Navitor Pharmaceuticals, Inc.

Last quarter, Abbott secured an FDA approval for its Tendyne mitral valve replacement implant as a complement to its MitraClip repair system. \n Abbott is doubling down on the structural heart space as it aims to gain ground in valve replacements following the recent global exit of Boston Scientific. CEO Robert Ford said sales of its Navitor transcatheter aortic valve replacement implant have doubled over the past two years—largely driven by increases in Europe and worldwide—and that the road ahead looks favorable. While the largest players in the sector remain Edwards Lifesciences and Medtronic, in late May Boston Scientific announced that it would pull its Acurate family of TAVR valves from the market, including versions recently approved in Europe, and that it would also halt its pursuits of FDA approval. The move came following stumbles in a U.S. clinical study and discussions with international regulators, the company said. Acurate valves had been available in more than 50 countries, and Boston Scientific said they have been used to treat more than 80,000 patients. “There\'s an opportunity here to accelerate growth internationally, with a competitor market exit,” Ford said on Abbott’s second-quarter earnings call with investors. “I know the team’s all over that, and with the upcoming CE mark that we have planned for Navitor to have a low and intermediate risk label expansion—it could come at a perfect time, to be quite honest with you.”Abbott is also working to grow its reach stateside by doubling the size of its related sales force by the end of this year, compared to 2024.“Right now we\'re in about 20% of the centers in the U.S., and the way to expand our position here is we’ve got to be in more centers. And the way to do that is you need more clinical people, you need more feet on the street,” Ford said. “We’re putting ourselves in the realm of being more competitive, in terms of access to sites.”Abbott is also developing a new balloon-expandable TAVR implant, with first-in-human procedures completed late last year, that will sit alongside Navitor’s self-expandable approach.“Once you commit yourself to developing next-generation, balloon-expandable TAVR, that also opens up a nice opportunity for us—even though that\'ll probably be more towards the end of this decade, in terms of a full launch,” he said. Outside of TAVR, last quarter Abbott secured an FDA approval for its Tendyne mitral valve replacement implant as a complement to its MitraClip repair system. The company also announced it plans to develop a new cardiovascular device manufacturing facility in Georgia by 2028. For Abbott’s second quarter, the company reported $11.14 billion in total sales, for 7.4% year-over-year growth. That includes $5.37 billion in medical device revenue, with $636 million coming from structural heart—both categories growing about 13%. Diabetes care, meanwhile, accounted for $1.98 billion in sales, for a gain of more than 20%. Recently, Abbott has been lining up insulin pump partnerships for its upcoming dual-sensor wearable based on its FreeStyle Libre CGM platform, which will track both glucose and ketone levels. “I think this is going to be a real, next-level, significant change in the CGM market, specifically for insulin intensive users,” Ford said. “Ketone monitoring helps prevent diabetic ketoacidosis.”While Ford did not offer details on the new sensor’s timing, including for regulatory submissions, he did say that Abbott has already completed “approximately five different trials” to support an application. He added that it has been working with insulin pump developers to make sure the sensor works for people with diabetes as soon as it gets the green light. Abbott also posted $2.17 billion in second-quarter sales for its diagnostics business, for a 0.8% gain when excluding COVID-19 related revenue, as well as $2.21 billion from its nutrition division, up 2.9%. The company’s ex-U.S. pharmaceuticals unit, meanwhile, brought in $1.38 billion, for 6.9% growth. For the remainder of 2025, Abbott projected full-year organic sales growth, again excluding COVID tests, to land between 7.5% and 8%. The company also forecast about $200 million in costs due to new U.S. tariffs. 

iStock, Nazan Akpolat After SPN-820’s failure, Supernus is relying on its non-stimulant ADHD drug Qelbree and the recently approved Parkinson’s therapy Onapgo to sustain the company. Supernus Pharmaceuticals’ drug candidate for treatment-resistant depression missed its primary endpoint in a Phase IIb study, the biotech revealed Tuesday. Patients on SPN-820, an oral activator of the mTORC protein, saw a 12.3-point improvement in their scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) at four weeks. Over the same time span, MADRS scores improved by 11.9 points in placebo comparators. The between-group difference failed to reach statistical significance, according to Supernus’ press announcement. Similarly, “there was no treatment difference” between the investigational treatment and placebo in terms of secondary endpoint, the biotech added. Supernus was down around 20% before the opening bell on Wednesday, as per SeekingAlpha . Analysts at Jefferies anticipated the selloff, writing to investors on Tuesday evening that “we see [Supernus] trading down -25%” due to the readout. CEO Jack Khattar in a statement said that the company is “disappointed” by these results, adding that it will “continue to analyze these data” and assess the path forward for SPN-820 with its development partner Navitor Pharmaceuticals. SPN-820’s failure is somewhat surprising given that the drug candidate in October 2024 aced a Phase II study in major depressive disorder. When taken once every three days as an adjunct to baseline antidepressant medication, SPN-820 elicited a “clinically meaningful improvement” as early as four hours after dosing when measured using MADRS. At the time, however, Jefferies cautioned that drugs that could work for both major depressive disorder and treatment-resistant depression are “rare”—a point the firm reiterated in its note on Tuesday. Despite the mid-stage stumble, Jefferies still sees some reasons to be positive about Supernus’ prospects, particularly with the “continued uptake” of its non-stimulant ADHD drug Qelbree. “Emphasis for [Supernus] will be on growing its core business moving forward.” In the near-term, Jefferies anticipates Qelbree to surpass its fourth-quarter 2024 sales consensus, putting it on-track to meet Jefferies’ projection of at least $500 million in peak sales for Supernus. A little further out is the recently approved apomorphine hydrochloride injection Onapgo for advanced Parkinson’s disease, which Jefferies expects could be “another potential growth driver for 2025-26” once it launches. Onapgo opens a $100 million to $300 million opportunity for Supernus, according to the analyst.

The Phase IIb study enrolled 250 adult patients with treatment-resistant depression. Credit: Justin Paget via Getty Images. Supernus Pharmaceutical’s stock declined following the release of disappointing Phase IIb trial results for SPN-820, an investigational treatment for adults with treatment-resistant depression (TRD). The company announced on 18 February that the trial did not meet its primary endpoint measured by a depression rating scale, with no statistically significant difference observed between the treatment and placebo groups. Supernus’ stock is down 17% from the close on 18 February to open on 19 February. The Phase IIb study (NCT05066672) enrolled 250 adult patients with TRD, who were randomised to receive either two or four 400mg doses of SPN-820 daily. After four weeks, patients receiving SPN-820 showed a 12.3-point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS), which assesses depression severity. However, the placebo group experienced an 11.9-point reduction, meaning the difference between the groups was not statistically significant. Supernus also reported no statistically significant differences in secondary endpoints. SPN-820, a mechanistic target of rapamycin complex 1 (mTORC1) activator, previously demonstrated promising results in an open-label Phase IIa trial (NCT06235905) conducted in patients with major depressive disorder (MDD). In that study, the drug showed a clinically meaningful improvement of -6.1 on the Hamilton Depression Rating Scale-6 items (HAM-D6) at two hours, improving to -9.6 by day ten. Suicidal ideation decreased by 80%, from 12.5% at baseline to 2.6% on day ten. In an October 2024 conference call, Supernus’s CMO Jonathan Rubin said the company would decide which indication to pursue further out of MDD or TRD based on the yet-to-be-unveiled latest Phase IIb data for the latter indication. Supernus licensed SPN-820 from Navitor Pharmaceuticals in 2020. The agreement included a $10m upfront payment and a $15m investment, with total potential payments exceeding $400m if all milestones are met. “We are disappointed that the trial did not meet its primary endpoint in this patient population,” said Supernus CEO Jack Khattar, who added that the company will continue to analyse the data and will discuss the future of the programme with Navitor. SPN-820 is not the only candidate in Supernus’s pipeline, should the company decide not to press ahead with its further development. The developer also has SPN-817, a reversible acetylcholinesterase inhibitor being developed for severe epilepsy. The candidate demonstrated positive results in an open-label Phase IIa trial (NCT05518578) and is currently being investigated in a larger placebo-controlled Phase II trial (NCT06798896). The standard of care for major depressive disorder (MDD) typically involves selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) as first-line treatments, often in combination with psychotherapy. However, these therapies can take weeks to take effect, and many patients do not respond adequately, leading to a need for innovative alternatives. Last month, Johnson & Johnson’s (J&J) nasal spray Spravato (esketamine) received a label expansion as a monotherapy treatment for MDD in adults who do not respond to two oral antidepressants. The US Food and Drug Administration’s (FDA) decision made Spravato the first-ever standalone treatment for adults with treatment-resistant depression.