2026-08-15 · trading-venues

Weekly Buzz: LNTH, CBLL Win FDA Nod; AURA Cuts Jobs; TDY Buys VREX; CGEM, DFTX Meet Trial Goals

(RTTNews) - This week's global biopharma sector roundup captured a mix of regulatory wins, restructuring activities, deals that expanded company pipelines, and clinical trial readouts.

Positive clinical readouts spanned non-small cell lung cancer, IDH1-mutant glioma, generalised anxiety disorder and Polycythemia Vera, a rare type of blood cancer.

Lantheus Holdings, Inc. (LNTH) gained FDA approval for TAUKLARIFY, a PET tracer for tau pathology in Alzheimer's. The approval was backed by two blinded-read studies in over 500 subjects, underscoring the tracer's ability to complement amyloid PET in clinical diagnosis. The approval expands Lantheus' neuroimaging portfolio and positions the company to capture growing demand in Alzheimer's diagnosis.

LNTH closed Friday's trading (August 14, 2026) at $100.95, up 0.01%.

Akeso Gains NMPA Nod for Ivonescimab Combo

Akeso, Inc. (AKESF) secured China NMPA approval for its supplemental New Drug Application covering Ivonescimab injection plus chemotherapy in advanced squamous non-small cell lung cancer. The decision was backed by positive Phase III HARMONi-6/AK112-306 study showing significant survival benefits and a favourable safety profile.

AKESF closed Friday's trading at $13.35, up 1.14%.

Galderma Wins EU Nod for Restylane Shaype

Galderma Group (GDERF) has received European Union clearance for Restylane Shaype, the first bone-mimicking hyaluronic acid injectable for chin augmentation. Approval was based on data showing durable improvements in chin definition, with 83% of patients reporting enhanced results at three months and 66% maintaining benefits at one year.

Restylane Shaype is already approved in Canada and Brazil, and the European Union approval expands Galderma's aesthetic portfolio across key global markets.

GDERF closed Friday's trading at $222.40, up 5.55%

Rhythm Wins UK MHRA Expansion for IMCIVREE

Rhythm Pharmaceuticals, Inc. (RYTM) received UK MHRA expanded authorization for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity in adults and children aged 4 and older. The approval was supported by Phase 2/3 TRANSCEND trial data showing significant reductions in BMI and improved hunger control, with treatment generally well tolerated. This milestone broadens IMCIVREE's reach across rare obesity indications.

RYTM closed Friday's trading at $115.48, down 0.47%

Acarix AB (ACARIX.ST) received regulatory clearance from the Emirates Drug Establishment (EDE) and the Ministry of Health and Prevention (MOHAP) for its CADScor System, enabling commercialisation in the UAE. The acoustic AI-based diagnostic helps rule out significant coronary artery disease in less than 10 minutes, reducing reliance on invasive procedures. The launch, supported by partner UniTech Solutions, marks entry into the Gulf region and a gateway to broader GCC markets.

ACARIX.ST closed Friday's trading at SEK 0.245, down 5.04%

CeriBell Receives FDA Clearance for AI EEG Enhancements

Ceribell, Inc. (CBLL) has secured FDA 510(k) clearance for two new AI algorithms— Epileptiform Abnormality Detection and Artifact Reduction—integrated into its Neurology Portal. The updates expand the utility of its point-of-care EEG system, enabling faster, high-confidence seizure assessment and streamlining hospital workflows.

CBLL closed Friday's trading at $23.33, up 0.34%

The FDA has approved Labcorp's (LH) PGDx elio tissue complete CDx, a next-generation sequencing test that identifies BRAF V600E/K variants in advanced melanoma patients. The approval enables clinicians to match patients to FDA-approved BRAF and BRAF/MEK inhibitor therapies, addressing a critical need for patients with stage IV disease, which has a 16% five-year survival rate. The kit-based solution can be deployed across hospitals and labs, expanding access to precision oncology testing and reinforcing Labcorp's growing portfolio in personalised cancer care.

LH closed Friday's trading at $318.13 down 1.38%.

GRAIL Faces FDA Panel Review for Galleri

GRAIL, Inc. (GRAL) announced that the FDA's Molecular and Clinical Genetics Panel will convene on September 23, 2026, to review its Premarket Approval application for Galleri, a multi-cancer early detection blood test. Galleri analyses methylation patterns to detect signals across multiple cancer types and predict their origin, supported by large studies including PATHFINDER 2 and the NHS-Galleri trial. The meeting marks a pivotal step toward potential FDA approval of the Breakthrough-designated test.

GRAL closed Friday's trading at $67.87, down 0.54%

Bavarian Nordic's IMVANEX Wins EU Pediatric Approval

Bavarian Nordic A/S (BVNKF, BAVA.CO) secured European Commission approval extending IMVANEX's marketing authorisation to children aged 2-12 for protection against mpox and smallpox. The decision, based on CHMP's positive opinion and Phase 2 trial data showing a non-inferior immune response in children, broadens access to the non-replicating MVA-BN vaccine.

BAVA.CO closed Friday's trading at 185.90 DKK, up 1.70%

Aura Biosciences Cuts 20% Workforce Amid Q2 Update

Aura Biosciences (AURA) reported second-quarter 2026 results alongside a strategic workforce reduction, trimming approximately 20% of its staff. The workforce reduction is intended to streamline operations, extend the cash runway, and advance its pipeline programs.

AURA closed Friday's trading at $7.69, up 0.52%

Schrödinger Flags Reorganization Costs Amid Q2 Results

Schrödinger Inc. (SDGR) has incurred $279,000 towards reorganisation expenses tied to workforce adjustments. The company highlighted these costs as part of broad efforts to streamline operations and align resources.

SDGR closed Friday's trading at $17.59, down 4.71%.

aTyr Pharma, Inc. (ATYR) announced Q2 results alongside a sweeping corporate restructuring that reduced its workforce by about 60%. The move is aimed at conserving capital and prioritising resources toward its lead program, Efzofitimod in interstitial lung disease (ILD), including pulmonary sarcoidosis and systemic sclerosis (SSc)-related ILD.

ATYR closed Friday's trading at $0.55 up 1.09%

RTW Biotech Opportunities Ltd. (RTW.L) announced that its private portfolio company Avere Therapeutics agreed to merge with NextCure Inc. (NXTC) in an all-stock transaction, and the merged company is expected to trade under the symbol "AVRX". Concurrently, Avere entered a private financing agreement expected to raise about $320 million in gross proceeds before closing, subject to standard closing conditions. The merger transaction is expected to close in the second half of 2026.

RTW.L closed Friday's trading at $2.58, down 1.15%

Mereo BioPharma Licenses Alvelestat Rights To Sentynl Therapeutics

Sentynl Therapeutics, Inc. signed an option and license agreement with Mereo BioPharma Group plc (MREO) for U.S. commercialisation rights to alvelestat, a Phase 3-ready treatment for AATD-associated lung disease. If Sentynl exercises the option, it will fund the Phase 3 trial, which is expected to begin as early as 2027.

Mereo will receive an option fee, up to $40 million in milestone payments, and tiered double-digit royalties on U.S. sales, while retaining rights outside the U.S.

MREO closed Friday's trade at $0.31, up 3.64%

Teledyne To Acquire Varex For Approx. $1.1 Bln

Varex Imaging Corporation (VREX), a manufacturer of X-ray imaging compounds and Teledyne Technologies Inc. (TDY), a digital imaging product provider, announced that they have entered into a definitive agreement under which Teledyne will acquire all outstanding shares of Varex for $18.90 per share, payable in cash, for an aggregate value of approximately $1.1 billion.

The deal is expected to close in early 2027, subject to customary closing conditions.

VREX closed Friday's trade at $18.49, down 0.05%

TDY closed Friday's trade at $679.67, up 0.89%

Jazz Pharmaceuticals To Acquire Actio Biosciences

Jazz Pharmaceuticals plc (JAZZ) announced that it has entered into a definitive agreement to acquire privately held Actio Biosciences, Inc. in a transaction that includes $820 million upfront and up to $500 million in contingent consideration and is expected to close by the fourth quarter of 2026.

The deal adds ABS-1230, a clinical-stage therapy for KCNT1+ epilepsy, to Jazz's rare Epilepsy portfolio, for which there are currently no FDA-approved therapies.

JAZZ closed Friday's trade at $244.96, down 0.36%.

Oculis To Acquire Rights To Privosegtor, ACT-02 From Accure Therapeutics

Oculis Holding AG (OCS) agreed to acquire global development and commercialisation rights to the neurological drug candidates Privosegtor and ACT-02 from Accure Therapeutics for a transaction that includes a $3.8 million up-front cash payment at closing and up to 2.05 million Oculis shares tied to a 2-year lock-up period, development, and regulatory milestones.

Privosegtor is being evaluated for neuropathies and acute multiple sclerosis (MS) relapses, with IND submission preparations underway for the fourth quarter of 2026.ACT-02 is an early-stage preclinical neurology drug candidate

Privosegtor (ACT-01) deal closure is expected by Feb. 28, 2027, while ACT-02, which depends on the Privosegtor deal closure, is expected by Mar. 31, 2027.

OCS closed Friday's trade at $12.94, up 0.94%

Clinical Trials - Breakthroughs & Setbacks

Cullinan, Taiho's Zipalertinib - Chemotherapy Combo Meets Key Goal In Phase 3 NSCLC Trial

Taiho Oncology Inc. and Cullinan Therapeutics Inc. (CGEM) announced that the Phase 3 REZILIENT3 trial evaluating Zipalertinib, an investigational oral small-molecule in combination with chemotherapy, met its primary endpoint of progression-free survival in first-line advanced non-small cell lung cancer (NSCLC) at an interim analysis.

According to the company, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib-containing arm, with manageable safety observed.

CGEM closed Friday's trade at $20.34, up 3.56%

NeOnc Technologies Reports Positive Topline Data of NEO100 Phase 2a Study

NeOnc Technologies Holdings, Inc. (NTHI) announced positive topline results from the Phase 2a portion of NEO100-01 trial, which is evaluating intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint, with a six-month progression-free survival rate of 48.9%, compared with the pre-specified 20% benchmark for standard of care.

NTHI closed Friday's trading at $4.22, up 31.46%

Definium Therapeutics Reports Positive Topline Data From Phase 3 DT120 Study

Definium Therapeutics, Inc. (DFTX) announced that its Phase 3 Voyage study evaluating DT120 Orally Disintegrating Tablet (ODT), an ergoline derivative of classic serotonergic psychedelics at 100 µg in adults with generalised anxiety disorder, met the primary endpoint and all key secondary efficacy endpoints.

According to the company, participants treated with DT120 ODT recorded a statistically significant improvement on the Hamilton Anxiety Rating Scale, or HAM-A, with a placebo-adjusted change from baseline of 5.4 points at week 12, and a generally well-tolerated safety profile.

DFTX closed Friday's trade at $42.63 down 2.89%.

Silence Therapeutics' Divesiran Meets Primary Goal In Phase 2 SANRECO Study

Silence Therapeutics plc (SLN) announced that the Phase 2 SANRECO trial of Divesiran in phlebotomy-dependent patients with Polycythemia Vera, a rare type of blood cancer, met its primary and secondary goals.

According to the company, the primary endpoint was met with 88% of Divesiran-treated patients responding compared to 19% with placebo. In addition, the key secondary endpoint of phlebotomy rate during weeks 0-36 was also met, with the mean number of phlebotomies per patient in the Divesiran groups significantly reduced compared to placebo, with a well-tolerated safety profile.

SLN closed Friday's trade at $13.72, down 1.79%.

Sionna Therapeutics, Inc. (SION) said that its Phase 2a PreciSION CF study of SION-719 plus Trikafta combo in cystic fibrosis did not meet its key activity endpoint. Based on these results, Sionna does not plan to advance SION-719 as an add-on to standard of care.

In parallel, the company announced that its phase 1 study of SION-451 in combination with either SION-2222 or SION-109 in healthy participants met its safety, tolerability, and pharmacokinetic objectives.

SION closed Friday's trade at $6.46, down 1.22%.

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