In April, the FDA hit BioCryst with a par­tial hold, lead­ing the biotech to pause en­roll­ment on three of its rare dis­ease clin­i­cal tri­als and send­ing its shares down 30%.

Last week, BioCryst said the par­tial clin­i­cal hold had been re­solved and that it would re­sume en­rolling its clin­i­cal tri­als for its drug, dubbed BCX9930, but with new pro­to­cols at a low­er 400 mg dose.

BioCryst’s drug is a fac­tor D in­hibitor, which was be­ing test­ed in an ar­ray of im­mune dis­eases. The biotech is run­ning two piv­otal tri­als for parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, as well as a third tri­al look­ing at a set of three dis­eases — C3 glomeru­lopa­thy, IgA nephropa­thy and pri­ma­ry mem­bra­nous nephropa­thy.

The Durham, NC-based biotech ini­tial­ly paused en­roll­ment af­ter find­ing in­creased cre­a­tine lev­els in pa­tients that had re­ceived the 500 mg dose of its drug. El­e­vat­ed cre­a­tine lev­els are a sign of po­ten­tial kid­ney dam­age.

Ea­gle in­vests $25 mil­lion in Enalare Ther­a­peu­tics for res­pi­ra­to­ry drug

Months af­ter it dropped $100 mil­lion to buy up Aca­cia and its two drugs, Ea­gle Phar­ma­ceu­ti­cals is back at it with a small­er $25 mil­lion in­vest­ment in Enalare Ther­a­peu­tics.

The spe­cial­ty phar­ma play­er will pay $12.5 mil­lion up­front, fol­lowed by an ad­di­tion­al $12.5 mil­lion in six months. Ea­gle is eye­ing Enalare’s lead can­di­date, ENA-001, a big potas­si­um (BK) chan­nel in­hibitor that is meant to stim­u­late breath­ing. The first in­di­ca­tion in which the biotech is test­ing the drug is post-op­er­a­tive res­pi­ra­to­ry de­pres­sion. Ac­cord­ing to the press re­lease, the drug should en­ter a Phase II tri­al ear­ly next year.

If the drug en­ters said Phase II tri­al and reach­es 50% en­roll­ment in that tri­al, Ea­gle has the op­tion to make two ad­di­tion­al in­vest­ments of $15 mil­lion each, and it al­so has the op­tion to ac­quire the biotech en­tire­ly.

Health­Care Roy­al­ty Part­ners deals $65 mil­lion to eye ther­a­py biotech

In Health­Care Roy­al­ty Part­ners’ lat­est deal, the in­vest­ment firm will loan up to $65 mil­lion to Clear­side Bio­med­ical.

Clear­side will get $32.5 mil­lion ini­tial­ly, fol­lowed by $12.5 mil­lion if the biotech reach­es cer­tain sales mile­stones for its mi­croin­jec­tion mac­u­lar ede­ma drug Xipere, which the FDA ap­proved in 2021. In 2024, if Clear­side meets ad­di­tion­al sales mile­stones, Health­Care Roy­al­ty Part­ners will loan an ad­di­tion­al $20 mil­lion.

Clear­side’s main prod­uct is its mi­croin­jec­tion tech­nol­o­gy for de­liv­er­ing eye ther­a­pies. Bausch + Lomb li­censed Xipere from Clear­side, and has ex­clu­sive rights to de­vel­op and com­mer­cial­ize the drug in the US and Cana­da.

Clear­side is al­so work­ing on an in­jectible TKI in­hibitor to po­ten­tial­ly treat wet AMD, di­a­bet­ic mac­u­lar ede­ma and di­a­bet­ic retinopa­thy. That can­di­date, dubbed CLS-AX, is ex­clud­ed from the Health­Care Roy­al­ty Part­ners deal.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Eisai will eliminate 91 after it out-licensed a seizure drug.

An Eisai spokesperson told Endpoints News that the change-up is tied to Fycompa, a seizure treatment that Florida rare disease biotech Catalyst Pharmaceuticals agreed to pay $160 million to Eisai in exchange for commercial rights back in December. The job cuts were originally flagged in a New Jersey state WARN notice.

The spokesperson said that Catalyst indicated interest in retaining up to 40 employees who work on Fycompa. Those who qualify will have an opportunity to interview with Catalyst.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.