On March 2, 2023 Bavarian Nordic A/S (OMX: BAVA) reported its Annual Report for 2022 (Press release, Bavarian Nordic, MAR 2, 2023, View Source [SID1234628011]). The consolidated, audited results were in line with the preliminary results, announced on January 16, 2023. The full report is attached as a PDF file and can be found on the company’s website, www.bavarian-nordic.com.

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We proudly delivered all-time high revenues in 2022 resulting from significant deliveries of mpox vaccine to countries worldwide during the outbreak, combined with a strong performance in the rabies business, particularly in the US. The travel vaccine market is rebounding, and we are anticipating stronger sales in 2023, which in combination with continued deliveries of mpox vaccines will generate even higher revenues in 2023. Through the recent acquisition of a travel vaccine portfolio from Emergent BioSolutions, we are not only strengthening our core, revenue-generating business, but are also adding a new, promising vaccine candidate in Phase 3 development with a significant potential to address a large, unmet medical need. We are anticipating data from this and our two other ongoing Phase 3 trials later in 2023 and are thus looking forward to another very busy and exciting year at Bavarian Nordic."

Important events after the balance sheet date

In February, Bavarian Nordic announced an update on the ongoing Phase 3 trial of the COVID-19 booster vaccine candidate, ABNCoV2. The recruitment of subjects ≥65 years of age is taking longer than anticipated, pushing the expected completion of enrollment into the second quarter of 2023 with topline results now anticipated around mid-2023.
In February, Bavarian Nordic announced the acquisition of a portfolio of travel vaccines from Emergent BioSolutions, which includes two marketed vaccines for the prevention of cholera and typhoid and a Phase 3 vaccine candidate for the prevention of Chikungunya. As part of the acquisition, Bavarian Nordic will also take over a manufacturing facility in Switzerland, an R&D facility in USA and a specialty sales force in both EU and the US. The total acquisition price is up to USD 380 million including an upfront payment of USD 270 million and conditional milestone payments of up to USD 110 million. The acquisition is expected to close in the first half of 2023, subject to customary closing conditions, including antitrust regulatory approval.
In February, Bavarian Nordic completed a private placement of ~7 million new shares, raising gross proceeds of DKK 1,642 million. The proceeds will be used together with the Company’s existing cash for the payment to Emergent BioSolutions upon closing of the acquisition.
In March, the Board of Directors appointed two observers to the board with the intent to nominate both for election at the annual general meeting on March 30, 2023, together with Luc Debruyne who has been observer to the board since 2022. The two new observers are Heidi Hunter, MBA, an American national and former President, Cardinal Health Specialty Solutions, who currently serves as member of the boards of Vicore Pharma and Sutro BioPharma, and Johan van Hoof, MD, a Belgian national and former Global Therapeutic Area Head, Infectious Diseases & Vaccines, R&D at Janssen, the pharmaceutical division of Johnson & Johnson, who currently works as independent advisor for the biotech/vaccine industry.
Financial performance
The consolidated, audited financial results for 2022 were in line with the preliminary financial results for 2022 which were announced on January 16, 2023, and which exceeded the latest guidance issued on September 7, 2022. The table below presents the actual, audited financial results for 2022 compared to the original and the latest guidance for 2022.

FY 2022 guidance
original, 04-Mar-2022
MDKK FY 2022 guidance
latest, 07-Sep-2022
MDKK FY 2022 actuals
Audited
MDKK FY 2022 actuals
Audited
MUSD*
Revenue 1,100 – 1,400 2,800 – 3,000 3,151 452
EBITDA (1,300) – (1,000) (200) – 0 328 47
Cash and cash equivalents 1,000 – 1,200** > 1,700** 1,742** 250

* Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.97 per 1.00 USD, which was the exchange rate as of December 31, 2022.
** Guidance assumed a bank debt level of DKK 600 million whereas actual year-end cash position includes no bank debt, as this was repaid during fourth quarter.

Revenue for the full year was DKK 3,151 million, compared to latest revised and upgraded guidance in the interval of DKK 2,800 to 3,000 million. Revenue was comprised of DKK 1,730 million from sale of JYNNEOS/IMVANEX/IMVAMUNE mpox/smallpox vaccine, DKK 879 million from sale of Rabipur/RabAvert, DKK 299 million from sale Encepur, DKK 79 million from sale of third-party products, and DKK 164 million in other revenue.

The operating result (EBITDA) was a profit of DKK 328 million, compared to the latest revised and upgraded guidance in the interval DKK -200 to 0 million.

Cash and cash equivalents at year-end was DKK 1,742 million, compared to latest revised and upgraded guidance of DKK >1,700 million. The guidance assumed a bank debt level at year-end of DKK 600 million, however remaining bank debt was repaid during the fourth quarter.

For a detailed financial review, see the annual report.

Outlook for 2023
For 2023, Bavarian Nordic expects revenue of approximately DKK 6,000 million and an EBITDA of approximately DKK 2,200 million.

Numbers are approximate 2023E
MDKK 2023E
MUSD*
Revenue 6,000 861
EBITDA 2,200 315
* Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.97 per 1.00 USD, which was the exchange rate as of December 31, 2022.

The financial guidance presented above is unchanged compared to the guidance announced in company announcement no. 02/2023 on February 15, 2023 and does not include financial impact from the acquisition of the travel vaccine portfolio from Emergent BioSolutions, which is pending final closing of the transaction and the timing thereof after which the Company will update its full-year guidance.

For a full description of assumptions for the 2023 outlook, see the annual report.

Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2:00 pm CET (8:00 am EST) to present the full-year results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via http://bit.ly/3lSQ92A. To join the Q&A session, please register in advance via http://bit.ly/3IQRBLV.

On March 2, 2023 Argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported financial results for the full year 2022 and provided a fourth quarter business update (Press release, argenx, MAR 2, 2023, View Source,the%20same%20periods%20in%202021. [SID1234628010]).

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In a separate press release, argenx also announced today the appointment of Karen Massey to Chief Operating Officer as part of a planned transition. Ms. Massey will succeed Keith Woods who will remain at the Company through the launch of subcutaneous (SC) efgartigimod after which he will retire and serve as a strategic advisor on the argenx Board of Directors.

"We began 2023 from a position of strength following the successful first year of our VYVGART launch where we were able to reach more than 3,000 gMG patients globally with our transformative therapy. Our focus for the year ahead is expansion; both through upcoming regulatory approvals and launches, and more broadly by reaching additional patient segments with the planned launch of SC efgartigimod and through our ongoing stakeholder engagement efforts," said Tim Van Hauwermeiren, Chief Executive Officer of argenx. "Looking ahead, we have the opportunity this year to showcase the innovation within our pipeline through multiple data catalysts, including three pivotal data readouts from efgartigimod and the first clinical efficacy data from ARGX-117, our next pipeline-in-a-product candidate. We are well-equipped to build on this significant momentum as we advance our mission to redefine the treatment of autoimmune disease."

FOURTH QUARTER 2022 AND RECENT BUSINESS UPDATE

VYVGART Expansion
VYVGART is the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. argenx is planning for multi-dimensional expansion to reach more patients with VYVGART through additional regulatory approvals for generalized myasthenia gravis (gMG), the launch of SC efgartigimod for gMG, and new autoimmune indications with the VYVGART regulatory submission for immune thrombocytopenia (ITP) in Japan.

Generated global net VYVGART revenues of $173 million in the fourth quarter of 2022 and $401 million in the full year of 2022
Additional VYVGART regulatory approvals and commercial launches expected in 2023
Approval decision expected in Canada in third quarter of 2023 and in China and Israel by end of 2023
gMG launch in France, United Kingdom and Italy expected by end of 2023 following review of respective reimbursement dossiers
Regulatory reviews of SC efgartigimod for gMG ongoing in the U.S., EU and Japan
Prescription Drug User Fee Act (PDUFA) target action date extended to June 20, 2023 following notification from the U.S. Food and Drug Administration (FDA) in January 2023
Marketing authorization application (MAA) filed in Japan in first quarter of 2023 with approval decision expected by first quarter of 2024
MAA review underway by European Medicines Agency with approval decision expected in fourth quarter of 2023
Submission of MAA in Japan for VYVGART for the treatment of ITP expected mid-2023

Efgartigimod Research and Development
argenx aims to solidify its FcRn leadership by expanding the scope of IgG-mediated autoimmune diseases in development and further demonstrating the potential of FcRn blockade in ongoing clinical trials. By the end of 2023, efgartigimod is expected to be approved, in regulatory review or in development in 13 severe autoimmune diseases.

Multiple data readouts expected from ongoing efgartigimod trials in 2023 and 2024:

ADHERE: Topline data in chronic inflammatory demyelinating polyneuropathy (CIDP) expected in second quarter of 2023
ADDRESS: Topline data in pemphigus expected in second half of 2023
ADVANCE-SC: Topline data from SC trial in ITP expected in second half of 2023
BALLAD and ALKIVIA: Interim data in bullous pemphigoid expected in first half of 2024 and in myositis in second half of 2024
ALPHA and RHO proof-of-concept (POC) trials through IQVIA collaboration: Topline data from ALPHA in post-COVID-19 postural orthostatic tachycardia syndrome (PC-POTS) expected in fourth quarter of 2023 and from RHO in primary Sjogren’s syndrome expected in 2024
POC trials underway in membranous nephropathy and lupus nephritis through Zai Lab collaboration
Clinical trials of efgartigimod in additional autoimmune indications to start this year:

Registrational trial to start in thyroid eye disease in fourth quarter of 2023
POC trials to start in ANCA-associated vasculitis (ANCA) and antibody mediated rejection (AMR) in kidney transplant in fourth quarter of 2023
Pipeline Progress
argenx is advancing a robust portfolio of innovative clinical programs, including ARGX-117 (C2 inhibitor) and ARGX-119 (muscle-specific kinase (MuSK) agonist). Both programs have the potential to be first-in-class opportunities for multiple severe autoimmune indications.

ARDA: Interim data from POC trial of ARGX-117 in multifocal motor neuropathy expected mid-2023
POC trial of ARGX-117 for prevention of delayed graft function after kidney transplantation expected to start in second half of 2023 following regulatory discussions
Dermatomyositis selected as third autoimmune indication for development of ARGX-117
Initiated Phase 1 dose-escalation trial of ARGX-119 in healthy volunteers; subsequent Phase 1b trial to assess early signal detection in patients
Continued investment in Immunology Innovation Program (IIP) to broaden autoimmune pipeline for sustained value creation opportunities

argenx continues to invest in its discovery engine, the Immunology Innovation Program, to foster a robust innovation ecosystem and drive early-stage pipeline growth. argenx expects to nominate one new development candidate in 2023.

Steve Krognes appointed as non-executive director and Chair of the Audit and Compliance Committee of the Company’s Board of Directors

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

ARGENX SE
UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS

Three Months Ended Twelve Months Ended
December 31, December 31,
(in thousands of $ except for shares and EPS) 2022 2021 2022 2021
Product net sales $ 173,396 $ — $ 400,720 $ —
Collaboration revenue 764 26,022 10,026 497,277
Other operating income 7,956 7,662 34,520 42,141
Total operating income 182,116 33,684 445,267 539,418

Cost of sales (12,786) — (29,431) —
Research and development expenses (147,798) (167,173) (663,366) (580,520)
Selling, general and administrative expenses (135,287) (97,422) (472,132) (307,644)
Loss from investment in joint venture (677) — (677) —
Total operating expenses (296,548) (264,596) (1,165,607) (888,164)

Operating loss $ (114,432) $ (230,912) $ (720,341) $ (348,746)

Financial income 13,925 1,199 27,665 3,633
Financial expense (990) (1,104) (3,906) (4,578)
Exchange gains/(losses) 60,259 (14,063) (32,732) (50,053)

Loss for the period before taxes $ (41,238) $ (244,880) $ (729,314) $ (399,743)
Income tax (expense)/benefit $ 2,625 $ 7,062 $ 19,720 $ (8,522)
Loss for the period $ (38,613) $ (237,818) $ (709,594) $ (408,265)
Loss for the period attributable to:
Owners of the parent (38,613) (237,818) (709,594) (408,265)
Weighted average number of shares outstanding 55,364,124 51,538,191 54,381,371

51,075,827
Basic loss per share (in $) (0.70) (4.61) (13.05) (7.99)
Diluted loss per share (in $) (0.70) (4.61) (13.05) (7.99)

Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2021 and 2020 $ (144,180) $ 340,276
Cash, cash equivalents and current financial assets at the end of the period $ 2,192,548 $ 2,336,728
DETAILS OF THE FINANCIAL RESULTS

Total operating income for the fourth quarter and year-to-date in 2022 was $182.1 million and $445.3 million, respectively, compared to $33.7 million and $539.4 million for the same periods in 2021, and consists of:

Product net sales from the sales of VYVGART for the three months ended December 31, 2022 were $173.4 million. The product net sales in the twelve months ended December 31, 2022 were $400.7 million. No product net sales were recognized during the same period in 2021.
Collaboration revenue for the fourth quarter and year-to-date in 2022 was $0.8 million and $10 million, respectively, compared to $26 million and $497.3 million for the same periods in 2021. The collaboration revenue during the twelve months ended December 31, 2022 primarily relates to the recognition of milestone revenue following the option exercise by LEO Pharma to enter into a commercial license for ARGX-112. The collaboration revenue for the twelve months ended December 31, 2021 was primarily attributable to the recognition of the transaction price as a consequence of the termination of the collaboration agreement with Janssen, resulting in the recognition of $315.1 million, and the recognition of $177.5 million in collaboration revenue related to the strategic collaboration with Zai Lab, including the development milestone which was triggered by the FDA approval of VYVGART.
Other operating income for the fourth quarter and year-to-date in 2022 was $7.9 million, and $34.5 million, respectively, compared to $7.7 million and $42.1 million for the same periods in 2021. During the twelve months ended December 31, 2022, and December 31, 2021, the fair value of the argenx profit share in AgomAb Therapeutics NV increased by $4.3 million and $11.2 million respectively. The increase is a result of the extension of a Series B financing round by AgomAb for which argenx maintains a profit share in exchange for granting the license for the use of HGF-mimetic antibodies from the SIMPLE Antibody platform.

Total operating expenses for the fourth quarter and year-to-date in 2022 were $296.5 million and $1,165.6 million, respectively, compared to $264.6 million and $888.2 million for the same periods in 2021, and consists of:

Cost of sales for the fourth quarter and year-to-date in 2022 was $12.8 million and $29.4 million, respectively. The cost of sales was recognized with respect to the sale of VYVGART during 2022. There was no cost of sales recognized in the comparable prior year periods.
Research and development expenses for the fourth quarter and year-to-date in 2022 were $147.8 million and $663.4 million, respectively, compared to $167.2 million and $580.5 million for the same periods in 2021. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates. The increase in research and development expense during 2022 is mainly driven by the recognition of the priority review voucher submitted with the BLA filing for SC efgartigimod for the treatment of gMG, which resulted in an expense of $99.1 million.
Selling, general and administrative expenses for the fourth quarter and year-to-date in 2022 were $135.3 million and $472.1 million, respectively, compared to $97.4 million and $307.6 million for the same periods in 2021. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to the commercialization of VYVGART in the U.S., Japan and the EU and personnel expenses.
Loss from investment in joint venture for the fourth quarter and year-to-date in 2022 was $0.7 million. The loss recognized was argenx’s share of losses in Oncoverity, Inc. There was no losses from investment in joint venture in the comparable prior year periods.
Financial income for the fourth quarter and year-to-date in 2022 were $13.9 million and $27.7 million respectively, compared to $1.2 million and $3.6 million for the same periods in 2021. The increase in financial income is mainly due to an increase in interest income on current financial assets and cash and cash equivalents attributable to higher interest rates.

Exchange gains/losses for the fourth quarter and year-to-date in 2022 were $60.3 million of gains and $32.7 million of losses, respectively, compared to $14.1 million and $50.1 million of exchange losses for the same periods in 2021. Exchange gains/losses are mainly attributable to unrealized exchange rate losses on the cash, cash equivalents and current financial assets position in Euro.

Income tax for the fourth quarter and year-to-date in 2022 was $2.6 million and $19.7 million of tax benefit, respectively, compared to $7.1 million of tax benefit and $8.5 million of tax expense for the same periods in 2021. Tax benefit for the three months ended December 31, 2022 consists of $12.1 million of income tax expense and $14.7 million of deferred tax income, compared to $1.2 million of income tax expense and $8.2 million of deferred tax income for the same period in 2021.

Net loss for the fourth quarter and year-to-date in 2022 was $38.6 million and $709.6 million, respectively, compared to net loss of $237.8 and $408.3 million for the same periods in 2021.

Cash, cash equivalents and current financial assets totaled $2.2 billion as of December 31, 2022, compared to $2.3 billion as of December 31, 2021. Net change in Cash and cash equivalents and current financial assets is primarily a result of the closing of a global offering of shares, which resulted in the receipt of $761.0 million in net proceeds in March 2022, offset by net cash flows used in operating activities.

FINANCIAL GUIDANCE
Based on current plans to fund anticipated operating expenses, working capital and capital expenditures, argenx expects to utilize up to $500 million cash in 2023.

EXPECTED 2023 FINANCIAL CALENDAR:

May 4, 2023: Q1 2023 financial results and business update
July 27, 2023: HY 2023 financial results and business update
October 27, 2023: Q3 2023 financial results and business update

On March 1, 2023 Allist Pharmaceuticals and Abbisko Therapeutics jointly reported the signing of a license agreement (Press release, Allist Pharmaceuticals, MAR 1, 2023, https://www.allist.com.cn/newsd/101/2063.html [SID1234642123]). According to the agreement, Heyu Pharmaceutical has granted Ellis the regional research, development, and development of ABK3376, a new generation of small molecule epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in China (Mainland China, Hong Kong, Macau and Taiwan). An exclusive license to manufacture, use and sell, and Ellis has the right to choose to exercise overseas rights and interests when the exercise conditions are met, expanding the authorized area to a global scale.

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According to the terms of the agreement, the company will pay Heyu Pharmaceutical an upfront payment of up to US$187.9 million, development and sales milestone payments, and a corresponding proportion of net sales license royalties for this authorization.

The third-generation EGFR TKI has become a routine clinical drug and has gradually become the standard therapy for first-line treatment. Although targeted therapy has improved the treatment of patients with EGFR-driven non-small cell lung cancer, drug resistance is still inevitable. C797S is an extremely important factor in targeted therapy. Common targeted resistance mechanisms. Furthermore, studies have shown that up to 40% of disease progression in patients with EGFR-mutant NSCLC with baseline brain metastases involves central nervous system (CNS) metastases. At present, there is no effective new generation targeted therapy drug on the market for non-small cell lung cancer carrying EGFR-C797S resistance mutation.

The ABK3376 introduced this time is a new generation of EGFR oral small molecule inhibitor that is independently developed by Heyu Pharmaceutical and has independent intellectual property rights. It is highly selective and can enter the brain. It can effectively inhibit the C797S mutation that occurs after resistance to third-generation EGFR TKIs. Currently, In preclinical development stage.

Preclinical research results show that ABK3376 has powerful tumor cell inhibitory and killing activities, and has shown the ability to inhibit and shrink tumors in tumor-bearing experimental model animals. ABK3376 also shows high selectivity for wild-type EGFR (WT selectivity), suggesting that it has good safety. Not only that, ABK3376 has the property of efficiently penetrating the blood-brain barrier and can obtain effective drug exposure in the central nervous system, and will be used to treat or prevent central nervous system metastasis of non-small cell lung cancer.

Preclinical studies have also shown that ABK3376 has achieved positive results both as a single agent and in combination with fumetinib, the third-generation EGFR TKI already on the market. It is expected to become a precision treatment for patients with EGFR-C797S drug-resistant mutations. A new generation of targeted therapeutic drugs for small cell lung cancer.

Du Jinhao, Chairman of Ellis, said, "I am very pleased to reach this cooperation with Heyu Pharmaceutical. Ellis is deeply involved in the field of lung cancer, and its core product Aifusa ( foumetinib mesylate) has "strong brain-transforming and curative effect". The clinical advantages of "excellent, good safety and wide therapeutic window" have shown the best-in-class potential. Currently, both first-line and second-line indications for lung cancer have been included in the national medical insurance catalog, benefiting Chinese patients. ArriVent and ArriVent Reaching the exclusive overseas authorization of Fumetinib, Aifusha begins its globalization process. As an innovative pharmaceutical company, Ailes insists on independent research and development and gives full play to its advantages in scientific research and innovation, CMC, clinical, registration and commercialization. , actively cooperate with outstanding innovative drug companies at home and abroad to expand pipelines and provide solutions for treatment areas that have unmet clinical needs. The new generation of EGFR inhibitors introduced from Heyu Pharmaceutical are in line with the development strategy of Ellis and will further enrich it. Ellis’s product pipeline will strengthen its competitiveness in the field of lung cancer treatment. As an excellent R&D-driven biopharmaceutical company, several products have entered clinical trials and have achieved fruitful results. We are very much looking forward to working with Harmony Pharmaceuticals. development. I wish the cooperation a complete success and the products will be launched as soon as possible."

"Over the past seven years, Heyu Pharmaceutical has built a world-class R&D engine. This proprietary technology platform has successfully developed 15 drug candidate molecules, including 7 drugs that have entered clinical trials. It is great to see that Our independently developed drugs have been recognized by more and more domestic and foreign companies," said Xu Yaochang, Chairman of Heyu Medicine. "Heyu Medicine will continue to focus on the research and development of new small molecule drugs for tumor and non-tumor diseases, and deeply explore the unmet needs of patients. clinical needs and make every effort to benefit patients. Ellis is an innovative pharmaceutical company that is deeply involved in the oncology industry and integrates R&D, production and marketing. It has successful experience in the development and commercialization of new drugs. It is believed that this cooperation can accelerate the development of ABK3376. , providing the latest and best treatment options to the majority of patients."

On March 1, 2023 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported that the company will participate in the Barclays Global Healthcare Conference in Miami, March 14 to 16, 2023 (Press release, Prelude Therapeutics, MAR 1, 2023, View Source [SID1234628682]).

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On March 16, at 9:30 a.m. ET, Kris Vaddi, Ph.D., CEO of Prelude, and Jane Huang, M.D., President and Chief Medical Officer, will participate in a fireside chat, hosted by Barclays. The company will host one-on-one meetings on March 15 and 16.

Jazz Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

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