NEW BRUNSWICK (dpa-AFX) - This week, the biotech sector saw a steady stream of high-impact news, including a major workforce reduction and a fresh round of regulatory clearances spanning diabetes, rare diseases, biosimilars, and women's health technologies.
-Sanofi secures EU nod for Teizeild in Stage 2 Type 1 Diabetes
-Sandoz Secures EU approval for Ondibta in Diabetes
-Boston Scientific to buy Penumbra For $14.5 Bln.
Let's break down the key specifics and major milestones shaping the biotech sector this week.
Layoffs
Lyra Therapeutics Announces Workforce Reduction After Halting Lead Program
Lyra Therapeutics, Inc. (LYRA) has initiated a major restructuring after suspending development of its lead product candidate, LYR-201, a Phase 3-stage therapy for chronic rhinosinusitis. The company will reduce its remaining workforce of 28 employees as it shifts focus toward evaluating strategic alternatives, including potential partnerships or asset sales. Despite previously reporting positive Phase 3 data, Lyra said it will discontinue product development operations to preserve capital while extending its cash runway into the third quarter of 2026.
LYRA closed Thursday's (January.15, 2025) trading at $1.94, up 2.91%.
FDA Approvals & Rejections
Sanofi Secures First EU Approval for Teizeild in Stage 2 Type 1 Diabetes
Sanofi (SNY) has received European Commission approval for Teizeild, the first disease-modifying therapy authorised in the EU for adults and children aged eight and older with stage 2 type 1 diabetes.
The treatment is designed to delay progression to stage 3 T1D by preserving beta-cell function, offering families a therapeutic option beyond insulin initiation.
The approval is supported by results from the TN-10 Phase 2 study, which showed Teizeild delayed the onset of stage 3 T1D by a median of 48.4 months- double that of placebo. Safety findings were consistent with prior trials, with transient lymphopenia and rash being the most common adverse events.
Already marketed as Tzield in multiple countries, the therapy continues to expand globally and is under priority review in the U.S. for younger pediatric patients.
SNY closed Thursday's trading at $47.47, down 0.88%.
Fortress Biotech Secures FDA Approval for ZYCUBO, First U.S. Treatment for Menkes Disease
Fortress Biotech (FBIO) and Cyprium Therapeutics have received U.S. FDA approval for ZYCUBO, the first and only approved therapy for Menkes Disease, a rare and often pediatric disorder caused by copper-transport defects. The copper histidinate injection showed a nearly 80% reduction in mortality risk when started early.
The approval includes a Rare Pediatric Disease Priority Review Voucher, and Cyprium may receive up to $129 million in milestones from Sentynl Therapeutics, which will commercialize the drug.
ZYCUBO marks Fortress' third FDA approval in 15 months, following EMROSI (rosacea) and UNLOXCYT (advanced cutaneous squamous cell carcinoma).
FBIO closed Thursday's trading at $3.48, up 6.10%.
Sandoz Secures EU Approval for Ondibta in Diabetes
Sandoz Group AG (SDZ.SW) announced that the European Commission has approved Ondibta (insulin glargine), a biosimilar to Sanofi's Lantus SoloStar, for the treatment of diabetes mellitus.
Ondibta, co-developed with Gan & Lee Pharmaceuticals, is a long-acting insulin analogue offering a lower-cost alternative with comparable safety and efficacy. The approval covers adults, adolescents, and children aged two years and older.
The decision strengthens Sandoz's biosimilars leadership and expands its pipeline in endocrinology. Commercial rollout in Europe is expected by early 2027, with regulatory filings in other markets under consideration.
SDZ.SW closed Thursday's trading at CHF 60.88.
BD Gains FDA Clearance for EnCor EnCompass Breast Biopsy System
BD (Becton, Dickinson and Company) (BDX) received U.S. FDA 510(k) clearance for its EnCor EnCompass Breast Biopsy and Tissue Removal System, designed to streamline minimally invasive breast cancer diagnosis.
The device combines tissue acquisition and removal in one platform, offering real-time feedback to improve sampling accuracy while reducing the need for multiple instruments. BD plans a U.S. launch before mid-2026, with clinical data to be presented at upcoming medical meetings.
This clearance expands BD's breast health portfolio and reinforces its focus on advancing women's health technologies.
BDXclosed Thursday's trading at $208.35, up 0.45%.
Deal or No Deal
XTL Biopharma Agrees To Acquire 85% Of Beyond Air Subsidiary NeuroNOS
XTL Biopharmaceuticals Ltd. (XTLB) has entered into a binding agreement to acquire 85% of NeuroNOS Ltd., a subsidiary of Beyond Air Inc. (XAIR), in a deal that places XTL Biopharma as a new candidate in the autism therapeutics market.
Under the terms of the deal, XTL will acquire its 85% stake through a combination of 19.9% of its issued share capital, $1 million in cash, and up to $32.5 million in development and commercial milestone payments to Beyond Air.
The milestone payments include up to $5.5 million associated with clinical progress through NDA submission, and up to $26 million linked to commercial sales thresholds. Beyond Air will retain a 19.99% post-transaction stake in XTL Biopharma.
XTLB closed Thursday's trade at $0.97, up 3.31%.
SciSparc Signs Agreement To Acquire Patent Portfolio For Endoscopic Technologies
SciSparc Ltd. (SPRC), a clinical-stage pharmaceutical company operating through its majority-owned subsidiary NeuroThera Labs, signed a definitive agreement to acquire a broad portfolio of patents, trademarks, and intellectual property related to innovative endoscopic systems and medical imaging technologies from Xylo Technologies Ltd.
Under the agreement, SciSparc will issue ordinary shares to Xylo representing 19.99% of SciSparc's outstanding share capital as of the closing date, set for March 8, 2026.
The portfolio includes rights to the MUSE system, a single-use endoscopic device designed for transoral fundoplication, a minimally invasive procedure used to treat gastroesophageal reflux disease (GERD).
SPRC closed Thursday's trade at $1.05, down 2.78%.
Boston Scientific To Buy Penumbra In $14.5 Bln Cash And Stock Deal
Boston Scientific Corp. (BSX) has entered into a definitive agreement to acquire Penumbra Inc. (PEN) for $374 per share, reflecting an enterprise value of roughly $14.5 billion.
Under the terms of the agreement, Penumbra stockholders may elect to receive either $374 in cash or 3.8721 shares of Boston Scientific common stock, subject to proration, with total deal consideration split approximately 73% in cash and 27% in Boston Scientific shares.
Boston Scientific's acquisition underscores its strategy to expand its interventional portfolio and strengthen its position in vascular therapies.
BSX closed Thursday's trade at $90.03, down 3.96%.
Clinical Trials - Breakthroughs & Setbacks
Creative Medical's ADAPT Trial of CELZ-201 In Chronic Lower Back Pain Shows Functional and Pain Improvement
Creative Medical Technologies Holdings Inc. (CELZ) reported positive interim 180-day data from its FDA-cleared ADAPT trial evaluating CELZ-201, the company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease.
In the ADAPT trial, CELZ-201 demonstrated a 15.3 percentage-point improvement in functional disability at 180 days, with approximately 79% of patients achieving a clinically meaningful benefit. Pain scores declined by an average of 3.9 points on a 10-point scale, with a similar proportion of patients experiencing at least a two-point reduction.
CELZ expects to advance toward additional regulatory interactions and strategic partnership discussions as it awaits final ADAPT trial data.
CELZ closed Thursday's trade at $1.90, up 2.70%.
BriaCell Reports 100% resolution of Lung metastasis
BriaCell Therapeutics Corp. (BCTX), a clinical-stage biotechnology company, on Tuesday reported durable, sustained complete resolution of a lung metastasis in a patient with metastatic breast cancer treated with its off-the-shelf immunotherapy candidate, Bria-OTS.
The first patient enrolled in the Phase 1/2a Bria-OTS study, a 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures and hormone receptor-positive (HR+), HER2-negative, achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy.
BCTX closed Thursday's trade at $4.49, down 7.61%.
Benitec Biopharma Reports Positive Long-Term Clinical Study Results From BB-301 Phase 1b/2a Trial
Benitec Biopharma Inc. (BNTC) announced promising long-term results from its Phase 1b/2a clinical study evaluating BB-301 for the treatment of dysphagia in oculopharyngeal muscular dystrophy (OPMD) after a 24-month post-treatment assessment.
Patient 1 of Cohort 1, who has completed the 24-month post-treatment assessment, continues to demonstrate great improvement in post-swallow pharyngeal residue and overall dysphagic symptom burden compared with both the pre-treatment baseline and the 12-month follow-up.
Patient 4 of Cohort 1 also continued to show a strong response to BB-301 at the 12-month follow-up, reinforcing the durability of treatment benefits.
These improvements were confirmed through x-ray-based swallowing studies and the Sydney Swallow Questionnaire (SSQ).
BNTC closed Thursday's trade at $11.71, down 3.46%.
Johnson & Johnson's TECVAYLI Shows 71% Risk Reduction in Multiple Myeloma while RYBREVANT Demonstrates Durable Responses in Metastatic Colorectal Cancer
Johnson & Johnson (JNJ) announced positive topline results from the investigational Phase 3 MajesTEC-9 study of TECVAYLI monotherapy and new longer-term follow-up results from the investigational Phase 1b/2 OrigAMI-1 study of RYBREVANT in combination with FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer.
-Phase 3 MajesTEC-9 study of TECVAYLI
The MajesTEC-9 study evaluated TECVAYLI monotherapy in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide predominantly refractory to anti-CD38 and lenalidomide therapies.
The MajesTEC-9 study demonstrated that Johnson & Johnson's TECVAYLI reduced the risk of disease progression or death by 71% and the risk of death by 40% in patients with multiple myeloma who were predominantly refractory to anti-CD38 therapy and lenalidomide.
The data confirm that TECVAYLI provides superior progression-free survival (PFS) and overall survival (OS) compared to standard of care as early as second-line treatment.
-Phase 1b/2 OrigAMI-1 study of RYBREVANT
The OrigAMI-1 is an open-label, Phase 1b/2 study assessing the efficacy and safety of RYBREVANT plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/BRAF WT mCRC.
Phase 1b/2 OrigAMI-1 study results of RYBREVANT demonstrated that more than 70% of patients in the first-line subgroup responded to treatment with RYBREVANT plus chemotherapy, with most responses lasting beyond 16 months.
These findings highlight the potential of RYBREVANT to deliver durable benefit in a difficult-to-treat patient population and mark the second positive Phase 3 study supporting TECVAYLI regimens as a potential new standard of care for patients experiencing their first relapse.
These promising responses support continued investigation of RYBREVANT in ongoing Phase 3 studies for both first- and second-line colorectal cancer treatment.
JNJ closed Thursday's trade at $219.57, up 0.47%
Teva's AJOVY Shows Efficacy in Children and Adolescents with Episodic Migraine
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that Phase 3 data on AJOVY, underscoring its efficacy and safety in children and adolescents with episodic migraine, were published in the New England Journal of Medicine (NEJM).
The SPACE study was a 3-month, randomised, placebo-controlled trial that enrolled 237 children and adolescents aged 6-17 years with episodic migraine.
Results from the SPACE trial showed that AJOVY reduced monthly migraine days by 2.5 days compared to 1.4 days with placebo. It also reduced monthly headache days of at least moderate severity by 2.6 days versus 1.5 days with placebo.
Importantly, 47.2% of participants achieved a 50% reduction in monthly migraine days with AJOVY, compared with 27.0% with placebo.
TEVA closed Thursday's trade at $32.35, down 0.89%.
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