Replies to post #247121 on Biotech Values

[Jake2234]

But let’s be clear- they aren’t running any Phase 3 by themselves. Too much unfiltered optimism…

Today approaching 7-year lows, no deal in sight. This is reality and fact.

[vinmantoo]

ENTA will likely be able to run a non-inferiority trial of EDP-235 vs Paxlovid because Paxlovid is sson expected to receive full-fledged FDA approval (rather than a mere EUA), enabling ENTA to obtain Paxlovid through commercial channels for use in the phase-3 trial. AVIR did not have this option when its own phase-3 trial commenced.

Thanks Dew. My view that analysts don't give their unvarnished views to the general public for free, or that they are idiots keeps getting reinforced. I have read a few recent ones about ENTA and EDP-235. They said ENTA has or appears to have lost confidence in EDP-235 because they aren't planning on running a phase 3 on their own. Even someone with the most casual knowledge of ENTA knows they have made it crystal clear from the start they weren't going to run a phase 3 trial of EDP-235. Rather they want a partner to do so just like they did for their HepC drugs. Anyone attacking ENTA by saying they lost confidence in EDP-235 aren't going to run a phase 3 by themselves are either ignorant or have an agenda.

Another report was about IMGN, and it was looking at their earnings history to try and predict when they would break even. Not a single mention of the recent stellar results of Elahere in PROC, and how sales are already ramping even up before submission to the FDA and to the EU for full approval. Not a single mention of the Elahere studies in PSOC and the potential it has if successful to greatly expand the market Not a single mention of the potential of the follow up ADC to Elahere which seems to be far more effective than Elahere when tumors have medium or even low alpha foliate receptor expression. I understand that the other trials have to be positive but at least point out they are wild cards that could significantly expand revenues.

[DewDiligence]

(ENTA)—Paxlovid receives full-fledged FDA approval—with boxed warning for DDIs:

https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults

Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

…Because of the importance of reducing the risk of significant drug-drug interactions with Paxlovid, the approved label and authorized Fact Sheet for Health Care Providers for the Paxlovid EUA come with a boxed warning with instructions for prescribers. Prescribers should review all medications taken by the patient to assess for potential drug-drug interactions and determine if other medicines that a patient may be taking require a dose adjustment, interruption and/or additional monitoring. Prescribers should consider the benefit of Paxlovid treatment in reducing hospitalization and death, and whether the risk of potential drug-drug interactions for an individual patient can be appropriately managed.

This FDA approval should enable ENTA to conduct a non-inferiority phase-3 trial of EDP-235 vs Paxlovid, as discussed in #msg-171965148.

EDP-235 does not have any significant drug-drug-interactions, so showing non-inferiority to Paxlovid on efficacy would be a big win for ENTA and its presumed EDP-235 partner.

[DewDiligence]

AVIR modifies phase-3 protocol for COVID antiviral, bemnifosbuvir—(f/k/a AT-527):

https://ir.ateapharma.com/news-releases/news-release-details/atea-pharmaceuticals-reports-second-quarter-2023-financial

The SUNRISE phase-3 trial has been upsized from 1,300 to 2,200 patients in the monotherapy cohort and the enrollment criteria have been loosened by accepting somewhat younger patients (depending on risk factors) and patients with renal impairment.

There are now two interim analyses after 650 and 1,300 patients have been enrolled for 29 days. The primary endpoint remains the rate of hospitalization or death at day 29 in the monotherapy cohort. AVIR says the final analysis is expected in mid-2024, but that’s optimistic, IMO.

Bemnifosbuvir is a nucleoside polymerase inhibitor that was designed for HCV and has been repurposed for COVID. The drug is not especially potent against SARS-CoV-2, which is why the daily dose being tested in the SUNRISE trial is a whopping 1100mg (550mg BID).

AVIR does have one thing in its favor: a cash balance of $647M at 6/30/23.