Myovant's Myfembree sNDA gets new PDUFA after CRL speculation; InxMed bags more funds for pivotal studies
Last month, analysts speculated the sNDA for Myovant Sciences and Pfizer’s Myfembree could be hit by a CRL after the FDA identified “deficiencies.” Now, the companies are saying the drug decision data has been pushed back.
The Swiss biotech said Friday that the PDUFA date was pushed from May 6 to Aug. 6, and Cowen analysts reacted positively.
“This is an encouraging development. Following the disclosure of deficiencies, we had expected a CRL today, but the extension suggests a path to approval this summer. We continue to believe MYOV is undervalued for the relugolix franchise,” Cowen analysts wrote in a note.
SVB Securities analysts were a little more cautious in their assessment, noting: “While this news is hopeful, we are still concerned that Myovant is not out of the woods yet.”
Myovant said last month the FDA had “identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitment at this time.”
The three-in-one pill is under review for an extension to treat moderate to severe pain associated with endometriosis. An FDA nod would trigger a $100 million regulatory milestone from partner Pfizer.
“We remain confident in the clinical profile of MYFEMBREE and its potential to become a therapeutic option for the management of endometriosis-associated pain,” Myovant medical chief Juan Camilo Arjona Ferreira said in a press release. “We will continue to work closely with the FDA to support the ongoing review of the sNDA.”
Myovant’s shares $MYOV have slid since the initial deficiencies disclosure last month, falling from about $14 apiece to $8.68 at the closing bell on Friday.
InxMed snags more money to bankroll pivotal studies of its fast track cancer drug
InxMed said it has picked up an additional $15 million in Series B funds after initially disclosing a $50 million round in March. The proceeds will bankroll the Nanjing, China-based biotech’s studies of IN10018, a focal adhesion kinase (FAK) small molecule inhibitor program.
That includes pivotal studies on tap for the second half of this year, InxMed said in a press release. The FDA gave the drug fast track designation last August and China’s regulator recently gave it breakthrough designation for the treatment of patients with platinum-resistant ovarian cancer. More data on the drug will be revealed next month at ASCO.
IN10018 is in multiple studies in the US and China across various cancers, including uveal melanoma and NRAS mutant metastatic melanoma; ovarian and gastric cancer; and pancreatic cancer and non-small cell lung cancer.
Founded in late-2018, the Merck, Roche and Boehringer Ingelheim-partnered biotech has workers in Shanghai, Beijing, Nanjing, the US, Canada and Australia. The company previously raised $19 million in a September 2020 Series A. Backers include Hyfinity Investments, Ennovation Ventures, China Growth Capital, InnoMed Capital, Grand Yangtze Capital, CS Capital, AIHC Fund, Growth Fund and Hosencare Fund.