(RTTNews) – The biotech industry witnessed several key events this week, including major FDA approvals, acquisitions, pivotal clinical trial results and setbacks.
• A series of FDA approvals were announced during the week, with GSK, Halozyme Therapeutics, Femasys, Johnson & Johnson, Amphastar Pharma, and Fortress Biotech getting the go-ahead to market their respective therapeutic candidates.
• XOMA Royalty and Swedish Orphan Biovitrum AB both opened their wallets, each signing acquisition agreements to strengthen their portfolios.
• Insmed and Argenx discontinued their clinical trials due to disappointing data.
• Processa Pharma, DBV Technologies, Kyverna Therapeutics, Immunome, Takeda Pharma, announced positive clinical results.
• Athira secured exclusive rights to a breast cancer drug.
Let’s take a closer look at the details.
FDA Approvals & Rejections
GSK’s Exdensur Won FDA Nod For Severe Asthma
The FDA has approved Exdensur, GSK plc’s (GSK) long-acting biologic for severe asthma. It is a monoclonal antibody targeting IL-5, designed for patients with eosinophilic asthma who remain uncontrolled despite standard therapies. The drug is administered subcutaneously every six months, offering a less frequent dosing schedule compared to existing IL-5 inhibitors. Approval was based on pivotal Phase 3 trials showing significant reductions in exacerbations and improvements in lung function.
GSK closed Friday’s trading at $48.61, up 0.66%.
FDA Approved RYBREVANT FASPRO, The First And Only Subcutaneous Therapy For EGFR-mutated NSCLC
Johnson & Johnson’s subcutaneously administered RYBREVANT FASPRO, co-formulated with recombinant human hyaluronidase PH20, Halozyme’s ENHANZE drug delivery technology, has received FDA approval for the treatment of adults with EGFR-mutated non-small cell lung cancer. The subcutaneous formulation was shown to deliver comparable pharmacokinetics to those of intravenous administration, while reducing infusion time to minutes. Halozyme noted that the approval highlights the versatility of its ENHANZE platform in enabling more convenient delivery of biologic therapies.
HALO closed Friday’s trading at $67.35, up 3.44%.
FDA Cleared Next-generation FemVue Diagnostic Device
Femasys Inc.’s (FEMY) next-generation FemVue device has received FDA clearance to evaluate fallopian tube patency in women undergoing infertility assessment. The updated system allows ultrasound visualization during saline-air contrast delivery, streamlining the in-office procedure.
FEMY closed Friday’s trading at $0.86, up 7.97%.
Johnson & Johnson Secured FDA Approval for Expanded TRUFILL nBCA Use
The FDA has approved an expanded indication for Johnson & Johnson (JNJ) MedTech’s TRUFILL n BCA Liquid Embolic System for embolization of the middle meningeal artery in symptomatic subacute and chronic Subdural Hematoma. The decision is supported by results from the MEMBRANE randomized controlled trial, which showed TRUFILL nBCA to be superior to standard of care for MMA embolization in cSDH and demonstrated a favourable safety profile.
TRUFILL nBCA has been used in neurovascular embolization for more than 25 years, and the new indication extends its use into a condition with high recurrence rates following surgery.
JNJ closed Friday’s trading at $206.37, down 0.93%.
Amphastar Got A Yes from FDA To Market Teriparatide Injection
Amphastar Pharmaceuticals Inc. (AMPH) received FDA approval for its Abbreviated New Drug Application for Teriparatide Injection, a single-patient-use prefilled pen determined to be bioequivalent and therapeutically equivalent to Eli Lilly’s FORTEO. The product is indicated for multiple osteoporosis populations at high risk for fracture, including postmenopausal women, men with primary or hypogonadal osteoporosis, and patients on sustained systemic glucocorticoid therapy.
The total U.S. sales of Teriparatide were approximately $585 million for the 12 months ended September 30, 2025, according to IQVIA data. Amphastar plans?to launch the product by year-end.
AMPH closed Friday’s trading at $26.60, up 0.38%.
Fortress Biotech’s Menkes Disease Drug To Face FDA Review in January
Fortress Biotech Inc.’s (FBIO) resubmitted NDA for CUTX-101 for the proposed treatment of Menkes disease in pediatric patients has been accepted for review by the FDA. The filing is classified as a Class 1 resubmission and has been assigned a new PDUFA action date of January 14, 2026. The U.S. regulatory agency declined to approve the investigational drug this September, citing cGMP deficiencies observed at the facility where CUTX-101 is manufactured.
FBIO closed Friday’s trading at $3.54, up 6.63%.
Cytokinetics’ MYQORZO Approved By FDA, Rivaling Camzyos
Cytokinetics Inc. (CYTK) announced that the U.S. Food and Drug Administration has approved MYQORZO (aficamten) tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The therapy is indicated to improve functional capacity and symptoms in patients living with this condition. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. By inhibiting myosin, MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM.
Until now, Bristol Myers Squibb’s Camzyos had been the only FDA-approved therapy for symptomatic oHCM.
CYTK closed Friday’s trading at $62.72, up 0.84%.
Deal or No Deal
XOMA Royalty to Acquire Generation Bio
XOMA Royalty Corp. (XOMA) agreed to acquire Generation Bio Co. (GBIO) for a cash price of $4.2913 per share at?closing. Through the acquisition, XOMA Royalty gains the opportunity to earn milestone and royalty payments tied to Generation Bio’s collaboration with Moderna.
Generation Bio stockholders will also get one non-transferable contingent value right (CVR) per share that can pay additional cash based on parameters like net cash at closing, savings from resolving Generation Bio’s Cambridge office lease obligations, share of proceeds from Generation Bio’s existing license agreement with Moderna, share of payments from any out-license or sale of Generation Bio’s ctLNP delivery platform.
The acquisition is expected to close in February 2026.
XOMA closed Friday’s trading at $25.39, up 1.97%.
Sobi to Acquire Arthrosi Therapeutics
Swedish Orphan Biovitrum AB (SOBI.ST) is all set to acquire privately-held Arthrosi Therapeutics, expanding its gout pipeline with a highly differentiated new asset. The deal is valued at up to $1.5 billion, including a $950 million upfront payment at closing and contingent milestone payments of up to $550 million.
SOBI.ST closed Friday’s trading up 1.17% at 328.00 SEK on the Stockholm Exchange
Athira Secured Exclusive Rights To Breast Cancer Drug Candidate Lasofoxifene
Athira Pharma, Inc. (ATHA) acquired exclusive global rights to Lasofoxifene, a selective estrogen receptor modulator now in a pivotal Phase 3 trial for ESR1-mutant metastatic breast cancer. Earlier Phase 2 studies with Lasofoxifene demonstrated positive results, including a median progression-free survival of 13 months in heavily pretreated patients and a 56% objective response rate when combined with Eli Lilly’s blockbuster drug, Verzenio (abemaciclib).
ATHA closed Friday’s trading at $6.97, up 3.72%.
Clinical Trials – Breakthroughs and Setbacks
Insmed’s Phase 2b BiRCh Trial Falls Short of Endpoints, Program Discontinued
Insmed Inc. (INSM) has discontinued its Phase 2b BiRCh study of Brensocatib for chronic rhinosinusitis without nasal polyps after it failed to meet its primary and secondary efficacy endpoints in both the 10 mg and 40 mg treatment arms. Brensocatib received its initial approval in the U.S. this August as the first and only FDA-approved treatment for non-cystic fibrosis bronchiectasis, and is marketed under the brand name BRINSUPRI.
INSM closed Friday’s trading at $174.84, up 4.98%.
Processa’s NGC-Cap Demonstrated Promising Results In Breast Cancer Study
Processa Pharmaceuticals, Inc. (PCSA) reported that its preliminary Phase 2 trial of lead oncology candidate, NGC-Cap, a combination of PCS6422 and capecitabine, demonstrated significantly increased exposure to cancer-killing metabolites while maintaining comparable safety to capecitabine monotherapy.
PCSA closed Friday’s trading at $3.78, down 3.08%.
DBVT’s Phase 3 Trial of VIASKIN Peanut Patch Met Endpoints
DBV Technologies (DBVT) announced positive topline results from its pivotal phase 3 VITESSE clinical trial, evaluating VIASKIN Peanut patch in children aged 4 to 7 years. Results showed that 46.6% of children treated with VIASKIN Peanut Patch met responder criteria at 12 months, compared to 14.8% in the placebo arm.?The company plans to submit a BLA to the U.S. FDA in the first half of 2026.
DBVT closed Friday’s trading at $22.76, up 5.76%.
Kyverna’s Miv-cel Demonstrated Clear Benefit for Stiff Person Syndrome
Kyverna Therapeutics, Inc. (KYTX) reported positive data from its registrational Phase 2 KYSA-8 trial of mivocabtagene (miv-cel) in patients with stiff person syndrome, marking a potential breakthrough for autoimmune CAR T-cell therapy. At the primary analysis time point of Week 16, patients experienced a median 46% improvement in the timed 25-foot walk, with 81% achieving more than a 20% improvement, a threshold considered clinically meaningful.
KYTX closed Friday’s trading at $7.19, up 2.71%.
Immunome To File Varegacestat NDA in Q2
Immunome Inc.’s (IMNM) pivotal phase 3 trial of Varegacestat in patients with desmoid tumours, dubbed RINGSIDE, met the primary and all key secondary endpoints. Varegacestat improved progression-free survival, and the risk of disease progression or death was reduced by 84%. The objective response rate was 56% with Varegacestat compared to 9% for placebo. The company is planning to submit the New Drug Application to the FDA in Q2 2026.
IMNM closed Friday’s trading at $21.44, up 7.47%.
Argenx Discontinued UplighTED Studies in Thyroid Eye Disease Due To Futility
Argenx SE (ARGX, ARGX.BR) discontinued its Phase 3 UplighTED studies evaluating Efgartigimod PH20 SC in adults with moderate to severe thyroid eye disease, following the Independent Data Monitoring Committee’s recommendation to stop the trials for futility.
ARGX closed Friday’s trading at $854.99, up 0.94%.
Takeda’s Phase 3 Study Of Oral Zasocitinib In Plaque Psoriasis Achieved Primary Endpoint
Takeda Pharmaceutical Co. Ltd.’s (TAK) Phase 3 studies of once-daily oral Zasocitinib met all primary and secondary endpoints in adults with moderate-to-severe plaque psoriasis. According to the study results, over half of the study participants treated with Zasocitinib achieved clear or almost clear skin, and on average, about 30% achieved completely clear skin by week 16
TAK closed Friday’s trading at $14.90, up 0.47%.
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