Shares of Aldeyra Therapeutics Inc. (NASDAQ:ALDX) were trading midday at $14.16, up $3.05, or 27%, on positive top-line results from the phase III trial called Invigorate with reproxalap ophthalmic solution in allergic conjunctivitis (AC). The study hit statistical significance for the primary endpoint – ocular itching – and all secondary endpoints. An earlier study in AC called Alleviate also yielded positive results with the compound, a small-molecule immune-modulating covalent inhibitor of reactive aldehyde species.

Arch’s CD47 antibody bolstered by a $105M series C

Privately held Arch Oncology Inc. has closed on a $105 million in a series C financing designed to propel its anti-CD47 candidate, AO-176, through its current phase I/II study of treating solid tumors and into a combination trial with Keytruda (pembrolizumab). The antibody is a “don’t eat me” signal blocker through its signal regulatory protein-alpha that induces phagocytosis. Preclinical data from a multiple myeloma study showed potent tumor inhibition and complete durable responses as a monotherapy, as well as in combination with several standard therapies, including proteasome inhibitors, immunomodulatory agents and anti-CD38 antibodies. The Brisbane, Calif.-based company’s financing was co-led by Eventide Asset Management, Cowen Healthcare Investments and 3x5 Partners.

EC to take Astrazeneca to court over vaccine supply

Astrazeneca plc’s saga of its COVID-19 vaccine continued this week with the European Commission (EC) deciding to begin legal action against the U.K. company, claiming it has failed to deliver doses in line with its contract. “Our priority is to ensure COVID-19 vaccine deliveries take place to protect the health of [the EU]. This is why [the] EU Commission has decided jointly with all member states to bring legal proceedings against Astrazeneca,” Commissioner Stella Kyriakides tweeted April 26. Astrazeneca said the litigation is without merit, adding that it has “fully complied with the advance purchase agreement with the European Commission and will strongly defend itself in court.”

Enzyvant resubmits BLA for congenital athymia therapy

About a year and a half after Enzyvant Inc.'s tissue-based therapy for children born without a thymus met with a complete response letter over chemistry, manufacturing and controls concerns, its BLA is once again on track for FDA review, the company told BioWorld. Following a resubmission intended to fully address the agency's concerns, the application has a new PDUFA date of Oct. 8.

Newco news: Stuart Therapeutics raise $11M to back topical dry eye disease candidate

Stuart Therapeutics Inc., a company developing peptide therapeutics for ophthalmic disease, has completed an $11 million series A financing led by Infocus Capital Partners, an ophthalmology-focused life sciences venture capital fund, with significant participation by the Wisconsin Alumni Research Foundation (WARF), Mimo Capital and Biobrit. Proceeds from the round will primarily fund phase II trials for the company's investigational fast-acting dry eye disease candidate, ST-100.

Clinical data rising over 2020; nearly 22% targets the pandemic

The volume of phase I-III clinical trial data so far in 2021 is a full 26% more than it was by this point last year, yet the proportion of news focused on the COVID-19 pandemic continues at much the same rate. More than a fifth of all clinical reports are related to the SARS-CoV-2 virus.

Also in the news

Affiris, Aim Immunotech, Aldeyra, Alkermes, Ampio, Anebulo, Aravive, Awakn Life Sciences, Blue Water Acquisition, Brickell, Canbridge, Clarus, Compugen, Cyclo, Daiichi Sankyo, Discgenics, DNA Script, Dynavax, Eledon, Enalare, Enzyvant, Epivax, Evotec, Fosun, Generex, Gilead Sciences, Glauconix, Guardant Health, Hillhurst, Inmed, Instil, Inveniai, Krystal, Logicbio, Lumos, Mablink, Merck, Moderna, Monopteros, Nascent, Neubase, Neurocrine, Noxopharm, Obseva, Ose Immunotherapeutics, Protagenic, Protagonist, Pyxis Oncology, RDIF, Reata, Reithera, Revance, Revive, Rockwell Medical, Sarepta, Sentia Medical Sciences, Shasqi, Shionogi, SIFI, Sol-Gel Technologies, Storm, Valeo, Veloxis, Verona, Zogenix, Zymergen