Bevacizumab biosimilar(Outlook Therapeutics)

Today, a brief rundown of news involving Capricor Therapeutics and Legend Biotech, as well as updates from AstraZeneca, Outlook Therapeutics and Otsuka Pharmaceutical that you may have missed.Capricor Therapeutics shares lost nearly two-thirds of their value on Monday after briefing documents indicated that Food and Drug Administration staff reviewers are highly critical of the data supporting the companys experimental cell therapy for Duchenne muscular dystrophy. The FDA previously turned back that cell therapy, deramiocel, but accepted a new application and scheduled a July 29 advisory committee meeting after the company accumulated new data. In documents filed ahead of the panel, FDA scientists noted that Capricors therapy missed its initial Phase 3 study goals, and that its final application included statistical analyses the agency hadnt agreed to. Those changes were unwarranted based on the studys design, powering, and original statistical assumptions, agency reviewers wrote. Capricors findings may have also been compromised by functional unblinding given a distinctive difference in the adverse events observed among drug and placebo recipients, they added.Legend Biotech CEO Ying Huang has stepped down as part of a leadership transition, the cell therapy developer said Friday. Huang has led Legend over the last seven years, during which time the company helped bring the Johnson & Johnson-partnered multiple myeloma treatment Carvykti to market and established a competitive position in in vivo cell therapy development. Still, company shares have lost about half their value over the last year amid crowding competition in multiple myeloma. Alan Bash, the head of Legends Carvykti business unit, will serve as interim CEO while the board searches for a full-time replacement.The incoming CEO, and their interactions/board alignment, will be critical to turning the story around, wrote Oppenheimer analyst Kostas Biliouris, in a Monday note to clients.A few weeks after disclosing a major research setback, AstraZenecahas reported mixed results in two more late-stage readouts. In one Monday announcement, the company revealed its rare disease drug Ultomiris failed a Phase 3 trial in a rare complication related to stem cell transplants. AstraZeneca also said that its antibody-drug conjugate sonesitatug vedotin meaningfully improved survivalwhen compared to standard treatment options in patients with certain gastric cancers, but missed statistical significance on a measure of tumor progression. The former readout erases a potential expansion opportunity for a drug AstraZeneca acquired from Alexion Pharmaceutical and that generated about $2.6 billion in sales between January and June. The latter could still give AstraZeneca a chance to gain an approval for an ADC it licensed in a 2023 deal. Itll share the results with global health authorities.The FDA on Friday finally cleared for use a treatment Outlook Therapeutics developed for a form of age-related vision loss. That medicine, Lytenava, is a version of bevacizumab the active ingredient in Avastin Outlook formulated as an eye drop for the wet form of age-related macular degeneration. Injectable Avastin is widely used off-label to treat wet AMD along with other drugs like Eylea and Vabysmo. Outlook said Lytenava is the first purpose-built ophthalmic formulation of bevacizumab and, while its been approved in Europe and the U.K. for multiple years, it was previously rejected by U.S. regulators three times. Outlook appealed the last rejection and was able to convince the agency earlier this year to change its position.The FDA on Friday also approved a new medicine for attention deficit hyperactive disorder, or ADHD. Called Simtriyo and developed by Otsuka Pharmaceutical, the drug is the first marketed medicine of its kind, targeting three brain chemicals norepinephrine, dopamine and serotonin instead of two, like Adderall or Ritalin. Otsuka said the therapy should be available later this year. '

Wet AMD is an eye disorder characterised by leaky vessels in the retina causing vision loss. Credit: PeopleImages/Shutterstock.com. Following years of regulatory setbacks that saw multiple rejections, Outlook Therapeutics has secured US Food and Drug Administration (FDA) approval for eye disease drug Lytenava (bevacizumab). Outlook’s Lytenava is approved for treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD. The drug is administered by intravitreal injection. Bevacizumab is already a commonly used first-line off-label treatment option for wet AMD, owing to its anti-vascular endothelial growth factor (anti-VEGF) action, which blocks a protein that causes leaky blood vessels. Bevacizumab was originally developed by Roche’s Genentech as an anti-cancer therapy under the brand name Avastin and is normally administered by intravenous injection. Outlook says that, for the first time, retina specialists and patients have access to an FDA-approved ophthalmic bevacizumab developed specifically for the eye. Wet AMD is an eye disorder characterised by the growth of abnormal vessels in the macula. These leak blood or fluid, which leads to a rapid loss of vision. Outlook’s CEO Bob Jahr commented: “Rather than relying on repackaged formulations originally intended for intravenous use, physicians now have access to a purpose-built ophthalmic formulation of bevacizumab designed specifically for intravitreal administration that delivers the manufacturing consistency, product quality, and regulatory oversight patients deserve.” Outlook stated it is executing the commercial launch for Lytenava, with availability for eligible US patients set to start before the end of 2026. While Lytenava is already approved in Europe and the UK, FDA approval for the injection means Outlook has its first commercial product in the US. It has been far from a straightforward journey to this milestone. The US biotech was on the receiving end of three complete response letters (CRLs) from the FDA since a first regulatory submission to the agency in 2022. The central underlying qualm from the agency was a lack of substantial evidence of effectiveness , which Outlook contested. Following the third CRL, Outlook filed a formal dispute resolution request in April 2026. The FDA Office of New Drugs granted the appeal a month later, agreeing that substantial evidence of effectiveness had in fact been met. With marketing authorisation granted, Outlook joins a competitive wet AMD market. While it has gone through significant shifts in recent years, it is still dominated by anti-VEGF drugs. Bayer and Regeneron’s Eylea (aflibercept) has long dominated the global wet AMD market, netting nearly $8bn in sales in 2025. However, Eylea is undergoing patent expiries, opening the door for Roche’s Vabysmo (faricimab) – also an anti-VEGF medication – to gain market share . Outlook places the value of the US anti-VEGF retina market alone at approximately $8.5bn. Analysis by GlobalData’s Pharma Intelligence Center forecasts it will rise to $13.8bn in 2033. GlobalData is the parent company of Pharmaceutical Technology .