Category

Healthcare

Daily Brief Health Care: Japan Eyewear Holdings , Innova Captab, Blueprint Medicines, Bio-Rad Laboratories A, SAI Life Sciences, Genomma Lab Internacional Sab, Tasly Pharmaceutical Group, CompuGroup Medical SE & Co KgaA, Scilex Holding , Talkspace and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • TOPIX Inclusions: Who Is Ready (Dec 2024)
  • The Beat Ideas: Innova Captab Ltd, Jammu Capex Kicker, Margin Expansion
  • Blueprint Medicines: Expanding International Market Footprint For A Potentially Unmatched Revenue Impact? – Major Drivers
  • Bio-Rad Laboratories: Digital PCR Platform Expansion &3 Critical Factors Driving Our Optimism! – Financial Forecasts
  • SAI Life Sciences IPO- Growing and Profitable Business; Aggressive Pricing Limits Upside Potential
  • Actinver Research – Genomma Lab: Reaching Healthier Valuation Levels (Company Update)
  • CR Sanjiu (000999CH) To Acquire Tasly (600535CH) Update- The Deal Is Proceeding in an Orderly Manner
  • C V C/CompuGroup Medical: Takeover Decision
  • SCLX: Deal Brings Huge Potential
  • Talkspace Inc (TALK) – Monday, Sep 9, 2024


TOPIX Inclusions: Who Is Ready (Dec 2024)

By Janaghan Jeyakumar, CFA

  • Quiddity’s “Who is Ready” series of insights aims to objectively identify names listed on the Tokyo Stock Exchange that are potential additions to the TOPIX Index in future.
  • Reently-Listed Tokyo Metro (9023 JP), Rigaku Holdings (268A JP), and Intermestic (262A JP) were added to the TOPIX index at the end of November 2024.
  • Our long-term pre-event candidate Japan Eyewear Holdings (5889 JP) has applied for a Section Transfer to the Prime Market which means there could be TOPIX Inclusion in the near future.

The Beat Ideas: Innova Captab Ltd, Jammu Capex Kicker, Margin Expansion

By Sudarshan Bhandari

  • Innova Captab (1605221D IN)’s New Jammu facility to be commercialized by Q3 FY25, expanding capacity and product range.
  • Strong order pipeline, diversified segments (CDMO, branded generics), and high-margin segments to drive profitability.
  • Aiming for 25-30% revenue CAGR and 4-5% margin expansion in upcoming years.

Blueprint Medicines: Expanding International Market Footprint For A Potentially Unmatched Revenue Impact? – Major Drivers

By Baptista Research

  • Blueprint Medicines Corporation, during its third quarter of 2024 financial results presentation, highlighted both promising developments and ongoing challenges.
  • The company reported robust revenue growth, primarily driven by the performance of AYVAKIT, which achieved $128.2 million in net product revenue, marking a 137% year-over-year increase.
  • This strong performance led the company to raise its annual revenue guidance to between $475 million and $480 million, positioning AYVAKIT on track for substantial long-term revenue, potentially exceeding $2 billion.

Bio-Rad Laboratories: Digital PCR Platform Expansion &3 Critical Factors Driving Our Optimism! – Financial Forecasts

By Baptista Research

  • Bio-Rad Laboratories, Inc. presented a mixed set of results for the third quarter of 2024, reflecting ongoing challenges and some positive developments across its business segments.
  • The company reported net sales of $650 million, a 2.8% increase from the previous year on a reported basis, attributed largely to its Clinical Diagnostics segment.
  • On a currency-neutral basis, sales increased by 3.4% year-over-year, driven primarily by a 6.4% increase in the Clinical Diagnostics group led by strong demand for quality control products, especially in the Asia Pacific region.

SAI Life Sciences IPO- Growing and Profitable Business; Aggressive Pricing Limits Upside Potential

By Tina Banerjee

  • The IPO of SAI Life Sciences, a contract research, development, and manufacturing organization,  is scheduled to open on December 11. The IPO consists of fresh issue as well as OFS.
  • Out of the fresh issue of proceeds, the company intends to use INR7.2B for repayment/prepayment of outstanding borrowings. As of September 30, 2024, total outstanding borrowing stands at INR7.6B.
  • We have high conviction on the growth prospect of SAI Life Sciences. Considering FY25 annualized post-IPO EPS of INR2.69, the company seeks a P/E valuation of 186.9–203.8x. 

Actinver Research – Genomma Lab: Reaching Healthier Valuation Levels (Company Update)

By Actinver

  • After a stunning YTD performance (up 90.68% as of 12/9/24 vs MEXBOL 9.05% down), we continue to see solid upside ahead.
  • Market conditions for most of the company’s segments are expected to remain mostly favorable, with FX remaining a neutral-to-positive factor amid its MXN-denominated costs.
  • From a valuation perspective, the company used to trade at higher levels —even in the double-digit EV/EBITDA range— some years ago.

CR Sanjiu (000999CH) To Acquire Tasly (600535CH) Update- The Deal Is Proceeding in an Orderly Manner

By Xinyao (Criss) Wang

  • Based on the new announcement released by CR Sanjiu, due diligence, auditing, evaluation, valuation and verification of material assets reorganization are in progress. Approvals by the SASAC/SAMR haven’t been obtained.
  • Sanjiu is now facing performance headwinds due to VBP. So, Sanjiu needs new/stable performance increments to alleviate future performance pressure, and completing the acquisition of Tasly becomes even more urgent.
  • China Resources excels in M&As and has strong internal business integration capabilities.We’re optimistic about the future synergies after the merger. Valuation for Tasly is expected to reach P/E of 30.

C V C/CompuGroup Medical: Takeover Decision

By Jesus Rodriguez Aguilar

  • CVC announced a voluntary public tender offer for CompuGroup Medical at €22 per share, a 33.5% premium, valuing the company at €1.13 billion equity value and 7.8x EV/EBITDA.
  • The offer highlights CompuGroup’s strong position in healthcare IT, with 75% recurring revenues and growth potential in Ambulatory and Hospital Information Systems supported by digitization trends and AI innovations.
  • The Gotthardts retain their 50.1%. CompuGroup’s board welcomes the strategic partnership and intends to recommend the offer, with plans to delist after completion in H1 2025. Spread is 1.36%/4.60% (gross/annualised).

SCLX: Deal Brings Huge Potential

By Zacks Small Cap Research

  • SCLX is filling a much-needed area of the health care sector, that of developing non-opioid pain relief products.
  • The company already has commercialized products that are proven to improve patients’ lives.
  • The company announced a deal with a developer of a Phase 2 drug with a large market potential to be the exclusive developer and have the right to commercialize the treatment targeting obesity and Alzheimer’s disease.

Talkspace Inc (TALK) – Monday, Sep 9, 2024

By Value Investors Club

  • Talkspace offers an asymmetric risk/reward opportunity in the defensive healthcare sector due to increasing demand for mental health care
  • The company has a strong balance sheet with significant net cash balance, recent profitability, and is expected to grow revenue by 20% annually
  • With limited downside risk and potential for substantial upside, particularly in their B2B business, Talkspace presents an enticing investment opportunity with minimal direct-to-consumer exposure

This content is sourced through publicly available sources and has been machine generated. Information displayed is for general informational purposes only. This article was originally published 3 months ago on Value Investors Club.


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Daily Brief Health Care: Shanghai Fosun Pharmaceutical (Group), ASKA Pharmaceutical Holdings Co Ltd, CEL-SCI , MediciNova , Nurexone Biologic and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Shanghai Fosun Pharmaceutical (2196.HK) – Performance Pain Points and Henlius’ Privatization Outlook
  • ASKA Pharmaceutical (4886) | Healthy Returns
  • CVM: CRO Selected for Registrational Trial
  • MNOV: Encouraging Interim Analysis for Phase 2b/3 ALS Trial
  • NRXBF: New Test Results Opens Potential New Market


Shanghai Fosun Pharmaceutical (2196.HK) – Performance Pain Points and Henlius’ Privatization Outlook

By Xinyao (Criss) Wang

  • Fosun Pharma is just “a platform” and its performance mainly relies on the contributions of subsidiaries. However, such investment-driven business model has led to the current performance difficulties.
  • Although the motivation/underlying logic for Fosun Pharma to privatize Henlius are solid, we don’t know how this privatization ranks in terms of strategic significance of capital operations within Fosun’s system.
  • If, for example, Fosun Pharma finds more important acquisitions/capital expenditures, the priority of Henlius’ privatization could fall. So, we think if it takes too long, there may be more uncertainties.

ASKA Pharmaceutical (4886) | Healthy Returns

By Mark Chadwick

  • ASKA Pharmaceutical Holdings represents an attractive investment opportunity with substantial upside potential
  • The company combines solid growth, strong profitability, and clear avenues for shareholder value enhancement.
  • With Nippon Active Value’s increasing involvement and the stock trading at deeply discounted valuations, ASKA is well-positioned for a re-rating.

CVM: CRO Selected for Registrational Trial

By Zacks Small Cap Research

  • CEL-SCI is developing two platforms: Multikine and LEAPS.
  • Multikine has completed a Phase 3 trial for head and neck cancer while LEAPS is conducting preclinical studies for RA, Pandemic Flu and breast cancer.
  • In June 2021, CEL-SCI reported selected data from its IT-MATTERS trial demonstrating a benefit in the low PD-L1, non-chemotherapy population.

MNOV: Encouraging Interim Analysis for Phase 2b/3 ALS Trial

By Zacks Small Cap Research

  • On December 5, 2024, MediciNova, Inc. (MNOV) announced a study update and interim analysis from the Phase 2b/3 COMBAT-ALS trial were scheduled to be presented at the 35th International Symposium on ALS/MND.
  • As of Nov.
  • 15, 2024, 217 participants had been enrolled and 183 participants were assigned to either MN-166 or placebo.

NRXBF: New Test Results Opens Potential New Market

By Zacks Small Cap Research

  • NurExone (OTC-NRXBF) is a preclinical stage biotech company that is developing a breakthrough treatment for spinal cord injuries that has the potential to dramatically improve lives.
  • The technology involved also has the potential to more efficiently get other treatments to the needed area.
  • The company is also expanding its potential treatments with ExoPTEN and announced preclinical results that showed promise in repairing optic nerve damage.

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Daily Brief Health Care: Clarity Pharmaceuticals Ltd, Paradigm Biopharmaceuticals, Intuitive Surgical, Certara , Innovent Biologics Inc and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • S&P/​​​​ASX Index Rebalance (Dec 2024): CAR, Clarity Pharma Added; Dexus, Spark Deleted
  • Paradigm Biopharmaceuticals (PAR AU): Fund Raising Amidst Pipeline Progress Raises Conviction
  • Intuitive Surgical: International Expansion & Regulatory Milestones & Other Major Drivers
  • Certara Inc.: Will Its Integration & Expansion via Strategic Acquisitions Be A Breakthrough Move? – Major Drivers
  • Innovent Biologics (1801.HK) – Wounds Heal but Scars Remain


S&P/​​​​ASX Index Rebalance (Dec 2024): CAR, Clarity Pharma Added; Dexus, Spark Deleted

By Brian Freitas


Paradigm Biopharmaceuticals (PAR AU): Fund Raising Amidst Pipeline Progress Raises Conviction

By Tina Banerjee

  • Paradigm Biopharmaceuticals (PAR AU) has requested a trading halt to the ASX pending an announcement in relation to a capital raising. Normal trading will resume on Monday, December 9, 2024.
  • Assuming quarterly cash burn rate of A$7M, Paradigm’s cash balance should provide a runway through mid-Q3FY25. The company is in a dire need to raise fund.
  • With lead drug being in late-stage trial and having huge market potential, Paradigm seems to be an attractive biotech investment opportunity. Recently, optimism is growing surrounding Paradigm’s lead drug candidate.

Intuitive Surgical: International Expansion & Regulatory Milestones & Other Major Drivers

By Baptista Research

  • Intuitive Surgical, Inc. reported robust third-quarter financial results for 2024, reflecting both significant positive developments and some areas of challenge.
  • The company demonstrated strong global growth in its key product lines, particularly the da Vinci systems, which is central to its operation.
  • On the positive side, Intuitive displayed robust procedure growth at 18% year-over-year, with contributions especially strong in the U.S., Japan, Germany, France, and the U.K. Notably, the introduction of the da Vinci 5 system, which launched in March 2024, saw promising early adoption with 188 installations and over 12,000 procedures completed.

Certara Inc.: Will Its Integration & Expansion via Strategic Acquisitions Be A Breakthrough Move? – Major Drivers

By Baptista Research

  • Certara’s latest quarterly earnings reveal a mixed set of financial and operational conditions that provide both promising prospects and certain challenges.
  • The company reported third-quarter revenue of $94.8 million, an 11% year-over-year increase.
  • This was bolstered by a 13% rise in total bookings, signaling a steady demand for Certara’s biosimulation services in the global drug development industry.

Innovent Biologics (1801.HK) – Wounds Heal but Scars Remain

By Xinyao (Criss) Wang

  • Innovent did a good job in 24Q3. The 2024 full-year revenue is estimated to reach above RMB8 billion. Peak sales to reach the level of RMB20 billion is entirely possible.
  • It’s a mistake for Innovent to sell a minority stake in Fortvita to Lostrancos. Alhough the Subscription Agreement has been terminated, the confidence in long-term holding this stock has decreased.
  • Innovent’s internationalization needs to be based on the parent company as the main body, which is the most suitable and in line with the interests of shareholders/investors/management/employees of the Company.

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Daily Brief Health Care: China Traditional Chinese Medicine and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • China Healthcare Weekly (Dec.8) – TCM VBP Update, GLP-1’s Good Story Broke, China TCM’s Sudden Rally


China Healthcare Weekly (Dec.8) – TCM VBP Update, GLP-1’s Good Story Broke, China TCM’s Sudden Rally

By Xinyao (Criss) Wang

  • The Medical Insurance Bureau of Hubei Province issued two documents on the VBP of TCM patent medicines.Shineway’s core product Qing Kai Ling is included, which would bring pressure on performance.
  • It’s time to be cautious about the outlook for GLP-1s. We may need to be mentally prepared in advance that the actual market size of GLP-1s is only US$100 billion.
  • Recent changes at the top of CNPGC have left some investors hopeful that China TCM will resolve horizontal competition as scheduled next year,but current bet on shares reversal isn’t wise.

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Daily Brief Health Care: Medical Data Vision and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Medical Data Vision Co., Ltd (4971 JP): Research Update


Medical Data Vision Co., Ltd (4971 JP): Research Update

By Nippon Investment Bespoke Research UK

  • MDV revised down its full-year FY24 guidance (discussed in more details on p.5) given the Q3 result [Q1~Q3 gross profit [GP] of ¥3,055mil (-12.8% YoY), operating loss of -¥140mil (vs FY23 Q3 OP of ¥1,111mil) on sales of ¥4,125mil (-8.1% YoY)], due to (1) the delay to the onboarding of the firm’s cloud-based health check system solution Alpha Salus as the debugging process continued through to September, and (2) a delay in mobilising potential users of the new content (no-contact vital sensing for cats) for MDV’s personal health management app Karteco, as the planned large-scale advertising campaign was pushed back following a delay in the launch of the content.
  • The firm is guiding for FY24 annual dividend of ¥6.5/share (unchanged from FY23) and generates a dividend pay-out ratio of 138.0% based on the revised FY24 EPS forecast of ¥4.71.

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Daily Brief Health Care: Janux Therapeutics , Electromed , Incyte Corp, Lexaria Bioscience , Roche Holding Ltd and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Janux Therapeutics: Transforming Prostate Cancer Treatment With Unprecedented Results!
  • Electromed Inc (ELMD) – Thursday, Sep 5, 2024
  • The Takeover Buzz Around Incyte: What Makes It Irresistible to Big Pharma?
  • LEXX: Phase I Start Imminent
  • Kronos Bio Strategic Review: Workforce Reduction, Leadership Changes, and Potential Sale Amid Genentech Partnership Uncertainty


Janux Therapeutics: Transforming Prostate Cancer Treatment With Unprecedented Results!

By Baptista Research

  • Janux Therapeutics has taken the biopharmaceutical industry by storm with its recent announcement of groundbreaking results from its Phase 1 clinical trial of JANX007, a tumor-activated T-cell engager targeting advanced prostate cancer.
  • The data reveals a stunning 100% PSA50 response rate among heavily pretreated patients, with 63% achieving PSA90 and 31% achieving PSA99—a significant milestone in prostate cancer treatment.
  • The company has prioritized the development of second- and third-line therapies for metastatic castration-resistant prostate cancer (mCRPC), aiming to address a substantial unmet need in oncology.

Electromed Inc (ELMD) – Thursday, Sep 5, 2024

By Value Investors Club

  • Electromed is a debt-free micro-cap medical device company specializing in HFCWO airway clearance products for home use
  • With $16.2 million in cash on hand, the company is growing revenue and profitability, attracting shareholder activists
  • Flagship product, SmartVest® Airway Clearance System, offers comfortable, easy-to-use device; direct-to-patient model streamlines referral process, insurance claims, product delivery, and training

This content is sourced through publicly available sources and has been machine generated. Information displayed is for general informational purposes only. This article was originally published 3 months ago on Value Investors Club.


The Takeover Buzz Around Incyte: What Makes It Irresistible to Big Pharma?

By Baptista Research

  • Incyte Pharmaceuticals has been the center of takeover speculation recently, with its stock rallying amid whispers of a potential acquisition.
  • Investors are abuzz with the possibility of a major pharmaceutical player eyeing Incyte for its innovative pipeline, robust revenue growth, and established commercial products.
  • In the third quarter of 2024, Incyte delivered strong financial results, including a 24% increase in total revenues, driven by its blockbuster drug Jakafi and rapid growth in Opzelura sales.

LEXX: Phase I Start Imminent

By Zacks Small Cap Research

  • Lexaria is a biotechnology company seeking to enhance the bioavailability of multiple drug agents using DehydraTECH (DHT), its technology using oral and topical delivery.
  • It combines lipophilic APIs with specific fatty acid and carrier compounds followed by dehydration.
  • DHT offers several attractive features: substantial improvement in bioabsorption in terms of time to measurable plasma levels & AUC, brain permeation, taste masking & side effect reduction.

Kronos Bio Strategic Review: Workforce Reduction, Leadership Changes, and Potential Sale Amid Genentech Partnership Uncertainty

By Dalius Tauraitis

  • Kronos Bio’s NAV is estimated at $1.39/share, 48% above current price, with strategic review ongoing for sale/reverse merger.
  • Significant insider ownership includes 14.7% by ex-CEO Norbert Bischofberger and 5.8% by chairman Arie Belldegrun.
  • Kronos Bio’s partnership with Genentech offers potential milestone payments, but no compounds identified for further development.

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Daily Brief Health Care: Ainos , MetaVia, Telomir Pharmaceuticals, VolitionRX and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Ainos, Inc.- Signed Veldona Partner for Manufacturing and Taiwan Marketing of Sjogren’s Drug
  • MTVA: NeuroBo Becomes MetaVia Topline Results for Phase 2a
  • TELO: Another Potential Breakthrough
  • VNRX: Reports 3Q 2024 results. Over 110


Ainos, Inc.- Signed Veldona Partner for Manufacturing and Taiwan Marketing of Sjogren’s Drug

By Water Tower Research

  • Key regional partner for Veldona; a good start for Ainos’ out-licensing strategy.
  • Ainos entered a strategic partnership with Taiwan Tanabe Seiyaku for Veldona in Sjogren’s syndrome.
  • Under a memorandum of understanding (MOU), the collaboration aims to advance Veldona development by leveraging Taiwan Tanabe’s established expertise in drug manufacturing and Taiwan market promotion. 

MTVA: NeuroBo Becomes MetaVia Topline Results for Phase 2a

By Zacks Small Cap Research

  • On November 18, 2024, NeuroBo Pharmaceuticals, Inc. (NRBO) announced a strategic realignment with a name change to MetaVia Inc. (MTVA).
  • The change became effective on November 29, 2024.
  • We are republishing the latest research report under the MTVA ticker.

TELO: Another Potential Breakthrough

By Zacks Small Cap Research

  • Telomir Pharmaceuticals is a preclinical stage company focused on the science of lengthening telomere caps, which the company believes will extend human lifespans and improve quality of life as people age.
  • Preclinical tests showed that the company’s signature therapy, Telomir-1, appeared to address insulin resistance and achieving reversal to near pre-diabetic levels.
  • These results add to previous testing results showing a myriad of potential life improving and extending benefits.

VNRX: Reports 3Q 2024 results. Over 110

By Zacks Small Cap Research

  • Volition’s Nu.Q Vet Canine Cancer Screening Test now available in 17 countries, particularly by Antech on its Element I+ diagnostic point-of-sale platform (in the U.S., Europe, Australia, India & Singapore) and by Fujifilm Vet Systems (Japan).
  • A Data Room that contains all clinical studies and other data related to Capture-PCR (human cancer detection method) and Nu.Q NETs for human sepsis has been set up to support licensing discussions and negotiations with interested parties.
  • Research continues on developing biomarkers for multiple cancers in proof of concept studies.

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Daily Brief Health Care: Agilent Technologies, Japan Lifeline, Arrowhead Pharmaceuticals , BioLine RX , Lantheus Holdings, Tonix Pharmaceuticals Holding and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Agilent Technologies: Pharma Market Expansion As A Key Growth Catalyst! – Major Drivers
  • Japan Lifeline Co., Ltd (7575 JP): Research Update
  • ARWR: License and Collaboration Deal with Sarepta Includes 825 Million Upon Closing
  • BLRX: Ayrmid Assumes Commercialization Efforts
  • LNTH: Initiating Coverage – A Glowing Recommendation
  • TNXP: NDA Filed for TNX-102 SL in Fibromyalgia


Agilent Technologies: Pharma Market Expansion As A Key Growth Catalyst! – Major Drivers

By Baptista Research

  • Agilent Technologies, Inc. recently reported its fourth quarter results for fiscal year 2024.
  • The company generated revenues of $1.701 billion, marking roughly 1% growth in reported figures, with core growth remaining flat despite challenging market conditions.
  • Notably, Agilent’s total company book-to-bill ratio exceeded one, indicating a steady market recovery and positioning for continued improvement into 2025.

Japan Lifeline Co., Ltd (7575 JP): Research Update

By Nippon Investment Bespoke Research UK

  • Japan Lifeline [JLL] produced historical semi-annual earnings with FY24 1H OP of ¥6,260mil (+14.4% YoY) on sales of ¥27,985mil (+11.4% YoY), which landed above expectation.
  • Despite this robust performance, JLL has not revised its full-year FY24 guidance as the 2H presents with several potential earnings risks such as 1) fewer operating days, which will impact device sales, 2) an increase in outsourced products reducing GPM, 3) the possibility of a change in the competitive landscape for one of JLL’s core products.
  • The company’s shareholder return policy is the higher of (1) a pay-out ratio of 40% or (2) a Dividend on Equity [DOE] of 5%.

ARWR: License and Collaboration Deal with Sarepta Includes 825 Million Upon Closing

By Zacks Small Cap Research

  • On November 26, 2024, Arrowhead Pharmaceuticals, Inc. (ARWR) announced a global licensing and collaboration agreement with Sarepta Therapeutics (SRPT) in which Arrowhead will receive $825 million on closing, consisting of a $500 million upfront payment and $325 million as an equity investment priced at a 35% premium.
  • The agreement includes four clinical stage products (ARO-DUX4, ARO-DM1, ARO-MMP7, ARO-ATXN2), three preclinical programs (ARO-HTT, ARO-ATXN1, ARO-ATXN3), and during the five-year term of the agreement Sarepta can propose up to six new CNS or muscle targets, with Arrowhead responsible for discovery and preclinical development.
  • This deal further validates Arrowheads technology and provides capital to fund operations into 2028.

BLRX: Ayrmid Assumes Commercialization Efforts

By Zacks Small Cap Research

  • BioLineRx is a commercial stage biopharmaceutical company with a development portfolio advancing motixafortide, a platform molecule targeting indications in stem cell mobilization (SCM) & in the treatment of advanced pancreatic cancer.
  • The candidate is approved in the US for SCM and is undergoing studies for use in gene therapy and in pancreatic cancer.
  • Partner Gloria Biosciences is developing motixafortide in Asia & is expected to be conducting bridging studies in the near term for SCM & longer-term studies for other indications.

LNTH: Initiating Coverage – A Glowing Recommendation

By Zacks Small Cap Research

  • Lantheus is a leader in radiopharmaceutical offerings in oncology & precision diagnostics.
  • It offers a portfolio of diagnostic & therapeutic products directly & via partnerships & licensing.
  • The primary revenue driver is Pylarify, a PET tracer for PSMA-expressing prostate cancer.

TNXP: NDA Filed for TNX-102 SL in Fibromyalgia

By Zacks Small Cap Research

  • On October 16, 2024, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that it submitted the New Drug Application (NDA) for TNX-102 SL for the treatment of fibromyalgia.
  • The NDA is supported by the results of two Phase 3 clinical trials that reported statistically significant results on the primary endpoint of reducing widespread pain.
  • The FDA typically has a 60-day filing review period to determine whether the submitted NDA is acceptable for review.

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Daily Brief Health Care: Telix Pharmaceuticals, Oramed Pharmaceuticals , Recce Ltd, Revelation Biosciences and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Telix Pharmaceuticals (TLX AU): Pipeline Progress to Expand Portfolio; Favorable Payment Rule in US
  • ORMP: Preparations for New Phase 3 Trial Advance
  • Recce Pharmaceuticals – Topical R327G approaching pivotal stages
  • REVB: Phase 1b Study Cleared


Telix Pharmaceuticals (TLX AU): Pipeline Progress to Expand Portfolio; Favorable Payment Rule in US

By Tina Banerjee

  • Telix Pharmaceuticals (TLX AU) initiated Phase 3 ZIRCON-CP trial of PET imaging candidate TLX250-CDx for clear cell renal cell carcinoma and dosed first patient in a cancer hospital in China.
  • Telix is focused on expanding the near-term opportunity in precision medicine diagnostics with three new products planned for launch in 2025.
  • CMS will unbundle and pay separately for specialized diagnostic radiopharmaceuticals for Medicare patients with per-day costs exceeding $630. The new payment decision is in favor of Telix.

ORMP: Preparations for New Phase 3 Trial Advance

By Zacks Small Cap Research

  • ORMP is leveraging its strong balance sheet – ~$142m in cash, equivalents, ST investments & deposits, no LT debt – to optimize its cash position.
  • The company is augmenting its cash position with repayments / interest from collateralized loans issued to Scilex & to a domestic real estate project.
  • Management expects its resources are sufficient to maintain planned activities for roughly at least the next year as clinical activities pick-up and as it maintains strategic share repurchases under its 2024 share buyback plan.

Recce Pharmaceuticals – Topical R327G approaching pivotal stages

By Edison Investment Research

Recce Pharmaceuticals has made several strides in advancing its topical gel formulation (R327G) of lead anti-infective therapeutic drug candidate RECCE® 327 (R327) as a topical treatment for acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFIs). The company received Human Research Ethics Committee (HREC) approval to start a registrational Phase III DFI study in Indonesia, which, if successful, could lead to a commercial launch in South-East Asia in CY26. With the near-term focus on advancing the ABSSSI and DFI indications providing a clearer path to future revenues, we have pushed back our timing expectations for the IV R327 formulation, resulting in an updated risk-adjusted net present value (rNPV) of A$593.6m (or A$2.60/share), versus A$688.5m (or A$3.07/share share) previously.


REVB: Phase 1b Study Cleared

By Zacks Small Cap Research

  • Revelation Biosciences is a life sciences company whose development of immunologic-based therapies is based on the well-established biology of phosphorylated hexaacyl disaccharide (PHAD) and its effect on the innate immune system.
  • The company announced that the FDA has accepted its IND application for Gemini and that it expects to begin the study in early 2025.

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Daily Brief Health Care: Sansure Biotech , Legend Biotech Corp, Akeso Biopharma Inc and more

By | Daily Briefs, Healthcare

In today’s briefing:

  • Quiddity CSI Medical Dec 24 Results: 3 Changes; All Expected; US$362mn One-Way
  • Legend Biotech: Can The Partnership With Multiply Labs Be A Game Changer? – Major Drivers
  • 2025 High Conviction – China Healthcare: Chinese Biotech to Compete on the International Stage


Quiddity CSI Medical Dec 24 Results: 3 Changes; All Expected; US$362mn One-Way

By Janaghan Jeyakumar, CFA

  • The December 2024 index review results for the CSI Medical Service Index were announced after market close on Friday 29th November 2024.
  • There will be 3 changes for the CSI Medical Service index.
  • We predicted all the changes correctly but we expected a couple of extra changes which did not materialize.

Legend Biotech: Can The Partnership With Multiply Labs Be A Game Changer? – Major Drivers

By Baptista Research

  • Legend Biotech, a biopharmaceutical company focused on cell therapies for cancer and other serious diseases, delivered robust financial performance in the third quarter of 2024.
  • The company reported accelerating adoption and sales of its flagship product, CARVYKTI, a CAR-T (chimeric antigen receptor T) cell therapy targeting multiple myeloma.
  • For the quarter, CARVYKTI generated approximately $286 million in net sales, reflecting an 87.6% increase year-over-year and 53.2% quarter-over-quarter.

2025 High Conviction – China Healthcare: Chinese Biotech to Compete on the International Stage

By Xinyao (Criss) Wang

  • Based on excellent data in HARMONi-2, Akeso’s investment certainty has significantly increased compared to a year ago. Accordingly, Summit plans to modify the clinical protocol to expand the ongoing HARMONi-3.
  • If the clinical trials go smoothly, Summit is able to sell AK112 (or the entire company) at a much higher price. Akeso would successfully become a Biopharma and achieve internationalization.
  • If AK112 is finally approved by the FDA based on HARMONi-2, Akeso’s market value would be higher than Innovent. If HARMONI-3 is successful, market value would be above RMB100 billion.

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