6 Drug Updates to Watch — September 2026

As part of the Athena BDA monthly pipeline news prompts, we tracked 27 news catalysts in September across approvals, new indication approvals, positive Phase 3 trial results and NDA updates. Eleven of those were outright FDA approvals, an unusually high conversion from pipeline to product in a single month.

Here are the six worth knowing about.

Moderna and Merck reported a topline win in Phase 3 testing for their cancer vaccine intismeran autogene in adjuvant melanoma, adding $45 billion to Moderna’s market cap. Analysts project the therapy could reach multi-billion in melanoma sales by 2040, prompting investor debate over whether the vaccine’s application can expand to rival the broad clinical impact of Keytruda.

Hot Tip Alert: Given the publicity around these clinical trial results, it should come as no surprise that this leads our Hot Tips this month. And with a slew of contacts confirmed as leading the launch across Merck and Moderna, now is the time to be getting in touch.

Novartis plans to seek global regulatory approval for Rhapsido to treat relapsing multiple sclerosis following positive Phase 3 data showing the oral BTK inhibitor reduced relapse rates and disability progression. The drug outperformed Sanofi’s Aubagio and demonstrated no liver safety signals, a key differentiator from competing BTK candidates from Sanofi and Roche that previously faced FDA clinical holds for liver toxicity.

Hot Tip Alert: Rhapsido has been approved for a year now, but MS has always been the bigger prize. These trial results represent a major step in the right direction and could significantly expand the opportunity for the brand.

Jazz announced that Ziihera plus chemotherapy demonstrated a statistically significant overall survival benefit over trastuzumab plus chemotherapy in Phase 3 testing for first-line HER2-positive gastroesophageal adenocarcinoma. Following the drug’s recent FDA approval in this indication, Jazz increased its peak sales projection for the bispecific antibody to between $3 billion and $5 billion.

Hot Tip Alert: A series of positive trial readouts and the recent label expansion have significantly increased expectations for Ziihera. That increased commercial potential should make Ziihera an even bigger priority for Jazz as it expands into new patient populations.

Revolution received FDA approval for Rasonque, a targeted therapy for patients with previously treated metastatic pancreatic adenocarcinoma who are ineligible for multiagent therapy. Following Phase 3 testing where patients lived a median of 13.2 months compared to 6.7 months on chemotherapy, the drug carries a 30-day list price of $39,800.

The FDA approved Takeda’s Orzeyful for Type 1 narcolepsy, introducing a first-of-its-kind orexin-2 amplifier with projected peak net annual sales of $2 billion. Following a DEA scheduling review of up to 90 days, the therapy will launch into a multibillion-dollar market ahead of emerging competitors from Alkermes, Eisai, and Lilly.

The FDA granted accelerated approval to BMS’s Zenbexus, the first approved CELMoD therapy, in combination with J&J’s Darzalex and dexamethasone for adults with previously treated multiple myeloma. Marking the first multiple myeloma approval driven directly by a minimal residual disease endpoint, the drug outperformed a traditional regimen during Phase 3 testing and is projected to surpass $1 billion in U.S. sales by early 2031.

The complete September News Digest, covering all 27 catalysts, is available in our Athena BDA Insights Hub, a free resource for pharma pipeline insights and more.