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By PharmaCompass
2026-04-30
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In Phispers this week, Indian drugmaker Sun Pharmaceutical acquired Jersey-based Organon in an all-cash deal valued at about US$ 11.75 billion. Eli Lilly continued to be on an acquisition spree, buying out Ajax Therapeutics for up to US$ 2.3 billion in cash. Lilly also signed a DNA-editing deal worth up to US$ 2.25 billion with AI-driven firm Profluent Bio.
In approvals, the US Food and Drug Administration (FDA) has granted accelerated approval to Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec-cwha), under the FDA Commissioner’s National Priority Voucher (CNPV) program. FDA also granted vouchers to three companies developing psilocybin-based medicines to treat mental illnesses under the CNPV program.
In clinical trials, Novo Nordisk’s oral GLP-1 drug — Rybelsus (semaglutide) — significantly lowered blood sugar levels in children and adolescents (in the age group of 10 to 17 years) with type 2 diabetes. Incyte’s povorcitinib proved to be effective in two phase 3 clinical trials for a skin condition known as non-segmental vitiligo. Intellia Therapeutics’ experimental gene-editing therapy — lonvoguran ziclumeran (lonvo-z) — reduced the frequency of swelling attacks in patients with a rare genetic disorder known as hereditary angioedema (HAE) in a late-stage trial.
And FDA’s Center for Drug Evaluation and Research (CDER) has proposed withdrawing approval of Amgen’s Tavneos (avacopan), a drug used for treating rare autoimmune diseases.
India’s Sun Pharma acquires Organon for about US$ 11.8 billion in all cash deal
Sun Pharmaceutical Industries made the largest overseas acquisition by an Indian drugmaker this week, as it acquired New Jersey-based Organon in an all-cash deal valued at about US$ 11.75 billion including debt. Upon completion, Sun Pharma will emerge as one of the top three players in global women’s health products.
Sun Pharma’s US sales have been declining due to shifting tariff policies. The acquisition also keeps open Sun’s options of expanding manufacturing in the US. Organon has more than 70 products across women’s health and general medicines, including biosimilars, sold across 140 countries. The company’s 2025 revenue was US$ 6.2 billion. Organon was formed through a spin-off from Merck in 2021.
Chiesi Group to buy KalVista: Italy’s Chiesi Group is acquiring US-listed KalVista Pharmaceuticals in an all-cash deal valued at about US$ 1.9 billion. Chiesi said the acquisition will strengthen its rare diseases strategy and expand its US commercial footprint.
Lilly to buy Ajax Therapeutics for up to US$ 2.3 bn to enhance oncology pipeline
After buying Kelonia Therapeutics last week, Eli Lilly announced the acquisition of Ajax Therapeutics for up to US$ 2.3 billion in cash in order to expand its oncology pipeline. Ajax’s lead asset, AJ1-11095, is an investigational, once-daily oral drug currently in early-stage clinical trial, designed to treat myeloproliferative neoplasms (MPNs), rare blood cancers that occur when the bone marrow creates too many blood cells. This is the sixth major acquisition announced by Eli Lilly this year.
Signs deal with AI-driven Profluent: Eli Lilly has signed a DNA editing deal worth up to US$ 2.25 billion with AI-driven firm Profluent Bio. The collaboration focuses on enabling large-scale, precise DNA editing capabilities that remain out of reach using conventional gene editing systems.
Novo’s diabetes pill cuts blood sugar in children in key late-stage trial
In a key late-stage trial, Novo Nordisk’s oral GLP-1 drug — Rybelsus (semaglutide) — significantly lowered blood sugar levels in children and adolescents (in the age group of 10 to 17 years) with type 2 diabetes. This is the first trial to test an oral GLP‑1 therapy (which is behind blockbuster diabetes and weight loss medications) in children and adolescents. As of today, the treatment options for young patients are limited to drugs like metformin or insulin.
Incyte claims double phase 3 win in vitiligo: Incyte’s povorcitinib has shown to be effective in two phase 3 clinical trials for a skin condition known as non-segmental vitiligo.
However, analysts have said povorcitinib didn’t quite live up to AbbVie’s Rinvoq (upadacitinib).
FDA okays Regeneron’s therapy for genetic hearing loss under voucher program
FDA has granted accelerated approval to Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec-cwha), making it the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher (CNPV) program. Otarmeni has been approved for the treatment of a rare genetic form of hearing loss caused by a faulty gene. Regeneron
plans to give its revolutionary therapy away for free in the US.
Awards vouchers to three psilocybin meds: Following US President Donald Trump’s April 18 executive order to accelerate access to psychedelic drugs for treating serious mental illnesses, the FDA has granted priority vouchers to three undisclosed companies developing psilocybin for the treatment of three mental illnesses.
The agency’s descriptions of the awarded products match announcements by three companies. Compass Pathways said FDA has selected COMP360, its proprietary formulation of synthetic psilocybin, for the CNPV program to treat a type of depression known as treatment-resistant depression.
Similarly, clinical-stage biotech Transcend Therapeutics said FDA has granted breakthrough therapy designation to its investigational therapy TSND-201 (methylone) for the treatment of post-traumatic stress disorder. And Usona Institute also said it has received FDA’s breakthrough therapy designation for psilocybin in the treatment of major depressive disorder.
FDA proposes withdrawal of Amgen’s Tavneos due to manipulation of data
FDA’s Center for Drug Evaluation and Research (CDER) has proposed withdrawing the approval of Amgen’s Tavneos (avacopan), a drug used for treating rare autoimmune diseases. According to CDER, new information indicates that Tavneos has not shown to be effective for its approved use, and the application that resulted in FDA approval contained untrue statements.
In March, the agency had identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos. Eight deaths were reported among those cases. Tavneos was approved in October 2021.
Intellia’s experimental rare disease gene therapy scores in late-stage trial
Intellia Therapeutics’ experimental gene-editing therapy — lonvoguran ziclumeran (lonvo-z) — reduced the frequency of swelling attacks in patients with a rare genetic disorder known as hereditary angioedema (HAE) in a late-stage trial.
Cohance appoints new group CEO: Advent International-backed contract development and manufacturing company Cohance Lifesciences Limited has appointed Umang Vohra as executive chairman, effective May 1, 2026, and group CEO, effective May 20, 2026. Vohra succeeds Vivek Sharma, who is stepping down as executive chairman. Vohra is the former CEO of Cipla.
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