PRME

CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the quarter ended March 31, 2026 and provided a business update. “Prime Medicine continues to execute with clear momentum and a focused strategy designed to deliver on the transformative potential of Prime Editing,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “We remain on track to file regulatory applications for PM577 in Wilson Disease in the first half of this year, and for PM647 in AATD mid-year, bringing two of our most advanced programs to the brink of clinical entry, with initial data from both expected in 2027. In parallel, we continue to progress toward a potential BLA filing for PM359, which, if successful, would bring a one-time, potentially curative therapy to people living with CGD, who today face a lifetime of debilitating infections and limited treatment options. With a strengthened leadership team and a continued commitment to disciplined capital allocation, we believe Prime Medicine is well positioned to execute across our pipeline and unlock the broad promise of Prime Editing for patients.” Prime Medicine’s Pipeline: Prime Medicine is currently advancing in vivo programs to cure two of the largest genetic liver diseases, Wilson Disease (WD) and Alpha-1 Antitrypsin Deficiency (AATD). Prime Medicine expects to file an Investigational New Drug application (IND) and/or Clinical Trial Application (CTA) for PM577 in WD in the first half of 2026 and for PM647 in AATD in mid-2026; initial clinical data from both programs are expected in 2027. Prime Medicine is also advancing an in vivo Cystic Fibrosis (CF) program with support from the Cystic Fibrosis Foundation, and efforts to develop Prime Edited CAR-T products for hematology, immunology and oncology in partnership with Bristol Myers Squibb. Additionally, following positive proof-of-concept data from the first two patients treated in its Phase 1/2 study of PM359 for the treatment of Chronic Granulomatous Disease (CGD), Prime Medicine continues to engage in regulatory dialogue with the U.S. Food and Drug Administration (FDA) toward a potential Biologics License Application (BLA) filing for PM359. Recent Corporate Updates: In April 2026, Pr...

Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.55 per share, missing the Zacks Consensus Estimate of $0.76 per share. This compares to earnings of $0.78 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -27.94%. A quarter ago, it was expected that this company would post earnings of $0.84 per share when it actually produced earnings of $0.38, delivering a surprise of -54.76%. Over the last four quarters, the company has not been able to surpass consensus EPS estimates. Harmony Biosciences, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $215.39 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 3.18%. This compares to year-ago revenues of $184.73 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Harmony Biosciences shares have lost about 12.4% since the beginning of the year versus the S&P 500's gain of 7.6%. While Harmony Biosciences has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Harmony Biosciences was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future...

RenovoRx, Inc. (RNXT) is expected to deliver flat earnings compared to the year-ago quarter on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report, which is expected to be released on May 14, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents no change from the year-ago quarter. Revenues are expected to be $0.5 million, up 150% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 6.67% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is signifi...

-- On track to file IND and/or CTA for Wilson Disease and AATD programs in 1H 2026 and mid-2026, respectively; initial clinical data for both expected in 2027 -- -- Ongoing engagement with FDA for PM359 in CGD; plan to submit BLA following final alignment -- -- Prime Medicine reported cash, cash equivalents, investments, and restricted cash of $191M providing cash runway into 2027 -- CAMBRIDGE, Mass., March 03, 2026 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the full year ended December 31, 2025 and provided a business update. “We are shaping the future of genetic medicine by advancing a platform that is rapidly emerging as the predominant gene editing technology. With Prime Editing, we have the opportunity to permanently and safely correct disease-causing mutations across a broad range of indications, supported by our comprehensive IP estate,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “With this foundation, our vision is bold and unwavering: to strategically deliver on the promise of Prime Editing and ensure patients have access to transformative therapies capable of delivering durable, and potentially lasting cures. This begins with PM359, our ex vivo Prime Edited autologous HSC product for CGD, for which we announced breakthrough data in 2025, which we believe supports an accelerated approval in the United States.” Dr. Reine continued, “We are also intensely focused on R&D execution. We are progressing toward key regulatory milestones for our two liver‑focused programs – in Wilson Disease and Alpha-1 Antitrypsin Deficiency – including planned IND and CTA submissions and the initiation of Phase 1/2 clinical trials. In parallel, we continue to generate compelling preclinical data across our portfolio, including for our program for Cystic Fibrosis; to further optimize our modular delivery and manufacturing approaches; and to explore additional collaborations that could expand the reach of our platform. These near‑ and mid‑term milestones position us to deliver important additional clinical validation of Prime Editing, as we accelerate our path toward bringing meaningful, life‑changing therapies to patients.” Prime Medicine’s Pipeline: Prime Medicine is advancing in vivo...

-- New preclinical data for PM577 in Wilson’s Disease (WD) to be presented at AASLD; on-track to file IND and/or CTA in H1’26, with initial clinical data expected in 2027 -- -- Nominated PM647 as development candidate for Alpha-1 Antitrypsin Deficiency (AATD); on-track to file IND and/or CTA in mid-2026, with initial clinical data expected in 2027 -- -- Strengthened leadership team with the appointment of Matthew Hawryluk, Ph.D., M.B.A. as Chief Business Officer -- -- Company to host virtual KOL event at 8:00am ET on Wednesday, November 12, 2025 to showcase Wilson’s Disease Strategy -- CAMBRIDGE, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the quarter ended September 30, 2025 and provided a business update. “We remain steadfast in executing our focused strategy, with efforts centered on advancing our liver-targeted programs in WD and AATD, our Cystic Fibrosis (CF) program as well as exploring additional collaborations – like our efforts with Bristol Myers Squibb – that can expand the reach and impact of our technology,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “In recent months, we’ve made meaningful progress across these priorities. In August, we nominated PM647 as our development candidate for AATD, marking a significant step toward delivering a best-in-class therapy capable of correcting the mutant AATD protein back to normal. And, earlier this week, we welcomed Matthew Hawryluk, Ph.D., M.B.A., as Chief Business Officer, adding a senior leader with deep experience in building companies through internal innovation and high-value strategic collaborations. Following our recent financing, we believe we are well positioned to continue executing across our pipeline and to leverage the versatility and broad reach of our platform to treat some of the most devastating genetic diseases.” Dr. Reine continued, “This progress continues as we enter the fourth quarter. This weekend, we’ll present new preclinical data with PM577 at AASLD, further reinforcing our belief that Prime Editing can precisely correct the disease-causing mutations in patients suffering from Wilson’s Disease.” Prime Medicine’s Pipeline: Prime Medicine is currently advancing in vivo program...

-- New preclinical data for PM577 in Wilson’s Disease (WD) to be presented at AASLD; on-track to file IND and/or CTA in H1’26, with initial clinical data expected in 2027 -- -- Nominated PM647 as development candidate for Alpha-1 Antitrypsin Deficiency (AATD); on-track to file IND and/or CTA in mid-2026, with initial clinical data expected in 2027 -- -- Strengthened leadership team with the appointment of Matthew Hawryluk, Ph.D., M.B.A. as Chief Business Officer -- -- Company to host virtual KOL event at 8:00am ET on Wednesday, November 12, 2025 to showcase Wilson’s Disease Strategy -- CAMBRIDGE, Mass., Nov. 07, 2025 (GLOBE NEWSWIRE) -- In a release issued earlier today by Prime Medicine, Inc. (Nasdaq: PRME) under the same headline, please note the first paragraph under "Prime Medicine’s Pipeline" has been amended to include "Prime Medicine expects to file an investigational new drug application (IND) and/or clinical trial application (CTA) for its WD program in the first half of 2026" rather than the "first half of 2027" as originally issued. Corrected release follows. Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the quarter ended September 30, 2025 and provided a business update. “We remain steadfast in executing our focused strategy, with efforts centered on advancing our liver-targeted programs in WD and AATD, our Cystic Fibrosis (CF) program as well as exploring additional collaborations – like our efforts with Bristol Myers Squibb – that can expand the reach and impact of our technology,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “In recent months, we’ve made meaningful progress across these priorities. In August, we nominated PM647 as our development candidate for AATD, marking a significant step toward delivering a best-in-class therapy capable of correcting the mutant AATD protein back to normal. And, earlier this week, we welcomed Matthew Hawryluk, Ph.D., M.B.A., as Chief Business Officer, adding a senior leader with deep experience in building companies through internal innovation and high-value strategic collaborations. Following our recent financing, we believe we are well positioned to continue executing across our pipeline and to leverage the versatility and broad reach of our...

-- Announced positive data from two patients in Phase 1/2 clinical trial in Chronic Granulomatous Disease (CGD), providing clinical proof-of-concept for Prime Editing; plan to have regulatory interactions based on current dataset -- -- Completed follow-on offering, raising $144.2 million in gross proceeds and extending cash runway into 2027 -- -- Secured up to $24 million in additional funding from the Cystic Fibrosis Foundation to advance Prime Editors for Cystic Fibrosis -- -- Announced leadership transition and strategic restructuring: Allan Reine, M.D., named Chief Executive Officer; focusing efforts on advancing liver franchise and programs funded through external partnerships -- CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the quarter ended June 30, 2025 and provided a business update. “Recent months have been transformative for Prime Medicine. We announced initial data from our CGD program, providing the first clinical evidence that Prime Editing may cure genetic diseases in humans, and outlined a strategic restructuring, reinforcing our commitment to operating with efficiency and financial discipline as we deliver the tremendous power of our technology,” said Allan Reine, M.D., Chief Executive Officer of Prime Medicine. “We enter the second half of 2025 in a position of strength, laser-focused on advancing our internally-funded programs to treat Wilson’s Disease and Alpha-1 Antitrypsin Deficiency, two of the largest genetic diseases treated by targeting the liver – as well as on programs to treat Cystic Fibrosis and with our partner BMS Prime Edited CAR-T products for hematology, immunology and oncology. Importantly, we are highly encouraged by the clinical data from the first two subjects from our CGD program and we intend to engage the FDA based on our current dataset to explore efficient ways to make this medicine available to patients in need.” Dr. Reine continued, “In recent weeks, we announced the successful closing of a $144.2 million financing and the receipt of additional funding from the Cystic Fibrosis Foundation. Together, these reflect a widespread belief in the transformative power of Prime Editing, as well as conviction in our focused strategy...

-- Initial data from Phase 1/2 trial of PM359 for p47phox CGD expected in 2025 -- -- IND and/or CTA for PM577 for Wilson’s Disease on-track for 1H 2026 -- -- Unveiled potentially best-in-class program for AATD; IND and/or CTA filing targeted for mid-2026 -- CAMBRIDGE, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results for the quarter ended March 31, 2025 and provided a business update. “We recently unveiled our AATD program, further demonstrating our commitment to building a liver franchise of Prime Editors designed to cure major genetic diseases,” said Keith Gottesdiener, M.D., President and Chief Executive Officer of Prime Medicine. “Both our Wilson’s Disease and AATD programs are advancing through preclinical development, and we look forward to initiating clinical trials in both indications in 2026. In addition, we remain on track to report initial data from our Phase 1/2 trial of PM359 in CGD this year, and continue to progress our efforts in CF.” Dr. Gottesdiener continued, “While PM359 leverages a different delivery mechanism from our programs in liver and lung diseases, we believe our forthcoming CGD data could provide important readthrough across our pipeline. If positive, these data would demonstrate the potential of Prime Editing as a powerful and differentiated technology, potentially capable of offering curative benefit to patients following a single treatment. We remain committed to executing with focus and discipline as we approach these first in-human data, which we hope will mark a key inflection point on our path to sustained growth.” Prime Medicine’s Pipeline: Prime Medicine is advancing a set of high-value programs across its core areas of focus (hematology, immunology and oncology, liver, and lung). These include ex vivo hematopoietic stem cell (HSC) programs for the treatment of p47phox chronic granulomatous disease (CGD) and X-linked CGD; lipid nanoparticle (LNP) Prime Editors for the treatment of Wilson’s Disease and alpha-1 antitrypsin deficiency (AATD); LNP or adeno-associated virus (AAV) Prime Editors for the treatment of cystic fibrosis (CF); and ex vivo T-cell therapies, which are being developed in collaboration with Bristol Myers Squibb. Recent Business Upda...