Biotech News Brief

Biotech news for Friday, May 8, 2026, ranked by our 5-dimension investment framework — regulatory, technology, commercial, manufacturing, and narrative.

May 8, 12:32 AM EDT

Palvella targets 2H 2026 NDA filing while outlining >$1B peak U.S. sales potential for QTORIN rapamycin in microcystic lymphatic malformations

PVLA

Earnings Call Insights: Palvella Therapeutics (PVLA) Q1 2026 Management view CEO Wesley Kaupinen said the company is “positioned for our first potential FDA approval and U.S. commercial launch,” citing “decisively positive Phase III results for QTORIN rapamyci…

May 8, 12:32 AM EDT

Arcturus outlines 12-week ARCT-032 Phase II enrollment and extends cash runway beyond Q2 2028

ARCT

Earnings Call Insights: Arcturus Therapeutics (ARCT) Q1 2026 Management View “The first quarter of 2026 was a period of solid execution for Arcturus as we continue to advance our rare disease pipeline and strengthen our leadership team,” said CEO Joseph Payne,…

May 7, 11:43 PM EDT

Verastem outlines cash runway into the first half of 2027 while targeting LGSOC self-sustainability in the second half of 2026

VSTM

Earnings Call Insights: Verastem (VSTM) Q1 2026 Management view “Since our launch in May 2025, we've seen steady growth quarter-over-quarter, achieving $18.7 million in net product revenue in Q1 with nearly $50 million in total net product revenue to date,” sa…

May 7, 11:32 PM EDT

Vericel forecasts $326M-$336M 2026 revenue as BARDA-backed NexoBrid procurement begins in H2

VCEL

Earnings Call Insights: Vericel Corporation (VCEL) Q1 2026 Management View "The company generated record first quarter total revenue of more than $68 million, which increased 30% over last year and significantly exceeded our guidance for the quarter" (CEO, Pre…

May 7, 11:12 PM EDT

Arrowhead anticipates SHASTA-3/4 topline in Q3 while planning an SHTG sNDA before end of 2026

ARWR

Earnings Call Insights: Arrowhead Pharmaceuticals (ARWR) Q2 2026 Management View “Arrowhead is now on the strongest footing of our history. We are commercial.” (Chairman, CEO & President Dr. Christopher Anzalone) “We are now seeing around 30 new prescripti…

May 7, 10:52 PM EDT

CytomX expects cash runway to at least the second half of 2028 as Varseta-M targets a first half of 2027 registrational study

CTMX

Earnings Call Insights: CytomX Therapeutics (CTMX) Q1 2026 Management View Dr. Sean McCarthy framed 2026 as “a transformational year for CytomX,” citing “excellent clinical progress with Varseta-M in late line colorectal cancer” and positioning Varseta-M as “t…

May 7, 10:42 PM EDT

Zai Lab expects Zoci Phase III enrollment completion in first half of 2027, while targeting first FDA BLA in late 2027

ZLAB

Earnings Call Insights: Zai Lab (ZLAB) Q1 2026 Management view CEO Ying Du framed the quarter as an inflection in global development, saying, "Zai Lab is at a pivotal moment," and linked the strategy to global execution and productivity, adding, "We are also l…

May 7, 8:22 PM EDT

Ironwood reiterates 2026 LINZESS guidance of $1.125B-$1.175B as STARS-2 initiation nears

IRWD

Earnings Call Insights: Ironwood Pharmaceuticals (IRWD) Q1 2026 Management View CEO Thomas McCourt said 2026 priorities remain “maximizing LINZESS, advancing apraglutide and delivering sustained profits and cash flow,” and highlighted Q1 execution across each.…

May 7, 8:13 PM EDT

Natera outlines 65% gross margin midpoint for 2026 while pulling forward $50M in R&D

NTRA

Earnings Call Insights: Natera (NTRA) Q1 2026 Management view "We posted revenues of $697 million in Q1, 39% growth over last year." (CEO & Director Steve Chapman) "Q1 was our first to deliver 1 million units in a single quarter

May 7, 5:22 PM EDT

Iovance outlines $350M-$370M 2026 revenue, while guiding Q2 total revenue to $86M-$88M

IOVA

Earnings Call Insights: Iovance Biotherapeutics (IOVA) Q1 2026 Management View "During the first quarter of 2026, we drove Amtagvi adoption, advanced our development pipeline, and streamlined costs and efficiencies," said "First quarter revenue grew approximat…

May 7, 5:12 PM EDT

Argenx targets 2.5x more VYVGART patients by decade-end as Phase III empasiprubart MMN readout nears 4Q

ARGNFARGX

Earnings Call Insights: argenx SE (ARGX) Q1 2026 Management View “Today is her first official day on the job,” Beth DelGiacco said, introducing “Karen Massey, our new Chief Executive Officer.” “Near term, we see continued growth with VYVGART across both MG

May 7, 3:52 PM EDT

Akebia outlines Phase II FSGS study of up to ~60 patients as Vafseo reaches nearly 7,500 patients

AKBA

Earnings Call Insights: Akebia Therapeutics (AKBA) Q1 2026 Management view "We are very pleased and excited by the start to 2026" (CEO, President & Director John Butler), highlighting three execution priorities: "drive the near-term launch performance of V…

May 7, 3:12 PM EDT

DiaMedica outlines ReMEDy2 interim analysis by end of 2026 with potential 300-700 patient resample size

DMAC

Earnings Call Insights: DiaMedica Therapeutics (DMAC) Q1 2026 Management View "We are pleased with the progress we've made so far in 2026 as we continue to advance DM199 across both our preeclampsia and acute ischemic stroke programs," said Dietrich Pauls (Pre…