Merck & Co. Inc. is pledging major resources on its prospect in the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor space with a phase III program that together will enroll about 17,000 subjects and test oral peptide MK-0616’s effect on tackling low-density lipoprotein cholesterol.
Apollomics Inc.’s business combination this spring with Maxpro Capital Acquisition Corp., along with data that emerged from competitors Merck KGaA and Johnson & Johnson during the more recent American Society of Clinical Oncology meeting, shone a spotlight on continuing efforts to develop mesenchymal-epithelial transition factor (cMET) inhibitors.
Jyong Biotech Ltd. filed for an IPO that could raise as much as $40 million to advance a pipeline that includes several prospects for urinary system disorders, including one that has reached the NDA stage in the U.S.
On the heels of the U.S. FDA clearance for Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. to treat Chaple disease, the regulatory rollercoaster ride for the firm’s bid with higher-dose Eylea (aflibercept) ended with a green light for that compound as well. Eylea HD is indicated for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Jyong Biotech Ltd. filed for an IPO that could raise as much as $40 million to advance a pipeline that includes several prospects for urinary system disorders, including one that has reached the NDA stage in the U.S. Based in New Taipei City, Taiwan, Jyong was founded in 2002. The lead compound is MCS-2 for benign prostatic hyperplasia with lower urinary tract symptoms.
Abcuro Inc. pulled down an oversubscribed $155 million series B financing co-led by Redmile Group and Bain Capital Life Sciences to advance cytotoxic T and natural killer cells therapies. Specifically, proceeds will back the phase II/III registrational trial of ABC-008, a first-in-class anti-killer cell lectin-like receptor G1 (KLRG1) antibody for inclusion body myositis (IBM) as well as fund continued development of other clinical programs.
Variable muscle expression of frataxin (FXN) protein in muscle plus five adverse events (AEs) of injection-site thrombophlebitis in the multiple ascending-dose (MAD) phase I study hamstrung Design Therapeutics Inc. in its Friedreich’s ataxia (FA) bid with DT-216. Wall Street punished the Carlsbad, Calif.-based firm’s stock (NASDAQ:DSGN) with a knockdown of 70%, or $5.17, leaving shares at $2.17 when the market closed Aug. 15.
Harmony Biosciences Holdings Inc.’s agreement to acquire Zynerba Pharmaceuticals Inc. for $60 million cash plus as much as $140 million in contingent value rights (CVRs) didn’t register as one of the larger potential outlays recently, but Wall Street had questions about the term sheet just the same. Plymouth Meeting, Pa.-based Harmony is paying about $1.10 per share in cash for Zynerba, of Devon, Pa., plus one non-tradeable CVR tied to clinical, regulatory and sales milestones.
The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well.
Terns Pharmaceuticals Inc.’s unveiled positive top-line data from the phase IIa Duet study testing TERN-501, an oral thyroid hormone receptor-beta (THR-B) agonist, given as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor agonist, for the treatment of nonalcoholic steatohepatitis (NASH).
