FDA grants accelerated approval to Wegovy for treating MASH; Lilly, Superluminal ink US$1.3 bn AI deal to treat obesity

By PharmaCompass

2025-08-21

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This week’s Phispers brings you updates on key drug approvals. The US Food and Drug Administration (FDA) has granted accelerated approval to Novo Nordisk’s Wegovy for treating metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis. The agency also approved Tonix Pharmaceuticals’ Tonmya to treat fibromyalgia and Precigen’s Papzimeos to treat recurrent respiratory papillomatosis (RRP), a benign condition.

FDA declined to approve PTC Therapeutics’ oral drug vatiquinone for a rare and progressive genetic disorder known as Friedreich’s ataxia, citing insufficient evidence of efficacy.

In deals, Eli Lilly signed a US$ 1.3 billion deal with Superluminal Medicines to use AI in discovering small-molecule drugs for obesity and cardiometabolic diseases. Another AI-driven deal of over US$ 1 billion was signed between VantAI and American biotech Halda Therapeutics.

In other deals, Merck KGaA struck a US$ 2 billion RNA-targeting pact with Skyhawk Therapeutics. And there were reports that India’s Aurobindo Pharma is eying Prague-based generic drugmaker Zentiva.

Schrödinger discontinued development of its candidate SGR-2921 after two patients with acute myeloid leukemia (AML) died in a phase 1 trial. And Pfizer reported that its experimental sickle cell therapy inclacumab failed to meet the primary endpoint in a phase 3 trial for patients aged 16 and older.

In the US, Health and Human Services (HHS) has reinstated the Task Force on Safer Childhood Vaccines after an anti-vaccine group filed a lawsuit. And, the American Academy of Pediatrics (AAP) has recommended routine Covid-19 vaccination for young children, diverging from federal directives.

FDA grants accelerated approval to Novo’s Wegovy for treating MASH

The US Food and Drug Administration (FDA) has granted accelerated approval to Novo Nordisk’s Wegovy (semaglutide) for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis, excluding those with cirrhosis. This is the first GLP-1 receptor agonist to receive approval for MASH. Wegovy is a once-weekly 2.4 mg subcutaneous injection.

Approves new fibromyalgia drug: FDA has approved Tonix Pharmaceuticals’ Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Fibromyalgia is a chronic disorder marked by widespread pain, fatigue, sleep, and cognitive problems. This is the first new FDA-approved fibromyalgia treatment in over 15 years.

Precigen’s Papzimeos okayed: FDA has approved Precigen’s Papzimeos (zopapogene imadenovec-drba), the first treatment for recurrent respiratory papillomatosis (RRP). Patients with RRP often need multiple surgeries each year to remove non-cancerous growths in the airway and voice box.

Lilly-Superluminal, VantAI-Halda ink over US$ 1 billion AI drug discovery deals

Eli Lilly has signed a US$1.3 billion deal with Superluminal Medicines to use artificial intelligence for discovering small-molecule drugs to treat obesity and cardiometabolic conditions. The agreement gives Lilly exclusive rights to develop and commercialize candidates identified through Superluminal’s AI platform.

VantAI, Halda sign AI deal: Drug discovery firm VantAI has entered into a deal worth over US$1 billion with Connecticut-based biotech Halda Therapeutics to develop bifunctional small-molecule drugs for cancer and immune-mediated diseases. The agreement includes an upfront payment, milestones across multiple programs and tiered royalties.

Merck, Skyhawk ink US$ 2 bn drug discovery deal; Aurobindo in race to buy Zentiva

Skyhawk Therapeutics has entered into a strategic research collaboration with Merck KGaA to develop RNA-targeting small molecules for neurological diseases. The deal, valued at over US$2 billion, includes upfront and milestone payments as well as tiered royalties on future product sales. Under the agreement, Skyhawk will lead discovery and preclinical work, while Merck KGaA will assume development and commercialization.

Aurobindo eyes Zentiva: Aurobindo Pharma has emerged as the frontrunner to acquire Prague-based generic drugmaker Zentiva from Advent International in a deal valued at US$ 5.5 billion. If finalized, it would mark the largest overseas acquisition by an Indian pharmaceutical company. US-based private equity firm GTCR is also reported to be in the race.

Saniona, Jazz ink deal for epilepsy therapy: Jazz Pharmaceuticals has secured exclusive worldwide rights to Saniona’s SAN2355, a preclinical activator for epilepsy and other neurological disorders. Under the agreement, Jazz will lead development, regulatory submissions and global commercialization. Saniona will receive US$ 42.5 million upfront and is eligible for up to US$ 1 billion in milestone payments and royalties.

Schrödinger halts leukemia trial after deaths of two patients

Schrödinger has discontinued development of its CDC7 inhibitor SGR-2921 after two patients with acute myeloid leukemia (AML) died in a phase 1 trial. In another trial, a patient on CytomX’s cancer drug CX-2051 died due to kidney injury. However, the safety board has allowed the study to continue.

FDA extends Eylea HD action date: FDA has extended the target action dates to the fourth quarter of 2025 for two regulatory submissions related to Regeneron’s Eylea HD (aflibercept 8 mg). The review extensions follow a recent FDA inspection of Catalent’s Indiana facility. This facility was acquired by Novo Nordisk in late 2024.

FDA rejects PTC’s oral drug for rare genetic disorder, seeks new trial

FDA has declined to approve PTC Therapeutics’ oral drug vatiquinone for a rare and progressive genetic disorder known as Friedreich’s ataxia, citing insufficient evidence of efficacy. It said a new study will be required before the company can resubmit its application.

Pfizer’s inclacumab fails sickle cell trial: Pfizer has reported that its experimental sickle cell therapy inclacumab failed to meet the primary endpoint in a phase 3 trial for patients aged 16 and older. The study showed no meaningful reduction in vaso-occlusive crises (painful events common in sickle cell disease) compared to a placebo.

HHS revives task force on childhood vaccine safety post anti-vax lawsuit

The US Department of Health and Human Services (HHS) has reinstated the Task Force on Safer Childhood Vaccines, a federal panel aimed at improving vaccine safety, oversight, and research. The task force was created in 1986 to provide compensation to children who had adverse reactions to vaccines. The decision follows a lawsuit filed on behalf of anti-vaccine group Children’s Health Defense.

Meanwhile, the American Academy of Pediatrics (AAP) has recommended routine Covid-19 vaccination for all children aged six to 23 months, regardless of prior infection or doses. This view differs from that of the US government — CDC doesn’t recommend Covid shots for healthy children of any age. Instead, it says children may get the shots in consultation with their physicians.

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