Target $45
Monday, September 12, 2022
BioLineRx: New Drug Application (NDA) to FDA for Motixafortide in Stem Cell Mobilization
Submission based on overwhelmingly positive top-line results from GENESIS Phase 3 study
Stem cell mobilization for bone marrow transplantation estimated to be > $360 million market in the U.S. ( > $500 million globally), with consistent growth
Regencell: Formulae Reduce ADHD and ASD Symptoms in Interim Results
- The Sik-Kee Au TCM Brain Theory® Assessment for ADHD and ASD ("SKATBT-A3"), which measures the effectiveness of the treatment on the patient’s overall body and neurodevelopmental conditions, showed a mean percentage improvement of 37% in the second efficacy trial based on the scoring system of SKATBT-A3.
- The first efficacy trial using personalized TCM formulae have shown a mean percentage improvement of 30% in ADHD symptoms and a mean percentage improvement of 37% in ASD symptoms, based on the scoring systems under the Vanderbilt ADHD Diagnostic Parent Rating Scale ("VADRS") and the Autism Treatment Evaluation Checklist ("ATEC"), respectively, after 3 months of treatment.
- The ongoing second efficacy trial using standardized TCM formulae have shown a mean percentage improvement of 21% in ADHD symptoms and a mean percentage improvement of 22% in ASD symptoms, based on the scoring systems under VADRS and ATEC respectively, after 3 months of treatment.
https://finance.yahoo.com/news/regencell-bioscience-standardized-formulae-shown-131500297.html
AmerisourceBergen to buy Germany's PharmaLex for $1.3 bln
U.S. drug distributor AmerisourceBergen Corporation said on Monday it would acquire privately held German company PharmaLex Holding GmbH for 1.28 billion euros ($1.30 billion) in cash to expand its global biopharma services platform.
AmerisourceBergen will acquire PharmaLex from funds advised by German private-equity firm AUCTUS Capital Partners AG, and the transaction is expected to close in March next year.
Upon deal closure, PharmaLex is expected to add about 15 cents per share to AmerisourceBergen's adjusted earnings for the last seven months of fiscal year 2023, the company said.
PharmaLex provides biopharma companies strategic guidance and regulatory support, including consulting during clinical development and marketing authorization.
Acadia: FDA Accepts New Drug Application for Trofinetide
Acadia Pharmaceuticals Inc. said Monday the U.S. Food and Drug Administration accepted its new drug application of trofinetide for the treatment of Rett syndrome.
The FDA has granted a priority review and assigned a Prescription Drug User Fee Act action date of March 12, the biopharmaceutical company said. The FDA told Acadia that it isn't planning to hold an advisory committee meeting, the company said.
Trofinetide has already been granted fast track status and orphan drug designation for the treatment of Rett syndrome in the U.S. and the rare pediatric disease designation by the FDA.
Rett syndrome is a neurodevelopmental disorder that includes a period of normal development followed by regression with loss of language and hand function skills, impaired gait and development of hand stereotypes. It occurs worldwide in about one of every 10,000 to 15,000 female births, Acadia said.
The company has Nuplazid on the market to treat Parkinson's disease psychosis. Sales of the drug were $134.6 million in the three months ended June 30. Trofinetide is the next drug candidate in Acadia's pipeline.
Ayala: Positive Interim Data from Pivotal Phase 2/3 Trial of AL102 in Desmoid Tumors
- Updated interim results from Part A of RINGSIDE show first confirmed partial response (PR) achieved at week 16 and 3 additional unconfirmed PRs over the follow-up period -
- Consistent early tumor shrinkage with measures deepening over time -
- AL102 was well tolerated at all doses evaluated -
- Part B and Open-Label Extension being initiated with the selected dose of 1.2mg once daily -
- Company to host Key Opinion Leader event on September 28 to discuss results -
https://finance.yahoo.com/news/ayala-pharmaceuticals-presents-positive-interim-120000799.html
Gritstone: Positive Initial Phase 2 Data in Late-Line Solid Tumor Patients
-- SLATE vaccines (version 1 and SLATE-KRAS) demonstrate early evidence of efficacy with a 39% molecular response rate in evaluable patients with late-line microsatellite-stable colorectal cancer (MSS-CRC) and non-small cell lung cancer (NSCLC) --
-- Molecular response, as measured by reduction in circulating tumor DNA (ctDNA) from baseline, demonstrates a correlation with overall survival (OS) in NSCLC, consistent with industry literature --
-- SLATE-KRAS vaccine candidate elicits robust KRAS neoantigen-specific CD8+ T cell responses --
-- Data support moving SLATE-KRAS into earlier lines of treatment --
https://finance.yahoo.com/news/gritstone-presents-positive-initial-phase-110000207.html
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