Phathom Pharmaceuticals Inc. will begin marketing Voquezna (vonoprazan) in December, thanks to the Nov. 1 approval by U.S. regulators, who cleared the potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition and relief of associated heartburn.
Gate Bioscience Inc., a new(ish) company with a new class of drugs in the works, emerged from stealth mode and disclosed a $60 million series A financing led by Versant Ventures and A16z Bio + Health. Arch Venture Partners and GV took part in the financing as well.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
With Deciphera Pharmaceuticals Inc.’s positive top-line data in hand from the pivotal phase III study called Motion, Wall Street speculation turned to the comparative safety and regulatory odds for vimseltinib (which analysts often refer to as “vim”) in patients with tenosynovial giant cell tumor (TGCT) not amenable to surgery.
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
The atopic dermatitis space gained another player in Triveni Bio Inc., which pulled down a $92 million series A financing co-led by Atlas Venture and Cormorant Asset Management to pay for a proof-of-concept study with lead program, TRIV-509, and boost the Waltham, Mass.-based firm’s broader pipeline.
Emerging from stealth mode, Rampart Bioscience Inc. pulled down $85 million in series A money for work on DNA-based drugs – a round that was led by Forbion with participation from seed investor Orbimed and new backers RA Capital Management and Healthcap.
This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced an ongoing interest in the pair of oncology targets, where a handful of developers remain busy. Most notably of late is Nuvalent Inc., which rolled out stock-boosting data Oct. 4.
Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress (ESMO). Wall Street immediately began comparing the compound, which takes aim at delta-like ligand 3 (DLL3) with a similar prospect from Amgen Inc. that recently yielded promising results.
The U.S. FDA cleared Pfizer Inc.’s Penbraya (meningococcal groups A, B, C, W and Y vaccine), the first pentavalent shot designed to provide coverage against the most common serogroups causing meningococcal disease in adolescents and young adults through age 25.
