BioCryst re­sumes en­roll­ment for im­mune dis­eases drug; Ea­gle buys stake in res­pi­ra­to­ry dis­ease biotech

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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

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 cut­ting 91 jobs af­ter out-li­cense deal; Mer­ck touts first-line Keytru­da re­sults in en­dome­tri­al can­cer

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.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

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.