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Weekly biotech pulse: Big catalysts on tap for Sarepta, Roche, Eyenovia, and more

By Vlad Schepkov -- Here is your weekly Pro Recap preview of key biotech and FDA catalysts to look out for in the next week: PDUFA reviews for Eyenovia and Protalix, an earnings release and Phase 1 results for Seres Therapeutics, and an FDA vote for Sarepta Therapeutics and Roche.

InvestingPro users always get news like this in real time. Start your 7-day free trial to see for yourself.

Eyenovia set for a review of its pupil dilation treatment

On Monday, make sure to watch Eyenovia (NASDAQ:EYEN), which is set for PDUFA review of MydCombi - the company's drug candidate for treatment of pupil dilation (mydriasis).


Keep in mind the drug previously received a Complete Response Letter (CRL) from the FDA back in October 2021, although investors are definitely excited for a potential green light this time around: Shares are up nearly 170% year to date.

Wall Street analysts have a positive view of the stock, as well: 5 buy ratings, 1 hold, and 0 sells.

Protalix Biotherapeutics

Another day, another PDUFA. On the docket for Tuesday is a PDUFA review for Protalix Biotherapeutics' (NYSE:PLX) PRX-102 compound, its Fabry disease candidate - news that InvestingPro subscribers will get in rapid fire.

Protalix likewise got a CRL back in April 2021 and also appears to have regained some trust among investors ahead of the key decision: Shares have gained just shy of 140% since the start of the year.

The company has 3 buy ratings from analysts, 5 holds, and 0 sells ahead of the decision.

Seres Therapeutics

Seres Therapeutics (NASDAQ:MCRB) has scheduled its Q1 earnings release and conference call for Tuesday before the market opens.

The company is also set to announce initial Phase 1b Cohort 1 safety and pharmacology data for SER-155, its investigational drug for treatment of gastrointestinal infections, bacteremia, and GvHD (graft versus host disease).

The stock sports 12 Buys, 1 Hold, and 2 Sells from analysts.

Sarepta Therapeutics and Roche

On Friday, it'll be worth watching shares of Sarepta Therapeutics (NASDAQ:SRPT) and those of its partner - the OTC-listed ADRs of Roche (OTC:RHHBY), the Swiss-based pharmaceutical giant.

The companies are co-developing SRP-9001, a candidate to potentially treat Duchenne muscular dystrophy. The drug currently has an FDA Advisory Committee (AdCom) vote planned for Friday, with a PDUFA set some two and half weeks after that - on May 29.

Here's what a Morgan Stanley analyst had to say about the upcoming vote back in April:

We expect a supportive AdCom based on the evidence supporting the surrogate endpoint and continue to see the AdCom as an opportunity for mgt. to present their case publicly.

SRPT currently has 31 buys, 7 holds, and 1 sell across analysts.

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