Q1 Earnings Wire

Tuesday May 12, 2026 AM

8 beats, 5 misses, 1 met. Tape sets up around LEGN reaction, ophthalmic gene therapy on IRD, and the ER+ breast cancer KAT6 lane.

Beats

PMVP, Beat 12.82 percent, PMV Pharmaceuticals Rezatapopt small-molecule p53 Y220C reactivator, tumor-agnostic precision oncology. PYNNACLE registrational Phase 2 trial in advanced solid tumors harboring TP53 Y220C mutation, enrollment continuing, focus remains on the ovarian cancer cohort in platinum-resistant or refractory disease. NDA submission targeted for Q1 2027 ovarian indication. No new interim efficacy or safety data disclosed today, prior Phase 2 interim ORR updates of 34 percent overall and 46 percent in ovarian were from 2025. Orphan Drug Designation in place. Earlier NEJM publication of Phase 1 data. Cash position and burn rate support continued execution.

OLMA, Beat 3.70 percent, Olema Oncology Palazestrant CERAN/SERD in two Phase 3 trials for ER+/HER2- breast cancer. OPERA-01 monotherapy 2L/3L top-line data expected fall 2026, OPERA-02 combo with ribociclib 1L enrollment ongoing. Additional Phase 1b/2 combos with CDK4/6i and alpelisib advancing. OP-3136 oral KAT6 Phase 1 enrolling, initial clinical data poster at ASCO 2026, preclinical synergy with palazestrant shown at AACR 2026. Cash $505M. ER+ SERD class consolidating fast on the back of Pfizer/Arvinas, AstraZeneca/Eccogen, and Menarini/Stemline activity.

SGMT, Beat 8.33 percent, Sagimet Biosciences Denifanstat FASN inhibitor. Positive long-term safety data from partner’s Phase 3 acne trial in China. US Phase 3 acne planned 2H 2026. TVB-3567 next-gen FASN Phase 1 ongoing. Cash $104M as of late Q1 update. Ascletis China deal sets the partnership template, US derm launch is the value inflection.

PRLD, Beat 51.85 percent, Prelude Therapeutics PRT12396 mutant-selective JAK2V617F inhibitor IND cleared Feb 2026, Phase 1 enrolling in polycythemia vera and myelofibrosis under the Incyte option deal. PRT13722 selective oral KAT6A degrader for ER+ breast cancer, IND filing mid-2026, Phase 1 start 2H 2026, AACR 2026 preclinical data highlighted differentiated profile. DAC platform and mCALR program preclinical expansion ongoing. Cash runway extended into Q2 2028 after $90M offering. Incyte built-in option is the embedded M&A trigger, KAT6 lane overlaps OLMA OP-3136.

TENX, Beat 12.50 percent, Tenax Therapeutics Levosimendan PH-HFpEF Phase 3 setup. PH lane was hot Monday with LQDA into BofA.

LEGN, Beat 78.57 percent, Legend Biotech CARVYKTI commercial BCMA CAR-T preliminary Q1 net trade sales approximately $597M, up 95 percent sequential from $306M Q4. Early pipeline in vivo CAR-T programs in blood cancers, solid tumors, autoimmune with first patients dosed. 1 to 2 US INDs planned by year-end, first clinical data mid-2026. New R&D and manufacturing facilities opened. Janssen partnership remains the commercial engine. Cash and time deposits $949M.

CCCC, Beat 20.0 percent, C4 Therapeutics Cemsidomide IKZF1/3 degrader Phase 2 MOMENTUM trial 4L+ multiple myeloma enrollment completion expected Q1 2027. Phase 1b combo with elranatamab initiation Q2 2026. DAC platform expanding with preclinical data vs traditional ADCs.

ARVN, Beat 6.25 percent, Arvinas Vepdegestrant PROTAC ER degrader commercialization, first approved PROTAC for breast cancer. Broader PROTAC pipeline advancing. No new specific trial readouts in preliminary commentary. Pfizer partnership economics drive the model. First commercial PROTAC is a unique strategic asset.

ABOS, Beat 32.65 percent, Acumen Pharmaceuticals Earnings focused primarily on financials and cash runway. Sabirnetug oligomer-specific anti-Aβ antibody ALTITUDE-AD Phase 2 the spine. AD space hot but crowded with Lilly Kisunla and Eisai Leqembi. Oligomer differentiation thesis needs Phase 2 readout to prove out, 2027 window.

Misses

UNCY, Miss 10.20 percent, Unicycive Therapeutics Oxylanthanum carbonate OLC NDA resubmission accepted PDUFA June 29, 2026. Commercial launch preparations underway for potential Q3 2026 approval in hyperphosphatemia in CKD dialysis patients. UNI-494 AKI/CKD remains in early development. Cash runway into 2027. Headline miss does not matter, the PDUFA is the entire story.

IMTX, Miss 19.05 percent, Immatics TCR platform. Earnings focused primarily on financials, no new INDs, data, or regulatory milestones called out. BofA Vegas multi-day, ASGCT Boston, PEGS Boston this week, the conference stack is the catalyst not the print. PRAME remains a hot target.

OVID, Miss 9.09 percent, Ovid Therapeutics Earnings focused on financials. OV329 GABAAT epilepsy lead. General regulatory submission planning noted, no fresh catalysts called out.

SION, Miss 17.65 percent, Sionna Therapeutics Earnings focused primarily on financials, standard language on ongoing early-stage programs. CF dual mechanism correctors and modulators. Recent IPO. Vertex CF dominance is the wall, but the multi-asset platform with differentiated mechanism makes this a long-tail watch.

IRD, Miss 435.71 percent, Opus Genetics Mathematical noise on a tiny EPS denominator. The print is the pipeline detail.

OPGx-LCA5 positive 6-month pediatric data with approximately 1.5 log unit cone sensitivity gains, FDA accepted into RDEP program, pivotal Phase 3 dosing Q4 2026. OPGx-BEST1 Phase 1/2 Cohort 1 enrollment complete, 3-month topline data September 2026. OPGx-RDH12 clinic entry Q4 2026, externally funded. OPGx-MERTK clinical activities underway, consortium funded. OPGx-RHO preclinical large-animal data supportive, clinic entry 2027.

Cash plus financing approximately $90M, runway into 2029. R&D Science Forum June 16, 2026. The Phase 3 LCA5 dosing trigger plus BEST1 readout in September are the near-term value events. Ophthalmic gene therapy is one of the hottest M&A verticals.

CNTB, Connect Biopharma, Q1 update Rademikibart IL-4Ralpha antibody. Phase 2 Seabreeze STAT asthma and COPD studies for acute exacerbations continuing per DMC interim review, no sample size change, no safety concerns. Topline data from both studies expected mid-2026, FDA Phase 3 alignment meeting to follow. No biologics currently approved or in development for acute exacerbations in either indication, the strategic moat. March Phase 1 IV pharmacology study showed single dose improved FEV1 within 15 minutes maintained up to four weeks, supports differentiated hospital channel. Simcere China Phase 3 atopic dermatitis hit all endpoints through 52 weeks with near maximal response in approximately 90 percent of patients, AAD 2026 Late-Breaking, validates the target. Cash $46.0M, runway into 2H 2027, $20.2M PIPE closed March 31 led by Panacea Venture. Simcere milestones up to approximately $110M plus tiered royalties intact.

Met

PRQR, Met at minus $0.15 per share, ProQR Therapeutics Axiomer RNA-editing platform AX-0810 lead. CTA filing on track for Q2 2026 targeting NTCP for cholestatic liver diseases. First healthy volunteer data expected Q4 2026. Broader liver and CNS programs advancing under the Eli Lilly partnership.

Summary takeaways

Best print of the morning is LEGN on the substance. $597M CARVYKTI Q1, up 95 percent sequential, is the kind of franchise inflection that resets the model.

IRD is the second tell. The 435.71 percent miss is meaningless. The actual print is the pipeline detail, with LCA5 6-month pediatric data positive, RDEP designation, Phase 3 dosing teed up Q4 2026, plus BEST1 readout in September. Five programs forward over 18 months on a $90M cash base with runway into 2029.

PRLD beat 51.85 percent on a meaningful base. The Incyte option on JAK2V617F is a built-in M&A trigger, KAT6 IND mid-2026, cash to Q2 2028. The PRLD KAT6 lane and OLMA OP-3136 lane both pulling KAT6 inhibitor science into ER+ breast cancer at the same moment is worth tracking as a cross-read.

OLMA palazestrant fall 2026 OPERA-01 readout is the SERD class catalyst that matters. $505M cash funds the entire program through readout and launch prep.

UNCY June 29 PDUFA is the M&A window opener, watch the approval reaction not the earnings miss.

ARVN is in the awkward middle of beating earnings while the stock fades, vepdegestrant commercial ramp visibility is the question Pfizer’s commentary will answer.

IMTX miss is irrelevant to the week, the conference stack at BofA, ASGCT, and PEGS is where the story moves.

Holdouts on the score book are PRQR met with Lilly partnership economics, plus the four financial-only prints SGMT, OVID, SION, ABOS where the underlying pipeline is the only thesis driver.

The KAT6 cross-read between OLMA and PRLD, the ER+ breast cancer SERD/PROTAC/CERAN consolidation continuing to play out, ophthalmic gene therapy on IRD, and cell therapy at the conference on LEGN and IMTX are the four threads worth following into BofA Day 1.