Avalyn Pharma found strong investor interest in its inhalable drugs in development for two types of pulmonary fibrosis, enabling the company to upsize its IPO. Data from two mid-stage studies are expected in 2027.

The post Avalyn Pharma Takes a Breath to Raise $300M in IPO Cash for Lung Drug Trials appeared first on MedCity News.

Coultreon Biopharma’s lead drug candidate, acquired from Galapagos, is a small molecule designed to selectively inhibit a novel immunology target called SIK3. The Series A financing will support Phase 2 clinical trials in psoriasis and ulcerative colitis.

The post Immunology-Focused Coultreon Adds $125M for Pills That Pack the Punch of Injectable Biologics appeared first on MedCity News.

Intellia Therapeutics’ lonvo-z uses CRISPR to inactivate a gene in the liver to reduce levels of a protein key to the swelling attacks from the rare disease hereditary angioedema. Intellia has filed a regulatory submission for this genetic medicine, which could become the first in vivo gene-editing therapy to land FDA approval.

The post Intellia’s Data Reveal Tees Up FDA Filing for CRISPR-Based In Vivo Gene-Editing Med appeared first on MedCity News.

The World Health Organization has prequalified Coartem Baby, the first and only antimalarial for babies. Novartis developed this combination drug in partnership with Medicines for Malaria Venture.

The post Novartis Antimalarial Clears Key WHO Review to Get the Combo Drug to Babies appeared first on MedCity News.

Regeneron Pharmaceuticals’ Otarmeni is now approved for treating hearing loss from an ultra-rare genetic mutation found in an estimated 50 newborns per year. While Regeneron will offer this gene therapy for free, the approval came with a rare pediatric disease priority review voucher that the company can sell for hundreds of millions of dollars.

The post Regeneron Gets Landmark FDA Approval for First Gene Therapy for Hearing Loss appeared first on MedCity News.

Merck’s HIV drug Idvynso could become a drug choice for patients who need to switch from Gilead Sciences’ Biktarvy for safety or tolerability reasons. The Merck combination drug pairs two molecules that bring different mechanisms of action to suppressing HIV.

The post FDA Nod for Merck HIV Drug Brings Competition to a Gilead Sciences Antiretroviral appeared first on MedCity News.

Obsidian Therapeutics aims to show its TIL cell therapy has advantages over an Iovance Biotherapeutics TIL therapy marketed for treating melanoma. Obsidian’s merger with Galera Therapeutics will give it a public listing and a private placement to support clinical development of the combined company’s cancer drug pipeline.

The post Obsidian, Galera Merger Comes With $350M Infusion for Cancer Drug Trials appeared first on MedCity News.

Kailera Therapeutics’ IPO proceeds will support global clinical trials for its obesity drug candidates. Meanwhile, proteomics company Alamar Biosciences upsized its own IPO while clinical-stage biotechs Seaport Therapeutics and Hemab Therapeutics joined the IPO queue.

The post Kailera’s Upsized IPO Brings In $625M for Pipeline of Injectable & Oral Obesity Drugs appeared first on MedCity News.

The fatty liver disease MASH is one of the metabolic disorders that Nula Therapeutics is pursuing. The startup’s small molecules are intended to restore the integrity of the nuclear envelope, a cellular membrane whose dysfunction can contribute to metabolic disease.

The post Startup Nula Emerges to Advance a New Class of Medicines for Metabolic Disease appeared first on MedCity News.

Eli Lilly is paying up to $300 million for CrossBridge Bio, a startup developing antibody drug conjugates that deliver two drug payloads to cancers. Beyond potentially better efficacy, CrossBio’s dual approach could also fight drug resistance.

The post Eli Lilly Buys Startup CrossBridge Bio to Bring a More Powerful Strike to Tumors appeared first on MedCity News.

Travere Therapeutics’ Filspari is now the first FDA-approved drug for focal segmental glomerulosclerosis (FSGS), a rare kidney disease. Analysts project the pill will become a blockbuster seller.

The post Bouncing Back From Trial Failure, Travere Wins First FDA Approval in Rare Kidney Disease appeared first on MedCity News.

Revolutions Medicines’ daraxonrasib met the main goals of its Phase 3 test in pancreatic cancer, posting results that were both statistically significant and clinically meaningful. The company now plans to file for speedy regulatory approval under a new FDA pilot program.

The post Revolution Medicines Reports ‘Unprecedented’ Survival in Pivotal Pancreatic Cancer Trial appeared first on MedCity News.

Sidewinder Therapeutics and Stipple Bio each raised mega-rounds of financing to support their approaches to improving the targeting abilities of antibody drug conjugates for cancer. Both startups are on track to enter the clinic next year.

The post Two New Takes on Making a Type of Targeted Cancer Therapy Even Better appeared first on MedCity News.

There are no FDA-approved therapies for GPC3, a protein highly expressed by liver cancers. Oricell Therapeutics claims its cell therapy could be best in this class, but it faces competition from companies such as AstraZeneca and Eureka Therapeutics.

The post Oricell Lands $110M to Take Cell Therapy to New Territory in Cancer appeared first on MedCity News.

Gilead Sciences exercised its option to license a Kymera Therapeutics’ protein-degrading drug designed to eliminate the cancer-driving protein CDK2. Meanwhile, Roche’s new partnership with C4 Therapeutics is focused on developing degrader antibody drug conjugates for undisclosed cancer targets.

The post Gilead and Roche Bet on Protein Degraders for Their Cancer Drug Pipelines appeared first on MedCity News.

[Sponsored] A new eBook explores how using real world data from patients can help drug developers improve outcomes for non-small cell lung cancer and other patient populations.

The post How to Use Real-World Data to Improve Drug Development, Starting with the Patient Journey appeared first on MedCity News.

Insmed drug Brinsupri failed to beat a placebo in a mid-stage clinical trial testing the daily pill as a treatment for hidradenitis suppurativa, a chronic inflammatory skin disorder. Brinsupri is still projected to become a blockbuster seller in non-cystic fibrosis bronchiectasis, where it is the first approved therapy for this chronic lung condition.

The post Trial Failure in the Skin Does Not Dent Insmed Drug’s Potential in the Lungs appeared first on MedCity News.

Soleno Therapeutics brings Neurocrine Biosciences Vykat XR, a drug commercialized for treating the rare genetic disease Prader-Willi syndrome. This blockbuster prospect complements Crenessity, a Neurocrine drug approved for treating a rare endocrine disorder called congenital adrenal hyperplasia.

The post Neurocrine’s $2.9B Soleno Buyout Brings What Could Become Its Next Blockbuster Drug appeared first on MedCity News.

Biogen’s Apellis Pharmaceuticals acquisition comes nearly two years after the drugmaker purchased immunology startup Human Immunology Biosciences. CEO Chris Viehbacher said Apellis accelerates Biogen’s expansion in nephrology, supporting a HI-Bio drug currently in pivotal testing for three kidney conditions.

The post Why Biogen Is Paying $5.6B to Buy Apellis Pharma appeared first on MedCity News.

FDA approval for Eli Lilly’s oral GLP-1 drug, Foundayo, comes about three months after Novo Nordisk launched its Wegovy pill. While clinical trial results for both daily pills showed comparable weight reduction, Lilly’s pill offers patients a slight dosing advantage.

The post Eli Lilly Gets Speedy FDA Nod for Oral GLP-1 Drug, a Competitor to New Novo Nordisk Pill appeared first on MedCity News.

Centessa Pharmaceuticals’ cleminorexton is part of the orexin agonist drug class, which could introduce a new approach to the treatment of narcolepsy and other sleep disorders. Acquiring Centessa brings Eli Lilly into a group of clinical-stage orexin agonist drug developers that includes Takeda Pharmaceutical, Alkermes, and Eisai.

The post Eli Lilly’s Neuro Prospects Expand to Sleep Science With $6.3B Centessa Acquisition appeared first on MedCity News.

Kailera Therapeutics’ planned IPO will fund ongoing clinical development of a pipeline led by a drug that could rival Eli Lilly’s Zepbound in both efficacy and tolerability. Meanwhile, Renaissance Capital’s recap of first quarter 2026 IPOs shows slowing activity amid market turbulence from tariffs and war.

The post Kailera Plans IPO for Obesity Drug That Could Top Lilly’s Zepbound appeared first on MedCity News.

Rocket Pharmaceuticals received FDA approval for Kresladi, a gene therapy developed to treat leukocyte-adhesion deficiency type 1, an inherited immunodeficiency that can become fatal to infants and young children. Kresladi is the first gene therapy for this ultra-rare disease and the first commercial product for Rocket.

The post FDA Approval Makes Rocket Pharma Gene Therapy the First for Ultra-Rare Immune Disorder appeared first on MedCity News.

Alumis’s genomic research guided its development of envudeucitinib, a TYK2 inhibitor that some analysts now view as best in class. The Phase 3 results that will support a planned FDA submission in plaque psoriasis are scheduled for presentation this weekend during the American Academy of Dermatology annual meeting in Denver.

The post Taking a Page From Cancer Drugs, Autoimmune Biotech Alumis Aims for Precision Immunology appeared first on MedCity News.

[Sponsored] A new eBook, sponsored by PurpleLab, examines how a significant number of patients with non-small cell lung cancer miss out on optimal care due to gaps in biomarker testing, socioeconomic barriers, incomplete patient journey data, and what can be done to change that.

The post How Real-World Data Is Reshaping the NSCLC Patient Journey appeared first on MedCity News.

Denali Therapeutics’ Avlayah received FDA approval for treating Hunter syndrome, a rare neurological disorder. The biologic medicine uses Denali’s proprietary drug delivery technology to cross the protective blood-brain barrier.

The post FDA Approval for Denali Therapeutics Blazes a New Trail for Brain-Penetrating Drugs appeared first on MedCity News.

Merck has been acquiring assets that could help make up for the coming revenue decline as its top product, the cancer drug Keytruda, drops off the patent cliff. Terns Pharmaceuticals’ lead product candidate, in development for treating a type of leukemia, could offer dosing and efficacy advantages over the Novartis drug Scemblix.

The post Merck’s $6.7B Terns Acquisition Positions It to Challenge a Blockbuster Novartis Cancer Drug appeared first on MedCity News.

Gilead Sciences is acquiring Ouro Medicines, a startup developing T cell engagers for a range of autoimmune diseases. Separately, Gilead is negotiating a deal with Galapagos to share in the development and potential commercialization of the Ouro drug.

The post Gilead Sciences Gains an Opportunity for Immune System Reset With $1.7B Ouro Acquisition appeared first on MedCity News.

Novartis already markets the PI3Kα inhibitor Piqray for breast cancer, but acquiring a Synnovation Therapeutics subsidiary brings an early clinical program that the pharma company claims could be best in the class of next-generation therapies for the target. Competitors include Eli Lilly, Relay Therapeutics, and OnKure Therapeutics.

The post Why Novartis Is Paying $2B for a Cancer Drug That Hits the Same Target as One of Its Own Products appeared first on MedCity News.

FDA approval of Icotyde covers the treatment of adults and adolescents with moderate-to-severe plaque psoriasis. This once-daily pill, developed by partners Johnson & Johnson and Protagonist Therapeutics, offers an easier dosing option compared to injectables and is projected to become a blockbuster seller across several immunological indications.

The post J&J Gets FDA Nod for Plaque Psoriasis Pill Positioned to Compete With Injectables appeared first on MedCity News.