Tristan Manalac

Tristan Manalac

Senior Staff Writer

Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. Being formally trained in molecular biology, he once dreamed of collecting degrees and starting his own lab. But these days, he finds his greatest joy in a bottle of beer and a beautiful sentence. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.

IPO
Kalohexis is working on peptide therapies, including one for obesity that could offer an alternative approach to the GLP-1s that currently dominate the weight loss space.
In AstraZeneca’s third trip to Asia this year, the pharma secured ex-China rights to a dual inhibitor of PDE3 and PDE4, which in a Phase 2b study significantly improved lung function and lowered symptom burden in patients with chronic obstructive pulmonary disorder.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
Vertex Pharmaceuticals’ acquisition of Crinetics Pharmaceuticals is the largest pickup in the company’s history, according to analysts at BMO Capital Markets.
Patients treated with Bristol Myers Squibb’s Krazati in combination with cetuximab saw shorter median overall and progression-free survival than comparators on chemotherapy.
IPO
Scribe Therapeutics’ pipeline is immature, with its lead program recently greenlit for first-in-human testing. The biotech is working on CRISPR-based therapies for cardiometabolic diseases.
The centerpiece of the acquisition is Myricx Bio’s novel N-myristoyltransferase inhibitor payload platform, which could help Novartis develop antibody-drug conjugates that can overcome the limitations of existing therapies.
BridgeBio’s Attruby preserves kidney function in patients with transthyretin amyloidosis cardiomyopathy, an effect that is “distinct” from other drugs in this space, according to Jefferies.
FDA
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FDA
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
AstraZeneca and CSPC Pharmaceutical Group have already inked two other agreements this year, including an obesity-focused deal in January and one focused on chronic diseases in June.
The mid-stage disappointment in Alzheimer’s disease delivers another blow to Neuphoria Therapeutics, which in November last year was forced to launch a strategic business review after a Phase 3 trial in social anxiety disorder failed.
The FDA approved the expansion of Casgevy, which had previously been greenlit for patients 12 and up, into a younger pediatric population under the agency’s Commissioner’s National Priority Voucher program.
Despite the late-stage fail, Vistagen will nevertheless continue to push its drug candidate forward and meet with the FDA to align on a potential registrational path.
Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a confirmatory trial.