ENDO

Crinetics Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Wednesday, February 28, 2024
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SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • ET Today
    SAN DIEGO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • We also expect full results from our Phase 2 study in carcinoid syndrome in the first half of this year.
  • In December 2023, Crinetics reported an initial analysis of data from a subset of 27 patients.
  • Earlier today, February 28, 2024, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.

BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

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Wednesday, December 13, 2023
ENDO, Hypochondroplasia, Achondroplasia, AHV, Research, FDA, PALO, Murdoch, Cancer, PROPEL, Growth, Safety, Child, Pharmaceutical industry

PALO ALTO, Calif., Dec. 13, 2023 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first child has been dosed in PROPEL 3, a Phase 3 clinical trial studying the efficacy and safety of infigratinib in children with achondroplasia. Both the U.S. FDA and the EU EMA indicated the trial design for PROPEL 3 would be acceptable as a registrational study to support a marketing application for the treatment of children with achondroplasia.

Key Points: 
  • “The Phase 2 data for infigratinib has been very promising and suggests potential to increase growth, improve functionality and reduce the associated medical complications in children with achondroplasia.
  • PROPEL 3 is a global, one-year, 2:1 randomized, double-blinded placebo-controlled clinical trial, which will evaluate the efficacy and safety of infigratinib in children with achondroplasia aged 3 to
  • Information about PROPEL (NCT04035811), BridgeBio’s observational lead-in study in achondroplasia for PROPEL 3 and other studies, can be found here on clinicaltrials.gov.
  • BridgeBio is committed to exploring the potential of infigratinib on wider medical and functional impacts of achondroplasia, hypochondroplasia and other skeletal dysplasias, which hold significant unmet needs for families.

EXPANDING INNOVATIONS, INC. ANNOUNCES COMMERCIAL LAUNCH OF X-PAC EXPANDABLE LATERAL CAGE SYSTEM

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Thursday, October 19, 2023
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LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Expanding Innovations, Inc. (EI), an emerging technology leader in the expandable interbody cage sector of the Spine Industry, has announced the full commercial launch of the X-PAC Expandable Lateral Cage System (X-PAC LLIF).

Key Points: 
  • LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Expanding Innovations, Inc. (EI), an emerging technology leader in the expandable interbody cage sector of the Spine Industry, has announced the full commercial launch of the X-PAC Expandable Lateral Cage System (X-PAC LLIF).
  • Expanding Innovations, Inc. has announced the full commercial launch of the X-PAC Expandable Lateral Cage System.
  • Dr. Strenge commented, "The X-PAC Expandable Lateral cage design incorporates the fundamental lateral interbody fusion principles of indirect decompression and bridging bone fusion.
  • The launch of X-PAC LLIF represents the first in a series of planned commercial releases aimed at expanding the EI portfolio of NON-SCREW based Expandable Cage Technology.

BridgeBio Pharma Announces Positive Feedback from the U.S. FDA and EU EMA on the Regulatory Path for a Pivotal Phase 3 Trial of Infigratinib in Children with Achondroplasia

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Wednesday, September 6, 2023
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”The regulatory feedback clearing the path to approval for infigratinib is great news for children living with achondroplasia and for physicians who treat them.

Key Points: 
  • ”The regulatory feedback clearing the path to approval for infigratinib is great news for children living with achondroplasia and for physicians who treat them.
  • ”We are thrilled to have regulatory alignment on key elements of our Phase 3 trial design and the path towards submitting a marketing application to both the FDA and the EMA.
  • Additionally, BridgeBio expects to initiate clinical development for infigratinib in hypochondroplasia, a skeletal dysplasia closely related to achondroplasia and similarly driven by FGFR3 gain-of-function variants.
  • BridgeBio has previously presented promising preclinical data for hypochondroplasia at ENDO 2023 and ASHG 2022.

Rani Therapeutics Reports Second Quarter 2023 Financial Results; Provides Corporate Update

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Friday, August 11, 2023
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SAN JOSE, Calif., Aug. 11, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended June 30, 2023, and provided a corporate update.

Key Points: 
  • SAN JOSE, Calif., Aug. 11, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter ended June 30, 2023, and provided a corporate update.
  • “We are thrilled to have the opportunity to build upon our existing partnership with Celltrion,” said Talat Imran, Chief Executive Officer of Rani.
  • This is the second deal announced between Rani and Celltrion, building upon a previously announced partnership for ustekinumab biosimilar for RT-111.
  • Under the terms of the new license and supply agreement announced in June 2023, Celltrion will exclusively supply to Rani the adalimumab biosimilar drug substance (CT-P17) required for RT-105.

Lumos Pharma Reports Second Quarter 2023 Financial Results, Provides Clinical Update

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Wednesday, August 9, 2023
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Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar

Key Points: 
  • Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar
    AUSTIN, Texas, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc .
  • (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, today announced financial results for the second quarter ended June 30, 2023.
  • Cash on hand as of June 30, 2023 is expected to support operations for at least 12 months following the date of the filing of our second quarter 2023 financial statements.
  • ET today to discuss its financial results and to give an update on clinical programs.

Crinetics Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, August 8, 2023
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SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • SAN DIEGO, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today reported financial results for the second quarter ended June 30, 2023.
  • Enrollment in our Phase 3 PATHFNDR-2 study is also now complete and we anticipate topline results in the first quarter of 2024,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.
  • “Unfortunately, we also suffered a setback with our CRN04777 program and made the difficult decision to wind down its development.
  • PATHFNDR-1 is a placebo-controlled Phase 3 clinical study of oral paltusotine in participants with acromegaly switching from standard-of-care peptide depots.

Rhythm Pharmaceuticals Reports Second Quarter 2023 Financial Results and Business Update

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Tuesday, August 1, 2023
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-- Enrollment ongoing in pivotal Phase 3 trial evaluating setmelanotide in hypothalamic obesity; based on rapid progress, study now expected to be fully enrolled by the end of 2023 --

Key Points: 
  • ET --
    BOSTON, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today reported financial results and provided a business update for the second quarter ended June 30, 2023.
  • R&D Expenses: R&D expenses were $33.5 million in the second quarter of 2023, as compared to $31.5 million in the second quarter of 2022.
  • S,G&A Expenses: S,G&A expenses were $30.0 million for the second quarter of 2023, as compared to $22.3 million for the second quarter of 2022.
  • ET today to review its second quarter 2023 financial results and recent business activities.

Lumos to Highlight New LUM-201 Data and Analysis Presented at ENDO 2023 in Virtual KOL Webinar

Retrieved on: 
Wednesday, June 21, 2023
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AUSTIN, Texas, June 21, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for idiopathic Pediatric Growth Hormone Deficiency (iPGHD) through Phase 2 clinical trials, is hosting today a virtual Key Opinion Leader (KOL) Webinar where Drs. Fernando Cassorla and Michael Tansey will highlight the encouraging new data and analysis on oral LUM-201 for idiopathic PGHD from the Phase 2 PK/PD OraGrowtH212 and dose-finding OraGrowtH210 Trials presented at the Endocrine Society (ENDO) Annual Meeting, held in Chicago, Illinois, June 15-18, 2023.

Key Points: 
  • Fernando Cassorla and Michael Tansey will highlight the encouraging new data and analysis on oral LUM-201 for idiopathic PGHD from the Phase 2 PK/PD OraGrowtH212 and dose-finding OraGrowtH210 Trials presented at the Endocrine Society (ENDO) Annual Meeting, held in Chicago, Illinois, June 15-18, 2023.
  • Cassorla and Tansey will be available to answer questions following their formal presentations.
  • To register for the virtual KOL Event, please click through the link HERE .
  • Cassorla and Tansey gave two oral presentations in the Update on Growth Disorders session at the 2023 ENDO Meeting.

Rani Therapeutics’ Presentation On Oral Delivery of PTH for Osteoporosis Named Presidential Poster Competition Winner at ENDO 2023 Annual Conference

Retrieved on: 
Wednesday, June 21, 2023
ENDO, Abstract, Bone, Teriparatide, Osteoporosis, Drug, Volunteering, Tech, DSM-IV codes, PTH, Patient, SAN, Fertility, Endocrine Society, Rare, News, Parathyroid hormone, Pharmaceutical industry

The Endocrine Society committee recognized Rani for its exceptional scientific work on RT-102, the company’s oral robotic RaniPill® delivering teriparatide, or parathyroid hormone (PTH) (1-34), which is being developed as an oral osteoanabolic therapy for osteoporosis.

Key Points: 
  • The Endocrine Society committee recognized Rani for its exceptional scientific work on RT-102, the company’s oral robotic RaniPill® delivering teriparatide, or parathyroid hormone (PTH) (1-34), which is being developed as an oral osteoanabolic therapy for osteoporosis.
  • In addition, results of the RT-102 study and its clinical implications were presented and discussed by Dr. Arvinder Dhalla, Vice President of Clinical Development in a Tech news conference hosted by The Endocrine Society.
  • Of the 2,500 submitted abstracts, The Endocrine Society selected 15 abstracts to be presented during the news conference and 18 were named Presidential Poster Competition winners.
  • “We are honored and humbled by the overwhelming endorsement of our work by our scientific peers this week at ENDO 2023 which culminated in the Presidential Poster Competition award.