After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered. Kalvista’s stock (NASDAQ:KALV) had surged 22% at midday to $22.64 each.
NDA filing in sight as Cogent reports phase II SM bezuclastinib data
Shares of Cogent Biosciences Inc. (NASDAQ:COGT) were trading at $9.64, up $2.06, or 27%, on word of positive top-line results from the registration-directed second part of the Summit phase II trial testing bezuclastinib in non-advanced systemic mastocytosis (SM). The results show clinically meaningful and highly statistically significant improvements in SM across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Waltham, Mass.-based Cogent is on track to submit its first NDA to the U.S. FDA by the end of this year. The drug is a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V.
Massive budget reconciliation bill restores deductibility of R&D expenses
President Donald Trump has signed House Resolution 1 (H.R. 1), the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year.
China approves Simcere’s suvemcitug for ovarian cancer
China’s National Medical Products Administration (NMPA) gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance. A category 1 biological new drug, Enzeshu is the first anti-angiogenic therapy approved in China for treatment of platinum-resistant ovarian cancer. Simcere Zaiming Vice President Jonathan Sun told BioWorld that almost all ovarian cancer patients receiving chemotherapy will eventually develop platinum resistance, and patients are “in urgent need of new and better choices.”
Briquilimab drug-lot issue slams Jasper
Jasper Therapeutics Inc.’s stock (NASDAQ:JSPR) took a blow after offering a clinical update with briquilimab. Shares tumbled to $3.10, down $3.67, or 54%, after the Redwood City, Calif.-based firm provided Beacon phase Ib/II results with subcutaneous briquilimab, an antibody therapy targeting KIT (CD117), in adults with chronic spontaneous urticaria. Data from dose cohorts of 240 mg every eight weeks and 240 mg followed by 180 mg every eight weeks “appear to be confounded” by an issue with one drug-product lot. Ten of the 13 patients have been dosed with drug from the lot in question. Jasper officials are investigating. Meanwhile, the company has shipped new, therapeutically active drug product to trial sites to maintain uninterrupted dosing and expects to enroll more patients, with updated Beacon findings due in the fourth quarter of this year.
Apogee’s Apex phase II reads out for APG-777 in atopic dermatitis
Part A of Apogee Therapeutics Inc.’s Apex phase II study of its anti-IL-13 antibody, APG-777, in patients with moderate to severe atopic dermatitis showed the drug improved symptoms with a 71% decrease in Eczema Area Severity Index score for those taking the drug for 16 weeks compared to a 33.8% decrease for those taking placebo. Apogee plans to continue to follow the patients over 52 weeks with data testing three- and six-month maintenance dosing expected in the first half of 2026. The company has already started enrolling part B of the Apex study that compares three different doses of APG-777 to placebo in about 280 patients with an initial readout expected in the middle of 2026.
Biopharma financings total $28.7B in H1, down 59% from 2024
Biopharma companies raised $7.38 billion across 99 transactions in June 2025, up from $5.55 billion in May and $2.4 billion in April. For the first half of the year (H1), total financings reached $28.74 billion, down 59% from the $70.32 billion raised during the same period in 2024. Although lower than the record-setting levels of 2020 and 2021, the current total aligns more closely with recent years, including $26.57 billion in the first half of 2022 and $30.57 billion in 2023.
EU unveils new ‘Choose Europe for life sciences’ strategy
The EU is to harness the “silver economy” of its aging population to help drive innovation and growth as part of a new strategy to make Europe “the most attractive place in the world for life sciences by 2030.” The strategy aims to take on what is described as an “alarming failure” to translate biomedical research into new products and services. The “Choose Europe for life sciences” strategy includes policy initiatives for the entire life sciences sector, but it points to clinical research and medical devices as key areas where Europe is losing competitiveness against the U.S. and China.
Wuhan Healthgen gets chance at China IPO with SSE market reforms
Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared toward supporting “unprofitable” biotechnology firms. Wuhan, China-based Healthgen’s founder Daichang Yang, a former senior scientist and lab director of Junction City, Kan.-based Ventria Bioscience Inc., was found by the U.S. International Trade Commission to have stolen trade secrets from Ventria in 2022, a ruling that was affirmed in 2025. Healthgen’s core product, HY-1001, is an injectable, plant-derived recombinant human serum albumin protein therapy that has completed a phase III clinical study in China.
Holiday notice
BioWorld's offices were closed in observance of Independence Day in the U.S. No issue was published Friday, July 4.