trial met its primary endpoint, showing that Dupixent significantly reduced exacerbations in patients with uncontrolled COPD with evidence of type 2 inflammation. Link
• Eli Lilly and Company announced positive data from the Phase 3 TRAILBLAZER-ALZ 2 trial of its monoclonal antibody Alzheimer's disease drug donanemab. The trial met its primary endpoint, showing that donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease. Link
• Eli Lilly and Company announced positive data from the Phase 3 SURMOUNT-2 trial of its dual GIP/GLP-1 receptor agonist type 2 diabetes and obesity drug Mounjaro (tirzepatide). The trial met its primary endpoint, demonstrating that Mounjaro achieved superior weight loss compared to placebo in adults with type 2 diabetes who are overweight or have obesity. Link
• Eli Lilly and Company announced positive data from the Phase 3 ACHIEVE-1 and ACHIEVE-2 trials of its oral GLP-1 receptor agonist obesity drug orforglipron. The trials met their primary endpoints, showing that orforglipron delivered significant weight loss in adults with obesity or overweight with weight-related comorbidities. Link
• Roche announced positive data from the Phase 3 INAVO120 trial of its small molecule breast cancer drug inavolisib. The trial met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival in patients with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. Link
• Bristol Myers Squibb announced positive topline results from the Phase 3 INDEPENDENCE trial of its erythroid maturation agent myelofibrosis-associated anemia drug Reblozyl (luspatercept-aamt). The trial met its primary endpoint, showing a statistically significant improvement in anemia in adult patients with myelofibrosis-associated anemia. Link
• Biogen and Eisai US announced positive data from a new analysis of the Phase 3 Clarity AD trial of the monoclonal antibody Alzheimer's disease drug Leqembi. The data showed that early treatment with Leqembi resulted in greater cognitive and functional benefits for patients with early Alzheimer's disease. Link
• AstraZeneca announced positive data from the Phase 3 DESTINY-Breast06 trial of its antibody-drug conjugate breast cancer drug Enhertu. The trial met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival in patients with HR-positive, HER2-low metastatic breast cancer. Link
• AstraZeneca announced positive data from the Phase 3 FLAURA2 trial of its small molecule lung cancer drug Tagrisso plus chemotherapy. The trial met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced lung cancer. Link
• AbbVie announced positive topline results from the Phase 3 UP-AA trial of its small molecule alopecia areata drug Rinvoq (upadacitinib). The trial met its primary endpoint, demonstrating a statistically significant improvement in hair regrowth in adults with severe alopecia areata. Link
• Takeda announced positive results from the Phase 3 OVEPOREXTON trial of its small molecule narcolepsy type 1 drug oveporexton. The trial met its primary endpoint, demonstrating a statistically significant improvement in wakefulness in adult patients with narcolepsy type 1. Link
• Gilead Sciences announced positive data from the Phase 3 PURPOSE 1 trial of its twice-yearly injectable HIV prevention drug lenacapavir. The trial met its primary endpoint, showing 100% efficacy in preventing HIV infection in cisgender women. Link
• Abivax announced positive Phase 3 results from the ABTECT-8 week induction trials of its oral small molecule ulcerative colitis drug obefazimod. Both trials met their primary endpoints, demonstrating that obefazimod induced clinical remission in adults with moderate to severely active ulcerative colitis. Link
• CinCor Pharma, Inc. , an AstraZeneca company, announced positive data from the Phase 3 BaxHTN trial of its small molecule hypertension drug baxdrostat. The trial met its primary and all secondary endpoints, demonstrating that baxdrostat significantly lowered blood pressure in patients with uncontrolled or treatment-resistant hypertension. Link
• Praxis Precision Medicines, Inc. announced positive data from the Phase 2 trial of its small molecule Best disease drug ulixacaltamide. The trial met its primary endpoint, demonstrating a statistically significant improvement in visual acuity in patients with Best disease, a rare genetic eye disorder. Link
• Hansa Biopharma announced positive data from a Phase 2 trial of its antibody-cleaving enzyme Duchenne muscular dystrophy gene therapy imlifidase. The data showed that imlifidase was well-tolerated and effectively cleared antibodies, potentially enabling more patients to be eligible for gene therapy. Link
• Fulcrum Therapeutics announced positive results from the 12 mg dose cohort of the Phase 1b trial of its small molecule sickle cell disease drug pociredir. The data showed that pociredir was well-tolerated and demonstrated a dose-dependent increase in fetal hemoglobin, a key marker of disease modification. Link
• Celcuity announced positive data from the Phase 2 trial of its PI3K/mTOR inhibitor breast cancer combination drug gedatolisib. The trial met its primary endpoints, showing a clinically meaningful and statistically significant improvement in progression-free survival in patients with HR+/HER2- advanced or metastatic breast cancer. Link
• Assembly Biosciences, Inc. announced positive interim results from the Phase 1b trial of its small molecule chronic hepatitis B virus infection drug ABI-4334. The data showed that ABI-4334 was well-tolerated and demonstrated potent antiviral activity, supporting its further development for the treatment of chronic hepatitis B. Link

✅🏆 Regulatory Approvals… 

• Novartis 's small molecule therapeutic Coartem (artemether/lumefantrine) Dispersible was approved in Switzerland for the treatment of uncomplicated malaria in newborn babies and young infants. This is the first medicine approved for this vulnerable patient population weighing less than 5 kg, addressing a significant unmet medical need. Link
• Bayer 's small molecule therapeutic Lynkuet (elinzanetant) was approved in the United Kingdom for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause. This is the first worldwide approval for the non-hormonal, dual neurokinin-1,3 receptor antagonist for this indication. Link
• KalVista Pharmaceuticals, Inc. ' small molecule therapeutic Ekterlyr (sebetralstat) was approved in the USA for the treatment of on-demand treatment of hereditary angioedema (HAE) attacks. This is the first oral, on-demand therapy approved for HAE attacks in patients 12 years of age and older. Link
• BeiGene 's monoclonal antibody therapeutic Tevimbra (tislelizumab) was approved in the European Union for the treatment of nasopharyngeal carcinoma. The approval covers its use in combination with chemotherapy as a first-line treatment for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma. Link
• ImmunityBio, Inc. 's biologic therapeutic Anktiva (nogapendekin alfa inbakicept-pmln) was approved in the United Kingdom for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The IL-15 superagonist is approved for use in combination with Bacillus Calmette-Guérin (BCG) for adult patients with carcinoma in situ. Link
• Sanofi 's monoclonal antibody therapeutic Dupixent (dupilumab) was approved in the USA for the treatment of uncontrolled chronic obstructive pulmonary disease (COPD). This is the first-ever approval of a biologic for COPD and is indicated for adult patients who have evidence of type 2 inflammation. Link
• Bayer 's small molecule therapeutic Kerendia (finerenone) was approved in the USA for the treatment of heart failure. This new indication is to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with a left ventricular ejection fraction of ≥40%. Link
• Bayer 's small molecule therapeutic Nubeqa (darolutamide) was approved in the European Union for the treatment of advanced prostate cancer. This third indication for Nubeqa is specifically for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy. Link
• Johnson & Johnson 's monoclonal antibody therapeutic Darzalex (daratumumab) was approved in the European Union for the treatment of high-risk smouldering multiple myeloma. This is the first licensed treatment for this patient population, aiming to delay the progression to active multiple myeloma. Link
• Johnson & Johnson 's small molecule therapeutic Imbruvica (ibrutinib) was approved in the European Union for the treatment of previously untreated mantle cell lymphoma. It is the first targeted therapy approved for this specific patient population who are eligible for autologous stem cell transplant. Link
• Jazz Pharmaceuticals ' small molecule therapeutic Modeyso (danapritorre) was approved in the USA for the treatment of urothelial carcinoma. The approval is for adult patients with locally advanced or metastatic disease that has progressed on or after treatment with platinum-containing chemotherapy. Link
• LENZ Therapeutics ' small molecule eye drop therapeutic Vizz (aceclidine) was approved in the USA for the treatment of presbyopia. The once-daily, preservative-free drop is designed to improve near vision in adults affected by age-related farsightedness without impacting distance vision. Link
• PTC Therapeutics, Inc. 's small molecule therapeutic Sephiencetm (sepiapterin) was approved in the USA for the treatment of phenylketonuria (PKU). The oral therapy is approved for adult and pediatric patients of all ages, offering a new option to reduce blood phenylalanine levels in this rare genetic disorder. Link
• Apellis Pharmaceuticals ' targeted C3 peptide therapeutic Empaveli (pegcetacoplan) was approved in the USA for the treatment of C3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). This is the first and only targeted therapy approved for these rare and debilitating kidney diseases. Link

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