Lilly acquires gene-editing firm Verve for US$ 1.3 bn, BioNTech buys CureVac; Astra signs US$ 5.3 bn AI deal with China’s CSPC

By PharmaCompass

2025-06-19

Impressions: 286

This week’s Phispers comes with news on several M&A deals. Eli Lilly made headlines with its US$ 1.3 billion acquisition of gene-editing partner Verve Therapeutics while the mRNA space saw consolidation as BioNTech moved to acquire fellow German rival CureVac for US$ 1.25 billion. Supernus Pharmaceuticals leapt into the depression market by snapping up Sage Therapeutics for up to US$ 795 million, gaining access to Zurzuvae, the only approved pill for postpartum depression.

In other deals, AstraZeneca inked a US$ 5.3 billion artificial intelligence (AI) research pact with China’s CSPC to co‑discover chronic‑disease drug candidates.

On the regulatory front, the US Food and Drug Administration (FDA) introduced an ambitious new voucher program designed to slash drug approval timelines from over a year to just one to two months for priority treatments. However, the agency has missed its target date for KalVista’s hereditary angioedema drug, citing resource constraints.

In drug approvals, CSL’s Andembry secured FDA clearance as a monthly treatment for hereditary angioedema, positioning it against Takeda’s established blockbuster. UroGen’s Zusduri broke new ground as the first non-surgical therapy for certain bladder cancer patients. Gilead’s lenacapavir was approved for preventing HIV infections in adults and adolescents. And, Moderna expanded its RSV vaccine reach to at-risk adults under 60.

However, the week also saw safety concerns being raised following a second death from liver failure of a patient who was on Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy. The company has suspended shipments of this therapy.

Lilly buys out gene-editing partner Verve Therapeutics for US$ 1.3 bn

Eli Lilly has announced its plan to acquire Verve Therapeutics, a Boston-based gene-editing company specializing in cardiovascular treatments, for up to US$ 1.3 billion. The deal includes an upfront payment of US$ 1 billion. Lilly and Verve have been teaming up since 2023. Verve is developing innovative gene-editing therapies aimed at providing one-time treatments for cardiovascular diseases.

BioNTech to buy CureVac for US$ 1.25 bn: BioNTech has agreed to acquire fellow German mRNA vaccine developer CureVac in an all‑stock transaction valued at approximately US$ 1.25  billion. With this acquisition, BioNTech aims to strengthen the research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy.

Supernus acquires Sage: Supernus Pharmaceuticals has announced the acquisition of Sage Therapeutics in a deal valued at up to US$ 795 million. Through this acquisition, Supernus gets access to Zurzuvae (zuranolone), the only US-approved postpartum depression pill, co-developed with Biogen.

Astra inks US$ 5.3 bn AI research deal with China’s CSPC Group for chronic diseases

AstraZeneca has entered into a significant research collaboration with China’s CSPC Pharmaceutical Group, valued at up to US$ 5.3 billion, to develop therapies for chronic diseases using artificial intelligence. This partnership aims to discover and develop pre-clinical drug candidates, including a small molecule oral therapy for immunological diseases. CSPC will conduct AI-driven research at its facility in Shijiazhuang City. This deal is part of AstraZeneca’s broader strategy to strengthen its presence in China, its second-largest market.

FDA announces voucher program for drugmakers to shorten approval timelines

FDA has launched the Commissioner’s National Priority Voucher (CNPV) program, designed to compress drug approval timelines from the current 10 to 12 months to just one to two months.

Under the one‑year pilot initiative, the FDA commissioner may award a limited number of non‑transferable vouchers, valid for two years, to companies developing drugs that align with US national priorities — such as those addressing health crises, meeting unmet medical needs, fostering innovative cures, or enhancing domestic drug manufacturing and national security.

Misses target date of KalVista’s drug: FDA has extended its review of KalVista Pharmaceuticals’ investigational drug, sebetralstat, intended for the treatment of hereditary angioedema (HAE), a disorder characterized by recurrent episodes of severe swelling. Originally scheduled for a decision by June 17, 2025, the FDA now anticipates reaching a conclusion within four weeks, citing heavy workload and limited resources as reasons for the delay. Meanwhile, FDA’s leader Marty Makary has said the agency is on track to meet all PDUFA targets.

FDA approves CSL’s Andembry for HAE, to take on Takeda’s blockbuster Takhzyro

CSL has secured FDA approval for Andembry (garadacimab‑gxii), a groundbreaking monoclonal antibody for the prevention of HAE in patients aged 12 and older. It marks the first-ever therapy to target activated factor XIIa, a promising area of research for developing angioedema therapies.

In a late-stage trial, 62 percent of participants remained completely attack‑free during six months of treatment. Administered via a once‑monthly subcutaneous autoinjector, Andembry offers a more convenient alternative to Takeda’s biweekly injectable Takhzyro (lanadelumab, US$ 1.2 billion in sales in 2024) and BioCryst’s daily oral Orladeyo (berotralstat).

UroGen’s bladder cancer therapy bags FDA nod, despite failing advisory panel vote

FDA has granted approval to UroGen Pharma’s Zusduri (mitomycin intravesical gel), marking the first-ever non-surgical therapy for adults with recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer (LG‑IR‑NMIBC). Administered via six weekly intravesical instillations, the gel formulation (RTGel) enhances dwell time in the bladder.

Notably, the FDA’s Oncologic Drugs Advisory Committee narrowly opposed the approval in May (5‑4 vote), citing concerns over the absence of a randomized control arm. Despite this, regulators determined that the non‑invasive benefits of Zusduri outweighed potential uncertainties.

Moderna’s RSV vaccine greenlit for at-risk adults: FDA has approved Moderna’s mRNA‑based RSV vaccine, mRESVIA, for adults aged 18 to 59 years who are at increased risk of severe respiratory syncytial virus (RSV) disease—a marked expansion from the prior over 60 age group approval. RSV can cause serious lower respiratory tract illness and contributes to approximately 15,000 to 20,000 hospitalizations annually among adults aged 50 to 59 years.

Gilead’s lenacapavir approved for preventing HIV: FDA has approved Gilead Sciences ’ lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents. The drug will be sold under the brand name Yeztugo. Lenacapavir proved nearly 100 percent effective at preventing HIV in large trials last year.

Second teenage boy dies due to liver failure after receiving Sarepta’s DMD therapy

Sarepta Therapeutics has reported a second patient death linked to its gene therapy, Elevidys (delandistrogene moxeparvovec), used for treating DMD. Both fatalities involved non-ambulatory teenage boys who developed acute liver failure following treatment.

In response, Sarepta has suspended shipments of Elevidys for non-ambulatory patients and paused dosing in a late-stage trial in patients who are unable to walk.

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