BTIG Bullish On Aerovate As Competitor Data Reinforce Lead Program Thesis

 

• BTIG upgraded Aerovate Therapeutics Inc 
  AVTE+0.17%+ Free Alerts
   from Neutral to Buy with a price target of $27.
• The analyst writes that to Aerovate's benefit, Gossamer Bio Inc's 
  GOSS+2.97%+ Free Alerts
   TORREY Phase 2 results validated dry powder inhaled (DPI)-administered TKIs in pulmonary arterial hypertension (PAH) as a safe and technically viable approach.
• But Gossamer's DPI seralutinib does not look like a competitive disease-modifying therapy in PAH, with a PVR reduction of only 14% in the overall study population and 21% in FC III pts (p=.04).
• BTIG says the results likely do not put pressure on the AV-101 opportunity at this time. 
• Oral imatinib (the AV-101 API) was previously shown in a Phase 3 study that showed a 32% reduction, and 0.7mg/kg sotatercept in Phase 2 showed a 34% PVR reduction.
• AVTE expects to complete enrollment in their Phase 2b trial of AV-101 in PAH in mid-2023 and data in 4Q23 or 1Q24. 
• By design, there is a seamless transition from Phase 2b to 3 in AVTE's IMPAHCT trial, so the analyst does not expect GOSS to have a material timeline advantage as GOSS is not initiating Phase 3 until 2H23. 

https://www.benzinga.com/analyst-ratings/analyst-color/22/12/29977274/analyst-turns-bullish-on-aerovate-as-competitor-data-reinforce-lead-program-thesis

US Supports Delay On COVID Patent Waiver Extension Decision

 

• Developing countries have been pushing for a patent waiver extension for COVID-19, which many developed countries argue could discourage pharma companies from responding rapidly to future global health crises.
• The deadline for a decision has been December 17, but there has been an unresolved stand-off on the issue at the WTO.
• The U.S. has backed delaying the decision to waive patent protection for COVID-19 treatments and tests.
• In June, World Trade Organization members agreed on a partial waiver of intellectual property rights for COVID-19 vaccines, with consideration of an extension within six months.
• "Real questions remain on a range of issues, and the additional time, coupled with information from the USITC, will help the world make a more informed decision," U.S. Trade Representative Katharine Tai said in a statement, Reuters reported.
• "The U.S. has had more than two years to meaningfully engage in WTO negotiations over access to lifesaving tests and treatments. Kicking the issue further into the long grass, just as the negotiating deadline approaches, is pathetic," policy co-leader Mohga Kamal-Yanni said.
• Last year, G20 supported the "voluntary licensing" of COVID-19 vaccine patents.

https://www.benzinga.com/general/biotech/22/12/29980720/us-supports-delay-on-covid-patent-waiver-extension-decision

Ala. Medicaid to end sobriety mandate on hepatitis treatment

 The U.S. Department of Justice said Monday that it has entered into a settlement agreement with Alabama’s Medicaid program to end a sobriety requirement for treatment of people with Hepatitis C.

Federal officials said Alabama agreed to end a a “blanket sobriety restriction” that refused to pay for antiviral treatment for Hepatitis C if the Medicaid patient had used drugs or alcohol six months before or during treatment

“Alabama Medicaid’s reversal of its longstanding sobriety restriction will finally allow Medicaid recipients with substance use disorders to have the same access as others to a cure for Hepatitis C,” Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division said in a news release.

The Justice Department had argued the sobriety policy was a violation of the Americans with Disabilities Act by discriminating against people with substance disorders. Alabama denied the Justice Department’s accusations, according to the settlement, but agreed it was best to resolve the dispute.

https://apnews.com/article/health-alabama-hepatitis-medicaid-us-department-of-justice-07174ef83e884b950e0e404af5821b8e