Cyclerion Expands Partnership With Medsteer; Plans Phase 2 Trial Of CYC-126 In 2H 2026

 Cyclerion Therapeutics, Inc. (CYCN), a biopharmaceutical company pioneering neuropsychiatric therapies, announced that it has entered into an application-specific, exclusive collaboration with Medsteer, which specialises in closed-loop anaesthetic delivery systems that use real-time patient data and algorithms.

Also, Cyclerion will host a webcast today, January 6, 2026, at 8:00 a.m. Eastern Time to discuss the Medsteer Development Collaboration and provide business updates on the path to initiating a Phase 2 Proof of Concept (POC) study of CYC-126 in Treatment-Resistant Depression (TRD) in 2026.

The collaboration is intended to integrate Medsteer's proprietary technology and leverage it into Cyclerion's lead program, CYC-126. Cyclerion plans to combine its neuropsychiatric and clinical development knowledge with Medsteer's closed-loop anaesthetic delivery systems and strengthen its development strategy and reinforce its clinical timeline.

Apart from Medsteer's Strategic Collaboration, the other key highlights include progress in product development and the regulatory strategy to support the initiation of a multinational Phase 2 POC clinical trial.

CYC 126 is being developed as a personalised, precision-delivered therapy that combines anaesthetic agents with real-time EEG monitoring and algorithm-guided dosing for Treatment-Resistant Depression. It is estimated that about 3 million Americans live with treatment-resistant depression.

https://www.nasdaq.com/articles/cyclerion-expands-partnership-medsteer-plans-phase-2-trial-cyc-126-2h-2026-stock

Alumis beams as pivotal data on Sotyktu rival drive stock surge

 A pair of phase 3 psoriasis studies of Alumis’ TYK2 inhibitor have hit their primary endpoints, setting the biotech up to file for approval of a potential challenger to Bristol Myers Squibb’s Sotyktu. With the news, Alumis’ shares more than doubled in premarket trading. 

The biotech tested its TYK2 inhibitor, envudeucitinib, in two studies that collectively enrolled more than 1,700 adults with moderate to severe plaque psoriasis. About half of the participants received Alumis’ oral drug candidate twice daily. The other half of the patients were split up to receive either apremilast, which Amgen sells as Otezla, or placebo. 

On average across the two trials, 74% of people on envudeucitinib experienced at least a 75% improvement in their symptoms, as measured on the Psoriasis Area and Severity Index (PASI), at Week 16. Alumis said 59% of patients scored zero or one on the static Physician’s Global Assessment (sPGA) at Week 16. The PASI 75 and sPGA results met the trials’ co-primary endpoints.

At Week 24, 65% of patients experienced at least a 90% improvement on the PASI. Alumis reported “clear separation from placebo” on PASI 90 as early as Week 4. More than 40% of patients met the PASI 100 criteria by Week 24, indicating that they had completely clear skin. Alumis also said it saw clinically meaningful improvements in patient-reported outcomes related to quality of life and itch.

BMS reported PASI 75 response rates of 53% and 58% at Week 16 in the phase 3 trials quoted (PDF) on the Sotyktu label. At Week 24, the proportion of patients achieving PASI 90 on Sotyktu ranged from 32% to 42%. BMS reported PASI 100 results in 10% to 14% of patients in the two Sotyktu studies. 

With the caveat that cross-trial comparisons can be unreliable, the results appear to favor Alumis' envudeucitinib over Sotyktu. The envudeucitinib results look to be in line with the expectations Alumis CEO Martin Babler set at an investor event in September. 

Noting that Alumis saw a 64% placebo-adjusted PASI 75 at Week 12 of a phase 2 trial, Babler said a result in the 50% to 60% range at Week 16 would be competitive. Alumis’ phase 3 release lacks results from the placebo arm. Between 9% and 13% of patients on placebo in BMS’ Sotyktu trials met the PASI 75 criteria at Week 16.

With no new safety signals emerging in its phase 3 trials, Alumis plans to file for FDA approval in the back half of 2026. FDA approval could add to the pressure on Sotyktu, which generated $206 million for BMS over the first nine months of 2025 and has underperformed prelaunch expectations.

Envudeucitinib is on course to come to market after icotrokinra, the oral IL-23 blocker Johnson & Johnson is lining up as a challenger to Sotyktu. J&J filed for FDA approval in adults and adolescents with plaque psoriasis in July. Icotrokinra performed similarly to envudeucitinib in two phase 3 trials, racking up PASI 75 rates of 74% and 77% at Week 16.

While J&J could be a tough competitor, the psoriasis market’s size, fragmentation and level of treatment switching mean there is room for multiple big products. Alumis plans to focus on the efficacy, safety and convenience of envudeucitinib as it tries to carve out a piece of the market. In parallel, the biotech will work to validate its molecule in lupus, where potentially pivotal phase 2b data are due this year.

In premarket trading Tuesday, Alumis' shares were up 115% to nearly $18 from a Monday closing price of $8.31.

https://www.fiercebiotech.com/biotech/alumis-beams-pivotal-data-sotyktu-rival-drive-stock-surge

Morgan Stanley files for spot Bitcoin, Solana ETFs

 Global financial services company Morgan Stanley filed S-1 registration statements on Tuesday with the US Securities and Exchange Commission to launch spot Bitcoin and Solana exchange-traded funds (ETFs).

According to the filings, the bank wants to introduce the ETFs Morgan Stanley Bitcoin Trust and Morgan Stanley Solana Trust tied to the prices of cryptocurrencies Solana and Bitcoin.

If approved, the move would strengthen the asset manager's position in the cryptocurrency market two years after the SEC authorized the first US-listed spot bitcoin ETF and would join major crypto ETF issuers like BlackRock and Fidelity.

https://breakingthenews.net/Article/Morgan-Stanley-files-for-spot-Bitcoin-Solana-ETFs/65431774

Gilead Keeps Dealing With $300M OncoNano Drug Delivery Cancer Pact

 

OncoNano’s platform, called ON-BOARD, packages drugs in pH-sensitive micelles that ensure their specific delivery near tumors, while also preventing systemic exposure.

Gilead is joining with Texas’ OncoNano Medicine to deliver one of Gilead’s investigational cancer drugs using the biotech’s platform, fulfilling a promise it made late last year to stay active in business development.

Details of the deal, announced Tuesday, were sparse, with the companies revealing only that the arrangement will mean a $300 million windfall for OncoNano—a sum that includes the upfront commitment, milestones and additional payments related to an additional target, if Gilead chooses to expand the collaboration.

At the heart of the partnership is OncoNano’s proprietary ON-BOARD platform, which uses “ultra pH-sensitive polymeric micelles” to encapsulate drugs and respond to the cellular environments shared by various cancers, according to the company’s website. This approach not only protects the therapeutic payload from being broken down in the body—therefore preventing systemic exposure—but also ensures their specific release into the tumor’s microenvironment.

“We believe it can complement Gilead’s oncology expertise to bring effective treatment options to patients,” OncoNano CEO Kartik Krishnan said in a statement.

The companies did not disclose which of Gilead’s cancer drugs they will apply ON-BOARD to.

Tuesday’s OncoNano partnership comes after Gilead last month finally gave up on its TIGIT therapy domvanalimab, which it had been developing in partnership with Arcus Therapeutics. The partners were studying domvanalimab in the Phase III STAR-221 trial in first-line advanced gastric and esophageal cancers. An interim analysis at the time found no significant improvements in overall survival compared with Bristol Myers Squibb’s Opdivo—and determined that continuing on with the study would be futile.

Gilead and Arcus decided to terminate STAR-221 as well as a Phase II trial called EDGE-Gastric.

The collaboration with OncoNano also comes a few months after Gilead expressed an eagerness to spend money in business development, especially looking to improve its portfolios in liver disease, immunology and cancer.

CFO Andrew Dickinson, speaking on the company’s Q3 earnings call, said Gilead is looking for “late-stage derisked assets” to pick up “every two to three years at a minimum.”

https://www.biospace.com/deals/gilead-keeps-dealing-with-300m-onconano-drug-delivery-cancer-pact

Sanofi’s MS Drug Tripped Up By Toxicities, Unclear Benefit, Rejection Letter Reveals

 

Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.

Following last month’s surprise rejection of Sanofi’s BTK inhibitor tolebrutinib in multiple sclerosis, the FDA has now made public its complete response letter to the company, in which it pointed to serious safety risks with the drug, as well as uncertainties regarding its efficacy.

“A favorable benefit-risk profile could not be established for any patient subpopulation,” the agency wrote in its CRL, dated Dec. 23, 2025. Sanofi and California-based partner Corcept Therapeutics were proposing tolebrutinib as a treatment for adult patients with non-relapsing secondary progressive multiple sclerosis (SPMS).

The FDA zeroed in on four main issues with tolebrutinib’s data package, one of which was the drug’s “serious risk of severe” drug-induced liver injury (DILI). Six such cases were detected among about 2,700 patients, according to the CRL. In one patient, this necessitated liver transplantation and ultimately led to death.

This safety signal, the FDA contended, “indicates a high level of hepatotoxic risk with tolebrutinib.” While the agency conceded that liver toxicities are known side effects of BTK inhibitors like tolebrutinib, “the risk of fatal DILI associated with tolebrutinib appears to be among the highest in the class.”

The FDA also flagged tolebrutinib’s efficacy, raising questions about its therapeutic benefit in certain patient subpopulations. The CRL noted that Sanofi was unable to distinguish between patients with active or non-active SPMS because it failed to collect historical MRI data.

Sanofi tried to provide such data in response to an information request from the FDA, but the MRI information were subject to “selection bias, as the data were only able to be collected from subjects who elected to enroll in and remained in the open-label extension study,” the letter read.

Nevertheless, an analysis of Sanofi’s follow-on submission suggested that tolebrutinib’s treatment effect was driven largely by patients with active SPMS, for which the FDA noted there are already approved therapies.

“The analyses raise substantial uncertainties about the SPMS population that is more likely to benefit from tolebrutinib,” the agency wrote. “Given the serious and unusually high risk of severe DILI, it is critical to have certainty about efficacy in a population in whom this level of DILI risk could be considered acceptable.”

Another critical issue for the FDA was the lack of conclusive evidence demonstrating tolebrutinib’s effectiveness at slowing the accumulation of disability in patients, independent of its ability to prevent relapses. Here, Sanofi was tripped up by the lack of established standards for this particular endpoint. “There are no widely accepted criteria for defining disability accumulation independent of relapse activity,” the FDA wrote in its rejection letter, noting that this particular endpoint “remains an emerging construct with multiple limitations.”

Taken together, these three shortcomings in the tolebrutinib package led to the FDA’s final sticking point, which is that tolebrutinib did not have a favorable risk-benefit profile in any tested patient subpopulation. In patients with active SPMS, the agency argued, tolebrutinib’s “benefits would not be anticipated to outweigh the risk of DILI” given the presence of approved alternatives.

Meanwhile, the drug’s lack of signal in terms of disease accumulation points to its unclear benefits in patients with non-active disease.

Despite the rejection, the FDA has left the door open to Sanofi, giving the pharma the opportunity to “identify a population for whom the potential benefits of your drug may outweigh the serious risk of severe DILI.”

https://www.biospace.com/fda/sanofis-ms-drug-tripped-up-by-toxicities-unclear-benefit-rejection-letter-reveals

Roche Clears Obesity Pill Legal Concerns With Structure Patent Agreement

 

The agreement, which BMO Capital Markets called a “mild positive” for Structure, appears to address Roche’s concerns about the composition of investigational weight loss drug CT-996.

In a bid to position itself as a leader in the oral obesity arena, Roche has entered into an agreement with Gasherbrum Bio, a subsidiary of Structure Therapeutics, to license certain patents of Structure’s that are incorporated into CT-996, Roche’s investigational weight loss pill.

The agreement, which was inked on Dec. 30, 2025 but announced in an SEC filing on Monday, grants Roche—through its subsidiary Genentech—a non-exclusive license to “make, use, sell, offer for sale and import” products containing CT-996. In exchange for these rights, the pharma will pay $100 million upfront and has promised Structure royalties in the low-single-digit range on net sales.

It remains unclear what these licensed patents are for, with Structure noting only that the deal “does not encumber any of the Company’s ongoing programs, including aleniglipron,” Structure’s own GLP-1 agonist, only relating to the CT-996 scaffold.

The agreement also contains “a covenant not to assert certain potential future patents with respect to [Genentech’s] and its affiliates’ manufacture, use, sale, offer for sale or importation of [Genentech] Products.”

While the specifics are not yet public, Leerink Partners noted that the deal appears to head off Roche’s legal concerns about CT-996’s composition, writing in a Monday afternoon note that “Roche approached [Structure] for the license after a full analysis of the IP landscape and a need for a license to avoid any potential infringement.”

Writing to investors on Monday evening, analysts at BMO Capital Markets called the Roche agreement “a mild positive” for Structure—one that “highlights the strength of Structure’s IP protections but represents a muted read-through to the stock.” At $64 apiece, the biotech was up 1.96% after the trading session, relative to its closing price of $62.77.

BMO insisted, however, that for Structure, Monday’s agreement with Roche “is not the large Pharma partnership that some Structure owners have been anxiously awaiting.” The biotech last month released Phase IIb data for aleniglipron, touting an 11.3% placebo-adjusted reduction in weight at 36 weeks.

William Blair analysts at the time said these findings are competitive with Eli Lilly’s own obesity pill orforglipron, noting that the biotech’s stock movement—shares spiked 100% in the wake of the data drop—could have been driven by the prospect of deals from Big Pharma.

BMO on Monday echoed this assessment, noting that “Structure now appears an even more viable option for large Pharma to partner with and expand commercially in the future.” While Roche did not provide the biotech with such an opportunity, the analysts added, the agreement still gives Structure “some incremental cash and future revenue.”

Leerink Partners saw the deal as a positive for Structure too, saying that the deal “support[s] [Structure] management’s view that the company has the broadest and strongest global IP portfolio related to GLP-1 receptor agonist small molecules.”

For Roche, the patent partnership is in line with its continued investment in the obesity space. In late 2023, the pharma swallowed Carmot Therapeutics in a $2.7 billion agreement, bringing into its fold CT-996, as well as the dual GLP-1 and GIP receptor agonist CT-388. Then, in May last year, Roche put $5.3 billion on the line to partner with Zealand Pharma and co-develop its amylin analog petrelintide.

https://www.biospace.com/deals/roche-clears-obesity-pill-legal-concerns-with-structure-patent-agreement

Clarivate: Drugs to Watch 2026

For Drugs to Watch 2026, our team of analysts systematically selected eleven therapeutics that are likely to transform treatment paradigms and/or become blockbusters in the next five years. We provide an overview of our methodology and summaries of the selected drugs on this site. Our in-depth analysis and drug descriptions are available in the downloadable full report.


This year’s Drugs to Watch include next-generation GLP-1 drugs for weight loss and type 2 diabetes mellitus (T2DM), targeted protein degraders for cancer, precision medicines for rare diseases and new therapies in women’s health.
Download the Drugs to Wat
ch 2026 reportdownload


2026 Drugs to Watch

Explore detailed summaries and analyst commentary on each drug





Drugs to Watch2026

BGB-16673


Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
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Drugs to Watch2026

Exdensur (depemokimab)


Asthma
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Drugs to Watch2026

Gedatolisib


Breast cancer
north_east
Drugs to Watch2026

Icotrokinra


Plaque psoriasis
north_east
Drugs to Watch2026

INLEXZO™ (TAR-200)


Bladder cancer
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Drugs to Watch2026

Mezigdomide


Multiple myeloma
north_east
Drugs to Watch2026

Orforglipron


Obesity, Type 2 diabetes mellitus (T2DM)
north_east
Drugs to Watch2026

Relacorilant


Ovarian cancer and hypercortisolism (Cushing syndrome)
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Drugs to Watch2026

Retatrutide


Obesity, Type 2 diabetes mellitus (T2DM)
north_east
Drugs to Watch2026

Tolebrutinib


Multiple sclerosis
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Drugs to Watch2026

VOYXACT® (sibeprenlimab)


IgA nephropathy
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How we identified the Drugs to Watch

Since 2013, our annual Drugs to Watch report has relied on our proprietary technologies, tools and techniques that are also trusted by our global life sciences customers.

To identify the Drugs to Watch 2026 list, we drew from expertise from over 160 Clarivate analysts covering hundreds of diseases, drugs and markets and 10 integrated, AI-enhanced data sets that span the R&D and commercialization lifecycle. For the first time this year, we validated our findings using AI platforms and grouped the drugs by industry-relevant trends.
Learn more about our methodology
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Industry trends driving innovation

Patients’ needs and expectations are reshaping biopharma as regulators push for innovation that results in meaningful outcomes. Together, they are driving progress across global health priorities including the obesity crisis, rare-yet-extremely burdensome conditions, women’s health and hard-to-treat cancers, showing how science and policy can align to advance care and close treatment gaps.

Our Drugs to Watch for 2026 reflect this dynamic, aligning roughly to these four key trends:
The race to revinvent weight lossnorth_east
Bridging the rare disease treatment gapnorth_east
Rethinking the research paradigm for women’s healthnorth_east
Redefining targetability with protein degradersnorth_east

https://clarivate.com/drugs-to-watch/