BASEL (dpa-AFX) - The holiday-shortened week delivered no shortage of action for the biotech sector, with a mix of FDA, China, Canada, and EU approvals, acquisitions, and positive clinical readouts, alongside regulatory rejections, program discontinuations, and trial goal misses.
Positive clinical updates span across (R/R) diffuse large B-cell lymphoma, Infantile-Onset Pompe disease. The late-stage clinical trial successes and setbacks reflected the sector's ongoing volatility and innovation cycle.
Let us unpack the specifics.
Regulatory Approvals
Novartis Gains EU Nod for Itvisma
Novartis AG (NVS) has received European Commission approval for Itvisma, a gene therapy for patients with 5q spinal muscular atrophy. The one-time intrathecal treatment, already cleared by the FDA in late 2025, showed sustained motor function improvements in clinical trials. Itvisma is now the only approved gene therapy for adults with SMA in Europe, expanding Novartis' neurology portfolio.
NVS closed Wednesday's trading (July 1, 2026) at $154.14, down 1.65%
HUTCHMED Wins China Nod for ORPATHYS in Gastric Cancer
HUTCHMED (China) Limited (HCM) announced that China's NMPA has approved ORPATHYS (savolitinib) for gastric cancer patients with MET amplification who have failed prior chemotherapy. The approval, based on positive Phase II data, makes ORPATHYS the first targeted therapy in China for this patient group.
HCM closed Wednesday's trading at $10.78, up 0.19%
Vertex Expands CASGEVY Approval to Children
Vertex Pharmaceuticals Inc. (VRTX) secured U.S. FDA approval to extend CASGEVY use to patients as young as two with sickle cell disease or transfusion-dependent beta thalassemia. The one-time gene-edited therapy, already approved for older patients, now reaches about 5,500 additional children in the U.S. CASGEVY generated $43 million in Q1 2026, marking strong early uptake.
VRTX closed Wednesday's trading at $498.01, up 0.26%
Unicycive Hit by FDA Setback
Unicycive Therapeutics, Inc. (UNCY) received a Complete Response Letter from the FDA for its oxylanthanum carbonate (OLC) NDA in chronic kidney disease patients on dialysis. The agency raised no concerns about safety or efficacy but flagged unresolved manufacturing inspection issues at a third-party vendor.
UNCY closed Wednesday's trading at $5.28, up 12.58%
Apotex Wins First Nod for SEVMIA
Apotex Health Corp. (APTX) has received Health Canada approval for SEVMIA, the first generic equivalent of Wegovy (semaglutide injection) for chronic weight management in adults.
The therapy, developed with Orbicular Pharmaceutical Technologies, is supplied as a multi-use pre-filled pen and expands Apotex's portfolio in diabetes and obesity care.
APTX closed Wednesday's trading at CAD 32.28, down 0.12%
Artivion Wins FDA Approval for AMDS Prosthesis
Artivion Inc. (AORT) secured U.S. FDA premarket approval for its AMDS Hybrid Prosthesis to treat Debakey Type 1 aortic dissections, a life-threatening condition affecting about 6,000 patients annually. Clinical trial data showed a 72% drop in all-cause mortality and no re-operations at two-year follow-up. The device will now be available nationwide without IRB clearance.
AORT closed Wednesday's trading at $23.55, up 4.81%
Bavarian Nordic Wins Canada Nod for VIMKUNYA
Bavarian Nordic A/S (BVNKF) has received Health Canada approval for VIMKUNYA, its single-dose vaccine to prevent chikungunya virus infection in individuals 12 and older. The approval marks the fifth global clearance following the U.S., EU, UK, and Swiss regulators. CEO Paul Chaplin called it a milestone in expanding access to the mosquito-borne disease vaccine.
BVNKF closed Wednesday's trading at $27.69
Viridian Wins First FDA Approval
Viridian Therapeutics, Inc. (VRDN) gained U.S. FDA approval for Lumvoa, its first commercial product to treat thyroid eye disease. The approval, backed by Phase 3 THRIVE trial results, showed durable improvements in eye bulging and double vision across both active and chronic disease. Lumvoa is given as a 12-week course, positioning Viridian as a new player in the rare disease market.
VRDN closed Wednesday's trading at $18.48, up 0.60%
Layoffs
BioCryst Winds Down Internal Discovery, Closes Birmingham Site
BioCryst Pharmaceuticals, Inc. (BCRX) announced it will discontinue all internal discovery programs and shut down its Birmingham, Alabama, research facility by the end of 2026. The move follows a strategic review aimed at sharpening focus on external innovation to build its rare disease pipeline more efficiently. CEO Charlie Gayer said the decision reflects a shift toward leveraging partnerships and external capabilities, while expressing gratitude to the Birmingham team and pledging support during the transition.
BCRX closed Wednesday's trading at $9.65, down 3.50%.
Deals
Abbisko and AstraZeneca Partner on Lumipodlin Plus TAGRISSO Trial For NSCLC
Abbisko Therapeutics Co., Ltd (2256.HK) entered a strategic collaboration with AstraZeneca (AZN) to jointly advance the clinical development of an IO-TKI combination therapy for non-small cell lung cancer (NSCLC).
The collaboration will evaluate Abbisko's oral small-molecule PD-L1 inhibitor, Lumipodlin (ABSK043), in combination with AstraZeneca's third-generation EGFR-TKI, TAGRISSO (osimertinib), with trial execution responsibilities shared between the companies.
AZN closed Wednesday's trading at $183.86, down 3.04%
2256.HK closed Wednesday's trade at HK$10.750.
Insilico Medicine Inks Strategic AI Drug Discovery Collaboration with Takeda
Insilico Medicine (3696.HK) has entered into a strategic collaboration with Takeda Pharmaceutical Company Ltd. (TSE:4502) to advance novel drug candidates across Takeda's therapeutic areas.
Under the agreement, Insilico will lead AI-driven discovery using its proprietary Pharma.AI platform to identify molecules meeting predefined scientific and early development criteria, while Takeda will apply its global development capabilities to advance selected candidates through clinical validation.
Financial terms include approximately $60 million in upfront and near-term payments to Insilico, with success-based milestone payments that bring the deal value to $600 million, plus tiered royalties on future sales.
3696.HK closed Wednesday's trade at HK$39.62.
Ipsen To Acquire Memo Therapeutics For Over 700 Mln Euros; Kartos Therapeutics For $450 Mln To Expand Rare Disease Portfolio
Ipsen S.A. (IPN.PA) entered into a definitive agreement to acquire Memo Therapeutics AG for a total payment of approximately 700 million Euros, and in the same week, it entered into another agreement to acquire Kartos Therapeutics for an upfront payment of $450 million.
The acquisition will expand Ipsen's rare disease portfolio as it gains Potravitug, in development to treat BK polyomavirus (BKPyV) reactivation in kidney transplant recipients, from Memo, and Navtemadlin, an investigational oral MDM2 inhibitor being developed for the treatment of Myelofibrosis, from Kartos.
As per the agreement with Memo, Memo's shareholders will receive an upfront payment of 200 million euros on a cash-free and debt-free basis and may receive more than 500 million euros in additional milestone payments upon regulatory approval for Potravitug.
And per the Kartos deal, Kartos will also be eligible for additional milestone payments of up to $1.3 billion, including a significant regulatory approval milestone, sales-based milestones, and upfront payments.
Both transactions are expected to close by the end of the third quarter of 2026.
Gannet BioChem Partners with Serina to Support SER-252 Development for Parkinson's Disease
Gannet BioChem entered into a development partnership with Serina Therapeutics, Inc. (SER) to support the development of SER-252, an investigational, twice-weekly polymer-conjugated apomorphine formulation for the treatment of advanced Parkinson's disease. Notably, the therapy recently received clearance of its Investigational New Drug (IND) application from the U.S. FDA.
SER closed Wednesday's trade at $1.92, down 2.04%.
Clinical Trials - Breakthroughs & Setbacks
IBio's IBIO-610 Achieves 98% Activin E Inhibition In Obese Primate Study
iBio, Inc. (IBIO) announced new preclinical results showing that a single dose of its antibody candidate, IBIO-610, reduced active Activin E levels by up to 98% in obese non-human primates, with suppression maintained for eight weeks.
In addition, the study demonstrated that IBIO-610 not only achieved durable pathway inhibition but also promoted fat-selective weight loss. When combined with Semaglutide, the therapy drove greater reductions in visceral and total fat while reducing lean mass loss by 73% compared with Semaglutide alone, according to the company.
IBIO closed Wednesday's trade at $1.75.
Vistagen's Fasedienol Misses Key Goal in Phase 3 PALISADE-4 Trial Of Fasedienol
Vistagen Therapeutics Inc. (VTGN) Phase 3 clinical trial of Fasedienol for the treatment of Acute Social Anxiety Disorder missed the key Subjective Units of Distress Scale (SUDS) primary endpoint. According to the company, there was no treatment difference between Fasedienol and placebo for the secondary endpoints.
Following that, Vistagen plans to transition from the acute treatment of social anxiety disorder symptoms to a pathway focused on the overall treatment of social anxiety disorder for Fasedienol over time.
VTGN closed Wednesday's trade at $0.24, up 7.52%.
Sanofi's Nexviazyme Meets Key Goals in Infantile-Onset Pompe Disease Phase 3 Study
Sanofi (SNY) announced that Nexviazyme (avalglucosidase alfa) met all primary and secondary endpoints in its phase 3 study, dubbed Baby-COMET, for treatment-naïve pediatric participants aged 6 months or younger with infantile-onset Pompe disease (IOPD). Nexviazyme was well tolerated, and safety was consistent with the established profile of avalglucosidase alfa, according to the company
The data will support a regulatory submission for a label extension in the US, anticipated in the second half of 2026.
SNY closed Wednesday's trade at $13.94, up 0.83%.
AbbVie's Epcoritamab Plus Lenalidomide Meets Primary Goals in Phase 3 Trial For R/R DLBCL
AbbVie Inc. (ABBV) announced that the Phase 3 trial, dubbed EPCORE DLBCL-4, evaluating subcutaneous Epcoritamab in combination with Lenalidomide in adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival.
Notably, the risk of disease progression and death was reduced by 60% under censoring rules in the U.S and 56% under censoring rules outside the U.S.
ABBV closed Wednesday's trade at $251.06, down 0.23%
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