With a phase II failure, Palisade Bio Inc. has decided to halt development into one of two indications for its only asset, LB-1148. The oral formulation of a broad-spectrum serine protease inhibitor missed the primary endpoint in the Profile study of reducing intra-abdominal adhesions after bowel resection. Palisade said the safety data and efficacy results no longer support further development of LB-1148 in the indication.
Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
Aravive Inc.’s sole asset missed a phase III primary endpoint in ovarian cancer but the company still has studies planned for treating renal cell carcinoma and pancreatic cancer. Aravive’s stock (NASDAQ:ARAV) dwindled dramatically on Aug. 3, with shares closing 77.2% lower at 28 cents each. That’s a massive drop from heights seen in the past 12 months, as shares hit $2.46 each in March 2023 and $2.09 each in November 2022. The company plans to study the data and make a decision about whether to proceed with the other studies.
Revolution Medicines Inc. is acquiring Eqrx Inc. in an all-stock transaction designed to add more than $1 billion in net cash for Revolution so it can forge ahead with its RAS pathway programs. Serial biotech entrepreneur and investor Alexis Borisy co-founded Eqrx in 2020 to deliver new medicines for cancer and other conditions at "radically lower prices." Borisy also co-founded Revolution, where he remains as executive chairman.
Positive top-line phase II results caused Mymd Pharmaceuticals Inc.’s stock (NASDQ:MYMD) to surge 31.8% on July 31 to close at $1.45 per share. The data behind the push were for MYMD-1 (isomyosmine) for treating chronic inflammation associated with sarcopenia.
Not hitting the primary endpoint of a phase III study caused the U.S. FDA to say it would not review Biohaven Ltd.’s NDA for troriluzole to treat spinocerebellar ataxia (SCA), an ultra-rare disorder.
The U.S. FDA has approved the first treatment directly targeting the mites that cause Demodex blepharitis, an eye disease shared by about 25 million people in the U.S. and now a huge market opportunity for the developer.
Fourth time’s a charm for Verrica Pharmaceuticals Inc. as the U.S. FDA has approved Ycanth (cantharidin) to treat molluscum contagiosum in those ages 2 and older. Three complete response letters (CRL) have stood in the treatment’s way for the past three years, blocking approval of the U.S.’s first approved treatment.
