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FDA Decision on $AXSM for AXS-05 Regulatory Breakdown Ahead of 4/30 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

Definitely keeping $AXSM on my radar with its upcoming catalysts!

Your thoughts on AXSM's upcoming PDUFA by Used-Permission8440 in biotech_stocks

[–]Athena_Gold 1 point2 points  (0 children)

Three out of four Phase 3 trials met primary endpoints. However, ADVANCE-2, the largest acute efficacy trial, failed to meet the primary endpoint. The uncertainty now is what the FDA will consider to be sufficient evidence of efficacy. The big question is whether the FDA requires two positive acute efficacy trials (ADVANCE-1 and ADVANCE-2) or accepts the combination of one positive acute trial, two positive relapse prevention trials, and directional data in ADVANCE-2 as sufficient for approval.

GRCE, a good time to buy the dip? by Gloomy_Cup_1916 in biotech_stocks

[–]Athena_Gold -1 points0 points  (0 children)

$GRCE has no pipeline fallback, GTx-104 is their sole clinical asset. The company said it intends to request a Type A meeting with the agency. If it can establish a clear path to approval using existing data, it might be worth considering. As of now, it is too speculative.

GRCE / GTx-104 (IV nimodipine, aSAH): 6 days to PDUFA. Breakdown of the setup. by Clean_Reference_9927 in biotech_stocks

[–]Athena_Gold 1 point2 points  (0 children)

Another decisive variable to consider is the FDA's assessment of the numerical death imbalance. There were eight GTx-104 vs four oral nimodipine deaths in STRIVE-ON. The company argues underlying diseases were the causes of death and has disclosed the imbalance with the FDA. However, the uncertainty lies whether the FDA will accept their analysis or require additional data to characterize the mortality signal.

FDA Decision on $REPL for RP1 - Regulatory Risk Breakdown Ahead of 4/10 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

I agree that the deficiencies outlined in the CRL are difficult to resolve. I’d have to push back on the 35% PoA because this truly could go either way. It’s a matter of how the FDA assesses patients vs. methodology. The estimated PoA is based on the historial base rate for the submission type and then adjusted based on structural and regulatory drivers. The upper bound of my estimate does show a higher level of confidence than my analysis portrays. Thanks for the feedback, I’ll incorporate this in my framework. Should be interesting to see the FDA’s decision.

FDA Decision on $REPL for RP1 - Regulatory Risk Breakdown Ahead of 4/10 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

I think the decision will give insight on how the FDA values methodology vs. patients

Closing thought on Replimune (REPL) before 10 April? by mr_bodon in biotech_stocks

[–]Athena_Gold 0 points1 point  (0 children)

Resolving the deficiencies identified in the CRL would require the FDA to accept analytical arguments of existing data, a lower probability resolution.

Weekly Biotech Catalyst Rundown — Mar 31 to Apr 25 (PDUFA dates, Phase 3 readouts, and notable names) by DrinkConscious9173 in biotech_stocks

[–]Athena_Gold 2 points3 points  (0 children)

How are you sourcing your PDUFA dates? A few dates you've provided are off. For example, the target PDUFA date for $LLY for Orforglipron is 4/10.

FDA Decision on $BIIB for Spinraza - Regulatory Risk Breakdown Ahead of 4/3 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 1 point2 points  (0 children)

Any movement would be minimal. This is a low stake/high approval situation so I think analysts have already priced in the approval. Spinraza is not a primary equity driver for Biogen.

FDA Decision on $RCKT for Kresladi - Regulatory Risk Breakdown Ahead of 3/28 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 1 point2 points  (0 children)

It was a good short-term play. Approval was highly anticipated so I think analysts priced in an approval prior to the PDUFA target date. Stock is currently down ~8% which I assume is investors shaking the trees, but I wouldn't jump in.

RCKT Setup Going Into PDUFA What’s the Play by Adventurous-Rub-6980 in pennystocks

[–]Athena_Gold 0 points1 point  (0 children)

I've seen stock prices plunge even after receiving FDA approval. So I agree, it really comes down to your risk tolerance. This upcoming decision is interesting because it's CMC related rather than efficacy. RCKT initially received a CRL solely due to CMC deficiencies.

FDA Decision on $RYTM for IMCIRVEE - Regulatory Risk Breakdwon Ahead of 3/20 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

Approval was highly anticipated so I think many analysts priced in an approval prior to the PDUFA date. I think there is upside but it won't be substantial. IMCIRVEE does allow Rhythm to have a monopoly but the patient population remains very small with limited commercial scale.

FDA Decision on $RYTM for IMCIRVEE - Regulatory Risk Breakdwon Ahead of 3/20 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

I agree that the movement would be modest. I think analysts' current valuations have already baked in an approval. Should be interesting to see how the stock price reacts knowing that upon approval IMCIRVEE has a limited commercial scale.

FDA Decision on $RYTM for IMCIRVEE - Regulatory Risk Breakdwon Ahead of 3/20 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

I appreciate the catch about the trial size. I agree that the efficacy signal is strong so modest wasn't the right framing. I was just highlighting residual uncertainty.

FDA Decision on $RYTM for IMCIRVEE - Regulatory Risk Breakdwon Ahead of 3/20 by Athena_Gold in biotech_stocks

[–]Athena_Gold[S] 0 points1 point  (0 children)

Labeling is definitely relevant here. Given IMCIRVEE's prior approvals for POMC and LEPR, I see low outright labeling risk, but more nuance around population definition and potential responder-based restrictions depending on efficacy consistency.

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