On May 4, 2021 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported positive top-line results from the Company’s GENESIS Phase 3 trial evaluating its lead clinical candidate, Motixafortide, in combination with granulocyte colony stimulating factor (G-CSF, the standard of care in this indication), for hematopoietic stem-cell mobilization for autologous bone marrow transplantation in multiple myeloma patients (Press release, BioLineRx, MAY 4, 2021, View Source [SID1234579067]).

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An analysis of data on all 122 enrolled patients (the intent to treat, or ITT, population) found highly statistically significant evidence across all primary and secondary endpoints favoring Motixafortide in addition to G-CSF, as compared to placebo plus G-CSF. In addition, the combination was found to be safe and well tolerated.

The primary endpoint of the study demonstrated a 4.9-fold increase (70.0% vs 14.3%; difference 54.6%; 95% CI 39.7-69.5%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm mobilizing ≥ 6 million CD34+ cells/kg in up to two apheresis sessions, and after only one administration of Motixafortide. This translates to an odds-ratio of 12.9.

The study also achieved its main secondary endpoint, demonstrating a 14.1-fold increase (67.5% vs 4.8%; difference 61.7%; 95% CI 49.5-73.8%; p<0.0001) in the proportion of patients in the treatment arm, as compared to the control arm, who mobilized ≥ 6 million CD34+ cells/kg in just one apheresis session. This translates to an odds-ratio of 56.0.

Other important data from the study include median number of CD34+ cells collected on the first day of apheresis (8.5 million in the treatment arm vs 1.5 million in the control arm) – a 5.6-fold increase. The addition of Motixafortide to G-CSF also allowed 88.3% of patients to undergo transplantation after only one apheresis session, compared to 10.8% in the G-CSF arm – an 8.2-fold increase. Engraftment endpoints, including the number of days needed for engraftment, success of engraftment and the durability of engraftment 100 days post-transplant, further support the study’s success.

"The results of the GENESIS study are extremely impressive, and all the more so when considering that almost 90% of the patients in the treatment arm proceeded to transplantation after only one apheresis session," stated John DiPersio, MD, Washington University School of Medicine, and lead investigator of the study. "This is a great achievement in alleviating the burden for the patients and reducing hospital resources. I believe these results make the combination of Motixafortide and G-CSF a very attractive candidate for use in all patients with multiple myeloma undergoing autologous stem-cell transplantation."

"These strikingly positive data significantly exceeded our expectations, and are truly transformational for our company," stated Philip Serlin, Chief Executive Officer of BioLineRx. "The statistical significance across all primary and secondary endpoints was consistent across twelve different sensitivity analyses. These results support our goal of becoming the standard of care for autologous bone-marrow transplantation, providing a strong clinical and pharmaco-economic advantage for its use, on top of G-CSF, in all transplant procedures.

"We are working aggressively to gain regulatory approval for Motixafortide in this transplant setting for multiple myeloma patients – with plans to make an NDA submission in the first half of next year – and we are also pressing forward to unlock the full potential of this therapy in this and other stem-cell mobilization indications. I would like to express our sincere thanks to the patients and investigators who participated in the study and enabled its great success," Mr. Serlin concluded.

Conference Call and Webcast Information
BioLineRx will hold a conference call today, Tuesday, May 4, 2021 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-860-9642 from the US or +972-3-918-0644 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available for a limited time approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 6, 2021; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

About the GENESIS Trial
The GENESIS trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem-cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. Local laboratories and a central laboratory were used to determine CD34+ cell yields. For regulatory purposes, efficacy endpoints were calculated using the percentage of CD34+ cells determined by the central laboratory. The local laboratory values were used for all clinical decisions, including the number of apheresis days and the decision to proceed to transplantation.

On May 4, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2021 financial results (Press release, Bausch Health, MAY 4, 2021, View Source [SID1234579066]).

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"Bausch Health entered 2021 with strong momentum as our recovery from the COVID-19 pandemic continues. Our business is generating strong cash flow, many of our leading products have increased market share in key markets, and we are advancing our pipeline," said Joseph C. Papa, chairman and CEO, Bausch Health.

"We are taking action to accelerate the strategic alternatives process to expedite the spinoff of Bausch + Lomb as we remain committed to unlocking value across our two attractive businesses. We are focused on execution and growth as we position these two strong, but dissimilar businesses as attractive growth opportunities in the markets they serve," continued Mr. Papa.

Select Company Highlights

Increased total Company reported revenue by 1% compared to the first quarter of 2020
Launched Solta Medical’s Clear + Brilliant Touch laser in the United States
Launched Bausch + Lomb’s Alaway Preservative Free (ketotifen fumarate ophthalmic solution, 0.035%), antihistamine eye drops in the United States
Entered into an agreement to divest Amoun Pharmaceutical Company S.A.E. to Abu-Dhabi based ADQ; the transaction is expected to close in the first half of 2021
Repaid debt by $200 million in the first quarter of 2021 using cash generated from operations; Bausch Health has no mandatory amortization payments or debt maturities until 2024
Announced in March that Sam Eldessouky, the Company’s current Controller and Chief Accounting Officer, has been appointed to the role of Chief Financial Officer (CFO) and will succeed Bausch Health’s current CFO Paul S. Herendeen, effective June 1, 2021. Mr. Herendeen will remain at Bausch Health in the newly created role of Advisor to the Chairman and CEO
Pipeline Advancements

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%, received regulatory approval in South Korea, Brazil and Qatar, and has launched in Taiwan
LUMIFY (brimonidine tartrate ophthalmic solution 0.025%) redness reliever eye drops received regulatory approval in South Korea
BAUSCH + LOMB ULTRA ONE DAY daily disposable silicone hydrogel contact lenses received regulatory approval in Taiwan
Announced statistically significant topline results from the first Phase 3 trial evaluating the investigational NOV032 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction
Announced statistically significant topline results from the second pivotal Phase 3 trial evaluating the investigational IDP-126 gel in acne vulgaris
Progress on Planned Separation of Eye Health Business
Today, the Company announced that Joseph C. Papa and Sam Eldessouky will serve as CEO and CFO of Bausch + Lomb upon separation of the Bausch + Lomb eye health business.3 In addition, the Company continued to make progress toward internal objectives necessary for the separation, including operating in five reportable segments commencing with the first quarter of 2021.

First-Quarter 2021 Revenue Performance
Total reported revenues were $2.027 billion for the first quarter of 2021, as compared to $2.012 billion in the first quarter of 2020, an increase of $15 million. Revenue was negatively impacted by approximately $100 million in the first quarter of 2021 due to the COVID-19 pandemic. Excluding the favorable impact of foreign exchange of $33 million and the impact of divestitures and discontinuations of $10 million, revenue declined organically1,4 by $8 million compared to the first quarter of 2020.

On May 4, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, led by its Orascovery platform, reported that it has acquired Kuur Therapeutics, Inc., the leading developer of off-the-shelf CAR-NKT cell immunotherapies for the treatment of solid and hematological malignancies (Press release, Athenex, MAY 4, 2021, View Source [SID1234579065]).

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"We are excited to add Kuur Therapeutics and its innovative allogeneic CAR-NKT technology to the Athenex platform," said Dr. Johnson Lau, Chief Executive Officer of Athenex. "Kuur’s innovative technology, combined with our TCR program, could propel us into a leadership position in cell therapy. This platform also has the potential to provide synergies with other assets in our pipeline."

Dr. Dan Lang, President of Athenex Cell Therapy, added, "We are thrilled to combine our TCR program with the groundbreaking NKT cell platform developed by Professor Leonid Metelitsa at Baylor College of Medicine and Texas Children’s Hospital. We are confident that we can continue to innovate on the NKT cell platform with Dr. Metelitsa to provide a solution that may address some of the known limitations associated with the first generation of cell therapy treatments focused on autologous CAR-T. We aspire to convert cancer into a chronic disease."

Under the terms of the agreement, Athenex will pay $70 million upfront to Kuur shareholders and certain of its former employees and directors, comprised primarily of equity in Athenex common stock. Additionally, they are eligible to receive up to $115 million of milestone payments, which may be paid, at Athenex’s sole discretion, in either cash or additional Athenex common stock (or a combination of both).

Kevin S. Boyle, Sr., Chief Executive Officer of Kuur, stated, "CAR-NKT cells offer a distinct set of advantages over other immune effector cells commonly used for cell therapy. We are excited that the leadership at Athenex recognizes the significant potential of this approach to provide effective treatment options for patients with both solid and hematological tumors. The development of these innovative therapies will be accelerated by combining Kuur’s experienced team with the extensive resources of Athenex."

About the CAR-NKT Platform and Pipeline

Natural killer T (NKT) cells are innate-like T lymphocytes that express a semi-invariant TCR and preferentially reside in and traffic to tissues, including the liver and bone marrow. Evidence suggests that NKT cells do not mediate graft-versus-host-disease (GvHD) making them an ideal candidate for off-the-shelf CAR therapy. In addition to this differentiated cellular biology, the CAR constructs are engineered to:

Secrete IL-15 to improve their activation, persistence and anti-tumor activity
Down-regulate human leukocyte antigen (HLA) class I and II to diminish their alloreactivity and improve persistence in allogeneic recipients
As described in Kuur’s January 2021 press release, the GINAKIT2 clinical trial is a phase I study of KUR-501, an autologous CAR-NKT cell product, targeting GD2 in patients with relapsed/refractory (R/R) high risk neuroblastoma conducted at Baylor College of Medicine (BCM) and Texas Children’s Hospital.

Out of 10 evaluable patients, one complete response (CR) and one partial response (PR) have been observed to date, with stable disease (SD) in three additional patients. Tumor biopsy shows CAR-NKT cells homing to the neuroblastoma tumor site at all dose levels, which is an important biological property of NKT cells. KUR-501 has so far demonstrated a promising safety profile, with only one case of grade two cytokine release syndrome (CRS) and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS).

Additional data on the GINAKIT2 phase I study will be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting on May 14, 2021.

The ANCHOR clinical trial is an ongoing phase I study of KUR-502, an allogeneic (off-the-shelf) CAR-NKT cell product, targeting CD19 in adult patients with relapsed/refractory lymphoma and leukemia conducted at BCM.

Out of two evaluable patients, one CR and one PR have been observed to date at the lowest dose level of 1×107 cells/m2. One patient was initially observed to be a PR four weeks after infusion, but subsequently converted to a CR without additional therapy 12 weeks later. Biopsy of the patient’s lymph node at five weeks after infusion, prior to conversion to CR status, revealed viable, allogeneic CD19 CAR-NKT cells. The patient with the PR had previously failed autologous CAR-T cell therapy. KUR-502 has so far demonstrated a promising safety profile with no CRS, no ICANS, and no evidence of GvHD.

In 2016, Kuur Therapeutics and BCM signed an exclusive licensing and co-development agreement around cellular immunotherapy products for the treatment of cancer. The co-development collaboration has been instrumental in advancing KUR-501 and KUR-502 into the clinic, and in advancing KUR-503 into IND-enabling preclinical studies. The collaboration accelerated the pioneering work of Dr. Leonid Metelitsa, Professor of Pediatrics – Oncology at BCM and Texas Children’s Hospital. Dr. Metelitsa and his team have shown the potential therapeutic advantages of functionally enhanced CAR-modified NKT cells. Dr. Metelitsa’s research team is part of Texas Children’s Cancer Center and the Center for Cell and Gene Therapy (CAGT) at BCM, Texas Children’s Hospital and Houston Methodist Hospital. The CAGT has more than 20 years of experience working with genetically modified immune cells for the treatment of cancer and has conducted more than 40 clinical studies investigating cellular immunotherapies for the treatment of cancer.

Cooley (UK) LLP is acting as the sole advisor to Athenex, Inc. and SVB Leerink is acting as financial advisor with HMB Legal Counsel acting as legal advisor to Kuur Therapeutics in connection with the transaction.

About KUR-501

KUR-501 is an autologous product in which NKT cells are engineered with a CAR targeting GD2, which is expressed on almost all neuroblastoma tumors, as well as other malignancies. KUR-501 is being tested in the phase 1 GINAKIT2 clinical study (NCT03294954) in patients with R/R high risk neuroblastoma. The single-arm study will evaluate six dose levels of KUR-501 with patients receiving pre-dose lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine.

Neuroblastoma is a pediatric cancer and patients with R/R high risk neuroblastoma have a poor prognosis and a significant unmet medical need. The KUR-501 development program is also designed to provide autologous proof-of-concept for CAR-NKT cells in solid tumors using a validated target.

The GINAKIT2 study is supported by Kuur Therapeutics and Alex’s Lemonade Stand Foundation, conducted by Kuur’s collaborator, BCM, and is currently recruiting patients.

About KUR-502

KUR-502 is an allogeneic product in which NKT cells are engineered with a CAR targeting CD19. KUR-502 is built on Kuur’s next-generation CAR-NKT platform with novel engineering capabilities that harness and enhance the unique properties of NKT cells. The NKT cells used in Kuur’s CAR-NKT platform have a semi-invariant TCR that does not distinguish between self- and non-self-tissues, making the cells unlikely to induce GvHD when given to another person.

The ANCHOR clinical study (NCT03774654) is a phase 1, first-in-human, dose escalation evaluation of KUR-502 in adults with R/R CD19 positive malignancies including B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL) The single-arm study will evaluate three dose levels with patients receiving lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by infusion with KUR-502.

Patients with R/R CD19-positive malignancies have limited effective treatment options. While CD19-directed autologous CAR-T cells are now available for these patients, they are limited by a requirement for patient leukapheresis, delays to receive treatment due to the requirement for autologous manufacturing, and variable final product quality. Off-the-shelf KUR-502 is designed to overcome these limitations.

The ANCHOR study is being sponsored and conducted by Kuur’s collaborator, BCM and is currently recruiting patients.

About KUR-503

KUR-503 is an allogeneic product under development in the laboratory of Dr. Andras Heczey, Assistant Professor of Pediatrics in the Section of Hematology-Oncology at BCM and Texas Children’s Hospital. KUR-503 is unique product, in which NKT cells are engineered with a CAR targeting GPC3 (glypican-3) and like all of Kuur’s allogeneic products, is built on Kuur’s next-generation CAR-NKT platform. GPC3 is a molecule that is highly expressed on most hepatocellular carcinomas (HCC), but not normal liver or other non-neoplastic tissue, making it an ideal target. Because NKT cells traffic to the liver, prevent the formation of new HCC, and their presence in HCC is associated with better outcomes, this platform is an excellent vehicle for delivery of immune effector therapy for patients with HCC. HCC is now the fourth most common cause of cancer related death worldwide, with an estimated 750,000 new cases each year. Although there have been some recent approvals of new agents to treat advanced HCC, these patients still have poor outcomes and there is a significant unmet need.

KUR-503 is currently in preclinical development and the company is planning to initiate a first in human phase 1 clinical trial in 1H 2022.

On May 4, 2021 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, reported financial results for the first quarter 2021, recent business highlights and key catalysts over the next 18 months (Press release, Atara Biotherapeutics, MAY 4, 2021, View Source [SID1234579064]).

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"Atara is off to a strong start in 2021, advancing all three strategic priorities to deliver on key value drivers," said Pascal Touchon, President and Chief Executive Officer of Atara. "We look forward to several milestones in 2021, including the expected tab-cel BLA and MAA filings, progress on the ATA188 program – especially the presentation of clinical and translational data from the Phase 1 OLE study, and the first clinical data on our mesothelin CAR T franchise."

Tabelecleucel (tab-cel) for Post-Transplant Lymphoproliferative Disease (PTLD)

Atara is in active discussions with the FDA and progressing toward alignment on the content of CMC Module 3, including methodologies to assess comparability between the product used in the pivotal ALLELE study and the intended commercial product
A recent analysis shows that duration of response (DoR) in its ALLELE study is maturing as anticipated with a larger number of responders followed for at least six months and a safety profile consistent with previously published data with no new safety signals
Atara is working toward completing a BLA submission in Q3 2021 pending alignment with the FDA
The Company has submitted a letter of intent to the European Medicines Agency (EMA), starting the process for a submission of an EU Marketing Authorization Application (MAA) for tab-cel in patients with EBV+ PTLD expected in Q4 2021
Atara has data at two medical congresses from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel demonstrating that patients with EBV+ PTLD, following both HCT (hematopoietic cell transplantation) and SOT (solid organ transplant), that is relapsed or refractory (R/R) to initial treatment, derived similar OS benefit greater than 80 percent at two years whether they achieved complete or partial response (CR or PR) with tab-cel
Data from the Phase 3 ALLELE study will be presented at an appropriate congress in Q4 2021
The Company is continuing to invest in U.S. commercial readiness activities in anticipation of tab-cel approval and planned launch in H1 2022. In addition, Atara is in discussions with potential partners for the commercialization of tab-cel in Europe
Tab-cel for Potential Additional Indications

Atara is actively opening sites in the Phase 2 multi-cohort study for patients with other EBV-driven cancers
ATA188 for Progressive Forms of Multiple Sclerosis (MS)

Atara continues to make progress enrolling the ATA188 Phase 2 randomized, double-blind, placebo-controlled trial (RCT) evaluating the efficacy and safety of ATA188 in patients with progressive forms of MS (PMS)
Atara plans to conduct an interim analysis (IA) in H1 2022 including efficacy and safety from the Phase 2 RCT in patients with PMS, and following the IA, expects to complete enrollment of the study in H1 2022
The Company plans to present long-term, two-year clinical data from the Phase 1 open-label extension (OLE) and translational data from the Phase 1 study in H2 2021
In the first quarter of 2021, Atara filed and received approval of a Clinical Trial Application (CTA) for the Phase 2 RCT in Canada
CAR T Programs

ATA2271/ATA3271 (Solid Tumors Over-Expressing Mesothelin)

The global strategic collaboration with Bayer including ATA2271 and ATA3271 is progressing well with successful launch of joint governance and activities
Enrollment of the first cohort in the Phase 1 clinical study of ATA2271 for patients with advanced mesothelioma has completed and the Company anticipates presentation of first clinical data in an appropriate forum in Q4 2021
Atara is continuing to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting mesothelin using a PD-1 DNR and 1XX CAR co-stimulatory signaling domain through its EBV T-cell platform, and expects an IND filing in Q2/Q3 of 2022
ATA3219 (B-cell Malignancies)

Atara expects to submit an IND for ATA3219, its next-generation off-the-shelf, allogeneic CAR T using a 1XX CAR co-stimulatory signaling domain through its EBV T-cell platform for patients with B-cell malignancies, in Q4 2021 / Q1 2022
First Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments as of March 31, 2021 totaled $435.2 million, as compared to $500.7 million as of December 31, 2020
Atara believes that its cash as of March 31, 2021 together with projected revenue from U.S. tab-cel sales is sufficient to fund its operations into 2023, including expenses related to the BLA filing and commercial launch of tab-cel in the U.S.
License and collaboration revenue was $3.6 million for the first quarter 2021 and consisted of revenue from activities performed under the Bayer Collaboration Agreements. Atara did not recognize any license and collaboration revenue for the same period in 2020
Net cash used in operating activities was $65.7 million for the first quarter 2021, as compared to $67.0 million for the same period in 2020
Atara reported net losses of $78.3 million, or $0.86 per share, for the first quarter 2021, as compared to $73.5 million, or $1.20 per share, for the same period in 2020
Total operating expenses include non-cash expenses of $14.4 million for the first quarter 2021, as compared to $14.5 million for the same period in 2020
Research and development expenses were $64.1 million for the first quarter 2021, as compared to $57.7 million for the same period in 2020
The increase in the first quarter 2021 was primarily due to higher employee-related costs from increased headcount, increased spending on the Company’s ATA188 and CAR T programs and increased facilities and information technology expenses allocated to research and development
Research and development expenses include $7.5 million of non-cash stock-based compensation expenses for the first quarter 2021, as compared to $7.7 million for the same period in 2020
General and administrative expenses were $17.7 million for the first quarter 2021, as compared to $17.0 million for the same period in 2020
General and administrative expenses include $4.7 million of non-cash stock-based compensation expenses for the first quarter 2021, as compared to $5.0 million for the same period in 2020

On May 4, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, reported that the company will participate at the BofA Securities 2021 Virtual Health Care Conference (Press release, Ascendis Pharma, MAY 4, 2021, View Source [SID1234579063]). Company executives will provide a business overview and an update on the Company’s pipeline programs.

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Details

Event BofA Securities 2021 Virtual Health Care Conference
Location Virtual
Date Tuesday, May 11, 2021
Time 4:15 p.m. Eastern Time
A live audio webcast of the presentation will be available on the Investors and News section of the Company’s website at www.ascendispharma.com. A webcast replay will also be available on the Company’s website shortly after conclusion of the event for 30 days.