A Randomized, Multicenter, Active-controlled Openlabelled, Multiple-Dose, Dose Finding, Parallel Group Trial, Investigating the Efficacy, Safety, Immunogenicity, Tolerability, Pharmacokinetics and Pharmacodynamics of Three Different Weekly Doses of ALT-P1 Compared to Daily Growth Hormone Treatment of GENOTROPIN® (Somatropin) for Injection in Growth Hormone Treatment naive Prepubertal Children with Growth Hormone Deficiency. - NIL

Start Date16 Sep 2024

Sponsor / Collaborator

Cristália Produtos Químicos Farmacêuticos Ltda.

[+1]

NCT04697381 / CompletedPhase 3

A PHASE 3 MULTICENTER, OPEN LABEL, MULTI COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SOMATROPIN IN JAPANESE PARTICIPANTS WITH PRADER-WILLI SYNDROME (PWS)

This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.

Start Date09 Feb 2021

Sponsor / Collaborator

Pfizer Inc.

NCT03878992 / Unknown statusNot ApplicableIIT

Effects of Growth Hormone and IGF-1 on Anabolic Signals and Stem Cell Recruitment in Human Skeletal Muscle

12 adult hypopituitary patients with newly diagnosed Growth hormone (GH)-deficiency will be studied two times. The first examinations will be performed shortly after time of diagnose before initiation of exogenous GH treatment, where each subject will receive a single intravenous bolus of 0.5 mg GH. The examination day will be repeated after prolonged GH replacement therapy (>3 month after treatment initiation).

Start Date30 Apr 2019

Sponsor / Collaborator

University of Aarhus

[+1]

100 Clinical Results associated with Somatropin (Pfizer)

100 Translational Medicine associated with Somatropin (Pfizer)

100 Patents (Medical) associated with Somatropin (Pfizer)

106

Literatures (Medical) associated with Somatropin (Pfizer)

28 Mar 2023·Journal of pediatric endocrinology & metabolism : JPEM

An open-label extension of a phase 2 dose-finding study of once-weekly somatrogon vs. once-daily Genotropin in children with short stature due to growth hormone deficiency: results following 5 years of treatment

Article

Author: Iotova, Violeta ; Malievsky, Oleg ; Pastrak, Aleksandra ; Zelinska, Nataliya ; Mauras, Nelly ; Zadik, Zvi ; Rosenfeld, Ron ; Skorodok, Yulia ; Valluri, Srinivas Rao

Abstract:

Objectives:

Somatrogon is a long-acting recombinant human growth hormone (GH) employed as a once-weekly treatment for children with GH deficiency (GHD). A 12-month, phase 2 study of once-weekly somatrogon vs. once-daily GH (Genotropin®) was initiated, after which participants could enroll into an open-label extension (OLE) evaluating the safety and efficacy of long-term somatrogon treatment.

Methods:

There were five study periods, Periods I and II were 6 months each while Periods III, IV, and V were 12 months each. In the main study (Periods I and II), 53 prepubertal children with GHD were randomized to once-weekly somatrogon (0.25, 0.48, or 0.66 mg/kg/week) or once-daily Genotropin (0.034 mg/kg/day); 48 continued into the OLE, consisting of Period III (original somatrogon dose; Genotropin recipients randomized to one of three somatrogon doses), Period IV (somatrogon 0.66 mg/kg/week), and Period V (prefilled somatrogon pen [0.66 mg/kg/week]).

Results:

At the end of Period III, the mean ± SD annual height velocity (HV) for 0.25, 0.48, and 0.66 mg/kg/week somatrogon groups was 7.73 ± 1.89, 7.54 ± 1.28, and 8.81 ± 1.12 cm/year, respectively; HV was sustained during Periods IV/V. Height SD scores (SDS) showed progressive improvement throughout the OLE, regardless of initial cohort assignment, approaching the normal range (−0.69 ± SD 0.87) at the end of Period V Year 1. Mild or moderate treatment-emergent adverse events were reported in 81.3% of participants, most unrelated to study drug.

Conclusions:

Up to 5 years of once-weekly somatrogon was well tolerated and resulted in sustained improvement in height SDS and delta height SDS in prepubertal short children with GHD.

01 Jan 2023·Frontiers in endocrinology

Normalization of puberty and adult height in girls with Turner syndrome: results of the Swedish Growth Hormone trials initiating transition into adulthood.

Article

Author: Kriström, Berit ; Nilsson, Karl Olof ; Albertsson-Wikland, Kerstin ; Barrenäs, Marie-Louise ; Ankarberg-Lindgren, Carina

Objective:

To study the impact of GH dose and age at GH start in girls with Turner syndrome (TS), aiming for normal height and age at pubertal onset (PO) and at adult height (AH). However, age at diagnosis will limit treatment possibilities.

Methods:

National multicenter investigator-initiated studies (TNR 87-052-01 and TNR 88-072) in girls with TS, age 3-16 years at GH start during year 1987-1998, with AH in 2003-2011. Of the 144 prepubertal girls with TS, 132 girls were followed to AH (intention to treat), while 43 girls reduced dose or stopped treatment prematurely, making n=89 for Per Protocol population. Age at GH start was 3-9 years (young; n=79) or 9-16 years (old; n=53). Treatment given were recombinant human (rh)GH (Genotropin^® Kabi Peptide Hormones, Sweden) 33 or 67 µg/kg/day, oral ethinyl-estradiol (2/3) or transdermal 17β-estradiol (1/3), and, after age 11 years, mostly oxandrolone. Gain in height_SDS, AH_SDS, and age at PO and at AH were evaluated.

Results:

At GH start, height_SDS was -2.8 (versus non-TS girls) for all subgroups and mean age for young was 5.7 years and that of old was 11.6 years. There was a clear dose-response in both young and old TS girls; the mean difference was (95%CI) 0.66 (-0.91 to -0.26) and 0.57 (-1.0 to -0.13), respectively. The prepubertal gain_SDS (1.3-2.1) was partly lost during puberty (-0.4 to -2.1). Age/height_SDS at PO ranged from 13 years/-0.42 for GH_67young to 15.2 years/-1.47 for GH_33old. At AH, GH_67old group became tallest (17.2 years; 159.9 cm; -1.27 SDS; total gain_SDS, 1.55) compared to GH_67young group being least delayed (16.1 years; 157.1 cm; -1.73 SDS; total, 1.08). The shortest was the GH_33young group (17.3 years; 153.7 cm: -2.28 SDS; total gain_SDS, 0.53), and the most delayed was the GH_33old group, (18.5 years; 156.5 cm; -1.82 SDS; total gain_SDS, 0.98).

Conclusion:

For both young and old TS girls, there was a GH-dose growth response, and for the young, there was less delayed age at PO and at AH. All four groups reached an AH within normal range, despite partly losing the prepubertal gain during puberty. Depending on age at diagnosis, low age at start with higher GH dose resulted in greater prepubertal height gain, permitting estrogen to start earlier at normal age and attaining normal AH at normal age, favoring physiological treatment and possibly also bone health, hearing, uterine growth and fertility, psychosocial wellbeing during adolescence, and the transition to adulthood.

01 Jan 2022·Hormone Research in PaediatricsQ3 · MEDICINE

Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study

Q3 · MEDICINE

Article

Author: Yorifuji, Tohru ; Hasegawa, Yukihiro ; Okayama, Akifumi ; Horikawa, Reiko ; Ng, David ; Shima, Daisuke ; Tanaka, Toshiaki ; Castellanos, Orlando ; Pastrak, Aleksandra ; Gomez, Roy ; Rosenfeld, Ron G ; Hoshino, Yuko

Introduction: Somatrogon is a long-acting recombinant human growth hormone being developed as a once-weekly treatment for children with growth hormone deficiency (GHD). The objective of this phase 3 study (NCT03874013) was to compare the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in Japanese children with GHD. Methods: In this open-label, randomized, active-controlled study, 44 prepubertal Japanese children with GHD (boys: 3 to <11 years; girls: 3 to <10 years) were randomized 1:1 to receive once-weekly somatrogon or once-daily Genotropin (0.025 mg/kg/day) for 12 months. Dose escalation for somatrogon-treated subjects occurred in the first 6 weeks (0.25, 0.48, and 0.66 mg/kg/week; 2 weeks each) with the remaining 46 weeks at a dose of 0.66 mg/kg/week. The study’s primary endpoint was annualized height velocity (HV) at 12 months. Results: Baseline characteristics were similar between treatment groups. Compared with Genotropin-treated subjects, somatrogon-treated subjects had higher least-squares mean HV at 12 months (9.65 cm/year vs. 7.87 cm/year). Once-weekly somatrogon was concluded as being comparable to once-daily Genotropin as the mean treatment difference (somatrogon-Genotropin) in HV was +1.79 cm/year (95% confidence interval, 0.97–2.61), which was greater than the preestablished margin (−1.8 cm/year). For both treatment groups, most adverse events were mild to moderate in severity and a similar proportion of subjects reported injection-site pain, although the somatrogon group reported more painful injections. Conclusion: In prepubertal Japanese children with GHD, once-weekly somatrogon was comparable to once-daily Genotropin in terms of annualized (12-month) HV. Both treatments had similar safety and tolerability profiles.

News (Medical) associated with Somatropin (Pfizer)

07 Nov 2024

·www.globenewswire.com

OPKO Health Reports Third Quarter 2024 Business Highlights and Financial Results

Conference call begins at 4:30 p.m. Eastern time todayMIAMI, Nov. 07, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and nine months ended September 30, 2024. Highlights from the third quarter of 2024 and recent weeks include the following: Completed sale of select assets of BioReference Health to Labcorp for $237.5 million. OPKO completed the sale of BioReference Health’s laboratory testing businesses focused on clinical diagnostics and women’s health, excluding operations in New York and New Jersey, for $237.5 million. BioReference Health will continue to offer oncology and urology diagnostic services nationwide, as well as maintain its full operations in New York and New Jersey. This transaction streamlines BioReference Health’s laboratory services business while retaining its core operations to better position the division for sustained growth and profitability. Net sales from operations continuing at BioReference Health exceeded $400 million in 2023.Entered into a $250 million note purchase agreement with HealthCare Royalty secured by profit share payments related to NGENLA. Under the terms of the note purchase agreement, in the near term OPKO retains a significant portion of the profit share payments from Pfizer received pursuant to its license agreement relating to NGENLA with upside over the long term, as well as the full $100 million of remaining potential milestone payments.OPKO’s Board of Directors authorized a $100 million share repurchase program. Under the program, OPKO may repurchase shares of its common stock from time to time through open-market purchases, block trades, privately negotiated transactions, accelerated share repurchase transactions and/or pursuant to Rule 10b5-1 plans, in compliance with applicable securities laws and other legal requirements. The Company repurchased and retired 14.9 million shares for approximately $23.8 million during the three months ended September 30, 2024, and thereafter, through November 6, 2024 repurchased and retired an additional 8.7 million shares for approximately $13.0 million. In addition, the Company repurchased approximately $3.5 million in principal of its Convertible Notes.Enrollment and dosing underway in the MDX2001 Phase 1 trial for the treatment of solid tumor cancers. MDX2001, a tetraspecific antibody, is designed to optimize T-cell function while preventing tumor antigen escape. This Phase 1 open-label trial is expected to enroll up to 45 patients at four clinical trial sites. The Phase 1a portion is primarily designed to evaluate the safety and immunogenicity of ascending doses of MDX2001 in patients with various solid tumors.Awarded $51 million of additional funding under an existing BARDA contract to develop COVID multispecific antibodies and to initiate an influenza program. ModeX Therapeutics was awarded $26.9 million of additional funding under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA). This funding will support the development of a second novel multispecific antibody to SARS-CoV-2 from preclinical through Phase 1 trials, as well as preclinical work on gene-based expression of multispecific antibodies to SARS-CoV-2 including mRNA and/or DNA vectors. In addition, BARDA activated an option for the second phase of funding totaling $24.1 million for ModeX to begin development of influenza multispecifics with gene and/or protein delivery modalities. Together, these funds bring the total support awarded to ModeX to $110 million, with up to $205 million in total, if all options are executed.Announced promising results of an orally delivered oxyntomodulin analog. OPKO is continuing to progress development of its long-acting oxyntomodulin analog in both its subcutaneous and oral formulations. The polyethylene glycol (PEG) linked peptide was studied and progressed to Phase 2 clinical trials before it was suspended due to dose limiting its formulation. The same key peptide as an acylated compound, OPK-88006, has been confirmed in in vitro assays and animal disease models to be a strong candidate for once-weekly subcutaneous administration. Entera and OPKO recently announced results from their ongoing collaborative research combining OPK-88006 and Entera’s proprietary N-Tab™ technology. The program is focused on developing the first oral dual-agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity and metabolic disorders. In vivo studies in rodent and pig models showed single dose administration, delivered orally, resulted in a desirable PK profile and bioavailability. Third Quarter Financial Results Consolidated: Consolidated total revenues for the third quarter of 2024 were $173.6 million compared with $178.6 million for the comparable period of 2023. Operating income for the third quarter of 2024 was $14.2 million compared with operating loss of $64.4 million for the 2023 quarter. The third quarter of 2024 included a gain of $121.5 million from the sale of certain BioReference assets and a gain of $10.5 million from the sale of shares of GeneDx, as well as non-cash other income of $35.4 million compared with non-cash other expense of $8.3 million in the year-ago quarter related to the change in the fair value of the GeneDx Holdings investment. As a result, net income for the third quarter of 2024 was $24.9 million, or $0.03 per diluted share, compared with net loss of $84.5 million, or $0.11 per share, for the 2023 quarter.Pharmaceuticals: Revenue from products in the third quarter of 2024 was $39.1 million compared with $40.7 million in the third quarter of 2023, reflecting lower Rayaldee sales and foreign currency exchange fluctuations. Revenue from sales of Rayaldee was $5.8 million compared with $7.3 million in the same period in 2023. Revenue from the transfer of intellectual property and other was $13.2 million in the third quarter of 2024 compared with $6.2 million in the 2023 period, primarily attributable to $5.5 million related to the BARDA contract. Gross profit share and royalty payments for NGENLA and Pfizer's Genotropin was $7.0 million in the 2024 quarter compared with $4.9 million in the same period for 2023. Total costs and expenses increased to $84.6 million in the third quarter of 2024 from $72.3 million in the prior-year period primarily due to higher research and development expenses related to increased activity within the ModeX development programs. Operating loss was $32.2 million in the third quarter of 2024, which included $18.0 million of depreciation and amortization expense, compared with $25.4 million in the third quarter of 2023, which included $17.8 million of depreciation and amortization expense.Diagnostics: Revenue from services in the third quarter of 2024 was $121.3 million compared with $131.7 million in the prior-year period, with the decrease primarily due to lower clinical test volume, principally as a result of the Labcorp transaction and a reduction in reimbursement rates. Total costs and expenses, net of the gain on the sale of assets, were $62.7 million in the third quarter of 2024 compared with $160.8 million in the third quarter of 2023. The decrease in costs and expenses were primarily attributable to a $121.5 million gain on the Labcorp transaction, partially offset by severance expense of $26.3 million and costs related to the closure of an office building, which reflect the continued progress with cost-reduction initiatives. The third quarter of 2024 included revenue from services of approximately $19.9 million and total costs and expenses of approximately $31.7 million related to assets acquired by Labcorp. Operating income was $58.5 million in the third quarter of 2024 compared with a loss of $29.1 million in the 2023 period and included $6.1 million and $8.4 million of depreciation and amortization expense, respectively.Cash, cash equivalents, marketable securities and restricted cash: Cash and cash equivalents were $400.1 million, marketable securities, principally shares of GeneDx were $92.2 million and restricted cash and escrow was $43.7 million (including $6.3 million of current restricted cash) as of September 30, 2024. In the third quarter, OPKO entered into a $250 million note purchase agreement secured by OPKO’s profit share payments to be received from Pfizer relating to NGENLA. In addition, OPKO received $237.5 million upon closing of the Labcorp transaction, of which $23.7 million was deposited in an escrow account and will be released upon the one-year anniversary of the transaction close less any outstanding adjustments or claims. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss third quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until November 14, 2024, by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 6323665. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including whether enrollment in a Phase 1 clinical trial for MDX2001 will be successful and whether the data will be positive, whether efforts to develop a daily oral dual-agonist GLP-1/glucagon peptide will succeed, whether and how many of our shares we will repurchase under a buyback program, whether NGENLA profits will be sufficient to provide long term upside after satisfying our obligations under the note purchase agreement, whether we can successfully progress the development of oxyntomodulin in both subcutaneous and oral formulations, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, our ability to market and sell any of our products in development, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, whether BioReference will be able to streamline its laboratory services business and better position the division for sustained growth and profitability, whether BioReference’s attempts at returning its core business to profitability will be successful, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:Alliance Advisors IRYvonne Briggs, 310-691-7100ybriggs@allianceadvisors.com orBruce Voss, 310-691-7100 bvoss@allianceadvisors.com —Tables to Follow— OPKO Health, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(in millions)Unaudited As of September 30, 2024 December 31, 2023Assets: Cash, cash equivalents, and current restricted cash$406.4 $95.9 Accounts receivable, net 106.6 123.4 Other current assets 116.6 90.2 Total current assets 629.6 309.5 In-process research and development and goodwill 730.9 793.3 Other assets 895.6 908.9 Total Assets$2,256.1 $2,011.7 Liabilities and Equity: Accounts payable$62.7 $69.7 Accrued expenses 122.8 90.1 Current portion of convertible notes 0.2 0.0 Other current liabilities 25.9 40.3 Total current liabilities 211.6 200.1 Long-term portion of convertible notes 178.7 214.3 Senior secured notes 245.4 0.0 Deferred tax liabilities, net 128.4 126.8 Other long-term liabilities, principally leases, and lines of credit 88.6 81.3 Total Liabilities 852.7 622.5 Equity 1,403.4 1,389.2 Total Liabilities and Equity$2,256.1 $2,011.7 OPKO Health, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in millions, except share and per share data)Unaudited For the three months endedSeptember 30, For the nine months endedSeptember 30, 2024 2023 2024 2023Revenues Revenue from services$121.3 $131.7 $377.5 $391.1 Revenue from products 39.1 40.7 117.7 124.6 Revenue from transfer of intellectual property and other 13.2 6.2 34.3 165.9 Total revenues 173.6 178.6 529.5 681.6 Costs and expenses Cost of service revenues 108.8 106.4 325.8 333.5 Cost of product revenues 24.7 24.5 69.8 74.7 Selling, general and administrative 98.2 72.3 237.2 227.7 Research and development 28.8 19.4 74.8 70.2 Contingent consideration 0.0 (1.1) 0.0 (1.0)Amortization of intangible assets 20.4 21.5 62.3 64.5 Gain on sale of assets (121.5) 0.0 (121.5) 0.0 Total costs and expenses 159.4 243.0 648.4 769.6 Operating income (loss) 14.2 (64.4) (118.9) (88.0)Other income (expense), net 34.2 (14.0) 73.6 (23.8)Income (loss) before income taxes and investment losses 48.4 (78.4) (45.3) (111.8)Income tax provision (23.5) (6.1) (21.9) (10.5)Loss before investment losses 24.9 (84.5) (67.2) (122.3)Loss from investments in investees (0.0) (0.0) (0.0) (0.1)Net income (loss)$24.9 $(84.5) $(67.2) $(122.4)Income (loss) per share, basic$0.04 $(0.11) $(0.10) $(0.16)Income (loss) per share, diluted$0.03 $(0.11) $(0.10) $(0.16)Weighted average common shares outstanding, basic 694,622,466 751,525,007 699,675,944 751,716,692 Weighted average common shares outstanding, diluted 998,363,636 751,525,007 699,675,944 751,716,692

Phase 1Financial StatementLicense out/inPhase 2

07 Aug 2024

·www.globenewswire.com

OPKO Health Reports Second Quarter 2024 Business Highlights and Financial Results

Conference call begins at 4:30 p.m. Eastern time todayMIAMI, Aug. 07, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three and six months ended June 30, 2024. Highlights from the second quarter and recent weeks include the following: Enrollment underway in the MDX2001 Phase 1 trial for the treatment of solid tumor cancers. MDX2001, a tetraspecific antibody, is designed to optimize T-cell function to stimulate tumor regression while minimizing the likelihood of antigen escape. This Phase 1 open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors at six clinical trial sites, and to evaluate safety, tolerability, pharmacokinetics and early evidence of anti-tumor activity. The global commercial launch of NGENLA® is ongoing by OPKO’s partner, Pfizer. NGENLA has been launched in all major markets. OPKO is entitled to gross profit sharing based on sales of both NGENLA and Pfizer’s daily growth hormone product, Genotropin®. In addition, OPKO is entitled to an additional $100 million in potential milestone payments associated with approvals for an adult indication for growth hormone deficiency and additional pediatric indications. Entered into a $250 million note purchase agreement with HealthCare Royalty secured by profit share payments related to NGENLA. Under the terms of the agreement, OPKO retains a significant portion of the profit share payments from Pfizer received pursuant to its license agreement relating to NGENLA in the near term with upside over the long term, as well as the full $100 million of remaining potential milestone payments. OPKO’s Board of Directors authorized a $100 million share repurchase program. Under the program, OPKO may repurchase shares of its common stock from time to time through open market purchases, block trades, privately negotiated transactions, accelerated share repurchase transactions and/or pursuant to Rule 10b5-1 plans, in compliance with applicable securities laws and other legal requirements. The Company had approximately 697 million shares outstanding as of June 30, 2024. This new authorization represented approximately 10.1% of shares outstanding at the stock price at the time of the announcement.Sale of select assets of BioReference Health expected to close toward the end of the third quarter. OPKO entered into an agreement in March 2024 to sell BioReference Health’s laboratory testing businesses focused on clinical diagnostics and women’s health, excluding operations in New York and New Jersey, for $237.5 million. BioReference Health will continue to offer oncology and urology diagnostic services nationwide, as well as maintain its full operations in New York and New Jersey. Continuing operations accounted for net sales of more than $400 million in 2023. This transaction is expected to streamline BioReference Health’s laboratory services business while retaining its core operations to better position the division for sustained growth and profitability. Second Quarter Financial Results Pharmaceuticals: Revenue from products in the second quarter of 2024 was $40.5 million compared with $43.5 million in the second quarter of 2023, reflecting lower sales in OPKO’s international operating companies primarily due to foreign currency exchange fluctuations. Revenue from sales of Rayaldee was $7.2 million compared with $7.7 million in the same period in 2023. Revenue from the transfer of intellectual property and other was $12.3 million in the second quarter of 2024, which included $5.0 million from the BARDA contract, compared with $94.9 million in the 2023 period, which included milestone revenue of $90.0 million triggered by the FDA approval of NGENLA. Gross profit share and royalty payments for NGENLA and Pfizer's Genotropin was $6.3 million in the 2024 quarter compared with $3.8 million in the same period for 2023. Total costs and expenses increased to $77.6 million in the second quarter of 2024 from $74.7 million in the prior-year period primarily due to higher research and development expenses related to increased activity within the ModeX development programs. Operating loss was $24.8 million in the second quarter of 2024, which included $17.9 million of depreciation and amortization expense, compared with operating income of $63.6 million in the second quarter of 2023, after giving effect to the $90.0 million milestone payment as described above and also included $17.8 million of depreciation and amortization expense.Diagnostics: Revenue from services in the second quarter of 2024 was $129.4 million compared with $127.0 million in the prior-year period, with the increase primarily due to higher clinical test reimbursement partially offset by lower clinical test volume. Total costs and expenses were $156.0 million in the second quarter of 2024 compared with $171.3 million in the second quarter of 2023, reflecting continued progress with cost-reduction initiatives. Included in second quarter 2024 results were revenue from services of approximately $25.5 million and total costs and expenses of approximately $32.5 million related to assets being acquired by Labcorp. Operating loss was $26.6 million in the second quarter of 2024 compared with $44.3 million in the 2023 period and included $6.2 million and $8.6 million of depreciation and amortization expense, respectively. Consolidated: Consolidated total revenues for the second quarter of 2024 were $182.2 million compared with $265.4 million for the comparable period of 2023. Operating loss for the second quarter of 2024 was $61.7 million compared with operating income of $7.0 million for the 2023 quarter, with the 2023 quarter benefiting from the $90.0 million milestone payment described above. The second quarter of 2024 included non-cash other income of $60.5 million compared with non-cash other expense of $19.9 million in the year-ago quarter related to the change in the fair value of the GeneDx Holdings investment. As a result, net loss for the second quarter of 2024 was $10.3 million, or $0.01 per share, compared with net loss of $19.6 million, or $0.03 per share, for the 2023 quarter. Cash and cash equivalents: Cash and cash equivalents were $40.6 million as of June 30, 2024 and OPKO’s Investments included liquid equity securities which had a market value of $101.5 million, primarily from the ownership interest in GeneDx. Subsequent to the end of the second quarter, OPKO entered into a $250 million note purchase agreement secured by OPKO’s profit share payments to be received from Pfizer relating to NGENLA. OPKO is also entitled to receive $237.5 million upon closing of the Labcorp transaction anticipated toward the end of the third quarter of 2024. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until August 14, 2024, by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 6314261. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, whether our products will launch in all the territories in which they have been approved for sale, the timing of such launches, whether Pfizer will obtain approvals for an adult indication for growth hormone deficiency or additional pediatric indications and accordingly, whether we will be entitled to any additional milestone payments, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including whether enrollment in a Phase 1 clinical trial for MDX2001will be successful and whether the data will be positive, whether and how many of our shares we will repurchase under a buyback program, whether NGENLA profits will be sufficient to provide long term upside after satisfying our obligations under the note purchase agreement, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, our ability to market and sell any of our products in development, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, whether the sale of selected BioReference assets will be completed in the third quarter or at all, and if this transaction is completed, whether BioReference will be able to streamline its laboratory services business and better position the division for sustained growth and profitability, whether BioReference’s attempts at returning its core business to profitability will be successful, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:LHA Investor RelationsYvonne Briggs, 310-691-7100ybriggs@lhai.com orBruce Voss, 310-691-7100 bvoss@lhai.com —Tables to Follow— OPKO Health, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(in millions)Unaudited As of June 30, 2024 December 31, 2023Assets: Cash and cash equivalents$40.6 $95.9 Assets held for sale 119.7 0.0 Other current assets 197.7 213.6 Total current assets 358.0 309.5 In-process research and development and goodwill 725.1 793.3 Other assets 896.8 908.9 Total Assets$1,979.9 $2,011.7 Liabilities and Equity: Accounts payable$82.2 $69.7 Accrued expenses 94.5 90.1 Liabilities associated with assets held for sale 8.9 0.0 Current portion of convertible notes 0.2 0.0 Other current liabilities 33.7 40.3 Total current liabilities 219.5 200.1 Long-term portion of convertible notes 175.9 214.3 Deferred tax liabilities, net 119.1 126.8 Other long-term liabilities, principally leases, and lines of credit 70.1 81.3 Total Liabilities 584.6 622.5 Equity 1,395.3 1,389.2 Total Liabilities and Equity$1,979.9 $2,011.7 OPKO Health, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in millions, except share and per share data)Unaudited For the three months endedJune 30, For the six months endedJune 30, 2024 2023 2024 2023 Revenues Revenue from services$129.4 $127.0 $256.3 $259.4 Revenue from products 40.5 43.5 78.5 83.9 Revenue from transfer of intellectual property and other 12.3 94.9 21.1 159.7 Total revenues 182.2 265.4 355.9 503.0 Costs and expenses Cost of service revenues 107.1 113.0 216.9 227.1 Cost of product revenues 23.5 25.9 45.2 50.2 Selling, general and administrative 68.8 79.8 139.0 155.4 Research and development 24.1 18.2 46.0 50.8 Contingent consideration 0.0 (0.0) 0.0 0.1 Amortization of intangible assets 20.4 21.5 41.9 43.0 Total costs and expenses 243.9 258.4 489.0 526.6 Operating loss (income) (61.7) 7.0 (133.1) (23.6)Other income (expense), net 51.1 (23.5) 39.4 (9.8)Loss before income taxes and investment losses (10.6) (16.5) (93.7) (33.4)Income tax benefit (provision) 0.3 (3.1) 1.6 (4.4)Loss before investment losses (10.3) (19.6) (92.1) (37.8)Loss from investments in investees (0.0) (0.0) (0.0) (0.1)Net loss$(10.3) $(19.6) $(92.1) $(37.9)Loss per share, basic and diluted$(0.01) $(0.03) $(0.13) $(0.05)Weighted average common shares outstanding, basic and diluted 697,211,592 751,727,383 702,036,148 751,617,431

Phase 1License out/inFinancial StatementDrug Approval

07 May 2024

·www.globenewswire.com

OPKO Health Reports First Quarter 2024 Business Highlights and Financial Results

Conference call begins at 4:30 p.m. Eastern time todayMIAMI, May 07, 2024 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended March 31, 2024. First quarter business highlights include the following: Entered into an agreement with Labcorp to sell select assets of BioReference Health. The transaction includes the sale of BioReference Health’s laboratory testing businesses focused on clinical diagnostics and women’s health, excluding operations in New York and New Jersey, for $237.5 million. These assets comprise patient service centers, certain customer contracts and operating assets, which account for approximately $100 million in annualized revenue. BioReference Health will continue to offer oncology and urology diagnostic services nationwide, as well as maintain its full operations in New York and New Jersey. This transaction is expected to streamline BioReference Health’s laboratory services business while retaining its core operations to better position the division for sustained growth and profitability. The transaction is subject to customary closing conditions and applicable regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The transaction is anticipated to close in the second half of 2024.The IND application for MDX2001, a tetraspecific antibody for the treatment of solid tumor cancers, received FDA clearance. MDX2001 is designed to optimize T-cell function while preventing tumor antigen escape. The first patient is expected to be enrolled in a Phase 1 trial to evaluate safety, tolerability, pharmacokinetics and anti-tumor activity in the second quarter of 2024.The global launch of NGENLA® is ongoing by OPKO’s partner, Pfizer. NGENLA is approved in over 50 countries including the U.S., Japan, EU Member States, Canada and Australia. OPKO is entitled to gross profit sharing based on sales of both NGENLA and Pfizer’s daily growth hormone product, Genotropin. In addition, OPKO is entitled to an additional $100 million in potential milestone payments associated with approvals for an adult indication for growth hormone deficiency and additional pediatric indications. First Quarter Financial Results Pharmaceuticals: Revenue from products in the first quarter of 2024 were $38.1 million compared to $40.4 million in the first quarter of 2023, resulting from lower sales in OPKO’s international operating companies and foreign currency exchange fluctuations, partially offset by an increase in sales of Rayaldee to $6.9 million from $6.6 million. Revenue from the transfer of intellectual property and other was $8.7 million in the first quarter of 2024 compared with $64.8 million in the 2023 period, which included $5.6 million in gross profit share and royalty payments for NGENLA and Pfizer's Genotropin® in the 2024 quarter compared with $3.1 million in the same period for 2023. The decrease in revenue from the transfer of intellectual property and other is primarily attributable to one-time milestone payments received in 2023 including a $50.0 million upfront payment from Merck, a $7.0 million milestone payment from Vifor Fresenius Medical Care Renal Pharma triggered by the German price approval for Rayaldee and a $2.5 million milestone payment from Nicoya Therapeutics for the submission of its IND application for Rayaldee to China's Center for Drug Evaluation. Total costs and expenses declined to $74.5 million in the first quarter of 2024 from $86.3 million in the prior-year period primarily due to a $10.6 million, or 33%, decrease in research and development expense as the 2023 period included a non-recurring payment to Sanofi related to our Merck collaboration, partially offset by increased activity within our ModeX development programs. Operating loss was $27.7 million in the first quarter of 2024 compared with operating income of $19.0 million in the first quarter of 2023, again with 2023 benefiting from over $59 million in milestones as described above.Diagnostics: Revenue from services in the first quarter of 2024 was $126.9 million compared with $132.4 million in the prior-year period, with the decline primarily due to lower clinical testing volume. Total costs and expenses were $161.3 million in the first quarter of 2024 compared with $172.4 million in the first quarter of 2023, reflecting the continued implementation of cost-reduction initiatives. Included in first quarter 2024 results were revenue from services of approximately $27.8 million and total costs and expenses of approximately $34.8 million related to assets being acquired by Labcorp. Operating loss was $34.4 million in the first quarter of 2024 compared with $40.0 million in the 2023 period. Consolidated: Consolidated total revenues for the first quarter of 2024 were $173.7 million compared with $237.6 million for the comparable period of 2023. Operating loss for the first quarter of 2024 increased to $71.5 million from $30.6 million for the 2023 quarter, with the 2023 quarter benefiting from the non-recurring license payments described above totaling $59.5 million. First quarter 2024 results included a non-cash, non-recurring expense of $26.3 million related to an embedded derivative as part of our convertible debt. In addition, both periods benefited from the increase of GeneDx’s stock price of $22.7 million and $8.3 million, respectively, for 2024 and 2023. As a result, net loss for the first quarter of 2024 was $81.8 million, or $0.12 per share, compared with $18.3 million, or $0.02 per share, for the 2023 quarter. Cash and cash equivalents: Cash and cash equivalents were $75.6 million as of March 31, 2024. In January, OPKO completed the sale of $230.0 million aggregate principal amount of 3.75% Convertible Senior Notes due 2029 and exchanged approximately $144.4 million of the Company’s outstanding 4.50% Convertible Senior Notes due 2025. The Company used approximately $50.0 million of the net proceeds to repurchase shares of the Company’s common stock from purchasers of the notes. Additionally, OPKO issued and sold approximately $71.1 million aggregate principal amount of its 3.75% Convertible Senior Notes due 2029 to several holders, including Company affiliates, in exchange for the outstanding 5% Convertible Promissory Notes and accrued interest. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss first quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until May 21, 2024 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 6926223. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, whether our products will launch in all the territories in which they have been approved for sale, the timing of such launches, whether Pfizer will obtain approvals for an adult indication for growth hormone deficiency or additional pediatric indications and accordingly, whether we will be entitled to any additional milestone payments, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including whether patients will be enrolled in a Phase 1 clinical trial for MDX2001 in the second quarter or if it all, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, our ability to market and sell any of our products in development, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, our expectations about RAYALDEE, whether the sale of selected BioReference assets will be completed within the second half of 2024 or at all, and if this transaction is completed, whether it will streamline BioReference Health’s laboratory services business and better position the division for sustained growth and profitability, whether BioReference’s cost-cutting initiatives and attempts at returning to its core business will be successful, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:LHA Investor RelationsYvonne Briggs, 310-691-7100ybriggs@lhai.com orBruce Voss, 310-691-7100 bvoss@lhai.com —Tables to Follow— OPKO Health, Inc. and SubsidiariesCondensed Consolidated Balance Sheets(in millions)Unaudited As of March 31, 2024 December 31, 2023Assets: Cash and cash equivalents$75.6 $95.9 Assets held for sale 120.3 0.0 Other current assets 195.4 213.6 Total current assets 391.3 309.5 In-process research and development and goodwill 725.6 793.3 Other assets 857.1 908.9 Total Assets$1,974.0 $2,011.7 Liabilities and Equity: Accounts payable$71.2 $69.7 Accrued expenses 88.8 90.1 Liabilities associated with assets held for sale 9.7 0.0 Current portion of convertible notes 0.2 0.0 Other current liabilities 34.5 40.3 Total current liabilities 204.4 200.1 Long-term portion of convertible notes 323.1 214.3 Deferred tax liabilities, net 121.6 126.8 Other long-term liabilities, principally contract liabilities, leases, contingent consideration, and lines of credit 72.1 81.3 Total Liabilities 721.2 622.5 Equity 1,252.8 1,389.2 Total Liabilities and Equity$1,974.0 $2,011.7 OPKO Health, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in millions, except share and per share data)Unaudited For the three months ended March 31, 2024 2023 Revenues Revenue from services$126.9 $132.4 Revenue from products 38.1 40.4 Revenue from transfer of intellectual property 8.7 64.8 Total revenues 173.7 237.6 Costs and expenses Cost of service revenues 109.9 114.1 Cost of product revenues 21.8 24.2 Selling, general and administrative 70.2 75.7 Research and development 21.9 32.6 Contingent consideration 0.0 0.1 Amortization of intangible assets 21.4 21.5 Total costs and expenses 245.2 268.2 Operating loss (71.5) (30.6)Other income and (expense), net (11.7) 13.6 Loss before income taxes and investment losses (83.2) (17.0)Income tax benefit (provision) 1.4 (1.2)Net loss before investment losses (81.8) (18.2)Loss from investments in investees (0.0) (0.1)Net loss$(81.8) $(18.3)Loss per share, basic and diluted$(0.12) $(0.02) Weighted average common shares outstanding, basic and diluted 706,882,189 751,506,257

Drug ApprovalPhase 1Financial Statement

100 Deals associated with Somatropin (Pfizer)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	H01AC01	DB00052

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Small-for-dates baby	JP	Pfizer Japan, Inc.	16 Oct 2008
Dwarfism	AU	Pfizer Australia Pty Ltd.	02 Dec 1991
Growth Disorders	AU	Pfizer Australia Pty Ltd.	02 Dec 1991
Growth hormone deficiency	AU	Pfizer Australia Pty Ltd.	02 Dec 1991
Prader-Willi Syndrome	AU	Pfizer Australia Pty Ltd.	02 Dec 1991
Turner Syndrome	JP	Pfizer Japan, Inc.	18 Jan 1991

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	US	Pfizer Inc.	01 Aug 2007
Juvenile Idiopathic Arthritis	Phase 3	US	Pfizer Inc.	01 Aug 2007
Idiopathic short stature	Phase 3	US	Pfizer Inc.	01 Dec 2006
Dwarfism, Pituitary	Phase 3	FR	Pfizer Inc.	01 Feb 1997
Fetal Growth Retardation	Phase 3	FR	Pfizer Inc.	01 Jul 1993
Growth retardation	Phase 3	FR	Pfizer Inc.	01 Jul 1993

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04697381 (CTgov)	Phase 3	Prader-Willi Syndrome	33	somatropin (Adult Cohort)	thrhqlbpjk(lspvggxtid) = dnfeuesweq gwsteqycue (lnazqvxhwg, akvyznhufk - aemtjhslnq) View more	-	05 Jun 2024
				somatropin (GH Naive Pediatric Cohort)	xitbcpcagr(kjcqftlbqz) = gotfbudrtq luacgdtdqw (tjepkubinw, xqsyzgrqou - oxndmfwlrr) View more
NCT03874013 (Phase 3 Study, ENDO2021)	Phase 3	Growth hormone deficiency	44	Somatrogon 0.66 mg/kg/week	ydqzrhpgkz(kdqftawbwo) = ulrwoinujc ilcvaygkmo (fxnlegglbz )	Positive	03 May 2021
				Genotropin 0.025 mg/kg/day	ydqzrhpgkz(kdqftawbwo) = crxrxtzscz ilcvaygkmo (fxnlegglbz )
NCT03831880 (ENDO2021)	Phase 3	Growth hormone deficiency	-	Somatrogon once weekly	qmdmrjevkz(lvwvyowqmz) = Injection site pain was the most common TEAE during the Genotropin (12.8%) and somatrogon (14.9%) treatment periods and was rated as mild in most cases. No severe or serious adverse events were reported. spznkjoedn (zkornckkmm ) View more	Positive	03 May 2021
				Genotropin once daily
NCT00766038 (Growth-TBI, CTgov)	Phase 2	Brain Injuries, Traumatic	63	estrogens (rhGH Treatment)	bbthlbqpns(wznjqxyggf) = edvtnckbfp pxtdmojiuc (xprsaywsus, zrhohnksri - yaekoogomn)	-	18 Nov 2019
				Placebo (Placebo Treament)	bbthlbqpns(wznjqxyggf) = bcyefkswco pxtdmojiuc (xprsaywsus, thmslrydbk - mqlxkxpvge)
NCT00511329 (CTgov)	Phase 2/3	Crohn Disease \| Juvenile Idiopathic Arthritis	10	somatropin [rDNA origin] for injection	aosussaodp(ruxugbhsds) = oshrniohei mlcvjgzizu (jpkptkexhi, jrhsxmxeeo - wzwgjxhdnj) View more	-	12 Apr 2018
Prospective Trial of Exogenous Growth Hormone Administration (ASN2016)	Not Applicable	Chronic Kidney Diseases α-Klotho \| IGF-1	-	Exogenous Growth Hormone	udympuaggu(dxkjvykkbj) = mvbfmzeuma qchhldjxnj (kvpczavwzv ) View more	Negative	15 Nov 2016
				Placebo	udympuaggu(dxkjvykkbj) = bbzxzdqhax qchhldjxnj (kvpczavwzv ) View more
NCT00627523 (EGN, CTgov)	Phase 3	-	43	Control-no treatment	mrutzocmgw(qnozpjiqry) = eosppojbjf dlccgigryf (gdwyrkmixc, pprwuhfshh - xjsptslqko) View more	-	18 Sep 2014
NCT00396097 (CTgov)	Phase 3	Idiopathic short stature	316	genotropin (Standard Dose Arm)	phghakbmqw(fzdsxkkxrc) = kdoxfumkrj djzeuuyzrx (wjlilamyzo, yazlzduxyq - fxezbjurbi) View more	-	13 Nov 2013
				genotropin (Individualized Dose Arm)	phghakbmqw(fzdsxkkxrc) = rucaptucli djzeuuyzrx (wjlilamyzo, qikvghdpjj - jqtytbhnqq) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis