August 7, 2026

BioMarin Q2 $990M +20% + Voxzogo, Arrowhead Acquires PRV, Nature Anticancer Peptide Paper, Hims Q2 Monday Preview

BioMarin Q2 $990M +20% on Voxzogo + Amicus. Arrowhead acquires PRV (10→6 month FDA review). Nature aMPC16-CA50 cancer peptide paper. Hims Q2 Monday.

4 stories · Covering industry, regulatory, research

Editor's Note

Friday closes the Q2 2026 pharma earnings week with continued follow-through and a fresh anticancer peptide paper. BioMarin Pharmaceutical (NASDAQ: BMRN) reported Q2 2026 revenue of $990 million (+20% year-over-year) after market close Thursday August 6, driven by Voxzogo (vosoritide, C-type natriuretic peptide analog for achondroplasia) commercial strength and the completed Amicus Therapeutics acquisition contribution. ROCTAVIAN (valoctocogene roxaparvovec hemophilia A gene therapy) revenue continued declining following the Q1 2026 voluntary market withdrawal. Arrowhead Pharmaceuticals (NASDAQ: ARWR) confirmed acquisition of a Priority Review Voucher (PRV) during the Fiscal Q2 2026 conference call August 4, providing the company with the option to shorten a future FDA new drug application review from 10 months to 6 months. REDEMPLO (plozasiran, siRNA for familial chylomicronemia syndrome and now advanced to Phase 3 SHASTA-3/SHASTA-4 win July 23) prescription volume approximately doubled over fiscal Q3. Nature published a landmark study on aMPC16-CA50, a synthetic acid-responsive membranolytic peptide that induces immunogenic membranolytic cell death in tumor cells and potentiates immune checkpoint blockade therapy, extending the anticancer-peptide research trajectory that has moved through preclinical validation into early clinical translation. And Hims & Hers Health (NYSE: HIMS) reports Q2 2026 earnings Monday August 10 after market close with analyst focus on the peptide-compounding trajectory (Leerink estimates $440 million peptide sales representing 15% of 2026 revenue midpoint) and the post-PCAC investor narrative.

Industry

BioMarin Pharmaceutical (NASDAQ: BMRN) Reports Q2 2026 Financial Results After Market Close Thursday August 6 With Total Revenue of $990 Million (+20% Year-Over-Year, Approaching the $1 Billion Quarterly Threshold), Non-GAAP Diluted EPS of $0.54 (Beating the $0.23 Consensus), Continued Commercial Strength From Voxzogo (Vosoritide, C-Type Natriuretic Peptide Analog for Achondroplasia in Children), Contribution From the Completed Amicus Therapeutics Acquisition Including GALAFOLD (Migalastat for Fabry Disease) and POMBILITI + OPFOLDA (Cipaglucosidase Alfa Plus Miglustat for Late-Onset Pompe Disease); ROCTAVIAN (Valoctocogene Roxaparvovec Hemophilia A AAV Gene Therapy) Revenue Continued Declining Following the Q1 2026 Voluntary Market Withdrawal

BioMarin Pharmaceutical (NASDAQ: BMRN) reported Q2 2026 financial results after market close Thursday August 6, 2026 with total revenue of $990 million (+20% year-over-year), approaching the $1 billion quarterly threshold. Non-GAAP diluted EPS of $0.54 beat the $0.23 analyst consensus. Growth drivers: continued commercial strength of Voxzogo (vosoritide, C-type natriuretic peptide analog administered as a daily subcutaneous injection for achondroplasia in pediatric patients); contribution from the completed Amicus Therapeutics acquisition adding GALAFOLD (migalastat for Fabry disease) and POMBILITI + OPFOLDA (cipaglucosidase alfa plus miglustat oral chaperone for late-onset Pompe disease) to the BioMarin rare-disease portfolio; and continued growth of Palynziq (pegvaliase-pqpz for phenylketonuria). ROCTAVIAN (valoctocogene roxaparvovec, hemophilia A AAV gene therapy) revenue continued to decline following the Q1 2026 voluntary market withdrawal announced earlier in the year. The Amicus acquisition adds cost synergies expected to accelerate revenue growth, non-GAAP diluted EPS accretion, non-GAAP operating margin expansion, and operating cash flow through the mid-2030s per BioMarin management commentary. BioMarin's Voxzogo peptide franchise represents one of the sole approved peptide therapies in the pediatric endocrine indication space and continues to demonstrate the commercial scalability of the C-type natriuretic peptide modality.

#biomarin #bmrn #q2-2026-earnings #voxzogo #vosoritide #amicus-therapeutics #galafold #pombiliti #opfolda #palynziq #roctavian #achondroplasia #fabry-disease #pompe-disease

Regulatory

Arrowhead Pharmaceuticals (NASDAQ: ARWR) Confirmed on the Fiscal Q2 2026 Conference Call Tuesday August 4 That the Company Has Acquired a Priority Review Voucher (PRV) Providing the Option to Shorten a Future FDA New Drug Application Review From the Standard 10-Month Timeline to a 6-Month Timeline; Simultaneously REDEMPLO (Plozasiran, ApoC-III-Targeting siRNA Approved November 2025 for Familial Chylomicronemia Syndrome and Now Advanced to Phase 3 SHASTA-3 and SHASTA-4 Positive Win July 23, 2026 for Severe Hypertriglyceridemia) Prescription Volume Approximately Doubled Over Fiscal Q3 With Continued Momentum Into the Current Quarter

Arrowhead Pharmaceuticals (NASDAQ: ARWR) confirmed on the Fiscal Q2 2026 conference call Tuesday August 4, 2026 that the company has acquired a Priority Review Voucher (PRV), a transferable FDA-issued voucher that provides the option to shorten a future FDA new drug application review from the standard 10-month timeline to a 6-month timeline. PRVs are issued to sponsors that develop drugs for rare pediatric diseases, tropical diseases, or specific medical countermeasures under FDA statutory authority; they are transferable and can be sold on the secondary market where recent transactions have priced PRVs in the $100-200 million range. Arrowhead did not disclose the specific candidate to which the PRV will be applied but the timing (following the July 23, 2026 Phase 3 SHASTA-3 and SHASTA-4 positive readouts for plozasiran/Redemplo in severe hypertriglyceridemia) suggests the voucher may support the sNDA filing planned before end of 2026 for the severe hypertriglyceridemia indication. Separately, REDEMPLO (plozasiran) prescription volume has approximately doubled over fiscal Q3 following the November 2025 FDA approval for familial chylomicronemia syndrome, with continued momentum into the current quarter. Arrowhead management expressed continued satisfaction with the launch trajectory approximately 8.5 months after initial approval.

#arrowhead-pharmaceuticals #arwr #priority-review-voucher #prv #redemplo #plozasiran #shasta-3 #shasta-4 #severe-hypertriglyceridemia #familial-chylomicronemia-syndrome #apoc-iii #sirna

Research

Nature Publishes Landmark Anticancer Peptide Study on aMPC16-CA50, a Synthetic Acid-Responsive Membranolytic Peptide That Induces Immunogenic Membranolytic Cell Death (MCD) in Tumor Cells and Substantially Potentiates Immune Checkpoint Blockade Therapy in Preclinical Mouse Models; The Membranolytic Mechanism Differentiates aMPC16-CA50 From Both Traditional Chemotherapy (Which Typically Induces Apoptosis) and From Antibody-Drug Conjugates and CAR-T Cell Therapies, Extending the Anticancer-Peptide Research Trajectory That Has Moved Through Preclinical Validation Into Early Clinical Translation With Products Like Cybrexa's CBX-12 (26-Amino-Acid Peptide-Drug Conjugate) and Novartis's Pluvicto (Lutetium-177 Vipivotide Tetraxetan, PSMA-Targeting Radiopeptide)

Nature published a landmark anticancer peptide study on aMPC16-CA50, a synthetic acid-responsive membranolytic peptide that induces immunogenic membranolytic cell death (MCD) in tumor cells and substantially potentiates immune checkpoint blockade (anti-PD-1/PD-L1) therapy in preclinical mouse tumor models. The peptide is designed to respond to the acidic microenvironment of tumor tissue: at neutral pH the peptide remains inactive, but at the lower pH characteristic of tumor tissue (pH 6.0-6.5) the peptide undergoes conformational changes that allow it to insert into tumor cell membranes and induce membranolytic damage. The resulting cell death is immunogenic (releases damage-associated molecular patterns that alert the immune system) rather than apoptotic (which is typically immunologically silent), producing a mechanism that synergizes with checkpoint inhibitor therapy. The membranolytic mechanism differentiates aMPC16-CA50 from both traditional chemotherapy (which typically induces apoptosis) and from antibody-drug conjugates and CAR-T cell therapies. The paper extends the anticancer-peptide research trajectory that has moved through preclinical validation into early clinical translation with products including Cybrexa Therapeutics's CBX-12 (26-amino-acid peptide-drug conjugate for platinum-resistant ovarian cancer, Phase 2 ongoing) and Novartis's Pluvicto (lutetium-177 vipivotide tetraxetan, PSMA-targeting radiopeptide approved for metastatic prostate cancer).

#nature #anticancer-peptide #ampc16-ca50 #membranolytic-peptide #immunogenic-cell-death #immune-checkpoint-blockade #acid-responsive #tumor-microenvironment #peptide-drug-conjugate #pluvicto #cbx-12

Industry

Hims & Hers Health (NYSE: HIMS) Q2 2026 Earnings Preview for Monday August 10 After Market Close With Koyfin Consensus Estimates of $730.12 Million Revenue (+20% YoY), $47.26 Million EBITDA (+7% YoY), and $0.11 Adjusted Diluted EPS; Analyst Focus on the Peptide-Compounding Revenue Trajectory (Leerink Estimates $440 Million Peptide Sales in 2026 Representing Roughly 15% of the Projected 2026 Revenue Midpoint) and the Post-PCAC Investor Narrative Following the July 23-24 FDA Advisory Panel 6-of-7 Vote Recommending BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon for the Section 503A Bulks List (DSIP Rejected)

Hims & Hers Health (NYSE: HIMS) reports Q2 2026 earnings Monday August 10, 2026 after market close, with a live conference call scheduled for 5:00 PM ET. Koyfin consensus estimates: revenue of $730.12 million (+20% year-over-year), $47.26 million EBITDA (+7% YoY), and $0.11 adjusted diluted EPS. Analyst focus areas beyond the top-line numbers: the peptide-compounding revenue trajectory following the July 23-24 FDA Pharmacy Compounding Advisory Committee (PCAC) 6-of-7 vote recommending BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon for the Section 503A Bulks List (DSIP was rejected); the branded GLP-1 supply migration through the Novo Nordisk Wegovy/Ozempic and Eli Lilly Zepbound/Mounjaro commercial partnerships since Q1 2026; and management commentary on the FDA rulemaking timeline (typically 12-24 months per PCAC-recommended substance) that gates when the July 23-24 PCAC recommendation actually translates into new compounded-peptide revenue lines. Leerink analysts estimate Hims peptide sales at approximately $440 million in 2026, representing roughly 15% of the projected 2026 revenue midpoint; Truist analysts have cautioned that substantial peptide revenue is unlikely before 2028 even with the PCAC advisory support. Chief Medical Officer Dr. Anant Vinjamoori's July 23 PCAC public-comment testimony (which reportedly moved several undecided panelists on the harm-reduction argument for legal 503A compounded peptides) added a public-facing dimension to the Hims peptide strategy that will likely be referenced on the earnings call.

#hims-hers #hims #q2-2026-earnings-preview #peptide-compounding-revenue #440-million #leerink #post-pcac #anant-vinjamoori #harm-reduction #branded-glp-1-migration