Otsuka’s drug eases symptom burden, anxiety in ADHD as FDA verdict nears

 

The positive ADHD data for Otsuka Pharmaceutical’s centanafadine is good news in what has of late been a mixed bag for the neuropsychiatric space.

Otsuka Pharmaceuticals’ investigational treatment for attention-deficit/hyperactivity disorder significantly reduced overall symptoms and feelings of anxiety in a Phase 3b study, beefing up the company’s case for the drug as an FDA decision looms.

At eight weeks, patients on Otsuka’s candidate, dubbed centanafadine, showed a 5.87-point improvement over placebo in ADHD symptom burden, as measured by a semi-structured interview tool. This effect was statistically significant, the company said in a Thursday release.

Moreover, Otsuka noted that statistical separation between centanafadine and placebo started as early as the first week and persisted through the rest of the follow-up period.

Centanafadine also significantly lowered anxiety symptoms, as measured by a separate scale, with a 1.92-point advantage in patients receiving the investigational drug. Otsuka said centanafadine also met other secondary outcomes, though it did not elaborate further. The company plans to present a more detailed analysis of the study at an upcoming scientific conference.

Designed to be taken orally, centanafadine is a triple reuptake inhibitor, preventing the reabsorption of norepinephrine, dopamine and serotonin into cells after they transmit a neuronal message. That way, these neurotransmitters stay in the synapse and continue signaling for longer than they would otherwise.

The drug is currently under FDA review for ADHD, with a target action date of July 24. Data from Thursday’s readout were not part of Otsuka’s regulatory submission.

Thursday’s positive data for centanafadine add to biopharma’s recent clinical and regulatory wins across the neuropsychiatric space. In February, the FDA signed off on Vanda Pharmaceuticals’ Bysanti for first-line treatment of schizophrenia and manic or mixed episodes in patients with bipolar I disorder.

Then, last week, an independent study found that the dopamine agonist pramipexole could help patients with mood disorders feel pleasure—an outcome that Jefferies said in a May 15 note “instills confidence” in Alto Neuroscience’s ALTO-207 for treatment-resistant depression. ALTO-207 is a fixed-dose combination of pramipexole with antiemetic ondansetron. The drug is in mid-stage development, with data expected later this year.

But not all has gone smoothly for the neuropsych field. In April, Newron Pharmaceuticals disclosed a patient death in a late-stage study of its oral glutamate modulator evenamide for treatment-resistant schizophrenia, prompting the FDA to put the trial under a clinical hold. Earlier this month, Neumora Therapeutics decided to scrap its oral drug candidate navacaprant after disappointing results in two Phase 3 studies.

https://www.biospace.com/drug-development/otsukas-drug-eases-symptom-burden-anxiety-in-adhd-as-fda-verdict-nears

Moderna looks out to R&D ‘horizons’ as 2028 break-even goal looms

 

Jefferies expects Moderna to have around seven commercial products in the coming years which, along with a projected 10% revenue growth, could help the company break even in 2028.

After running into an FDA-shaped speedbump earlier this year, Moderna appears to have regrouped and is plotting an R&D roadmap for the coming years as the company continues to move toward its goal of breaking even in 2028.

During its Science Day investor event on Thursday, Moderna broke down its pipeline into three waves—or “horizons,” as the company calls them. The first focuses on its most mature assets, including both late-stage candidates and commercial products, designed and developed using the company’s established mRNA modalities.

“By 2027-28, MRNA could be marketing 7+ products” across the respiratory disease, oncology and rare disease spaces, Jefferies told investors in a Thursday note. The company has three marketed products at the moment: the COVID vaccines Spikevax and mNEXSPIKE and the respiratory syncytial virus shot mRESVIA.

Further building out its commercial portfolio will prove critical for Moderna’s goal of hitting its well known break-even target in 2028, especially after recent regulatory roadblocks. The FDA in February refused to review the company’s mRNA flu vaccine mFluvisa (mRNA-1010), citing issues with how the pivotal study was conducted. Faced with strong industry blowback, however, the agency backtracked and days later accepted the application for review.

MFluvisa has since made a triumphant comeback, winning overwhelming support from a panel of independent FDA advisors last week. The agency’s Vaccines and Related Biological Products Advisory Committee unanimously supported the shot’s full approval in adults aged 50 through 64 years, and its accelerated approval in those 65 years and older.

The FDA is expected to make a decision on or before Aug. 5.

An approval for mFluvisa would give a boost to another of Moderna’s first-horizon assets, Jefferies said, “enabling MRNA to seek FDA clarity on mCombriax,” the company’s combination shot for flu and COVID. The vaccine won European approval in April, but its U.S. prospects may be dimmer. In May 2025, Moderna pulled its FDA application for mCombriax, saying a resubmission hinged on further data for mFluvisa.

Aside from respiratory vaccines, the first horizon of Moderna’s R&D strategy also includes its personalized cancer shot intismeran autogene, which the company is developing alongside Merck’s Keytruda for high-risk advanced melanoma. Jefferies expects data for this indication to come later this year, with additional readouts continuing through 2027. The shot is also in late-stage development for non-small cell lung cancer and mid-stage assessments for renal cell and bladder cancers.

These products, along with Moderna’s May forecast of a 10% year-on-year revenue growth, could help the biotech “reduce cash burn . . . ensuring 2028 cash breakeven,” Jefferies said.

Moderna on Thursday also looked out to further horizons, presenting its pipeline built on emerging modalities. The company’s second horizon includes assets currently in the clinic, such as cancer antigen therapies, cell therapy enhancers and T cell engagers, plus an investigational asset for multiple sclerosis.

Longer-term, the biotech is also looking to expand into future treatment modalities, with its push powered by AI and other advanced technologies. Modalities under this third horizon include in vivo dual CAR T treatments, in vivo CAR M assets and tolerizing therapies.

https://www.biospace.com/business/moderna-looks-out-to-r-d-horizons-as-2028-break-even-goal-looms

Alpha Tau 1st-Ever Brain-Cancer Patient Treated Outside the U.S.

 Alpha Tau Medical (NASDAQ: DRTS) announced yesterday that the first glioblastoma patient ever treated with Alpha DaRT outside the United States has undergone the procedure at Hadassah University Medical Center. The case is the latest in an unusually dense run of milestones for the small-cap oncology developer, arriving roughly three weeks after a major U.S. commercial partnership was signed and less than two weeks after the U.S. FDA cleared the Company’s pivotal brain-cancer trial to full enrollment.

https://finviz.com/news/363778/alpha-tau-medical-continues-its-winning-streak-with-first-ever-brain-cancer-patient-treated-outside-the-us

Anticipation of imminent REGAL Phase 3 AML readout drives SLS

 

Anticipation of imminent REGAL Phase 3 AML readout drives SLS 18% surge

• As of May 11 2026 REGAL trial of GPS in AML maintenance had reached 78 of 80 required events triggering final analysis upon the 80th
• No new company press release on June 25 but time elapsed since May update has heightened expectations that the 80th death event is near
• Retail chatter on Reddit X and forums plus heavy call option activity amplified momentum with traders citing "data any day"
• Stock broke above $10 hitting multi-week highs extending gains from Cramer endorsement and May trial progress update
• Breakout occurred on elevated volume in small-cap biotech with pending binary catalyst for GPS in high-risk AML patients
• Minor 8-K filed updating executive change-of-control severance but not viewed as primary driver

https://finviz.com/stock?t=SLS&p=d

EU, China to discuss trade relations on June 29

 European Commission spokesperson Olof Gill said on Friday that the upcoming meeting between European Trade Commissioner Maros Sefcovic and Chinese Commerce Minister Wang Wentao will focus on the "entirety" of the EU-China trade and investment relationship.

Gill refused to elaborate on the reason for the meeting, stating instead that the two sides are "among each other's most important partners." He said the meeting has been under preparation for "many weeks," including discussions between technical teams.

https://breakingthenews.net/Article/EU-China-to-discuss-trade-relations-on-June-29/66582579

Xi: China ready to help Venezuela after quake

 Chinese President Xi Jinping expressed his condolences to Venezuela's Acting President Delcy Rodriguez following a series of devastating earthquakes that struck the country earlier this week, Chinese Xinhua shared on Friday.

In a message, Xi stated that Beijing is "ready to provide assistance to Venezuela in disaster relief and reconstruction," further adding that he hopes the Venezuelan people will overcome the situation.

According to the latest figures, the number of deaths surpassed 230, while at least 4,300 individuals were injured.

https://breakingthenews.net/Article/Xi:-China-ready-to-help-Venezuela-after-quake/66582720

Iran: 3 foreign tankers tried to pass through Hormuz

 Iranian state television announced on Friday that three foreign oil tankers attempted to pass through the Strait of Hormuz "without authorization."

A correspondent shared that Iran's Islamic Revolutionary Guard Corps (IRGC) Navy issued a warning at around 4 am local time, declaring that a new transit route announced by some authorities without coordination with Iran was "illegal, unacceptable and highly dangerous."

According to the correspondent, following the IRGC warning, tankers that had planned to use the southern corridor through the Strait stopped and "changed their course toward the Persian Gulf."

https://breakingthenews.net/Article/Iran:-3-foreign-tankers-tried-to-pass-through-Hormuz/66582780