The FDA’s reversal of its earlier refusal to review mRNA-1010, the seasonal flu vaccine being developed by Moderna (NASDAQ: MRNA), accelerated a revival of Moderna shares that has been in progress over recent months—but the rebound has not lifted the prices of other vaccine stocks.
Moderna announced Wednesday a positive outcome to a “Type A” meeting with FDA officials in which the agency agreed to set aside its earlier refusal to file (RTF) letter to the company and instead evaluate mRNA-1010, with a target Prescription Drug User Fee Act (PDUFA) decision date of August 5.
In return, Moderna proposed a revised regulatory pathway based on age, agreeing to seek full approval for adults ages 50–64 and accelerated approval for adults ages 65 and older, with the accelerated approval subject to a post-marketing requirement that Moderna conduct an additional study in older adults.
“We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement. “Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
While Moderna cited the Type A meeting, a different explanation for the FDA’s about face emerged from Politico, which cited two unnamed sources in reporting that President Donald Trump called FDA Commissioner Martin A. Makary, MD, to the White House on February 18 and “expressed frustration” over the agency’s handling of vaccine issues, two days after the company announced the RTF letter. The Type A meeting was scheduled faster than usual and “gave them [the FDA] a public way to save face,” according to an unnamed source.
The story included a denial attributed to an unnamed White House official that Trump influenced the FDA’s reversal on the Moderna application: “Nothing the FDA has done recently on this has been choreographed.”
The Trump-Makary meeting may explain why five days after meeting with Trump and a day before the FDA about-face became public, Makary signaled the agency was more flexible when it came to Moderna’s flu vaccine than conveyed by its RTF letter last week.
Addressing the industry group Pharmaceutical Research and Manufacturers of America at its PhRMA Forum in Washington, D.C., as reported by NPR, Makary said the letter “in my mind is part of a conversation where you’ll see a dialogue between the company and the agency, and they can always, after that letter, ask for a more detailed review. But that’s part of the process. That’s a conversation.”
If approved, mRNA-1010 would be the first mRNA-based seasonal flu vaccine to reach the market, just in time for the 2026–27 flu season. Approval of the seasonal flu vaccine would also help Moderna by paving the way for approval of a combined COVID/flu vaccine, also being developed by Moderna, mRNA-1083.
“Meaningful opportunity”
“[Wednesday’s] course correction from the FDA reopens a meaningful opportunity for Moderna to capture a piece of the U.S. flu market near term,” Myles R. Minter, PhD, a partner and biotechnology analyst with William Blair, wrote Wednesday in a research note.
Andrew Tsai, equity analyst with Jefferies, has projected Moderna stands to generate $750 million in combined U.S. flu vaccine and flu/COVID combination vaccine sales by 2030, though the firm is not modeling any U.S. sales for ‘1010 this year.
‘1010 is under review in the EU, Canada, and Australia, and could generate enough sales in those regions plus the United States in 2027 to achieve a total addressable market of more than $1 billion. As for the combination vaccine, its total addressable market could reach $1.7 billion (including $700 million in COVID-19 revenue), Tsai projected.
“’1010 could actually contribute to U.S. sales as early as 2026 (pot’l upside to expectations), helping mgmt achieve its guidance for 2026 revenues to grow by up to +10% Y/Y [year-over-year],” Tsai wrote Wednesday in a research note.
Investors responded to the FDA’s about-face with a buying surge that sent the company’s stocks rising 6% from $43.93 to $46.60. The shares rose another 7% to $49.70, then finished the week inching up 0.3% Friday, closing at $49.87.
Moderna shares have climbed 66% year to date and have more than doubled, soaring 123% since reaching their 52-week low of $22.28 on November 21, 2025, following a smaller than expected 2025 loss, better than expected 2026 revenue guidance, and positive five-year data for the cancer vaccine or Individualized Neoantigen Therapy (INT/mRNA-4157) being developed with Merck & Co. (NYSE: MRK).
But the current surge is a far, far cry from Moderna’s all-time high closing price of $484.47 on August 9, 2021, months after Moderna’s COVID-19 mRNA-based vaccine SpikeVax™ reached the market, where it generated $17.7 billion in 2021 sales.
At least three analysts raised their 12-month price targets on Moderna shares following the FDA reversal. Evercore ISI analyst Cory Kasimov, a senior managing director and fundamental research analyst who leads its coverage of mid- and small-cap biotech companies, raised the firm’s price target on Moderna shares 25%, from $28 to $35, but retained its “In-Line” rating on the stock.
Luca Issi, PhD, senior biotechnology analyst with RBC Capital Markets, elevated his firm’s price target 20% from $25 to $30, maintaining its “Sector Perform” rating, while Salveen Richter, Goldman Sachs’ lead analyst for the U.S. biotechnology sector, lifted her firm’s price target 14% from $36 to $41, retaining its “Neutral” rating.
A consensus of analysts also projects a 10% revenue jump this year from the $1.9 billion generated in 2025, with the company having told investors in 2024 it expects to achieve cash breakeven status by 2028, two years later than once expected—a forecast that will require continued cost-cutting by Moderna.
That will be harder to achieve given the need for a large-scale clinical trial for the seasonal flu vaccine: “We believe this will likely be a sizable vaccine efficacy study in this population that is required for full approval, but does go against Moderna’s expense guidance, which assumes no new large respiratory vaccine studies,” Minter observed.
Seven new products
To achieve that, Moderna plans to launch seven new products—‘1010, ‘1083, the cancer 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 is also pursuing an expansion of approval for the respiratory syncytial virus (RSV) vaccine mRESVIA beyond patients ages 60+, to ages 18–59.
Moderna’s stock surge has not extended to other publicly traded vaccine developers since the companies that showed increases did so based on their own news, a spot check by GEN shows:
- BioNTech (NASDAQ: BNTX)—Shares of the German mRNA vaccine developer climbed 3% since the Moderna announcement from $106.99 to $110.14 and have increased 16% year to date.
- GeoVax Labs (NASDAQ: GOVX)—Shares fell 3% from $1.58 to $1.53 and have plummeted 64% year to date after carrying out several financing rounds and a 1-for-25 reverse stock split aimed at regaining compliance with NASDAQ’s $1 minimum bid price. The company has labeled 2026 a pivotal inflection year that will see multiple late-stage clinical, regulatory, and manufacturing milestones.
- Novavax (NASDAQ: NVAX)—Shares rose 6% from $8.65 to $9.20 but have jumped 37% year to date following recent announcements, including a partnership announced with Pfizer (NYSE: PFE) and Cantor Fitzgerald reiterating its “Overweight” rating and $18 price target.
- Sanofi (Euronext Paris: SAN)—Shares grew 3% from €78.13 ($92.03) to €79.58 ($93.74) but have dropped 4% year to date on news capped by the February 12 announcement of the abrupt departure of CEO Paul Hudson, effective Tuesday.
- Vaxart (OTCQX: VXRT)—Shares increased 5% from 56 to 59 cents but have leaped 69% year to date as investors have embraced recent news such as positive clinical data for its COVID-19 and norovirus oral vaccine candidates, and an up-to-$700 million exclusive license for the COVID-19 pill vaccine with Dynavax Technologies (NASDAQ: DVAX).
Stunning letter
The FDA stunned Moderna earlier this month by rejecting Moderna’s biologics license application (BLA) for mRNA-1010, instead handing the company the RTF letter. Moderna had based its application on data from the 40,800-patient pivotal Phase III P304 trial (NCT06602024), which showed mRNA-1010 to have achieved relative vaccine efficacy (rVE) of 26.6% overall, including 27% for study participants aged 65 and older vs standard‑dose control.
Moderna’s rVE was comparable, Tsai reported, to those seen in trials evaluating Fluzone® (~24%) and Flublok (~30%), both marketed by Sanofi Pasteur. However, the FDA—specifically Center for Biologics Evaluation and Research (CBER) director Vinayak (Vinay) Prasad, MD—took issue with Moderna’s comparing ‘1010 to a licensed standard‑dose flu vaccine instead of a high-dose flu vaccine, saying the company’s comparator did not constitute the best‑available standard of care, particularly among older patients.
“CBER does not consider the application to contain a trial ‘adequate and well controlled,’ and the application is therefore, on its face, inadequate for review. This is because your control arm does not reflect the best-available standard of care in the United States at the time of the study,” Prasad wrote.
Prasad’s sharp tone in the RTF letter sparked some rare public blowback from Moderna’s CEO: “This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Bancel stated in a Moderna press release. He said CBER had raised no objections or clinical hold comments about the adequacy of the Phase III P304 trial after Moderna submitted the trial protocol in April 2024 or at any time before the study began five months later in September 2024.
“It should not be controversial to conduct a comprehensive review of a flu vaccine submission that uses an FDA-approved vaccine as a comparator in a study that was discussed and agreed on with CBER prior to starting,” Bancel added.
Mani Foroohar, MD, a senior research analyst with Leerink Partners focused on genetic medicines, wrote in a Wednesday research note that Moderna’s public airing of its dispute with the FDA was uncommon.
“But the quick reversal of FDA’s initial position should be a tailwind for bulls who argue MRNA can effectively leverage public pressure against an agency that has been skeptical of mRNA flu vaccines under current HHS/FDA leadership,” Foroohar commented. “It remains to be seen how this more assertive approach to the FDA ultimately impacts the review outcome for mRNA-1010, details of a post-marketing study, and—most financially important for MRNA—approval path for the combo flu/COVID vaccine.”
Leaders and laggards
- Compass Pathways (NASDAQ: CMPS) shares soared 45% over two trading days from $5.81 to $8.45 Wednesday, after the psychedelic drug developer announced positive results from two Phase III placebo-controlled trials—the 258-patient COMP005 (NCT05624268) and 581-patient COMP006 (NCT05711940)—assessing the company’s synthetic psilocybin formulation COMP360 in treatment-resistant depression. Compass said the 25 mg arm of COMP360 showed clinically meaningful (≥25%) reductions in the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 6 for 25% of 171 treatment-arm participants in COMP005 and 39% of 296 treatment-arm participants in COMP006. In COMP005, participants who achieved a clinically meaningful reduction in MADRS at Week 6 with COMP360 25 mg were shown to have maintained durability of effect at least through Week 26 after one or two doses. Compass said it has requested a meeting with the FDA to discuss a rolling submission and review and expects to complete a New Drug Application (NDA) submission in 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 said it agreed to immediately exercise outstanding warrants to purchase up to 2,122,652 shares of company stock at $3.90 per share, in a transaction expected to raise approximately $8.3 million in gross proceeds. In return, Moleculin will issue new unregistered warrants to purchase up to 6,367,956 shares of common stock for the lesser of either $3.90 per share or the lowest volume weighted average price of the company’s common stock on any trading day through February 25. Moleculin said it intended to use net proceeds from the offering for working capital and general corporate purposes. Roth Capital Partners acted as Moleculin’s financial advisor for the transaction, which was expected to close on February 20.
