Ipsen re­ceives new palo­varotene PDU­FA date; Ac­er halts de­vel­op­ment of ex-Sanofi drug

The FDA will be giv­ing Ipsen an­oth­er shot at ap­proval for one of its can­di­dates.

Ipsen an­nounced that the FDA has set the PDU­FA date for Aug. 16, 2023, as more in­for­ma­tion on palo­varotene’s clin­i­cal tri­al will be in­clud­ed in the re­sub­mis­sion. This com­pris­es more analy­ses across the clin­i­cal tri­al pro­gram, in­clud­ing the first Phase III study that was car­ried out in pa­tients with fi­brodys­pla­sia os­si­f­i­cans pro­gres­si­va, or FOP.

The FDA had orig­i­nal­ly re­ject­ed the drug due to the agency want­i­ng the ad­di­tion­al in­for­ma­tion. At the time, Ipsen stat­ed that there were no is­sues around ef­fi­ca­cy or safe­ty da­ta.

Ipsen is al­so re­quest­ing a re-ex­am­i­na­tion of the EMA’s opin­ion on palo­varotene as well. So far, the drug has ap­proval in Cana­da, where it is mar­ket­ed as So­honos, and in the Unit­ed Arab Emi­rates. — Tyler Patchen

Ac­er puts a halt to ex-Sanofi drug

Ac­er Ther­a­peu­tics is putting a ki­bosh on one of its pro­grams.

On Fri­day, the biotech an­nounced that it is putting a pause on its AC­ER-801 pro­gram, a pos­si­ble treat­ment for mod­er­ate to se­vere va­so­mo­tor symp­toms that are as­so­ci­at­ed with menopause. The biotech’s Phase IIa tri­al for the drug did not reach sta­tis­ti­cal sig­nif­i­cance. Ac­er will be plac­ing a hold on the can­di­date un­til a re­view of the da­ta set is com­plet­ed.

Ac­er al­so stat­ed in its re­lease that it will fo­cus on prep­ping for the launch of Ol­pru­va and the Phase III tri­al for Ed­si­vo.

“We in­tend to con­duct a com­pre­hen­sive analy­sis of the to­tal­i­ty of the clin­i­cal tri­al da­ta – in­clud­ing the phar­ma­co­ki­net­ic da­ta, which has not yet been an­a­lyzed – which will in­form our path for­ward for the pro­gram, in­clud­ing our col­lab­o­ra­tions for prostate can­cer and post-trau­mat­ic stress dis­or­der (PTSD),” said Ac­er CEO Chris Schelling in a re­lease.

Sanofi li­censed the drug to Ac­er in Jan­u­ary 2019. The news hit the com­pa­ny’s stock price $AC­ER hard, drop­ping it by over 41% so far since Fri­day’s open­ing bell. — Tyler Patchen

Dig­i­tal ther­a­peu­tics mak­er Pear starts hunt for sale, or al­ter­na­tive

Pear Ther­a­peu­tics, the first com­pa­ny to get FDA clear­ance for a pre­scrip­tion dig­i­tal ther­a­peu­tic back in 2017, said Fri­day morn­ing it is ex­plor­ing “strate­gic al­ter­na­tives.”

Like is the case for mul­ti­ple oth­er com­pa­nies in life sci­ences right now, that could mean a sale, some sort of M&A, di­vesti­ture, li­cens­ing, ad­di­tion­al fi­nanc­ing or oth­er type of trans­ac­tion.

The Boston com­pa­ny did not set a timetable and said it will not pro­vide up­dates un­less or un­til the board green lights a “de­fin­i­tive course of ac­tion.” If a trans­ac­tion doesn’t hap­pen, Pear might re­or­ga­nize, re­struc­ture or liq­ui­date, the com­pa­ny warned in a press re­lease. Ad­vis­ing the com­pa­ny is MTS Health Part­ners.

Pear picked up steam over the pan­dem­ic, rak­ing in an $80 mil­lion Se­ries D in 2020 and went pub­lic with a SPAC in 2021. — Kyle LaHu­cik

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 clinicaltrials.gov, 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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89bio to net $275M from stock of­fer­ing; As­sem­bly Bio to pause work on one HBV in­hibitor pro­gram

San Francisco-based biotech 89bio announced on Friday that it expects to rake in $275 million on a stock offering. The raise comes after 89bio announced on Tuesday results of a Phase II study showing that its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH.

To run a Phase III study, 89bio CEO Rohan Palekar told Endpoints News that the biotech “would need to raise additional capital.” 89bio offered over 16 million shares of its common stock at $16.25 per share, and expects the offering closes on March 28.

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.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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