2027 FDA Calendar: 5 PDUFAs Ranked

2027’s first half has 9 confirmed PDUFA dates. That looks like a target-rich calendar. It is not. Strip out the mega-cap rubber stamp, the foreign-listed drug with no US ticker, and the one catalyst that already resolved, and you are left with five genuine binary events where the decision moves a stock by double digits. Two of them land in the same week in late February.

The Q4 2026 calendar is resolving now, and the forward-looking money is rotating into 2027. Here is the full confirmed slate, then the ranked playbook for the five names that matter.

The 2027 PDUFA calendar

Date	Ticker	Drug	Indication	App Type	Market Cap
Jan 4	NUVB	IBTROZI (taletrectinib)	ROS1+ NSCLC label update	sNDA	$2.02B
Feb 27	CGEM	zipalertinib	EGFR ex20ins NSCLC	NDA	$953M
Feb 28	BMRN	vosoritide (Voxzogo)	achondroplasia full approval	sNDA	$11.66B
Apr 23	PHVS	deucrictibant	HAE on-demand	NDA	$2.25B
Apr 28	IMNM	varegacestat	progressing desmoid tumors	NDA	$2.56B
Apr 24	ORGO	ReNu (Amnuvx)	knee osteoarthritis	BLA	$181M
Apr 30	ALCOX	NCX-470 (K-911)	glaucoma	NDA	N/A (foreign)
May 1	AXSM	AXS-12 (reboxetine)	cataplexy	NDA	$10.22B
May 13	BMY	mezigdomide (MeziKd)	R/R multiple myeloma	NDA	$128.4B

Prices and market caps via Polygon, September 25, 2026 close.

1. Cullinan (CGEM) at $14.81, $953M: the cleanest binary on the board

Cullinan is the cleanest risk-reward trade on the 2027 calendar: a sub-$1 billion company with one asset, one NDA, and one decision that either doubles the stock or cuts it in half. Zipalertinib (CLN-081) is an oral EGFR inhibitor for exon 20 insertion NSCLC, the 1 to 2 percent of lung cancers that standard EGFR drugs cannot reach. The Phase 2b REZILIENT1 trial posted a 40 percent confirmed ORR (95% CI 31.3 to 49.1) in the primary platinum-only cohort, with a 31.3 percent intracranial response rate by RANO-BM and mostly dermatologic toxicity. It has held Breakthrough Therapy designation since 2021. The full data set is in the zipalertinib NDA analysis.

The risk has a name: Exkivity. Takeda won a single-arm, response-rate accelerated approval for mobocertinib in this exact indication in 2021, then had it pulled in 2023 when the confirmatory trial failed. The FDA has tightened its posture on single-arm oncology approvals since, and the 14 percent ORR in the subgroup with prior amivantamab plus prior TKI is the number the agency will scrutinize hardest. The 40 percent ORR plus the Breakthrough Therapy designation is the case for approval, but the 30 to 60 percent downside on a complete response letter is real. Size it like the binary it is, and understand you are paying $953M for a coin flip on a single-arm dataset.

2. Pharvaris (PHVS) at $32.02, $2.25B: the approval is priced, the launch is not

Deucrictibant would be the first oral on-demand treatment for hereditary angioedema, replacing injectable rescue drugs (Firazyr, Berinert, Kalbitor) with a capsule a patient takes the moment an attack starts. The NDA rests on RAPIDe-3, a placebo-controlled Phase 3 that met its primary endpoint and all 11 secondary endpoints, with a median time to onset of symptom relief of 1.28 hours. It carries Priority Review with an April 23 date. The RAPIDe-3 trial and the deucrictibant NDA coverage have the endpoint detail.

Approval probability is high, and the stock already reflects it. The actual trade is launch execution: Pharvaris has no commercial infrastructure and is building it from scratch against entrenched injectables with years of real-world safety data. At $2.25B, PHVS prices the approval and leaves the execution risk for the buyer. The re-rate happens only if the launch converts, and the extended-release prophylaxis formulation is the real upside. This is a Hold into the PDUFA, not a buy.

3. Immunome (IMNM) at $22.58, $2.56B: the first approval in desmoid tumors

Varegacestat is an oral, once-daily gamma-secretase inhibitor for progressing desmoid tumors, an aggressive non-metastatic soft-tissue tumor with roughly 1,000 to 1,650 US diagnoses a year and no FDA-approved therapy. The RINGSIDE Phase 3 (n=156) met its primary endpoint with an 84 percent reduction in the risk of progression or death (hazard ratio 0.16) and a 56 percent confirmed objective response rate versus 9 percent on placebo. At $2.56B, the April 28 decision is a genuine binary. The catch is tolerability - 82 percent diarrhea - plus a gamma-secretase class history of Notch-mediated toxicity from the Alzheimer’s failures. The varegacestat NDA coverage has the full trial data.

4. Axsome (AXSM) at $195.09, $10.22B: first cataplexy label, crowded shelf

AXS-12 (reboxetine) would be the first therapy specifically approved for cataplexy, the sudden loss of muscle tone that hits roughly 70 percent of narcolepsy type 1 patients. Two Phase 3 trials met their endpoints and the FDA scheduled no advisory committee, a signal of a clean review. In ENCORE, weekly cataplexy attacks rose 10.29 on placebo versus 1.32 on drug (p=0.017); in SYMPHONY, AXS-12 cut weekly attacks 83 percent versus 66 percent, with 33 percent complete remission versus 9.5 percent. The AXS-12 PDUFA analysis breaks down the math.

The problem is the competitive clock, and it has a name: Takeda’s oveporexton. The orexin receptor agonist posted greater than 80 percent cataplexy reduction in Phase 3, targets the underlying orexin deficiency, and carries a Q3 2026 PDUFA. It could be on the market six months before AXS-12. At $10.22B, Axsome is the most expensive of the four names and carries the smallest percentage move on approval. The catalyst is real, but the launch will fight for share in a compact specialist market where first-mover advantage usually holds.

5. BioMarin (BMRN) at $60.26, $11.66B: a label conversion, not a launch

This is not a new approval. Voxzogo is already on the market and earning more than $700 million a year. The February 28 sNDA converts the achondroplasia indication from accelerated approval to full approval, fulfilling the postmarketing requirement with long-term data from three ongoing studies. The downside is capped because the franchise is already real; the upside is removing the “continued approval contingent on confirmatory data” overhang and locking the label in permanently. The Voxzogo sNDA primer has the mechanism and the competitive threat (BridgeBio infigratinib, Ascendis TransCon CNP).

BioMarin is the lowest-risk and lowest-reward entry of the four. If you own it, the conversion is a modest positive. If you do not, this is not the catalyst that makes you buy an $11.66B rare disease name.

The ghosts: two dates that are not trades

NUVB IBTROZI (Jan 4) is already done. The FDA approved the supplemental NDA on September 16, 2026, nearly four months ahead of its January 4 PDUFA, and the framing was never a first-line expansion. The sNDA updated the label with longer follow-up duration-of-response data: a median DOR of 49.7 months in TRUST-I TKI-naive patients, the longest reported for any ROS1 inhibitor. Nuvation’s announcement confirms it. Cross the January 4 date off; there is nothing to trade. The IBTROZI sNDA primer stands as the historical record.

NCX-470 (Apr 30) has no investable US ticker. The drug, a nitric oxide-donating bimatoprost eye drop for glaucoma, is real and the April 30 PDUFA is real, but the US rights sit with Kowa, a private Japanese pharma, and the sponsor Nicox trades on Euronext Growth Paris as ALCOX. There is no way for a US investor to buy the catalyst. Note it, then move on.

The small speculative and the mega-cap noise

ORGO’s ReNu (Apr 24) is a cryopreserved amniotic allograft for knee osteoarthritis pain, backed by three randomized trials in more than 1,300 patients and an RMAT designation. At $181M it is a genuine small-cap lottery ticket, but it is a regenerative biologic with reimbursement risk and thin liquidity. Only the most aggressive accounts should touch it.

BMY’s mezigdomide (May 13) is a real drug with a real PDUFA and a 52 percent reduction in the risk of progression or death in SUCCESSOR-2. It is also the second CELMoD from a $128.4B company, immaterial to the stock. The May 13 decision is a pipeline signal, not a stock mover. The MeziKd analysis has the data for the completists.

The verdict

Rank the five investable binaries by risk-reward and the order is CGEM, PHVS, IMNM, AXSM, BMRN. CGEM has the most upside and the most downside, the textbook single-asset micro-cap binary. PHVS has the highest approval odds but the launch risk. IMNM has the strongest data on the calendar - an 84 percent risk reduction in a disease with zero approved options - but the smallest commercial footprint and an unproven launch model. AXSM has the cleanest review but the most expensive valuation and a competitive clock. BMRN has the lowest risk and the lowest reward, a conversion on a drug already earning $700M.

The 90-day pre-PDUFA positioning window for the late-February pair (CGEM, BMRN) opens in late November, but the sizing decision happens now. Buy CGEM before the year-end crowd piles into the most obvious binary on the board, treat PHVS as a Hold into the April date, and watch AXSM and BMRN as calendars to monitor rather than a menu to buy. For the full ranked picture across every 2027 catalyst, see the Q1 2027 catalyst ranking.