Offering $2.2 billion for Rapt Therapeutics Inc. and gaining its long-acting lead drug, ozureprubart, for food allergy and other indications, GSK plc is positioning itself to compete with market leader Xolair (omalizumab), developed by Roche AG’s Genentech unit and Novartis AG. “Food allergy prevention continues to be an attractive market for large pharma … ,” noted H.C. Wainwright analyst Emily Bodnar. Rapt’s president and CEO recently estimated the food allergy market is worth more than $40 billion. GSK intends to pay Rapt’s shareholders $58 per share at closing, expected in the first quarter of 2026, for an equity value of $2.2 billion, or $1.9 billion net of cash acquired. Rapt’s stock (NASDAQ:RAPT) climbed 64% to $57.52 in early trading Jan. 20.

Corvus skyrockets on new phase I data with soquelitinib in AD

Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) were trading at $15.40, up $7.35, or 91%, on positive results from cohort 4 of the randomized, blinded, placebo-controlled phase I trial testing soquelitinib in patients with moderate to severe atopic dermatitis (AD). The cohort 4 data showed favorable safety and efficacy results consistent with results from cohorts 1-3, with a deepening of responses in the latest cohort over the eight-week treatment period compared to four weeks. Clinical activity turned up in AD patients already given systemic therapies, including those resistant to drugs such as the IL-4 receptor alpha antagonist Dupixent (dupilumab), from Sanofi SA and Regeneron Pharmaceuticals Inc., as well as JAK inhibitors. Soquelitinib is an IL-2-inducible T-cell kinase inhibitor.

Astrazeneca expands China cell therapy footprint with Abelzeta CAR T

Astrazeneca plc is paying up to $630 million to acquire China rights to Abelzeta's Pharma Inc.’s C-CAR031, an autologous glypican 3 (GPC3)-targeting CAR T, securing global rights to develop, manufacture and commercialize the CAR T for liver cancer. Abelzeta will be eligible to receive up to $630 million, including an up-front payment, and development, regulatory and sales milestone payments for the GPC3 program in China. C-CAR031 is based on a novel GPC3-targeting CAR T (AZD-5851) designed by Astrazeneca using its transforming growth factor-beta receptor II dominant negative armoring platform and is manufactured by Abelzeta in China. Astrazeneca manufactures the CAR T outside of China.

China accepts Telix/Grand Pharma NDA for TLX-591-CDx

China’s National Medical Products Administration (NMPA) has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer. For Grand Pharma, the NDA acceptance marks a major step in executing its integrated “diagnosis-plus-therapy” nuclear medicine strategy. Alongside the diagnostic filing, therapeutic counterpart TLX-591 has been cleared to enter a China-based international multicenter phase III trial, positioning the pair as a potential theranostic platform for prostate cancer.

Exciva adds $59.9M series B for Alzheimer’s disease agitation trial

Neuropsychiatry specialist, Exciva GmbH raised €51 million (US$59.9 million) in a series B round to fund a phase II/III trial of Deraphan, a combination therapy for treating agitation in patients with Alzheimer’s disease. The 300-patient study is ready to begin recruitment at centers in North America and Europe, with the readout expected in 2028. One component of Deraphan is dextromethorphan, a NDMA receptor antagonist available over the counter for the treatment of dry coughs. The second component is EXV-801, a dual antagonist of the 5-HT2A and 5-HT2C serotonin receptors, plus an inhibitor of the liver enzyme CYP2D6, which slows down the metabolism of dextromethorphan, increasing the plasma concentration.

The nose could be the key to common-cold immunity

The range of effects caused by rhinoviruses – the pathogens responsible for the common cold – motivated scientists at Yale University to study the human nasal epithelium and uncover a previously undescribed defense mechanism. The interferon-mediated protective response in these cells can limit infection, whereas a maladaptive response tends to worsen it. Based on these findings, the researchers have identified potential therapeutic targets to reduce inflammation associated with rhinovirus infection.

FY 2025 a banner year for US False Claims Act recoveries

The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from healthcare cases. Perhaps of equal significance, however, is the fact that FCA cases for cybersecurity considerations will continue to trend upward, a particularly salient source of risk for med tech firms.

Skinny labeling to get its day before the US Supreme Court

The U.S. Supreme Court agreed Friday to delve into the dark hole the Federal Circuit has dug for drug label carveouts, or so-called “skinny labels,” that allow generic drugs to come to market even though certain indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl). During oral argument before the Federal Circuit, Hikma’s attorney asserted that the dispute was a “test case” the entire industry was watching.

Misleading statements result in civil penalties for Spero execs

Two former Spero Therapeutics Inc. executives are on the hook for a total of $187,500 in civil penalties in a settlement resolving U.S. SEC allegations of issuing misleading statements centered on the FDA’s evaluation of Spero’s lead drug candidate that resulted in a 64% stock drop in May 2022. As part of the agreement, former CEO Ankit Mahadevia will pay $112,500, and former CFO Satyavrat Shukla is to pay $75,000, according to an SEC cease-and-desist order issued Friday. Mahadevia continues to serve on the company’s board, whereas Shukla stepped down from the board this past May.

Holiday notice

BioWorld’s offices were closed in observance of Martin Luther King Jr. Day in the U.S. No issue was published Monday, Jan. 19.

Also in the news

Arch, Cardiol, Immunitybio, J&J, Metavia, Orsobio, Orthocell, Sobi, Tiziana