
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