Category Reports Biotech

Viridian Therapeutics is trying to become the second major commercial player in thyroid eye disease after Amgen’s Tepezza, with a TED franchise built around veligrotug (IV) and VRDN-003 (subcutaneous), plus an FcRn platform (VRDN-006/008) that targets broader autoimmune indications.

Deep dive on Moleculin Biotech, Inc. (NASDAQ: MBRX), a Phase 3 oncology company built around Annamycin (AnnAraC) in relapsed/refractory AML, with additional programs in STS lung metastases, brain tumors and viral indications. We walk through MIRACLE’s design and timelines, Phase 1b/2 AML data, the latest December 2025 updates, the balance sheet and why the stock still trades like a distressed nano-cap.

Processa Pharmaceuticals is a clinical-stage company built around a simple idea: instead of discovering entirely new oncology molecules, it re-engineers existing, FDA-approved chemotherapies to improve their therapeutic index. The Next Generation Cancer (NGC) platform aims to keep the same cancer-killing mechanism, while changing metabolism and distribution to reduce toxicity and potentially increase efficacy.

SELLAS Life Sciences is a late-stage oncology biotech whose near-term equity story is dominated by a single survival-driven Phase 3 trial (REGAL with GPS in AML maintenance) and a rapidly de-risking CDK9 program (SLS009 in AML-MR).

Beam Therapeutics is one of the purest listed plays on base editing. Its pipeline spans ex vivo and in vivo programs: risto-cel (BEAM-101) for sickle cell disease, BEAM-201 for aggressive T-cell malignancies, BEAM-301 for glycogen storage disease type Ia (GSD1a) and BEAM-302 for severe alpha-1 antitrypsin deficiency, plus an engineered stem-cell antibody-paired evasion (ESCAPE) platform aimed at non-genotoxic conditioning.

Mereo BioPharma is now a concentrated bet on setrusumab (UX143), an anti-sclerostin monoclonal antibody partnered with Ultragenyx for osteogenesis imperfecta (OI), plus a back-up program in respiratory alpha-1 antitrypsin deficiency (alvelestat) and an earlier-stage bone asset (vantictumab) licensed to āshibio for autosomal dominant osteopetrosis type 2, where Mereo retains European commercial rights.

Abivax SA is a French biotech now focused almost entirely on chronic inflammatory diseases, with obefazimod as its lead – and effectively only late-stage – asset. Originally developed for HIV, obefazimod was repositioned in ulcerative colitis after mid-stage virology data underwhelmed but immune-modulation readouts looked promising. Over time, the company abandoned its older infectious disease and oncology projects and concentrated resources on inflammatory bowel disease.

Cytokinetics enters 2026 in a very different position from just a year ago. After years as a development-stage muscle biology company – including the high-profile failure of omecamtiv mecarbil in chronic heart failure – the company now has its first approved product: MYQORZO (aficamten) for symptomatic obstructive HCM.

On December 18, 2025, Altimmune announced 48-week data from the IMPACT Phase 2b trial of pemvidutide for MASH (metabolic dysfunction-associated steatohepatitis). While the company highlighted “key measures of success” including improvements in non-invasive fibrosis markers (ELF, LSM, cT1), sustained weight loss, and favorable safety, the stock fell by more than 20% in the following sessions.

Reviva Pharmaceuticals is a small late-stage clinical company built almost entirely around one asset: brilaroxazine (RP5063), a serotonin-dopamine modulator for schizophrenia and other CNS / inflammatory indications. The company has successfully completed one large global Phase 3 trial (RECOVER-1) and a 1-year open-label extension and is now preparing for a pre-NDA meeting with the FDA in Q4 2025, targeting a full NDA submission in Q2 2026 for schizophrenia.

On 18 December 2025, law firm Bragar Eagel & Squire announced a new investigation into certain officers and directors of Unicycive Therapeutics. The investigation follows the securities class action already filed in August 2025 over the company’s public statements around the OLC New Drug Application and the June 2025 FDA Complete Response Letter.

In practical terms this does not change day-to-day operations, but it reinforces a clear message: the OLC NDA path and related communication are now under legal as well as regulatory scrutiny.

Tradipitant (motion sickness) is under NDA review with an unchanged PDUFA action date on December 30, 2025. FDA has started formal labeling discussions.
The FDA has lifted the partial clinical hold on long-term tradipitant studies, accepting that motion sickness is acute, so a 6-month dog tox study is no longer required.