Belite continues ascent as Stargardt drug hits mark in late-stage trial

 

• An experimental drug from Belite Bio succeeded in a Phase 3 trial in the most common form of Stargardt disease, positioning the company to seek regulatory approval next year of what could be the first marketed medicine for the condition.
• According to Belite, treatment with its drug, known as tinlarebant, was associated with a roughly 36% reduction in the growth rate of retinal lesions compared to a placebo over the course of two years, meeting the trial’s main goal. Both study groups had a minimal overall change in visual acuity, but Belite said that finding was “consistent” with historical data.
• Belite said tinlarebant was “well tolerated,” with only four patients stopping treatment due to adverse events. The most common eye side effects related to treatment were a type of color vision deficiency and issues seeing at night or adjusting to a dark environment. The majority of those cases were mild, and most resolved during the trial, the company said.

Though it raised only $36 million in an initial public offering three years ago, Belite has quietly been one of the biopharmaceutical sector’s top performers ever since, according to BioPharma Dive data. Company shares, which debuted at $6 apiece, opened Monday trading at nearly $140. Belite is currently valued at around $5 billion.

The reason is tinlarebant, an oral drug with the chance to become the first marketed medicine for Stargardt. In Stargardt, a genetic defect changes how the body processes the vitamin A used to make retinal cells. That defect causes yellowish clumps to form in the eyes, destroying cells and triggering progressive vision loss. There are no available treatments for the roughly 50,000 people in the U.S. Belite estimates to have the disease.

Tinlarebant is designed to reduce the accumulation of toxic vitamin A byproducts in the eye. The drug was first studied at Columbia University over a decade ago, and then put up for bid in a National Institutes of Health program in 2016. Belite’s CEO and chairman, Tom Lin, licensed it and formed Belite around the program two years later. Belite has since brought tinlarebant into late-stage testing in Stargardt as well as geographic atrophy, a more common type of vision loss.

Belite’s value had already doubled this year in anticipation of the results in Stargardt. The company also received a positive recommendation from trial monitors that the 104-patient study continue without modifications, and noted that China’s drugs regulator had begun reviewing an application based on interim results showing statistical significance on the study’s main measure. The likelihood of success was “fairly high” given those updates, Leerink Partners analyst Marc Goodman wrote last month. Goodman has forecast anywhere from $1.4 billion to $3.6 billion in peak annual sales, depending on the drug’s price.

With the positive results, Belite intends to discuss an approval application with regulatory authorities in the U.S. and elsewhere in first half of 2026. It could face competition soon, however. Alkeus Pharmaceuticals, a privately held company, is preparing a submission for a new drug that’s similarly designed to reduce the buildup of harmful vitamin A byproducts in the eye. Ocugen, AAVantgarde, Splice Bio and others are advancing genetic medicines for the condition, too.

Stargardt experts believe gene therapy will eventually “be the preferred treatment approach” for the condition, wrote Mizuho Securities’ Graig Suvannavejh. But for now, the lack of other available therapies should mean “enthusiastic market uptake” for a drug proven to slow disease progression, he wrote in November.

Belite shares climbed by double digits before reversing course and dipping a few percentage points early Monday.

https://www.biopharmadive.com/news/belite-stargardt-tinlarebant-dragon-study-results/806622/

Akebia to pay $12M to Q32 Bio for centerpiece of rare kidney disease pipeline

 Akebia Therapeutics has struck a deal for Q32 Bio’s deprioritized complement inhibitor ADX-097, paying $7 million upfront for an asset that forms the centerpiece of its new rare kidney disease pipeline. 

Q32 hung a for-sale sign on ADX-097 in February. Needing cash for an alopecia areata trial, the biotech stopped a phase 2 renal basket clinical trial of the drug candidate and began evaluating strategic options for its tissue-targeted complement inhibitor platform. In Akebia, Q32 has found a buyer for its C3d-Factor H fusion protein complement inhibitor ADX-097.

Akebia is paying $7 million upfront and guaranteeing another $5 million to buy ADX-097. Q32 will receive $3 million six months after the deal closes and the final $2 million slice of the guaranteed payments by the end of next year.

The deal features $580 million in milestones, most of which are tied to sales of ADX-097. Akebia is on the hook for up to $92.5 million related to development and regulatory milestones. The remaining $487.5 million in potential paydays for Q32 are related to commercial milestones.

Akebia framed the deal as part of its construction of a rare kidney disease pipeline, which is happening in the aftermath of a setback to its approved drug Vafseo. The biotech plans to run a phase 2 basket trial to evaluate the complement inhibitor in multiple rare kidney disease indications. Akebia aims to start the study next year.

The trial is one of two Akebia rare kidney disease studies that could start dosing patients next year. The other study is a phase 2 trial of praliciguat in focal segmental glomerulosclerosis. Akebia licensed the sGC stimulator from Cyclerion Therapeutics in 2021. Preparations to make praliciguat for use in clinical trials took longer than expected, but Akebia now has FDA clearance to run a phase 2 study. 

For Q32, the deal provides a cash boost to fund development of bempikibart in alopecia areata. While bempikibart failed a phase 2b eczema study, Q32 has cut back in other areas to advance the anti-IL-7R antibody in alopecia. The sale of ADX-097 will extend Q32’s cash runway into the second half of 2027, compared to the second half of 2026 without the deal. Phase 2 alopecia data are due in mid-2026.  

With Akebia only buying ADX-097, Q32 is continuing to evaluate options for the rest of its tissue-targeted complement inhibitor platform. The remaining assets include ADX-096, a C3d mAb—CR1 fusion protein that has undergone preclinical tests in eye indications. 

https://www.fiercebiotech.com/biotech/akebia-pays-12m-complement-q32-bio-centerpiece-rare-kidney-disease-pipeline

Roche shares hit milestone with 19% November surge on breast cancer, promising MS drug trials

 Shares of Swiss pharmaceutical giant Roche (OTCQX:RHHBY) saw their strongest monthly gain since 1997 in November, fueled by optimism around an experimental breast cancer drug and positive trial results.

The stock gained 19% last month after Roche said its giredestrant medicine helped women with a form of early breast cancer. Additionally, news of two late-stage trials showed that a multiple sclerosis drug could work for most forms of the disease.

As such, Seeking Alpha investing group leader Edmund Ingham upgraded Roche to Buy, citing strong 2025 performance, a robust pipeline, and attractive valuation metrics.

While RHHBY faces major patent expirations, new launches like Phesgo, Helimbra, and Vabysmo, plus a deep pipeline, can offset losses, Ingham added.

He further noted that Roche's obesity assets, for example, could drum up billions, or potentially even tens of billions, of revenues in the 2030s - provided they are approved with a similar safety and efficacy profile to Novo Nordisk's (NVO) semaglutide and Eli Lilly's (LLY) tirzepatide - better known as Ozempic / Wegovy and Zepbound / Mounjaro.

Furthermore, the company has lifted its full-year guidance for per-share core earnings growth to a high single- to low double-digit range from the prior outlook of a high single-digit rise in currency-adjusted terms. However, the company reiterated its annual sales forecast, implying mid-single-digit growth.

YTD, the stock is up 37%.

https://www.msn.com/en-us/money/markets/roche-shares-hit-milestone-with-19-november-surge-on-breast-cancer-and-promising-ms-drug-trials/ar-AA1RtkvB

UnitedHealth to exit Latin America with $1B Banmedica sale

 The sale marks the conclusion of UnitedHealth’s planned exit from Latin America, a process that began in 2022 and previously included divestments in Brazil and Peru.

・The company recorded an $8.3 billion loss in full-year 2024, tied to its South American divestments, including $7.1 billion from its exit in Brazil.

UnitedHealth Group (UNH) has agreed to sell its last remaining South American asset, Banmedica, to Brazilian private equity firm Patria Investments for about $1 billion, Reuters reported on Sunday. The final agreement was signed on Saturday, with an official announcement expected on Monday.

Talks over the sale of Banmedica began nearly a year ago. The sale marks the conclusion of UnitedHealth’s planned exit from Latin America, a process that began in 2022 and previously included divestments in Brazil and Peru. UnitedHealth had acquired the Chilean company for $2.8 billion in 2018.

The company recorded a $8.3 billion loss in full-year 2024, tied to its South American divestments, including $7.1 billion from its exit from Brazil.

Banmedica, which operates in Colombia and Chile, serves 1.7 million insurance members and operates seven hospitals and 47 medical centers.

The move reportedly allows the company to stabilize following a turbulent period marked by rising medical costs, a federal investigation, and the murder of former CEO Brian Thompson in December 2024.

CEO Stephen Hemsley, who previously held the role from 2006 to 2017, was reinstated amid a broader management overhaul after the company posted its first earnings miss in more than a decade in April.

Earnings Outlook

In October, the insurer lifted its 2025 earnings forecast, projecting net earnings of at least $14.90 per share and adjusted net earnings of $16.25 per share.

“We remain focused on strengthening performance and positioning for durable and accelerating growth in 2026 and beyond,” Hemsley said in a press release in October.

https://www.msn.com/en-us/money/news/unitedhealth-sells-last-south-american-asset-for-1-billion-report/ar-AA1RtYMd

Eli Lilly lowers starting dose costs for Zepbound on direct purchase platform

 Eli Lilly cut prices of its Zepbound drug single-dose vials on its direct-to-consumer platform after it lowered prices of its multi-dose pens last month.

The 2.5 milligram starting dose of Zepbound will now be available for $299 a month, down from $349. The 5 milligram dose will cost $399 a month, compared with its previous price of $499.

The 7.5 milligram, 10 milligram, 12.5 milligram and 15 milligram doses will all now cost $449, down from $499.

The lower prices are available for Eli Lilly's Zepbound Self-Pay Journey Program via its LillyDirect digital platform.

In November, the company made a deal with the U.S. government that included an agreement to lower prices of its Zepbound multi-dose pen.

https://www.morningstar.com/news/dow-jones/202512013225/eli-lilly-lowers-price-of-zepbound-single-dose-vials

Former NASDAQ-Listed Firm Exec Gets Life In Prison Over Murder-For-Hire Plot

 The First Assistant U.S. Attorney for Vermont announced that on November 24, 2025, Chief Judge Christina Reiss sentenced Serhat Gumrukcu, 43, of Los Angeles—formerly the "scientific founder", "inventor" and largest shareholder of publicly listed Enochian Biosciences, which eventually became Renovaro—to life in prison for the January 6, 2018, murder-for-hire of Gregory Davis in Barnet, Vermont.

Gumrukcu was first brought to the attention of market participants by former short seller Hindenburg Research back in 2022 who called his company a $600 million Nasdaq-listed scam "based on a lifetime of lies". 

A jury convicted him in April 2025 of murder-for-hire, conspiracy to commit murder-for-hire, and conspiracy to commit wire fraud, according to the DOJ. 

Gumrukcu had formerly been praised by Enochian (then Renovaro) CEO Mark Dybul - who once worked under Anthony Fauci at the National Institute of Health - with Dybul writing in November 2019 that he was "one of those rare geniuses that is not bound by scientific discipline or dogma". Hindenburg then accused Dybul of turning a "blind eye to outrageous fraud" perpetrated by Gumrukcu in a stunning follow up report after the "inventor's" death. 

The Department of Justice press release says that his co-conspirators were sentenced in September 2025: Berk Eratay received 110 months of imprisonment followed by three years of supervised release; Aron Ethridge received 140 months followed by five years of supervised release; and Jerry Banks received 200 months followed by five years of supervised release.

According to prosecutors, Gumrukcu ordered Davis’s killing because Davis threatened legal action over a failed oil-commodities deal that was also the basis of Gumrukcu’s wire-fraud conviction. Gumrukcu also feared that Davis would interfere with a biotech merger involving his claimed HIV “cure.”

Evidence showed that Eratay enlisted Ethridge, who then hired Banks. On January 6, 2018, Banks posed as a Deputy U.S. Marshal and abducted Davis from his Vermont home; Davis’s body was found the next day nearby. Communications, financial records, and location data documented the dispute between Gumrukcu and Davis and tied Gumrukcu, Eratay, Ethridge, and Banks to the crime.

At sentencing, Melissa Davis, the victim’s widow, thanked investigators and prosecutors. She praised the Vermont State Police “for every call, every update,” the FBI for its “coordination across state lines” and “relentless pursuit of truth,” and the prosecution team whose “strength, commitment, and unwavering pursuit of justice…will stay with me for the rest of my life.”

She said she often felt proud in court, “knowing God had appointed each of you to pursue justice for Gregg,” and also expressed gratitude to her victim advocate, the U.S. Marshals Service, and Chief Judge Reiss.

A supposed mind-reading magician turned biomedical entrepreneur, Gumrukcu mingled with Hollywood elites and earned millions through unconventional medical ventures. But during his five-week trial in Burlington, he faced a far different spotlight—three days on the witness stand, denying involvement in the 2018 murder-for-hire of former business partner Gregory Davis.

Though he claimed innocence, Gumrukcu admitted under oath to lying to authorities and said he'd told “so many lies” in past deals he couldn’t remember them all. He acknowledged buying a fake medical degree from Russia, calling it “cheating,” and described his younger self as “arrogant,” advocating unorthodox treatments like leeches and mistletoe.

As part of their investigation into Enochian and Gumrukcu, Hindenburg Research ordered the very same degree to prove that it was fake back in 2022. 

Way back when, @HindenburgRes published on Enochian Biosciences, now Renovaro $RENB. Their scientific genius, Serhat Gumrukcu, just took the stand this week to deny he hired someone to murder a dude he defrauded. But he DID admit, just as Hindenburg uncovered, that he bought a… pic.twitter.com/G7cfLCV1zB

— Codfish Johnny (@CodfishJohnny) April 17, 2025

Prosecutors argued Gumrukcu had Davis killed to prevent him from exposing fraud tied to a failed oil deal—one that could have derailed a lucrative biomedical contract with Enochian BioSciences.

“Gregg Davis was a problem for the defendant,” said prosecutor Paul Van de Graaf. “It was the defendant who paid for the murder.”

Van de Graaf outlined how Gumrukcu financed the $200,000 plot, with testimony from three co-conspirators, including former assistant Berk Eratay. Eratay claimed Gumrukcu told him he wanted to “get rid of a problem,” prompting Eratay to enlist others, including hitman Jerry Banks. Banks testified he posed as a U.S. marshal, kidnapped Davis, and executed him in rural Vermont.

Defense attorney Ethan Balogh argued it was Eratay who “ran the op,” not Gumrukcu. He said the funds were meant for a cryptocurrency project and portrayed Davis as untrustworthy. Balogh accused the three key witnesses—who took plea deals to avoid life sentences—of lying to save themselves: “These men were all going to die in the cage.”

Prosecutors countered that none of them had a reason to kill Davis—except Gumrukcu. As Van de Graaf said, even “peaceful” men can outsource their violence.

As Hindenburg noted in a subsequent report, the story of Gumrukcu’s rise and fall, up to awaiting trial was chronicled in a podcast produced by Amazon’s Wondery (Spotify, Apple).

https://www.zerohedge.com/markets/former-nasdaq-listed-company-executive-serhat-gumrukcu-gets-life-prison-murder-hire-plot

'Putin Might Soon Clinch A Large-Scale Labor Migration Deal With Modi'

 by Andrew Korybko via Substack,

Putin will visit India late next week to meet with Modi for their annual summit, the first time that the Russian leader will travel to India since the special operation began, his last one being in December 2021.

Aleksei Zakharov, a Fellow at India’s esteemed Observer Research Foundation, published a detailed article about how “Key Policy Outcomes Expected at the India-Russia Summit”.

It’s an excellent read, but it omits mention of their large-scale labor migration talks, which might lead to a deal next week.

Air Marshal Anil Chopra (Retired), the former Director-General of the Center for Air Power Studies in New Delhi, published an intriguing piece about this at RT in early November.

He noted how both countries representatives “discussed potential collaboration on social and labor issues”, contextualizing their conversation by adding that Russia “plans to recruit up to 1 million foreign workers – including from India. The Russian Labor Ministry estimates the shortfall could expand to 3.1 million workers by 2030.”

He makes a lot of compelling arguments about how India could help resolve this dimension of “Russia’s demography problem”, but what’s left out is how its labor migrants pose less of a security risk than Russia’s traditional ones from Central Asia. Conor Gallagher touched upon this in early November in his extensively detailed analysis about the US’ evolving strategy towards that region. From this point here near the end for the next several paragraphs, he describes Russia’s new approach towards migration.

Not only is Russia “getting rid of 700,000-plus migrants, mostly Central Asians, a process which was jumpstarted by the terrorist attack on Crocus City Hall in outer Moscow in March 2024”, but “the Concept of State Migration Policy for 2026-2030…focuses not on increasing the population through Central Asian citizens, but on strengthening control, digitalization, and the task of attracting only those migrants who share the ‘traditional spiritual and moral values’ of Russian society.”

Putin spoke about the security threats posed by “the migration factor” in early November during a meeting with the Council on Interethnic Relations where they discussed ways to fine-tune the State Interethnic Policy, the updated version of which was then approved by month’s end. It’s not declared, but the innuendo is that Central Asian Muslims are at a greater risk of radicalism and being manipulated by foreign forces than other labor migrants such as Indians (both Muslims and especially Hindus).

It’s within this economic-security context that Russia is exploring a large-scale migrant labor deal with India that might be clinched during the Putin-Modi Summit. To be clear, recent policy changes won’t lead to Indians playing a role in “population replacement”, only in labor replacement since most likely won’t be offered a path to residency and then citizenship. The sole purpose is for Indians to meet Russia’s labor shortage in lieu of Central Asian Muslims in exchange for profitable remittance opportunities.

Indians are among the most Russian-friendly people in the world as proven by credible surveys, and unlike Central Asian Muslims, they harbor no historical grievances (whether objectively existing or subjectively perceived) that could be manipulated by foreign forces to weaponize them against Russia.

Their society is also proudly secular and this makes them much less likely to be radicalized into terrorists.

It therefore wouldn’t be surprising if Putin clinches a large-scale labor migration deal with Modi.

https://www.zerohedge.com/geopolitical/putin-might-soon-clinch-large-scale-labor-migration-deal-modi