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BridgeBio Pharma (NASDAQ: BBIO) Stock Quote

Last Trade: US$30.86 1.10 3.70
Volume: 1,453,959
5-Day Change: 8.55%
YTD Change: -23.56%
Market Cap: US$5.690B

Latest News From BridgeBio Pharma

PALO ALTO, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on March 16, 2024, the compensation committee of BridgeBio’s board of directors approved equity grants to 16 new employees in restricted stock units for an aggregate of 71,146 shares of the... Read More
PALO ALTO, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced the pricing on March 5, 2024 of an underwritten public offering of 8,620,690 shares of its common stock at a public offering price of $29.00 per share, before deducting underwriting discounts and commissions. In... Read More
PALO ALTO, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has commenced an underwritten public offering of $250 million of shares of its common stock. BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of... Read More
BridgeBio grants Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe BridgeBio to receive royalties according to a tiered structure beginning in the low-thirties percent, designed to provide BridgeBio the opportunity to maximally share in the blockbuster potential of acoramidis BridgeBio will also receive up to $310 Million USD in... Read More
Submitted New Drug Application (NDA) to US Food and Drug Administration (FDA) for acoramidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) based on positive results of Phase 3 ATTRibute-CM trial, which were published in the New England Journal of Medicine; NDA has been accepted for review with a PDUFA date of November 29, 2024; Marketing Authorization Application (MAA) for acoramidis has also been... Read More
BridgeBio grants Kyowa Kirin exclusive license to develop and commercialize infigratinib for skeletal dysplasias in Japan BridgeBio to receive upfront payment of USD 100 million with royalties up to the high-twenties percent, with additional milestone-based payments Infigratinib is a once daily oral treatment option under development for achondroplasia, which was well-tolerated and demonstrated potentially best-in-class... Read More
PALO ALTO, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on February 05, 2024, the compensation committee of BridgeBio’s board of directors granted thirty-five new employees restricted stock units for an aggregate of 123,838 shares of the Company’s common... Read More
Accepted with Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024; FDA not currently planning to hold an advisory committee meeting to discuss application Marketing Authorization Application accepted by the European Medicines Agency (EMA) with additional global regulatory submissions planned In ATTRibute-CM, acoramidis treatment demonstrated an 81% absolute survival rate and a 0.29 observed mean annual... Read More
Phase 3 open-label, single-arm study conducted in Japan by BridgeBio licensing partner Alexion, AstraZeneca Rare Disease showed consistency with global ATTRibute-CM Phase III trial No mortality was reported over the 30 month acoramidis treatment period Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified These results support local regulatory submission in Japan The findings from... Read More
The raise includes $500 million in cash from Blue Owl and CPP Investments in exchange for a 5% royalty on future global net sales of acoramidis The raise also includes a $450 million credit facility from Blue Owl that refinances existing senior secured credit, extending maturity from 2026 to 2029 subject to certain conditions Additionally, the agreement with Blue Owl provides for the possibility of additional incremental... Read More
ATTRibute-CM demonstrated a significant treatment effect of acoramidis on the primary endpoint (a hierarchical analysis inclusive of all-cause mortality (ACM) and frequency of cardiovascular-related hospitalization (CVH)), with a Win Ratio of 1.8 (p<0.0001) Acoramidis demonstrated an observed 30-month survival rate of 80.7% in the treatment arm of ATTRibute-CM; recent data from the U.S. Social Security Administration... Read More
PALO ALTO, Calif., Jan. 10, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on January 08, 2024, the compensation committee of BridgeBio’s board of directors granted twenty five new employees restricted stock units for an aggregate of 66,963 shares of the Company’s common... Read More
PALO ALTO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will present at the 42 nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 8 at 8:15 am PT. To access the live webcast of BridgeBio’s... Read More
The United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for BBO-8520, a first-in-class orally bioavailable and potentially highly potent small molecule direct inhibitor of KRAS G12C that binds to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRAS G12C BBO-8520 is expected to significantly improve outcomes for patients with... Read More
BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) shared positive feedback that the PROPEL 3 trial design would be acceptable as a registrational study to support a marketing... Read More
PALO ALTO, Calif., Dec. 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on December 05, 2023, the compensation committee of BridgeBio’s board of directors granted thirty new employees restricted stock units for an aggregate of 147,373 shares of the Company’s common... Read More
NDA submission is based on positive results from ATTRibute-CM Phase 3 study, including a highly statistically significant result, demonstrated by a Win Ratio of 1.8 (p<0.0001), on the primary endpoint (a hierarchical analysis prioritizing in order all-cause mortality (ACM), then frequency of cardiovascular-related hospitalization (CVH), then change from baseline in N-terminal prohormone of brain natriuretic peptide... Read More
As previously announced, the primary endpoint (a hierarchical analysis inclusive of all-cause mortality and frequency of cardiovascular-related hospitalization) was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001) The placebo and acoramidis time-to-first event Kaplan-Meier (K-M) curves for a composite of all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH) separated... Read More
PALO ALTO, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that additional Phase 3 data on clinical outcomes from ATTRibute-CM, its study of acoramidis in ATTR-CM will be presented at the AHA Scientific Sessions 2023, taking place in Philadelphia, Pennsylvania... Read More
PALO ALTO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on November 07, 2023, the compensation committee of BridgeBio’s board of directors granted thirty-three new employees restricted stock units for an aggregate of 183,533 shares of the Company’s... Read More
Presented detailed positive results from the ATTRibute-CM Phase 3 study of acoramidis at the European Society of Cardiology (ESC) Congress, demonstrating that patients survived more and were hospitalized less than has been seen in other interventional studies of transthyretin amyloid cardiomyopathy (ATTR-CM) to the Company’s knowledge, including real-world evidence presented at recent cardiology medical meetings The... Read More
PALO ALTO, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on October 06, 2023, the compensation committee of BridgeBio’s board of directors granted nineteen new employees restricted stock units for an aggregate of 227,507 shares of the Company’s common... Read More
In our study, encaleret restored physiologic mineral homeostasis in 13 participants with ADH1, specifically correcting hypocalcemia and reducing hypercalciuria Rapid and sustained impact of encaleret on mineral homeostasis was observed, specifically in the normalization of blood calcium, urine calcium and parathyroid hormone (PTH) No serious adverse events were reported with encaleret and no treatment discontinuations or... Read More
Early assessment of increased glycosylated ⍺DG levels at 3 months predicted subsequent ambulatory improvements at 9 months, supporting the use of glycosylated ⍺DG levels as a potential surrogate endpoint in LGDM2I/R9 Long-term data from the ongoing Phase 2 study of BBP-418 in patients with LGMD2I/R9 at Month 21 demonstrate a well-tolerated safety profile, and stabilization in 10 meter walk test (10MWT), 100-m timed test... Read More
Resilience to manufacture BridgeBio’s lead investigational gene therapy treatments, BBP-631 and BBP-812 Partnership provides an innovative, capital efficient, sustainable model for BridgeBio to develop, test and deliver transformative medicines for patients more quickly PALO ALTO, Calif. & SAN DIEGO / Oct 03, 2023 / Business Wire / BridgeBio Pharma, Inc. (NASDAQ: BBIO) (BridgeBio), a commercial-stage biopharmaceutical... Read More
$250 million financing led by Qatar Investment Authority (QIA) with significant participation from four of the largest investment management firms in the US BridgeBio anticipates this raise, coupled with several less dilutive financings available to the Company, fully capitalizes the Company to profitability PALO ALTO, Calif., Sept. 25, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio or the... Read More
PALO ALTO, Calif., Sept. 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on September 06, 2023, the compensation committee of BridgeBio’s board of directors granted twenty-four new employees restricted stock units for an aggregate of 154,186 shares of the Company’s... Read More
PALO ALTO, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will present at the Morgan Stanley 21st Annual Global Healthcare Conference in New York, NY on Tuesday, September 12 at 10:50 am ET. To access the live webcast of... Read More
BridgeBio completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), and a scientific advice engagement with the European Union (EU) European Medicines Agency (EMA) FDA and EMA alignment was reached on the adequacy of a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial for infigratinib to support a marketing application for the treatment of children with achondroplasia The primary... Read More
The primary endpoint was met (Win Ratio of 1.8) with a highly statistically significant p-value (p<0.0001); this primary endpoint result consistently favored acoramidis treatment across key subgroups, including across both variant and wild-type ATTR patients as well as across New York Heart Association (NYHA) Class I, II, and III patients. In particular, in contrast to results observed in prior studies of TTR stabilizers,... Read More
PALO ALTO, Calif., Aug. 24, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that detailed Phase 3 results from ATTRibute-CM, its study of acoramidis in transthyretin amyloid cardiomyopathy, or ATTR-CM, will be presented at the European Society of Cardiology (ESC) Congress 2023,... Read More
PALO ALTO, Calif., Aug. 04, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on August 02, 2023, the compensation committee of BridgeBio’s board of directors granted seven new employees restricted stock units for an aggregate of 26,657 shares of the Company’s common stock.... Read More
Announced consistently positive results from the Phase 3 ATTRibute-CM study of acoramidis in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), including a highly statistically significant result observed on the primary endpoint with a Win Ratio of 1.8 (p<0.0001) and clinically meaningful and consistent separation observed on measures of mortality, morbidity, function, and quality of life; the Company intends to... Read More
BridgeBio met with the U.S. Food and Drug Administration (FDA) to discuss the use of glycosylated αDG levels as a surrogate endpoint; based on this meeting, the Company believes there is potential to pursue Accelerated Approval in the U.S. for BBP-418 BridgeBio has dosed the first participant in FORTIFY, its global Phase 3 study of BBP-418 in patients with LGMD2I/R9 FORTIFY includes an interim analysis at 12 months focused... Read More
PALO ALTO, Calif., July 18, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on July 10, 2023, the compensation committee of BridgeBio’s board of directors granted eight new employees restricted stock units for an aggregate of 71,250 shares of the Company’s common stock.... Read More
Highly statistically significant result observed on primary endpoint with a Win Ratio of 1.8 (p<0.0001) 58% of ties in Finkelstein-Schoenfeld (F-S) primary analysis broken by all-cause mortality and frequency of cardiovascular-related hospitalization; statistical significance also achieved on an F-S test with those two parameters alone (p=0.0182) Clinically meaningful and consistent separation observed on all measures of... Read More
PALO ALTO, Calif., July 14, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will host an investor call on Monday, July 17 at 8:00 am ET to share topline results from the Phase 3 ATTRibute-CM clinical study in patients with transthyretin amyloid cardiomyopathy... Read More
Project ‘NADER’ is intended to span multiple phases, starting from mapping rare diseases in the UAE and wider region through innovative risk assessment algorithms, and moving towards clinical trials with transformative medicines ABU DHABI, United Arab Emirates and PALO ALTO, Calif., July 12, 2023 (GLOBE NEWSWIRE) -- Burjeel Holdings, one of the largest healthcare providers in the MENA region, and BridgeBio Pharma, Inc. , a... Read More
Treatment with infigratinib at the Cohort 5 dose level resulted in a significant and robust increase in annual height velocity (AHV), with a mean change of +3.38 cm/year from baseline 83% of children in Cohort 5 responded to infigratinib, as defined by an increase from baseline AHV of at least 25%. The mean change from baseline in AHV of responders was +4.08 cm/year Early but promising trends towards improvement in... Read More
PALO ALTO, Calif., June 13, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on June 11, 2023, the compensation committee of BridgeBio’s board of directors granted 14 new employees restricted stock units for an aggregate of 76,800 shares of the Company’s common stock.... Read More
PALO ALTO, Calif., June 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that the updated six month results from Cohort 5 in PROPEL2, a Phase 2 trial of the investigational therapy, infigratinib in children with achondroplasia will be featured in an oral presentation at the... Read More
Following treatment, the N-acetylaspartate (NAA) levels of CANaspire participants are consistent with levels seen in individuals with milder Canavan disease based on findings from the Company’s natural history study and reports in the scientific literature Sustained reductions in NAA were measured in the urine, cerebrospinal fluid (CSF), and brain of all participants and have been observed for over a year in the earliest... Read More
PALO ALTO, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that updated data from CAN aspire , its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease,... Read More
PALO ALTO, Calif., May 11, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on May 9, 2023, the compensation committee of BridgeBio’s board of directors granted 12 new employees restricted stock units for an aggregate of 149,400 shares of the Company’s common stock.... Read More
Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) has now completed last patient last visit and remains on track for topline month 30 registrational data to be announced in late July 2023 Positive results announced in Cohort 5 of Phase 2 PROPEL 2 trial of low-dose infigratinib in children with achondroplasia, demonstrating mean increase in annualized height velocity... Read More
PALO ALTO, Calif., April 27, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will present at the Bank of America Merrill Lynch Global Healthcare Conference in Las Vegas, NV on Wednesday, May 10 at 10:00 am PT. To access the live webcast of... Read More
PALO ALTO, Calif., April 11, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on April 7, 2023, the compensation committee of BridgeBio’s board of directors granted 11 new employees restricted stock units for an aggregate of 134,300 shares of the Company’s common stock. All... Read More
PALO ALTO, Calif., April 07, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on March 7, 2023, the compensation committee of BridgeBio’s board of directors granted five new employees restricted stock units for an aggregate of 25,900 shares of the Company’s common stock. All... Read More
BBP-398, an investigational SHP2 inhibitor, is a potentially best-in-class therapy for use in combination approaches, which is shown by preclinical findings demonstrating its safety profile, continuous, once-daily dosing regimen and synergistic efficacy to treat cancers driven by KRAS mutations If successful, the combination of investigational therapy BBP-398 and OPDIVO has the potential to address the serious unmet need for... Read More
BridgeBio has developed a validated bioassay that directly measures glycosylated ⍺DG, which is central to LGMD2I disease, and enables monitoring of responses to disease-modifying therapies in LGMD2I patients BridgeBio also shared 15-month results from its ongoing Phase 2 study, which showed a doubling of glycosylated ⍺DG in LGMD2I patients treated with BBP-418 A sustained decrease of ≥70% in creatine kinase (CK), a marker of... Read More
- BridgeBio will also share 15-month Phase 2 data and review the Phase 3 clinical trial design of BBP-418, a potential therapeutic for patients with LGMD2I, with initiation of its Phase 3 study expected in mid-2023 - Preliminary findings and study results will be presented in an oral presentation and posters at the Muscular Dystrophy Association (MDA) 2023 Annual Meeting - Additionally, BridgeBio will host an investor call... Read More
PALO ALTO, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced the pricing on March 7, 2023 of an underwritten public offering of 8,823,530 shares of its common stock at a public offering price of $17.00 per share, before deducting underwriting discounts and commissions. In... Read More
PALO ALTO, Calif., March 06, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has commenced an underwritten public offering of $150 million of shares of its common stock. BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of... Read More
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In the highest dose level (Cohort 5, 0.25 mg/kg once daily), the mean change from baseline in annualized height velocity (AHV) at six months was +3.03 cm/yr (p = 0.0022) for the first 10 children with at least six months of follow-up in Cohort 5. The two remaining children who have not yet had six months of follow-up have a... Read More
PALO ALTO, Calif., March 03, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will host an investor call on Monday, March 6 at 7:30 am ET to discuss Phase 2 Cohort 5 data from its PROPEL2 clinical trial of the investigational therapy infigratinib in children with... Read More
Phase 3 ATTRibute-CM registrational trial of acoramidis for transthyretin amyloid cardiomyopathy (ATTR-CM) continues to have high operating fidelity; month 30 topline registrational data are expected to be announced in mid-2023 Phase 2 PROPEL 2 trial of low-dose infigratinib as a potential treatment option for children with achondroplasia continues to progress with Cohort 5 data expected to be announced in March of 2023... Read More
PALO ALTO, Calif., Feb. 17, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that on February 13, 2023, the compensation committee of BridgeBio’s board of directors granted 11 new employees restricted stock units for an aggregate of 59,800 shares of the Company’s common stock.... Read More
PALO ALTO, Calif., Feb. 13, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will host a roundtable discussion on Thursday, February 16 at 12:00 pm ET with Melita Irving, clinical geneticist at Guy's and St Thomas' NHS Foundation Trust, London,... Read More
PALO ALTO, Calif., Feb. 08, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of the management team will participate in the following upcoming investor conferences: SVB Securities Global Biopharma Conference, Virtual: Tuesday, February 14 th at 2:20 pm ET Goldman... Read More
PALO ALTO, Calif., Jan. 04, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 9 at 3:00 pm PT. To access the live webcast of BridgeBio’s... Read More
The CALIBRATE Phase 3 study design incorporates feedback from global regulatory agencies and will compare the effects of encaleret to standard of care on blood and urinary calcium concentrations over a 24 week treatment period in patients with autosomal dominant hypocalcemia type 1 (ADH1) The primary composite endpoint evaluates the proportion of participants with ADH1 achieving blood and urinary calcium within widely... Read More
BridgeBio to host investor call today (October 17, 2022) at 1:30 pm ET to discuss its two most advanced RAS precision oncology programs – KRAS G12C GTP/GDP dual inhibitor development candidate BBO-8520, and its novel PI3Kα:RAS breaker mechanism which is in late lead optimization KRAS G12C GTP/GDP dual inhibitor BBO-8520 has shown significantly greater potency in KRAS models than first-generation KRAS G12C GDP-only inhibitors... Read More
Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG from baseline towards normal levels, suggesting that the investigational oral therapy, BBP-418, has the potential to address the root cause of LGMD2i Large, sustained reduction in creatine kinase (CK) (>75%), a key marker of... Read More
Robust post-dosing changes continue to be seen in key markers associated with severity of disease Pharmacodynamic data from the first three participants show sustained reductions in N-acetylaspartate (NAA) in the brain and urine, suggesting that the investigational therapy is producing functional ASPA enzyme If successful, BridgeBio’s gene therapy could be the first therapeutic option for children born with Canavan disease,... Read More
BBP-398, an investigational SHP2 inhibitor, is a potentially optimal agent for use in combination therapies given its continuous, once-daily dosing in addition to synergistic activity with other agents to treat cancers driven by KRAS G12C mutations The combination of investigational therapy BBP-398 and LUMAKRAS, if successful, has the potential to address the serious unmet need for patients with KRAS G12C-mutated non-small... Read More
The conference will take place at the National Cancer Institute at Frederick, Maryland from October 17-19, 2022 Presentation to include details from next-generation G12C dual inhibitor clinical candidate and characterization of advanced leads from the PI3Kα:RAS breaker program BridgeBio will host an investor call on October 17, 2022 at 1:30 pm ET to discuss the data and next steps for its two lead RAS programs RAS is the... Read More
The first and only treatment in Europe to treat patients with molybdenum cofactor deficiency (MoCD) Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years. European Commission (EC) decision is based on the efficacy and safety data collected to date compared to data from a natural history study. NULIBRY was BridgeBio’s first... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of the management team will participate in the following upcoming investor conferences: Citi’s 17th Annual BioPharma Conference, Boston, MA: September 7 th at 8:50 am ET Morgan Stanley Global Healthcare Conference, New York, NY: September 13... Read More
Initial data readout for patients with PA and MMA expected in the first half of 2023 Interim data from healthy individuals, reported earlier this year, showed that BBP-671 was detected in plasma and cerebrospinal fluid (CSF) at concentrations above predicted therapeutic thresholds, suggesting the compound has the potential to impact key systemic and neurological complications of PA and MMA BridgeBio is in active discussions... Read More
NULIBRY is the first and only approved therapy in the United States (U.S.) and in Israel to treat patients with MoCD Type A, an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants with a median overall survival age of about four years NULIBRY received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2022 recommending approval by the European... Read More
Reported positive interim Phase 2 data for infigratinib in achondroplasia demonstrating a mean increase in annualized height velocity (AHV) of 1.52 cm/year among all Cohort 4 children 5 years of age and older, and announced addition of a 5 th cohort to the trial Reported positive Phase 2 data for encaleret in autosomal dominant hypocalcemia type 1 (ADH1) and announced design of the Phase 3 pivotal study, which is expected to... Read More
At the highest dose level evaluated to date (Cohort 4, 0.128 mg/kg once daily), the mean change from baseline in annualized height velocity (AHV) was +1.52 cm/yr (p=0.02, n=11) and the responder rate was 64% in children 5 years and older 1 Infigratinib was well-tolerated with no serious adverse events (SAE) and no discontinuations due to adverse events (AE) including in Cohort 5 (dose: 0.25 mg/kg once daily) participants... Read More
CHMP recommendation for approval of NULIBRY in the European Union (EU) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A is based on the efficacy and safety data collected to date compared to data from a natural history study Under an accelerated assessment pathway, a decision by the European Commission (EC), which authorizes marketing approval in the European Union (EU), is expected on the... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced a new collaboration with Baylor College of Medicine to identify and translate cutting-edge research into potential therapies for patients with genetic diseases. “In these challenging times we believe it is more important than ever to be a stalwart partner to academic institutions... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced its founding affiliation with Bakar Labs, the incubator at UC Berkeley’s Bakar BioEnginuity Hub. Bakar Labs was established by the University of California (UC), Berkeley and QB3, UC’s research institute for innovation and entrepreneurship in the life sciences and is open to academic... Read More
BBP-711 led to near complete inhibition of glycolate oxidase throughout the dosing period and greater than 10-fold increases in plasma glycolate, suggesting it has the potential to be both a best-in-class therapy and the first oral therapy for PH1 and recurrent kidney stone formers Based on the tolerability and potency of the oral therapy, BridgeBio has met with regulators and intends to initiate a Phase 2/3 pivotal study by... Read More
These results are the first reported demonstration of rapid and robust treatment changes in key disease markers associated with the severity of disease Initial pharmacodynamic results for two participants show unprecedented decreases in N-acetylaspartate (NAA) in the brain and urine, suggesting the therapy is producing functional ASPA enzyme If successful, BridgeBio’s gene therapy could be the first therapeutic option for... Read More
Treatment with encaleret resulted in rapid and sustained restoration of normal mineral homeostasis, with mean values of blood calcium, urinary calcium, and blood PTH within the normal range by day 5 of therapy and sustained at 24 weeks, and was well-tolerated without any reported serious adverse events At week 24 of encaleret treatment, 92% (12/13) of participants had achieved normal trough blood calcium levels in the... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio) and its affiliate company Venthera, Inc. (Venthera), today announced preliminary data from the Phase 1b trial of VT30 topical gel (BBP-681) in patients with venous, lymphatic and mixed venolymphatic lesions of the skin (VM, LM and VLM, respectively), which are rare genetic vascular anomalies driven by dysregulated activation of intracellular PI3K. The data are being shared in... Read More
BridgeBio will host an investor call on June 13, 2022, at 4:30 pm ET to discuss the Phase 2b study results and the planned pivotal Phase 3 study design BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that 24-week Phase 2b data of encaleret in patients with autosomal dominant hypocalcemia type 1 (ADH1)... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of the management team will participate in the following upcoming investor conferences: Jefferies Healthcare Conference, New York, NY: Thursday, June 9 th at 4:00 pm ET Goldman Sachs Global Healthcare Conference, Ranchos Palos Verdes, CA:... Read More
BBP-671 detected in healthy volunteer plasma and cerebrospinal fluid (CSF), suggesting that BBP-671 is entering the brain, a location critical to target neurological complications of PKAN and organic acidemias at their source Results showed BBP-671 increased whole blood acetyl-coenzyme-A (CoA) levels, a signal supporting proof of mechanism of the therapy Based on these data, BridgeBio intends to move forward with the second... Read More
PTR-01 was well-tolerated over a four-month treatment period in RDEB patients Treatment with PTR-01 led to rapid, consistent, and durable wound healing as observed in reduction of wound surface area and clinician-reported assessments All patients that completed the study reported a decrease in pain over the course of treatment with PTR-01 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate company Phoenix Tissue Repair,... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of the management team will participate in the following upcoming investor conferences: Citi Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Panel, Virtual : Wednesday, May 18 th at 2:30 pm ET H. C. Wainwright Global Investment Conference,... Read More
-Entered into a definitive agreement to sell the rare pediatric disease Priority Review Voucher (PRV) it obtained in February 2021 for $110 million -Secured a two-year extension of interest-only period on its existing senior secured credit facility BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that it has entered into a... Read More
BridgeBio is eligible to receive up to $905 million, including an upfront payment of $90 million, and up to $815 million in additional milestone payments and royalties SHP2 inhibitor deal expands earlier agreement between BridgeBio and Bristol Myers Squibb to study BBP-398 in combination with OPDIVO® (nivolumab) in advanced solid tumors with KRAS mutations BridgeBio will continue to lead its three current Phase 1 monotherapy... Read More
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that members of its management team will participate in the Bank of America Securities Healthcare Conference in Las Vegas, NV on Wednesday, May 11 th at 7:40 pm ET. To access the live webcast of BridgeBio’s presentation, please visit the “Events &... Read More
Completed sale to Sentynl Therapeutics of BridgeBio’s NULIBRY™ (Fosdenopterin) for Injection Updated strategic collaboration with Helsinn Group to develop, manufacture and commercialize infigratinib in oncology indications in the U.S.; BridgeBio is eligible to receive regulatory and commercial milestone payments as well as tiered royalties on adjusted net sales from Helsinn Released positive data from Phase 2 study of... Read More
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