NEW BRUNSWICK (dpa-AFX) - Biotech and healthcare saw regulatory approvals, strategic partnerships, M&A activity, and a steady stream of clinical trial updates driving investor attention.
Notable developments include Axogen's planned acquisition of BioCircuit Technologies, Bluejay Diagnostics' partnership with Lovell Government Services, positive data from Roivant, AstraZeneca, Structure Therapeutics, and Pharvaris, and a Phase 3 miss for Novartis' del-desiran.
Let's dive into the details...
FDA Approvals
JNJ Expands Eye Care Portfolio
Johnson & Johnson (JNJ) received CE Marking for its ACUVUE OASYS MAX 2-Week reusable contact lenses, designed to improve comfort and clarity for patients facing increased screen time and blue-violet light exposure. The lens will launch in select European markets later this year, with a broader rollout planned in 2027.
JNJ closed Thursday's trading (September 10, 2026) at $266.35, down 0.27%.
GSK Expands Shingrix Use in Japan
GSK plc (GSK) received Japanese approval for a new pre-filled syringe presentation of its shingles vaccine Shingrix, already approved in the market since 2018 for adults at risk of shingles. The expanded approval aims to improve convenience and broaden access, reinforcing Shingrix's position as the leading non-live, recombinant vaccine for shingles prevention.
GSK closed Thursday's trading at $48.12, down 1.05%
Deals
Axogen To Acquire BioCircuit Technologies
Axogen Inc.(AXGN) has entered into a definitive agreement to acquire BioCircuit Technologies, Inc., an advanced neural interface and bioelectronic devices developer, for $200 million in cash.
The transaction is expected to close in the fourth quarter and will add BioCircuit's FDA-approved NerveTape device to Axogen's portfolio, expanding its reach in nerve repair markets. Axogen plans to leverage its established sales force, surgeon relationships, and hospital contracting infrastructure to bolster market penetration.
AXGN closed Thursday's trade at $41.85, down 11.47%.
Femasys Partners With CapexMD To Expand Access To FemaSeed Fertility Portfolio
Femasys Inc. (FEMY) announced a partnership with CapexMD, which specialises in fertility financing, to expand patient access to its FemaSeed-led fertility portfolio, including FemVue and FemaSeed, through dedicated financing solutions. The partnership aims to reduce financial barriers to fertility care across OB/GYN practices and fertility centres.
The financing program will support access to FemaSeed Complete, an in-office intratubal insemination solution designed as a first-line fertility treatment.
FEMY closed Thursday's trade at $2.74, down 3.18%.
EpilepsyGTx Partners with Viralgen To Advance AAV Gene Therapy For Epilepsy
EpilepsyGTx, a biotechnology company focused on gene therapies for drug-resistant epilepsy, has entered into a collaboration with Viralgen, a subsidiary of AskBio Inc., which operates under Bayer AG (BAYN.DE), to accelerate the production of EPY201, EpilepsyGTx's lead investigational program for focal refractory epilepsy. The first-in-human clinical trial of EPY201 for focal refractory epilepsy is expected to begin in the first half of 2027.
Under the agreement, Viralgen will leverage its proprietary AAV production platform, designed to enable scalable, high-yield manufacturing across all AAV serotypes.
BAYN.DE closed Thursday's trading at 48.70 Euros, down 1.14%.
HCW Biologics Partners with Akron Biotech to Commercialize HCW11-006
HCW Biologics Inc. (HCWB) announced that it has entered into a distribution agreement with Akron Biotech, a supplier of materials and accessory molecules for cell and gene therapy manufacturing, to commercialise HCW11-006, a multi-cytokine fusion molecule as a reagent used to support the production of human CAR-T cells for cancer, autoimmune and infectious diseases.
Under the agreement, HCW Biologics will supply research- and cGMP-grade HCW11-006, while Akron will market and distribute the reagent through its network of research institutions, biopharmaceutical companies and advanced therapy developers.
HCWB closed Thursday's trading at $2.43, down 1.22%.
Bluejay Diagnostics, Lovell Team Up To Access U.S. Federal Healthcare Market
Bluejay Diagnostics (BJDX) announced a distribution, co-marketing and strategic partnership with Lovell Government Services, Inc. to support Bluejay's product access into the U.S. federal healthcare market, subject to FDA clearance or other required regulatory approvals.
Under the agreement, Lovell will serve as Bluejay's exclusive distributor for SDVOSB-designated and preferred federal procurement opportunities across the VA, DoD, Military Health System, and Indian Health Service.
BJDX closed Thursday's trade at $1.01.
Transgene And ProBioGen Expand Strategic Partnership
Transgene SA (TNG.PA, TRGNF), which develops virus-based immunotherapies, and ProBioGen, a CDMO for biologics, vaccines, and viral vectors, announced that they have broadened the scope of their existing collaboration made in 2024, under which Transgene licensed ProBioGen's AGE1.CR.pIX suspension cell line technology platform for vaccine production.
Transgene's currently expanded license agreement is intended to strengthen its manufacturing capabilities.
TNG.PA closed Thursday's trade at 0.881 Euros.
Clinical Trials - Breakthroughs & Setbacks
Oncolytics Reports Positive Pelareorep Data in Colorectal Cancer Study
Oncolytics Biotech Inc. (ONCY) announced positive preclinical results evaluating pelareorep, an investigational, intravenously delivered immunotherapy in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model.
According to the company, the pelareorep combo reduced tumour growth compared to the control, showing that pelareorep activity was maintained in the presence of RAS inhibition, with no evidence of blocking between the two therapies. Oncolytics plans broader pelareorep testing with RAS inhibitors in RAS-driven tumour models.
ONCY closed Thursday's trade at $0.77, down 2.89%.
Disc Medicine Reports Positive Phase 2 RESTORE-PV Data For DISC-3405 In Polycythemia Vera
Disc Medicine, Inc. (IRON) presented positive initial results from the RESTORE-PV Phase 2 trial of DISC-3405, an investigational anti-TMPRSS6, in patients with polycythemia vera (PV), a rare blood cancer.
According to the company, treatment with DISC-3405 increased hepcidin and lowered serum iron, reducing phlebotomy (blood-removal procedures), controlling hematocrit (red-cell production), and improving symptom burden in patients with PV.
Key findings also included dose-proportional pharmacokinetics, elevated hepcidin, reduced serum iron, increased ferritin, mean hematocrit control, and fewer total phlebotomy events, with a generally well-tolerated profile. The company plans to provide additional data by the end of 2026.
IRON closed Thursday's trade at $74.14, down 3.10%.
BioMarin's VOXZOGO Hits Phase 3 Growth Endpoint In Hypochondroplasia
BioMarin Pharmaceutical Inc. (BMRN) announced that its Phase 3 CANOPY-HCH-3 study of VOXZOGO (vosoritide) in children with hypochondroplasia, a rare genetic skeletal condition, met its primary endpoint, showing statistically significant improvements in annualised growth velocity compared to placebo.
VOXZOGO is a C-type natriuretic peptide (CNP) already approved by the FDA to support the growth of children with achondroplasia starting from birth.
According to the company, VOXZOGO demonstrated statistically significant improvements across multiple measures of growth, including annualised growth velocity, standing height, height Z-score and arm span, with overall safety consistent with previous studies.
BMRN closed Thursday's trade at $65.51, up 1.71%.
Tyra Biosciences Reports Positive SURF302 Results
Tyra Biosciences, Inc. (TYRA) reported initial results from its Phase 2 SURF302 study evaluating oral dabogratinib, an investigational oral FGFR3-selective inhibitor, in patients with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer or LG IR NMIBC.
According to the company, dabogratinib at 60 mg once daily demonstrated an overall response rate (ORR) of 79%, and complete response (CR) was 64% in all patients (n=14), rising to 100% and 75%, respectively, in single-marker lesion patients (n=8), supporting the planned Phase 3 adjuvant strategy with a favourable safety profile.
TYRA closed Thursday's trade at $23.54, up 6.95%.
Pyxis Oncology Reports Positive MICVO Phase 1 Data In 2L+ Head And Neck Cancer
Pyxis Oncology, Inc. (PYXS) announced positive updated data from its ongoing Phase 1 monotherapy study of micvotabart pelidotin (MICVO), an investigational antibody-drug conjugate in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
According to the company, MICVO demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR). In addition, survival outcomes include median progression-free survival (mPFS) of 6.2 months and a 12-month overall survival (OS) probability of 79%, with no new safety signals observed.
Pyxis plans to advance MICVO into a pivotal program, with initiation of the Phase 3 Headliner trial planned for mid-2027.
PYXS closed Thursday's trade at $3.27, down 3.25%.
AstraZeneca Reports Positive Data For Tozorakimab From Phase III OBERON, TITANIA Trials In COPD
AstraZeneca PLC (AZN) announced positive results from the Phase III OBERON and TITANIA trials evaluating Tozorakimab, an investigational IL-33-targeting monoclonal antibody in chronic obstructive pulmonary disease (COPD).
According to the company, Tozorakimab showed statistically significant and clinically meaningful efficacy in reducing moderate and severe exacerbations, with a generally well-tolerated safety profile, in chronic obstructive pulmonary disease (COPD) patients still experiencing exacerbations while on inhaled standard of care.
AZN closed Thursday's trade at $159.64, up 1.72%.
BrainsWay Reports Positive Pilot Study Results For Deep TMS In Depression & Early Alzheimer's
BrainsWay Ltd. (BWAY) reported results from a peer-reviewed pilot study evaluating its Deep Transcranial Magnetic Stimulation Technology (Deep TMS), a non-invasive neurostimulation technology that uses specialised coils to stimulate targeted brain regions in patients with major depressive disorder (MDD) and comorbid early-stage Alzheimer's disease.
The study included 12 patients who received 36 Deep TMS sessions using the H1 and H7 coils, and following the treatment, preliminary findings showed that 83.3% of patients achieved a response, defined as at least a 50% reduction in Patient Health Questionnaire-9 (PHQ-9) scores, while 50% achieved remission, defined as a PHQ-9 score of 4 or less in depressive symptoms following treatment.
BWAY closed Thursday's trade at $13.91, down 3.47%.
Roivant Reports Positive Phase 2 Results For Mosliciguat In PH-ILD
Roivant (ROIV) reported that the Phase 2 PHocus trial evaluating Mosliciguat, an investigational, once-daily inhaled soluble guanylate cyclase (sGC) activator, met its primary and secondary endpoints in adults with Pulmonary hypertension associated with interstitial lung disease. (PH-ILD).
According to the company, mosliciguat was well tolerated, with a favourable safety profile, and met its primary endpoint at week 16, delivering a clinically meaningful and statistically significant placebo-adjusted 56.3% reduction in pulmonary vascular resistance (PVR) (p<0.0001). It also met key secondary endpoints, including a 35.2-meter improvement in six-minute walk distance and a 53.2% (357.7 pg/mL) reduction in NT-proBNP versus placebo, both clinically meaningful and statistically significant.
ROIV closed Thursday's trading at $40.94, down 2.08%.
Structure Therapeutics Reports Positive Data From Oral Amylin And GLP-1 Programs
Structure Therapeutics Inc. (GPCR) reported positive clinical data from its two lead oral small-molecule candidates: ACCG-2671, an investigational dual amylin and calcitonin receptor agonist evaluated in a Phase 1/2a single ascending-dose (SAD) trial, and aleniglipron, an oral GLP-1 receptor agonist being developed for chronic weight management in the ACCESS open-label extension (OLE) clinical trial.
According to the company, in the SAD trial, ACCG-2671 demonstrated a long half-life of about 6 days, supporting potential once-weekly dosing, with no serious adverse events (SAEs) or liver enzyme elevations. Based on these findings, the company has initiated the Phase 1/2a MAD portion, with topline data expected in the first half of 2027.
In the 72-week ACCESS OLE study data, participants receiving 180 mg of aleniglipron achieved up to 16.2% weight loss with no plateau, while placebo crossover patients starting at 2.5 mg showed improved tolerability.
GPCR closed Thursday's trade at $39.55, down 4.07%.
Spyre Hits Primary Goal in UC Trial
Spyre Therapeutics, Inc. (SYRE) reported positive 12-week induction results from Part A of its Phase 2 SKYLINE trial evaluating SPY003 in moderately to severely active ulcerative colitis.
The study met its primary endpoint, showing a statistically significant 10-point reduction in Robart's Histopathology Index at Week 12, alongside 20% clinical remission and 30% endoscopic improvement. SPY003 was generally well tolerated, with adverse events consistent with the IL-23 class.
SYRE closed Thursday's trading at $88.71, up 2.05%.
Pharvaris Delivers Positive Phase 3 Data
Pharvaris N.V. (PHVS) announced topline results from the Phase 3 CHAPTER-3 trial of deucrictibant extended-release (XR) tablets, an investigational orally bioavailable small-molecule bradykinin B2 receptor antagonist for hereditary angioedema (HAE) prophylaxis.
The study met its primary endpoint, reducing mean monthly HAE attack rates by 83% versus placebo, with an 87% reduction in Type 1 or 2 patients. All secondary endpoints were achieved, and the therapy showed early-onset protection with a favourable safety profile.
Pharvaris plans to use the CHAPTER-3 results as the basis for marketing authorisation applications, with submissions beginning in the first half of 2027. The ongoing CHAPTER-4 OLE study is evaluating long-term prophylaxis with deucrictibant XR. The pivotal Phase 3 CREAATE study is assessing prevention of acquired angioedema (AAE-C1INH), with topline Part 1 data expected in first quarter of 2027.
PHVS closed Thursday's trading at $37.51, down 0.61%.
Novartis' Del-Desiran Misses Phase 3 Goal
Novartis AG (NVS) reported that the pivotal HARBOR trial of del-desiran, an investigational antibody oligonucleotide conjugate in myotonic dystrophy type 1, failed to meet its primary endpoint of video hand opening time. The 54-week, placebo-controlled study enrolled 150 patients and assessed del-desiran every eight weeks.
While the primary goal was missed, Novartis noted evidence of clinical activity in secondary endpoints such as grip strength and mobility, with safety consistent with prior data. The company is reviewing the full dataset and plans to engage regulators on next steps.
NVS closed Thursday's trading at $137.48
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