July 30, 2026

Alnylam Q2 Amvuttra $1B + Guidance Cut, Sanofi Q2 Dupixent Surge + Amlitelimab Kill, FDA 503B GLP-1 Docket Closes

Alnylam Q2: Amvuttra $1.012B first $1B+ quarter but TTR guidance cut. Sanofi Q2 Dupixent +37.6%, kills amlitelimab. FDA 503B GLP-1 docket closes.

4 stories · Covering industry, regulatory, clinical-trials

Editor's Note

Thursday's peptide-adjacent news carries two major Q2 earnings and one regulatory-deadline story. Alnylam Pharmaceuticals (NASDAQ: ALNY) reported Q2 2026 before market open with Amvuttra (vutrisiran) crossing $1 billion in quarterly revenue for the first time ($1.012 billion, roughly a $4 billion annualized run rate about 15 months after the ATTR-CM launch). Total Q2 revenue reached $1.29 billion (+67% YoY) but fell short of the $1.31 billion analyst consensus, and Alnylam revised full-year 2026 TTR product sales guidance down to $4.2-4.5 billion on normalized second-line volume after initial pent-up demand. Sanofi (NASDAQ: SNY) delivered a Q2 2026 beat with net sales of €11.6 billion (+17.8% at constant exchange rates) driven by Dupixent (+37.6% CER to €5.15 billion) and new pharma launches (+48.3% CER to €1.3 billion), and raised full-year guidance to approximately 10% CER growth. On the same day, Sanofi discontinued three pipeline assets: amlitelimab (OX40-ligand antibody for atopic dermatitis; €952 million intangible impairment), itepekimab, and balinatunfib. And the FDA's public comment period on the April 30, 2026 proposal to permanently exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List closes today, potentially closing the last legal pathway for large-scale compounding of the branded GLP-1s. AIDS 2026 Day 4 in Rio de Janeiro continued with lenacapavir implementation-science programming and the ANRS RHIVIERA satellite on treatment interruption and resumption from HIV cure clinical trials.

Industry

Alnylam Pharmaceuticals (NASDAQ: ALNY) Reports Q2 2026 Earnings Thursday July 30 With Amvuttra (Vutrisiran) Quarterly Revenue Crossing $1 Billion for the First Time at $1.012 Billion (Approximately $4 Billion Annualized Run Rate ~15 Months After the ATTR-CM Launch); Total Q2 Revenue of $1.29 Billion (+67% Year-Over-Year) Fell Short of the $1.31 Billion Analyst Consensus and Full-Year 2026 TTR Product Sales Guidance Revised Down to $4.2-4.5 Billion on Normalized Second-Line Volume; Second-Half 2026 Readouts Expected From ALN-6400 (Hereditary Hemorrhagic Telangiectasia) and ALN-2232 (Obesity/Weight Management)

Alnylam Pharmaceuticals (NASDAQ: ALNY) reported Q2 2026 earnings Thursday July 30, 2026 before market open. Amvuttra (vutrisiran) quarterly revenue crossed $1 billion for the first time at $1.012 billion (approximately a $4 billion annualized run rate approximately 15 months after the ATTR-CM launch). Total Q2 revenue reached $1.29 billion (+67% year-over-year) but fell short of the $1.31 billion analyst consensus. Net product revenues were $1.17 billion (+74% YoY) versus the $1.22 billion estimate. GAAP diluted EPS was $1.21 versus the $1.49 estimate. Full-year 2026 TTR product sales guidance was revised down to $4.2-4.5 billion to reflect normalized second-line volume after the initial pent-up demand from patients waiting for a new therapy. Pipeline updates: Alnylam expects to announce clinical data from Phase 1 and Phase 2 trials of ALN-6400 in healthy volunteers and patients with hereditary hemorrhagic telangiectasia (HHT) in second-half 2026, plus results from the Phase 1 trial of ALN-2232 (Alnylam's second obesity-track siRNA) in the same second-half window. The ALN-6222 obesity siRNA Phase 1 trial (NCT07624071) opened enrollment in July 2026 with a first-in-human single-ascending-dose design in adults with BMI 30-40 kg/m² at a single site in Mount Royal, Canada through December 2027.

#alnylam #alny #q2-2026-earnings #amvuttra #vutrisiran #attr-cm #hattr-pn #aln-6222 #aln-2232 #aln-6400 #hereditary-hemorrhagic-telangiectasia #guidance-cut

Industry

Sanofi (NASDAQ: SNY) Reports Q2 2026 Earnings Thursday July 30 With Net Sales of €11.6 Billion (+17.8% at Constant Exchange Rates) Driven by Dupixent (+37.6% CER to €5.15 Billion) and New Pharma Launches (+48.3% CER to €1.3 Billion), Business EPS of €2.09 (+33.3% CER); Sanofi Discontinues Three Pipeline Assets in the Quarter (Amlitelimab OX40-Ligand mAb for Atopic Dermatitis With a €952 Million Intangible Impairment, Plus Itepekimab and Balinatunfib) and Raises Full-Year 2026 Guidance to Approximately 10% CER Sales Growth With Business EPS Growing Slightly Faster

Sanofi (NASDAQ: SNY) reported Q2 2026 earnings Thursday July 30, 2026 with net sales of €11,597 million (+17.8% at constant exchange rates, +16.0% at actual rates) and business EPS of €2.09 (+33.3% CER), both beating consensus. Growth drivers: Dupixent (dupilumab, IL-4/IL-13 receptor blocking antibody co-marketed with Regeneron) reached Q2 sales of €5,154 million (+37.6% CER); new pharma launches reached €1,305 million (+48.3% CER). Sanofi raised full-year 2026 guidance: sales now expected to grow approximately 10% at CER, with business EPS at CER expected to grow slightly faster than sales. Three pipeline discontinuations disclosed with the earnings release: amlitelimab (OX40-ligand monoclonal antibody previously advanced in atopic dermatitis after acquisition from Kymab; the intangible asset was impaired by €952 million with an announced decision that the drug would not represent a substantial improvement to the standard of care), itepekimab (IL-33 antibody previously advanced in COPD, chronic urticaria, and other Type 2 inflammation indications), and balinatunfib. Stock reaction was mixed with Sanofi shares slipping in premarket trading on the pipeline setbacks despite the earnings beat.

#sanofi #sny #q2-2026-earnings #dupixent #dupilumab #amlitelimab #itepekimab #balinatunfib #atopic-dermatitis #pipeline-discontinuation #impairment #guidance-upgrade

Regulatory

FDA Public Comment Period Closes Thursday July 30, 2026 on the April 30, 2026 Proposed Rule to Permanently Exclude Semaglutide, Tirzepatide, and Liraglutide From the Section 503B Bulks List, Which Would Close the Last Legal Pathway for Large-Scale FDA-Registered Outsourcing Facility Compounding of the Branded GLP-1 Molecules; Docket Followed the FDA Category-2-Unwind Timeline That Also Culminated in the July 23-24 Pharmacy Compounding Advisory Committee (PCAC) Vote Recommending 6 of 7 Peptides for Section 503A Bulks List Inclusion

The FDA public comment period on the April 30, 2026 proposed rule to permanently exclude semaglutide, tirzepatide, and liraglutide from the Section 503B Bulks List closed Thursday July 30, 2026. If the FDA finalizes the rule, large-scale FDA-registered 503B outsourcing facilities will no longer be able to legally prepare compounded semaglutide, tirzepatide, or liraglutide once the shortage-based compounding pathway has fully closed. The 503B exclusion is the parallel-track regulatory action to the July 23-24 PCAC vote on the 7 research peptides for the 503A Bulks List. Where 503A operates under state pharmacy board licensure for individual-patient prescriptions, 503B operates under FDA registration for bulk manufacturing at outsourcing facilities. The 503A vote broadened access to 6 of 7 research peptides (BPC-157, KPV, TB-500, MOTS-c, Semax, Epitalon; DSIP rejected). The 503B exclusion narrows access for the branded GLP-1 franchise. Both actions require FDA rulemaking to formalize, with typical timelines of 6-18 months from the date the agency decides to act. Telehealth companies including Hims & Hers Health (NYSE: HIMS) and LifeMD (NASDAQ: LFMD) have already migrated to branded supply through Novo Nordisk and Eli Lilly commercial channels ahead of the expected 503B closure.

#fda #503b-bulks-list #semaglutide #tirzepatide #liraglutide #comment-period #compounding #outsourcing-facility #peptide-compounding #rulemaking

Clinical Trials

AIDS 2026 Day 4 on Thursday July 30 in Rio de Janeiro Continues With Lenacapavir Implementation Science Programming Including a Cross-Country Implementation Learning Presentation Introducing a Structured Demand Generation Playbook Supporting Effective Introduction and Uptake of Lenacapavir Within a Broader PrEP Choice Framework (16:33-16:41 BRT / 3:33-3:41 PM EDT), Plus the ANRS RHIVIERA Consortium Satellite Symposium 6:00-7:30 PM BRT on 'Treatment Interruption and Treatment Resumption: Lessons Learned From HIV Cure Clinical Trials'

The 26th International AIDS Conference (AIDS 2026) Day 4 continued Thursday July 30, 2026 at Riocentro in Rio de Janeiro. Two Thursday programming highlights: a cross-country implementation learning presentation on lenacapavir demand generation (16:33-16:41 BRT / 3:33-3:41 PM EDT) that introduces a structured demand generation playbook supporting effective introduction and uptake of lenacapavir within a broader PrEP Choice framework, following the Wednesday late-breaker on the Gilead-Merck ISLEND-1 and ISLEND-2 detailed Phase 3 data and the 52-week PURPOSE 1 and PURPOSE 2 open-label extension data on twice-yearly injectable lenacapavir. The ANRS RHIVIERA consortium (French research agency) satellite symposium (18:00-19:30 BRT) covers 'Treatment interruption and treatment resumption: lessons learned from HIV cure clinical trials,' addressing the analytical treatment interruption (ATI) research methodology and the observational learnings from HIV cure-focused trials that have paused antiretroviral therapy to test cure candidates. The conference closes Friday July 31 with the closing session and additional late-breaker presentations. Generic lenacapavir from Dr. Reddy's Laboratories, Hetero Labs, and four other manufacturers is expected in 2027 at approximately $40 per person per year across 120 low- and lower-middle-income countries.

#aids-2026 #lenacapavir #prep-choice #demand-generation #implementation-science #anrs-rhiviera #analytical-treatment-interruption #hiv-cure #rio-de-janeiro #day-4