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

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.

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.

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.