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By PharmaCompass
2026-02-19
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Last week, the US Food and Drug Administration (FDA) had said it will not review Moderna’s application for its experimental influenza vaccine — mRNA-1010. This week, the agency did a volte-face, agreeing to review an amended application filed by the American biotech.
On its part, Moderna has said it is looking for growth overseas, by leveraging its partnership with governments in the UK, Canada, and Australia.
Eli Lilly is swiftly building stock of its experimental weight loss drug orforglipron, which is likely to receive an FDA approval in April. Its approved weight loss medicine Zepbound (tirzepatide) has shown greater benefit in treating psoriasis when used along with its approved treatment for psoriasis Taltz (ixekizumab), as compared to Taltz alone, in a late-stage study. And its cancer drug Retevmo (selpercatinib) has shown statistically significant and clinically meaningful improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive non-small cell lung cancer (NSCLC).
FDA has rejected Disc Medicine’s new drug application (NDA) for bitopertin as a treatment for a rare blood disorder. The drug was being reviewed under the FDA Commissioner’s National Priority Voucher (CNPV) program. Disc Medicine will now pursue a traditional FDA approval pathway for this drug.
In trials, Compass Pathway’s psilocybin-based therapy — COMP360 — eased symptoms in patients with treatment-resistant depression (TRD). Ocular Therapeutix’s experimental eye drug — Axpaxli — has shown superior benefits in treating wet age-related macular degeneration (wet-AMD) as compared to Regeneron’s Eylea (aflibercept) in a key late-stage trial. And Roche’s Gazyva met its primary endpoint in a phase 3 trial in patients with primary membranous nephropathy (pMN), a rare autoimmune kidney disorder.
Meanwhile, PTC Therapeutics has withdrawn the NDA resubmission for its Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) following FDA’s negative feedback on the data submitted.
In a volte-face, FDA to review Moderna’s amended flu vaccine application
A week after rejecting the original submission, FDA has agreed to review an amended application filed by Moderna for its mRNA-based flu vaccine candidate — mRNA-1010. The agency is expected to make a decision on the vaccine by August 5.
Last week, the agency declined to review the vaccine, arguing that Moderna lacked an “adequate and well-controlled” study. In August last year, the Trump administration halted funding for certain mRNA projects amid growing skepticism toward immunizations.
Following FDA’s initial refusal, Moderna said it is looking for growth overseas. The vaccine maker plans to leverage its partnership with governments in the UK, Canada, and Australia to drive growth this year, a Reuters report said.
In its fourth-quarter results, Moderna has forecast up to 10 percent revenue growth in 2026 compared to the previous year, driven primarily by international sales. The company now expects roughly half of its revenue to come from the US, down from about 62 percent in 2025.
Lilly builds stock of obesity drug orforglipron ahead of FDA approval
Anticipating approval in the coming months, Eli Lilly has stockpiled US$ 1.5 billion worth of its experimental weight loss drug orforglipron. This will ensure a strong launch to the product. FDA is likely to approve orforglipron in April.
Lilly has been gearing up for the orforglipron launch for a long time and has been ramping up manufacturing capacity since 2024. In February 2025, it had said it has already stockpiled US$ 548 million worth of orforglipron.
Zepbound+Taltz shows benefit in psoriasis: Lilly’s weight loss medicine Zepbound (tirzepatide) used along with its psoriasis treatment Taltz (ixekizumab) has shown better results in psoriasis patients in a late-stage study, as compared to Taltz alone.
Retevmo shows benefit in NSCLC: Lilly’s Retevmo (selpercatinib), an FDA-approved drug to treat lung and thyroid cancers that have a mutation or fusion to the RET gene, has demonstrated “highly statistically significant and clinically meaningful” improvement in event-free survival in patients with early-stage (2-3A) RET fusion-positive NSCLC. The twice-daily oral medication was tested against placebo in patients who had undergone surgery or radiation therapy.
No accelerated approval for Disc’s rare disease med under priority voucher program
Disc Medicine has said the FDA has rejected its application for bitopertin as a treatment for patients with erythropoietic protoporphyria (EPP), a rare blood disorder characterized by extreme sensitivity to light. The drug was being reviewed under the FDA Commissioner’s National Priority Voucher (CNPV) program, which fast-tracks the process to one to two months from the typical 10 to 12 month timeline. Incidentally, the rejection took four months to materialize, raising questions about the CNPV program. According to a Reuters report, Disc Medicine will now pursue a traditional FDA approval pathway for its rare disease drug.
Compass’ psychedelic-based depression treatment scores second late-stage study win
In a late-stage trial, Compass Pathways’ psilocybin-based therapy — COMP360 — eased symptoms in treatment-resistant depression (TRD). This is the second such late-stage trial win for the therapy, which consists of a synthetic formulation of psilocybin, the active ingredient in “magic mushrooms”, and is designed as a short-term, episodic alternative to daily antidepressants for TRD patients.
Ocular’s wet AMD drug beats Regeneron’s Eylea: Ocular Therapeutix’s experimental eye drug — Axpaxli — has shown superior benefits as compared to Regeneron’s Eylea (aflibercept) in a key late-stage trial. Ocular said Axpaxli is the first experimental treatment for wet age-related macular degeneration to show better results than an approved treatment, while also meeting FDA’s strict trial standards.
Roche’s Gazyva scores phase 3 win in rare autoimmune kidney disorder
Roche’s Gazyva (obinutuzumab) could emerge as the first approved therapy for primary membranous nephropathy (pMN), a rare autoimmune kidney disorder. In a phase 3 trial, Gazyva met its primary endpoint, and according to top-line results, significantly more people achieved complete remission at two years with Gazyva, as compared to immunosuppressant tacrolimus.
PTC withdraws DMD drug application: PTC Therapeutics has withdrawn the NDA resubmission for its Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) following FDA’s negative feedback on the data submitted.
Gilead in licensing deal with Chinese biotech for cancer therapy
Gilead Sciences has entered into a licensing agreement with Chinese biotech Genhouse Bio to secure exclusive worldwide rights to GH31, an experimental therapy targeting multiple types of tumor. Under the agreement, Gilead will pay US$ 80 million upfront to Genhouse Bio, with potential milestone payments worth up to US$ 1.45 billion.
Sanofi names Belén Garijo as new CEO: Sanofi’s board has ousted Paul Hudson and appointed Belén Garijo as the new chief executive officer. She will take up her duties on April 29.
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