Aglatimagene besadenovec

Candel Therapeutics will pay tiered single-digit percentage of annual net sales of aglatimagene to RTW Investments.\n As Candel Therapeutics gears up for a planned U.S. approval push for its prostate cancer drug later this year, RTW Investments has stepped in with $100 million to bankroll the launch.The nine-figure fund is conditional on Candel securing FDA approval for the oncolytic virus, called aglatimagene besadenovec or CAN-2409, in intermediate- to high-risk localized prostate cancer. The biotech currently expects to file for approval in the fourth quarter.In return, RTW will be in line for a tiered single-digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap, according to a Feb. 19 release.“This non-dilutive strategic financing will support the U.S. launch of aglatimagene besadenovec, assuming FDA approval, and will allow us to further invest in what we believe will be a world class commercial program,” Candel CEO Paul Peter Tak, M.D., Ph.D., said in the release.“We remain on track to submit the BLA for aglatimagene in Q4 of this year, and we look forward to collaborating with the FDA to pursue an expeditious approval of aglatimagene,” Tak added. “We are thrilled with our RTW partnership, as we seek to provide a new treatment option for patients in the early stages of prostate cancer who are treated with curative intent, a disease that has seen minimal innovation over the past two decades.”         Aglatimagene is administered as an injection into the prostate of an adenovirus encoding an enzyme. Candel saw its stock surge 200% at the end of 2024 as the company unveiled phase 3 data linking the therapy to a 14.5% relative improvement in disease-free survival.Roderick Wong, M.D., managing partner and chief investment officer at RTW, said the phase 3 readout had “demonstrated the potential of aglatimagene besadenovec in early, localized prostate cancer.” “Today’s commitment reflects our confidence in Candel and the strong commercial potential of this therapy,” Wong added in yesterday’s release. “We are proud to partner with the Candel management team and look forward to supporting their efforts to bring this meaningful treatment to patients with localized prostate cancer.” Candel ended September 2025 with $87 million in the bank, although the company had already been planning to augment this with a loan facility from Trinity Capital that could stretch to $130 million. As well as the deal with RTW, the biotech also announced yesterday that it hopes to raise a further $100 million in a public offering of its common stock, with the proceeds earmarked for ensuring aglatimagene is ready for launch.

Roche’s oral SERD gets December decision deadline from FDATeva's long-acting schizophrenia injection nears FDA finish lineCandel bags $100M to support launch of viral immunotherapyRoche’s oral SERD gets December decision deadline from FDA The FDA on Friday accepted for review an NDA from Roche for its experimental oral selective oestrogen receptor degrader (SERD), giving it a Dec. 18 PDUFA date. The Swiss pharma is seeking giredestrant's approval in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen.Giredestrant impressed physicians and investors alike across two back-to-back readouts late last year. At the San Antonio Breast Cancer Symposium (SABCS), Roche reported that the oral SERD significantly reduced the risk of invasive disease recurrence or death by 30% versus standard-of-care endocrine therapy in the specific breast cancer patient population (see – Spotlight On: Interim lidERA success lifts Roche's giredestrant into adjuvant spotlight and raises CDK4/6 inhibitor combo questions).Roche's candidate stands to be the second oral SERD to receive an FDA nod, following approval for Eli Lilly's Inluriyo (imlunestrant) in September; AstraZeneca is also developing its own candidate, camizestrant. The competition between the three pharmas to bring oral SERDs into frontline breast cancer care is a key oncology story FirstWord is watching this year (see – Spotlight On: Five key oncology stories to watch in 2026).-Elizabeth EatonTeva's long-acting schizophrenia injection nears FDA finish lineThe FDA is reviewing a marketing application for Teva's experimental schizophrenia treatment, the company said Friday. TEV-'749 is a long-acting formulation of the atypical antipsychotic olanzapine, designed to improve treatment adherence and help patients maintain long-term stability.According to Teva, other long-acting versions of the therapy carry a risk of post-injection delirium/sedation syndrome; Eli Lilly currently markets olanzapine in a once-daily oral formulation as Zyprexa.The Israeli drugmaker's submission is based on data from the Phase III SOLARIS study, which showed that TEV-'749 led to a clinically meaningful and statistically significant change in the Positive and Negative Syndrome Scale total score compared to placebo.If the FDA approves Teva's extended-release injectable formulation of olanzapine, Royalty Pharma will receive low- to mid-single digit royalties, per an agreement signed in 2023 under which it provided Teva with up to $125 million in development funding for the candidate. -Elizabeth EatonCandel bags $100M to support launch of viral immunotherapyCandel Therapeutics inked a $100-million royalty funding agreement with RTW Investments, contingent on the FDA approval of the former's lead asset aglatimagene besadenovec (CAN-2409) — a viral immunotherapy for intermediate- to high-risk localised prostate cancer."This non-dilutive strategic financing will support the US launch of aglatimagene besadenovec…and will allow us to further invest in what we believe will be a world-class commercial programme," said Paul Peter Tak, chief executive of Candel.Backed by favourable disease-free survival data in a pivotal prostate cancer study, the biotech plans to submit a marketing application to the US regulator in the fourth quarter. Upon FDA approval of the therapy, RTW is eligible for a tiered, capped single-digit royalty on annual net US sales. -Pavan Kamat