Roche Holding AG

Welcome back to another edition of Endpoints Weekly! For those that had time off for Presidents’ Week, we hope you had a restful vacation. If you missed any of the headlines, we had a lot of biotech news this week. We covered clinical trial data from an Eylea competitor, Moderna’s flu shot fracas, another rare disease rejection, and an update on a potential psilocybin treatment. And in a potential shift, the pharma industry seems to be signaling that it’s done negotiating with the Trump administration over trying to codify “most favored nation” deals into law, Max Bayer wrote. White House officials have tried to convince lawmakers that industry supports the effort, but it still hasn’t been made clear what exactly Trump’s team is hoping to codify. For an industry so closely tapped into Washington, its failure to pacify the president with concessions is an unexpected turn. Read more from Max here . Have a great weekend, and we’ll see you next week! — Max Gelman 👁️ Ocular Therapeutix is working on a therapy it hopes can compete with the blockbuster drug Eylea in an eye disease called wet age-related macular degeneration, or wet AMD. The biotech read out Phase 3 data this week for its experimental drug Axpaxli, in which 74.1% of patients reached their goal on a test that measures a patient’s vision. Comparatively, this goal was hit by 55.8% of Eylea patients, an observed difference of 18.3 percentage points. The result was statistically significant, with a p-value of p=0.0006. However, this difference underwhelmed Wall Street, sending Ocular’s stock price down more than 20% on the day it released the data. The difference between the treatment and comparator arms might be the issue for shareholders: Judging by remarks CEO Pravin Dugel made at investor conferences last year, Ocular expected this level of performance from Axpaxli, but set expectations for Eylea at about 20%. The control drug did much better than that prediction. Axpaxli should still have a relatively smooth path to FDA approval, senior biopharma journalist Elizabeth Cairns writes . The trial was designed to support a potential superiority label and was agreed to by the FDA. The superiority claim could also mean Axpaxli will leapfrog Eylea HD, the less frequently administered version of Regeneron and Bayer’s drug, and Roche’s newer entrant Vabysmo. The timing for an FDA filing is not yet set, but Ocular is seeking to meet with the agency as soon as possible. Next steps include a second Phase 3 study for the noninferiority of Axpaxli given every six months versus Eylea at 2 mg every two months and Eylea HD every four. And Ocular is eyeing up a much bigger market: diabetic retinopathy. Data from the first of two Phase 3 studies could come next year. 💉 The company announced this week that the two sides have agreed to an amended filing . Following a Type A meeting with regulators, Moderna said it will apply for a standard approval in the 50 to 64 age group and accelerated approval in adults 65 years and older. The company said it will conduct a post-marketing study in the older age group to produce more clinical data. The FDA set an Aug. 5 date to decide on both submissions. If approved, the vaccine could be available for the upcoming flu season. The resolution comes about a week after Moderna announced that it received a refusal-to-file letter, and the ultimate decision followed an unusual path through FDA, Endpoints’ Zachary Brennan reported . Read more here. The FDA rejected yet another rare disease drug from a biotech seeking accelerated approval, this time from Disc Medicine. But this drug was also part of the Commissioner’s National Priority Voucher (CNPV) program, a pilot that aims to significantly shorten the typical 10- to 12-month review times. Disc’s drug was one of the first in the pilot to go through FDA review, and the rejection suggests drugs that are selected won’t be guaranteed an approval. In the rejection letter, FDA officials cited concerns about the surrogate biomarker used in clinical trials. An HHS spokesperson said there “was agreement amongst the review division that a CRL was appropriate and a career official signed off” on the rejection. Analysts viewed the rejection as a surprise, particularly since Disc was one of the first companies to get the voucher. “It’s hard to connect the dots on this one,” Stifel analyst Stephen Willey wrote in a note to investors. Read more here . 🧠 The company announced this week that it met the primary endpoint in a second pivotal trial. The study tested its psilocybin formulation, COMP360, in patients with treatment-resistant depression. But unlike the first pivotal trial, which pitted COMP360 against placebo, this trial compared different doses against each other. The trial followed an unusual design because the drug’s powerful mental effects make blinding versus a placebo nearly impossible. Roughly half the patients took two 25 mg doses of the drug three weeks apart. A quarter of the trial’s subjects received two doses of 10 mg, and another quarter two doses of 1 mg. Results showed a greater benefit with the highest dose than with the lowest at the six-week mark, as assessed by a commonly used measure of depression symptoms. Compass’ chief medical officer Guy Goodwin said the experience is “ often likened to a waking dream in that people have very intense perceptual, emotional and memory experiences, which can be literally regarded by some people who take it as the most significant experience of their life.” The trial will continue to evaluate the pill’s effectiveness at the six-month mark. Those results are expected in the summer. And Compass is hoping for a regulatory approval by the middle of next year. Read more from Elizabeth Cairns here. 🤝 Novartis is tapping into a macrocyclic peptide platform from Unnatural Products. The Swiss pharma giant will pay $100 million in upfront and pre-IND milestone payments, and Unnatural Products could get up to $1.7 billion in biobucks spread across development, regulatory and commercial milestones. Novartis will be in the driver’s seat for everything beginning at the IND-enabling stage, Kyle LaHucik reported. The progress of macrocyclic chemistry is “opening entirely new avenues in drug discovery,” Muneto Mogi, head of global discovery chemistry at Novartis Biomedical Research, said in a statement. Multiple startups are trying to pave those new avenues, including Danish contender Orbis Medicines, Boehringer Ingelheim-paired Circle Pharma, and Vilya, which was co-founded by Nobel Prize winner David Baker. DON’T MISS:

On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Full prescribing information for Calquence and Venclexta will be posted on Drugs@FDA . Efficacy and Safety Efficacy was evaluated in AMPLIFY (NCT03836261), a randomized, multicenter trial in adult patients previously untreated for CLL without del(17p) or TP53 mutation. Patients were randomized to receive acalabrutinib and venetoclax (AV) or Investigator’s choice of chemotherapy (fludarabine plus cyclophosphamide plus rituximab [FCR] or bendamustine plus rituximab [BR]). The major efficacy outcome measure was progression-free survival (PFS) as assessed by independent review committee for the AV arm versus the investigator’s choice arm (FCR/BR). The median duration of PFS follow-up was 42.6 months. Median PFS was not estimable (NE) (95% CI: 51.1, NE) in the AV arm and 47.6 months (95% CI: 43.3, NE) in the FCR/BR arm (Hazard ratio 0.65 [95% CI: 0.49, 0.87]; p-value 0.0038). With a median follow-up of 41.0 months, there were 18 (6%) deaths in the AV arm and 42 (14%) in the FCR/BR arm. The acalabrutinib prescribing information includes warnings and precautions for serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrythmias, and hepatotoxicity. The venetoclax prescribing information includes warnings and precautions for tumor lysis syndrome, neutropenia, infections, and embryo-fetal toxicity. In AMPLIFY, serious adverse reactions occurred in 25% of patients receiving AV, and serious or Grade 3 or higher infections in 14%. The recommended regimen for acalabrutinib in combination with venetoclax consists of up to 14 cycles of acalabrutinib and 12 cycles of venetoclax starting at cycle 3. Each cycle is 28 days. The recommended acalabrutinib dose is 100 mg taken orally approximately every 12 hours until disease progression, unacceptable toxicity, or completion of 14 cycles of treatment. Start venetoclax at 20mg according to the 5-week ramp-up dosing schedule in the prescribing information. Following the ramp-up, the recommended venetoclax dose is 400 mg orally once daily until disease progression, unacceptable toxicity, or until the last day of Cycle 14. Expedited Programs This review used the Assessment Aid , a voluntary submission from the applicant to facilitate the FDA’s assessment. The applications were granted orphan drug designation. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov . Follow the Oncology Center of Excellence on X: @FDAOncology . Content current as of: 02/20/2026 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

💰 Candel prices $100M offering, inks $100M royalty deal: Candel aims to use the funds from the offering to boost its aglatimagene besadenovec program, a virus-based therapy also known as CAN-2409 or aglatimagene. The biotech is trying to get the drug approved in a form of prostate cancer, and plans to launch a Phase 3 lung cancer trial in the second quarter. The royalty deal, signed with RTW Investments, is contingent on a prostate cancer approval. Candel said it intends to file for the prostate cancer FDA submission by the end of 2026. — Max Gelman 🟢 FDA approves AstraZeneca’s fixed duration Calquence regimen for certain blood cancers: The treatment was approved for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, and is meant to give them time off therapy. The regimen combines Calquence, a BTK inhibitor , with AbbVie and Roche’s Venclexta. — Lei Lei Wu Editor’s note: This article has been updated to correct the spelling of Candel Therapeutics and to correct that CAN-2409 is not an oncolytic virus-based therapy.