Catalyst Updates

Calendar year 2025, what a year! Whiplash from tariffs to HHS turbulence to FDA dysfunction to a reduction in vaccine administrations. BioPharma held up selectively, especially Big Pharma who set…

Companies with mature science such as kinase inhibitors and “zombie” biotechs – public companies that remain listed despite numerous failures – rarely thrive in the biopharma M&A market. Bidders typically…

IDEAYA Biosciences, Inc. (NASDAQ:IDYA) said on September 8 that 76% (16/21) of uveal melanoma (UM) patients who were treated with the company’s drug darovasertib achieved a ≥20% ocular tumor shrinkage…

The FDA issued a complete response letter (CRL) on August 28 for Telix Pharmaceuticals Ltd.’s (OTCPK:TLPPF) TLX250-CDx (Zircaix), an imaging agent designed to non-invasively diagnose and characterize clear cell renal…

The FDA issued a complete response letter (CRL) on August 19 for PTC Therapeutics, Inc.’s (PTCT) vatiquinone to treat the rare neuromuscular disorder Friedreich’s ataxia (FA). In line with recent…

The FDA issued a complete response letter (CRL) on July 30 for Regeneron Pharmaceuticals, Inc.’s (NASDAQ:REGN) odronextamab to treat relapsed/refractory (r/r) follicular lymphoma (FL). The CRL was the second for…

If the buyout market signals biotech and medtech are rebounding in the midst of RFK Jr. and Trump II, two deals in the past week present convincing evidence. One was…

Hereditary angioedema (HAE) is a rare genetic disease that has proven to be stubborn to treat, particularly when HAE attacks manifest. KalVista’s (KALV) sebetralstat, now branded as Ekterly,  will enter…

Early in June, Ascendis Pharma A/S (NASDAQ:ASND) said its once-weekly combination of TransConCNP (navepegritide) plus TransConhGH (lonapegsomatropin) demonstrated mean annualized growth velocity (AGV) of 9.14 cm/year over 26 weeks in…

Merus N.V.’s (NASDAQ:MRUS) rose ~32% on May 23, 2025, after the company presented phase II interim data on Merus’ petosemtamab combined with Merck & Co., Inc.’s (NYSE:MRK) pembrolizumab as a…