BASEL (dpa-AFX) - This week's biotech landscape witnessed key FDA approvals, rejections, NDA resubmissions, merger terminations, trial discontinuations, and clinical trial data readouts across therapeutic areas such as Turner Syndrome, Late-Line Colorectal Cancer, Obesity, and Type 1 Diabetes.
Let us unpack the key developments and milestones in the biotech space this week.
FDA and EU Approvals & Rejections
GSK's Lynavoy Wins FDA Approval for Cholestatic Pruritus in PBC
GSK plc (GSK), secured FDA approval for Lynavoy, the first U.S. treatment for cholestatic pruritus in adults with primary biliary cholangitis (PBC).
The decision is supported by the Phase 3 GLISTEN trial, which demonstrated rapid and sustained reductions in itching and sleep disturbance compared with placebo. GSK said the approval marks the first liver-disease therapy to emerge from its internal pipeline.
GSK closed Thursday's trading (March 19, 2026) at $52.37, up 0.60%.
Knight Therapeutics Gains Brazil Approval for New MINJUVI Indication
Knight Therapeutics Inc. (GUD.TO) received approval from ANVISA, Brazil's health regulator, for an additional indication of MINJUVI in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma.
The decision follows a supplemental regulatory review and is supported by clinical data showing meaningful response rates and durable disease control. Knight said the rapid review highlights the company's regulatory execution and partnership strength.
GUD.TO closed Thursday's trading at C$6.30, up 2.11%.
Novartis' Cosentyx Wins FDA Approval for Pediatric Hidradenitis Suppurativa
Novartis AG (NVS) received FDA approval for Cosentyx (secukinumab) to treat moderate to severe hidradenitis suppurativa in adolescents aged 12 and older, making it the first IL-17A inhibitor cleared for this younger population.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that often begins around puberty, and more than half of patients experience symptoms during adolescence. The approval is supported by data extrapolated from adult trials, pharmacokinetic modelling, and pediatric studies from other Cosentyx indications.
Cosentyx, already approved for adults with HS, has been used globally for over a decade across multiple autoimmune conditions. The drug generated $6.7 billion in sales in 2025, up 8% from the prior year.
NVS closed Thursday's trading at $148.19, down 1.08%.
FDA Clears Myriad's MyChoice CDx Ovarian Cancer Test
Myriad Genetics, Inc., (MYGN) received FDA approval for its MyChoice CDx test as the companion diagnostic for GSK's PARP inhibitor Zejula in adults with advanced ovarian cancer.
The decision is supported by final data from the PRIMA trial, where the test was used to determine homologous recombination deficiency (HRD) status- a key biomarker that helps identify patients most likely to benefit from PARP inhibition. MyChoice CDx is now the only FDA-approved HRD test for guiding Zejula treatment in the U.S.
MYGN closed Thursday's trading at $4.75, up 2.37%.
FDA Rejects Aldreya's Dry Eye Drug Again
Aldeyra Therapeutics, Inc. (ALDX) shares plunged nearly 75% on Tuesday after the FDA issued a Complete Response Letter for Reproxalap in dry eye disease.
The agency said the application still lacks 'substantial evidence' from adequately controlled studies to show meaningful improvement in the signs and symptoms of dry eye. Regulators also pointed to inconsistent trial results, though no safety or manufacturing issues were raised.
Reproxalap has now faced three FDA rejections since 2023. Aldeyra plans to request a Type A meeting to discuss potential next steps. The company ended 2025 with $70 million in cash, expected to fund operations into 2028.
ALDX closed Thursday's trading at $1.83, up 28.87%.
Telix Resubmits NDA for Brain Cancer Imaging Agent TLX101-Px
Telix Pharmaceuticals Ltd. (TLX) has resubmitted its NDA to the FDA for TLX101-Px (Pixclara), an investigational PET imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related changes in both adults and children.
The new filing includes the additional clinical evidence the FDA requested in last year's Complete Response Letter. Telix said the updated package addresses all outstanding issues, and the drug continues to hold fast-track and orphan drug designations. A parallel application is also under review in Europe.
TLX closed Thursday's trading at $8.57, up 1.90%.
FDA Approves Rhythm's IMCIVREE for Hypothalamic Obesity
Rhythm Pharmaceuticals, Inc. (RYTM) won FDA approval of IMCIVREE to treat acquired hypothalamic obesity, making it the first therapy cleared for this rare condition. The decision is backed by the Phase 3 TRANSCEND trial, where the drug delivered a placebo-adjusted BMI reduction of -18.4% at 52 weeks. IMCIVREE will be available in the U.S. immediately.
RYTM closed Thursday's trading at $90.31, up 5.18%.
FDA Approves Novo Nordisk's Higher-Dose Wegovy HD for Weight Loss
Novo Nordisk (NVO) won FDA approval for Wegovy HD(semaglutide 7.2 mg), a higher-dose, once-weekly injectable version of its blockbuster obesity drug.
The new formulation delivered 20.7% average weight loss in the STEP UP trial and is expected to launch in the U.S. in April 2026.
The approval, granted under the FDA Commissioner's National Priority Voucher pilot program, expands Novo Nordisk's obesity portfolio as demand and competition continue to rise.
NVO closed Thursday's trading at $37.08, down 0.99%.
Deals
Monte Rosa Signs Supply Agreement with JNJ For Phase 2 Prostate Cancer Study
Monte Rosa Therapeutics, Inc. (GLUE), a clinical-stage biotechnology company, announced that the company has entered into a supply agreement with Johnson & Johnson (JNJ) to evaluate its MRT-2359 in combination with JNJ's ERLEADA or Apalutamide for the treatment of metastatic castration-resistant prostate cancer or mCRPC.
Monte Rosa plans to initiate a new, signal-confirming Phase 2 study of MRT-2359 in combination with ERLEADA in AR-mutant patients in the third quarter of 2026.
As per the terms of the pact, Monte Rosa will conduct and sponsor the trial, and Johnson & Johnson will provide ERLEADA.
GLUE closed Thursday's trade at $16.06, up 1.90%.
LENSAR Terminates Merger Agreement with Alcon Research
LENSAR, Inc. (LNSR), a commercial-stage medical device firm focused on developing robotic laser solutions for the treatment of cataracts, announced that it reached an agreement to terminate the merger agreement with Alcon Research, LLC, entered in March 2025.
According to the firm, the Federal Trade Commission intended to seek an injunction against the acquisition contemplated by the merger agreement.
LENSAR and Alcon have mutually agreed to terminate the merger agreement in the best interests of both companies, as obtaining all required U.S. regulatory approvals was unlikely by either the original April 23, 2026, or the extended July 23, 2026, dates set forth in the merger agreement.
LNSR closed Thursday's trade at $6.11, down 7.14%.
Clinical Trials - Breakthroughs & Setbacks
Ascendis Reports Positive Results from Phase 2 Trial for TransCon HGH in Turner Syndrome
Ascendis Pharma A/S (ASND) announced positive topline 52-week results from its Phase 2 trial, dubbed New InsiGHTS, evaluating once-weekly TransCon hGH (Lonapegsomatropin), its investigational Growth Hormone Deficiency treatment for prepubertal children with Turner syndrome, versus daily somatropin.
In the New InsiGHTS trial, at week 52, annualised height velocity (AHV) was similar to daily somatropin, independent of starting dose, with an LS mean AHV of 9.05 cm/year in all TransCon hGH-treated children, compared with 9.04 cm/year in those treated with daily somatropin.
Also, TransCon hGH demonstrated a safety and tolerability profile similar to that of daily somatropin through follow-up of up to 143 weeks.
ASND closed Thursday's trade at $223.82, down 1.58%.
CytomX Reports New Positive Varseta-M Data in Late-Line Colorectal Cancer
CytomX Therapeutics, Inc. (CTMX) reported new positive expansion data for its lead antibody-drug conjugate, Varsetatug masetecan (Varseta-M) in late-line metastatic Colorectal Cancer (CRC).
As of the data cutoff, 56 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. The latest Phase 1 expansion data for Varseta-M confirmed response rates of 32% (6 out of 19) at the 10 mg/kg dose, and 20% (4 out of 20) at the 8.6 mg/kg dose in patients.
Median progression-free survival was 7.1 months, 6.8 months, and 5.5 months at doses of 10 mg, 8.6 mg, and 7.2 mg/kg, respectively. The disease control rate was 88% (49/56) across the expansion doses of 7.2 - 10 mg/kg.
The doses of 8.6 mg/kg and 10 mg/kg have been prioritised for further evaluation with the goal of selecting a dose or doses for a registrational study.
The company aims to align with the FDA in 2026 on a potential registrational study design for Varseta-M monotherapy in advanced CRC.
CTMX closed Thursday's trade at $4.78, down 8.64%.
Rhythm's EMANATE Trial Misses Endpoint but Shows BMI Reductions
Rhythm Pharmaceuticals, Inc. (RYTM) has announced topline results from its global Phase 3 EMANATE trial of Setmelanotide, an MC4R agonist designed to address rare, genetically driven forms of obesity, that failed to meet the primary endpoint.
The EMANATE trial was randomized, double-blind, placebo-controlled study spanning four genetic subgroups: POMC/PCSK1, LEPR, SRC1 (NCOA1), and SH2B1. The primary endpoint was the difference in mean per cent change in BMI from baseline to Week 52 versus placebo.
According to the firm, their four sub-studies did not meet their pre-specified primary endpoints, but post hoc analyses revealed statistically significant and clinically meaningful reductions in body mass index (BMI) among patients with heterozygous variants of the POMC/PCSK1 and SRC1 (NCOA1) genes at 52 weeks
No new safety concerns emerged; the most common side effects were skin reactions, nausea, vomiting, and headache.
RYTM closed Thursday's trade at $90.31, up 5.18%.
Sana Reports Continued Positive 14-Month Results for UP421 In Type 1 Diabetes Cell-Therapy Study
Sana Biotechnology, Inc. (SANA) reported positive 14-month follow-up results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy, into a patient with type 1 diabetes without any immunosuppression.
Results from more than 1 year after cell transplantation demonstrate sustained survival and function of pancreatic beta cells, as measured by circulating C-peptide, a biomarker of endogenous insulin production by transplanted beta cells.
Fourteen-month results also demonstrated that the transplanted cells survived long-term, continued to produce insulin, increased insulin secretion during a mixed-meal tolerance test, and remained undetected by the immune system, indicating successful immune evasion.
The company expects to file an IND application for SC451 and begin a Phase 1 trial as early as this year.
SANA closed Thursday's trade at $8.17, up 1.28%.
Immutep Discontinues Phase III Trial Of Eftilagimod Alfa In First-Line NSCLC
Immutep Ltd. (IMM.AX, IMMP) announced that the Independent Data Monitoring Committee (IDMC) for the TACTI-004 Phase III study evaluating Eftilagimod Alfa in first-line non-small cell lung cancer has recommended discontinuation of the trial.
Based on its review of available safety and efficacy data, the IDMC recommended discontinuing the trial due to futility.
In response to the IDMC's recommendation, enrolment in the study will be halted, and Immutep will implement an orderly wind-down, including patient follow-up and site close-out.
IMMP closed Thursday's trade at $0.41, down 0.70%.
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