A session that requires a closer look at the evidence

This September 15 Radar brings together the September 14–15 developments remaining outside our Stock Hub updates. Connect Biopharma, BioVie, Corbus and Armata lead the edition: four different examples of why a biological signal, a convincing clinical result and a regulatory designation need to be understood on their own terms.

Connect reports improved lung function alongside a primary endpoint that did not reach statistical significance. BioVie is looking for a better-defined Long COVID population through subgroup findings. Corbus has twelve-week data for an oral obesity candidate. Armata has received Breakthrough Therapy designation for its bacteriophage program.

The wider coverage includes GT Biopharma, Bionano, Clene, Jaguar, MindWalk, Profusa and Tenon, followed by a separate digital-health section on Veea and NovaGen. The selection originated in our IBKR, Finviz and Seeking Alpha news review. The analysis below uses the original releases, trial registries and documents linked within each section. Sponsor topline results remain preliminary. Earlier intraday stock moves are not presented as closing prices.

Connect Biopharma ($CNTB): a lung-function signal alongside a primary endpoint miss

On September 15, Connect released preliminary results from Seabreeze STAT Asthma, its Phase 2 trial of the IL-4Rα antibody rademikibart. The randomized, double-blind study enrolled 160 participants during an asthma exacerbation and compared a single 600 mg subcutaneous dose with placebo, both added to standard treatment.

The primary endpoint was treatment failure over 28 days. That composite included death, asthma-related hospitalization or rehospitalization, emergency or unscheduled visits for worsening disease, and treatment intensification. Connect reported a 66% relative reduction, with p=0.153. The percentage reduction is large, but the primary result was not statistically significant. The company points to fewer treatment-failure events than expected; that is the sponsor’s explanation for the result, rather than evidence that the original objective was met.

The more encouraging finding was a secondary lung-function measure. At week one, post-bronchodilator FEV1 improved by 250 mL with rademikibart versus 120 mL with placebo: a 130 mL difference, p=0.023. FEV1 measures how much air a person can forcefully exhale in one second. This suggests activity on respiratory function, while leaving the primary clinical outcome unresolved. Interpretation also requires the full context of the secondary analyses and statistical plan.

The sponsor reported no new safety signal, with one serious adverse event in the treatment group and three with placebo. The trial’s size and duration still limit conclusions about uncommon risks. Connect plans to discuss a Phase 3 program using FEV1 with the FDA and expects a separate COPD exacerbation readout later in September.

Merlintrader view: the next meaningful step is whether the lung-function finding can support a confirmatory program with an agreed clinical and statistical objective. Selecting a different endpoint for a future trial does not change the outcome of this one. COPD results will provide another test of the development thesis; they cannot automatically resolve the asthma result.

Sources: Connect’s September 15 release, NCT06940141 registry. The registry documents the study design; the new results come from the sponsor.

BioVie ($BIVI): Long COVID subgroup findings need prospective confirmation

ADDRESS-LC evaluated bezisterim in 203 adults with Long COVID and cognitive difficulties or fatigue. It was an exploratory, randomized, double-blind, placebo-controlled Phase 2 trial designed to identify signals for subsequent development across 22 clinical measures.

The distinction from Connect matters. BioVie says no single endpoint was designated as the determinant of overall study success, so the two trials should not be described with an identical primary-endpoint label. The central limitation nevertheless remains: no individual endpoint reached p<0.05 in the full intention-to-treat population, the analysis including all randomized participants. Twenty-one of the 22 measures numerically favored treatment, but directional consistency is not the same as statistical significance.

The company emphasizes patients with a higher baseline symptom burden. It reports significant findings on selected measures in subgroups with more severe fatigue or cognitive impairment. According to the sponsor, these analyses were prespecified in the statistical plan submitted to the FDA before unblinding. That makes them more informative than purely retrospective selection, without turning them into definitive confirmation of efficacy.

With numerous measures and subgroups, interpretation requires details on multiple comparisons, the size of each subgroup, missing observations and the practical importance of the changes. An encouraging effect size also cannot substitute for a confirmatory test. The company describes tolerability as similar to placebo.

Merlintrader view: the dataset’s potential value lies in refining who should enter the next trial and what that trial should measure. Any later-stage program needs to test that hypothesis prospectively, with sufficient size and predefined objectives. Today’s announcement does not establish a broadly applicable benefit across the Long COVID population.

Sources: BioVie’s September 15 release, ADDRESS-LC registry. This assessment uses sponsor topline reporting rather than a complete independent clinical publication.

Corbus ($CRBP): twelve-week weight loss sets up a longer test for CRB-913

Corbus’s catalyst is its September 14 release, followed by continued attention on September 15. CANYON-1 is a Phase 1b study of oral CRB-913, a peripherally restricted CB1 inverse agonist. This is a different approach from incretin-based therapies, and the results should be assessed within the trial’s own design rather than used to rank drugs across unrelated studies.

The sponsor reported 254 adults with obesity and no diabetes, assigned to placebo or 20, 40 and 60 mg. At twelve weeks, estimated mean weight changes were 0.0%, −2.8%, −3.3% and −5.0%, respectively, with p<0.0001 for each active dose versus placebo. These are the company’s reported efficacy-analysis estimates. The registry lists safety and adverse events as primary objectives of the randomized portion, with weight among secondary objectives; it still shows estimated enrollment of 252, separate from the 254 reported in the topline release.

The highest dose therefore provides an interesting quantitative signal, but twelve weeks covers only an early portion of what could be a long treatment course. An absence of an observed plateau does not establish how much additional weight will be lost or how much will be maintained after treatment stops. Longer exposure, adherence, persistence of benefit and a more extensive tolerability picture will help define the candidate’s position.

Safety deserves a complete reading. The company reported no serious or severe psychiatric adverse events, but described irritability, anxiety and gastrointestinal events. Discontinuations due to adverse events ranged from 3.1% to 13.1% across dose groups. Those observations do not support a blanket statement that psychiatric issues were absent, or a claim of superior safety to GLP-1 therapies based on separate studies.

Corbus expects further presentation at ObesityWeek, November 14–17, and points to the first half of 2027 for a Phase 2 monotherapy study. These are company expectations, subject to program development and regulatory discussions.

Merlintrader view: CRB-913 has a dose-related activity signal worth examining in a more mature dataset. The next test is whether it remains useful as duration, enrollment and treatment complexity increase. Oral administration may matter commercially, but the route itself does not answer questions about efficacy, safety or weight maintenance.

Sources: Corbus release and tables, 8-K filing, CANYON-1 registry. The filing repeats sponsor data and does not constitute independent clinical validation.

Armata ($ARMP): Breakthrough Therapy designation advances the AP-SA02 pathway

On September 14, Armata announced FDA Breakthrough Therapy designation for AP-SA02 in complicated Staphylococcus aureus bacteremia, including methicillin-sensitive and methicillin-resistant infections. The product uses bacteriophages, viruses that infect bacteria, and is being developed as an addition to best available antibiotic therapy.

The designation is based on preliminary clinical evidence and can facilitate more intensive FDA interaction during development and review. It is not marketing approval, and it does not predict the outcome of a confirmatory trial. That distinction is particularly relevant when the word “breakthrough” can make an investigational program sound further advanced than it is.

The company cites its Phase 1b/2a diSArm study and plans a Phase 3 superiority trial in the second half of 2026. That trial will need to establish in a larger population whether adding AP-SA02 to antibiotics produces a reproducible improvement in outcomes. A planned start should be distinguished from actual first-patient enrollment.

Merlintrader view: this development primarily changes the program’s regulatory setting. The next questions concern the final protocol, success criteria, patient selection and study execution. The designation can help that work progress; the clinical proof still has to be completed.

Sources: Armata release, FDA explanation of the designation, diSArm registry. The specific designation is reported by the sponsor; the FDA page explains the general process.

GT Biopharma ($GTBP): a myeloma IND cleared, with trial funding still required

GT Biopharma announced FDA clearance of a new IND for GTB-5550 in multiple myeloma on September 15. The TriKE candidate is intended to engage natural killer cells against B7-H3-expressing cells. This program is separate from its already enrolling Phase 1 study in solid tumors.

The investigator-sponsored myeloma study plans dose escalation followed by expansion to 25 patients at the maximum tolerated dose. Initiation is contingent on receipt of non-dilutive grant funding. Permission to proceed with clinical investigation therefore does not mean enrollment has started, nor does it demonstrate efficacy in patients.

The company expects a solid-tumor update in the fourth quarter of 2026. It also reports an unaudited pro forma cash balance of approximately $11 million as of September 15 and estimates runway into the third quarter of 2027. Those are management estimates; the myeloma study’s grant requirement remains a separate condition.

What to follow: the funding award, an actual first patient and safety and activity findings from ongoing programs. GT Biopharma release.

Bionano ($BNGO): optical genome mapping adds detail in myeloid cancers

On September 14, Bionano highlighted three peer-reviewed studies of optical genome mapping, or OGM, in myelodysplastic syndromes and acute myeloid leukemia. The technology identifies structural genomic abnormalities that conventional cytogenetic methods may miss.

A direct cross-check is available in the Oulu study: among 48 AML cases with a normal karyotype, investigators detected abnormalities in 22 cases, or 46%. The abstract also reports an association with worse disease-specific survival. The paper was already available online in May; the September company release brings it back to market attention rather than marking the dataset’s first publication.

The other two studies highlighted by Bionano address complex chromosome alterations in MDS and more detailed characterization of therapy-related myeloid neoplasms and MDS in younger patients. For those two papers, this Radar uses the company’s summary rather than presenting a complete review of the underlying articles.

Merlintrader view: detecting additional abnormalities can improve biological characterization and risk classification. That is a different evidentiary step from prospectively demonstrating that using the test improves survival or generates additional revenue. Laboratory adoption, integration into diagnostic workflows and economic sustainability remain important practical questions.

Sources: Bionano release, original Turtinen et al. abstract.

Clene ($CLNN): a $4 million financing supports the CNM-Au8 effort

Clene announced a registered direct offering of 1,219,513 shares at $3.28, for approximately $4 million gross. Existing shareholders are participating, including its chairman, CEO and Kensington Capital Holdings. Closing is expected on September 17; the September 15 announcement does not report a completed transaction.

The company estimates sufficient resources through the middle of the first quarter of 2027. Proceeds support corporate needs and CNM-Au8 activities, including regulatory dialogue, filing preparation and manufacturing work. Insider participation is a feature of the financing rather than validation of approval prospects.

Merlintrader view: this is a capital-raising development with share dilution upon completion, rather than a new clinical result. The runway estimate needs to be considered alongside the spending required for the regulatory pathway. Clene release.

Jaguar Health ($JAGX): a 1-for-15 reverse split scheduled for September 17

Jaguar announced a consolidation of fifteen shares into one, with split-adjusted trading expected from the September 17 market open. The stated purpose is to support compliance with Nasdaq listing standards. The ticker remains JAGX, with cash paid in lieu of fractional shares.

The transaction changes the share count and theoretical per-share price without creating economic value through the consolidation itself. A nominal price increase following the adjustment is not, by itself, a positive investment return. Continued satisfaction of listing requirements must also be assessed separately.

Merlintrader view: today’s news concerns the capital structure. It adds no new evidence of crofelemer efficacy and should be kept separate from earlier clinical announcements. Jaguar / ACCESS Newswire release.

MindWalk ($HYFT): revenue growth and a credit commitment, in different currencies

MindWalk reported its fiscal first quarter of 2027, ended July 31, on September 14. Revenue increased 21.3% to C$3.834 million, while gross margin rose from 48.3% to 58.6%. The continuing-operations net loss widened to C$6.085 million. Operating cash use was C$4.042 million, with approximately C$7.6 million cash at quarter-end.

On the same day, the company announced a binding commitment for a revolving facility of up to US$30 million, carrying 7% fixed interest and no warrants or equity conversion feature. A definitive agreement and applicable conditions remain, with closing targeted within 60 days. Potential borrowing capacity is not cash already received.

Merlintrader view: the margin improvement accompanies ReefIQ’s commercial launch, but has not yet offset higher operating spending. Customer negotiations are not booked revenue. Under the announced terms, borrowing could fund expansion without issuing shares, while still creating debt-service and repayment obligations when drawn.

Sources: quarterly results, credit commitment.

Profusa ($PFSA): Nasdaq compliance restored, with monitoring continuing

Profusa announced on September 15 that a September 9 Nasdaq letter confirmed compliance with the minimum bid-price and stockholders’ equity requirements. It remains subject to a one-year Mandatory Panel Monitor. A new failure to meet the equity requirement during that period would lead to a delisting determination without the usual opportunity to submit a compliance plan, subject to the appeal process described by the company.

Merlintrader view: this improves the company’s listing position. It is neither device authorization nor evidence of diagnostic-platform efficacy. Maintaining compliance will depend on its evolving financial position. Profusa release.

Tenon Medical ($TNON): financing closed, with new warrants outstanding

Tenon’s warrant-inducement transaction closed on September 14 for $2,872,338.58 gross. Existing warrants covering 572,179 shares were exercised; the investor received new warrants covering an additional 858,269 shares at a $5.02 exercise price, with a five-year term.

Proceeds are before fees and expenses. Potential cash from the new warrants is excluded and is not guaranteed. The financing adds resources, while the shares already issued and potential further dilution remain part of the economic picture.

Merlintrader view: this is a medtech financing development without a new clinical result in the transaction announcement. Release from WallachBeth, the transaction’s financial adviser.

Digital health — Veea ($VEEA) and NovaGen propose a combination

Veea and NovaGen signed a term sheet for a potential combination and a platform linking edge AI infrastructure with healthcare services. Management’s cited value of approximately $750 million relies on internal projections and a valuation prepared using those projections. It is not an acquisition price already paid.

GeoNova’s proposed initial $10 million investment is also subject to definitive documentation and closing conditions. Initial network deployments are planned for the fourth quarter; later diagnostic and therapeutic applications depend on clinical validation and applicable regulatory authorizations.

Merlintrader view: the announcement belongs in digital health and corporate transactions. Longevity terminology does not establish therapeutic benefits. The verifiable next steps are a definitive agreement, economic terms, financing and implementation. Joint release.

The next developments that matter

• Later in September: Connect expects COPD results, which must be assessed separately from the asthma study.
• September 17: expected Clene financing close and Jaguar split-adjusted trading.
• Second half of 2026: Armata plans Phase 3 initiation; an actual start remains to be confirmed.
• Fourth quarter of 2026: GTB-5550 solid-tumor update and planned initial Veea/NovaGen deployments, with very different evidentiary meaning and conditions.
• November 14–17: additional Corbus presentation expected at ObesityWeek; Phase 2 monotherapy is targeted for the first half of 2027.
• Without a firm date: GTBP myeloma grant funding, BioVie’s next development design and MindWalk’s definitive credit agreement.

These future windows are company expectations and can change. For BIAF, BLIV, INDP, SCNI and SLXN, which appeared in the screening, no substantive new company catalyst was verified within the reviewed window. A stock move alone is not treated as clinical news.

The common thread is practical: identify what changed, how strong the evidence is and which document could clarify the next step. Experimental results, access to regulatory development and financing needs all appear in this edition. Keeping those levels clear makes the individual stories easier to evaluate beyond their headlines.