Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash deal worth $4.1 billion. The acquisition gives Angelini ownership of three marketed drugs for treating epilepsy and neuromuscular diseases that had combined sales of $589 million in 2025, a 19.8% increase over 2024. Angelini is paying $31.50 per share, a 21% premium to Catalyst’s (NASDAQ:CPRX) share price on April 22, 2026, before news broke of a possible transaction. It is a 28% premium to the average price over the 30 days before that, but a much smaller mark-up on the closing price of $30.52 on May 6, the day before the deal was announced.

Roche to acquire Pathai for up to $1.05B

Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.

Entrada sinks on mixed DMD data with ENTR-601-44

A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 52%, despite the cohort meeting the safety and tolerability primary objective. Entrada had previously expected a “double-digit increase,” according to analysts, but dystrophin rose by only 2.36% over the 4% baseline mark, well below the 25% increase seen with competitor Avidity Biosciences Inc.’s del-zota in its phase I/II trial last September. Nevertheless, a statistically significant functional benefit was seen in most participants, a mean change in time-to-rise velocity vs. placebo of 0.115 – which is 3.5 times higher than the minimal clinically important difference threshold. Shares (NASDAQ:TRDA) were trading at about $7.69, down $8.34, on May 7.

Engene plummets on more phase II data with detalimogene in NMIBC

Shares of Engene Therapeutics Inc. (NASDAQ:ENGN) were trading at $1.82, down 79%, or $7.04, after the company disclosed further interim results from the 125-patient, pivotal cohort of its ongoing, phase II Legend trial of detalimogene voraplasmid, a nonviral, gene-based immunotherapy, in high-risk, Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer patients (NMIBC). The drug is being tested in subjects with carcinoma in situ with or without concomitant papillary disease. As of April 21, patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. Engene said the progression rate to muscle-invasive or advanced disease was low, at 3.2%, and the compound proved generally well tolerated, with 55% of patients developing a treatment-related adverse event, mostly mild (grade 1 and 2).

Hantavirus is ‘sentinel’ more than acute pandemic threat, for now

News to date of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Honduz, the ship currently heading to the Canary Islands with its remaining passengers plus assorted medical, WHO and European Center for Disease Prevention and Control staff, is 2026s’ Diamond Princess. Human to human transmission of the Andes hantavirus strain that has afflicted the Honduz is rare. At a press conference of the Infectious Disease Society of America, CEO Jeanne Marrazzo said that the outbreak is “emblematic of how the U.S. has kneecapped itself by leaving the WHO and slashing funding for the Centers for Disease Control and Prevention and global health funding.

FDA slowdown on Tzield sBLA underlines CNPV questions

Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency. Sanofi isn’t commenting on its “confidential ongoing discussions with the FDA” on the sBLA, a company spokesperson told BioWorld, adding that the application is “currently pending a decision.” If approved, the sBLA would expand Tzield’s label for use in patients with recently diagnosed stage 3 type 1 diabetes. In October, the FDA selected the Tzield sBLA as one of the first nine drugs chosen for the new CNPV program, which is intended to shorten the agency review time to one or two months, as compared with six months for a priority review and 10 months for standard review.

First measles treatment advances as vaccination rates drop

Scientists at the La Jolla Institute for Immunology have identified and characterized human antibodies that neutralize the measles virus by blocking its entry into the cell. This is the first time that antibodies have been shown to bind effectively to two essential viral proteins, creating a dual blockade that prevents infection. Unlike the current vaccine, which is based on an attenuated virus and is not recommended for immunocompromised individuals, these monoclonal antibodies could be used both as a new vaccine approach and as a treatment for the entire population.

Moderna, Vir among early 2026 top infectious disease gainers

Stocks tracked on the BioWorld Infectious Disease Index posted widely divergent performances in early 2026, with AN2 Therapeutics Inc., Vaxart Inc., Vir Biotechnology Inc., Armata Pharmaceuticals Inc. and Moderna Inc. among the sector’s top gainers over the first four months of the year. Shares of Vir (NASDAQ:VIR) closed up nearly 28% after signing a global co-development deal with Astellas Pharma Inc.

US FDA tries out 1-day inspections

Even before the U.S. FDA announced its one-day inspection pilot yesterday, it already had test-flown 46 of the shorter inspections across several of its centers. Part of a broader agency initiative to make its inspectional resources more targeted and efficient, the one-day assessments are expected to strengthen the FDA’s inspections program by focusing time and resources where they are most needed, FDA Commissioner Marty Makary said. The one-day assessments are intended to complement, not replace, the agency’s standard inspections.

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