FDA Reversal Boosts Moderna, However Not Different Vaccine Firms

The FDA’s reversal of its earlier refusal to evaluation mRNA-1010, the seasonal flu vaccine being developed by Moderna (NASDAQ: MRNA), accelerated a revival of Moderna shares that has been in progress over current months—however the rebound has not lifted the costs of different vaccine shares.

Moderna introduced Wednesday a constructive final result to a “Kind A” assembly with FDA officers wherein the company agreed to put aside its earlier refusal to file (RTF) letter to the corporate and as an alternative consider mRNA-1010, with a goal Prescription Drug Consumer Price Act (PDUFA) choice date of August 5.

In return, Moderna proposed a revised regulatory pathway primarily based on age, agreeing to hunt full approval for adults ages 50–64 and accelerated approval for adults ages 65 and older, with the accelerated approval topic to a post-marketing requirement that Moderna conduct an extra examine in older adults.

“We respect the FDA’s engagement in a constructive Kind A gathering and its settlement to advance our utility for evaluation,” Moderna CEO Stéphane Bancel stated in a press release. “Pending FDA approval, we look ahead to making our flu vaccine out there later this yr in order that America’s seniors have entry to a brand new choice to guard themselves towards flu.”

Whereas Moderna cited the Kind A gathering, a unique clarification for the FDA’s about face emerged from Politico, which cited two unnamed sources in reporting that President Donald Trump known as FDA Commissioner Martin A. Makary, MD, to the White Home on February 18 and “expressed frustration” over the company’s dealing with of vaccine points, two days after the corporate introduced the RTF letter. The Kind A gathering was scheduled sooner than traditional and “gave them [the FDA] a public option to save face,” based on an unnamed supply.

The story included a denial attributed to an unnamed White Home official that Trump influenced the FDA’s reversal on the Moderna utility: “Nothing the FDA has finished lately on this has been choreographed.”

The Trump-Makary assembly might clarify why 5 days after assembly with Trump and a day earlier than the FDA about-face turned public, Makary signaled the company was extra versatile when it got here to Moderna’s flu vaccine than conveyed by its RTF letter final week.

Addressing the business group Pharmaceutical Analysis and Producers of America at its PhRMA Discussion board in Washington, D.C., as reported by NPR, Makary stated the letter “in my thoughts is a part of a dialog the place you’ll see a dialogue between the corporate and the company, they usually can at all times, after that letter, ask for a extra detailed evaluation. However that’s a part of the method. That’s a dialog.”

If accredited, mRNA-1010 can be the primary mRNA-based seasonal flu vaccine to succeed in the market, simply in time for the 2026–27 flu season. Approval of the seasonal flu vaccine would additionally assist Moderna by paving the best way for approval of a mixed COVID/flu vaccine, additionally being developed by Moderna, mRNA-1083.

“Significant alternative”

“[Wednesday’s] course correction from the FDA reopens a significant alternative for Moderna to seize a bit of the U.S. flu market close to time period,” Myles R. Minter, PhD, a accomplice and biotechnology analyst with William Blair, wrote Wednesday in a analysis be aware.

Andrew Tsai, fairness analyst with Jefferies, has projected Moderna stands to generate $750 million in mixed U.S. flu vaccine and flu/COVID mixture vaccine gross sales by 2030, although the agency shouldn’t be modeling any U.S. gross sales for ‘1010 this yr.

‘1010 is beneath evaluation within the EU, Canada, and Australia, and will generate sufficient gross sales in these areas plus america in 2027 to attain a complete addressable market of greater than $1 billion. As for the mixture vaccine, its whole addressable market might attain $1.7 billion (together with $700 million in COVID-19 income), Tsai projected.

“’1010 might truly contribute to U.S. gross sales as early as 2026 (pot’l upside to expectations), serving to mgmt obtain its steering for 2026 revenues to develop by as much as +10% Y/Y [year-over-year],” Tsai wrote Wednesday in a analysis be aware.

Traders responded to the FDA’s about-face with a shopping for surge that despatched the corporate’s shares rising 6% from $43.93 to $46.60. The shares rose one other 7% to $49.70, then completed the week inching up 0.3% Friday, closing at $49.87.

Moderna shares have climbed 66% yr up to now and have greater than doubled, hovering 123% since reaching their 52-week low of $22.28 on November 21, 2025, following a smaller than anticipated 2025 loss, higher than anticipated 2026 income steering, and constructive five-year knowledge for the most cancers vaccine or Individualized Neoantigen Remedy (INT/mRNA-4157) being developed with Merck & Co. (NYSE: MRK).

However the present surge is a far, far cry from Moderna’s all-time excessive closing worth of $484.47 on August 9, 2021, months after Moderna’s COVID-19 mRNA-based vaccine SpikeVax™ reached the market, the place it generated $17.7 billion in 2021 gross sales.

No less than three analysts raised their 12-month worth targets on Moderna shares following the FDA reversal. Evercore ISI analyst Cory Kasimov, a senior managing director and basic analysis analyst who leads its protection of mid- and small-cap biotech firms, raised the agency’s worth goal on Moderna shares 25%, from $28 to $35, however retained its “In-Line” score on the inventory.

Luca Issi, PhD, senior biotechnology analyst with RBC Capital Markets, elevated his agency’s worth goal 20% from $25 to $30, sustaining its “Sector Carry out” score, whereas Salveen Richter, Goldman Sachs’ lead analyst for the U.S. biotechnology sector, lifted her agency’s worth goal 14% from $36 to $41, retaining its “Impartial” score.

A consensus of analysts additionally tasks a ten% income leap this yr from the $1.9 billion generated in 2025, with the corporate having advised traders in 2024 it expects to attain money breakeven standing by 2028, two years later than as soon as anticipated—a forecast that can require continued cost-cutting by Moderna.

That will probably be more durable to attain given the necessity for a large-scale medical trial for the seasonal flu vaccine: “We imagine this can doubtless be a large vaccine efficacy examine on this inhabitants that’s required for full approval, however does go towards Moderna’s expense steering, which assumes no new giant respiratory vaccine research,” Minter noticed.

Seven new merchandise

To realize that, Moderna plans to launch seven new merchandise—‘1010, ‘1083, the most cancers vaccine, plus a next-generation COVID-19 vaccine (mNEXSPIKE/mRNA-1283), a norovirus vaccine (mRNA-1403), a propionic acidemia (PA) therapeutic (mRNA-3927), and a methylmalonic acidemia (MMA) therapeutic (mRNA-3705). Moderna can be pursuing an enlargement of approval for the respiratory syncytial virus (RSV) vaccine mRESVIA past sufferers ages 60+, to ages 18–59.

Moderna’s inventory surge has not prolonged to different publicly traded vaccine builders for the reason that firms that confirmed will increase did so primarily based on their very own information, a spot verify by GEN exhibits:

• BioNTech (NASDAQ: BNTX)—Shares of the German mRNA vaccine developer climbed 3% for the reason that Moderna announcement from $106.99 to $110.14 and have elevated 16% yr up to now.
• GeoVax Labs (NASDAQ: GOVX)—Shares fell 3% from $1.58 to $1.53 and have plummeted 64% yr up to now after finishing up a number of financing rounds and a 1-for-25 reverse inventory break up aimed toward regaining compliance with NASDAQ’s $1 minimal bid worth. The corporate has labeled 2026 a pivotal inflection yr that can see a number of late-stage medical, regulatory, and manufacturing milestones.
• Novavax (NASDAQ: NVAX)—Shares rose 6% from $8.65 to $9.20 however have jumped 37% yr up to now following current bulletins, together with a partnership introduced with Pfizer (NYSE: PFE) and Cantor Fitzgerald reiterating its “Obese” score and $18 worth goal.
• Sanofi (Euronext Paris: SAN)—Shares grew 3% from €78.13 ($92.03) to €79.58 ($93.74) however have dropped 4% yr up to now on information capped by the February 12 announcement of the abrupt departure of CEO Paul Hudson, efficient Tuesday.
• Vaxart (OTCQX: VXRT)—Shares elevated 5% from 56 to 59 cents however have leaped 69% yr up to now as traders have embraced current information resembling constructive medical knowledge for its COVID-19 and norovirus oral vaccine candidates, and an up-to-$700 million unique license for the COVID-19 capsule vaccine with Dynavax Applied sciences (NASDAQ: DVAX).

Gorgeous letter

The FDA surprised Moderna earlier this month by rejecting Moderna’s biologics license utility (BLA) for mRNA-1010, as an alternative handing the corporate the RTF letter. Moderna had primarily based its utility on knowledge from the 40,800-patient pivotal Part III P304 trial (NCT06602024), which confirmed mRNA-1010 to have achieved relative vaccine efficacy (rVE) of 26.6% general, together with 27% for examine individuals aged 65 and older vs normal‑dose management.

Moderna’s rVE was comparable, Tsai reported, to these seen in trials evaluating Fluzone® (~24%) and Flublok (~30%), each marketed by Sanofi Pasteur. Nonetheless, the FDA—particularly Heart for Biologics Analysis and Analysis (CBER) director Vinayak (Vinay) Prasad, MD—took problem with Moderna’s evaluating ‘1010 to a licensed normal‑dose flu vaccine as an alternative of a high-dose flu vaccine, saying the corporate’s comparator didn’t represent the very best‑out there normal of care, significantly amongst older sufferers.

“CBER doesn’t think about the appliance to comprise a trial ‘ample and nicely managed,’ and the appliance is due to this fact, on its face, insufficient for evaluation. It is because your management arm doesn’t mirror the best-available normal of care in america on the time of the examine,” Prasad wrote.

Prasad’s sharp tone within the RTF letter sparked some uncommon public blowback from Moderna’s CEO: “This choice by CBER, which didn’t determine any security or efficacy issues with our product, doesn’t additional our shared aim of enhancing America’s management in creating revolutionary medicines,” Bancel acknowledged in a Moderna press launch. He stated CBER had raised no objections or medical maintain feedback concerning the adequacy of the Part III P304 trial after Moderna submitted the trial protocol in April 2024 or at any time earlier than the examine started 5 months later in September 2024.

“It shouldn’t be controversial to conduct a complete evaluation of a flu vaccine submission that makes use of an FDA-approved vaccine as a comparator in a examine that was mentioned and agreed on with CBER previous to beginning,” Bancel added.

Mani Foroohar, MD, a senior analysis analyst with Leerink Companions centered on genetic medicines, wrote in a Wednesday analysis be aware that Moderna’s public airing of its dispute with the FDA was unusual.

“However the fast reversal of FDA’s preliminary place must be a tailwind for bulls who argue MRNA can successfully leverage public strain towards an company that has been skeptical of mRNA flu vaccines beneath present HHS/FDA management,” Foroohar commented. “It stays to be seen how this extra assertive method to the FDA in the end impacts the evaluation final result for mRNA-1010, particulars of a post-marketing examine, and—most financially essential for MRNA—approval path for the combo flu/COVID vaccine.”

Leaders and laggards

• Compass Pathways (NASDAQ: CMPS) shares soared 45% over two buying and selling days from $5.81 to $8.45 Wednesday, after the psychedelic drug developer introduced constructive outcomes from two Part III placebo-controlled trials—the 258-patient COMP005 (NCT05624268) and 581-patient COMP006 (NCT05711940)—assessing the corporate’s artificial psilocybin formulation COMP360 in treatment-resistant despair. Compass stated the 25 mg arm of COMP360 confirmed clinically significant (≥25%) reductions within the Montgomery-Åsberg Melancholy Score Scale (MADRS) at week 6 for 25% of 171 treatment-arm individuals in COMP005 and 39% of 296 treatment-arm individuals in COMP006. In COMP005, individuals who achieved a clinically significant discount in MADRS at Week 6 with COMP360 25 mg had been proven to have maintained sturdiness of impact a minimum of by Week 26 after one or two doses. Compass stated it has requested a gathering with the FDA to debate a rolling submission and evaluation and expects to finish a New Drug Software (NDA) submission within the fourth quarter.
• Moleculin Biotech (NASDAQ: MBRX) shares nosedived 44% from $4.81 to $2.68 Thursday after the developer of therapeutics for hard-to-treat tumors and viruses stated it agreed to instantly train excellent warrants to buy as much as 2,122,652 shares of firm inventory at $3.90 per share, in a transaction anticipated to boost roughly $8.3 million in gross proceeds. In return, Moleculin will problem new unregistered warrants to buy as much as 6,367,956 shares of widespread inventory for the lesser of both $3.90 per share or the bottom quantity weighted common worth of the corporate’s widespread inventory on any buying and selling day by February 25. Moleculin stated it supposed to make use of internet proceeds from the providing for working capital and common company functions. Roth Capital Companions acted as Moleculin’s monetary advisor for the transaction, which was anticipated to shut on February 20.