Biotech news for Wednesday, May 13, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.
Earnings Call Insights: TriSalus Life Sciences (TLSI) Q1 2026 Management View CEO Mary Szela framed Q1 as a deliberate build year, saying the company executed a “deliberate realignment and significant expansion of our commercial organization” to “capture the m…
Earnings Call Insights: Kura Oncology (KURA) Q1 2026 Management View "In our first full quarter of launch, we generated $5.8 million in net product revenue ahead of expectations" (Chairman, CEO & President Troy Wilson), while emphasizing early commercial s…
Earnings Call Insights: Capricor Therapeutics (CAPR) Q1 2026 Management view Linda Marbán said the “most significant development” is that “our biologics license application, or BLA, for deramiocel is currently under active review by the FDA with a PDUFA target…
Earnings Call Insights: Lineage Cell Therapeutics (LCTX) Q1 2026 Management View Brian Culley (CEO, President & Director) highlighted platform expansion and new pipeline launches: "I do definitely want to highlight the successful expansion of AlloSCOPE, ou…
Kyverna Therapeutics ( KYTX ) has started the rolling BLA process with the US FDA for its autoimmune CAR T therapy, miv-cel, in stiff person syndrome. The company and the agency have agreed that results from the phase 2 single-arm KYSA-8 single-arm
Earnings Call Insights: IMUNON (IMNN) Q1 2026 Management View Dr. Stacy Lindborg (President, CEO & Director) said the company entered Q2 “with continued momentum” after announcing “the final clinical data from our completed Phase II study OVATION 2,” addin…
Earnings Call Insights: Achieve Life Sciences (ACHV) Q1 2026 Management View "I'm honored to step into the role of Chief Executive Officer at such an important time." (CEO, President & Director Andrew Goldberg) Goldberg said Achieve is developing cytisinic…
Earnings Call Insights: Acumen Pharmaceuticals (ABOS) Q1 2026 Management View "In the first quarter, we continued to advance sabirnetug through our Phase II ALTITUDE-AD trial, building on the clinical momentum established over the past year." (CEO & Direct…
Earnings Call Insights: Acurx Pharmaceuticals (ACXP) Q1 2026 Management View "On March 9, '26, we issued a press release announcing that we're starting up a ground-breaking ibezapolstat clinical trial program in patients with recurrent CDI or rCDI, that has th…
Earnings Call Insights: Coherus Oncology (CHRS) Q1 2026 Management view Chairman, President & CEO Dennis Lanfear said the strategy is built around LOQTORZI as “both a revenue generator” in nasopharyngeal cancer (NPC) and “a revenue multiplier” in combinati…
Earnings Call Insights: AIxCrypto Holdings, Inc. (AIXC) Q1 2026 Management view Co-CEO Jiawei Wang framed Q1 as the first execution quarter of the company’s Web3 and AI infrastructure pivot, saying, “The first quarter of 2026 is our first reporting period exec…
Shidlovski Alkermes ( ALKS ) shares gained in the premarket on Tuesday after the company announced that its sleep disorder therapy Lumryz reached the primary goal in a late-stage trial for patients with idiopathic hypersomnia, a rare condition characterized by…
AC Immune ( ACIU ) on Tuesday said co-founder and CEO Andrea Pfeifer will retire at the company’s upcoming annual general meeting after leading the neurodegenerative disease drug developer for 23 years. Board Chair Martin Zügel will take over as interim CEO
MicroStockHub/iStock via Getty Images Arvinas ( ARVN ) announced on Tuesday that the company and its partner, Pfizer ( PFE ), reached an agreement with Rigel Pharmaceuticals ( RIGL ) to sell global licensing rights to their jointly developed breast cancer ther…
Earnings Call Insights: Exagen (XGN) Q1 2026 Management View “We reported record first quarter revenue of $17.3 million, up 12% year-over-year,” and “gross margin was 59% and adjusted EBITDA loss reduced to $2.2 million,” CEO John Aballi (CEO, President &…
CEL-SCI ( CVM ) priced a public offering of 6M shares of common stock at $1.20 per share, Total gross proceeds from the offering, before deducting the placement agent’s fees and offering expenses, are expected to be approximately $7.2M. The offering is expecte…
Earnings Call Insights: Halozyme Therapeutics (HALO) Q1 2026 Management view "We started 2026 with exceptional momentum," said President, CEO & Director Helen Torley, pointing to "strong conviction in the 2026 to 2028 financial guidance" and saying partner…