Actinogen: Therapeutic effect in early-stage Alzheimer's

 Actinogen Medical Limited (ASX: ACW) today announces positive Phase 2a clinical data from its Alzheimer's Disease (AD) biomarker study, which validates the Company's planned Xanamem program in AD.

Key points:

• Phase 2a placebo-controlled trial re-run in biomarker-positive patients using available blood biomarker levels in 72 patients from the prior XanADu study of 185 patients with mild AD over 12 weeks
• Used a pre-specified analysis plan and protocol to avoid bias
• Patients with elevated blood pTau above the median value showed a clinically significant Xanamem effect on the CDR-SB endpoint plus trends in a Neurologic Test Battery (NTB) and the Mini Mental State Exam (MMSE)
• CDR-SB effect of 0.6 - 0.8 points is larger than the 0.45 points reported recently for the anti-amyloid antibody lecanemab and represents a 60-80% reduction in progression over 12 weeks compared with placebo (lecanemab reported to show 27% over 18 months)^[1]
• Twice as many patients (56%) in the Xanamem group were stable or improved compared with placebo
• CDR-SB will be a primary endpoint in the upcoming Phase 2b trial of 6 months duration
• Regulatory path to approval in AD is clear and uncontroversial using CDR-SB
• Findings significantly de-risk and improve AD program efficiency.

https://www.biospace.com/article/releases/actinogen-medical-limited-acw-announces-large-xanamem-therapeutic-effect-in-early-stage-alzheimer-s-disease-ad-patients/

Dare: FDA OKs application for Hormone-Free Monthly Intravaginal Contraceptive trials

 Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive. The IDE approval reflects that the FDA determined the Company provided sufficient data to support the initiation and conduct of the study. The IDE submission included the results of the postcoital test (PCT) clinical study of Ovaprene, in which Ovaprene prevented essentially all sperm from entering the cervical canal across all women and all cycles evaluated. PCT clinical trials have been used as a surrogate marker for contraceptive effectiveness.

https://finance.yahoo.com/news/dar-bioscience-announces-ide-approval-120000143.html

Bristol=Myers cut to Neutral by Guggenheim

 From Buy

https://finviz.com/quote.ashx?t=BMY&ty=c&ta=1&p=d

Supernus: FDA Declines OK of Parkinson's Treatment

 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the SPN-830 New Drug Application (NDA). SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).

The CRL requires additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis. In addition, the FDA mentions that approval of the NDA requires inspections that could not be completed in a timely manner due to COVID-19 travel restrictions. The CRL does not request additional efficacy and safety clinical studies. Supernus will continue to work closely with the FDA to address all questions, and when possible, to provide clarity regarding the potential timing of a resubmission of the NDA. The FDA has made an initial determination that the amendment to the Company’s application in response to the CRL will be subject to a Class 2, or six-month, review timeline.

“SPN-830 remains a key priority for Supernus as there is a need to provide a minimally invasive therapy for PD patients who are experiencing motor fluctuations not adequately controlled with current treatment options,” said Jack Khattar, President and CEO of Supernus. “We are committed to PD patients and to working with the FDA to address the CRL issues so that we can put the NDA back on track towards potential U.S. approval.”

https://finance.yahoo.com/news/supernus-provides-regulatory-spn-830-123000016.html

scPharma: FDA OKs FUROSCIX First and Only Self-administered, Subcutaneous Treatment in Heart Failure

  scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has approved FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure. FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the FUROSCIX Infusor.

https://finance.yahoo.com/news/scpharmaceuticals-announces-fda-approval-furoscix-120000548.html

Nevro Comments on UnitedHealthcare Medical Coverage Policy Update

  Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that on October 1, 2022, UnitedHealthcare ("United") released an update to its medical coverage policy (number 2022T0567V) and added language to indicate spinal cord stimulation (SCS) devices are not covered for treating chronic intractable back pain without prior spine surgery (NSBP). This policy becomes effective on December 1, 2022.  All other elements of their SCS coverage policy remained as they were before, including their recent decision to cover the use of SCS for Painful Diabetic Neuropathy (PDN).

Prior to this change, United had no coverage policy regarding NSBP patients. The company will continue to utilize the outcomes of its SENZA-NSRBP randomized controlled trial for chronic intractable back pain patients without prior spine surgery to support the patient prior authorization and appeals process.

The company does not expect this coverage decision to have a material impact on its go-forward revenue, and currently estimates the potential impact on 2023 revenues could be no more than the low to mid-single digit millions of dollars.

"Although this update is disappointing, there were United NSBP cases getting approved (and denied) before this change, and that will continue to be the case moving forward on an individual patient basis depending on a patient's unique clinical history and medical necessity," stated D. Keith Grossman, Chairman, CEO and President of Nevro. "As part of our ongoing reimbursement and access initiatives, we will continue to urge United, as well as other payers, to appropriately consider compelling, Level 1 clinical evidence, such as the NSBP data we and our investigators have produced. We view these decisions as a very normal part of the market access pathway for new products and patient indications, and believe our continued generation of high-quality clinical evidence will ultimately carry the day, just as it has thus far with the PDN indication."

The company expects to present its two-year follow-up data for the SENZA-NSRBP randomized controlled trial at the NANS 2023 meeting in January 2023 with a publication of the data to follow.

https://finance.yahoo.com/news/nevro-comments-unitedhealthcare-medical-coverage-110000848.html

Merck's blood vessel disorder drug succeeds in late-stage study

 Merck & Co said on Monday a therapy it gained through the drugmaker's $11.5 billion acquisition of Acceleron Pharma last year met the main goal of a late-stage study in patients with a progressive blood vessel disorder.

Merck's shares rose 2.5% at $89.79 in premarket trading.

Sotatercept, when compared to placebo, significantly extended how far patients with pulmonary arterial hypertension (PAH) could walk in six minutes.

Merck last year bought Acceleron to gain access to the treatment sotatercept, as it sought to bulk up its pipeline ahead of blockbuster cancer drug Keytruda losing key patents in 2028.

At that time, Merck had forecast that PAH could become a $7.5 billion market by 2026.

The trial data validates the Acceleron acquisition, and also supports Merck's budding portfolio of cardiovascular drugs, Truist Securities analyst Robyn Karnauskas said in a note.

The cardiovascular portfolio, expected to be made up of eight approved drugs, could bring in $10 billion in peak sales in 2030, Merck has said.

Pulmonary arterial hypertension is a rare type of high blood pressure that affects an estimated 40,000 people in the United States, according to Merck.

https://finance.yahoo.com/news/1-mercks-blood-vessel-disorder-111349603.html