🧩 FDA reviews Roche SERD NDA; Teva LAI; Candel $100M

Roche’s giredestrant — an oral SERD — is now under FDA review with a Dec. 18 PDUFA date, seeking approval with everolimus for ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic Breast Cancer after progression on prior endocrine therapy. The filing follows data Roche highlighted at SABCS showing a 30% reduction in invasive disease recurrence or death vs standard endocrine therapy in the specified population.

Why It Matters To Oncology

• Oral SERDs are moving from promise to practice: giredestrant could become the second FDA-approved oral SERD, after Lilly’s Inluriyo (imlunestrant) cleared in September; AstraZeneca’s camizestrant remains in the race.

• The target population is clinically important: ESR1 mutations are a common mechanism of endocrine resistance in ER+ metastatic disease, making effective next-line endocrine backbones strategically valuable for combination regimens.

• Combination strategy is the story: Roche is pairing giredestrant with everolimus, positioning the SERD as a platform partner rather than a standalone endocrine swap.

• While outside oncology, Teva’s long-acting olanzapine (TEV-’749) underscores a broader R&D theme: formulation innovation to drive adherence and real-world durability—an increasingly relevant lens for chronic oral oncology regimens too.

The Financials

• Roche: NDA accepted; Dec. 18 PDUFA date set for giredestrant + everolimus.

• Teva: If TEV-’749 is approved, Royalty Pharma earns low- to mid-single-digit royalties under a 2023 deal that included up to $125M in development funding.

• Candel: Secured a $100M non-dilutive royalty funding agreement with RTW Investments, contingent on FDA approval of CAN-2409 (aglatimagene besadenovec) for localized prostate cancer.

• RTW’s take: Upon approval, it receives a tiered, capped single-digit royalty on annual net U.S. sales of CAN-2409.

What They're Saying

• Roche’s recent readouts “impressed physicians and investors alike,” with SABCS data pointing to a 30% reduction in invasive disease recurrence or death vs standard endocrine therapy in the defined setting.

• Teva frames TEV-’749 as an adherence play, noting other long-acting olanzapine options carry post-injection delirium/sedation syndrome risk; its submission is backed by Phase III SOLARIS showing a clinically meaningful, statistically significant PANSS total score change vs placebo.

• Candel CEO Paul Peter Tak calls the RTW financing “non-dilutive” and aimed at supporting a “world-class commercial programme” for CAN-2409 if approved.

What's Next

• Roche: FDA decision due Dec. 18; watch labeling specifics (mutation requirement, line of therapy) and how the everolimus combo is positioned vs competing oral SERDs.

• Field: Oral SERD competition intensifies as companies push toward earlier-line Breast Cancer use and differentiated combination partners.

• Teva: FDA review continues for TEV-’749; approval would trigger downstream royalty economics for Royalty Pharma.

• Candel: Plans to submit its marketing application for CAN-2409 in Q4; the RTW capital unlocks on FDA approval and would help fund launch execution.