Key Outcomes:
- Lilly’s Foundayo (orforglipron) – 1st GLP-1 weight-loss pill with no food/water restrictions, ~$25/mos with insurance
- Dupixent – EU approved for CSU in kids aged 2–11, 1st targeted therapy for this group
- Neffy nasal spray – 1st needle-free epinephrine approved in Canada for anaphylaxis
- YUVIWEL – orphan drug exclusivity granted for achondroplasia in kids ≥2 years
- Generic Ozempic – 1st tentative FDA approval granted to Apotex
- AB-1002 (gene therapy for heart failure) – P2 enrollment complete, results expected 1H 2027
- HXN-1001 (anti-TL1A for UC) – 1st patient dosed in P2a
- IDE574 (dual KAT6/KAT7 inhibitor) – entered 1st-in-human study for multiple solid tumors
- AK0406 (long-acting influenza antiviral) – 1st cohort dosed in P1
- Lorigerlimab – FDA lifted clinical hold, P2 LINNET study resuming
- INGREZZA outperformed AUSTEDO XR in treatment persistence for Tardive Dyskinesia at 6 mos
- OneCyte + Kemp Proteins partnered to accelerate cell line development for biologics
- Neurocrine triggered a $22.5M milestone to Nxera as NBI-1117570 enters P2 for schizophrenia
April 01, 2026
AskBio Reports Enrollment Completion of AB-1002 in P2 GenePHIT Study
AskBio, wholly owned and independently operated as a subsidiary of Bayer, has completed randomization of the final participant in its P2 GenePHIT study, evaluating AB-1002, an investigational gene therapy for heart failure with reduced ejection fraction (HFrEF). The initial results are expected in 1H 2027. The therapy was previously tested in the P1 non-randomized, dose-escalation study in patients with NYHA Class III non-ischemic HFrEF. 12 mos data from that study were published online in Nature Medicine in Oct 2025, in print in Nov 2025, and presented earlier at the European Society of Cardiology Heart Failure Meeting in May 2025. AB-1002 remains investigational and has not yet been approved by regulatory authorities; its safety and efficacy continue to be under evaluation.
Source: Bayer PR Apr 01, 2026
April 02, 2026
Earendil Labs Doses 1st Patient in P2a Study for Ulcerative Colitis
Earendil Labs has dosed the first patient in a P2a study of HXN-1001, a half-life-extended anti-TL1A antibody for UC, and completed P1 enrollment in healthy volunteers in Australia. Designed as a high-concentration SC therapy for IBD, including Crohn’s Disease, HXN-1001 showed strong preclinical activity and good PI tolerability, with an ~8-wk half-life and a low incidence of anti-drug antibodies. The P2a study marks a key step in developing potentially more effective and convenient biologics for IBD and other high-need diseases.
Source: PR Newswire PR Apr 02, 2026
April 06, 2026
IDE574 Enters FIH Study as IDEAYA Explores Dual KAT6/KAT7 Inhibition
IDEAYA Biosciences reported that the first patient dosing in a P1 study of IDE574 (a potential FIC oral dual inhibitor of KAT6 and KAT7). The dose-escalation study will assess safety, PK, and preliminary efficacy as a monotherapy in patients with advanced breast, prostate, CRC, and lung cancers. IDE574 targets epigenetic pathways that drive tumor survival and has shown strong preclinical anti-tumor activity, including potential activity against ESR1-mutant hormone-resistant breast cancer. The company also plans to explore combination approaches, and preclinical data highlighting its potential first- and best-in-class profile will be presented at the AACR 2026.
Source: IDEAYA PR Apr 06, 2026
April 08, 2026
MacroGenics Restarts LINNET Study Enrolment After FDA Decision
MacroGenics reported that the U.S. FDA has removed the partial clinical hold on the P2 LINNET study of lorigerlimab, a bispecific DART molecule targeting PD-1 and CTLA-4. Previously enrolled patients were allowed to continue treatment during the hold, and new participants will now be enrolled under a revised protocol that includes additional safeguards for potential hematologic and cardiac toxicities. The company plans to resume enrollment and expects to provide a mid-year clinical update. So far, 41 patients have been treated in the LINNET study (n=60 total), with more than 300 participants dosed across earlier P1 and P2 lorigerlimab studies.
Source: MacroGenics PR Apr 08, 2026
April 09, 2026
AK0406 Enters FIH P1 as ArkBio Advances Novel Long‑Acting Antiviral for Influenza
Shanghai Ark Bio completed dosing of the 1st cohort of HVs in a P1 study for AK0406 (a long-acting antiviral drug-Fc conjugate) for influenza, following approval from the HREC in Australia. This trial is designed to combine potent antiviral effects with Fc-mediated immune clearance. Preclinical studies indicate it has broad-spectrum activity against both influenza A and B, and an optimized profile for prophylaxis and treatment vs. earlier ADFC molecules. The trial aims to assess PK, safety, and tolerability in healthy adults, with findings to guide further trials, optimised dose for POC study in at-risk populations.
Source: PRNewswire PR Apr 09, 2026
April 14, 2026
INGREZZA Outperforms AUSTEDO XR in Real-World Treatment Persistence Study
Neurocrine Biosciences presented the first real-world head-to-head claims analysis comparing INGREZZA (valbenazine) and AUSTEDO XR (deutetrabenazine) in Tardive Dyskinesia patients at the AMCP 2026. The retrospective study analyzed 2,988 propensity-matched adults and found that significantly more INGREZZA patients remained on therapy after 6mos.
Key Results (6-Month Follow-Up):
Statistically significant vs. AUSTEDO XR (p<0.0001 for persistence and time; p=0.0012 for switching) – These persistence advantages emerged early in treatment and were sustained throughout the follow-up period, reinforcing INGREZZA’s profile as 1L therapy for TD. The study was funded by Neurocrine Biosciences. TD is a movement disorder affecting at least 800,000 adults in the U.S., often caused by long-term use of antipsychotic medications. Both INGREZZA and AUSTEDO XR are VMAT2 inhibitors approved to treat it.
Source: PRNewswire PR Apr 14, 2026
April 01, 2026
Lilly’s Foundayo Becomes First GLP-1 Weight-Loss Pill Without Food Restrictions
Eli Lilly got approval to FOUNDAYO (orforglipron) from U.S. FDA for adults with obesity or overweight with weight-related conditions. The drug is the only GLP-1 weight-loss pill that can be taken at any time of day without food or water restrictions, offering a more convenient alternative to injectable therapies. Approval was supported by the P3 ATTAIN-1 study, in which participants receiving the highest dose lost an average of 27.3 pounds (12.4%), significantly more than placebo. Foundayo is intended to be used alongside diet and exercise and will be distributed through LillyDirect and retail pharmacies, with prices starting around $25/mos with commercial insurance or $149 for self-pay patients.
Source: Eli Lilly PR Apr 01, 2026
April 06, 2026
FDA Grants Orphan Drug Exclusivity to YUVIWEL
Ascendis Pharma received orphan drug exclusivity by the U.S. FDA for YUVIWEL (navepegritide), now launched in the U.S. for children ≥2 years of age with achondroplasia with open epiphyses. Approved on Feb 27, 2026, under accelerated review, YUVIWEL’s orphan exclusivity extends through Feb 27, 2033. The company has begun revenue recognition as patients initiate therapy, supported by the Ascendis Signature Access Program. YUVIWEL is a once-weekly prodrug of C-type natriuretic peptide that delivers sustained exposure to counteract FGFR3 overactivity, with continued approval contingent on confirmatory trials.
Source: Ascendis PR Apr 06, 2026
April 07, 2026
FDA Grants FTD to SIM0505 for Ovarian Cancer
NextCure has received FTD from the U.S. FDA for SIM0505, a CDH6-targeted ADC being developed for women with platinum-resistant ovarian cancer (PROC). The company plans to begin dose optimization studies in ovarian cancer patients in Q2 2026 and will present P1 study data at the upcoming ASCO 2026. Simcere Zaiming Pharmaceutical is the originator and holds rights for China, Hong Kong, and Macau, while NextCure holds exclusive global rights for SIM0505
Source: NextCure PR Apr 07, 2026
April 10, 2026
U.S. FDA Grants First Tentative Approval for a Generic Version of Ozempic
Apotex received the first U.S. FDA Tentative Approval for its ANDA for semaglutide injection, a key step toward offering a more affordable alternative in a complex peptide therapy class. Developed in partnership with Orbicular Pharmaceutical Technologies using advanced analytical and process expertise, the product has met stringent regulatory standards.
Source: PRNewswire PR Apr 10, 2026
April 13, 2026
EU Approves Dupixent for pCSU, Marking First Targeted Option for Ages 2-11
The EC has approved Dupixent for moderate-to-severe chronic spontaneous urticaria (CSU) in children (aged 2-11). The approval is based on the P3 LIBERTY-CSU CUPID and LIBERTY-CSU CUPIDKids studies. Across studies, Dupixent significantly reduced urticaria activity (itch and hives) and increased rates of well-controlled disease and CR at Wk 24 vs placebo. Safety in children was consistent with the known profile, with common AEs including ISRs, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Dupixent inhibits IL-4 and IL-13 signaling and represents the 1st targeted therapy approved in the EU for this pCSU population. A supplemental application for this indication is also under review in the U.S.
Source: Sanofi PR Apr 13, 2026
April 15, 2026
First Needle-Free Epinephrine Spray Approved in Canada
Health Canada has approved Neffy 2mg (epinephrine nasal spray) as the first needle-free emergency treatment for anaphylaxis in adults and children (≥30 kg). Developed by ARS Pharmaceuticals and commercialized by ALK-Abelló, Neffy offers a portable, easy-to-use nasal alternative to injectable epinephrine, with clinical data supporting comparable effectiveness. It is pocket-sized, has a 30-mos shelf life, and can withstand temp. up to 50°C. The 2 mg version is expected to launch in Canada in the coming months, while a regulatory submission for the 1 mg dose (for children 15-30 kg) is planned later in 2026.
Source: GlobalNewswire PR Apr 15, 2026
April 03, 2026
OneCyte and Kemp Proteins Enters in Strategic Partnership
OneCyte and Kemp Proteins have entered a strategic partnership to streamline and enhance cell line development for next-generation biologics. The collaboration integrates OneCyte’s high-throughput single-cell cloning technology with Kemp’s PROTiQ platform, which leverages protein engineering and machine learning to boost expression levels, productivity, and development speed for complex biologics. Through a combined workflow that combines predictive in-silico modeling and rapid experimental screening, the partnership aims to efficiently identify top-performing cell clones. Additionally, it offers biopharma developers access to a royalty-free CHO-K1 GS knockout cell line and a transposase-based expression system, enabling greater flexibility and efficiency in biologics production.
Source: PR Newswire PR Apr 03, 2026
April 12, 2026
Nxera Pharma Earns $22.5M Milestone as NBI-1117570 Advances to Phase 2
Nxera Pharma reported that partner Neurocrine Biosciences has initiated dosing in a P2 study of NBI-1117570 (oral dual M1/M4 muscarinic receptor agonist) discovered using Nxera’s NxWave platform. As part of the agreement, Nxera will receive milestone payments totalling $22.5M from Neurocrine, to be recognized in Q1’26. The double-blind, placebo-controlled study will enrol around 120 adult patients with schizophrenia to assess efficacy, safety, and tolerability. The primary endpoint is the change from baseline in the PANSS total score, while TEAEs serve as the key secondary measure.
Source: Global Newswire PR Apr 12, 2026
Babli Singh is a Senior Analyst with strong analytical skills and a deep understanding of the biopharmaceutical and healthcare industries. She specializes in monitoring emerging trends and distilling complex information into concise, insightful summaries that deliver clear value and actionable intelligence for a global professional audience.
