Category Reports Biotech

On February 1, 2026, Pharming announced that the U.S. FDA issued a Complete Response Letter (CRL) to its supplemental New Drug Application (sNDA) for Joenja (leniolisib) in children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS). The letter does not question the fundamental clinical benefit of leniolisib in APDS but raises two specific technical concerns

From the January “deficiencies” shock to a Complete Response Letter focused on packaging and administration, why the market is suddenly relieved and why the story is still a multi-quarter grind.

Artiva Biotherapeutics is a clinical-stage biotech company focused on off-the-shelf allogeneic NK cell therapies built on a standardized, donor-derived, manufacturing platform. The lead asset, AlloNK (AB-101), is being developed in combination with anti-CD20 therapy both in B-cell non-Hodgkin lymphoma (NHL) and in autoimmune d

Allogene Therapeutics is not the 2+ billion dollar hype story it was a few years ago. After the initial enthusiasm around off-the-shelf CAR T, the stock has been crushed by a sequence of events: an FDA clinical hold in 2021, years of execution risk, pipeline reshuffling and workforce reductions.

REGAL Survival Clock, SLS009 Momentum and the Waiting Game
Monthly recap on SELLAS Life Sciences: what changed since the December update, how the 72/80 events in the REGAL Phase 3 trial reshaped the narrative, and which catalysts traders are watching next.

From 48-week IMPACT data and a CEO switch to FDA Breakthrough status, a 75M$ raise and a +50% month: how the Altimmune story and the tape have changed in a few weeks

Since the last Merlintrader pieces on ImmunityBio, the story has accelerated on several fronts. Anktiva net product revenue exploded to a preliminary 113 million dollars for 2025, a roughly 700 percent year-over-year jump with 38.3 million in the fourth quarter alone, backed by strong unit growth and broader coverage in the United States and abroad, as detailed in the company’s mid-January 2026 update and echoed across financial coverage.

The core of the Protalix model today is Elfabrio (pegunigalsidase alfa) for Fabry disease, commercialized globally by Chiesi under the two Chiesi agreements described in the FY 2024 release and 10-K. :contentReference[oaicite:2]{index=2} Protalix manufactures the drug substance in Carmiel and sells finished product to Chiesi, receiving tiered payments in the 15–35% ex-US and 15–40% US range on average selling price, linked to purchased volumes, as outlined in the “Chiesi Agreements” and “Revenues from selling goods” sections.

Deep dive (as of January 30, 2026) on Kyverna Therapeutics (KYTX): autologous CD19 CAR-T mivocabtagene (miv-cel, KYV-101) in autoimmune diseases, positive registrational KYSA-8 data in stiff person syndrome (SPS), RMAT/Fast Track designations, 2026 BLA ambitions and cash runway into 2027. Educational only, not investment advice

Tiziana Life Sciences is building an entire company around one idea: that intranasal delivery of a fully human anti-CD3 antibody, foralumab, can re-educate the immune system and cool down chronic neuroinflammation without broad systemic immunosuppression.

Quince Therapeutics (QNCX) released topline results from its pivotal Phase 3 NEAT clinical trial of eDSP (EryDex) in Ataxia-Telangiectasia, a rare pediatric neurodegenerative and immunodeficiency disorder. The press release confirms that the study did not meet its primary endpoint on the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS), with insufficient separation versus placebo despite prior Phase 2 and ATTeST signals

“Good headline, bad read” session
Fractyl reported 6-month randomized midpoint data from a blinded, sham-controlled cohort in REMAIN-1. The release highlights less weight regain vs sham, better cardiometabolic profile, and a De Novo pathway discussion. The stock is getting hit because traders are discounting the quality of the signal and the timeline.

From “great science” to “great delivery”: Ekterly’s launch is now the purest real-world test of whether KalVista can turn first-in-class oral HAE convenience into durable cash flow before competition closes the gap.