BridgeBio Pharma Inc

BridgeBio Pharma, Inc. engages in identifying and advancing transformative medicines to treat patients who suffer from Mendelian diseases. Its pipeline of development programs includes product candidates ranging from early discovery to late-stage development. The company was founded by Charles Homcy, Frank McCormick, Philip Reilly, and Neil Kumar in 2015 and is headquartered in Palo Alto, CA.

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BridgeBio stock rallies on upbeat study results of a drug for a genetic disease that affects the limbs and spine.

BridgeBio Stock Makes A Bullish Move On Dwarfism Treatment Results

- In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015)

BridgeBio Announces Durable Month 12 and 18 Phase 2 Cohort 5 Results of Oral Infigratinib in Achondroplasia, and First Participant Consented in ACCEL for Hypochondroplasia

PALO ALTO, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases, today announced that members of its management team, along with Ravi Savarirayan, M.D., Ph.D., of Murdoch Children's Research Institute in Melbourne, Australia, and the global lead investigator for PROPEL 2, will host a call on June 4, 2024, at 8:00 am ET to share results from Month 12 and Month 18 from Cohort 5 of PROPEL 2, a Phase 2 trial of the investigational oral therapy infigratinib in children with achondroplasia.

BridgeBio to Host Call on Month 12 and 18 Phase 2 Cohort 5 Results of Oral Infigratinib in Achondroplasia on June 4, 2024

BridgeBio Pharma, Inc. stock has fallen by 10% since December, but recent trial data and analyst support have boosted investor enthusiasm recently. The company's primary drug candidate, Acoramidis, has a marketing application accepted by the FDA for review, with a decision expected in November. Acoramidis could have significant peak sales potential in the rapidly growing ATTR-CM market.

BridgeBio Pharma: Upping An Existing Position (Rating Upgrade)

- Acoramidis treatment resulted in increased serum transthyretin (TTR) levels by Day 28 that were sustained and were correlated with a reduced risk of all-cause mortality (ACM), cardiovascular mortality (CVM), and cardiovascular-related hospitalization (CVH) in ATTR-CM participants through month 30

Additional Data Showing Acoramidis Increases Serum Transthyretin Which is Associated with Improved Cardiovascular Outcomes Presented at ISA from BridgeBio Pharma's Phase 3 ATTRibute-CM Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

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- BridgeBio to host investor call on Wednesday, May 29, 2024 at 5:30 pm ET, with presentations from Mathew Maurer, M.D. of Columbia University Irving Medical Center, U.S. and Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S.

BridgeBio Pharma to Present Additional Analyses from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the 2024 ISA Meeting

PALO ALTO, Calif., May 14, 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 Bank of America Merrill Lynch Global Healthcare Conference 2024 in Las Vegas, NV on Wednesday, May 15 at 3:00 pm PT.

BridgeBio Pharma to Participate in the Bank of America Merrill Lynch Global Healthcare Conference 2024

- In a pre-specified Cochran-Mantel-Haenszel sensitivity analysis applied to the entire intention-to-treat (ITT) population of the study (N=632), acoramidis significantly reduced all-cause mortality (p=0.04), with no safety signals of potential clinical concern

BridgeBio Pharma Presents Additional Data and Analyses from its Phase 3 ATTRibute-CM Study in Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at ESC-HF, Including That Acoramidis Treatment Significantly Reduced All-Cause Mortality in a Pre-specified Sensit

- Presented cardiac magnetic resonance (CMR) imaging evidence consistent with clinical improvement observed in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in the ATTRibute-CM Phase 3 study of acoramidis at the American College of Cardiology Annual Scientific Sessions; additional detailed results from ATTRibute-CM are planned for presentation at 2024 medical meetings, including four abstracts accepted for the European Society of Cardiology Heart Failure conference and eleven abstracts accepted for the International Symposium on Amyloidosis in May 2024

BridgeBio Pharma Reports First Quarter 2024 Financial Results and Business Update

BridgeBio Pharma (BBIO) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will BridgeBio Pharma (BBIO) Report Negative Q1 Earnings? What You Should Know

- In this exploratory substudy, treatment with acoramidis was associated with possible cardiac structural and functional improvement compared with placebo, with potential cardiac amyloid regression

BridgeBio Pharma Presents Cardiac Magnetic Resonance (CMR) Imaging Evidence Consistent with Clinical Improvement Observed in the ATTRibute-CM Phase 3 Study in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

BridgeBio Pharma has submitted a New Drug Application (NDA) for acoramidis, a potential treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), to the FDA and a Marketing Authorisation Application (MAA) to the EMA. The company has made deals with partners for revenue sharing, including with Bayer, to market and sell the drug in Europe with a >30% royalty share, and $1.25bn financing. Analysts have speculated that acoramidis could generate peak revenues of $1.8bn, although this may be conservative. Pfizer's Vyndamax/Vyndaqel earned nearly $4bn last year in the indication.

BridgeBio Pharma: Assessing Acoramidis' Market Opportunity, Further Upside Potential Evident

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 addition, BridgeBio has granted the underwriters a 30-day option to purchase up to an additional 1,293,103 shares of its common stock on the same terms and conditions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $250.0 million, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares in the offering to be sold by BridgeBio.

BridgeBio Pharma Announces Pricing of Public Offering of Common Stock

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 shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

BridgeBio Pharma Announces Proposed Public Offering of Common Stock

Bayer AG

BridgeBio Pharma has granted German drugmaker Bayer an exclusive license to commercialize its heart disease drug in Europe, the companies said on Monday.

BridgeBio Pharma, Bayer agree on licensing deal for heart disease drug in Europe

Bayer snagged commercial rights to BridgeBio's lead asset, acoramidis, in Europe for $310 million. BridgeBio stock is nearing a breakout.

BridgeBio, A Top 3% Biotech, Just Snagged A $310 Million Deal; Will Shares Break Out?

- BridgeBio grants Bayer exclusive license to commercialize acoramidis as a treatment for patients with transthyretin amyloid cardiomyopathy (ATTR-CM) in Europe

BridgeBio Pharma and Bayer Announce European Licensing Agreement for Acoramidis in ATTR-CM

BridgeBio Pharma (BBIO) came out with a quarterly loss of $0.96 per share versus the Zacks Consensus Estimate of a loss of $0.95. This compares to loss of $0.87 per share a year ago.

BridgeBio Pharma (BBIO) Reports Q4 Loss, Lags Revenue Estimates

- 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 accepted by the European Medicines Agency (EMA)

BridgeBio Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Analysts Estimate BridgeBio Pharma (BBIO) to Report a Decline in Earnings: What to Look Out for

- BridgeBio grants Kyowa Kirin exclusive license to develop and commercialize infigratinib for skeletal dysplasias in Japan

BridgeBio Pharma and Kyowa Kirin Announce Partnership with an Upfront Payment of $100 Million for an Exclusive License on Infigratinib in Skeletal Dysplasias in Japan

- 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

BridgeBio Pharma Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application (NDA) for Acoramidis for the Treatment of Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

- 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

BridgeBio Pharma Shares Positive Results of Single-Arm Phase 3 Study of Acoramidis in Japanese Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Including No Mortality Reported in the Trial at 30 Months

Invitae

SAN FRANCISCO , Jan. 30, 2024 /PRNewswire/ -- Invitae  (NYSE: NVTA), a leading medical genetics company, today announced a partnership with BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, designed to advance genetics-based drug discovery for rare diseases. The goal of the collaboration is to generate new insights focused on genetic modifiers and the discovery of novel therapeutic targets for rare diseases and other unmet medical needs.

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