Merck KGaA, of Darmstadt, Germany, made official its agreement to buy Springworks Therapeutics Inc. for $47 per share in cash, which represents an equity value of about $3.9 billion and an enterprise value of $3.4 billion, based on Stamford, Conn.-based Springworks’ cash as of the end of last year. The price comes out to a premium of 26% over Springworks’ unaffected 20-day volume-weighted average price of $37.38 on Feb. 7, which was the day before the first market speculation regarding the deal began to perk up the stock. Shares (NASDAQ:SWTX) were trading April 28 at $46.12, up $1.40.

CG Oncology’s bladder cancer therapy impresses in phase III

Shares of CG Oncology Inc. were trading up 30% at midday on phase III data presented at the American Urological Association meeting over the weekend showing its cretostimogene grenadenorepvec yielded durable response rates in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ with or without Ta or T1 disease. CG is planning a BLA submission in the second half of 2025, with analysts predicting an “intense battle” for the post-BCG NMIBC market between CG’s oncolytic immunotherapy and Johnson & Johnson’s TAR-200, a novel delivery approach for administering chemotherapy gemcitabine directly into the bladder.

AACR 2025: Revolution has early stage KRAS success in NSCLC

Early phase I data for Revolution Medicines Inc.’s RAS(ON) G12D-selective inhibitor zoldonrasib encouraged both the company and analysts. The inhibitor is a monotherapy for treating KRAS G12D mutant non-small-cell lung cancer. Initial study data produced a 61% objective response rate in 11 solid tumor patients receiving the 1,200-mg dose once a day. The disease control rate for 16 patients came in at 89%. Revolution also is developing daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, and elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor. The results from the open-label, dose expansion and dose escalation study were presented this past weekend at the American Association for Cancer Research’s annual meeting in Chicago.

FDA issues CRL for Telix's glioma imaging agent, wants more data

The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence. “This is a disappointing outcome and not what was expected by the company,” Telix CEO Chris Behrenbruch said during an April 28 conference call with analysts. As previously reported by BioWorld, Melbourne, Australia-headquartered Telix filed an NDA with the FDA for TLX-101-CDx in September 2024 for the characterization of progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. TLX-101-CDx targets LAT1 and LAT2, enabling it to be used as a “companion” theranostic imaging agent for TLX-101, which targets the same amino acid transporter mechanism with therapeutic targeted radiation.

Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP

Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is added to previous approvals in myasthenia gravis and adds momentum to the Ghent, Belgium-based company as it evaluates the potential of Vyvgart in 15 other autoimmune indications, including thyroid eye disease, Sjogren’s disease, lupus nephritis, systemic sclerosis and stiff person syndrome. Vyvgart was one of 16 products recommended for approval by EMA’s Committee for Medicinal Products for Human Use (CHMP) at its April meeting, of which nine are biosimilars. Also meeting with CHMP’s approval was Oczyesa, Camurus AB’s monthly depot formulation of octreotide for treating acromegaly.

China pharma migration: Hengrui greenlighted for Hong Kong IPO

Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange (HKEX), winning clearance April 28 from the China Securities Regulatory Commission (CSRC) to float new H-shares. On the Shanghai Stock Exchange (SSE), Hengrui said in its securities filing that it would issue up to 815 million shares on HKEX, although details on share price or gross proceeds were not disclosed. Funds raised from the IPO will be allocated primarily to its R&D initiatives.

Psychedelics modulate neuroimmune interactions that control fear

Research of the neuroimmune mechanisms involved in stress-related fear revealed how astrocytes interact with neurons in the amygdala. The study, led by Harvard scientists, also unveiled that this interaction recruited monocytes to the meninges during chronic stress and showed how psychedelic compounds reversed monocyte accumulation in the meninges and reduced fear behavior. “There are low-grade inflammatory responses in depression, and these are somewhat recapitulated in stressed animals,” senior author Michael Wheeler, assistant professor of neurology at Brigham and Women’s Hospital, Massachusetts General Hospital, Harvard Medical School, told BioWorld.

100 days of uncertainty

Massive terminations. Axed programs. Canceled grants and contracts. Communication freezes. Threats and more threats of tariffs. Lawsuit upon lawsuit. Policy whiplash. The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe.

Also in the news

Alcyone, Alx Oncology, Araceli, Avidicure, Caribou, Cptx, Cytoagents, Ensysce, Genentech, Geovax, Innate, Inventiva, Neurocrine, Orphan, Oryzon, Realta, Roche, Vyne.