Shares of Minneapolis-based Celcuity Inc. (NASDAQ:CELC) were trading at $37.52, up $23.75, or 172%, on strongly positive top-line results from the PIK3CA wild-type cohort of the phase III Viktoria-1 trial evaluating gedatolisib plus the estrogen receptor antagonist Faslodex (fulvestrant, Astrazeneca plc) with and without the CDK4/6 inhibitor Ibrance (palbociclib, Pfizer Inc.) vs. Faslodex in adults with hormone receptor-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer. Enrolled were patients who showed disease progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Gedatolisib is a multitarget PAM inhibitor that takes aim at all four class I PI3K isoforms, mTORC1, and mTORC2 for a broad blockade of the PAM pathway.

GSK, Hengrui in $12.5B deal for HRS-9821 and 11 other drugs

Hengrui Pharmaceuticals Co. Ltd. is out-licensing to GSK plc its potential best-in-class phase I phosphodiesterase 3 and 4 inhibitor (HRS-9821) for treating chronic obstructive pulmonary disease (COPD), along with 11 additional programs in development, for $500 million up front and up to $12 billion in potential milestones. Under terms of the deal, the up-front amount covers 12 assets, including HRS-9821. In exchange, GSK gains an exclusive worldwide license (excluding mainland China, Hong Kong, Macau and Taiwan) for HRS-9821, which is in phase I trials for treating COPD as an add-on maintenance treatment. The agreement also includes a collaboration to generate up to 11 programs in addition to HRS-9821, each with its own financial structure.

EU president: 15% tariffs 'a clear ceiling' for pharma exports to US

Pharmaceutical exports from the EU to the U.S. are facing a leap in tariffs from zero duty to 15%, following the trade deal between EU Commission President Ursula von der Leyen and U.S. President Donald Trump sealed in Scotland July 27. With the threat that a 30% tax on most imports from the EU to the U.S., including on pharmaceuticals, would come into force on August 1, the agreement was sold as positive by von der Leyen. However, uncertainty continues to hover over pharmaceuticals, as the sector awaits the outcome of the Section 232 investigation into the national security implications of importing prescription drugs. That is expected to lead to the imposition of tariffs higher than 15%. Von der Leyen was adamant that the 15% tariff on EU pharmaceuticals is fixed, regardless of the findings of the Section 232 investigation. “This 15% is a clear ceiling,” she said.

Recognify’s phase IIb in cognitive impairment fails; backer Atai steps away

After Recognify Life Sciences Inc.’s phase IIb failure in treating the cognitive impairment in those with schizophrenia, the indication is no closer to a U.S. FDA approved therapy. The placebo-controlled study of inidascamine missed its primary endpoint to improve cognition, though the company said the data revealed what it called modest but consistent numerical improvement in some cognitive subdomains. Atai Life Sciences, an investor in privately held Recognify, saw its stock drop 9% at midday to $3.25 per share. Atai said the results have prompted a reallocation of its resources to bolster its pipeline of psychedelic candidates for treating affective disorders.

Republican senators flag NIH funding delays

While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Eight senators recently wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds. “Suspension of these appropriated funds – whether formally withheld or functionally delayed – could threaten Americans’ ability to access better treatments and limit our nation’s leadership in biomedical science,” according to the senators’ letter. “It also risks severing ongoing NIH-funded research prior to actionable results.”

Bavarian Nordic's top shareholder a holdout on private equity buy

Danish vaccines manufacturer Bavarian Nordic A/S is to be taken private in a DKK233 per-share deal valuing the company at DKK19 billion (US$2.97 billion). The board of the Copenhagen-based company is recommending acceptance of the offer, which is a 21% premium to the closing price on July 23. The bid is from a new company, Innosera ApS, which has been formed by Nordic Capital Fund XI and funds managed and advised by Permira, as the vehicle for the acquisition. The deal needs the support of 90% of Bavarian Nordic shareholders to go through, and as things stand may not reach that target because it does not have the support of the largest shareholder, the Danish pension fund ATP, which owns 10.17%.

China financings pick up: Everest's $200M placement, Leads' $189M IPO

Chinese financings are picking up, with Everest Medicines Ltd. raising US$200 million and Nanjing-based Leads Bioloabs Co. Ltd. listing on the main board of the Hong Kong Stock Exchange (HKEX) in a $189 million IPO. As previously reported by BioWorld, 36 biopharma and med-tech companies sought a capital raise on HKEX in the first half of 2025. Of those, 34 companies were from mainland China.

Endogenous allies: autoantibodies join the frontline against cancer

Researchers at the Fred Hutchinson Cancer Research Center found that autoantibodies targeting the exoproteome reshaped checkpoint inhibitor responses and opened new avenues to enhance immunotherapy. In the study published in the July 23, 2025, issue of Nature, the authors set out to address a long-standing question in cancer immunotherapy: why patients with the same type of cancer, treated with the same immunotherapy, can experience such drastically different outcomes. “We wondered if self- and tumor-reactive autoantibodies in patients might explain some of these differences,” senior author Aaron Ring told BioWorld.

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Abivax, Absci, Adocia, Algernon, Astrazeneca, Biogen, Biontech, Biovie, BMS, Eli Lilly, Everest, Gilead, GSK, Hemostemix, Incannex, Indivior, Ipsen, Jeune, Kintor, Klotho, Krystal, Liminatus, Memo, Moderna, Novo Nordisk, Omeros, Pfizer, Pharvaris, Revolution, Roche, Sanofi, Servier, Sobi, Targepeutics, Tonghua Dongbao