Aldeyra Therapeutics Inc. disclosed hitting the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% reproxalap ophthalmic solution for dry eye disease (DED). For the prespecified primary endpoint of ocular discomfort, a symptom of DED, reproxalap was statistically significantly superior to vehicle on the ocular discomfort symptom score (0‑100) from 80 to 100 minutes after chamber entry. Aldeyra plans to resubmit in the middle of this year the NDA for the drug, which garnered a complete response letter from the U.S. FDA in April. Less happy news came in the form of Aldeyra’s disclosure that a recently finished DED field trial fell short of statistical significance. Shares of Aldeyra (NASDAQ:ALDX) were trading midday at $2.12, down 58 cents, or 21%.

Actuate posts improved phase II data in pancreatic cancer

Actuate Therapeutics Inc. said elraglusib in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to convince investors. The company’s stock (NASDAQ:ACTU) had rallied at midday from earlier morning losses but still sagged 6.5% lower to $9.24 per share. Top-line phase II data show elraglusib combined with gemcitabine/nab-paclitaxel hit the primary endpoints and reached statistical significance in treating metastatic pancreatic ductal adenocarcinoma. More detailed top-line data on the glycogen synthase kinase-3 beta inhibitor’s performance in the study will be released at the upcoming American Society of Clinical Oncology’s annual meeting later in May.

Nuevocor draws $45M series B for gene therapy in rare heart disease

Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy. NVC-001 is designed to address mutations in the lamin gene which expresses lamin A and lamin C, two proteins that form structural elements of the lining of the inner surface of the nuclear envelope.

Innovent’s IBI-302 meets phase II endpoints in neovascular AMD

Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in phase II, showing a gain of 10 or more letters in visual acuity from baseline at one year in Chinese patients with neovascular age-related macular degeneration (nAMD). Innovent said both doses of the treatment drug were noninferior to the comparator drug, aflibercept, for change in best corrected visual acuity (BCVA) at week 40. Now in pivotal phase III trials, IBI-302 is a recombinant human VEGFR-antibody human complement receptor 1 fusion protein.

US states seek to undo HHS reorg, terminations

Claiming that they’re suffering the consequences of a March 27 directive ordering a mass reduction in force and reorganization throughout the U.S. Department of Health and Human Services (HHS), 19 states and the District of Columbia took their grievances to court May 5. Their 101-page complaint, filed in the U.S. District Court for the District of Rhode Island, seeks a declaration that HHS Secretary Robert Kennedy’s directive is unlawful, along with an injunction on implementing the directive and the states’ costs.

US drug tariff threat persists as EO offers onshoring relief

In an ongoing effort to onshore more of the biopharma supply chain, President Donald Trump signed an executive order (EO) late yesterday to shorten the time involved in bringing a new manufacturing plant or expansion online and to remove some of the incentives for foreign production. After signing the order, he said he’d “have a big announcement next week on some of this kind of thing, but more related to costs – the costs of medicines and drugs because we’re being ripped off . . . very badly.” When asked whether he’d made a decision about biopharma tariff rates and timing, Trump responded, “I have.” That announcement will be coming in the next two weeks, he said. In addition to the drug manufacturing order, Trump signed an EO ending current and “all future federal funding of dangerous gain-of-function research in countries of concern like China and Iran and in foreign nations deemed to have insufficient research oversight.”

Also in the news

Adial, Alterity, Alvotech, Aptose, Biontech, Biovie, Can-Fite, Capricor, Chemomab, Eupraxia, Ichnos, Immunitybio, Immutep, Innospera, Inventiva, Janus, Johnson & Johnson, Mammoth, Mendus, Nanobiotix, Novavax, Novo Nordisk, Opus, PTC, Rakovina, Recursion, Regeneration, Rezolute, Rose Hill, Spyre, Teva, Tharimmune, Theralase, Unity, Vanda, Vaxart