- The CALIBRATE study of encaleret for patients with ADH1 met all pre-specified primary and key secondary efficacy endpoints  - The primary endpoint was met with 76% of participants administered encaleret achieving 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) - In a key secondary analysis, 91% of participants administered encaleret achieved intact PTH above the lower limit of the reference range at Week 24 compar ...

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

Core Insights - BridgeBio Pharma, Inc. is set to release topline results from the CALIBRATE Phase 3 trial for autosomal dominant hypocalcemia type 1 (ADH1) on October 28, 2025, before market opening [1] - A conference call will be held by management at 8:00 a.m. ET on the same day to discuss the trial data [1] Company Overview - BridgeBio Pharma, Inc. is a biopharmaceutical company focused on discovering, creating, testing, and delivering transformative medicines for genetic diseases [3] - Founded in 2015, the company has a pipeline that includes programs from early science to advanced clinical trials [3] - The team consists of experienced professionals dedicated to applying advances in genetic medicine to benefit patients quickly [3]

Core Insights - BridgeBio Pharma (BBIO) shares experienced a significant increase of 17.1%, closing at $63.56, driven by impressive trading volume and a prior 8.4% gain over the last four weeks [1][2] Company Performance - The stock's rally followed the announcement of positive top-line data from the pivotal phase III FORTIFY study for BBP-418, which met all primary and secondary interim analysis endpoints and showed good tolerability without new safety concerns [2] - The company is expected to report a quarterly loss of $0.88 per share, reflecting a year-over-year decrease of 2.3%, while revenues are projected to reach $105.47 million, marking a substantial increase of 3763.3% compared to the same quarter last year [3] - The consensus EPS estimate for the upcoming quarter has been revised 3.1% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] Industry Context - BridgeBio Pharma is categorized within the Zacks Medical - Generic Drugs industry, which includes other companies like Supernus Pharmaceuticals (SUPN), that recently closed at $52.72, down 0.2% [5] - Supernus has seen a 12.3% return over the past month, with its consensus EPS estimate increasing by 14.3% to $0.3, although this represents a significant decline of 71.7% from the previous year [6]

Core Insights - BridgeBio Pharma, Inc. (NASDAQ:BBIO) is a biotechnology company focused on developing treatments for genetic diseases, particularly rare diseases with significant unmet medical needs [1] - The company has received a price target of $69 from Raymond James, indicating a potential increase of approximately 9.17% from its current stock price of $63.21 [2][6] - Positive interim results from the Phase III FORTIFY trial for Limb-Girdle Muscular Dystrophy Type 2I/R9 have been announced, marking a significant milestone for the company [3][6] - Following the announcement of trial results, BBIO's stock price increased to $63.56, reflecting a 17.14% rise and strong investor confidence [4][6] - BBIO's market capitalization stands at approximately $12.15 billion, indicating its substantial presence in the biotech industry, with a trading volume of 8,339,257 shares today [5]

BridgeBio Pharma (NASDAQ:BBIO) shares rose after it announced positive results from its late-stage study of BBP-418 on patients with limb-girdle muscular dystrophy type 2I/R9. The study successfully met all its main and secondary goals, showing a safety profile that aligns with ...

Core Insights - The webinar is focused on the interim analysis results of the Phase III FORTIFY study for Limb-Girdle Muscular Dystrophy Type 2i/R9 conducted by BridgeBio Pharma [1] Group 1 - The conference is hosted by Krista, the conference operator, indicating a formal presentation setting [1] - Dr. Neil Kumar, the Chief Executive Officer of BridgeBio Pharma, is set to present the findings [1]

U.S. stocks were higher, with the Nasdaq Composite gaining around 1% on Monday.Shares of Janus Henderson Group plc (NYSE:JHG) rose sharply during Monday's session after the company confirmed receiving a non-binding takeover proposal from Trian Fund Management for $46 per share.Janus Henderson Group shares surged 16.2% to $48.36 on Monday.Here are some other big stocks recording gains in today’s session.Avidity Biosciences, Inc. (NASDAQ:RNA) shares jumped 43% to $70.22 after Novartis announced it will acquir ...

Group 1 - The article does not provide any specific content related to a company or industry [1]

Summary of BridgeBio Pharma's FORTIFY Phase Three Interim Analysis Results Webinar Company Overview - **Company**: BridgeBio Pharma - **Focus**: Development of therapies for genetic diseases, specifically targeting limb girdle muscular dystrophy type IIi/R9 (LGMD2i/R9) with the drug BBP-418 - **History**: Founded nearly 10 years ago, has generated almost 20 INDs and three approvals to date [3][25] Key Industry and Company Insights - **Clinical Trial**: FORTIFY is a randomized, placebo-controlled phase three study of BBP-418 - **Patient Population**: Focused on patients with LGMD2i/R9, a progressive genetic disease [9][10] - **Significance of Results**: The interim analysis showed statistically significant improvements in multiple clinical endpoints, marking a potential breakthrough in treatment for LGMD2i/R9 [7][24] Core Findings from the Webinar - **Positive Results**: The phase three results were described as "strongly positive" and exceeded expectations, particularly in functional measures [2][7] - **Key Endpoints**: - **Glycosylated Alpha-Dystroglycan**: Increased by 17% at three months and 23% at 12 months from baseline, significantly exceeding the target of 5% [17][18] - **Serum Creatine Kinase**: Decreased by 82% from baseline at 12 months, indicating reduced muscle breakdown [18] - **100-Meter Time Test**: Patients treated with BBP-418 showed a 0.27 meters per second improvement compared to placebo, translating to a 14-second faster performance [20][21] - **Forced Vital Capacity (FVC)**: Patients experienced a 3% increase from baseline, representing a 5% improvement compared to placebo [22][23] Implications for Patients and Market - **Transformative Potential**: BBP-418 could be the first disease-modifying therapy for LGMD2i/R9, with the potential to improve patient quality of life [6][8] - **Commercial Strategy**: Plans to file an NDA with the FDA in the first half of 2026, with a potential launch in late 2026 or early 2027 [26][27] - **Market Preparation**: The company has been building a commercial foundation in anticipation of positive trial results, aiming to position BBP-418 as the standard of care [27][28] Additional Considerations - **Safety Profile**: The interim analysis indicated a favorable safety profile with no new or unexpected safety findings [24] - **Regulatory Pathway**: Discussions with the FDA will focus on whether to pursue accelerated approval or full approval based on the strength of the data [55][63] - **Patient Identification**: Approximately 7,000 patients are estimated to be diagnosed with LGMD2i/R9 globally, with 2,000 to 2,500 in the U.S. [46][47] Conclusion - The results from the FORTIFY trial represent a significant advancement in the treatment of LGMD2i/R9, with the potential for BBP-418 to transform patient care and establish a new standard in the market for genetic therapies [79]