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TG Therapeutics: A Look At New Briumvi Data And Ocrevus Zunovo Approval
Seeking Alpha· 2024-09-22 12:17
I publish my best ideas and top coverage on the Growth Stock Forum . If you're interested in finding great growth stocks, with a focus on biotech, consider signing up. We focus on attractive risk/reward situations and track each of our portfolio and watchlist stocks closely. To receive e-mail notifications for my public articles and blogs, please click the follow button . And to go deeper, sign up for a free trial to Growth Stock Forum. Shares of TG Therapeutics (NASDAQ: TGTX ) made new 52-week highs this w ...
Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses
GlobeNewswire News Room· 2024-09-19 05:00
Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global phase III study Reducing the spread of infection in the household could help limit transmission within communities and societies, easing the burden of both seasonal and pandemic influenza on healthcare systems Basel, 1 ...
Healthy Returns: How competitive can Roche be in the weight loss drug market?
CNBC· 2024-09-17 19:00
A version of this article first appeared in CNBC's Healthy Returns newsletter, which brings the latest healthcare news straight to your inbox. Subscribe here to receive future editions. Good afternoon! Roche is one of several drugmakers hoping to join the booming weight loss drug market, which Novo Nordisk and Eli Lilly are currently dominating. But can the Swiss company develop drugs that can compete with that duopoly? The answer isn't clear yet. We need to see more data from longer and larger clinical tri ...
RHHBY or ABBV: Which Is the Better Value Stock Right Now?
ZACKS· 2024-09-17 16:41
Core Viewpoint - The article compares Roche Holding AG (RHHBY) and AbbVie (ABBV) to determine which stock is more attractive to value investors [1] Group 1: Zacks Rank and Earnings Outlook - Roche Holding AG has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook, while AbbVie has a Zacks Rank of 3 (Hold) [3] - The Zacks Rank emphasizes companies with positive earnings estimate revisions, suggesting RHHBY is likely experiencing a more favorable earnings outlook [3] Group 2: Valuation Metrics - RHHBY has a forward P/E ratio of 14.51, compared to ABBV's forward P/E of 18.01, indicating RHHBY may be undervalued [5] - The PEG ratio for RHHBY is 2.26, while ABBV's PEG ratio is 2.67, suggesting RHHBY has a better expected EPS growth relative to its valuation [5] - RHHBY's P/B ratio is 7.93, significantly lower than ABBV's P/B of 50.69, further indicating RHHBY's relative undervaluation [6] Group 3: Value Grades - Based on various valuation metrics, RHHBY holds a Value grade of B, while ABBV has a Value grade of C, making RHHBY a more attractive option for value investors [6]
FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis
GlobeNewswire News Room· 2024-09-16 05:00
OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's office This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally OCREVUS ZUNOVO™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs Basel, 16 September 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug A ...
Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq
ZACKS· 2024-09-13 17:56
Core Viewpoint - Roche has received FDA approval for the subcutaneous formulation of its immunotherapy drug Tecentriq, branded as Tecentriq Hybreza, making it the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the United States [1][4]. Roche's Tecentriq SC Approval - The subcutaneous formulation combines Tecentriq with Halozyme Therapeutics' Enhanze drug delivery technology [4]. - Approval was based on data from the phase IB/III IMscin001 study, showing comparable blood levels of Tecentriq and a safety and efficacy profile consistent with the intravenous formulation [4]. - A mid-stage study (IMscin002) indicated that 71% of patients preferred the subcutaneous option over intravenous infusion [4]. - The new formulation reduces treatment time to approximately seven minutes compared to 30-60 minutes for intravenous infusion [5]. - The SC formulation will be available for all adult indications of Tecentriq in the U.S., including various cancers [5]. Tecentriq's Market Position - Tecentriq is a leading drug for Roche, with sales totaling CHF 1.8 billion in the first half of 2024 [7]. - It is approved for multiple cancer types globally, either alone or in combination with other therapies [6][7]. Competitive Landscape - The phase II/III SKYSCRAPER-06 study did not meet its primary endpoints when comparing tiragolumab plus Tecentriq to Merck's Keytruda [8]. - Keytruda is a leading immuno-oncology treatment, generating over $14 billion in sales in the first half of 2024 [9]. Roche's Current Standing - Roche holds a Zacks Rank 2 (Buy) [10]. - Comparatively, Eli Lilly has a Zacks Rank 1 (Strong Buy) and Novartis has a Zacks Rank 2 [10].
Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis
Prnewswire· 2024-09-13 17:30
OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery technology for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PP ...
Roche Stock to Benefit From Accu-Chek Smartguide Launch in Europe
ZACKS· 2024-09-13 13:26
Core Viewpoint - Roche is entering the competitive continuous glucose monitor (CGM) market in Europe with the launch of its Accu-Chek Smartguide, targeting adults with Type 1 or Type 2 diabetes following CE mark approval [1][10]. Product Features - The Accu-Chek Smartguide offers a 14-day wearability period and utilizes predictive algorithms to differentiate itself from competitors like Abbott and Dexcom [2][8]. - The device can assess the risk of low blood glucose within 30 minutes, forecast glucose levels for the next two hours, and predict the likelihood of night-time hypoglycemia, providing timely alerts for preventative actions [3][5]. - In trials, the Smartguide demonstrated 95% sensitivity and 99% specificity in predicting low glucose levels within 30 minutes, and 77% accuracy for detecting night-time hypoglycemia [5]. Market Competition - Roche will face strong competition from established players such as Abbott and Dexcom, whose devices are known for ease of use and factory-calibrated sensors [8][9]. - The requirement for initial calibration via a finger stick for the Smartguide may be a drawback compared to competitors' factory-calibrated models [9]. Industry Outlook - The CGM device market was valued at $4.6 billion in 2023 and is expected to grow at a CAGR of 7.2% from 2024 to 2030, indicating significant market potential for Roche's entry [11].
Viking Therapeutics: A Bad Result for Roche's Weight-Management Pill Is Great News for Oral VK2735
The Motley Fool· 2024-09-13 07:51
Recently revealed trial results for Roche's experimental weight-management drug suggest Viking Therapeutics is on the right track. Weight-management treatments are all the rage lately. According to Morgan Stanley, combined sales of injections that curb appetites and promote weight loss could reach an estimated $105 billion by 2030. Viking Therapeutics (VKTX 3.25%) is still a clinical-stage drugmaker that's developing an anti-obesity candidate called VK2735 that appears competitive with a similar drug the U. ...
Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer
Prnewswire· 2024-09-13 00:00
FDA approval marks first and only subcutaneous anti-PD-(L)1 cancer immunotherapy SAN DIEGO, Sept. 12, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) inf ...