Daily Snap - 22. August 2025

Author

Joachim Eeckhout
August 22, 2025

Good morning! Biotech may talk a lot about saving lives, but one company seems more focused on saving your hairline. Germany’s Mallia Aesthetics is gearing up to launch MAL-838, a hair-growth stimulant based on a soluble human protein called sCD83. The company has cleared the regulatory hoops to market MAL-838 as a cosmetic (translation: don’t call it a drug, even if it seems to grow follicles in lab tests), and plans to roll it out later this year under the brand 8T3. Who knows, maybe the next blockbuster in biotech will shrink bald spots rather than tumors.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

🧊Trial freeze: Krystal Biotech has discontinued its phase 1/2 OPAL-1 trial of KB707, a herpes simplex virus-based intratumoral gene therapy for advanced melanoma, following the FDA’s rejection of a similar therapy from Replimune. The regulatory decision has raised industry concerns over changing FDA standards for accelerated approvals, particularly regarding trial design and patient heterogeneity. While enrolled patients will continue to be monitored, Krystal cited increased uncertainty in approval pathways as a reason for halting new enrollment. The company will now focus on an inhaled version of KB707, alongside its existing programs in ophthalmology, dermatology, and the marketed gene therapy Vyjuvek.

💪Barth boost: The FDA has accepted Stealth BioTherapeutics’ third new drug application for elamipretide, a treatment for the ultrarare Barth syndrome, and plans to issue a decision by September 26, months ahead of the expected February 2026 PDUFA date. This accelerated timeline follows public and congressional pressure after previous rejections and delays, despite advisory committee support and the drug's strong safety profile. The urgency reflects growing concern over the unmet need for Barth syndrome patients, with Stealth facing financial strain and no approved therapies currently available.

🥊Shingles showdown: Dynavax reported promising early results for its investigational shingles vaccine Z-1018, which matched GDK’s Shingrix in immune response while demonstrating a better tolerability profile in a phase 1/2 trial. Z-1018 achieved a 100% antibody response rate one month after the second dose, compared to 96.9% for Shingrix, and showed comparable CD4+ T cell activity. Importantly, Z-1018 had lower rates of moderate-to-severe post-injection and systemic reactions than Shingrix. Based on these results, Dynavax will advance a 100-mcg formulation into further testing in patients 70 and older, with the goal of competing in the multi-billion-dollar shingles vaccine market.

👁️Glaucoma drops: Nicox is preparing regulatory filings in the US and China for NCX 470, its nitric oxide donating bimatoprost eyedrop for glaucoma, after a second successful Phase 3 trial confirmed its effectiveness in lowering intraocular pressure (IOP). The study showed NCX 470 matched standard therapy latanoprost in IOP reduction, with some secondary analyses suggesting numerical but not overall statistical superiority. The drug was well tolerated, with eye redness as the main side effect, and discontinuation rates slightly higher than latanoprost. Nicox is advancing toward commercialization in a $6 billion global glaucoma market, while also progressing follow-up candidate NCX 1728.

🌱Seed boost: Axelyf, a biotech company specializing in advanced lipid nanoparticle delivery systems for RNA therapeutics, has secured $2.6 million in seed funding, with potential to reach $4.1 million, supported by three Icelandic venture capital firms. The company integrates AI through its ANNA platform to optimize lipid design and aims to address delivery challenges for complex RNA therapies. Örn Almarsson, who previously led drug delivery efforts at Moderna for COVID-19 vaccine and therapeutics development, co-founded the company and will lead it as CEO.

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