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Which April '23 PDUFAs are Seeing Run-Ups into Approval Decisions?

Updated: Apr 11, 2023

What Are We Looking At:

There are six PDUFA dates in April 2023 for small to large cap biotech. However, a majority of these upcoming PDUFA dates are for larger cap biotech companies. We have looked into how each company has been performing since the beginning of 2023 and how these companies performed running up to the Phase 3 data readout for these potential products. We have broken up each PDUFA by company to provide you with more specific information about these catalyst events. Markets are down overall in 2023 with XBI down 5.65% YTD, so this could also affect these run-ups.


  • IONS is the only April PDUFA to have an AdComm meeting before the target action date.

  • ASND received negative feedback from the FDA in regards to its NDA for TransCon PTH on April 3rd, which could lead to problems on the PDUFA date.

  • VRTX saw a run-up prior to the Phase 3 data readout of 43% (3/20/2020 to 7/20/20) for TRIKAFTA, which could be why VRTX has had a run-up since January 2023 in anticipation of its two PDUFA dates in April (TRIKAFTA) and May (KALYDECO- children one to four months old).

See our previous free forum with additional info on historical PDUFA decisions since September 2021!!

About PDUFA dates An important note to remember especially for newer investors is that PDUFA target dates are just that, a target date. Thus, approval usually happens just before or on the date. However, especially with Covid travel restrictions affecting site inspections, approval or a CRL (i.e. a letter from FDA that the drug candidate will NOT be approved unless something is fixed), can come after the target date.

April PDUFAs and Run-ups:

IONS - Tofersen PDUFA 4/25/23

  • IONS has not seen much of a run-up except for a small run-up starting a week before the AdComm meeting on March 22, 2023.

  • No run-up was seen into the Ph3 data reported October 17, 2021 and currently IONS is slightly down in 2023.

  • While the stock was down after the AdComm vote, we have started to see an increase in the stock again since March 27.

  • Will the stock continue to run-up until April 25?

  • This PDUFA decision will be very interesting as Ph3 data did not seem positive, but the AdComm voted unanimously in favor of Tofersen approval.

Fig. 1 IONS Stock Chart YTD

Fig. 2 - IONS Small run-up into AdComm (March 22, 2023)

MCRB - SER-109 PDUFA 4/26/23

  • MCRB has been running steady between $4 and $6 since January 2023.

  • MCRB did not see a run up prior to Phase 3 data readout for SER-109, instead they had a -32.55% change.

  • Hopefully the upcoming PDUFA on April 26th 2023 will change things around for them, but for now no run up is seen.

Fig. 3 MCRB Stock Chart YTD

Fig. 4 MCRB Stock down into Ph3 data


  • VRTX has been running up since January 1st 2023 (18.46%) in anticipation of the TRIKAFTA PDUFA date on April 28th 2023.

  • Also, VRTX was running up prior to the Phase 3 data readout for TRIKAFTA (7/20/2020) by 12.5%.

  • We are looking forward to seeing what will happen April 28th as VRTX has another PDUFA date in May for KALYDECO extended use in children under four months of age.

Fig. 5 VRTX Stock Chart YTD

Fig. 6 Run-up into Ph3 data (7/20/2020)

ASND TransCon PTH 4/30/23

  • ASND had been going steady since the beginning of 2023 until April 3rd when they had a press release.

  • In this press release, ASND said that the FDA noted deficiencies in the TransCon PTH NDA and the stock went down over 35%.

  • This could have a major impact with the PDUFA scheduled for April 30th.

  • We are curious to see what this means for TransCon PTH.

Fig. 7 ASND Stock Chart YTD

PFE 20vPnC April

  • PFE has an April PDUFA date for 20vPnC but there is no specific date given by the company.

  • PFE has been down almost 19% this year, unfortunately as have many companies as well.

  • Pediatric data for this asset was reported 9/19/2022 and adult data was reported 3/18/2020.

  • PFE was down 28% leading up to the adult data, but this is likely because of the effect of Covid. Stock was also down leading up to the pediatric data in Sept 2022.

  • It will be interesting to see if we see any run-up as we get farther into April because PFE is such a large company and no specific date is given.

Fig. 8 PFE Stock chart YTD

Fig. 9 Ph3 data readouts w/o run-ups

EBS AV7909 April

  • While EBS has been down 13% in 2023, there was a run-up in stock of 33% since around March 22, 2023.

  • This looks promising for EBS, but was likely due more to a run-up into approval of NARCAN over the counter on March 29 rather than the AV7909 April PDUFA.

  • As with PFE, no specific date in April is given for this PDUFA.

  • The AV7909 BLA was accepted in June 2022 and already used under a BARDA contract, so no specific Phase 3 data has been recently reported.

Fig. 10 EBS Stock chart YTD

Fig. 11 Run up into NARCAN approval on 3/29/23

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This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.

Article history:

Originally posted 4/6/23


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