With the FDA’s blessing, Biohaven Pharmaceutical Holding Co. Ltd.’s Nurtec ODT (rimegepant) enters a massive market for treating migraine in adults. In the U.S. alone, more than 25 million people have been diagnosed and seek treatment.
Aivita Biomedical Inc.’s CEO, Hans Keirstead, just finished up a $12.5 million fundraiser and he’s prepping for another $12.5 million in a second effort. In the two months since he started raising the money, he has hired four more people and plans to hire four more by year-end, bringing the company’s headcount to 36 employees.
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
Updated results from IMV Inc.’s ongoing phase II trial of DPX-Survivac to treat advanced recurrent ovarian cancer show the company’s lead candidate was active and well-tolerated in patients.
H. Lundbeck A/S’ antibody-based migraine therapy, Vyepti (eptinezumab-jjmr), which just received FDA approval as the first and only intravenous preventive treatment for adults, enters a market forecast to grow to $7 billion by 2027. While some analysts placed Vyepti’s earnings potential at about $800 million annually, the drug itself is positioned to become a possible blockbuster, earning $1 billion annually.
Infectious disease has been rough going for all comers the past few years, as companies have floundered. Appili Therapeutics Inc.’s CEO, Armand Balboni saw the troubles others encountered with the indication and also saw companies with thin pipelines struggle, but it hasn’t stopped him from forging on.
It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
