Neal Fowler, Pathalys Pharma CEO

Pathalys inks de­vel­op­ment deal with Abing­worth com­pa­ny, rais­ing $150M

Pathalys Phar­ma, a pri­vate biotech co-found­ed by Japan­ese VC Catalys Pa­cif­ic and DaVi­ta Ven­ture Group in late 2020 to fo­cus on chron­ic kid­ney dis­ease, an­nounced Wednes­day morn­ing it reached a deal with Launch Ther­a­peu­tics to ad­vance two Phase III tri­als for a drug de­signed to treat a parathy­roid con­di­tion for he­modial­y­sis pa­tients. The drug is called upaci­cal­cet, al­so known as PLS240.

As part of the deal, Pathalys al­so raised $150 mil­lion in se­cured prod­uct fi­nanc­ing and eq­ui­ty to push upaci­cal­cet through Phase III and to sup­port a po­ten­tial launch if it’s ap­proved. Abing­worth led the round, while Car­lyle and Or­biMed joined in, as did Catalys Pa­cif­ic and DaVi­ta Ven­ture Group.

In re­turn for the in­vest­ment, Pathalys re­tains world­wide com­mer­cial rights to upaci­cal­cet out­side Japan and Asia. The prod­uct fi­nanc­ing fund­ing gets paid back out of rev­enues of the drug.

The drug, so far Pathalys’ on­ly drug in its pipeline, is a cal­cimimet­ic — a type of drug that mim­ics the ac­tion of cal­ci­um on tis­sues. Oth­er cal­cimimet­ics al­ready ap­proved in the US come from Big Phar­ma Am­gen, with its brand drugs Sen­si­par and Parsabiv in­di­cat­ed to treat hy­per­parathy­roidism.

Pathalys’ drug was ap­proved as Up­a­sita in Japan back in 2021 for sec­ondary hy­per­parathy­roidism in dial­y­sis pa­tients — the same con­di­tion it’s shoot­ing for in the US. The drug was de­vel­oped by EA Phar­ma, which kicked off in 2016 as a gas­troin­testi­nal dis­ease biotech formed by Ei­sai Group and Aji­nomo­to Group.

Pathalys got the li­cense to de­vel­op the drug in US and Eu­rope in 2021, CEO Neal Fowler told End­points News.

Launch Ther­a­peu­tics, which kicked off in 2022, is es­sen­tial­ly the drug de­vel­op­ment arm of Car­lyle and its-now life sci­ence sub­sidiary Abing­worth. Fowler said that while the com­pa­ny was in dis­cus­sions with in­vestors to find cap­i­tal for Phase III tri­als, Pathalys be­came fa­mil­iar with Launch af­ter start­ing dis­cus­sions with Abing­worth.

Car­lyle, the pri­vate eq­ui­ty gi­ant, leapt in­to the biotech in­vest­ment scene last year when it bought out Abing­worth. At the time of the deal, Abing­worth and Car­lyle brought Launch Ther­a­peu­tics in­to the fold — which takes on clin­i­cal tri­al risk in ex­change for a share of the prof­its.

Launch Ther­a­peu­tics will have the lead role in ex­e­cut­ing and man­ag­ing the clin­i­cal tri­als, while Pathalys will be re­spon­si­ble for man­u­fac­tur­ing, com­mer­cial­iza­tion and work­ing with the FDA. The two iden­ti­cal tri­als, ex­pect­ed to launch in the first half of this year, will en­roll 375 pa­tients each and last for 20 months. Fowler said by that time­line, da­ta will read out in ear­ly 2025.

Fowler said that while the com­pa­ny is ex­cit­ed to get its first clin­i­cal tri­al un­der­way, Pathalys has big­ger am­bi­tions — and wants to ex­pand in­to mul­ti­ple as­sets in chron­ic kid­ney dis­ease.

“It’s just the be­gin­ning, and we’re ea­ger to get mov­ing,” Fowler added.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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