Tag: Update

DURECT Corporation Reports First Quarter 2023 Financial Results and Business Update

– Webcast of Earnings Call Today, May 8th at 4:30 p.m. ET

– Topline data from AHFIRM trial expected in 2H 2023

CUPERTINO, Calif., May 8, 2023 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended March 31, 2023 and provided a corporate update.

“We are rapidly approaching the completion of enrollment in our Phase 2b AHFIRM trial later this quarter and remain on track to report topline data in the second half of 2023.  We are preparing to file an NDA for larsucosterol in alcohol-associated hepatitis (AH) if the AHFIRM trial outcome is positive and are in the early stages of commercial launch planning in the U.S.,” stated James E. Brown, D.V.M., President and CEO of DURECT.  “If approved, larsucosterol would be the first FDA-approved treatment for AH.  We also are pleased that an article describing our Phase 2a data in AH has been published online in The American Journal of Gastroenterology.  This peer-reviewed publication provides further insight into the efficacy and safety of larsucosterol in AH and underscores the insufficiency of current treatment approaches for this highly lethal disease.” 

Recent Business Highlights:

  • AHFIRM approaching completion – DURECT has enrolled more than 285 patients in the AHFIRM trial to date, which exceeds 95% of the target enrollment for the 300-patient trial.  We have enrolled patients at leading hospitals in the U.S., Australia, E.U. and U.K., including prominent transplant centers.  We continue to expect to complete enrollment in the AHFIRM trial in the second quarter of 2023, which should enable topline data to be reported in the second half of 2023.
  • Peer-reviewed publication of Phase 2a trial of larsucosterol in AH – Additional data from our previously completed Phase 2a trial evaluating larsucosterol in AH was recently published online by
Read More ...

ERYTECH Provides Business and Financial Update for the First Quarter of 2023

Erytech Pharma S.A.

Erytech Pharma S.A.

ERYTECH Provides Business and Financial Update
for the First Quarter of 2023

Lyon (France) and Cambridge (MA, US), May 9, 2023 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today provided a business and financial update for the first quarter of 2023.

In February this year, we were pleased to announce our strategic plans with Pherecydes, with the intent to build a global leader in phage therapy and address the huge medical need caused by antimicrobial resistance. We are now progressing through the preparation steps for this merger, and, as our teams have started intensive interactions in that respect, we already see a remarkable match of our respective capabilities and prospects for fruitful synergies., said Gil Beyen, Chief Executive Officer of ERYTECH. The Management and Board of ERYTECH are convinced that the strategic choice of combining with Pherecydes and creating a champion in AMR is of the best interest of ERYTECH and its stakeholders, and will be pleased to propose this ambitious strategic move for approval to the Company’s shareholders at the next General Assembly Meeting in June. For the sake of transparency, we inform the market that ERYTECH was recently contacted by a new shareholder, Akkadian Partners, who shared with us its opposition to ERYTECH’s merger project with the objective to conduct alternative acquisition projects through ERYTECH. After due consideration by Management and the Board of directors of ERYTECH, these alternative ideas were deemed not to be in the best interest of ERYTECH and its stakeholders and certainly not of sufficient robustness and value to distract the Company from its strategic direction.

Business Highlight

Read More ...

Global Weekly Economic Update | Deloitte Insights

  • Another bit of good news concerns inflation. The US government reported that, in March, consumer prices were up only 5% from a year earlier, the lowest reading since May 2021. Recall that inflation peaked at 9.1% in June 2022. Thus, inflation has receded quite quickly. However, the bad news is that core inflation remains more persistent. That is, when volatile energy and food prices are excluded, core prices were up 5.6% from a year earlier, slightly higher than in the previous month. Still, core inflation is down from a peak of 6.6% in September 2022. Core inflation is being sustained, in part, by the lagged effect of rising home prices. The shelter component of the consumer price index was up 8.2% in March from a year earlier. It is expected that, later this year, the recent decline in home prices will help to dampen core inflation. Meanwhile, a debate rages about the persistence of inflation and whether the Federal Reserve should retain a tight monetary policy. 
  • Also on the positive side is the condition of financial markets. Recall that the Federal Reserve spent much of 2022 tightening monetary policy with the intention of weakening credit markets in order to fight inflation. For much of 2022, credit market conditions did, in fact, worsen. Risk spreads rose and financial market indicators worsened. Yet starting in October 2022, things reversed. Measures of financial-market stress improved while risk spreads fell sharply—at least until the banking crisis that began when Silicon Valley Bank failed. Then, risk spreads rose sharply. However, the successful intervention by the Fed and the US Treasury stabilized the banking sector and led to a quick decline in risk spreads to the precrisis level. Thus, a Lehman Brothers–type event was averted and markets appear to be in reasonably good shape. The perceived
Read More ...

Catalent Provides Business Update and Names Ricky Hopson as Interim Chief Financial Officer

SOMERSET, N.J., April 14, 2023–(BUSINESS WIRE)–Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced a business update. While complete financial information and operating data for the Company’s third fiscal quarter ended March 31, 2023 are not yet finalized, the Company expects that productivity issues and higher-than-expected costs experienced at three of its facilities, including two of its largest manufacturing facilities, during the quarter will materially and adversely impact the Company’s financial results for the third fiscal quarter and its outlook for the remainder of the 2023 fiscal year.

The Company also today announced that Ricky Hopson will assume the role of Interim Chief Financial Officer, effective April 14, 2023. Catalent is engaging a leading, global executive search firm to evaluate candidates for a permanent Chief Financial Officer.

Business Update

One of the facilities that experienced productivity issues is the Company’s gene therapy manufacturing site located in Harmans, Maryland near the BWI airport (“BWI”), where the Company’s plans to increase capacity for a customer’s product during the third quarter in order to ramp production was slower than expected. During this ramp-up, certain operational challenges, including those related to the initial deployment of a new enterprise resource planning (ERP) system at BWI, significantly reduced the expected revenue in the third fiscal quarter associated with the site, and will also impact revenue previously expected in the fourth quarter.

Timely resolution of these issues was delayed by the necessity of focusing site resources on important regulatory inspections involving the BWI site, which were successfully completed. The ERP-related challenges were operational in nature and will not impact the Company’s ability to produce timely and accurate financial statements.

None of these issues is expected to adversely

Read More ...

Ascendis Pharma Announces First Quarter 2023 Financial Results and Business Update Conference Call on April 27

Ascendis Pharma

Ascendis Pharma

COPENHAGEN, Denmark, April 13, 2023 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that the company will hold a conference call and live webcast on Thursday, April 27, 2023, at 4:30 p.m. Eastern Time (ET) to review its first quarter 2023 financial results and provide a business update.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.

About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated, global biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg, Munich, and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ ability to apply its TransCon platform technology to build a leading, fully integrated global biopharmaceutical company, and (ii) Ascendis’ use of its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out

Read More ...

Exscientia Business and Financial Update for the Full Year 2022

OXFORD, U.K., March 23, 2023–(BUSINESS WIRE)–Exscientia plc (Nasdaq: EXAI)

Recent developments in the Company’s pipeline, collaborations, and operations as well as financial results for the fourth quarter and full year 2022 are summarised below. Exscientia will host a conference call today, March 23, at 12:30 p.m. GMT / 8:30 a.m. EDT.

“2022 was marked by significant milestones for Exscientia, including signing a groundbreaking strategic collaboration with Sanofi, as we continue to validate our end-to-end platform of AI-driven tools and distinguish ourselves as leaders in AI-based drug design, discovery and development,” said Professor Andrew Hopkins, D.Phil., founder and Chief Executive Officer of Exscientia. “We also initiated IGNITE, a Phase 1/2 study of our A2A receptor antagonist EXS21546 (‘546), and are using the clinical data to further confirm biomarker accuracy in selecting patients likely to respond best to treatment. More recently, last month, Bristol Myers Squibb initiated a first-in-human study of EXS4318 (‘4318), our fourth AI-designed molecule to enter the clinic and the first in inflammatory disease. Looking at progress to date, we remain very confident in our differentiated approach and our company’s ability to bring innovative, high-quality treatments to patients faster and more efficiently than today’s industry standard.”

Recent Highlights

Internal pipeline

  • In March 2023, Exscientia highlighted two new differentiated precision oncology programmes in IND-enabling studies; EXS74539 (‘539), a reversible and brain penetrant LSD1 inhibitor and EXS73565 (‘565), an allosteric MALT1 protease inhibitor

  • In November 2022, Exscientia initiated IGNITE, a Phase 1/2 study of its A2A product candidate, ‘546, with the first patient expected to be enrolled in the first half of 2023

    • The trial is examining the safety, efficacy, pharmacokinetics and pharmacodynamics of ‘546 when used in combination with anti-PD-1 therapy in renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC), and will enrol

Read More ...

Study update Possibility Intelligence, Q4 2022: Substantial worldwide prospects can give a raise

Investigate update, Danger Intelligence

Read the complete investigate update listed here:

Hazard Intelligence has adopted new accounting concepts for its revenue recognition. Net sales ended up marginally above our modified forecast, whilst profitability lagged. Significant units ARR grew year-on-year by 9.7% to DKK 16.0m. We estimate a honest price for every share of DKK 5.7 (6.7).

Income over anticipations and new income recognition method

To superior evaluate Danger Intelligence to other organizations with a large proportion of recurring revenues, the firm has preferred to periodise the recurring revenues. That is, in its place of recognising them as revenue when the consumer is invoiced.

The adjust in accounting was carried out forward of the Q4 report. For the duration of the past quarter, web gross sales increased by 11.1% to DKK 4.8m. That was a little over our forecast of DKK 4.6m. In parallel, the most important corporations go on to make development. At the finish of Q4 2022, recurring program profits (Method ARR) amounted to DKK 16.0m, corresponding to a progress of 9.7%. Note that adjustments in accounting policies negatively impacted the ARR determine. ARPU grew by 9.4% 12 months-on-12 months. Revenues from the present shopper base amplified by around 11%.

The charge foundation, excluding depreciation and amortisation, enhanced by 42.5%. At the exact same time, the unfavorable EBITDA result of minus DKK 2.5m improved by a element of 2.2x, YoY. We experienced expected an EBITDA outcome of minus DKK .8m. No cost dollars flow was minus DKK 1.4m, in contrast to minus DKK 1.2m in Q4 2021. At the conclusion of Q4 2022, cash amounted to DKK .3m. Finances are as a result below strain. In our situation, the business will need to have to raise new exterior money. Also, all through the recent quarter, the business has reimbursed

Read More ...

Albemarle to Host 2023 Strategic Update Including New 5-Year Outlook and Preliminary 2022 Results

CHARLOTTE, N.C., Jan. 23, 2023 /PRNewswire/ — Albemarle Corporation (NYSE: ALB), a leader in the global specialty chemicals industry, will host its virtual 2023 Strategy Update tomorrow, Jan. 24, 2023, at 9:00 a.m. ET.  The event is expected to conclude at approximately 10:45 a.m. ET.

Albemarle CEO Kent Masters and CFO Scott Tozier will present alongside Netha Johnson, president, Specialties, and Eric Norris, president, Energy Storage. The presentations and related discussions will provide details on corporate strategy, preliminary and unaudited fourth-quarter and full-year 2022 results and highlights, 2023 guidance and five-year outlook.

Key Themes for the 2023 Strategic Update include:

  • Building on durable competitive advantages to accelerate growth and deliver long-term value
  • Reshaping the company’s core portfolio with a stronger focus on growth opportunities to enable mobility, energy, connectivity and health
  • Reinforcing Albemarle’s commitment to advancing sustainability and building a more resilient world
  • Expanding capacity while maintaining financial flexibility and a disciplined approach to capital allocation 
  • Adding new leadership to reinforce relationships with external stakeholders 
  • Delivering on the company’s comprehensive operating model to drive operational performance

“We delivered record results in 2022, exceeding our previous projections, and our updated outlook and long-term targets reflect further growth acceleration,” said Albemarle CEO Kent Masters. “Albemarle is a leading producer of critical ingredients for some of the most powerful trends transforming the modern world, and we are partnering with other industry leaders to provide secure supply, innovative technologies and improved sustainability. Our virtual strategy event will give investors a deeper understanding of who we are, where we are headed and how we plan to manage our growth to balance short- and long-term opportunities.”

Albemarle is introducing full-year 2023 guidance and 2027

Read More ...

CARMAT Provides a Business Update and Communicates Its Financial Targets for the First Time

PARIS–(BUSINESS WIRE)–Regulatory News:

CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, provides a business update, and communicates its financial targets for the first time.

Sales forecast of €10 to €13 million in 2023

CARMAT resumed commercial implants of its Aeson® artificial heart in November 2022. The Company continues to train additional hospitals very actively, and targets 30 operational centers in Europe by the end of 2023, primarily in Germany and Italy.

In France, Aeson® will be made available to patients via the EFICAS study, which was initiated last December, in 6 hospitals: Lille Regional University Hospital, Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon). The Company aims to complete the study in 2025.

The production ramp-up will be gradual and should allow more than 100 artificial hearts to be produced in 2023.

Based on this, the Company forecasts sales of €10 million to €13 million in 2023.

Break-even anticipated in 2027

Moreover, in order to support a strong demand for Aeson® in Europe, and its commercial launch in the United States, anticipated in 2026, CARMAT has planned an ambitious industrial plan which should enable the Company to achieve a manufacturing capacity of 500 prostheses in 2024 and 1,000 prostheses by 2027.

Based on this, the Company anticipates to be in position to achieve break even within 5 years, i.e. in 2027.

Stéphane Piat, Chief Executive Officer of CARMAT, commented: The last few months have been full of valuable learnings and have allowed us to fine-tune our market access and our industrial strategies. Given

Read More ...