Sarepta Therapeutics (SRPT) has received FDA approval for the expanded label of its gene therapy drug Elevidys, now approved for patients aged four years and older who are ambulatory and have a mutation in the DMD gene. This approval, which was driven by CBER Director Peter Marks despite opposition from FDA reviewers, has led to a significant increase in Sarepta's stock price, which rose by 30% following the news. Analysts have responded positively, with several firms raising their price targets for Sarepta, including BofA to $213, Baird to $200, Barclays to $226, and Needham to $235. The approval is expected to generate substantial revenue, with projections of $700 million annually by 2025-2026. Sarepta's CEO Doug Ingram highlighted the strong demand anticipated from patients and their families, estimating that 15,000 patients could benefit from the therapy. The decision has been seen as a major win for DMD patients, providing a new treatment option for this debilitating disease.
$VKTX - one nugget today is $VKTX confirmed all VENTURE data is now complete - so $VKTX has all PK Data & Tmax etc also was asked if FDA has that data and YES they do - 2Q $VKTX earnings call going to have lots of info to digest https://t.co/crhgSrD5cJ
That was a good call if I say so myself! $SRPT https://t.co/WlWQPvQtJD
$VKTX worth repeating “VK2735 duration of benefit with very little exposure” is what makes $VKTX unique & most likely as good as -Mounjaro if not better on efficacy & especially on safety is what the conviction is & was reenforced by $VKTX MGT today at OPPY https://t.co/HcBV1TkcN7
Sarepta CEO Doug Ingram is live w/ my @StreetBeatsPros colleague @davidmaris right now Worth a listen (and $SRPT shares are up >30% today). Fantastic story https://t.co/u2xIE1EThF
Sarepta's Elevidys projected to generate $700M annually in 2025-2026, a significant increase from $425M in 2023. Catalent's stock experiences a rise with 3.6M trade volume. #Sarepta #Elevidys #Catalent $TMO $SRPT $CTLT
Filled few more $SRPT LEAPS
$VKTX once again stressed VK2735 PK profile & Tmax $VKTX VK2735 demonstrated a half-life of approximately 170 to 250 hours, a Tmax (time to reach maximum plasma concentration) ranging from approximately 75 to 90 hours,excellent therapeutic exposures. https://t.co/JJLrUwmI9G
$VKTX management exceptionally smart, they know how competitive their pipeline assets are and they are executing well by focusing more on Obesity which is a straightforward program vs NASH at the moment. They can finish both oral and subq phs3 programs on their own Cash is king
$VKTX - when asked today about its Amylin program “it’s pretty interesting- it’s potent. Also can use same oral peptide technology as VK2735 https://t.co/AIXqwFNqPJ
$VKTX - once again Brian did not disappoint- took some notes -need to digest - hopefully OPPY will put out something - - I share more later-know $VKTX story well but learn many things everytime Brian speaksalso loved part about Capex today obviously directed at bears to digest😎 https://t.co/TH8AMnWOT4
Would love to see a tally of how many times a center director has overruled agency reviewers on an approval — maybe 15 times ever? …and yet, $SRPT has had 4 overrules in 8 years (Woodcock, Stein, Marks x2) https://t.co/qh7SwGg1ID
2PM ET today. I am pleased to speak with $SRPT CEO about the landmark approval of the expanded label. https://t.co/1iPI7FVRD5 https://t.co/Kmq9BhdcdF
$SLDB bigger funds that are involved - piper -Catalysts Brief safety update after first 3-4 patients are dosed with SGT-003 in mid- 2024 (likely late summer). While this may appear to be a non-significant catalyst, differ. think “no news is good news” shares could move on this https://t.co/K0HaFNSxJW https://t.co/IJOCaAMU4K
$SLDB right D Data this year for DMD, should be a good catalyst. Risk reward based on cash and market cap $SRPT https://t.co/ZnfNa2ckvF
$SLDB basically at cash here - name big funds own - & likely to get more attention 2H2024 especially off $SRPT news https://t.co/4Xgj8w8oOP
$SRPT my long term target after FDA full approval is 250+
$XBI reacting well to $SRPT Decision
$VKTX - meeting with OPPY today -ADA tomorrow
$SRPT You won't question approval if your kid needed the drug. That simple
Not matter what bears say about $SRPT and FDA decision. Drug has been helping so many kids that have no options on the table for this debilitating disease. It's so obvious to question FDA based on study results but put yourself in those parents shoes whose kids lives have…
$srpt the Elevidys eligible patient pop must have 10x or more today, right? If 50% of US patients get it over time, that would be 15k times price of Elevidys. CEO predicts 'ferocious' demand. Personally, I like LGMD data best. Long.
$SRPT fresh highs into 170 now.. hell of a spec trade but doing the research for hours on this one made me confident.. closed July call spreads at $16.. bought the past month under $6.. also had a few small spreads.. all together banked $3000 profit on just $1700 in risk https://t.co/cprI8E9RON
$SRPT will be over 200 and higher @Gantosj
$SRPT will rule DMD market, no competition whatsoever in nearby future. Revenue to tick in big time with FDA label expansion. This is like $LLY controlling the Obesity market ATM. $SLDB position more for DMD data later this year.
Sold yesterday at 50%+ acquired price $SRPT. A nice profit after months of drought... https://t.co/nFWuAXJfue
Large buyer today +40k SFRH5 9675/9775cs 4.75 ref SFRH5 9548. Below chart is rolling 4th quarterly slot...currently H5. High sett in last yr and a half was SVB failure...9616.5. Call sprd buyer doesn't need to actually get thru lower strike, but needs wheels to come off the… https://t.co/KKhL5Njfx3
$SRPT up near 165 premarket on the good news, should be a big win for the call spreads that were buying that past several days and July spreads in open interest. Also CEO insider buy for $2M at $78 back in November looks better and better now
Tom @HedgeyeHC is reviewing $SRPT LIVE on The Call right now @HedgeyeTV @Mike_Taylor1972
$SRPT PT upgraded to - $182 at RBC $200 at Baird $213 at BofA $226 at Barclays $235 at Needham
$SRPT BofA Raises Price Objective to $213 From $166
$SRPT well, the descn is made, people can debate the +ve and -ve side of the case from here onward - one thing for sure that I find interesting is the CRL recommendation went all the way up - even at the top of OTP with Nicole Verdun ... An FDA unit director overruling staff…
Baird $SRPT Demand should be fierce. Given the disease's debilitating nature, expect vociferous demand from patients and their families, and we expect effectively all patients without neutralizing antibodies to be treated as soon as they can manage. Raise PT to 200
$SRPT Marks and review team differ again though no adcom to support Marks this time. Some interesting tidbits about older patients and dystrophin levels, AE's from the review document https://t.co/KGfLKn40R8
Plot twist! $SRPT https://t.co/VPVyXCggg3
Sarepta APPROVED! +33% right in the projected range. We had it at +25% to the upside. 🚀 Big win for DMD patients & nice to see FDA open to risk. https://t.co/7CA4LxUNFI https://t.co/PUSfpCiu5m
First Janet, now Peter overrules staff. For some strange reason, $SRPT owns the FDA. https://t.co/SrnvijlTH9
$srpt viewed positively, US patients at least get a choice with the obvious risks and costs to healthcate system and potential political repercussions for sector.
$SRPT will be looking to add on dips to my position.
BofA $SRPT US: Sarepta Therapeutics: Price Objective Change - Elevidys label expansion is the best-case scenario; Reiterate Buy - BUY raising PT 213 from 166
$XBI shall thrive off the $SRPT news tomorrow https://t.co/p6HlUOpzl3
$SLDB Big names in it Perceptive 18% RA Capital added recently https://t.co/3qRWIRzdFy
Someone is Salty eh $SRPT
Cantor $SRPT better outcomes investors were looking for (stock trade up esp as degree of confidence was slowly fading),with only remaining risk now being on ENVISION study reading out positively,In midst of weak biotech tape, news should also be viewed favorably in #biotech
$SRPT saw IV rising into the final hours today and these July $160 call buyers we tracked should be happy campers tomorrow @OptionsHawk https://t.co/JmQGb04Je1
And it happened… $SRPT up 30% https://t.co/dLGWgNMcGH https://t.co/ywvkI6SU9Q
$SRPT Let’s give a shout out to @Gantosj for his consistent commentary despite price fluctuations and being attacked for his stand on SRPT therapy for DMD kids.
Congratulations $SRPT Team
$SLDB sorry meant data for DMD will be released this year Market cap is over 200 million with cash 206 million Good risk reward play for DMD $SRPT
$SRPT Once again, Peter Marks overrules his staff, who wanted to reject Elevidys. I guess we knew this was going to happen back in January, when Marks, on stage at our JPM event, told us that failed randomized clinical trials don’t matter in gene therapy. Still, amazing…
$SLDB topline readout of safety, microdystrophin expression and functional benefit by year end. Will slowly add to my position risk based $SRPT main conviction play
$SRPT when others were selling, I took my calculated risk and added $58+ https://t.co/hmauQ64B61
Bought $SLDB as a sympathy play after hours for $SRPT
$SRPT Irrational fear and panic gave a huge hindsight buying around $60 Bashed by few on twitter $VKTX same thing being a target for several when in fact has the best efficacy and safety Patience
Decisional memo from FDA's Peter Marks here: https://t.co/DUCLtp9ubN And memo from FDA office directors, who advocated for a rejection (complete response) to $SRPT's application: https://t.co/LgqNPlWVzs https://t.co/gFAxdMr7Ct
$SRPT Hindsight dips recall hitting 60+ Bought those dips Now 180
Those July $140/$200 call spreads held 5000x in open interest still since they bought in March.. $SRPT https://t.co/KEVB9RQlet
CBER Director Peter Marks once again overrode review staff in directing that $SRPT Elevidys receive full approval; OTP's Lola Fashoyin-Aje and Nicole Verdun supported CRL, as recommended by reviewers
$SRPT Halted Label expansion for 4 yrs of age who are ambulatory and have a mutation in DMD gene https://t.co/yumtz4z3wB
$SRPT I will sit this 1 out tomorrow. Ultimately, this is a political decision. 4 months ago, I would have said best-case scenario (Marks' view that we need to take educated chances), but recent DMD-specific issues have questioned FDA's laissez-faire attitude in DMD.
$SLDB holders are way more nervous about the FDA decisison on Elevidys than $SRPT holders
Sarepta $SRPT expecting FDA news tomorrow and seeing early buyer of 500 June 28th $120/$155 call spreads for $14.60, adjusts June $115 calls
Been saying it for quite some time Tolerability is as important as weight loss numbers $VKTX best in safety https://t.co/yPcxMrLeva
TOLERABILITY TOLERABILITY TOLERABILITY $NVO $LLY $VKTX https://t.co/m83VGURSRB