News

• Phase 3 CALIBRATE primary results were presented in an oral presentation at the 2026 ECE, demonstrating the rapid and durable benefit of encaleret across key clinical parameters in ADH1
• All pre-specified primary and key secondary efficacy endpoints were met in the Phase 3 CALIBRATE trial; 76% of participants administered encaleret achieved both serum and urine calcium within the respective target ranges at Week 24 compared to 4% when on conventional therapy at Week 4 (p<0.0001)
• Encaleret may be eligible for priority review; BridgeBio anticipates U.S. launch in early 2027
• If approved, encaleret could be the first approved therapy specifically indicated for individuals living with ADH1
• BridgeBio also intends to initiate the RECLAIM-HP Phase 3 clinical study of encaleret in chronic hypoparathyroidism in Summer 2026

Palo Alto, CA -- May 12, 2026 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the submission of its New Drug Application (NDA) to the FDA for encaleret as a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1).

CALIBRATE, the Phase 3 clinical trial of encaleret in ADH1, successfully achieved all pre-specified primary and key secondary efficacy endpoints, supporting encaleret’s potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1. The topline results can be found here. Additional positive results were presented at the European Congress of Endocrinology (ECE) 2026 in an oral presentation, with data showing comprehensive normalization of mineral homeostasis.

• Compass is the most advanced company in classic psychedelics and has generated positive data from two ongoing large, well controlled Phase 3 clinical trials, designed to uphold the highest regulatory standards
• FDA grants Compass NDA rolling submission and review request, based on Phase 3 data
• CNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin, for treatment-resistant depression (TRD)
• CNPV further accelerates momentum and Compass is confident and ready to deliver for patients

London and New York, NY -- April 24, 2026 -- Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be entitled to benefits including enhanced communications and a shortened 1-2 month review time following filing of a New Drug Application (NDA), while maintaining FDA’s rigorous safety and efficacy standards.

• BBO-11818 is currently being evaluated in the Phase 1 KONQUER-101 trial in subjects with locally advanced unresectable or metastatic KRAS-mutant solid tumors
• Updated Phase 1 clinical data are expected in the second half of 2026

South San Francisco, CA -- April 20, 2026 -- BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BBO-11818 for the treatment of adult patients with advanced KRAS-mutant pancreatic ductal adenocarcinoma.

"Receiving Fast Track designation from the FDA for BBO-11818 in KRAS-mutant pancreatic ductal adenocarcinoma reflects the importance and urgency of accelerating the development of our pan-KRAS inhibitor in this serious disease," said Yong Ben, MD, Chief Medical and Development Officer of BBOT. "Pancreatic cancer remains one of the most difficult-to-treat malignancies. KRAS mutations are present in the vast majority of cases, yet patients have had few targeted options. This designation will help us collaborate closely with the FDA to advance BBO-11818 as efficiently as possible for patients who need new options."

• Comprehensive submission includes interim Phase 3 FORTIFY data demonstrating BBP-418’s rapid, consistent treatment effect and favorable safety profile, with statistically significant and clinically meaningful improvements in ambulation and pulmonary function
• Based on ongoing discussions with the FDA, BridgeBio anticipates approval with a U.S. launch anticipated in late 2026/early 2027
• If approved, BBP-418 has the potential to become the first and only therapy for individuals living with LGMD2I/R9 and may represent the first approved treatment for any form of LGMD

Palo Alto, CA -- March 30, 2026 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today announced the submission of its New Drug Application (NDA) to the FDA for oral BBP-418 for the treatment of individuals living with limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).

“This NDA submission brings us one step closer to delivering the first approved therapy to individuals and families affected by LGMD2I/R9, a severe, progressive neuromuscular disease,” said Christine Siu, Chief Executive Officer of BridgeBio Neuromuscular. “This achievement not only reflects the strength of the data, but also our dedicated focus on addressing the urgency of a community that has long been waiting for meaningful treatment options. We are committed to working closely with the FDA to make this potential disease-modifying therapy available as quickly as possible.”

• Earliest timepoint in an open-label extension with this magnitude of risk reduction at 44.7% in ACM (p<0.0001) and 49.3% in CVM (p<0.0001)
• Acoramidis mitigated the rise in NT-proBNP through Month 54 to an extent not seen in the era of disease modifying treatments
• Early and continuous acoramidis treatment stabilized and maintained all measures of heart failure-related QOL scores (KCCQ-OS), which demonstrates that the improvement in duration and quality of life in patients with ATTR-CM by acoramidis is sustained

Palo Alto, CA -- March 30, 2026 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a biopharmaceutical company focused on developing medicines for genetic conditions, today presented long-term efficacy and safety data from the ATTRibute-CM open-label extension (OLE) trial, demonstrating sustained clinical benefit of acoramidis through Month 54 in patients with ATTR-CM. These data were presented at the American College of Cardiology (ACC) Annual Scientific Sessions & Expo in a late-breaking oral presentation by Prem Soman, M.D., Ph.D. of University of Pittsburgh School of Medicine and it was the only ATTR-CM presentation selected for the ACC late-breaker session. These data are now simultaneously published in JAMA Cardiology. Acoramidis is the only selective small molecule, orally administered, near-complete (≥90%) transthyretin (TTR) stabilizer.

London and New York, NY -- February 26, 2026 -- Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the exercise of 35,059,448 warrants, which were issued on January 13, 2025, for proceeds of approximately $200 million. Upon exercise of these outstanding warrants, Compass Pathways is issuing 15,160,619 American Depositary Shares (“ADSs”) and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 19,898,829 ADSs.

Compass Pathways currently intends to use the proceeds from these warrant exercises, together with its existing cash and cash equivalents, to fund ongoing COMP005 and COMP006 Phase 3 trials, its Phase 2b/3 trial of COMP360 in PTSD, acceleration of its commercial readiness activities, and for working capital and general corporate purposes.

The net proceeds from these warrant exercises, along with the net proceeds of approximately $141 million from the recent public offering that closed on February 20, 2026, and its existing cash and cash equivalents, is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028.

London and New York, NY -- February 18, 2026 -- Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of its public offering of 17,500,000 American Depositary Shares (“ADSs”) at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per pre-funded warrant. In addition, Compass Pathways has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 ADSs at the public offering price, less the underwriting discounts and commissions. All of the securities are to be sold by Compass Pathways. The offering is expected to close on or about February 20, 2026, subject to the satisfaction of customary closing conditions.

The gross proceeds to Compass Pathways from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be $150.0 million. Compass Pathways currently intends to use the net proceeds from this offering, together with its existing cash and cash equivalents, to fund ongoing COMP005 and COMP006 Phase 3 trials, its Phase 2b/3 trial of COMP360 in PTSD, acceleration of its commercial readiness activities, and for working capital and general corporate purposes.

Jefferies, TD Cowen, Cantor and Stifel are acting as joint book-runners for the offering. H.C. Wainwright & Co. is also acting as lead manager for the offering. LifeSci Capital is acting as Compass Pathways’ financial advisor.

NEW HAVEN, CT -- February, 3, 2026 -- Veradermics, Incorporated (“Veradermics”), (NYSE: MANE) a dermatologist-founded, late clinical-stage biopharmaceutical company focused on developing innovative therapeutics for common aesthetic and dermatological conditions, today announced the pricing of its upsized initial public offering of 15,077,647 shares of its common stock at an initial public offering price of $17.00 per share. All of the shares are being offered by Veradermics. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $256.3 million. Veradermics’ common stock is expected to begin trading on the New York Stock Exchange on February 4, 2026 under the ticker symbol “MANE”. The offering is expected to close on February 5, 2026, subject to the satisfaction of customary closing conditions. In addition, Veradermics has granted the underwriters a 30-day option to purchase up to an additional 2,261,647 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

Jefferies, Leerink Partners, Citigroup, and Cantor are acting as joint book-running managers for the offering.

Boston, MA -- January 8, 2026 -- Monte Rosa Therapeutics, Inc. (“Monte Rosa”) (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced the pricing of an underwritten public offering of 11,125,000 shares of its common stock at a public offering price of $24.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,375,000 shares of common stock at a public offering price of $23.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant. Monte Rosa also granted the underwriters a 30-day option to purchase up to an additional 1,875,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Monte Rosa from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $300 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares and pre-funded warrants in the offering are to be sold by Monte Rosa. The offering is expected to close on or about January 12, 2026, subject to satisfaction of customary closing conditions.

Jefferies, TD Cowen and Piper Sandler are acting as joint book-running managers for the offering. Wedbush PacGrow and LifeSci Capital are acting as passive bookrunners for the offering.

- Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes

- Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date:

- In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalizations (CVH)) durably separated relative to placebo
- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30

- With this approval, BridgeBio will receive a $500 million payment under our royalty funding agreement

Palo Alto, CA -- November 22, 2024 -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the Company), a new type of biopharmaceutical company focused on genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.

“We are excited to be part of the celebration for the FDA approval of Attruby. The need for more treatment options for patients living with ATTR-CM is crucial to achieving the goal of better outcomes and improved quality of life. Access to this new therapy means more hope and more opportunity to improve the lives of patients with amyloidosis,” said Muriel Finkel, President of Amyloidosis Support Groups, a non-profit organization dedicated to the support of amyloidosis patients and caregivers.

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby was designed to mimic a naturally occurring "rescue mutation” of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.

The ATTRibute-CM Phase 3 study enrolled 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR. Participants were randomized 2:1 to receive Attruby or placebo for 30 months. As published in The New England Journal of Medicine, the trial successfully met its primary endpoint of a 4-component composite endpoint of ACM, CVH, N-terminal prohormone of brain natriuretic peptide (NT-proBNP), and 6-minute walk distance with a Win Ratio of 1.8 (p<0.0001). Attruby demonstrated a statistically significant treatment effect at 30 months on the Kansas City Cardiomyopathy Questionnaire and 6-minute walk test. Additionally, the increase in NT-proBNP on treatment was about half that of placebo.