Coverage
Daily commentary on the catalysts moving small-cap biotech — FDA decisions, clinical readouts, financings and deals.
Fulcrum Therapeutics (Nasdaq: FULC) announced on August 17, 2026, that it will merge with privately held Slate Medicines in an all-stock transaction — a deal that values Slate at $350 million and…
The FDA granted accelerated approval on August 6, 2026, to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune Inc.; NASDAQ: REPL) in combination with nivolumab for adult patients with unresectable…
The FDA approved daraxonrasib (RASONQUE) on August 26, 2026 for adults with metastatic pancreatic adenocarcinoma — making it the first RAS inhibitor cleared for the disease, per the company's news…
Today, August 27, 2026, is the PDUFA action date for Gilead Sciences' (NASDAQ: GILD) New Drug Application for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) — a once-daily single-tablet regimen for…
Ascendis Pharma A/S announced on August 25, 2026 that it will deliver an oral presentation of Week 104 data from the pivotal ApproaCH Trial of TransCon CNP (navepegritide) at the International…
Moleculin Biotech (MBRX) has interim data worth reading carefully: complete remission rates of 43% and 36% in its two Annamycin arms versus 12% in the control arm of the pivotal MIRACLE trial in…
Three complete response letters. One successful appeal. One approval.
InduPro, Inc. closed a $77 million Series B financing and dosed the first patient in its Phase 1 study of IDP-001 on August 12, 2026, per a Business Wire release that day. The Seattle-based private…
The most consequential binary event in small-cap biotech this week lands on Friday, August 22: the FDA's PDUFA decision on Capricor Therapeutics' (CAPR) deramiocel BLA for Duchenne muscular dystrophy…
Ultragenyx Pharmaceutical (NASDAQ: RARE) has a hard regulatory date on the calendar: the FDA's August 23, 2026 PDUFA decision on DTX401 (pariglasgene brecaparvovec), an AAV8 gene therapy for Glycogen…
Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) received FDA clearance on August 14, 2026 to proceed with its Lucid-MS Phase 2 clinical trial in progressive multiple sclerosis, per the…
Replimune Group (NASDAQ: REPL) cleared its hardest regulatory hurdle on August 6, 2026: FDA accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults…
Corbus Pharmaceuticals (NASDAQ: CRBP) received FDA clearance on July 28, 2026 to initiate TEMPO-1, a registrational study of CRB-701 in second-line oropharyngeal squamous cell carcinoma (OPSCC) — a…
Attovia Therapeutics priced its initial public offering on August 4, 2026, and began trading on the Nasdaq Global Market on August 5, 2026 under the symbol "ATTO" — closing its first session at…
The FDA's advisory committee delivered a lopsided verdict on Capricor Therapeutics' Deramiocel on July 29, 2026: 9 against, 3 for, 0 abstaining on whether available evidence supported the therapy's…
Thirteen biotech offerings have priced through late June, raising $5.0 billion in aggregate — a figure that already exceeds every full-year total from 2022 through 2025, according to data reported at…
Attovia Therapeutics, Inc. (Nasdaq: ATTO) priced its initial public offering at $17.00 per share on August 4, 2026 — the top of its targeted range — raising $289.0 million in gross proceeds before…
Zhengye Biotechnology Holding Limited (Nasdaq: ZYBT) regained compliance with Nasdaq's minimum bid price rule on August 5, 2026 — and the stock responded with a violent move the following session.
Three distinct small-cap biotech catalysts set the agenda for the week of August 4, against a backdrop where the Russell 2000 has already returned 22.93% in the first half of 2026 — its best…
Medicus Pharma Ltd. (NASDAQ: MDCX) received a 'Study May Proceed' letter from the FDA on July 27, 2026, clearing the company to launch SKNJCT-005 — an NDA-enabling, open-label, multicenter Phase 2b…
Crescent Biopharma (CBIO) closed a public offering on July 16, 2026, raising $143.7 million in gross proceeds before underwriting discounts, commissions, and other offering expenses, according to the…
Apnimed is moving to raise $150 million on Nasdaq this week — ticker APMD — with a February 28, 2027 FDA decision date on its oral obstructive sleep apnea drug already on the calendar.
Discovery drill hole 3TS-26-39 intersected 9.10 metres grading 14.70 grams per tonne gold and 36.70 g/t silver, with an estimated true width of 7.00 metres, according to Independence Gold Corp.'s…
Twenty years of failed attempts at the PI3K/AKT/mTOR pathway ended on July 14, 2026, when the FDA approved Celcuity Inc.'s (Nasdaq: CELC) Revtorpyk (gedatolisib) for HR+/HER2− locally advanced or…
The FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) on July 7, 2026. The number that defined the filing: a 46% reduction from baseline in proteinuria, drawn from a…
Crystalys Therapeutics announced on July 22, 2026 a $130 million Series B financing — oversubscribed and closed — less than a year after the company launched with a $205 million Series A announced…
Oncolytics Biotech Inc. (Nasdaq: ONCY) received its third FDA Fast Track designation for pelareorep on July 20, 2026 — this one for pelareorep combined with a checkpoint inhibitor in patients with…
Dyne Therapeutics landed a concrete regulatory milestone on July 20, 2026: the FDA accepted its Biologics License Application for zeleciment rostudirsen — also designated DYNE-251, or z-rostudirsen —…
The FDA accepted Dyne Therapeutics' Biologics License Application for zeleciment rostudirsen on July 20, 2026, assigning a PDUFA target action date of January 21, 2027 — a hard deadline that now…
Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma, with a 51.9% response rate and a 79.1% three-year progression-free rate.
REGENXBIO reported long-term data showing its AbbVie-partnered gene therapy sura-vec preserved vision and cut injection burden through five years in wet AMD.
4DMT presented two-year Phase 2b PRISM data showing its gene therapy 4D-150 cut anti-VEGF treatment burden by 78% while maintaining vision in wet AMD.
Trevi Therapeutics shares climbed nearly 10% after GSK abandoned its chronic cough candidate camlipixant, removing a leading competitor to Trevi's Haduvio.
Jasper Therapeutics announced an all-stock merger with Kira Pharmaceuticals alongside a roughly $132 million private placement, reshaping its pipeline and balance sheet.
Intensity Therapeutics resumed dosing of INT230-6 in its Phase 2 presurgical triple-negative breast cancer trial under an amended, lower-dose protocol.
Celcuity won FDA approval for REVTORPYK in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, marking the company's first commercial product.
Q32 Bio reported 36-week Phase 2a data showing its antibody bempikibart drove meaningful hair regrowth in patients with severe alopecia areata.
Cue Biopharma announced a $50 million private placement led by Cormorant Asset Management to fund clinical development, expected to close on or about July 13, 2026.
Forte Biosciences reported that its FB102 candidate met the primary endpoint in a Phase 1b vitiligo study, showing a statistically significant improvement over placebo at week 24.
The FDA accepted Arcutis Biotherapeutics' supplemental application to expand ZORYVE cream into infants with atopic dermatitis, with a decision targeted for February 2027.
MeiraGTx entered a largely non-dilutive financing of up to $400 million with Oberland Capital to support its late-stage retinitis pigmentosa and xerostomia gene therapy programs.
Aligos Therapeutics received a $25 million upfront payment and could earn up to $420 million in milestones from an exclusive Greater China license for its hepatitis B candidate.
Can-Fite said its Phase 2a study of namodenoson in advanced pancreatic cancer met the primary safety endpoint and showed durable survival in heavily pretreated patients.
The FDA approved Arcutis' supplemental application to expand ZORYVE cream 0.3% for plaque psoriasis to children as young as age 2, broadening the product's eligible patient population.
NeuroSense reported that its Phase 2b PARADIGM study of PrimeC in ALS met its primary endpoint on a TDP-43 biomarker, with the company already cleared to start Phase 3.
Capricor Therapeutics said the FDA will convene an advisory committee on July 29 to review its Duchenne muscular dystrophy cell therapy deramiocel ahead of an August 22 decision date.
The FDA approved Viridian Therapeutics' Lumvoa for thyroid eye disease across active and chronic stages, marking the company's first commercial product following its pivotal THRIVE Phase 3 program.
ProQR Therapeutics reported Phase 1 target-engagement data that it says provides the first clinical validation of its Axiomer RNA-editing platform, and priced a $50 million financing the same day.
Zevra Therapeutics published positive Phase 2/3 pediatric substudy data for its Niemann-Pick type C therapy MIPLYFFA in infants under two, adding to the approved rare-disease drug's safety profile.
Achieve Life Sciences received an FDA complete response letter for cytisinicline tied to third-party manufacturing, not efficacy or safety, and plans to resubmit the smoking-cessation drug in late 2026.
REGENXBIO reached alignment with the FDA on an accelerated approval path for its MPS II gene therapy NAVSUNLI, reversing a February complete response letter and enabling a third-quarter resubmission.